The history of madness is a litany of cruel failure. In Bedlam patients were shackled to the wall by iron cuffs and treated by shaking the body tissues in a gyrating chair or taking "the bath of surprise". The patient would walk a plank in which a hole was cleverly concealed. One step too far and, splash, the lunatic fell into the freezing cold water. This was less an episode of madness and more an episode of It's a Knockout.
In the 1930s the men in white coats got in on the act. First, schizophrenics had insulin injected into their bodies. When that didn't work, they had electric currents passed through their heads. The failure of electroconvulsive therapy led, by 1935, to the lobotomy. With the patient shocked into a coma, a surgeon would smash a sort of icepick through the top of each eye socket, severing the nerves that connect the frontal lobes to the part of the brain that controls emotional response. Tens of thousands of patients went through this gruesome charade which, apart from killing a quarter of them, cleared out the madness in the rest by clearing out the personality. Even the personalities who didn't die, died.
Since then, we have prescribed drugs. First sedatives such as barbiturates, then palliatives such as lithium and valium. Even when they calm the everyday anger the drugs have no impact on the underlying condition. For lots of people, they are a slow lobotomy. There are so many stories, all inexpressibly sad, about how the main effect of drugs supposed to mask psychosis was to take away the creative impulse.
The 20th century has been an era of remarkable medical progress. But schizophrenics can still expect to live 20 years less than the national average. Schizophrenia is the most common cause of a long stay in hospital. Mental illness is more common and more costly than cancer, yet attracts a fraction of the research, money or sympathy.
It is obvious that something is going very wrong with how this country cares for its mentally ill. Just how wrong is set out in Doctoring the Mind, by the clinical psychologist Richard Bentall. He assessed the success rate of drug-based psychiatry in treating serious psychoses and found it was not much better than the old astrologers and apothecaries.
Dr Bentall cites a World Health Organisation study from the late 1960s into schizophrenia in both poor and rich nations. The researchers found schizophrenics everywhere. But, five years later, when the results came in, it turned out that schizophrenics in poor countries were doing a lot better than those in rich countries. In poorer parts of the world, more than a quarter of patients suffered just a single episode and made a complete recovery. In the richer nations, only 7 per cent recovered. This was so striking that the WHO didn't believe it. So it did the study again, only bigger, in the 1980s. This time around, 16 per cent of patients in rich countries made a complete recovery. In the developing world, 37 per cent of the people named as schizophrenics threw off the label.
Therefore schizophrenia is not a lifetime's fate. It is something from which people can come round. So we urgently need to know - and this will be one task for Rethink's commission - why we are so bad at achieving it. There is not a single physical condition in which recovery in the developed world trails the developing world, but it does in mental illness. It's an astonishing and shaming fact.
This awful record probably has something to do with how have turned mental health into a system. There is nothing technical about a lot of mental health services and they would be better provided by former patients and your peers than by doctors and nurses. A patient in need of an operation will want a doctor. But when you're living with voices every day you want someone who knows what it's like.
Don't Try This At Home
In 1984, Professor Barry Marshall swallowed a brew of Helicobacter pylori to test his radical theory that these tiny microbes were the root cause of stomach ulcers. His rapid development of bad breath, vomiting and exhaustion proved the drastic experiment a success, and silenced his sceptical peers. Since then, the discovery has saved an estimated 500,000 lives a year and scooped Marshall a Nobel Prize in 2005, as he'll describe on Friday at The Times Cheltenham Science Festival.
But making use of a living laboratory is something scientists have been up to for years. Back in the late 1790s, the Cornish chemist Sir Humphry Davy began probing the effects of nitrous oxide on the human body. His body, as it happens. Without knowing whether the gas was toxic, he took in several lungfuls, becoming giddy with happiness. This 'laughing gas' was so potent that later experiments at the Pneumatic Institution of Bristol were reported to have converted the laboratory into the region of hilarity and relaxation. But the research wasn't all a giggle: nitrous oxide was also found to be a useful anaesthetic.
Long before Davy discovered this novel way to relax, the Italian physician Santorio Santorio had already perfected the art of leading a balanced life. For 30 years, he spent large amounts of time on an enormous set of scales, weighing his body, his food - and his excretions. He found that what went into his body didn't weigh the same as what came out, concluding in 1614 that a large amount of weight is lost in 'insensible perspiration', the evaporation of water from the skin and lungs that we now know is linked to metabolism.
Understanding optics, however, was the task weighing on the mind of Isaac Newton in the 1660s when he began poking a needle-like object between his eye and the bone of his socket. By waggling it about he produced all sorts of optical effects that he dutifully noted down, helping him to investigate the nature of colour. And if that makes you feel squeamish then brace yourself, as Professor Kevin Warwick's self-experiments called for some serious surgery. You may think cyborgs from films such as The Matrix and I, Robot are a bit far-fetched, but Warwick's research turned him into the first part-human, part-machine.
After instructing doctors to implant a silicon chip into his arm in 1998, the cyborg professor was able to open doors and operate lights without touching a single switch. The experiments didn't stop there. In 2002 he received a high-tech implant that effectively plugged his nervous system into a computer, allowing him to control a robotic arm with his brain. Pushing the boundaries even farther, his wife Irena also received an implant, allowing their nervous systems to be hooked up through a computer so that when Irena opened and closed her hand, Warwick felt electronic pulses.
Luckily these scientists undertook their experiments in controlled conditions, under the supervision of their colleagues, so don't be tempted to try anything similar at home. But in risking life and limb to advance research, healthcare and technology, these brave pioneers form an elite band of scientists: the human guinea pigs.
Human bodies contain 10 percent human cells and 90 percent microbes, so why not target both of them?
Almost 100 studies on a revolutionary approach to developing new medicines and treatments to target both the human and non-human components of people is reviewed in ACS' Journal of Proteome Research.
Liping Zhao, Jeremy K. Nicholson and colleagues explain that human beings have been called "superorganisms" because their bodies contain 10 percent human cells and 90 percent microbes, which live mainly in the intestines.
Scientists thus are viewing people as vast ecosystems in which human, bacterial, fungal and other cells interact with each another. Microbes, for instance, release substances that determine whether human genes turn on or off and influence the immune system's defenses against disease. And populations of microbes in the body change with changes in diet, medications and other factors.
"This superorganism view of the human body provides a complete new systems concept for managing human health at the clinically relevant whole body level," say the authors. They term it "one of the most significant paradigm shifts in modern medicine."
The article describes how this revolutionary change is fostering emergence of an approach called 'functional metagenomics' for developing new medicines. It opens the possibility of sustaining health and treating disease with medicines and other substances that target non-human cells in the body. The article notes that many substances in traditional Chinese medicines may work in that way.
"There is widespread and increasing international interest in understanding the properties of traditional Chinese medicines (TCMs) for their potential utilization as a source of new drugs for Western markets," the article notes. "Emerging evidence indicates that most TCM drugs are actually targeting both the host and its symbiotic microbes."
The review explores the challenges of and opportunities for harmonizing Eastern-Western drug discovery paradigms by focusing on emergent functions at the whole body level of humans as superorganisms. This could lead to new drug candidate compounds for chronic diseases targeting receptors outside the currently accepted 'druggable genome' and shed light on current high interest issues in Western medicine such as drug-drug and drug-diet-gut microbial interactions that will be crucial in the development and delivery of future therapeutic regimes optimized for the individual patient."
The Nocebo Effect
What if taking an absolutely harmless substance could make you sick? What if a sugar pill caused you to feel nausea, or a fake dose of lactose triggered unwelcome stomach symptoms in patients who are lactose intolerant?
The strange truth about medicine and the brain is that they often interact in completely unpredictable and counterintuitive ways. Nowhere is this more true than with the bewildering phenomenon known as the nocebo effect.
Most of us already know about the placebo effect. As part of medical studies, a control group is typically given an inert substance (usually a sugar pill) that provides a baseline to which researchers can compare the effectiveness of the new medicine being tested. The members of this group are told that the placebo is real - and surprisingly, they sometimes experience an actual improvement in their symptoms, simply because they expect that the medicine will make them feel better.
An opposite tendency - and one that has been largely overlooked by the research community - is the nocebo effect. Put simply, it is the phenomenon in which inert substances or mere suggestions of substances actually bring about negative effects in a patient or research participant. For some, being informed of a pill or procedure's potential side effects is enough to bring on real-life symptoms. Like the placebo effect, it is still poorly understood and thought to be brought about by a combination of Pavlovian conditioning and a reaction to expectations.
Last week, researchers from the Technical University of Munich in Germany published one of the most thorough reviews to date on the nocebo effect. Breaking down 31 empirical studies that involved the phenomenon, they examined the underlying biological mechanisms and the problems it causes for doctors and researchers in clinical practice. Their conclusion: although perplexing, the nocebo effect is surprisingly common and ought to be taken into consideration by medical professionals on an everyday basis.
In many of the experiments they analyzed, the suggestion or expectation of pain brought about significant increases in the amount of negative side effects experienced by participants. For example, in one study, 50 people who suffered from chronic back pain were given a flexibility test. Half were told beforehand that the test might cause some pain, while the others were not. Afterward, the first group reported a significantly higher amount of pain, despite enduring the exact same procedure.
In another experiment, the drug finasteride was administered to help relieve symptoms of prostate disease, and half the participants were told that it could cause erectile dysfunction, while the other half was kept in the dark. Forty-four percent of the first group reported that they'd experienced ED, compared with just 15 percent of the uninformed group.
The nocebo effect might even be powerful enough to kill. In one case study, researchers noted an individual who attempted to commit suicide by swallowing 26 pills. Although they were merely placebo tablets without a biological mechanism to harm the patient even at such a high dose, he experienced dangerously low blood pressure and required injections of fluids to be stabilized, based solely on the belief that the overdose of tablets would be deadly. After it was revealed that they were sugar pills, the symptoms went away quickly.
The researchers suggest that doctors reconsider conventional beliefs about pain management to avoid magnifying painful side effects. It's commonly thought that properly preparing a patient for pain - for example, 'this might hurt quite a bit' - is the best way to minimize anxiety, so the patient knows what to expect. But one experiment analyzed showed that the very words used by a doctor before injecting radiographic substances affected the amount of pain experienced. The more frequently the words sting, burn, hurt, bad and pain were said, the more discomfort felt by patients.
Of course, trying to avoid this sort of scenario puts a doctor in an ethical dilemma - limiting the patient's discomfort could be at odds with keeping them informed about the procedure. To navigate this tension, the study's authors advise doctors to emphasize positives (re-framing warnings into phrases such as 'the majority of patients tolerate this well') and, in some cases, actually getting permission from patients to keep them in the dark about certain mild side effects.
Figuring out how to handle patients' fears and anxieties, it turns out, can be just as difficult as fighting real diseases and infections. The surprising conclusion you might come to after learning about the nocebo effect? What you don't know can't hurt you.
Apps to Crowd Source Medical Help
AUTOMATIC external defibrillators (AEDs) are a common sight in America, where many states now require them at fitness centres, schools or airports. These devices deliver potentially life-saving electric shocks to victims of sudden cardiac arrest, a condition that claims 300,000 American lives each year, more than AIDS and lung, breast and prostate cancers combined.
AEDs have the best chance of working if action is taken promptly in the event of an emergency. The probability of survival decreases by 10% for every minute of hesitation, and by 5% even if cardiopulmonary resuscitation, better known as CPR, is performed. But even though America is home to over 1.5m public AEDs, they are used in fewer than one in twenty sudden cardiac arrests that occur outside hospitals. In many cases, there are no AEDs in the immediate vicinity. Often, though, bystanders either do not realise that somebody is experiencing a cardiac arrest, cannot find an AED, or do not know they should be looking for one. Partly as a result, the survival rate for such incidents is the same today as it was two decades ago: a shocking 8%. By the time trained paramedics, with their own AEDs, arrive on the scene, most victims are irredeemably deceased.
Now a small fire department in California is tackling all three problems with a smartphone app which relies on the idea of crowdsourcing. When someone reports a sudden cardiac arrest in the San Ramon Valley, 30 miles (48 km) north of San Jose, the fire department immediately dispatches an ambulance. It simultaneously sends out an alert to users of its iPhone app, showing directions on a digital map to both the victim and the nearest public AED. The app uses geo-location to alert only those people within 500 feet (160 metres) of the incident—in other words, those who may be able to get to the sufferer those crucial minutes ahead of the paramedics.
The system went live this summer and already has 40,000 active users. So far it has been activated just once, after someone exercising at a local gym collapsed. Eight citizens were alerted, two responded and a nearby AED was put into action. The patient survived. The app, which was developed entirely using local taxpayer's money and is free to download, has since attracted wider attention. The cities of San Jose and San Francisco are now planning trials of the technology, as is the state of Arizona. New Zealand is hoping to be the first country to deploy it nationwide.
Of course, such apps are only as good as the AED databases they rely on. California requires owners of public AEDs to register their devices but other states do not. Even in the Golden State, though, not all organisations comply. Moreover, few emergency services will have sufficient resources to check that all public AEDs are accessible, in good condition and ready for use.
Raina Merchant, of the University of Pennsylvania, believes that crowdsourced Good Samaritans can help here, too. She is about to launch a project that uses another smartphone app to plot the locations of Philadelphia's public AEDs. The app, called MyHeartMap Challenge, encourages people to take geo-tagged pictures of public AEDs in their neighbourhood and note details such as their colour and manufacturer. Philadelphia may be Greek for "brotherly love", but Dr Merchant is not counting solely on its citizen's warm-hearted do-goodery. The individuals and teams who capture the most devices during the Challenge this winter will earn cash prizes of up to several thousand dollars.
Diagnostic Help
More than a year after it won the quiz show Jeopardy!, IBM's supercomputer is learning how to help doctors diagnose patients.
IT IS more than a year since Watson, IBM's famous supercomputer, opened a new frontier for artificial intelligence by beating human champions of the quiz show Jeopardy!. Now Watson is learning to use its language skills to help doctors diagnose patients.
Progress is most advanced in cancer care, where IBM is working with several US hospitals to build a virtual physicians' assistant. "It's a machine that can read everything and forget nothing," says Larry Norton, a doctor at the Memorial Sloan-Kettering Cancer Center in New York, who is collaborating with IBM.
When playing Jeopardy!, Watson analysed each question in a bid to guess what it was about. Then it looked for possible answers in its database, made up of sources such as encyclopaedias, scoring each according to the evidence associated with it and answering with the highest rated answer. The system takes a similar approach when dealing with medical questions, although in this case it draws on information from medical journals and clinical guidelines.
To test the system, Watson was first tasked with answering questions taken from Doctor's Dilemma, a competition for trainee doctors that takes place at the annual meeting of the American College of Physicians. Watson was given 188 questions that it had not seen before and achieved around 50 per cent accuracy - not bad for an early test, but hardly ideal (Artificial Intelligence, doi.org/h6m).
To improve, Watson is now absorbing records - tens of thousands at Sloan-Kettering alone - of treatments and outcomes associated with individual patients. Given data on a new patient, Watson looks for information on those with similar symptoms, as well as the treatments that have been the most successful. The idea is it will give doctors a range of possible diagnoses and treatment options, each with an associated level of confidence. The result will be a system that its creators say can suggest nuanced treatment plans that take into account factors like drug interactions and a patient's medical history.
William Audeh, a doctor at Cedars-Sinai Medical Center in Los Angeles, who is working with IBM, says the last few months have involved "filling Watson's brain" with medical data. Watson is answering basic questions based on the treatment guidelines that are published by medical societies and is showing "very positive" results, he adds.
The technology is particularly useful in oncology because doctors struggle to keep up with the explosion of genomic and molecular data generated about each cancer type. This means it can take years for findings to translate into medical practice. By contrast, Watson can absorb new results and relay them to doctors quickly, together with an estimate of their potential usefulness. "Watson really has great potential," says Audeh. "Cancer needs it most because it's becoming so complicated so quickly."
The IBM system could also approve treatment requests more quickly. At WellPoint, one of the largest insurers in the US, nurses use guidelines and patient history to determine if a request is in line with company policy. Nurses are now training Watson by feeding it test requests and observing the answers. Progress is good and the system could be deployed next year, says WellPoint's Cindy Wakefield. "Now it can take up to a couple of days," she says. "We hope Watson can return the accurate recommendation in a matter of minutes."
Judging Research
Doctors use different standards to judge scientific research depending on who funded it. They judge research funded by industry as less rigorous, have less confidence in the results, and are less likely to prescribe new drugs than when the funding source is either the NIH or unknown - even when the apparent quality of the research is the same.
Those were the results of a study published by Harvard researchers Dr. Aaron Kesselheim and colleagues in the New England Journal of Medicine last month. The story has received a fair amount of coverage since then, including being analyzed by the Scientific American Guest Blog, the Los Angeles Times, and the New York Times.
There's a question of ethical and practical relevance embedded in this: is it justifiable to judge a paper by its author or funding source - even when you cannot discern a difference in quality?
The perspective from much of the medical side seems to be a definite yes. The divide between doctors and Big Pharma is nothing new. Pharma has a bad reputation in the medical community, and there is history to back it. One of the most well-known scandals involved Vioxx being taken off the market in 2004 after Merck admitted it withheld information about known adverse risk of heart disease, resulting in tens of thousands of deaths. In 2008, physician and former Editor in Chief of the New England Journal of Medicine Marcia Angell wrote, "Bias in the way industry-sponsored research is conducted and reported is not unusual and by no means limited to Merck." In 2011, Harriet Washington published a piece in The American Scholar highlighting some of the ways industry has misled and manipulated data, which include: comparing a new drug against a placebo rather than against another treatment option, comparing drugs to competitors in wrong dosages, pairing a drug with one known to work well, ending a trial prematurely when they see "clues that the trial is going south," and cherry-picking only positive findings to report. This type of behavior can and should be called out as scientific misconduct, and those who commit it must be held accountable.
But if there's something just a bit unsavory about judging a paper solely by who wrote it, there's good reason for it. The scientific world prides itself on judging content of ideas, not presumed integrity of authors. It's the rationale behind the widespread practice of research journals blinding reviewers of authors' names. Using any criteria other than quality in scientific evaluation is admittedly a kind of bias - something we are usually quite wary of in science. As the authors of the study succinctly put it, "The methodologic rigor of a trial, not its funding disclosure, should be a primary determinant of its credibility." Moreover, if we're comfortable using authorship as a proxy for quality, it's not an absurd leap to start extending that approach to authors outside of industry. It's not uncommon to hear accusations of industry bias because of self-interest in financial gain; but imagine if we started hearing sweeping accusations that young researchers, for example, should be trusted less because of their self-interest in trying to advance their careers. Industry is not alone in being capable of bias. The problem of publishing only positive results, for instance, is a recognized problem that has been discussed in the scientific community at large for years.
