Thursday, October 19, 2006

Doctors say drugmakers are "disease-mongering" to boost sales

Hey, You Don't Look So Good

As diagnoses of once-rare illnesses soar, doctors say drugmakers are "disease-mongering" to boost sales

By Catherine Arnst
BusinessWeek, MAY 8, 2006

If you have high blood pressure, you may be at risk for heart disease. And given that an estimated 65 million Americans have hypertension, it's not surprising that drugs to treat it are among the most prescribed medicines in the world. But why stop at prescribing drugs to people whose readings are 140/90 or higher, the standard definition of high blood pressure? In the Apr. 20 issue of The New England Journal of Medicine, a research team reported on "prehypertension," the condition of being in danger of developing hypertension.

Prehypertension was first identified in 2003, and some studies claim as many as 50 million U.S. adults have the condition, defined as blood pressure readings from 120/80 to 139/89. This risk of being at risk can be modified with diet and exercise, but the NEJM study reports that it can also be treated with Atacand, a drug from AstraZeneca Pharmaceuticals PLC (AZN ).

To a growing chorus of physicians and health-care specialists, the very idea of treating the risk of a risk is wrong. They have labeled the phenomenon "disease-mongering," defined as the corporate-sponsored creation or exaggeration of maladies for the purpose of selling more drugs. Prehypertension "is a classic case of a risk factor being turned into the disease," says Dr. Steven Woloshin of the Veterans Affairs Outcomes Group in White River Junction, Vt. "If you make a cut-off for blood pressure that's close to the normal range, then just about everyone can be diagnosed." An AstraZeneca spokesman responds that the trial was considered important enough to be published in the prestigious NEJM. "I think that speaks for itself."

DEMAND FOR A QUICK FIX
According to critics, disease-mongering is on the rise. It starts when a drug is developed for some once-rare condition. Then heavily promoted disease-awareness campaigns kick into gear, leading to increasing numbers of diagnoses and prescriptions. The list of suspects includes restless legs syndrome, social anxiety disorder, premenstrual dystrophic disorder, irritable bowel syndrome, female sexual dysfunction, and more. "Of course, some people have these diseases very seriously," says Dr. Robert L. Klitzman, a psychiatrist and bioethicist at Columbia University. "The problem is that mild cases are being made to seem more serious than they are."

The other problem, say the anti-disease-mongerers, is that the vagaries of everyday life, such as sadness, shyness, forgetfulness, and the occasional upset stomach, are being turned into medical conditions. Before Pfizer Inc.'s (PFE ) Viagra was introduced, erectile dysfunction was a medical problem only when associated with an underlying biological cause, such as diabetes or prostate cancer. Now, Pfizer's Web site claims that half of all men over 40 have problems getting or maintaining an erection. Social anxiety disorder, defined as severe shyness, was rarely seen until GlaxoSmithKline PLC's (GSK ) Paxil was approved to treat it. A disease-awareness campaign by Glaxo in the late 1990s, with the tag line "imagine being allergic to people," was quickly followed by rising prevalence estimates.

Disease promotion is not just the purview of drug companies. "Doctors should set more boundaries," asserts Dr. David Henry, a pharmacology professor at the University of Newcastle in Australia and a leading critic of disease-mongering. Then there are patients seeking a quick fix for conditions that might better be treated through lifestyle changes. "Drug companies are playing off the desire we all have to get rid of things that bother us," says Klitzman. But ridding oneself of bothersome symptoms without changing the behaviors that contribute to them can mean taking a pill every day for years, a proposition that is both risky and costly.

YOUNGER AND YOUNGER
Also of concern are efforts to expand the definition of serious diseases to cover more and more people. Loosened criteria for bipolar disorder, a dire psychological disease once thought to affect only 0.1% of the population, have led some experts to claim prevalence rates of anywhere from 5% to 10%. Dr. David Healy of Cardiff University in Wales says the higher estimates are based on ill-defined surveys that followed the introduction in the mid-1990s of mood stabilizer drugs, promising relief even for people with mild emotional swings. In the U.S., children as young as age 2 are being diagnosed as bipolar even though, in the classic definition of the illness, symptoms don't usually show up until the teens. "These young kids are started on two or three medicines when there isn't even any evidence that any of them work in children," says Dr. Jon McClellan at the University of Washington in Seattle.

