Friday, November 02, 2012
The danger of annual checkups
Thursday, January 27, 2011
Why Almost Everything You Hear About Medicine Is Wrong
by Sharon Begley, Newsweek, January 24, 2011
"If you follow the news about health research, you risk whiplash. First garlic lowers bad cholesterol, then—after more study—it doesn’t. Hormone replacement reduces the risk of heart disease in postmenopausal women, until a huge study finds that it doesn’t (and that it raises the risk of breast cancer to boot). Eating a big breakfast cuts your total daily calories, or not—as a study released last week finds. Yet even if biomedical research can be a fickle guide, we rely on it.
But what if wrong answers aren’t the exception but the rule? More and more scholars who scrutinize health research are now making that claim. It isn’t just an individual study here and there that’s flawed, they charge. Instead, the very framework of medical investigation may be off-kilter, leading time and again to findings that are at best unproved and at worst dangerously wrong. The result is a system that leads patients and physicians astray—spurring often costly regimens that won’t help and may even harm you.
It’s a disturbing view, with huge implications for doctors, policymakers, and health-conscious consumers. And one of its foremost advocates, Dr. John P.A. Ioannidis, has just ascended to a new, prominent platform after years of crusading against the baseless health and medical claims. As the new chief of Stanford University’s Prevention Research Center, Ioannidis is cementing his role as one of medicine’s top mythbusters. “People are being hurt and even dying” because of false medical claims, he says: not quackery, but errors in medical research.
This is Ioannidis’s moment. As medical costs hamper the economy and impede deficit-reduction efforts, policymakers and businesses are desperate to cut them without sacrificing sick people. One no-brainer solution is to use and pay for only treatments that work. But if Ioannidis is right, most biomedical studies are wrong.
In just the last two months, two pillars of preventive medicine fell. A major study concluded there’s no good evidence that statins (drugs like Lipitor and Crestor) help people with no history of heart disease. The study, by the Cochrane Collaboration, a global consortium of biomedical experts, was based on an evaluation of 14 individual trials with 34,272 patients. Cost of statins: more than $20 billion per year, of which half may be unnecessary. (Pfizer, which makes Lipitor, responds in part that “managing cardiovascular disease risk factors is complicated”). In November a panel of the Institute of Medicine concluded that having a blood test for vitamin D is pointless: almost everyone has enough D for bone health (20 nanograms per milliliter) without taking supplements or calcium pills. Cost of vitamin D: $425 million per year.
Ioannidis, 45, didn’t set out to slay medical myths. A child prodigy (he was calculating decimals at age 3 and wrote a book of poetry at 8), he graduated first in his class from the University of Athens Medical School, did a residency at Harvard, oversaw AIDS clinical trials at the National Institutes of Health in the mid-1990s, and chaired the department of epidemiology at Greece’s University of Ioannina School of Medicine. But at NIH Ioannidis had an epiphany. “Positive” drug trials, which find that a treatment is effective, and “negative” trials, in which a drug fails, take the same amount of time to conduct. “But negative trials took an extra two to four years to be published,” he noticed. “Negative results sit in a file drawer, or the trial keeps going in hopes the results turn positive.” With billions of dollars on the line, companies are loath to declare a new drug ineffective. As a result of the lag in publishing negative studies, patients receive a treatment that is actually ineffective. That made Ioannidis wonder, how many biomedical studies are wrong?
His answer, in a 2005 paper: “the majority.” From clinical trials of new drugs to cutting-edge genetics, biomedical research is riddled with incorrect findings, he argued. Ioannidis deployed an abstruse mathematical argument to prove this, which some critics have questioned. “I do agree that many claims are far more tenuous than is generally appreciated, but to ‘prove’ that most are false, in all areas of medicine, one needs a different statistical model and more empirical evidence than Ioannidis uses,” says biostatistician Steven Goodman of Johns Hopkins, who worries that the most-research-is-wrong claim “could promote an unhealthy skepticism about medical research, which is being used to fuel anti-science fervor.”