There are also practical concerns of being overly dismissive of industry. Amidst the history of manipulation and fraud, there are medical contributions too. In the New York Times, surgeon and author Pauline Chen cited data showing that industry was responsible for nearly 60 percent of the more than $100 billion spent on research in 2007. Using authorship ties as a proxy for quality means possibly overlooking research of potential value for patients.
So why not just use quality, removing the need to probe into researchers' background, affiliations, and motivations? Unfortunately, letting the data speak for themselves is not always possible. The low quality parts could be found in what does not make it to print. In the list of misconduct Washington's article described, ending a trial prematurely and failing to report negative results are forms of misconduct that would not be transparent from a paper alone. Similarly, failing to report side effects, as in the Vioxx scandal, is another way relevant data can be hidden. That's conscious and explicit manipulation, but there's evidence for unconscious manipulation too. Numerous studies have found that the 'funding bias,' in which conclusions of research are more likely to agree with the sponsor's aims, is a real phenomenon. While unconscious bias is again not unique to industry, there's something to be said for awareness of the trend where it has been clearly tracked.
At the end of all this, we are left with two competing facts: 1) Industry sometimes produces valuable research that contributes to patient care. 2) There is also a significant history of manipulation. Is it possible to reconcile these two facts, in a way that is both vigilant against misconduct but also doesn't pass over potentially valuable findings?
I think the last point about quality not always being transparent is the critical fact. Given that it's entirely scientifically feasible for a study that appears to be of good quality to actually be flawed, holding research conducted by authors with a dubious history seems justifiable. Should you dismiss industry across the board? Probably not. I think the authors' caution against the dangers of excessive skepticism is sensible. I also agree that more fundamental strategies such as increased protocol and data transparency will make the whole process of determining quality easier. But as it stands, those doctors in the study voicing skepticism about the conclusions of industry sponsored research is understandable. As it goes, a critical eye and looking to others to replicate findings before you embrace new conclusions is probably a good approach to research in general, no matter who the initial authors are.
Finding Zebras
Scientists have created a powerful new search engine designed to diagnose rare diseases, believing the tool could save many lives among the millions who suffer from unusual ailments.
Danish researchers have unveiled a free site called FindZebra in an effort to give doctors a new weapon to deal with tricky medical cases.
The creators, a team of computer programmers and medical professionals based in Copenhagen, said that they were inspired to create the product because young doctors when confronted with difficult medical cases, currently often resort to searching Google.
Inexperienced medics do this because they are familiar with using the world's leading search engine and are often seeking quick results. Many type a patient's symptoms into Google and examine the suggested list of potential diseases.
But Google is not optimised for medical use and is especially unsuited to the task of spotting rare diseases, which do not have a high presence on the web. It is also difficult to choose between helpful links and those from irrelevant sources.
FindZebra, however, is designed to look through a selected set of curated databases on rare diseases, meaning a process that might take hours if done manually instead takes the search engine a few seconds.
The researchers said that their bespoke search engine returns significantly better answers than Google. When symptoms were entered into FindZebra, it was able to named the correct rare disease 67 per cent of the time, within the first 20 results obtained. This is compared to 32 per cent within Google searches.
Ragu Dragusin, the lead developer for the project from the Technical University of Denmark, said the search engine got its name because medical students are told to concentrate on prevalent diseases and disregard exotic ones. They are taught to remember the phrase: "When you hear hoofbeats behind you, don't expect to see a zebra."
Today, doctors are known to use the term 'zebra' to describe a rare disease, usually defined as one that occurs in less than 1 in 2,000 of the population.
The hope is that FindZebra, which remains a research initiative that requires more funding, can be improved to become a valuable tool to help save millions of lives.
According to European Organisation for Rare Diseases (EURORDIS), there are around 30 million people suffering from rare diseases in Europe alone; 40 per cent are either misdiagnosed before the correct diagnosis is made, or receive no diagnosis. More troubling is that 25 per cent of Europeans suffering from rare diseases have to wait between five and 30 years before the final correct diagnosis is made.
In one example, the researchers entered: "Boy, normal birth, deformity of both big toes (missing joint), quick development of bone tumor near spine and osteogenesis at biopsy" into their special search engine.
As its first result, FindZebra returned the correct diagnosis "Fibrodysplasia ossificans progressiva" - a disease known as Stone Man Syndrome, because the body responds to damage to muscle tissue by turning it into bone. However, this diagnosis does not appear in the results from a Google search whatsoever.
Though the site may be a boon for doctors, the general public are warned to steer clear, with one American commentator suggesting that FindZebra could become a hypochondriac's charter. In recent times, patients have increasingly turned to the internet to gain more information before visiting their doctors.
The site's makers believe that the complicated nature of the results offered mean that ordinary members of the public cannot evaluate the results. The site features a health notice: "Warning! FindZebra is a research project and it is to be used only by medical professionals".
Algorithms Beat Experience
Mathematical prediction models are better than doctors at predicting the outcomes and responses of lung cancer patients to treatment, according to new research presented today (Saturday) at the 2nd Forum of the European Society for Radiotherapy and
These differences apply even after the doctor has seen the patient, which can provide extra information, and knows what the treatment plan and radiation dose will be.
"The number of treatment options available for lung cancer patients are increasing, as well as the amount of information available to the individual patient. It is evident that this will complicate the task of the doctor in the future," said the presenter, Dr Cary Oberije, a postdoctoral researcher at the MAASTRO Clinic, Maastricht University Medical Center, Maastricht, The Netherlands. "If models based on patient, tumour and treatment characteristics already out-perform the doctors, then it is unethical to make treatment decisions based solely on the doctors' opinions. We believe models should be implemented in clinical practice to guide decisions."
Dr Oberije and her colleagues in The Netherlands used mathematical prediction models that had already been tested and published. The models use information from previous patients to create a statistical formula that can be used to predict the probability of outcome and responses to treatment using radiotherapy with or without chemotherapy for future patients.
Having obtained predictions from the mathematical models, the researchers asked experienced radiation oncologists to predict the likelihood of lung cancer patients surviving for two years, or suffering from shortness of breath (dyspnea) and difficulty swallowing (dysphagia) at two points in time:
1) after they had seen the patient for the first time, and
2) after the treatment plan was made. At the first time point, the doctors predicted two-year survival for 121 patients, dyspnea for 139 and dysphagia for 146 patients.
At the second time point, predictions were only available for 35, 39 and 41 patients respectively.
For all three predictions and at both time points, the mathematical models substantially outperformed the doctors' predictions, with the doctors' predictions being little better than those expected by chance.
The researchers plotted the results on a special graph [1] on which the area below the plotted line is used for measuring the accuracy of predictions; 1 represents a perfect prediction, while 0.5 represents predictions that were right in 50% of cases, i.e. the same as chance. They found that the model predictions at the first time point were 0.71 for two-year survival, 0.76 for dyspnea and 0.72 for dysphagia. In contrast, the doctors' predictions were 0.56, 0.59 and 0.52 respectively.
The models had a better positive predictive value (PPV) -- a measure of the proportion of patients who were correctly assessed as being at risk of dying within two years or suffering from dyspnea and dysphagia -- than the doctors. The negative predictive value (NPV) -- a measure of the proportion of patients that would not die within two years or suffer from dyspnea and dysphagia -- was comparable between the models and the doctors.
"This indicates that the models were better at identifying high risk patients that have a very low chance of surviving or a very high chance of developing severe dyspnea or dysphagia," said Dr Oberije.
The researchers say that it is important that further research is carried out into how prediction models can be integrated into standard clinical care. In addition, further improvement of the models by incorporating all the latest advances in areas such as genetics, imaging and other factors, is important. This will make it possible to tailor treatment to the individual patient's biological make-up and tumour type.
"In our opinion, individualised treatment can only succeed if prediction models are used in clinical practice. We have shown that current models already outperform doctors. Therefore, this study can be used as a strong argument in favour of using prediction models and changing current clinical practice," said Dr Oberije.
"Correct prediction of outcomes is important for several reasons," she continued. "First, it offers the possibility to discuss treatment options with patients. If survival chances are very low, some patients might opt for a less aggressive treatment with fewer side-effects and better quality of life. Second, it could be used to assess which patients are eligible for a specific clinical trial. Third, correct predictions make it possible to improve and optimise the treatment. Currently, treatment guidelines are applied to the whole lung cancer population, but we know that some patients are cured while others are not and some patients suffer from severe side-effects while others don't. We know that there are many factors that play a role in the prognosis of patients and prediction models can combine them all."
At present, prediction models are not used as widely as they could be by doctors. Dr Oberije says there are a number of reasons: some models lack clinical credibility; others have not yet been tested; the models need to be available and easy to use by doctors; and many doctors still think that seeing a patient gives them information that cannot be captured in a model. "Our study shows that it is very unlikely that a doctor can outperform a model," she concluded.
Nurses and Technology Are The Future
As the Affordable Care Act continues to fitfully entrench itself in the American political landscape, the pressing issues in health care policy will increasingly switch from financing to supply-side. If we're committed to paying for everyone to have access to health care, we need efficient ways of purchasing lots of health care services. There's a lot that can be done here simply in terms of prices, but technological and organizational innovations should also be on the table. Anna Reisman did a great piece for Slate last week about growing evidence that nurse practitioners can do just as good a job as doctors for a range of health care needs at a lower cost. Most folks were probably too riveted to Boston Marathon bombing news when it came out to focus on it, but in the long run this is the more important story. You should check the map to see if your state is one of the ones that allows nurse practitioners to practice independently. It's hard to predict from general ideological considerations. New York and California are in thrall to the doctors' cartel, but so are Florida and Texas and virtually every Southern state.
This is an issue that I think will only increase in importance thanks to technology. An important study presented last week in Europe appears to show that mathematical models now exist that do better than doctors at predicting treatment outcomes and responses of lung cancer patients. That holds even if the doctor has a full opportunity to examine the patient, while the computer just has basic facts put into the system. Of course this is just one study and one form of cancer, but knowing what we know about digital technology, it seems safe to assume a large amount of progress in this kind of algorithmic diagnosis over the next five to 15 years.
There's a lot of talk lately about the alleged decline of "middle skilled" occupations. But different categories of nursing ought to be a huge source of growth in this field. An aging country is going to demand more health care services. A country that's politically committed to meeting the health care needs of the poor is going to demand more health care services. A wealthier society is going to demand more health care services. And with digital medical technology improving, there's going to be a broader and broader range of health care services that a well-trained nurse can provide without needing the many extra years of expensive medical education required to churn out a doctor. But this bold new world of mid-skilled health care professionals harnessing the power of technology to treat patients is only going to come to pass if states alter their "scope of practice" rules to make it possible.
Mental Imagery and Recovery
Mental imagery might help you 'find a happy place' in more ways than one: it can actually hasten recovery from surgery, according to two recent studies.
In the first study, people who had undergone surgery to repair the anterior cruciate ligament of the knee (ACL) were randomly assigned to one of two groups. All participants received standard rehabilitation during the six months after surgery, but one group also practiced guided imagery while recovering. The imagery, which was conducted in sessions with a therapist and recorded for later listening, included mentally rehearsing physical therapy exercises and visualizing the physiological healing process specific to ACL surgery, such as scar tissue becoming flexible with gentle stretching. According to the results published in the December 2012 issue of the Scandinavian Journal of Medicine and Science in Sports, the group that practiced imagery showed greater improvements in knee stability and reduced levels of stress hormones. The study authors speculate that imagery may speed recovery by reducing stress, which has been shown to interfere with healing.
The other experiment focused on patients scheduled for gallbladder removal and was published in the February 2012 issue of Brain, Behavior, and Immunity. The patients were randomly assigned to either a group receiving only standard care or to one that also involved relaxation and guided imagery for three days before and seven days after surgery. "We used a relaxation intervention to try to reduce stress and therefore get a better inflammatory response to surgery and improve healing," says Elizabeth Broadbent, professor of medicine at the University of Auckland in New Zealand and co-author of the study. The first set of imagery exercises focused on being relaxed and ready for surgery, whereas the postsurgery imagery concentrated on the body's healing process. For example, participants imagined oxygen and nutrients traveling to the surgical wound and helping the body knit the skin back together, easing discomfort and bringing soothing relief.
Compared with the control group, participants who practiced imagery reported a larger reduction in stress, and their wounds showed signs of greater collagen deposition and faster healing. Although it is not possible to determine how much the effects result from the imagery versus simply being relaxed, Broadbent says both factors probably worked together and that the imagery most likely enhanced the stress-reducing effects of the relaxation.
Slow Change
Why do some innovations spread so swiftly and others so slowly? Consider the very different trajectories of surgical anesthesia and antiseptics, both of which were discovered in the nineteenth century. The first public demonstration of anesthesia was in 1846. The Boston surgeon Henry Jacob Bigelow was approached by a local dentist named William Morton, who insisted that he had found a gas that could render patients insensible to the pain of surgery. That was a dramatic claim. In those days, even a minor tooth extraction was excruciating. Without effective pain control, surgeons learned to work with slashing speed. Attendants pinned patients down as they screamed and thrashed, until they fainted from the agony. Nothing ever tried had made much difference. Nonetheless, Bigelow agreed to let Morton demonstrate his claim.
On October 16, 1846, at Massachusetts General Hospital, Morton administered his gas through an inhaler in the mouth of a young man undergoing the excision of a tumor in his jaw. The patient only muttered to himself in a semi-conscious state during the procedure. The following day, the gas left a woman, undergoing surgery to cut a large tumor from her upper arm, completely silent and motionless. When she woke, she said she had experienced nothing at all.
Four weeks later, on November 18th, Bigelow published his report on the discovery of 'insensibility produced by inhalation' in the Boston Medical and Surgical Journal. Morton would not divulge the composition of the gas, which he called Letheon, because he had applied for a patent. But Bigelow reported that he smelled ether in it (ether was used as an ingredient in certain medical preparations), and that seems to have been enough. The idea spread like a contagion, travelling through letters, meetings, and periodicals. By mid-December, surgeons were administering ether to patients in Paris and London. By February, anesthesia had been used in almost all the capitals of Europe, and by June in most regions of the world.
There were forces of resistance, to be sure. Some people criticized anesthesia as a 'needless luxury'; clergymen deplored its use to reduce pain during childbirth as a frustration of the Almighty's designs. James Miller, a nineteenth-century Scottish surgeon who chronicled the advent of anesthesia, observed the opposition of elderly surgeons: "They closed their ears, shut their eyes, and folded their hands. . . . They had quite made up their minds that pain was a necessary evil, and must be endured." Yet soon even the obstructors, "with a run, mounted behind - hurrahing and shouting with the best." Within seven years, virtually every hospital in America and Britain had adopted the new discovery.
Sepsis - infection - was the other great scourge of surgery. It was the single biggest killer of surgical patients, claiming as many as half of those who underwent major operations, such as a repair of an open fracture or the amputation of a limb. Infection was so prevalent that suppuration - the discharge of pus from a surgical wound - was thought to be a necessary part of healing.
In the eighteen-sixties, the Edinburgh surgeon Joseph Lister read a paper by Louis Pasteur laying out his evidence that spoiling and fermentation were the consequence of microorganisms. Lister became convinced that the same process accounted for wound sepsis. Pasteur had observed that, besides filtration and the application of heat, exposure to certain chemicals could eliminate germs. Lister had read about the city of Carlisle's success in using a small amount of carbolic acid to eliminate the odor of sewage, and reasoned that it was destroying germs. Maybe it could do the same in surgery.
During the next few years, he perfected ways to use carbolic acid for cleansing hands and wounds and destroying any germs that might enter the operating field. The result was strikingly lower rates of sepsis and death. You would have thought that, when he published his observations in a groundbreaking series of reports in The Lancet, in 1867, his antiseptic method would have spread as rapidly as anesthesia.
Far from it. The surgeon J. M. T. Finney recalled that, when he was a trainee at Massachusetts General Hospital two decades later, hand washing was still perfunctory. Surgeons soaked their instruments in carbolic acid, but they continued to operate in black frock coats stiffened with the blood and viscera of previous operations - the badge of a busy practice. Instead of using fresh gauze as sponges, they reused sea sponges without sterilizing them. It was a generation before Lister's recommendations became routine and the next steps were taken toward the modern standard of asepsis - that is, entirely excluding germs from the surgical field, using heat-sterilized instruments and surgical teams clad in sterile gowns and gloves.
In our era of electronic communications, we've come to expect that important innovations will spread quickly. Plenty do: think of in-vitro fertilization, genomics, and communications technologies themselves. But there's an equally long list of vital innovations that have failed to catch on. The puzzle is why.
Did the spread of anesthesia and antisepsis differ for economic reasons? Actually, the incentives for both ran in the right direction. If painless surgery attracted paying patients, so would a noticeably lower death rate. Besides, live patients were more likely to make good on their surgery bill. Maybe ideas that violate prior beliefs are harder to embrace. To nineteenth-century surgeons, germ theory seemed as illogical as, say, Darwin's theory that human beings evolved from primates. Then again, so did the idea that you could inhale a gas and enter a pain-free state of suspended animation. Proponents of anesthesia overcame belief by encouraging surgeons to try ether on a patient and witness the results for themselves - to take a test drive. When Lister tried this strategy, however, he made little progress.
The technical complexity might have been part of the difficulty. Giving Lister's methods a try required painstaking attention to detail. Surgeons had to be scrupulous about soaking their hands, their instruments, and even their catgut sutures in antiseptic solution. Lister also set up a device that continuously sprayed a mist of antiseptic over the surgical field.
But anesthesia was no easier. Obtaining ether and constructing the inhaler could be difficult. You had to make sure that the device delivered an adequate dosage, and the mechanism required constant tinkering. Yet most surgeons stuck with it - or else they switched to chloroform, which was found to be an even more powerful anesthetic, but posed its own problems. (An imprecise dosage killed people.) Faced with the complexities, they didn't give up; instead, they formed an entire new medical specialty - anesthesiology.