Disease-mongering isn't new. The term was coined by Lynn Payer in her 1994 book Disease-Mongers: How Doctors, Drug Companies, and Insurers are Making You Feel Sick. But the advent of direct-to-consumer advertising in the U.S. in 1999 fanned the trend, say drug industry critics. Their complaints reached a critical mass this spring. The April issue of the journal PLoS Medicine ran 11 articles on disease-mongering to coincide with the first conference devoted to the topic, held Apr. 11-13 in Newcastle.

Drugmakers say they're only trying to educate patients who are struggling with serious illnesses. "We realize that not every medicine is for every person," says a spokeswoman for Glaxo, which makes drugs for restless legs syndrome, social anxiety disorder, and other diagnoses that are under fire. "The labels contain important information about whether it's appropriate, and we're confident that doctors consulting with patients will assess their health-care issues and the risks and rewards and make an appropriate decision."

The skeptics aren't convinced that doctors will be so discriminating, in part because many get their information about disease treatment from the drug industry. Pharmaceutical companies routinely subsidize continuing medical education courses for doctors. They fund research for diseases that then gets published in medical journals, and they underwrite patient advocate groups, which in turn promote the underwriter's drugs on their Web sites. Witness the Child & Adolescent Bipolar Foundation: It lists four pharmaceutical companies as major donors, including Eli Lilly & Co. and Janssen LP, makers of leading mood stabilizers.

All these factors come into play with restless legs syndrome, a case history detailed in PLoS Medicine. Defined as the urge to constantly move one's legs, the condition can be truly disruptive for people with severe symptoms, but such severity is considered rare. That didn't stop GlaxoSmithKline from launching a disease awareness campaign in 2003. The company kicked off the blitz with a press release stating that a "new survey reveals a common yet underrecognized disorder -- restless legs syndrome -- is keeping Americans awake at night." News articles proliferated, most stating that the condition affects up to 10% of adults in the U.S., based on the study Glaxo promoted.

In 2005, Glaxo's Requip, a treatment for Parkinson's disease, was approved for restless legs. At the same time the Restless Legs Syndrome Foundation, which receives funding from Glaxo, issued a press release about "a new national survey that shows [the] syndrome is largely underrecognized and poorly understood." A Glaxo spokeswoman says that most Requip prescriptions are written for Parkinson's.

The VA's Dr. Woloshin grants that some people are helped by Requip, Paxil, and Viagra. But he worries that overtreatment drains money from research into more serious illnesses. "None of these companies is coming up with a cure for TB," he notes. That's a disease no one is trying to monger.

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Wednesday, October 18, 2006

Invasive Procedures: Less is More ... And Better

Invasive Procedures: Less is More ... And Better

By Donald M. Berwick, M.D.
Newsweek, October 16, 2006

The modern hospital is the cathedral of our time—gleaming, mystical, intimidating, even majestic. It seems to contain miracles and, sometimes, it does; bioscientific breakthroughs have changed the course of illness, curing cases of leukemia, fixing hearts, transplanting organs. It is easy to be in awe. We want whatever the magic of health care can give us—the more, the better.

So it comes as a surprise to most people that the facts often suggest otherwise, as researchers at Dartmouth Medical School—led by Profs. John Wennberg and Elliott Fisher—have been showing for years in the so-called Dartmouth Atlas project. They sort the United States into 307 geographically defined "hospital service areas," and study how often Medicare patients in those areas get specific medical and surgical procedures.

For many procedures, the variation is stunning. Compared with the lowest-use areas, people in the highest-use areas get 10 times as many prostate operations, six times as many back surgeries, seven times as many coronary angioplasties and 10 times as many hospital days if they have heart failure. It all raises an obvious question: if medical technology is being used so differently, who's right?