Even a cursory glance at medical journals shows that once heralded studies keep falling by the wayside. Two 1993 studies concluded that vitamin E prevents cardiovascular disease; that claim was overturned by more rigorous experiments, in 1996 and 2000. A 1996 study concluding that estrogen therapy reduces older women’s risk of Alzheimer’s was overturned in 2004. Numerous studies concluding that popular antidepressants work by altering brain chemistry have now been contradicted (the drugs help with mild and moderate depression, when they work at all, through a placebo effect), as has research claiming that early cancer detection (through, say, PSA tests) invariably saves lives. The list goes on...."
Thursday, October 28, 2010
As much as 90 percent of the published medical information that doctors rely on is flawed
Lies, Damned Lies, and Medical Science - Magazine - The Atlantic
"Much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong. So why are doctors—to a striking extent—still drawing upon misinformation in their everyday practice? Dr. John Ioannidis has spent his career challenging his peers by exposing their bad science."
"...Though the results of drug studies often make newspaper headlines, you have to wonder whether they prove anything at all. Indeed, given the breadth of the potential problems raised at the meeting, can any medical-research studies be trusted?
That question has been central to Ioannidis’s career. He’s what’s known as a meta-researcher, and he’s become one of the world’s foremost experts on the credibility of medical research. He and his team have shown, again and again, and in many different ways, that much of what biomedical researchers conclude in published studies—conclusions that doctors keep in mind when they prescribe antibiotics or blood-pressure medication, or when they advise us to consume more fiber or less meat, or when they recommend surgery for heart disease or back pain—is misleading, exaggerated, and often flat-out wrong. He charges that as much as 90 percent of the published medical information that doctors rely on is flawed. His work has been widely accepted by the medical community; it has been published in the field’s top journals, where it is heavily cited; and he is a big draw at conferences. Given this exposure, and the fact that his work broadly targets everyone else’s work in medicine, as well as everything that physicians do and all the health advice we get, Ioannidis may be one of the most influential scientists alive. Yet for all his influence, he worries that the field of medical research is so pervasively flawed, and so riddled with conflicts of interest, that it might be chronically resistant to change—or even to publicly admitting that there’s a problem....
[Ioannidis] goes on to suggest that an obsession with winning funding has gone a long way toward weakening the reliability of medical research....
In poring over medical journals, he was struck by how many findings of all types were refuted by later findings....
And before long he discovered that the range of errors being committed was astonishing: from what questions researchers posed, to how they set up the studies, to which patients they recruited for the studies, to which measurements they took, to how they analyzed the data, to how they presented their results, to how particular studies came to be published in medical journals.
This array suggested a bigger, underlying dysfunction, and Ioannidis thought he knew what it was. “The studies were biased,” he says. “Sometimes they were overtly biased. Sometimes it was difficult to see the bias, but it was there.” Researchers headed into their studies wanting certain results—and, lo and behold, they were getting them. We think of the scientific process as being objective, rigorous, and even ruthless in separating out what is true from what we merely wish to be true, but in fact it’s easy to manipulate results, even unintentionally or unconsciously. “At every step in the process, there is room to distort results, a way to make a stronger claim or to select what is going to be concluded,” says Ioannidis. “There is an intellectual conflict of interest that pressures researchers to find whatever it is that is most likely to get them funded.”....
How should we choose among these dueling, high-profile nutritional findings? Ioannidis suggests a simple approach: ignore them all.
For starters, he explains, the odds are that in any large database of many nutritional and health factors, there will be a few apparent connections that are in fact merely flukes, not real health effects—it’s a bit like combing through long, random strings of letters and claiming there’s an important message in any words that happen to turn up. But even if a study managed to highlight a genuine health connection to some nutrient, you’re unlikely to benefit much from taking more of it, because we consume thousands of nutrients that act together as a sort of network, and changing intake of just one of them is bound to cause ripples throughout the network that are far too complex for these studies to detect, and that may be as likely to harm you as help you. Even if changing that one factor does bring on the claimed improvement, there’s still a good chance that it won’t do you much good in the long run, because these studies rarely go on long enough to track the decades-long course of disease and ultimately death....
“The odds that anything useful will survive from any of these studies are poor,” says Ioannidis—dismissing in a breath a good chunk of the research into which we sink about $100 billion a year in the United States alone.
And so it goes for all medical studies, he says. Indeed, nutritional studies aren’t the worst. Drug studies have the added corruptive force of financial conflict of interest....