So what were the key differences? First, one combatted a visible and immediate problem (pain); the other combatted an invisible problem (germs) whose effects wouldn't be manifest until well after the operation. Second, although both made life better for patients, only one made life better for doctors. Anesthesia changed surgery from a brutal, time-pressured assault on a shrieking patient to a quiet, considered procedure. Listerism, by contrast, required the operator to work in a shower of carbolic acid. Even low dilutions burned the surgeons' hands. You can imagine why Lister's crusade might have been a tough sell.
This has been the pattern of many important but stalled ideas. They attack problems that are big but, to most people, invisible; and making them work can be tedious, if not outright painful. The global destruction wrought by a warming climate, the health damage from our over-sugared modern diet, the economic and social disaster of our trillion dollars in unpaid student debt - these things worsen imperceptibly every day. Meanwhile, the carbolic-acid remedies to them, all requiring individual sacrifice of one kind or another, struggle to get anywhere.
The global problem of death in childbirth is a pressing example. Every year, three hundred thousand mothers and more than six million children die around the time of birth, largely in poorer countries. Most of these deaths are due to events that occur during or shortly after delivery. A mother may hemorrhage. She or her baby may suffer an infection. Many babies can't take their first breath without assistance, and newborns, especially those born small, have trouble regulating their body temperature after birth. Simple, lifesaving solutions have been known for decades. They just haven't spread.
Many solutions aren't ones you can try at home, and that's part of the problem. Increasingly, however, women around the world are giving birth in hospitals. In India, a government program offers mothers up to fourteen hundred rupees - more than what most Indians live on for a month - when they deliver in a hospital, and now, in many areas, the majority of births are in facilities. Death rates in India have fallen, but they're still ten times greater than in high-income countries like our own.
Not long ago, I visited a few community hospitals in north India, where just one-third of mothers received the medication recommended to prevent hemorrhage; less than ten per cent of the newborns were given adequate warming; and only four per cent of birth attendants washed their hands for vaginal examination and delivery. In an average childbirth, clinicians followed only about ten of twenty-nine basic recommended practices.
Here we are in the first part of the twenty-first century, and we're still trying to figure out how to get ideas from the first part of the twentieth century to take root. In the hopes of spreading safer childbirth practices, several colleagues and I have teamed up with the Indian government, the World Health Organization, the Gates Foundation, and Population Services International to create something called the BetterBirth Project. We're working in Uttar Pradesh, which is among India's poorest states. One afternoon in January, our team travelled a couple of hours from the state's capital, Lucknow, with its bleating cars and ramshackle shops, to a rural hospital surrounded by lush farmland and thatched-hut villages. Although the sun was high and the sky was clear, the temperature was near freezing. The hospital was a one-story concrete building painted goldenrod yellow. (Our research agreement required that I keep it unnamed.) The entrance is on a dirt road lined with rows of motorbikes, the primary means of long-distance transportation. If an ambulance or an auto-rickshaw can't be found, women in labor sit sidesaddle on the back of a bike.
The hospital delivers three thousand newborns a year, a typical volume in India but one that would put it in the top fifth of American hospitals. Yet it had little of the amenities that you'd associate with a modern hospital. I met the physician in charge, a smart and capable internist in his early thirties who had trained in the capital. He was clean-shaven and buzz-cut, with an Argyle sweater, track shoes, and a habitual half smile. He told me, apologetically, that the hospital staff had no ability to do blood tests, to give blood transfusions, or to perform emergency obstetrics procedures such as Cesarean sections. There was no electricity during the day. There was certainly no heating, even though the temperature was barely forty degrees that day, and no air-conditioning, even though summer temperatures routinely reach a hundred degrees. There were two blood-pressure cuffs for the entire facility. The nurse's office in my neighborhood elementary school was better equipped.
The hospital was severely understaffed, too. The doctor said that half of the staff positions were vacant. To help with child deliveries for a local population of a quarter of a million people, the hospital had two nurses and one obstetrician, who happened to be his wife. The nurses, who had six months of childbirth training, did most of the deliveries, swapping shifts year-round. The obstetrician covered the outpatient clinic, and helped with complicated births whenever she was required, day or night. During holidays or sickness, the two nurses covered for each other, but, if no one was available, laboring women were either sent to another hospital, miles away, or an untrained assistant might be forced to step in.
It may be surprising that mothers are better off delivering in such places than at home in a village, but studies show a consistently higher survival rate when they do. The staff members I met in India had impressive experience. Even the youngest nurses had done more than a thousand child deliveries. They've seen and learned to deal with countless problems - a torn placenta, an umbilical cord wrapped around a baby's neck, a stuck shoulder. Seeing the daily heroism required to keep such places going, you feel foolish and ill-mannered asking how they could do things better.
But then we hung out in the wards for a while. In the delivery room, a boy had just been born. He and his mother were lying on a cot, bundled under woollen blankets, resting. The room was coffin-cold; I was having trouble feeling my toes. I tried to imagine what that baby must have felt like. Newborns have a high body-surface area and lose heat rapidly. Even in warm weather, hypothermia is common, and it makes newborns weak and less responsive, less able to breast-feed adequately and more prone to infection. I noticed that the boy was swaddled separately from his mother. Voluminous evidence shows that it is far better to place the child on the mother's chest or belly, skin to skin, so that the mother's body can regulate the baby's until it is ready to take over. Among small or premature babies, kangaroo care (as it is known) cuts mortality rates by a third.
So why hadn't the nurse swaddled the two together? She was a skilled and self-assured woman in her mid-thirties with twinkly eyes, a brown knit hat, and a wool sweater over her shalwar kameez. Resources clearly weren't the issue - kangaroo care costs nothing. Had she heard of it? Oh, yes, she said. She'd taken a skilled-birth-attendant class that taught it. Had she forgotten about it? No. She had actually offered to put the baby skin to skin with the mother, and showed me where she'd noted this in the record.
"The mother didn't want it," she explained. "She said she was too cold."
The nurse seemed to think it was strange that I was making such an issue of this. The baby was fine, wasn't he? And he was. He was sleeping sweetly, a tightly wrapped peanut with a scrunched brown face and his mouth in a lowercase 'o.'
But had his temperature been taken? It had not. The nurse said that she had been planning to do so. Our visit had disrupted her routine. Suppose she had, though, and his temperature was low. Would she have done anything differently? Would she have made the mom unswaddle the child and put him to her chest?
Everything about the life the nurse leads - the hours she puts in, the circumstances she endures, the satisfaction she takes in her abilities - shows that she cares. But hypothermia, like the germs that Lister wanted surgeons to battle, is invisible to her. We picture a blue child, suffering right before our eyes. That is not what hypothermia looks like. It is a child who is just a few degrees too cold, too sluggish, too slow to feed. It will be some time before the baby begins to lose weight, stops making urine, develops pneumonia or a bloodstream infection. Long before that happens - usually the morning after the delivery, perhaps the same night - the mother will have hobbled to an auto-rickshaw, propped herself beside her husband, held her new baby tight, and ridden the rutted roads home.
From the nurse's point of view, she'd helped bring another life into the world. If four per cent of the newborns later died at home, what could that possibly have to do with how she wrapped the mother and child? Or whether she washed her hands before putting on gloves? Or whether the blade with which she cut the umbilical cord was sterilized?
We're infatuated with the prospect of technological solutions to these problems - baby warmers, say. You can still find high-tech incubators in rural hospitals that sit mothballed because a replacement part wasn't available, or because there was no electricity for them. In recent years, though, engineers have produced designs specifically for the developing world. Dr. Steven Ringer, a neonatologist and BetterBirth leader, was an adviser for a team that made a cheap, ingenious, award-winning incubator from old car parts that are commonly available and easily replaced in low-income environments. Yet it hasn't taken off, either. "It's in more museums than delivery rooms," he laments.
As with most difficulties in global health care, lack of adequate technology is not the biggest problem. We already have a great warming technology: a mother's skin. But even in high-income countries we do not consistently use it. In the United States, according to Ringer, more than half of newborns needing intensive care arrive hypothermic. Preventing hypothermia is a perfect example of an unsexy task: it demands painstaking effort without immediate reward. Getting hospitals and birth attendants to carry out even a few of the tasks required for safer childbirth would save hundreds of thousands of lives. But how do we do that?
The most common approach to changing behavior is to say to people, "Please do X." Please warm the newborn. Please wash your hands. Please follow through on the twenty-seven other childbirth practices that you're not doing. This is what we say in the classroom, in instructional videos, and in public-service campaigns, and it works, but only up to a point.
Then, there's the law-and-order approach: "You must do X." We establish standards and regulations, and threaten to punish failures with fines, suspensions, the revocation of licenses. Punishment can work. Behavioral economists have even quantified how averse people are to penalties. In experimental games, they will often quit playing rather than risk facing negative consequences. And that is the problem with threatening to discipline birth attendants who are taking difficult-to-fill jobs under intensely trying conditions. They'll quit.
The kinder version of "You must do X" is to offer incentives rather than penalties. Maybe we could pay birth attendants a bonus for every healthy child who makes it past a week of life. But then you think about how hard it would be to make a scheme like that work, especially in poor settings. You'd need a sophisticated tracking procedure, to make sure that people aren't gaming the system, and complex statistical calculations, to take prior risks into account. There's also the impossible question of how you split the reward among all the people involved. How much should the community health worker who provided the prenatal care get? The birth attendant who handled the first twelve hours of labor? The one who came on duty and handled the delivery? The doctor who was called in when things got complicated? The pharmacist who stocked the antibiotic that the child required?
Besides, neither penalties nor incentives achieve what we're really after: a system and a culture where X is what people do, day in and day out, even when no one is watching. "You must" rewards mere compliance. Getting to "X is what we do" means establishing X as the norm. And that's what we want: for skin-to-skin warming, hand washing, and all the other lifesaving practices of childbirth to be, quite simply, the norm.
To create new norms, you have to understand people's existing norms and barriers to change. You have to understand what's getting in their way. So what about just working with health-care workers, one by one, to do just that? With the BetterBirth Project, we wondered, in particular, what would happen if we hired a cadre of childbirth-improvement workers to visit birth attendants and hospital leaders, show them why and how to follow a checklist of essential practices, understand their difficulties and objections, and help them practice doing things differently. In essence, we'd give them mentors.
The experiment is just getting under way. The project has recruited only the first few of a hundred or so workers whom we are sending out to hospitals across six regions of Uttar Pradesh in a trial that will involve almost two hundred thousand births over two years. There's no certainty that our approach will succeed. But it seemed worth trying.
Reactions that I've heard both abroad and at home have been interestingly divided. The most common objection is that, even if it works, this kind of one-on-one, on-site mentoring isn't scalable. But that's one thing it surely is. If the intervention saves as many mothers and newborns as we're hoping - about a thousand lives in the course of a year at the target hospitals - then all that need be done is to hire and develop similar cadres of childbirth-improvement workers for other places around the country and potentially the world. To many people, that doesn't sound like much of a solution. It would require broad mobilization, substantial expense, and perhaps even the development of a new profession. But, to combat the many antisepsis-like problems in the world, that's exactly what has worked. Think about the creation of anesthesiology: it meant doubling the number of doctors in every operation, and we went ahead and did so. To reduce illiteracy, countries, starting with our own, built schools, trained professional teachers, and made education free and compulsory for all children. To improve farming, governments have sent hundreds of thousands of agriculture extension agents to visit farmers across America and every corner of the world and teach them up-to-date methods for increasing their crop yields. Such programs have been extraordinarily effective. They have cut the global illiteracy rate from one in three adults in 1970 to one in six today, and helped give us a Green Revolution that saved more than a billion people from starvation.
In the era of the iPhone, Facebook, and Twitter, we've become enamored of ideas that spread as effortlessly as ether. We want frictionless, turnkey solutions to the major difficulties of the world - hunger, disease, poverty. We prefer instructional videos to teachers, drones to troops, incentives to institutions. People and institutions can feel messy and anachronistic. They introduce, as the engineers put it, uncontrolled variability.
But technology and incentive programs are not enough. "Diffusion is essentially a social process through which people talking to people spread an innovation," wrote Everett Rogers, the great scholar of how new ideas are communicated and spread. Mass media can introduce a new idea to people. But, Rogers showed, people follow the lead of other people they know and trust when they decide whether to take it up. Every change requires effort, and the decision to make that effort is a social process.
This is something that salespeople understand well. I once asked a pharmaceutical rep how he persuaded doctors - who are notoriously stubborn - to adopt a new medicine. Evidence is not remotely enough, he said, however strong a case you may have. You must also apply "the rule of seven touches." Personally "touch" the doctors seven times, and they will come to know you; if they know you, they might trust you; and, if they trust you, they will change. That's why he stocked doctors' closets with free drug samples in person. Then he could poke his head around the corner and ask, "So how did your daughter Debbie's soccer game go?" Eventually, this can become "Have you seen this study on our new drug? How about giving it a try?" As the rep had recognized, human interaction is the key force in overcoming resistance and speeding change.
In 1968, The Lancet published the results of a modest trial of what is now regarded as among the most important medical advances of the twentieth century. It wasn't a new drug or vaccine or operation. It was basically a solution of sugar, salt, and water that you could make in your kitchen. The researchers gave the solution to victims of a cholera outbreak in Dhaka, the capital of what is now Bangladesh, and the results were striking.
Cholera is a violent and deadly diarrheal illness, caused by the bacterium Vibrio cholera, which the victim usually ingests from contaminated water. The bacteria secrete a toxin that triggers a rapid outpouring of fluid into the intestine. The body, which is sixty per cent water, becomes like a sponge being wrung out. The fluid pouring out is a cloudy white, likened to the runoff of washed rice. It produces projectile vomiting and explosive diarrhea. Children can lose a third of their body's water in less than twenty-four hours, a fatal volume. Drinking water to replace the fluid loss is ineffective, because the intestine won't absorb it. As a result, mortality commonly reached seventy per cent or higher. During the nineteenth century, cholera pandemics killed millions across Asia, Europe, Africa, and North America. The disease was dubbed the Blue Death because of the cyanotic blue-gray color of the skin from extreme dehydration.
In 1906, a partially effective treatment was found: intravenous fluid solutions reduced mortality to thirty per cent. Prevention was the most effective approach. Modern sewage and water treatment eliminated the disease in affluent countries. Globally, though, millions of children continued to die from diarrheal illness each year. Even if victims made it to a medical facility, the needles, plastic tubing, and litres of intravenous fluid required for treatment were expensive, in short supply, and dependent on medical workers who were themselves in short supply, especially in outbreaks that often produced thousands of victims.
Then, in the nineteen-sixties, scientists discovered that sugar helps the gut absorb fluid. Two American researchers, David Nalin and Richard Cash, were in Dhaka during a cholera outbreak. They decided to test the scientific findings, giving victims an oral rehydration solution containing sugar as well as salt. Many people doubted that victims could drink enough of it to restore their fluid losses, typically ten to twenty litres a day. So the researchers confined the Dhaka trial to twenty-nine patients. The subjects proved to have no trouble drinking enough to reduce or even eliminate the need for intravenous fluids, and none of them died.
Three years later, in 1971, an Indian physician named Dilip Mahalanabis was directing medical assistance at a West Bengal camp of three hundred and fifty thousand refugees from Bangladesh's war of independence when cholera struck. Intravenous-fluid supplies ran out. Mahalanabis instructed his team to try the Dhaka solution. Just 3.6 per cent died, an unprecedented reduction from the usual thirty per cent. The solution was actually better than intravenous fluids. If cholera victims were alert, able to drink, and supplied with enough of it, they could almost always save their own lives.
One might have expected people to clamor for the recipe after these results were publicized. Oral rehydration solution seems like ether: a miraculous fix for a vivid, immediate, and terrifying problem. But it wasn't like ether at all.
To understand why, you have to imagine having a child throwing up and pouring out diarrhea like you've never seen before. Making her drink seems only to provoke more vomiting. Chasing the emesis and the diarrhea seems both torturous and futile. Many people's natural inclination is to not feed the child anything.
Furthermore, why believe that this particular mixture of sugar and salt would be any different from water or anything else you might have tried? And it is particular. Throw the salt concentration off by a couple of teaspoons and the electrolyte imbalance could be dangerous. The child must also keep drinking the stuff even after she feels better, for as long as the diarrhea lasts, which is up to five days. Nurses routinely got these steps wrong. Why would villagers do any better?
A decade after the landmark findings, the idea remained stalled. Nothing much had changed. Diarrheal disease remained the world's biggest killer of children under the age of five.
In 1980, however, a Bangladeshi nonprofit organization called brac decided to try to get oral rehydration therapy adopted nationwide. The campaign required reaching a mostly illiterate population. The most recent public-health campaign - to teach family planning - had been deeply unpopular. The messages the campaign needed to spread were complicated.
Nonetheless, the campaign proved remarkably successful. A gem of a book published in Bangladesh, "A Simple Solution," tells the story. The organization didn't launch a mass-media campaign - only twenty per cent of the population had a radio, after all. It attacked the problem in a way that is routinely dismissed as impractical and inefficient: by going door to door, person by person, and just talking.
It started with a pilot project that set out to reach some sixty thousand women in six hundred villages. The logistics were daunting. Who, for instance, would do the teaching? How were those workers going to travel? How was their security to be assured? The brac leaders planned the best they could and then made adjustments on the fly.
They recruited teams of fourteen young women, a cook, and a male supervisor, figuring that the supervisor would protect them from others as they travelled, and the women's numbers would protect them from the supervisor. They travelled on foot, pitched camp near each village, fanned out door to door, and stayed until they had talked to women in every hut. They worked long days, six days a week. Each night after dinner, they held a meeting to discuss what went well and what didn't and to share ideas on how to do better. Leaders periodically debriefed them, as well.
The workers were only semi-literate, but they helped distill their sales script into seven easy-to-remember messages: for instance, severe diarrhea leads to death from dehydration; the signs of dehydration include dry tongue, sunken eyes, thirst, severe weakness, and reduced urination; the way to treat dehydration is to replace salt and water lost from the body, starting with the very first loose stool; a rehydration solution provides the most effective way to do this. brac's scientists had to figure out how the workers could teach the recipe for the solution. Villagers had no precise measuring implements - spoons were locally made in nonstandard sizes. The leaders considered issuing special measuring spoons with the recipe on the handle. But these would be costly; most people couldn't read the recipe; and how were the spoons to be replaced when lost? Eventually, the team hit upon using finger measures: a fistful of raw sugar plus a three-finger pinch of salt mixed in half a "seer" of water - a pint measure commonly used by villagers when buying milk and oil. Tests showed that mothers could make this with sufficient accuracy.
Initially, the workers taught up to twenty mothers per day. But monitors visiting the villages a few weeks later found that the quality of teaching suffered on this larger scale, so the workers were restricted to ten households a day. Then a new salary system was devised to pay each worker according to how many of the messages the mothers retained when the monitor followed up. The quality of teaching improved substantially. The field workers soon realized that having the mothers make the solution themselves was more effective than just showing them. The workers began looking for diarrhea cases when they arrived in a village, and treating them to show how effective and safe the remedy was. The scientists also investigated various questions that came up, such as whether clean water was required. (They found that, although boiled water was preferable, contaminated water was better than nothing.)
Early signs were promising. Mothers seemed to retain the key messages. Analysis of their sugar solutions showed that three-quarters made them properly, and just four in a thousand had potentially unsafe salt levels. So brac and the Bangladeshi government took the program nationwide. They hired, trained, and deployed thousands of workers region by region. The effort was, inevitably, imperfect. But, by going door to door through more than seventy-five thousand villages, they showed twelve million families how to save their children.
The program was stunningly successful. Use of oral rehydration therapy skyrocketed. The knowledge became self-propagating. The program had changed the norms.
Coaxing villagers to make the solution with their own hands and explain the messages in their own words, while a trainer observed and guided them, achieved far more than any public-service ad or instructional video could have done. Over time, the changes could be sustained with television and radio, and the growth of demand led to the development of a robust market for manufactured oral rehydration salt packets. Three decades later, national surveys have found that almost ninety per cent of children with severe diarrhea were given the solution. Child deaths from diarrhea plummeted more than eighty per cent between 1980 and 2005.
As other countries adopted Bangladesh's approach, global diarrheal deaths dropped from five million a year to two million, despite a fifty-per-cent increase in the world's population during the past three decades. Nonetheless, only a third of children in the developing world receive oral rehydration therapy. Many countries tried to implement at arm's length, going 'low touch,' without sandals on the ground. As a recent study by the Gates Foundation and the University of Washington has documented, those countries have failed almost entirely. People talking to people is still how the world's standards change.
Surgeons finally did upgrade their antiseptic standards at the end of the nineteenth century. But, as is often the case with new ideas, the effort required deeper changes than anyone had anticipated. In their blood-slick, viscera-encrusted black coats, surgeons had seen themselves as warriors doing hemorrhagic battle with little more than their bare hands. A few pioneering Germans, however, seized on the idea of the surgeon as scientist. They traded in their black coats for pristine laboratory whites, refashioned their operating rooms to achieve the exacting sterility of a bacteriological lab, and embraced anatomic precision over speed.
The key message to teach surgeons, it turned out, was not how to stop germs but how to think like a laboratory scientist. Young physicians from America and elsewhere who went to Germany to study with its surgical luminaries became fervent converts to their thinking and their standards. They returned as apostles not only for the use of antiseptic practice (to kill germs) but also for the much more exacting demands of aseptic practice (to prevent germs), such as wearing sterile gloves, gowns, hats, and masks. Proselytizing through their own students and colleagues, they finally spread the ideas worldwide.
In childbirth, we have only begun to accept that the critical practices aren't going to spread themselves. Simple "awareness" isn't going to solve anything. We need our sales force and our seven easy-to-remember messages. And in many places around the world the concerted, person-by-person effort of changing norms is under way.
I recently asked BetterBirth workers in India whether they'd yet seen a birth attendant change what she does. Yes, they said, but they've found that it takes a while. They begin by providing a day of classroom training for birth attendants and hospital leaders in the checklist of practices to be followed. Then they visit them on site to observe as they try to apply the lessons.
Sister Seema Yadav, a twenty-four-year-old, round-faced nurse three years out of school, was one of the trainers. (Nurses are called 'sisters' in India, a carryover from the British usage.) Her first assignment was to follow a thirty-year-old nurse with vastly more experience than she had. Watching the nurse take a woman through labor and delivery, she saw how little of the training had been absorbed. The room had not been disinfected; blood from a previous birth remained in a bucket. When the woman came in - moaning, contractions speeding up - the nurse didn't check her vital signs. She didn't wash her hands. She prepared no emergency supplies. After delivery, she checked the newborn's temperature with her hand, not a thermometer. Instead of warming the baby against the mother's skin, she handed the newborn to the relatives.
When Sister Seema pointed out the discrepancy between the teaching and the practice, the nurse was put out. She gave many reasons that steps were missed - there was no time, they were swamped with deliveries, there was seldom a thermometer at hand, the cleaners never did their job. Sister Seema - a cheerful, bubbly, fast talker - took her to the cleaner on duty and together they explained why cleaning the rooms between deliveries was so important. They went to the medical officer in charge and asked for a thermometer to be supplied. At her second and third visits, disinfection seemed more consistent. A thermometer had been found in a storage closet. But the nurse still hadn't changed much of her own routine.
By the fourth or fifth visit, their conversations had shifted. They shared cups of chai and began talking about why you must wash hands even if you wear gloves (because of holes in the gloves and the tendency to touch equipment without them on), and why checking blood pressure matters (because hypertension is a sign of eclampsia, which, when untreated, is a common cause of death among pregnant women). They learned a bit about each other, too. Both turned out to have one child - Sister Seema a four-year-old boy, the nurse an eight-year-old girl. The nurse lived in the capital, a two-hour bus ride away. She was divorced, living with her mother, and struggled with the commute. She'd been frustrated not to find a hospital posting in the city. She worked for days at a stretch, sleeping on a cot when she got a break. Sister Seema commiserated, and shared her own hopes for her family and her future. With time, it became clearer to the nurse that Sister Seema was there only to help and to learn from the experience herself. They even exchanged mobile-phone numbers and spoke between visits. When Sister Seema didn't have the answer to a question, she made sure she got one.
Soon, she said, the nurse began to change. After several visits, she was taking temperatures and blood pressures properly, washing her hands, giving the necessary medications - almost everything. Sister Seema saw it with her own eyes.
She'd had to move on to another pilot site after that, however. And although the project is tracking the outcomes of mothers and newborns, it will be a while before we have enough numbers to know if a difference has been made. So I got the nurse's phone number and, with a translator to help with the Hindi, I gave her a call.
It had been four months since Sister Seema's visit ended. I asked her whether she'd made any changes. Lots, she said.
"What was the most difficult one?" I asked.
"Washing hands," she said. "I have to do it so many times!"
"What was the easiest?"
"Taking the vital signs properly." Before, she said, "we did it haphazardly." Afterward, "everything became much more systematic."
She said that she had eventually begun to see the effects. Bleeding after delivery was reduced. She recognized problems earlier. She rescued a baby who wasn't breathing. She diagnosed eclampsia in a mother and treated it. You could hear her pride as she told her stories.
Many of the changes took practice for her, she said. She had to learn, for instance, how to have all the critical supplies - blood-pressure cuff, thermometer, soap, clean gloves, baby respiratory mask, medications - lined up and ready for when she needed them; how to fit the use of them into her routine; how to convince mothers and their relatives that the best thing for a child was to be bundled against the mother's skin. But, step by step, Sister Seema had helped her to do it. "She showed me how to get things done practically," the nurse said.
"Why did you listen to her?" I asked. "She had only a fraction of your experience."
In the beginning, she didn't, the nurse admitted. "The first day she came, I felt the workload on my head was increasing." From the second time, however, the nurse began feeling better about the visits. She even began looking forward to them.
"Why?" I asked.
All the nurse could think to say was "She was nice."
"She was nice?"
"She smiled a lot."
"That was it?"
"It wasn't like talking to someone who was trying to find mistakes," she said. "It was like talking to a friend."
That, I think, was the answer. Since then, the nurse had developed her own way of explaining why newborns needed to be warmed skin to skin. She said that she now tells families, "Inside the uterus, the baby is very warm. So when the baby comes out it should be kept very warm. The mother's skin does this."
I hadn't been sure if she was just telling me what I wanted to hear. But when I heard her explain how she'd put her own words to what she'd learned, I knew that the ideas had spread. "Do the families listen?" I asked.
"Sometimes they don't," she said. "Usually, they do."
Drug Companies
Doctors at the Madras Medical Group had grown wary of the pharmaceutical sales pitch. They were thinking of banning drug reps from their practice, but worried their low-income patients would lose access to the free samples the drug reps left behind.
That changed when a rep arrived with a gourmet meal over which he planned to educate the doctors about the benefits of his company's latest brand-name drug. “We had this really lavish meal, butter with all the fancy curlicues — it was really something," Dr. Doug Lieuallen recalls.
As they eyed the creamy yellow rosettes and the elaborate spread on the table for the six providers and two dozen staff members, it became clear the drug company had spent a tidy sum to butter them up.
“That," he said, “sort of pushed us over the edge."
Drug reps weren't always a problem for the rural clinic. A town of only 6,000 people, Madras wasn't even on the radar for most of the big pharmaceutical companies in the 1990s. When Dr. David Evans joined the primary care practice, he'd see no more than a single rep each month.
But by the early 2000s, Bend had grown from sleepy lumber town to recreational mecca with a thriving medical community, attracting reps from miles around. Seemingly overnight, Madras became a regular stop for Portland-based drug reps on their way to Bend.
“When it started being several per day, it made us start to think a little bit more," Evans said. “What is this all about? It just doesn't feel right."
Drug company sales representatives are, in essence, sales people with no access to their customers. It's the patients who buy the drugs, but it's the doctors who control the sale. The way to sell more drugs is to get the doctors to write more prescriptions. And to do that, the reps need to get face to face with the men and women with the prescribing pad.
As the Madras doctors emerged from their exam room in between patients, the nurses would pull them aside and let them know a drug rep was waiting. “It was never anybody by name," Evans said. “It was always the Lipitor guy or the Effexor guy." The drug reps said they needed a doctor's signature for the samples, and used that to ensure a face-to-face meeting.
The reps wanted to talk to as many doctors as they could, handing them their glossy handouts, touting the benefits of their drugs over those of their competitors. Reps are trained to assess personalities, analyze prescribing patterns and determine what needs to be done to get the physician prescribing more of the company's products. The drug firms buy prescribing information from health informatics companies who purchase de-identified records from pharmacies, then match each record with the doctor's prescriber number sold to them by the American Medical Association. In 2006, the AMA allowed doctors to opt out of the reporting and withhold most prescribing information from drug reps and their supervisors. But few do.
Doctors are categorized by drug reps into percentile groups based on their prescribing volume and given colorful monikers such as high-prescriber, spreader, mercenary or sample-grabber.
Reps have a specific strategy for each category, said Dr. Shahram Ahari, a drug rep turned physician, who described a rep's strategy in a 2007 article in the online journal PLOS Medicine.
“For some it's dinner in the finest restaurants, for others it's enough convincing data to let them prescribe confidently, and for others, it's my attention and friendship," Ahari said. “But at the most basic level, everything is for sale and everything is an exchange."
Biased information
The Madras Medical doctors grew more and more uncomfortable with the process. The reps showed them only the data that put their drugs in the most favorable light, highlighting company-funded studies published in less-than-prestigious journals.
“It didn't have any meaning to it," Lieuallen said.
The doctors would attend drug company-sponsored educational meetings that became glorified pitches for pharmaceutical drugs. Whatever the patient's illness, the sponsor's product was sure to be the cure.
“If it's sponsored by whoever makes Nexium, it's amazing, the only thing that is going to make them any better is Nexium," he said. “It just got very, very old and all of us felt that we were whores."
Lieuallen said that of the five practitioners at the clinic, two — he and Evans — wanted to kick the reps out. Two others, however, were opposed, concerned about the loss of drug samples. A fifth was on the fence.
The two doctors who opposed kicking the reps out were managing a number of patients out of the sample closet. Patients who have no insurance or who can't afford the copays would get free samples, often for months at a time, as the doctors tried to keep them on their medicines.
For a while, it was a stalemate as the practitioners debated what to do. In 2004, however, they hired another physician, Dr. Gary Plant, shifting the balance of the internal politics. Plant was accustomed to choosing generics over brand-name drugs and was bothered by the notion that patients were being prescribed drugs that were not better, just more expensive.
They offered reps a compromise. They would listen to the sales pitch if the reps would give them the money they would normally spend on lunches and promotional materials so they could help low-income patients buy generic drugs.
“Don't buy us lunch; give us $100 and we'll buy 25 people a month's worth of their blood-pressure pills," Plant said.
They thought the clinic could become a dispensing practice, diverting the funds the reps were spending to woo their prescribing to “sample" patients with low-cost generic drugs.
“Of course, that went over like a lead balloon," Lieuallen said. Only one of the drug reps agreed to the new arrangement but was summarily overruled by his supervisor.
Then the Vioxx scandal hit.
Off the fence
Vioxx was Merck's blockbuster anti-inflammatory pain drug. Approved in 1999, it was touted as a safer alternative to naproxen sodium or ibuprofen, causing less gastrointestinal bleeding. By 2004, however, the company could no longer hide the increased risk of heart attacks caused by the drugs. It pulled the product, but not until 25 million Americans had taken the drug, suffering an estimated 38,000 heart attacks as a result, according to a Food and Drug Administration report.
“I remember asking the rep to tell me about the heart attacks, and they would very artfully steer the conversation in a different direction," Evans said.
Congress launched investigations. Company documents were leaked, pharmaceutical tactics revealed, and the holdout docs at Madras Medical were converted.
“It moved everybody over a little bit," Evans said. “Those of us who were happy with the drug reps became a little bit more skeptical; those who were on the fence got off the fence in our direction."
In six months before Madras Medical cut the cord, reps visited the clinic 199 times, an average of 33 times per month. From February to November 2005, the reps brought 23 lunches, a rate of two to three each month.
A analysis of the sample closet revealed very few first-line drugs, the type of medications that doctors would normally try first because they work best for most patients. The samples were for drugs that cost patients an average of $90 a month. There were less expensive generics available for 38 of the 46 sample drugs, cutting the patients' average cost to $22 a month.
Research suggests there's a hidden cost to samples. In 2008, researchers from the University of Chicago calculated that patients who received samples paid between $212 and $244 a month in average prescription costs, compared with $168 a month for those who never got a sample.
Samples are primarily given to promote the use of the more expensive, brand-name drugs, which in the end may be no more effective than lower-cost generics. But studies show that once a patient is started on a medication with a free sample, he is rarely switched to a lower-cost alternative.
“It's not really charity, or that we're giving out drugs because we're nice people," Ahari said. “Once you're on it and you establish a therapeutic effect, most doctors will be reluctant to switch you to an equally effective but cheaper generic."
Studies have also shown that most samples don't end up in the hands of the most needy patients anyway. They're more likely to end up in the hands of higher-income, insured patients, or taken home by staff for their own family.
“There are some physicians who manage to get samples for their poor patients, but they're the exception, not the rule," Ahari said. “And if the drug rep generally speaking isn't getting something out of it, you'll see your supply dry up."
Samples tend to be the most expensive drugs, new drugs that companies are trying to establish, or drugs that are vying for market share after another drug has left the market. In 2002, for example, the most widely distributed sample was Vioxx.
“Truthfully, the pharmacy reps don't leave anything that's useful to our patients," said Judy Carroll, a nurse at Madras Medical. “It's the expensive stuff that no one in this area can afford."
About 30 percent of the clinic's patients are on Medicare, another 25 percent on Medicaid, while 15 percent are self-pay. Many of the clinic's patients cannot afford the copays on a brand-name drug, much less pay the entire cost out of pocket.
The first question Lieuallen would always ask the drug reps about a new drug was whether it was covered by the Oregon Health Plan, the state's Medicaid program.
“I think that helped us make the decision," Plant said. “We got tired of hearing people say, 'No, but it's covered by Blue Cross.'"
Going pharma-free
The nurses told the doctors how disruptive the rep visits had become, and how banning drug reps would make it easier to deal with patients who called regularly seeking free samples of their medications.
The staff liked the pens and mugs they got for free from the reps. There were toys they could give their children or the odd collectibles their families would covet. The Viagra pens were particularly popular.
But what the staff would really miss were the lunches. Each month when drug reps brought in food, the staff had a chance to sit down in the middle of a hectic day and catch up on their lives and families.
“Really, it was the social interaction the staff was concerned about," Evans said. “It was easy for us as a practice to spend $50 to $80 a month to have a little luncheon that served the social purpose and didn't want us to take a shower afterward."
Now each month, the doctors order pizza, Chinese food or lasagna for the office, rotating through the local restaurants. It's a far cry from the catered gourmet lunches they once got.
“But we don't have to listen to the sales pitch," said Margo Alley, a nurse at the clinic.
The clinic notified the sales reps that starting Jan. 1, 2006, they would no longer be welcome in the clinic. As the date neared, the staff worked to clear the detritus after years of intense marketing.
“The whole office was sort of permeated with all this pharmaceutical paraphernalia," Lieuallen said. “It was actually challenging when we started to get rid of it. We were going to have to buy clocks. We had to start buying scratch paper. We had to start buying pens."
The doctors filled a garbage can full of pens and mugs and other trinkets, and tossed it all into a dumpster. The office manager purchased $200 worth of office supplies to restock the clinic.
Meanwhile, the decision did not go over well with the drug reps.
“Most of them tried to convince us that was the wrong thing to do," Evans said. “'How on Earth, doctor, will you stay up to date if we're not here to keep you up to date? What will your indigent patients do if you don't have samples of this, that or the other thing?'"
Some brought in their supervisors to try to convince the doctors otherwise. “They definitely tried," he said. “But we had made our decision."
The reps continued to try to find ways around the ban, talking to staff instead of doctors, asking them to pass the marketing brochures and promotional trinkets to their bosses. Others enlisted the U.S. Postal Service, sending the usual glossy brochures in plain brown envelopes.
Evans received one with a sticky note attached. “Only Avandia has 5-year data on glycemic control!" it said. “Please try to get more patients on our therapy."
Like Vioxx, Avandia was subsequently linked to an increased risk of heart attacks. The FDA opted not to pull the drug from the market, but it placed significant restrictions on its use.
Patient reaction
For the most part, patients applauded the move. Many commended the doctors on the new policy. Others bemoaned the lack of free samples but understood.
“The patients who were most upset about the loss of the sample cabinet were the ones who most had the means to pay for their medicines," Evans said. “Those who had been stomped on by the man in other aspects of their life could certainly understand how Big Brother could be influencing my prescribing patterns."