Nature, the grande dame of science journals, stated in a 2006 editorial, “Scientists understand that peer review per se provides only a minimal assurance of quality, and that the public conception of peer review as a stamp of authentication is far from the truth.”...
Doctors may notice that their patients don’t seem to fare as well with certain treatments as the literature would lead them to expect, but the field is appropriately conditioned to subjugate such anecdotal evidence to study findings. Yet much, perhaps even most, of what doctors do has never been formally put to the test in credible studies, given that the need to do so became obvious to the field only in the 1990s, leaving it playing catch-up with a century or more of non-evidence-based medicine, and contributing to Ioannidis’s shockingly high estimate of the degree to which medical knowledge is flawed. That we’re not routinely made seriously ill by this shortfall, he argues, is due largely to the fact that most medical interventions and advice don’t address life-and-death situations, but rather aim to leave us marginally healthier or less unhealthy, so we usually neither gain nor risk all that much.
Medical research is not especially plagued with wrongness. Other meta-research experts have confirmed that similar issues distort research in all fields of science, from physics to economics (where the highly regarded economists J. Bradford DeLong and Kevin Lang once showed how a remarkably consistent paucity of strong evidence in published economics studies made it unlikely that any of them were right). And needless to say, things only get worse when it comes to the pop expertise that endlessly spews at us from diet, relationship, investment, and parenting gurus and pundits. But we expect more of scientists, and especially of medical scientists, given that we believe we are staking our lives on their results. The public hardly recognizes how bad a bet this is. The medical community itself might still be largely oblivious to the scope of the problem, if Ioannidis hadn’t forced a confrontation when he published his studies in 2005....
[His] bigger worry, he says, is that while his fellow researchers seem to be getting the message, he hasn’t necessarily forced anyone to do a better job. He fears he won’t in the end have done much to improve anyone’s health. “There may not be fierce objections to what I’m saying,” he explains. “But it’s difficult to change the way that everyday doctors, patients, and healthy people think and behave.”...
What [doctors are] not trained to do is to go back and look at the research papers that helped make these drugs the standard of care. “When you look the papers up, you often find the drugs didn’t even work better than a placebo. And no one tested how they worked in combination with the other drugs,” she says. “Just taking the patient off everything can improve their health right away.” But not only is checking out the research another time-consuming task, patients often don’t even like it when they’re taken off their drugs, she explains; they find their prescriptions reassuring.
In fact, the question of whether the problems with medical research should be broadcast to the public is a sticky one in the meta-research community. Already feeling that they’re fighting to keep patients from turning to alternative medical treatments such as homeopathy, or misdiagnosing themselves on the Internet, or simply neglecting medical treatment altogether, many researchers and physicians aren’t eager to provide even more reason to be skeptical of what doctors do—not to mention how public disenchantment with medicine could affect research funding. Ioannidis dismisses these concerns. “If we don’t tell the public about these problems, then we’re no better than nonscientists who falsely claim they can heal,” he says. “If the drugs don’t work and we’re not sure how to treat something, why should we claim differently? Some fear that there may be less funding because we stop claiming we can prove we have miraculous treatments. But if we can’t really provide those miracles, how long will we be able to fool the public anyway? The scientific enterprise is probably the most fantastic achievement in human history, but that doesn’t mean we have a right to overstate what we’re accomplishing.”...
But as long as careers remain contingent on producing a stream of research that’s dressed up to seem more right than it is, scientists will keep delivering exactly that.
“Science is a noble endeavor, but it’s also a low-yield endeavor,” he says. “I’m not sure that more than a very small percentage of medical research is ever likely to lead to major improvements in clinical outcomes and quality of life. We should be very comfortable with that fact.” "
Wednesday, March 04, 2009
Asking Tough Questions of Doctors
""The culture around medicine is changing very quickly as patients begin to understand the full impact of medical errors and see that quality health care is not a given," says Bruce Siegel, a professor in the department of health policy at George Washington University who runs the Aligning Forces for Quality program. Many physicians are trained "to think of ourselves as little gods" and resist patients who question their authority, Dr. Siegel says. But "the more enlightened physicians are beginning to realize this could be a positive thing for health care."