The doctors worked to help their low-income, uninsured patient find ways of affording their drugs without the freebies. That year, Wal-Mart announced a new $4 generic program, which was then matched by some of the local pharmacies in Madras.
“It turns out a lot of those patients probably could afford a $4-a-month medicine," Plant said.
The clinic tried to quantify the savings, comparing their level of generic use with that of doctors in a neighboring county. But with a number of blockbuster brand-name drugs going generic around the same time, it was hard to quantify the impact.
“I don't really recall any really negative kickback," Lieuallen said. “I bet a few people were frustrated because I couldn't get them their Cialis, but that's a $25-a-pop pill."
As long as the doctors had a sample closet, they could convince themselves they were helping patients by giving them free medications. Removal of the sample closet, they said, forced them to prescribe more based on cost and efficacy, eliminating their irrational prescribing patterns.
For example, patients might come in with a garden-variety infection needing antibiotic therapy. If they couldn't afford it, doctors wouldn't have any first-line antibiotics to give them. The samples invariably were for newer broad-spectrum antibiotics best reserved for treating difficult, drug-resistant cases.
“When you're getting it out of the sample closet," Lieuallen said, “what you've got is the latest gorillacillin."
Within months, the doctors knew they had made the right decision. They didn't miss the drug reps and thought their patients were better off in a pharma-free clinic.
“I know that I lost one patient as a result," Evans said. “He just could not figure out how I could keep current and know about the best drugs without having the industry rep come talk to me about it."
Medical education
The majority of physicians still rely on drug reps to bring them that information. But increasingly doctors are becoming skeptical of the bias. The Madras Medical doctors always felt they were getting half of the story, with data presented in the most favorable way. They realized they needed a better way of learning about the hundreds of drugs they could prescribe to their patients. They had long subscribed to two independent publications, The Medical Letter and the Prescriber's Letter, which gave unbiased reviews of medications.
Every first Wednesday of the month, the doctors invite other physicians from the community and review the literature and discuss the pros and cons of various therapies.
“It's made us better doctors," Lieuallen said.
Their decision also had broader impacts for the community. Madras Medical treated more than half of the town and the surrounding community. Other doctors told them the number of reps has dropped off since they made their decision. In Bend, other primary clinics are following suit. St. Charles Family Care, which was launched in 2011, does not see drug reps, and Bend Memorial Clinic, the region's largest multispecialty clinic, plans to cut ties within its primary care offices this year.
Recent surveys of more than 237,000 physician offices by Irvine, Calif.-based research firm SK&A found that only 23 percent of doctors refuse to see sales reps and an equal number refuse drug samples.
In one survey, 84 percent of physicians agreed that drug reps influenced prescribing habits, but 61 percent maintained they themselves were not affected.
“Drug companies aren't stupid. If they didn't think they could influence you with that pen or that notepad or that clock, they wouldn't do it," Lieuallen said.
All of the Madras Medical doctors, even those who were most skeptical about the drug reps, believe the interactions affected their prescribing patterns. When a class of high-blood-pressure medications called angiotension-receptor blockers first came out, there were six to eight equally effective, similarly priced brand-name drugs on the market with no generic alternative.
“So the one that you're going to use is the first one that you think of," Plant said. “So they know that if their pen or their notepad is in front of you, that's the name you think of, that's the drug you're going to prescribe."
Higher education
Larger academic medical centers and medical schools have been more likely than smaller community-based practices to close their doors to drug reps. The American Medical Students Association began advocating for medical schools to become pharma-free in 2002, and in 2007 released its first scorecard grading schools on their rules regarding industry contact with students. Out of 158 U.S. medical schools graded in 2013, 114 received an A or B score, compared with only 21 in 2008.
The University of Washington, where Evans now teaches in the Department of Family Medicine, received an A. As a teaching exercise, the faculty decided to invite sales reps to talk to their medical students. Despite hearing that the professors planned to critique their presentation for usefulness and accuracy, the reps jumped at the chance.
“They know if they get 10 minutes of your time, even if you're going to spend a half an hour afterward kicking their message apart, you have just filled everybody's head with your drug," Evans said. “I'm sure that these (reps) went back to their bosses and said, 'Hey, I got in the University of Washington!' and counted it as a real score."
While the scorecard shows a significant change in reps' access to students over the past five years, most of the physicians in practice today were trained in a different atmosphere. Plant said when he was in medical school, attendance at noon lectures generally depended on whether drug reps were bringing a free lunch.
“I remember we were having discussions about (banning drug reps) back in the early 2000s, and we were saying, 'Who's going to provide the lunch if the drug reps aren't there?'" Plant said.
Studies conducted around the same time found that residents received an average of six gifts a year from pharmaceutical companies.
Many doctors bristle at the notion they can be “bought" with a pen or a free meal, but research suggests it's not the size of the gift that really matters.
“Social science research shows that smaller-value gifts can be as effective or more effective than big gifts, because the giver believes that because it's small it doesn't have an influence," said Dr. Eric Campbell, a sociologist with the Institute for Health Policy in Boston, who specializes in physician conflict-of-interest issues. “If you think about it, it's brilliant. If you give somebody something of great, great value, they assume you want something from them."
Several studies have shown the more gifts doctors get, the more likely they are to believe the gifts didn't influence them.
“I've often argued if you really want to see the drug reps, see them. But don't take their food, don't take their money, don't take their gifts, don't go to dinner with them," Campbell said. “What's interesting is when you put those restrictions on it, doctors aren't that interested in drug reps."
Industry response
The Bulletin's calls to pharmaceutical manufacturers and drug reps in the region were referred to the Pharmaceutical Research and Manufacturers of America. Officials for the industry trade group maintain that drug reps serve a valuable purpose, passing on information to overworked doctors about the safety and efficacy of prescription drugs that might not be available yet in the published literature.
“The demands on their time is increasing, and their ability to wade through all of the information and stay on top of it is kind of limited," said Kendra Martello, assistant general counsel for the group.
Drug reps, she said, can also provide a vehicle for doctors to provide feedback to the drugmaker on the way the drug behaves in real-world situations.
“Ultimately I think that benefits patient care," she said. “If you take that away and cut off that open line of communications, then the worry is that patients ultimately could suffer."
Martello also defended the use of drug samples as a way for patients to try out a new medication, to see whether it works and is tolerable, without having to pay for a full prescription.
“We think they're beneficial in also helping patients start their medication earlier," she said. “We would hate to see them banned, but we do understand that some practices have made that decision."
An industry-funded study published last year tried to quantify the potential harm of doctors not seeing drug reps. The researchers looked at prescriptions for diabetes drugs among high-prescribing doctors and how those correlated with the number of drug rep visits. Physicians who saw the fewest drug reps took longer to begin prescribing Januvia, the first in a new class of diabetes medication when it came on the market in 2006. They were slower to cut back on Avandia prescriptions after the FDA added a black box warning about heart attacks in 2007.
Both doctors' groups and the pharmaceutical industry have taken steps over the years to rein in the worst of the gift-giving behavior. The American Medical Association adopted voluntary guidelines that allow doctors to accept patient-care-related items valued under $100. And in 2009, the pharmaceutical industry updated a voluntary code that eliminated the brand-name laden pens or mugs, and the lavish meals. It would still allow a modest lunch aimed at educating providers or promotional items that doctors can use in patient care. More than 50 pharmaceutical manufacturers have signed on to the code.
In August, pharmaceutical companies will have to start reporting their payments and gifts to physicians under the Sunshine Act, a provision passed as part of the Affordable Care Act in 2010. It requires companies to disclose any payment or gift over $10 in value and any combination of gifts that exceed $100 for the year.
Campbell said that while the Sunshine law may help, unless the field of medicine polices itself, the relationship isn't going to change.
“Physicians have to come to the realization that it is unethical for them to pass the cost of their lunches and their trinkets on to the American people in the form of higher drug prices," he said. “(That's) just what they're doing, and it is not professional behavior and it needs to stop."
In the 12 months ending March 2012, the number of drug reps in the U.S. dropped to 72,000, down from 105,000 in 2007, according to market-research firm Cegedim Strategic Data. Spending on drug samples fell from $8.4 billion in 2007 to $6.3 billion in 2011. And the number of drug rep visits that included samples dropped 35 percent from 116 million in 2007 to 76 million in 2011. Some of that may be due to the economic downturn, and some to the large number of brand-name drugs whose patent protection has expired in recent years.
But while the number of physicians who don't see drug reps has been inching up, many doctors still vehemently defend the right of drug reps to influence them.
“I think most doctors have a subconscious desire to be OK with this," said Ahari, the former drug rep. “That's the name of the game when you're a drug rep, too. You're supposed to generate this subconscious OK with the doctor that it's not as bad as it seems, that the doctor is really independent, autonomous and can't be swayed. You cultivate that illusion."
Campbell said the relationship between drug reps and doctors represented a sort of “underground economy" that only in recent years has come to light.
The average physician, he said, receives about $5,000 a year in gifts from drug reps.
“A quarter of that will get you a brand-new, high-def TV. It probably gets you a couple of seats to the Super Bowl," he said. “When you put it in that perspective, it's hard to argue that these things aren't influential."
(Fark thread on this story):
Having had to wait for hours at doctors offices while the pharma reps get in instantly I'm getting a kick out of this thread....No really. The office my mom goes to now charges the pharma reps full price for a visit,which is $200, and makes them wait til all the actual patients are seen or tells them to just come back after business hours are over. It's hilarious to see a pharma rep get all indignant at having to wait like a normal people would. These bastards shouldn't even be allowed to come in when an office is seeing patients.
Male Doctors Earn (Much) More
While there have been some gains in closing the pay gap generally, new research published in the Journal of the American Medical Association shows that it's actually getting worse between male and female doctors, as well as among other health care workers. In the 1980s, male doctors made about 20 percent more than their female counterparts, but now that number has ballooned to 25 percent, making the gap in real dollars more than $50,000 a year. For those eager to blame this on women's "choices" and not on discrimination, I have bad news: The study controlled for hours worked and years of experience.
But as Sarah Kliff of the Washington Post explains, the difference in what kind of medicine female and male doctors practice may play a major role. Men dominate the ranks of surgeons, radiologists, and other high-paid specialties, whereas women are more likely to become family care doctors or pediatricians. The researchers couldn't say why this is but suggested it could be a matter of preference or discrimination—or some combination of the two—and called for more research to get to the bottom of this conundrum.
Regardless of the cause, however, this gap should be a major concern, not just for equality but also for the quality of our health care system. Right now, the country is experiencing a major shortage of doctors, particularly the kind of family care physicians that women are more likely to become. The primary care doctors there are, especially in rural areas, are often overworked and stressed out from handling more than their fair share of the nation's health care workload. Or, put another way: Women are taking on the necessary if unglamorous work of handling a massive number of patients who need basic doctoring, and their reward for doing what needs to be done is to get paid significantly less than their male counterparts, who are more likely to join more lucrative, specialized fields.
Instead of looking at this as an issue of simply getting more women into higher-paid specialist jobs, we should also have a national conversation about why we don't value primary care physicians and pediatricians enough. As the new health care law rolls out and the number of people who can afford to get to a doctor for basic care increases, the demand for this necessary, female-heavy work is just going to get higher. Do we need to pay these doctors more? Create incentive structures to make doing this work more rewarding? Regardless of how we tackle this problem, the fact remains that we have an opportunity to both improve the health care system and strike a blow for more gender equality, all at once. So what are we waiting for?
Dr Walmart
The idea that technology will change medicine is as old as the electronic computer itself. Actually, even older. In 1945, Vannevar Bush, the man with the vision for the National Institutes of Health, foresaw a Memex computer program that would allow access to past books and records. A lone physician searching for a diagnosis in far-flung case histories was one of the applications Bush imagined.
Medicine is an information intensive industry. Yet there’s still no medical Memex. Even though the Internet teems with health information, study after study shows that medical care often differs greatly from what the guidelines say—when there are guidelines. Doctors frequently rely on their own experience, rather than the experience of millions of patients who have seen thousands of doctors. Not only is the past lost, the present is missing. How many times has a patient received a drug that causes an allergic reaction, just because that information is not available at the time it is needed?
Bit by bit, this situation is changing. The 2009 American Recovery and Reinvestment Act (aka the stimulus bill), created the HiTech program, which allocates billions of dollars for doctors and hospitals to buy electronic health records systems. Since the program was enacted, rates of ownership of such systems have tripled among hospitals and quadrupled among physicians. In just a few years, it is reasonable to think that the entire medical system will be wired.
What will happen then? The introduction of information technology into the core operations of hospitals and doctors’ offices is likely to make health care much more like the retail sector or financial services. Health care will be provided by big institutions, in a more standardized fashion, with less overall cost, but less of a personal touch.
Health care today looks a lot like the retail sector did in the early 1980s, when clothes and household products were sold by many local stores and small chains. Quality was haphazard, prices were higher, and buyers’ experiences were mixed. Consumers had only the information they could see in the store or the Sunday paper.
Retail firms got larger when information technology became widespread. Walmart replaced the corner drug store and Amazon put the local book shop out of business because large firms can use information technology better than small ones—to manage inventories, create consistency, automate routine activities, and lower prices. Output per worker grew over 4 percent annually in the retail sector since 1995. Output per worker has fallen in health care over the same time period.
When the medical Memex finally arrives, look for health care to follow the retail track. The solo practitioner is likely to be the first to go. He or she will have to decide whether to try to become an IT manager as well as a doctor, or join a larger group of doctors. For most, the choice will be easy. The chance that a doctor over 65 works alone or in a two-person practice is about 40 percent. For young doctors, it’s less than 5 percent.
Small hospitals will suffer the same fate. Already, small hospitals that have seen the price tag of medical records systems—$20 million or more to purchase, then millions to maintain—are seeking shelter in the arms of their big neighbors. I suspect most cities will go from 10 to 15 independent institutions a decade ago to three to five large health-care systems a decade hence. These systems will do everything: checkups, nursing the elderly, treating heart failure, and dispensing allergy pills.
Who treats us, and where, will change as well. With an electronic backbone in place, one doesn’t need to see a doctor for every issue. There is little the primary care doctor does that can’t—and increasingly isn’t—being done by a nurse practitioner, perhaps at a clinic in a Walmart or CVS. Routine prescriptions for medication refills can be handled online, with an electronic doctor watching. Even high-end services can be spread widely, with specialized centers coördinating the treatment of patients far from its walls.
The biggest changes are likely to come from reimagining the role of the patient—the single most underused person in health care. Today, patients are thought of as close to a nuisance (“I told him to take his pills …”). But imagine that the patient was a participant and contributor to the medical Memex. Blood-pressure cuffs can be in the house of every person with high blood pressure; the daily pressure would be transmitted to the doctor’s electronic record and monitored by a computer for outlying values. Decision-support software might allow people with localized cancer to choose between surgery, radiation, and watchful waiting—decisions which are, today, heavily influenced by doctors (and none too objectively).
Information technology is going to change the game because it will affect how people view themselves, their illness, and the people who care for them. Amazon’s loyalty comes in no small part because it uses our past searches and the searches of people like us to predict what we will want. The customer is part of Amazon’s Memex. Health care will be less frustrating when the power shifts from sellers to buyers, and when patients are more in charge.
Some worry that a health-care system that’s concentrated like retail will drive up costs. But it’s also true that organizational changes are easier when more doctors work together in one system. According to the Institute of Medicine, inappropriate care, lack of adequate prevention, administrative waste, and prices that are too high account for nearly one-third of medical spending. Just the billing and collection operations in health care account for 25 percent of total costs; Walmart and Amazon spend an order of magnitude less on administration. Prices have fallen across the board in the retail sector.
Norman Rockwell’s classic painting, “Doctor and the Doll,” is memorable for how the doctor is comforting the little girl by listening to her doll’s heart. Norman Rockwell’s doctor knew everything about the girl and her family. The doctor of the future will not. Rather than being a living electronic record consulting an internal Memex, tomorrow’s doctor will be there to direct patients to the right specialized resources, to reassure those in need, and to comfort the terminally ill. This life may not be as exciting as the surgeons or diagnostic sleuths one sees on TV, but it is a noble calling nonetheless.
Compassion
It's not exactly something you can turn on like a tap, says Auckland psychiatrist Tony Fernando, but nothing tells a patient that you care about their problems more clearly than if you actually start crying during a consultation. It happened to Fernando the day he was talking to a psychiatric patient whose psychosis was coming back.
The patient had enough insight to know he was losing it again - that the voices in his head were returning. He was despairing. He was crying, and so was his partner. The analytical, medical, part of Fernando's brain was concerned with diagnosis. "I was thinking, 'He's getting sick again. That's annoying. The treatment isn't working.'" But at the same time he felt terribly sad for his patient, and became "quite tearful".
Later, the patient told Fernando that seeing those tears had been important. "He told me: 'I then had so much trust in the system that I didn't choose to end my life.'"
When people are in extreme distress, says Fernando, "they can feel so overwhelmed that they'll want to end it. All we can offer at that time is to say 'we are here for you and we'll go through this with you' ".
A doctor's display of compassion isn't always literally life-saving, but it's a crucial part of medical practice.
It's a core requirement in the New Zealand Medical Association's code of ethics. Its absence is frequently cited in complaints by health consumers to the Health and Disability Commission.
And its value isn't just touchy-feely, says Fernando. A recent Italian study showed patients of doctors with higher empathy (a precondition for compassion) ended up managing their diabetes better - it seems a doctor who actually cares will give advice more patiently, and a patient who likes their doctor is more likely to want to follow it.
Yet despite its obvious value, compassion in healthcare workers can all too easily go missing in action.
Consider the GP who tells a patient they have cancer as casually as a mechanic tells you the car's radiator needs replacing. Or the registrar who's halfway through telling grieving relatives their father has died, only to be called away to another case before questions have been answered.Or the doctor who starts to get snappy because their patient doesn't speak English.
When compassion falters and the patient starts to believe that the doctor doesn't really care, "it can destroy the relationship".
Which is why Fernando - an academic researcher as well as a clinician - is conducting research into compassion in healthcare, and the reasons it sometimes runs dry. Collaborating with Auckland University associate professor Nathan Consedine, Fernando surveyed hundreds of doctors in New Zealand and in the Philippines (his homeland) about what they saw as the barriers to compassionate care. The study is awaiting final review in an international journal, but in the meantime Fernando has written an article on compassion for the peer-reviewed Journal of Pain and Symptom Management.
Fernando says while has been a lot of research into so-called "compassion fatigue" in doctors, there has been very little into exactly how compassion works, and why it fails.
Many researchers have focused only on the idea that compassion runs out when doctors work too hard, use up their limited resource of compassion, and burn out.
That's only part of the story, says Fernando. He took a much wider view, developing a checklist of more than 50 possible barriers to compassion in doctors that ranged from "Feeling tired or fatigued" to "Patient is unkempt and malodorous" and "You are not sure if the patient will get better".
Boiled down, the results clearly showed there were three major barriers other than burnout:
- Distracting working environments (it's hard to focus on caring for a grieving family if your buzzer is going off every minute).
- Difficult patients (it's harder to remain compassionate if a patient is being rude or hostile or refusing to follow their treatment course).
- Clinically complex situations (the idea is that the doctor's brain switches into a more analytical and less caring mode as they try to understand an unexpected outcome or side-effect).
People working in healthcare generally are there because they have a strong motivation to help people, says Fernando, but sometimes there are so many hurdles it doesn't look that way.
"As doctors, when we experience distress or annoyance, it's very easy to focus on that. We're thinking, 'This freaking patient again?' "What the patient will notice is that you have that look on your face. They can interpret that as 'no one really cares', when in fact you're frustrated because the treatment isn't working."
Fernando says it is important to understand the difference between empathy - which is the ability to recognise, and perhaps share in, the feelings or suffering of others - and compassion, which involves the crucial additional step of actually doing something to alleviate the suffering.
As a social species, humans have evolved to experience empathy and act compassionately, says Fernando. "We don't have the wiring of snakes, who'd rather be alone and look after themselves."
When a doctor sees someone is suffering, feels that suffering and then acts on it, "it's a reflection of our true nature, which is that we're tightly connected with each other".
Anna Morrow, a general surgical registrar at South Auckland's Middlemore Hospital, experienced a serious absence of compassion in her intern year, after graduating from Otago's medical school in 2010.
The reasons weren't mysterious - burnout after underestimating how hard the job was going to be, and working month after month of punishing shifts. "Work felt like such a drain that there was very little fulfilment or joy, which made it very hard to connect with patients," says Morrow. "I know what kind of person I am. I want to help people and that motivates me, but I just couldn't get myself to do it. That's how I knew something wasn't quite right."
Things came right after some time off, some reflection and a change of role. But Morrow is still conscious of the day-to-day pressures that can cause compassion levels to dip.
Middlemore is in one of New Zealand's most culturally diverse areas, and many of Morrow's patients speak little or no English. It can get frustrating, she says, when someone is very unwell and you really need to communicate with them but an interpreter isn't available.
She has a little trick, though, for keeping herself in the right frame of mind even when she's 12 hours into a 16-hour shift, talking to the eighth person in a row with poor English, and she can hear herself starting to speak faster and lose patience.
She'll try to think about her parents, who are Korean and for whom English is a second language. She thinks: "If these were my parents, how would I want them to be talked to?" More often than not, it helps.
Fernando's research is only a first step. Coming next is a wider study across a range of healthcare workers, to figure out whether the reasons for compassion failure are different between, say, psychiatrists and GPs, or between nurses and surgeons.
The big prize, though, will be figuring out methods for actually boosting and preserving compassion levels.
Fernando says one obvious step would be to train doctors more explicitly about the barriers to compassion, so they can try to sidestep them.
What's particularly promising, though, is recent research suggesting anyone can boost their compassion by doing "mindfulness meditation" - exercises that help you to breathe calmly and become aware of the world around you right now, rather than fretting about the past and the future.
Fernando says trials at Stanford and Emory universities in the United States have shown experimental subjects taught versions of Buddhist meditations (you don't even need to sit cross-legged) found their levels of compassion increased. Fernando plans to conduct similar trials here."The studies were done on lay people not doctors, but there's no reason why you can't use those protocols to teach doctors and health providers."
Fernando says doctors routinely switch their minds into an "analytical" mode when they need to, and he believes it should be possible to teach them to do the same with compassion. When a doctor is feeling rushed, or their patient is being obnoxious, or they can't figure out why a treatment is failing, "that's when you have to flick the compassion switch".
There's another good reason for doctors to put compassion higher on their list of skills. Being compassionate is good for the doctor too. Fernando still gets a warm glow when he thinks back to the occasion he gave that psychotic patient hope.
"When I do lectures to medical students and doctors, I ask, 'At the end of the day after seeing so many patients, how many of you reflect, and count the number of patients and families you have helped that day?' "Very few will. But I say, 'Why not? It can sustain you.'"It's a very stressful vocation. It will deplete us. But we're sitting on a goldmine in terms of our own self-care. If you reflect daily on the number of people you've helped or attempted to help, then you'll feel good, and realise it's worth the effort."
A COMPASSION CRISIS?
One person watching Tony Fernando's compassion research with interest is Kiwi anaesthesiologist Robin Youngson, co-founder of Hearts in Healthcare, a group lobbying internationally for health systems to place more emphasis on compassion and "whole patient" care.
Youngson said research shows doctors who are empathetic and who listen get better results in patients.
A recent study of 20,000 diabetes patients in Italy found those who rated their doctors as empathetic had 40 per cent fewer hospital admissions. He said the medical benefit of compassion had been shown to be more powerful than that of many medicines.
Yet Youngson said medical training appeared to be pushing things in the wrong direction - one study showed that despite arriving at medical school full of altruistic passion and a desire to help people, medical students had lower levels of empathy at the end of their training than at the beginning.
Youngson said "Hearts in Healthcare" wasn't rejecting any of the technological and pharmacological benefits of modern medicine - it was simply pointing out that when guided by compassion, a doctor is able to apply their technical skills and knowledge better.
He said compassionate care was about treating not just the physical needs of a patient but also their emotional, psychological and spiritual needs, and looking at the patient as a complex individual, rather than just a collection of symptoms.
Youngson agrees the secret for boosting compassion in healthcare workers may lie in teaching them the skills of "mindfulness", which means a doctor must "set aside all their busy-ness and distraction, and for every patient be fully present and listening - with all their senses".
Hospital Food
Doctors must take more responsibility for hospital food and drink, the top patient advocate in the NHS says.
Neil Churchill argues that heads of catering should go on ward rounds to find out what patients want to eat, telling the NHS to recognise that hospital meals are “absolutely crucial” to patient care. Bad food is poor care, said Mr Churchill, director of patient experience at NHS England.
Even something as simple as making sure that frail elderly patients can have a cup of tea when they want one can make a big difference to their recovery and doctors cannot assume this has nothing to do with them, he said. Doctors’ leaders accepted that food was important, but said a wider team needed to be involved.
For frail elderly patients who will never be cured, kindness and a sense of control are often more important than any medical treatment, he said.
“People want to be in control. If you talk to old people themselves, they will say, ‘But I don’t have a cup of tea at three o’clock, I have a cup of tea at four o’clock’. And it’s part of them saying, ‘I’ve lost control of quite a lot in this environment, but this is what I do and this is what I’m going to carry on doing’. And we need to adapt to meet those needs and bring in flexibility around those patients.
“I think it’s really important. If someone leaves hospital having retained as much control as possible over what happens to them, they’re much more likely to go back to their own home and recover. If people start to feel they’ve lost control they’re on a bit of a downward slope,so the experience of care is crucial.”
Doctors needed to start realising that “these things matter”, and think about “how their ordinary working practices affect whether someone gets a cup of tea”, he said.
“One of the challenges with nutrition and hydration is to talk to doctors who, if you’re talking about a cup of tea, will say, ‘That’s a support service, I’m not interested in that’. If you say, ‘Is your patient hydrated or not?’ they will think that’s a clinical issue.
“The overarching challenge we have is to say the say food and drink that people have or don’t have is absolutely crucial to the care they get. It’s not an ancillary service, it’s not something for somebody else to worry about, it’s actually crucial to your care of that patient.”
Some hospitals spend as little as £4 per patient per day on food, while others spend more than £20. Amid widespread dissatisfaction with the quality and choice of hospital food, the Government has promised a review of standards. Mr Churchill said: “The sort of thing I really like is when heads of catering do ward rounds. They see who’s on their wards and they find out what people want. I’ve met heads of catering coming back from the shops with a tin of baked beans, which is what a patient wanted more than anything else.”
He added: “Where we go wrong sometimes is we have a segregated workforce. You’ve got doctors doing this, nurses doing that and catering people who are not seen to be part of the core.”
Paul Hodgkin, chief executive of Patient Opinion, said: “Food is really important nutritionally and emotionally to patients. Eating is also an important social time where we reaffirm our sense of belonging, so eating a nutritionally poor meal that tastes lousy whilst feeling alone and ill ..... is a triply bad for your health.”
Andrew Rowland, of the British Medical Association’s Consultants Committee, said: “It is incredibly important that patients have access to appropriate healthy food and drinks during their hospital stay.
“The nutrition of patients, particularly those who are vulnerable, is a key part of their care and treatment. This is something that the whole clinical team will consider.”
Knee Operations
Hundreds of thousands of people may be having needless knee operations, after a study found that one procedure that deals with a common knee problem worked no better than if patients had no surgery but were told that they had.
The study, conducted in Finland but published in The New England Journal of Medicine, involved people with a torn meniscus, the crescent-shaped cartilage that helps cushion the knee. A common treatment is “arthroscopic” surgery, in which small incisions are made and a doctor can use a camera to look inside and then smoothe or trim the torn meniscus.
One group in the study had the operation, but another group did not but was told that they had. A year later, both groups claimed that their knees felt better.
This has led experts to say that, because 80 per cent of meniscus tears are due to wear and old age, surgery in these cases should be limited. Other options such as physical therapy, may be just as good instead. Researchers suggest that knee surgery should be limited to younger patients and those who suffered serious sports injuries.
Arthroscopic surgery on the meniscus is the most common orthopedic procedure in the US. It is carried out 700,000 times a year, at an estimated cost of $4 billion.
Drs Editing Wikipedia
It’s a bit frightening that Wikipedia is the number one source of health information on the internet, but don’t fret. More and more of that information will be coming straight from doctors. Dr. Amin Azzam, a professor at the University of California, San Francisco School of Medicine, is doing his best to get as many doctors on Wikipedia as possible—and he’s doing it by catching them young.
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In November, Azzam launched an elective for fourth-year medical students that consists solely of editing Wikipedia articles for accuracy. When one of his former students came up with the concept over a year ago, Azzam was skeptical. But then, he told Quartz, he saw the wisdom of the idea. “A lot of professors have done it,” he said. “I’m not all that innovative. But it hasn’t been done at the medical school level, at least not in the US.” And since medical school is structured from month to month, with fourth years requiring time and flexibility to find their internships for the following year, Azzam realized it was a perfect fit. “It’s a travel-friendly elective while they’re interviewing,” he said. “You can literally do it anywhere.”
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The pilot run, he said, was a great success. Five students (believe it or not, that’s a lot of students for a fourth-year elective in medical school, according to Azzam), after being oriented to the structure and editing process of the site, spent their month targeting articles that required improvement: the most read and those with the greatest potential health impact. They put their medical knowledge—after all, Azzam said, the students were less than six months away from being doctors—to good use. Most of Wikipedia is surprisingly accurate, Azzam said, because it uses the “wisdom of the crowd” to vet information. But medical pages have catching up to do. “Medical professionals haven’t been editing Wikipedia,” he said. “In fact, we were told not to go near it.” This anti-crowdsourcing bias has kept doctors from contributing to the site’s accuracy until now, Azzam said. But current students are more open to the value of editing the articles.
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The endeavor will get a boost from two other initiatives: Wikipedia Zero, which aims to provide mobile access to the site without any data charges (specifically in developing countries), and Translators Without Borders, which plans to translate the 100 most widely read health articles on Wikipedia into 100 languages. “Now you’ll have high quality medical information available to the world’s poor, in the language of their choosing, in the way they already access the internet, and for free. That’s huge.”
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Azzam is holding his class again in the spring—and he feels it’s part of a growing shift in the medical community’s level of engagement. Azzam’s students have promised that they’ll continue to edit Wikipedia’s health articles, but since the end of the course in mid-December, only one has. Azzam says they’re “busy figuring out where they’ll be starting their careers, so we’ll have to give them some time.” The next generation of doctors may be kinder to Dr. Wikipedia, but even the youngest doctors may be too busy to give away all of their prized advice.
Telemedicine
ANDREA MAGGIONI can sit at his desk in the state-of-the-art telehealth command centre at Miami children’s hospital, press a button ... and vanish.
The glass walls of the paediatrician’s office are fitted with a special privacy element that switches from clear to opaque, blocking the view from outside. Maggioni then starts to talk softly to his patient, a boy 2,500 miles away in Lima, Peru.
Maggioni and his team of paediatric specialists are trying to resolve a dilemma: the boy’s parents have received conflicting opinions about a possible heart abnormality that may endanger their football-mad son if he undertakes strenuous physical activity.
The family is thinking of flying to Miami to let American doctors decide if an operation is necessary. The boy’s medical records, including contradictory echocardiograms, flash up on Maggioni’s screen.
A Peruvian doctor applies a Bluetooth-equipped stethoscope to the boy’s chest in Lima. The heartbeat thumps across the internet to headphones in Miami.
“They were ready to fly over,” Maggioni recalled last week. “We looked at the boy and told them not to worry about a thing. The kid’s heart was fine.”
The future of medicine has arrived in Miami, and Maggioni and his team may be checking British children soon. The Miami telehealth unit is already treating children in Peru, Ecuador, Russia, Haiti and Ukraine, and plans to expand its services to Europe, the Gulf and Asia.
Extraordinary advances in remote-controlled medical capabilities, many of them pioneered by American military surgeons unable to reach battlefield casualties, are transforming the healthcare industry.
A new generation of robotic instruments, including a virtual glove that may soon be able to convey a sense of touch down a phone line, are enabling doctors to perform almost all their medical tasks over long distance.
They are beginning to offer patients radical health alternatives that will soon be as easy to access as an app on an iPad.
“The basic idea we now know as telemedicine has been in its infancy for a few decades,” said Jacques Orces, the Miami hospital’s chief medical information officer. “But it’s really starting to explode right now.”
Miami’s spanking new $3m telehealth centre looks like a set from a James Bond film. Last week a wall of tiled video touchscreens connected the children’s hospital with clinics in Quito, Lima and Kiev. Rows of computer monitors flashed x-rays, charts and high-definition video links to doctors’ offices abroad.
The hospital is convinced there is a global market for US medical expertise and has developed an app that will eventually allow any international patient with a computer or mobile phone to connect to the Miami command centre.
It has also devised a prototype diagnostic unit known as a “pod” — a kiosk operated by local technicians that offers patients a direct connection to specialist advice. Pods may be installed in shopping malls, hotels and local health clinics around the world.
Each pod includes a Bluetooth stethoscope, an ultrasound scanner, a hand-held high-definition camera, and the capability for blood and other tests, with all the results fed via satellite, wi-fi or mobile networks to Miami.
Maggioni said: “The technology now enables us to provide the same care that we give patients upstairs in this hospital to patients in Russia, Peru and Panama.”
Even more intimate examinations may be possible with the development of a so-called “haptic” glove, from the Greek word haptikos, meaning to grasp or perceive.
The glove is designed to capture data from its movement across any human surface — external or internal — and duplicate the pressure exerted by the doctor’s fingers.
“It may be a few years down the line,” said Maggioni, “but you cannot stop this technology. One day I will put on a virtual glove in Miami and feel a patient anywhere else in the world.”
Not the least of the reasons the privately run hospital is so keen to drum up international business — and counts Britons as possible clients for diagnostic services, second opinions and follow-up care — is the American healthcare system is largely regulated by its states, all of which have different rules that currently deter cross-border medicine.
“If I’m licensed in Florida, I can’t practise medicine in Georgia,” said Orces. “It is actually easier for me to treat a patient in Quito, Ecuador, than a patient in Atlanta.”
Traditional rules governing doctors’ credentials, insurance coverage and malpractice liability have been slow to adapt to the unbounded promise of telemedicine, forcing American hospitals that have invested in remote or robotic technology to seek customers elsewhere.
In Washington DC, the Children’s National Medical Centre routinely works with patients who never leave Saudi Arabia.
The Moffitt Cancer Centre in Tampa, Florida, offers diagnostic services to Argentina, Colombia and Brazil. At the Ryder Trauma Centre in the Jackson Memorial Hospital in Miami, doctors provide 24-hour consultations to five clinics serving American contractors in Iraq.
However, the internet cannot solve all problems. “If someone has been shot in the head, it’s probably not a telemedicine case,” said Orces.
Yet the doctors also believe that medical attention delivered online will expand the options for patients ready to pay for American expertise — and change the healthcare industry as swiftly as the internet changed the media.
The concept of global medicine might well attract crooks and charlatans, but Maggioni believes the advantages will rapidly become clear to patients tired of long journeys and endless waits to see a doctor, only to be told: “Keep taking the pills.”
“Take those follow-up visits,” said Orces. “Do you really need to slog into the hospital once again? Or do you sit at home with your iPad, video-chat to your doctor, point your camera at your healing wound and tell him you’re feeling fine?”
Improving The System
MEDICAL advances mean that cancer no longer has to be a death sentence. But for too many people in Britain, it still is. We have world-class treatments, but antediluvian processes. Patients are being shunted around a system that ought to be organised around them, but where at every stage their diagnosis and treatment can be held up, sometimes fatally.
We reveal today that thousands of seriously ill cancer patients are waiting more than 100 days for urgent treatment. In some cases, people are waiting for more than a week just for the results of a scan or diagnostic test to be sent back to their GP. It is hard to imagine any other western nation that would put up with potentially lifesaving test results languishing in out-trays and postboxes.
There are many reasons why Britain lags behind most other European countries in cancer survival rates. One is the stoic reluctance of some people to visit their doctor. Another is the wide variation across the country in how early cancers are being diagnosed. While some GPs are acting swiftly to refer people for tests, others are failing to spot cancer even after a patient has made repeated visits: as the tragic cases of Max Earley and Peter Standing demonstrate on these pages.
The cumbersome relationship between different parts of a disjointed system is also a problem. People wait to see the GP; then they wait for the GP to refer them to hospital. They wait for a test to be done. Then they wait for the results of that test to be sent back to their GP. If that test comes back clear, the GP may have to start the whole cycle again.
One merit of this system is that it reduces over-testing. GPs have long played an important rationing role in the NHS. But a reluctance to refer patients for what are often quite cheap tests will be a false economy if it means people develop late-stage cancers that are hard to treat and cure.