The Pennsylvania Patient Safety Authority, which tracks medical errors and recommends preventive measures, says research conducted in the state shows patients are increasingly willing to ask certain questions of their doctor. It says patients will seek a better explanation of something they don't understand or question the reason for a procedure or unfamiliar drug.
But patients are most reluctant to ask anything that might be viewed as confrontational, such as requesting that health-care providers confirm a patient's identity before a procedure or asking practitioners to wash their hands, the group says. Hand washing is considered the most important preventive measure against the spread of potentially deadly infections....
Many hospitals make use of the 'Speak Up' campaign launched in 2002 by the Joint Commission, the nonprofit group that accredits hospitals. The program provides free brochures and posters to hospitals urging patients to take a role in preventing medication errors, infections and wrong-patient procedures. The brochures, available at www.jointcommission.org, provide lists of questions to ask medical practitioners, urging patients, for instance, to make sure doctors and nurses check their wristband and ask their name before administering medicine."Doctors have long resisted having science guide their practice
"Doctors have long resisted having science guide their practice. That's obvious from the disparity in clinical practices from one region of the U.S. to another, as The Dartmouth Atlas of Health Care has been finding since the early 1990s. Rates of coronary-bypass surgery among Medicare patients in McAllen, Texas, are five times those in Pueblo, Colo. Rates of back surgery in Casper, Wyo., are six times those in Honolulu and the Bronx. From one city to another, the frequency of visits to specialists varies more than fivefold. Yet elderly people in Casper don't have worse back pain than those in the Bronx, and those in Texas aren't suffering occluded arteries at higher rates than those in Colorado. Instead, the enormous disparity in how doctors in different regions treat the same condition reflects medical culture, not medical science."
Wednesday, January 28, 2009
Babies Know - A Little Dirt Is Good for You
"In studies of what is called the hygiene hypothesis, researchers are concluding that organisms like the millions of bacteria, viruses and especially worms that enter the body along with “dirt” spur the development of a healthy immune system. Several continuing studies suggest that worms may help to redirect an immune system that has gone awry and resulted in autoimmune disorders, allergies and asthma.
These studies, along with epidemiological observations, seem to explain why immune system disorders like multiple sclerosis, Type 1 diabetes, inflammatory bowel disease, asthma and allergies have risen significantly in the United States and other developed countries.
Training the Immune System
“What a child is doing when he puts things in his mouth is allowing his immune response to explore his environment,” Mary Ruebush, a microbiology and immunology instructor, wrote in her new book, “Why Dirt Is Good” (Kaplan). “Not only does this allow for ‘practice’ of immune responses, which will be necessary for protection, but it also plays a critical role in teaching the immature immune response what is best ignored.”
One leading researcher, Dr. Joel V. Weinstock, the director of gastroenterology and hepatology at Tufts Medical Center in Boston, said in an interview that the immune system at birth “is like an unprogrammed computer. It needs instruction.”
He said that public health measures like cleaning up contaminated water and food have saved the lives of countless children, but they “also eliminated exposure to many organisms that are probably good for us.”
“Children raised in an ultraclean environment,” he added, “are not being exposed to organisms that help them develop appropriate immune regulatory circuits.”"Thursday, January 15, 2009
The simple choices that we make in our lifestyle can be as powerful as drugs and surgery
By Deepak Chopra, Dean Ornish, Rustum Roy and Andrew Weil
"...if we want to make affordable health care available to the 45 million Americans who do not have health insurance, then we need to address the fundamental causes of health and illness, and provide incentives for healthy ways of living rather than reimbursing only drugs and surgery.
Heart disease, diabetes, prostate cancer, breast cancer and obesity account for 75% of health-care costs, and yet these are largely preventable and even reversible by changing diet and lifestyle....
The latest scientific studies show that our bodies have a remarkable capacity to begin healing, and much more quickly than we had once realized, if we address the lifestyle factors that often cause these chronic diseases. These studies show that integrative medicine can make a powerful difference in our health and well-being, how quickly these changes may occur, and how dynamic these mechanisms can be.