People whose cancer is terminal may end up on drugs that prolong their life by a few desperate months, or occasionally years. Yet those drugs can be very expensive. And they would have been unnecessary, had the cancer been spotted earlier.
The cancer drug budget is £2bn a year, compared with a radiotherapy budget of about £350m. Yet 40% of major cancers are cured by radiotherapy, about half by surgery, and just 11% by chemotherapy.
Let us imagine, for a moment, what the system might look like if it was truly organised around the patient. First, if doctors were connected to each other by something more sophisticated than the Royal Mail. What if a woman who went to see her GP with a skin lesion could sit with the GP while he called a consultant on Skype to take a look? If the consultant deemed it to be shingles or eczema, this could obviate unnecessary tests. If he suspected skin cancer, he could expedite the tests.
The NHS is, sadly, a world way from such a joined-up state. Patients’ medical records are not even routinely available to hospitals. And hospitals are paid by the number of patients they treat inside their building. There is no payment for consultants having a time-saving phone conversation with the GP, or preventing patients from making needless journeys.
There are ways to bridge the gaps between patients, GPs and hospitals. In Doncaster, a scheme called “Cough, Cough” improved the number of early lung cancer diagnoses by encouraging patients to visit their GP if they had been coughing for more than three weeks, and by briefing doctors and radiologists to expect more demand for appointments and x-rays. The scheme raised the number of people diagnosed with lung cancer from 32 in 2007, to 54 in 2008. Some of the GPs with the best results were those who had initially been most sceptical.
Breast cancer mortality rates are also plummeting because of more joined-up thinking. GPs are making immediate referrals for testing if they see certain symptoms, and those tests are being expedited in hospitals.
There is no doubt that financial and demand pressures are straining cancer (and other) services. But the variability of diagnosis and treatment around the country is far too great to be explained by this alone. We know that faster diagnosis and treatment can make the difference between life and death: and that is what the Sunday Times campaign is focusing on. We also believe that faster diagnosis could actually save money, as well as lives.
The strapline of the Doncaster Cough campaign was “We [the doctors] are waiting. You shouldn’t.” That is the kind of NHS The Sunday Times is campaigning for.
Unhappy Doctors
By the end of this year, it’s estimated that 300 physicians will commit suicide. While depression amongst physicians is not new - a few years back, it was named the second most suicidal occupation - the level of sheer unhappiness amongst physicians is on the rise.
Simply put, being a doctor has become a miserable and humiliating undertaking. Indeed, many doctors feel that America has declared war on physicians—and both physicians and patients are the losers.
Not surprisingly, many doctors want out. Medical students opt for high-paying specialties so they can retire as quickly as possible. Physician MBA programs—that promise doctors a way into management—are flourishing. The website known as the Drop-Out-Club—which hooks doctors up with jobs at hedge funds and venture capital firms—has a solid following. In fact, physicians are so bummed out that 9 out of 10 doctors would discourage anyone from entering the profession.
It’s hard for anyone outside the profession to understand just how rotten the job has become—and what bad news that is for America’s healthcare system. Perhaps that’s why author Malcolm Gladwell recently implied that to fix the healthcare crisis, the public needs to understand what it’s like to be a physician. Imagine, for things to get better for patients, they need to empathize with physicians—that’s a tall order in our noxious and decidedly un-empathetic times.
After all, the public sees ophthalmologists and radiologists making out like bandits and wonder why they should feel anything but scorn for such doctors—especially when Americans haven’t gotten a raise in decades. But being a primary care physician is not like being, say, a plastic surgeon—a profession that garners both respect and retirement savings. Given that primary care doctors do the work that no one else is willing to do, being a primary care physician is more like being a janitor—but without the social status or union protections.
Unfortunately, things are only getting worse for most doctors, especially those who still accept health insurance. Just processing the insurance forms costs $58 dollars for every patient encounter, according to Dr. Stephen Schimpff, an internist and former CEO of University of Maryland Medical Center who is writing a book about the crisis in primary care. To make ends meet, physicians have had to increase the number of patients they see. The end result is that the average face-to-face clinic visit lasts about 12 minutes.
Neither patients nor doctors are happy about that. What worries many doctors, however, is that the Affordable Care Act has codified this broken system into law. While forcing everyone to buy health insurance, ACA might have mandated a uniform or streamlined claims procedure that would have gone a long way to improving access to care. As Malcolm Gladwell noted, “You don’t train someone for all of those years in [medicine]… and then have them run a claims processing operation for insurance companies.”
To make ends meet, physicians have had to increase the number of patients they see. The end result is that the average face-to-face clinic visit lasts about 12 minutes.
In fact, difficulty dealing with insurers has caused many physicians to close their practices and become employees. But for patients, seeing an employed doctor doesn’t give them more time with the doctor—since employed physicians also have high patient loads. “A panel size of 2,000 to 2,500 patients is too many,” says Dr. Schimpff. That’s the number of patients primary care doctors typically are forced to carry—and that means seeing 24 or more patients a day, and often these patients have 10 or more medical problems. As any seasoned physician knows, this is do-able, but it’s certainly not optimal.
Most patients have experienced the rushed clinic visit—and that’s where the breakdown in good medical care starts. “Doctors who are in a rush, don’t have the time to listen,” says Dr. Schimpff. “Often, patients get referred to specialists when the problem can be solved in the office visit.” It’s true that specialist referrals are on the rise, but the time crunch also causes doctors to rely on guidelines instead of personally tailoring medical care. Unfortunately, mindlessly following guidelines can result in bad outcomes.
Yet physicians have to go along, constantly trying to improve their “productivity” and patient satisfaction scores—or risk losing their jobs. Industry leaders are fixated on patient satisfaction, despite the fact that high scores are correlated with worse outcomes and higher costs. Indeed, trying to please whatever patient comes along destroys the integrity of our work. It’s a fact that doctors acquiesce to patient demands—for narcotics, x-rays, doctor’s notes—despite what survey advocates claim. And now that Medicare payments will be tied to patient satisfaction—this problem will get worse. Doctors need to have the ability to say no. If not, when patients go to see the doctor, they won’t actually have a physician—they’ll have a hostage.
But the primary care doctor doesn’t have the political power to say no to anything—so the “to-do” list continues to lengthen. A stunning and unmanageable number of forms—often illegible—show up daily on a physician’s desk needing to be signed. Reams of lab results, refill requests, emails, and callbacks pop up continually on the computer screen. Calls to plead with insurance companies are peppered throughout the day. Every decision carries with it an implied threat of malpractice litigation. Failing to attend to these things brings prompt disciplining or patient complaint. And mercilessly, all of these tasks have to be done on the exhausted doctor’s personal time.
Almost comically, the response of medical leadership—their solution— is to call for more physician testing. In fact, the American Board of Internal Medicine (ABIM)—in its own act of hostage-taking—has just decided that doctors should be tested not every ten years, but every two years. If a physician doesn’t comply by the end of this month, the ABIM will strip away the doctor’s board certification status.
In an era when nurse practitioners and physician assistants have shown that they can provide excellent primary care, it’s nonsensical to raise the barriers for physicians to participate. In an era when you can call up guidelines on your smartphone, demanding more physician testing is a ludicrous and self-serving response.
It is tone deaf. It is punitive. It is wrong. And practicing doctors can’t do a damn thing about it. No wonder doctors are suicidal. No wonder young doctors want nothing to do with primary care.
But what is a bit of a wonder is how things got this bad.
Certainly, the relentlessly negative press coverage of physicians sets the tone. “There’s a media narrative that blames physicians for things the doctor has no control over,” says Kevin Pho, MD, an internist with a popular blog where physicians often vent their frustrations. Indeed, in the popular press recently doctors have been held responsible for everything from the wheelchair-unfriendly furniture to lab fees for pap smears.
The meme is that doctors are getting away with something and need constant training, watching and regulating. With this in mind, it’s almost a reflex for policy makers to pile on the regulations. Regulating the physician is an easy sell because it is a fantasy—a Freudian fever dream—the wish to diminish, punish and control a disappointing parent, give him a report card, and tell him to wash his hands.
To be sure many people with good intentions are working toward solving the healthcare crisis. But the answers they’ve come up with are driving up costs and driving out doctors. Maybe it’s too much to ask for empathy, and maybe physician lives don’t matter to most people.
But for America’s health to be safeguarded, the wellbeing of America’s caretakers is going to have to start mattering to someone.
Have You Washed Your Hands?
Doctors and nurses have been told to wash their hands more to cut “unacceptable” rates of hospital infections which make hundreds of thousands of patients even sicker.
Patients should not be afraid of asking staff if they have washed their hands before being treated, the National Institute for Health and Care Excellence says.
One in sixteen patients will pick up an infection during their NHS treatment and the health service must do more to bring this figure down, the watchdog says in guidance today.
While hospitals have made good progress in the fight against superbugs, NICE warned that there had been a lack of focus on the common problems which make up the vast majority of healthcare infections.
“Healthcare associated infections are still a very real threat to patients,” Professor Gillian Leng, deputy chief executive of NICE, said. “It is unacceptable that infection rates are still so high within the NHS. Infections are a costly and avoidable burden. They hinder a patient’s recovery, can make underlying conditions worse, and reduce quality of life.”
About 300,000 people acquire an infection while using the NHS in England every year, and Professor Lang said this number had remained “pretty static” in recent years. Almost a quarter of them are chest infections, with urinary tract infections and surgical-site bugs also very common.
Checklists must be followed by staff putting in drips and catheters or taking blood, while doctors and nurses must wash their hands before and every direct contact with patients, NICE recommends.
Antibiotics should not be prescribed for coughs, sore throats or chest infections to slow the evolution of bugs that are resistant to the drugs, its guidance says. They should not be prescribed over the phone except in “exceptional cases”.
Professor Leng said that hand-washing “is basic and people are supposed to be doing it but we know that when staff are busy or stretched it can be something that gets left out. So this quality standard is to reaffirm the importance of this”.
She said that some staff still did not appreciate how often they needed to wash their hands, which should be “before and after every episode of direct contact or care, any physical aspect of treatment or administration of medication. If in doubt, wash your hands, that’s the main message.”
Patients should “cut a bit of slack” to staff taking time to wash their hands, she said. “Patients might want to be proactive and say ‘I assume you’ve washed your hands’. Patients should feel they can ask politely about all aspects of their care, because they are the ones that are potentially at risk and it’s entirely legitimate to make polite inquiries. And I would hope staff would be receptive to that.”
A crackdown on hospital superbugs has brought an 18-fold fall in MRSA infections since 2006, with C. difficile infections down fivefold. Professor Leng said that this kind of attention must now be paid to ordinary bugs. “Some of the other general infections are not coming down as fast as we would like,” she said.
Tom Sandford, of the Royal College of Nursing, said: “Infection prevention and control are key to patient safety and need to be prioritised by every health service organisation. It is vital that all healthcare workers are actively involved in upholding infection control and hygiene standards.”
Checklists
A simple procedure borrowed from the airline industry and a bit of humility has ensured many more patients survive
The biggest problem in giving patients the best medical care is the sheer complexity of what we’re trying to do. The case of a three-year-old girl taught me how to take care of somebody who has drowned.
She had been out for a walk with her parents one winter day in Austria. It was one of those terrible things: the parents lost sight of her for a moment and the next thing, they saw her on the surface of an icy fishpond. She fell through the ice and was gone. They jumped in but could not find her. It was more than 30 minutes before they felt a limb at the bottom of the pond and pulled her out. But, of course, by then she wasn’t breathing.
They called the local emergency services, and the operator told them how to start doing cardiopulmonary resuscitation, or CPR. The rescue team arrived eight minutes later and took the first vital signs. The girl’s temperature was just 66F, more than 30F below normal. She had no pulse and her pupils were fixed wide open. That means the brain is gone.
She was flown by helicopter to the nearest hospital. They bypassed A&E and went straight to the operating theatre to begin warming her. Two hours later, they’d raised her temperature by ten degrees — and her heart began to beat. One organ back. They then tried putting her on a ventilator. But it didn’t work. Her lungs were too full of pond water and debris for oxygen to get through.
So they tried a different machine. It’s an artificial lung called an extracorporeal membrane oxygenator. For this, they had to open her chest with a saw and plug the machine directly into her heart, but it got oxygen to her bloodstream. For 24 hours, the team worked to clear her lungs, and finally the oxygen got through. Two organs back.
After two days, they’d got all her organs back except one: her brain. The neurosurgery team drilled a hole in her skull and inserted a probe to gauge the pressure in her brain so they could dial her fluids and drugs up and down until they lowered it. She remained comatose for a week. But then her pupils began to react to light. Then she began to breathe on her own. And then one day, she simply awoke. Her eyes opened and she was there.
Two weeks later, she went home. And two years later, they found her physical and neurological capabilities were exactly as they were supposed to be. She was, in other words, after all of that, just like any other five-year-old girl that you and I know.
Her lucky escape was 15 years ago. The extent of what was required to pull it off seemed almost impossible. There were dozens, probably hundreds, of people involved in her care, and any one of them could have made a small mistake. If one nurse forgot to wash his or her hands, it would have been over.
The 20th century has given us a volume of knowledge and skill greater than any individual can hold in their own head or know how to deliver alone. How do we solve that? Simply telling or ordering people to do certain things isn’t very effective. We need to make doing the right thing the norm. We do that through systems. And those systems can be as simple as a checklist. The important thing is to make it easy for everybody to follow.
My team was approached by the World Health Organisation several years ago with a project designed to reduce deaths in surgery. I thought: how can you possibly do that? But we worked with a safety engineer from the airline industry to design what emerged as a checklist. It had some dumb things — “Do you have the right side of the body you’re operating on?” — but the most powerful components were “Does everybody on the team know each other’s name and role?” and “Has the surgeon briefed the team on the goals of the operation?”
Only then do you begin.
After we had tested the checklist in eight cities around the world — including St Mary’s Hospital in west London — the average reduction in deaths was 47 per cent. In Scotland, it has saved the lives of 9,000 people over the past four years.
Clearly, it’s not just the checklist. The hardest part is making even the most experienced people feel enough humility to accept that they can make mistakes. We fear these kinds of system. We fear that it’ll lead to a loss of daring, a loss of heroism.
When we surveyed surgeons three months after they introduced checklists, we found that 20 per cent or more really disliked them. Then we asked: “If you’re having an operation, would you want the team to use the checklist?” And 94 per cent did. What you discover is that discipline makes daring possible.
When I read about the drowned girl, I was puzzled to know how they discovered what to do in such a small hospital — it was Klagenfurt in Austria. Every year, large numbers of people were admitted after being caught in avalanches, which is like being drowned. Markus Thalmann, a cardiac surgeon at the hospital, was convinced he could save them.
He had a plan. It required speed. You needed an array of things at the ready: the pump, the trauma surgeon, cardiac surgeon, anaesthetist. But there was always a problem: the anaesthetist would be at home 30 minutes away, or the pump wasn’t be ready. He tried to fix things in the usual way that surgeons do: by yelling at everyone.
That, of course, didn’t work. So he decided to try something new. He made a checklist. Interestingly, he gave it to the person who had the least power in the system: the telephone operator. When the operators got the call, they had the authority to activate the checklist. They could call the doctors at home and tell them, “You need to come in now.” They’d tell the engineer to get the machine ready. And this was the way they had their first survivor — that little girl. Since then, I learnt, they’d had many. He told me about the most recent.
A mother driving her daughter on a mountain road lost control of her car, which crashed through a barrier. The mother died instantly. The car fell into a river and the emergency crews arrived just in time to see it disappear under the water. They managed to cut open the car and get the girl out. By then she had gone for more than half an hour without breathing.
But, after that, the system at the hospital went like clockwork. The teams were ready. They went straight to the operating theatre. As her body warmed up, her heart came back. In the ICU, a ventilator, fluids and drugs kept her going while the rest of her body recovered. The next day, the doctors removed her lines and tubes. The day after that, she was sitting up in bed, ready to go home.
Doctors vs Specialists
The doctor is in. The senator is out.
Rand Paul, the ophthalmologist and Republican senator from Kentucky, officially launched his presidential campaign on Tuesday, complete with a little rebranding. Paul's Twitter handle had previously been “@SenRandPaul.” That old profile is gone. Now, his handle is “@RandPaul” and the official name on the account is “Dr. Rand Paul.” Paul’s campaign website refers to him throughout as Dr. Paul and the official campaign biography focuses on his work as a physician -- including a history of performing surgery at deep discounts, or at no charge, for people without the ability to pay for it.
Playing up Paul’s medical background has several benefits. As my colleague Scott Conroy has observed, it burnishes Paul’s image as an outsider -- somebody who's not a politician at heart, who will challenge the Washington establishment and the way it normally conducts business. Paul often refers to himself as a "country doctor," as a way to sand down whatever sheen of elitism the title might convey -- and, perhaps, to conjure up nostalgic images of the bygone America that ignites conservative enthusiasm.
But the “doctor” honorific has one other purpose as well. It lends Paul an aura of compassion, something that most physicians have and that Paul, a libertarian who has advocated reducing government spending on the poor and elderly, could desperately use. It’s no coincidence that the campaign bio notes, in bold, near the end, “A large part of Rand’s daily work as an ophthalmologist was dedicated to preserving the vision of our seniors.”
Paul’s charitable work seems to be genuine and, for the people who benefit from it, of real life-changing value. But if you’re looking for insights into Paul’s policy priorities -- and what his presidency would actually mean for people in need -- you need to be careful about how you interpret his professional history.
The fact that he’s a doctor tells you something. The fact that he’s an ophthalmologist tells you more.
That’s because the medical profession has a well-known, well-documented divide when it comes to politics. On one end are specialists. Think orthopedists, anesthesiologists, plastic surgeons, radiologists and, yes, ophthalmologists. They tend to be conservative and support Republicans, whether you measure this by self-described political affiliation or by campaign contributions.
On the other end of the spectrum are general practitioners -- pediatricians, family doctors and internists. Psychiatrists usually fall into this category, as do many oncologists and obstetricians. They tend to be liberal and support Democrats. (Greg Dworkin, a pediatrician who writes for Daily Kos, had a great write-up on this recently.)
The split makes sense if you understand the very different work these doctors perform -- and the money they get paid for it. Specialists' clinical interactions tend to be episodic: A surgeon called in to remove a gall bladder, repair a ligament or install a stent is probably meeting his or her patient for the first time -- and may have little contact, or even none at all, with that patient once the procedure and rehabilitation are over. Such encounters may reinforce a more individualistic, atomistic view of one's relationship with patients and one's role in society.
Among physicians, specialists and surgeons have the highest incomes and, according to a Rand Corp. study, are the most likely to face a malpractice claim. Not surprisingly, they gravitate to the party that puts a high priority on lowering taxes for the wealthy, reducing malpractice liability and generally pushing the government out of health care.
Ophthalmologists in particular are also fond of talking about LASIK surgery, something they perform on a cash-only basis, as proof that health care would be cheaper without government interference.
Generalists, on the other hand, don’t deal with body parts. They deal with whole bodies. And inevitably, that approach forces them to consider how patients live. It’s the generalists who end up asking about conditions at home, who see connections between lifestyle and health, and who think about the ways in which economic insecurity affects long-term health. (Pediatricians are frequently the first ones to pick up signs of developmental delays and mental health problems, both of which can be products of struggles at home.)
Overall, these doctors have lower incomes than specialists and surgeons -- and are less likely to face malpractice claims. Their kindred spirits are the politicians who put a high priority on making health insurance more easily available and helping people pay for basic needs like food and shelter -- even if that means higher taxes and, yes, bigger government.
These trends probably reflect a great deal of self-selection. Medical students who care more about making money and operating free of government interference are more likely to pursue surgical training. Those who care more about improving general health, particularly among the poor, gravitate to fields like pediatrics. Choices about medical careers tend to go hand in hand with other variables that correlate with political affiliation, such as gender. Men (who are more likely to vote Republican) still dominate the surgical fields, while women (who are more likely to vote Democratic) make up the majority of primary care doctors.
You’ll find plenty of exceptions to these crude categories. But Rand Paul is not one of them. His medical profile lines up perfectly with his ideological profile -- not to mention with the policies he’s proposed. As Dylan Matthews has noted at Vox, the budget proposals that Paul has endorsed are more extreme than anything else you’ll see in this presidential campaign. They would effectively dismantle Medicaid, Medicare and the Affordable Care Act, among others -- forcing literally millions to lose health insurance and endure economic hardship. The vast majority of these people would be elderly or poor or both.
As a surgeon doing charity work, Paul could help a few of these people. The rest would be on their own.
Weekend Work
A report published today in the British Medical Journal (BMJ) suggests there is a “weekend effect” that extends beyond just Saturday and Sunday and that the number of excess deaths is higher than previously thought.
The study found there was a double whammy, with hospital services winding down on Friday and the backlog of patients waiting for treatment over the weekend then causing disruption to hospital services on Monday morning.
The analysis put the number of excess deaths over the weekend period at 11,000. Previous reports that looked just at Saturday and Sunday had figures ranging from 4,000 to 6,000.
The findings follow a Sunday Times campaign for the NHS to offer the same standard of care at the weekend as during the week and will increase pressure on NHS consultants to change their working week to include weekend shifts.
The report comes on the eve of negotiations this week between Jeremy Hunt, the health secretary, and the BMA, the doctors’ union, over the consultants’ contract. The government wants consultants to drop a clause that allows them to opt out of nonemergency work at the weekend or after 7pm.
Sir Bruce Keogh, the medical director of NHS England, who was involved in the study, said: “The moral and social case for action is simply unassailable and there is widespread clinical consensus about that. Change always brings practical difficulties that must be tackled but we cannot duck the facts.”
The BMJ figures show that patients are 15% more likely to die if they are admitted on a Sunday, 10% more likely to die if admitted on a Saturday, 5% more likely to die if admitted on a Monday and 2% more likely to die if admitted on a Friday, compared to admissions on Tuesday, Wednesday or Thursday. Patients are more likely to die when they are admitted at the weekend even when the severity of their illness is accounted for.
The analysis, which was carried out by University Hospitals Birmingham NHS Foundation Trust and University College London, with the involvement of Keogh, examined the effect of hospital admission day on death rates across NHS England hospitals for 2013-14.
A separate paper, by the Royal College of Surgeons (RCS), has also concluded that the risk of death is higher for patients admitted at the weekend. The RCS said staffing levels and access to scans and tests were worse for all patients at the weekend, including those needing emergency treatment.
Clare Marx, president of the RCS, said: “Patients who need to be treated at the weekend are less likely to be seen by the right mix of junior and senior staff and experience reduced access to diagnostics.” Marx said it was not standard practice for consultants to work nights and at weekends, even in high-risk emergency care: “This has to change. An example is the evidence of a recent audit of patients needing emergency bowel surgery, demonstrating that both consultant surgeons and anaesthetists were present for just 41% of operations after midnight.
“The same study showed that some of the sickest patients were undergoing their surgery at this time.”
The BMJ results confirm findings from an earlier analysis that the authors carried out for 2009-10. Earlier studies have shown that patients are 16% more likely to die if they are admitted on a Sunday compared with a Wednesday.
The government argues that as no other hospital staff, including nurses, midwives and junior doctors, can opt out of working at the weekend, there should be no exception for consultants.
The average salary for a hospital consultant is £118,000. This is in the top 2% of earners in the country. The NHS often has to pay expensive rates for weekend work on top of these salaries to consultants who have no contractual obligation to do nonurgent work at weekends.
In 2013 the Commons public accounts committee criticised this arrangement, saying some trusts were paying up to £200 an hour. The BMA argues that 88% of consultants already work on call from home in the evenings and at weekends. It says they receive an average of three telephone calls to their homes in the evenings and five telephone calls when they are on call over the weekend.
Over the course of a week, almost half of those consultants on call in the evening had to go into the hospital to deal with an emergency. Twothirds of consultants on call at the weekend had to attend the hospital at some point.
The RCS says consultants need to be in hospital at weekends to supervise junior staff and make decisions about patients’ treatment.
Fixing Mistakes
Doctors and nurses who admit to their mistakes will be promised immunity under a new regime that seeks to end a blame culture in the NHS.
Jeremy Hunt, the health secretary, warns that medical staff are hiding their errors amid fear of punishment. He said that they needed “safe spaces” free from professional consequences for telling the truth.
In an attempt to make the NHS the safest healthcare system in the world, a new investigation branch modelled on airline accident inquiries will be given legal powers to keep revelations secret. “What they say cannot be disclosed except by a court order. It cannot be used by the GMC [General Medical Council], it cannot be used in a disciplinary proceeding, it can’t be used in legal action unless there’s a court order,” Mr Hunt told The Times. “There’s no hiding place for gross negligence but if you just make a human mistake we need to learn from it.”
Local hospital investigators could also be granted powers to offer immunity under new legislation, Mr Hunt said. Regulators and disciplinary panels could still punish staff if they discovered the same facts independently.
Under the new regime, families will be encouraged to raise suspicions over how their relatives die.
A dishonesty league table that names and shames hospitals which fail to admit how often they harm patients has been created in an effort to end the “scandal” of thousands of needless deaths each year. The table shows serious concerns over almost half of hospitals, with East Sussex healthcare trust rated the least honest about mistakes.
Mr Hunt argued that airlines became ten times safer when they stopped sacking pilots after crashes and started to encourage them to admit mistakes so that their colleagues could learn.
Doctors and nurses were “worried that if they’re open about something that went wrong they might be individually blamed when actually there was a system-wide issue that meant it was very difficult for an individual not to make a mistake,” Mr Hunt said.
“So if someone is injected with the wrong medicine with fatal consequences, that is a mistake. But if the label on the syringe was an identical colour and the two medicines were right next to each other and the doctor was in a rush and he was handed the wrong medicine by a stressed nurse, then in that situation what you want to say is: ‘How can we change the system so that no one is ever given the wrong medicine in that situation again?’.”
He promised that independent medical examiners would review the causes of all deaths, a change first urged by the Harold Shipman inquiry more than a decade ago. A fight over the cost of the scheme delayed the change, he said.
While acknowledging that all 500,000 deaths a year could not be studied in detail, he pointed out that a report on the suffering of hundreds of patients under the Mid Staffordshire trust had identified families as an “early warning system” for problems. Doctors might study one death in more detail “because the relatives have made a noise about it and then you’ll be much quicker at uncovering the Mid Staffs style problems,” Mr Hunt said.
“To deliver a safer NHS for patients seven days a week, we need to unshackle ourselves from a quick-fix blame culture and acknowledge that sometimes bad mistakes can be made by good people. It is a scandal that every week there are potentially 150 avoidable deaths in our hospitals and it is up to us all to make the need for whistleblowing and secrecy a thing of the past.”
James Titcombe, whose son Joshua died after a failure and cover-up at the Morecambe Bay trust and who advised on the changes, said: “Time and time again, we hear the promise that ‘lessons will be learnt’. Yet far too often the same mistakes are repeated.”
Mark Porter, chairman of the British Medical Association council, said that reforms must “overcome an oppressive, management-driven culture which often deters openness and transparency”.
Medical Errors
A tragedy is unfolding in healthcare with an estimated 8,000 people dying every year in English hospitals because of avoidable mistakes. This places preventable medical error as one of the nation’s biggest killers, even outscoring traffic accidents.
Why is this happening on such a scale? A common explanation is the “blame culture”, in which the rush to scapegoat professionals who have been let down by defective processes, such as poor labelling on drugs, has created widespread fear and undermined reporting.
This is why it is so important to have independent investigations and legally protected safe spaces where professionals can speak up, such as came into effect in the NHS last Friday. Modelled on the aviation industry, the Health Safety Investigation Branch will play a vital role in creating greater transparency.
Yet I want to focus on a different problem: ego. Senior clinicians who have reached the top of the hierarchy are revered by their juniors and by patients, and the culture of healthcare is, to a large extent, constructed upon their status. But this sets up a formidable psychological barrier: what actually happens when they make mistakes?
Consider, for a moment, the language used after medical error. Each tragedy is a precious learning opportunity, and with open reporting and honest evaluation, the same mistake can be prevented from happening again. But instead of ’fessing up, senior doctors all too often engage in creative obfuscation. As John Banja, a health academic, put it: “Health professionals are known to be immensely clever at drawing attention away from an error by the language they use. Their facility with linguistic subterfuge is cultivated during their residency years or on special training.”
The formulations used by doctors to self-justify are well studied. Instead of admitting to a mistake, they spin it as “just one of those things” or “an unavoidable sideeffect”. Doctors “learn how to talk about unanticipated outcomes until a ‘mistake’ morphs into a ‘complication’ ”, Nancy Berlinger, a research scholar at the Hastings Center in New York, has written. A medical journal study found that doctors “narrow the definition of a mistake so that they disappear, or are seen as inconsequential”.
This process of creative denial not only protects the ego, but also “justifies” non-disclosure. After all, why admit to an error if it wasn’t really an error, but merely a “complication”? A European study discovered that although 70 per cent of doctors accepted they should admit mistakes, only 32 per cent did. A study of 800 patient records in three leading hospitals found more than 350 errors. How many were voluntarily reported? Only four.
This is about more than healthcare, however. One of the most paradoxical findings in social science is that high-reputation economists (as measured by how often they visit TV studios) make the worst predictions. Why? Because with really famous economists, the ego comes into play. Instead of learning when they make errors of prediction, thus revising or enriching their assumptions, they engage in tortuous rationalisations as to why they were right all along.
Sydney Finkelstein, professor of management at Dartmouth College, New Hampshire, has found the same in business: “The higher people are, the more they tend to supplement their perfectionism with blanket excuses, with CEOs usually being the worst of all.”
The hallmark of successful institutions is that they invert the operation of the ego. While their professionals may be assertive and confident, they also have the humility to recognise that in a complex world they do not understand everything. This orients the mind towards learning from errors. Google, for example, is constantly testing its assumptions, running 12,000 experiments a year. Team Sky, the cycling team, has a system of “marginal gains”, scrutinising all weaknesses to turn them into strengths. Aviation learns from every single crash thanks to black boxes, and has driven down the accident rate for major airlines to one crash for every 8.3 million take-offs. Ego, in these places, is bound up not with justifying the status quo, but in the speed and dexterity of adaptation.
The scientific revolution happened for the same reason: instead of getting irate (or murderous) when people such as Galileo demonstrated that existing theories were wrong (about the Earth, say, being the centre of the universe and 6,000 years old), scholars engaged with this “error data”. To put it starkly: the dawning of science, one of the great watersheds in history, occurred because they started to do something they had resisted for centuries: learn from mistakes.
Now let us return to healthcare. Until recently, central line (catheter) infections killed thousands of people every year. This was described as “just one of those things” until a pioneering doctor investigated. He found that a key problem was that clinicians were not sterilising the catheter site, and so he recommended a solution — a checklist. What happened? Deaths fell to zero.
This is the mindset we need in the NHS. While many doctors are superb, a critical mass are held back by the dangers of ego. As the philosopher Karl Popper put it: “True ignorance is not the absence of knowledge, but the refusal to acquire it.”
Too Many Misleading Tests
Diagnostic tests are becoming too good for our own good, warns H. Gilbert Welch, who believes it is time to reassess what medicine is for.
IN THE 1970s, H. Gilbert Welch drove an ambulance as a college job in Boulder, Colorado, often blaring out Elton John’s Someone Saved My Life Tonight. Wanting to save lives led him to study medicine, but he came to realise that saving lives wasn’t as clear cut as he thought. Sometimes, he found, it can be better to do nothing.
Welch became a physician and academic researcher, and he has spent the last 25 years warning of the dangers of overzealous medicine. He worries that doctors are detecting problems too early, convincing healthy people they are sick, and treating them too aggressively.
His latest research, published in December in the Journal of the American Medical Association, is a case in point. He has found that in US hospital regions with high rates of CT scans – which are typically ordered to check the lungs and abdomen – many more kidneys are removed. So what is going on? When doctors look at the images, they can see the kidneys too, and often stumble on innocuous cancers, says Welch. “It’s leading some people to be treated for disease that was never going to bother them.” And at significant risk: 1 in 50 of those who underwent the surgery died within a month.
A professor at the Dartmouth Geisel School of Medicine who only stopped practising medicine five years ago, Welch has written three books highlighting unnecessary medical care, as well as dozens of journal articles and call-to-arms pieces in newspapers such as The New York Times. He travels the globe to speak to fellow doctors and researchers. With biomedical companies designing ever more tests, such as breath-tests for cancer, the problem seems poised to worsen. “It’s a very frothy industry right now,” says Welch.
The JAMA study was inspired by a patient we will call Robert, who came to Welch at a Veterans Affairs medical centre in Vermont, complaining of lingering hoarseness. Welch referred him to a specialist, who found a small tumour on his vocal chord. The tumour was removed and his hoarseness went away. Then Welch had to call Robert back. Somewhere along the line, a CT scan had been taken of Robert’s lungs, which showed his chest was fine but revealed a cancer in his kidney. This was, in medical terms, an incidentaloma. “He was just so funny about it,” Welch recalls. The urologist wanted the kidney out, and Robert said to Welch, “C’mon, you’re kidding me, doc. You just did surgery in my throat and now you’re going after my kidney? Let’s you and I talk about this.” So Welch challenged the urologist. He followed the cancer for 10 years with imaging; it stayed the same size. Robert eventually died of pneumonia.
“I was taught in medical school that once a cancer was formed, it was going to relentlessly progress to metastatic cancer,” says Welch. “We now know it’s a whole lot more complex than that.” Cancers can grow quickly and slowly; some even vanish on their own. There are the bird cancers, which have already spread before tests notice them; the rabbit cancers, which can be treated before they spread if caught early; and the turtle cancers, which never spread. The problem, says Welch, is “there’s a whole lot of turtles out there”, but doctors and patients alike want to treat all cancers.
A new test that worries Welch is liquid biopsy, which identifies pieces of “cell-free DNA” in the blood to determine whether someone has cancer, and how bad that cancer is. “You think, ‘How could you possibly argue with that?’ until you look under the hood,” says Welch. We all have cell-free DNA in our blood, and liquid biopsy analyses about 2000 different mutations in this DNA. An algorithm then determines what thresholds and combinations of mutations equal cancer. Welch worries about a future in which people are told: “You have a positive liquid biopsy, but we don’t know where the tumour is, so we’re gonna have to start looking.”
Richard Baker, a radiologist in Madison, Wisconsin, worked with Welch at the Veterans Affairs centre. As a result of Welch’s influence, and against his own financial interest, Baker often dissuades his patients from getting a biopsy on their thyroids after imaging has found a nodule, even though that is why they are seeing him. “Thyroid biopsies are skyrocketing in this country,” says Baker, yet deaths from thyroid cancer have always been rare in the US, and treatment carries risks of its own. “These are difficult ideas for both patients and physicians to accept,” he says.
In 2016, Welch reported that screening in the US had found many more non-progressing breast cancers in the 20 years up until then, but helped very little in catching fast-progressing cancers early on. In earlier work looking at women who were screened every year for a decade from the age of 50, he found that for every 1000 of those women, roughly one will avoid death through breast cancer, more than 500 will have at least one false alarm and 10 will be treated needlessly.
Welch advocates for reductions in screening mammography. Taking this sort of position doesn’t win popularity contests, and Welch decided early on to direct all profits from his books to charity to avoid the criticism that he is making provocative arguments to cash in.
“[Welch] has had an enormous negative impact on the practice of medicine,” says Daniel Kopans, a professor of radiology at Harvard University. He disagrees with Welch’s research on a number of methodological points, and on his larger conclusions as well. “Addressing overtreatment by stopping screening is like removing the engines from our cars to stop automobile accidents.”
Kopans believes in the life-saving good of mammography, and he isn’t alone. Likewise, many healthcare providers stand in Welch’s camp. One side emphasises the lives saved by mammography. The other side puts more weight on the very common post-mammography anxiety women experience as they wait for a biopsy of a suspect mass, and on the risk of undergoing chemotherapy for a cancer that would have gone forever unnoticed. Welch thinks women should have mammography’s risks and benefits explained, then be encouraged to choose for themselves.
When Welch began practising 30 years ago, the suggestion that screening was responsible for overdiagnosis was a radical one. Now, thanks to the work of Welch and his ilk, the debate isn’t whether overdiagnosis occurs, but how big a problem it is.
Welch suggests it is time we reassessed what medicine is for. “Do people want medical care as a way to deal with acute problems; things that are bothering them? Or do they want to take the power of medicine to look hard to try to find things wrong with them?” he says. Because in this age of super-sensitive diagnostics, seek and ye shall find.