Many people tend to think of breakthroughs in medicine as a new drug, laser or high-tech surgical procedure. They often have a hard time believing that the simple choices that we make in our lifestyle -- what we eat, how we respond to stress, whether or not we smoke cigarettes, how much exercise we get, and the quality of our relationships and social support -- can be as powerful as drugs and surgery. But they often are. And in many instances, they're even more powerful....
Our "health-care system" is primarily a disease-care system. Last year, $2.1 trillion was spent in the U.S. on medical care, or 16.5% of the gross national product. Of these trillions, 95 cents of every dollar was spent to treat disease after it had already occurred. At least 75% of these costs were spent on treating chronic diseases, such as heart disease and diabetes, that are preventable or even reversible....
The disease that accounts for more premature deaths and costs Americans more than any other illness is almost completely preventable simply by changing diet and lifestyle. And the same lifestyle changes that can prevent or even reverse heart disease also help prevent or reverse many other chronic diseases as well....
It's time to move past the debate of alternative medicine versus traditional medicine, and to focus on what works, what doesn't, for whom, and under which circumstances...."
Dr. Chopra, the author of more than 50 books on the mind, body and spirit, is guest faculty at Beth Israel Hospital/Harvard Medical School. Dr. Ornish is clinical professor of medicine at the University of California, San Francisco. Mr. Roy is professor emeritus of materials science at Pennsylvania State University. Dr. Weil is director of the University of Arizona Center for Integrative Medicine.
Wednesday, February 23, 2005
Medicine is, and always has been, an evolving discipline
"Medicine's Progress, One Setback at a Time
By Lisa Sanders, M.D., The New York Times, March 16, 2003
A decade ago, I stood alongside my 99 fellow freshmen as we were welcomed into the ranks of medicine in a ''white coat ceremony.'' Here, on our first day of med school, we were presented with the short white coats that proclaimed us part of the mystery and the discipline of medicine. During that ceremony, the dean said something that was repeated throughout my education: half of what we teach you here is wrong -- unfortunately, we don't know which half.
At the time it was hard to believe. Within those walls, in the anatomy lab, in the lecture hall, you feel that you are being shown the secrets of how the body is put together, how it lives, how it works, how it dies. It has the feel of authority and certainty. Like math, it has a feeling of inevitability.
But now, as a practicing doctor and teacher of residents, I relive that dean's aphorism daily. Medicine is, and always has been, an evolving discipline. And this necessarily means that what we know about medicine is constantly changing; that medicine is forever putting forth, and simultaneously upending, assumptions (as can be seen in the accompanying chart). This is particularly true at this moment. Virtually all of our medical therapeutic options are being questioned, evaluated and re-evaluated by researchers across the globe. Certainly in this century there will be new genes discovered and inventions developed, but medical progress right now centers on the rapid displacement of old ideas to make room for new knowledge. Medicine, always a fluid and dynamic science, is in the midst of a major growth spurt.
This wave of research changes what we as doctors do almost daily. When I started on the wards as a third-year medical student, for example, we were taught that the use of beta blockers, a class of powerful medicines for the treatment of high blood pressure, could endanger the life of a patient with heart failure. The thinking was that beta blockers, which slow the heart rate, could make an already poorly performing heart perform even worse.
Now, less than eight years later, the opposite is thought to be true: beta blockers reduce the risk of death in patients who suffer heart failure. By slowing the heart, reducing its workload, a poorly performing heart improves. We know this now because researchers tested both theories, side by side, to see which was correct. One group of patients with heart failure was treated with beta blockers, another identical group was not. After several years the answer was clear. Beta blockers are now a widely accepted therapy for heart failure.
These rigorous studies, and their sometimes counterintuitive results, make up the headlines of medical journals -- and sometimes daily papers -- announcing essentially the death of one idea or the birth of another.
This is a relatively new phenomenon. Although the first randomized controlled trial was done more than half a century ago (in that study researchers tested the use of an early antibiotic against TB), it wasn't until the 70's that this sort of scientific examination came into widespread use. Therapies of all kinds had blossomed and so had the expectation that there needed to be a systematic way of evaluating their effectiveness.
By the late 90's, doctors had the appetite for this type of information, and researchers had the technique. Before the computer made its way into virtually every office, doctors often had filing cabinets where they kept articles on topics of interest. It was a reasonable way to keep track of a small amount of data but was easily overwhelmed by the new flood of research. It was technology -- the computer, the Internet -- that finally made it possible for the doctors in the trenches, doctors taking care of patients, to systematically practice what could be considered ''evidence-based medicine.'' We all now have access to the newest and best in medical research right at our own desks. We can find out quickly, for example, that arthroscopic knee surgery for osteoarthritis and postmenopausal hormone replacement for the prevention of heart disease have lost their standing as effective therapies and even that certain techniques discarded long ago can serve a new purpose. (Leeches, for example, are now used on some patients to treat the pain of arthritis.)
Recently, a patient I took care of in the hospital brought that point home to me. She was a youngish woman, in her 40's, with honey-colored hair and bright blue eyes. She had come to this small Connecticut city from her farm in Maine to judge a local dog show, and on the way to the show she had fainted twice. In the E.R., she seemed a little winded, her heart was beating more rapidly than normal and the oxygen meter on her finger showed that despite her efforts she wasn't getting quite as much oxygen as she needed.
She had no fever, chills or cough, and a chest X-ray confirmed that she didn't have pneumonia. A lung scan showed that she had a pulmonary embolus, a clot from somewhere in her veins that had broken loose and traveled to her lungs. She was put on a blood thinner and admitted to the hospital. After a couple of days, she felt better and expressed her eagerness to go home: ''I've got four collies and a husband, and they need me.''
Most patients with a pulmonary embolus are started on blood thinners and sent home within a few days. But since our patient lived an eight-hour car ride away, I was worried. Travel is a risk factor for this disease. When you don't move -- for example, when you're sitting in a car for a long stretch of time -- your blood doesn't move, and whenever blood slows down, there is a chance of clots forming. When you start moving again, the clots can break free and travel to the vital organs.
What if another piece of her clot broke off and went to her lungs again? The clot that brought her to the hospital had been a small one and she had tolerated its effect easily, but large pulmonary emboli are life-threatening. Just the isolation of highway driving might put her at risk. The old teaching was that you kept a person in the hospital for 72 to 96 hours while the clot ''stabilized,'' though like most of the old teachings, that wasn't based so much on research as on reason. What was the real risk of a second clot, perhaps an even larger one, traveling to her lungs even when she was on a blood thinner?
I promised her an answer before lunch, and after completing my rounds, I sat at my computer and called up the related research. A quick review of the literature showed that the average patient had a risk of recurrence of as little as 4 percent over the first six months, and a fraction of that in the first week. I went back to the patient with the good news. Her husband could take her home the next day, given the minimal possibility of a recurrence. Standing at this woman's bedside, explaining her illness and her risk, I felt once again the excitement that feels particular to medicine at this time in history. And yet, even as I rattled off statistics, I had to acknowledge that what feels definitive now may change, as have so many certainties of the past.
From a distance, medicine looks like a complete and beautiful body of knowledge. You get sick, and your doctor examines the sick part and figures out how to make it well. You live happily ever after. And there are aspects of medicine that work that way. But here, up close, where medicine is practiced, it's clear that our body of knowledge is growing rapidly, changing constantly. Every week's journals and patients challenge the old knowledge and sometimes provide the new. It's how progress is made in medicine, one answer at a time.
A patient of mine who came to the office recently was in the hospital a week earlier for an irregular heartbeat. In the hospital, his cardiologist started him on medicine to make his heart beat regularly again, and he was discharged on that medication. When he came to see me, he was still taking it, but his heart had started to beat irregularly once more. He was supposed to see his cardiologist the next week but wanted to know if he would have to keep taking the rhythm medicine. It made him feel tired, and he didn't like it.
Not that long ago, on hearing this story, I would have tried to convince the patient that keeping his heart in a regular rhythm was the best option and that if this drug wasn't working and made him tired, well, there were others we could try. Now I had a different option. A recent study showed that patients who were allowed to remain in an irregular rhythm did just as well as patients who took medicine to control the rhythm, as long as their heart rates -- the number of beats per minute -- were controlled. Now I could tell him that it was probably going to be O.K. for him to stay in that rhythm. He probably wouldn't have to take that medicine anymore.
That study? It was published just three months ago."
Original copy