A lot of the variation depends not on clear-cut scientific evidence that one treatment is better than another, but on the beliefs of specialists in the area and the supply of doctors and hospital beds. The use of specialist visits varies by 660 percent, and what best predicts the rate is the number of specialists per capita. The more doctors, the more doctor visits. The more hospital beds, the more days spent in the hospital.

Are you lucky if you live in a high-use region? Not necessarily. Landmark studies by Fisher showed that high use did not mean better quality of care and outcomes. In fact, for many measures, quality and outcomes were best in the low-use areas and worst in the high-use areas. The less, the better.

Fisher and Wennberg suggest that the rates of use of health-care procedures and treatments should, indeed, vary a lot, but not according to where you live. Rather, variation should reflect the preferences of patients ("Would you rather wait a bit to see if your back pain gets better, Mr. Smith, or try surgery now?") instead of the local habits of doctors or, worse, the local supply of specialists. When patients are actually invited to participate in decisions about their care—"shared decision-making"—both costs and rates of use of expensive, invasive procedures tend to fall, and outcomes and satisfaction improve. The Dartmouth team calls this "preference-sensitive care," and it thinks health care driven by necessity rather than supply could be both more responsive to our needs and, overall, far less costly.


A shortlist of "high variation" surgical procedures in the Dartmouth Atlas includes gallbladder removal; coronary-artery bypass and coronary angioplasty (in people with minimal symptoms); hip replacement; carotid-artery surgery; radical breast surgery (instead of lumpectomy) for localized breast cancer, and prostate removal for benign enlargement of the gland. If you or a loved one is scheduled for one of these, you might pause and ask some questions. Do you understand the alternatives to surgery? Would a period of "watchful waiting" help? Is the decision to operate based on your own assessment of your options? Or does it reflect mainly the local habits of the medical-care system? Surgery may be the right choice, but that ought to depend on the patient's preferences as well as the scientific facts.

Berwick is clinical professor of pediatrics at Children's Hospital and Harvard Medical School, and CEO of the Institute for HealthcareImprovement. For health information from Harvard, go to health.harvard.edu

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The Toll on Patients - Injuries and deaths resulting from preventable errors in medical care

An alarming number of injuries and deaths result from preventable errors in medical care

Newsweek, October 16, 2006

An alarming number of injuries and deaths result from preventable errors in medical care

1.5 million Americans are harmed or killed by medication-related mistakes each year

$3.5 billion in extra medical costs is spent annually to treat injuries caused by drug-related errors.

44,000 to 98,000 Americans die each year of medical errors, such as wrong-site surgery.

18,000 Americans die each year of heart attacks because they didn't receive preventative drugs.

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Friday, July 21, 2006

Medication errors injure more than 1.5 million yearly, study finds

Medication errors injure more than 1.5 million yearly, study finds

Hospital patients said at risk for at least one drug mistake daily

AP, July 20, 2006

Medication mistakes injure well over 1.5 million Americans every year, a toll too often unrecognized and unfought, says a sobering call to action.

At least a quarter of the errors are preventable, the Institute of Medicine said Thursday in urging major steps by the government, health providers and patients alike.

Topping the list: All prescriptions should be written electronically by 2010, a move one specialist called as crucial to safe care as X-ray machines.

Perhaps the report's most stunning finding was that, on average, a hospitalized patient is subject to at least one medication error per day.

A serious drug error can add more than $5,800 to the hospital bill of a single patient. Assuming that hospitals commit 400,000 preventable drug errors each year, that's $3.5 billion -- not counting lost productivity and other costs -- from hospitals alone, the report concluded.

"I'm a patient-safety researcher (yet) I was surprised and shocked at just how common and how serious a problem this is," said Dr. Albert Wu of Johns Hopkins University, co-author of Thursday's report.

Worse, there's too little incentive for health providers to invest in technology that could prevent some errors today, added Dr. J. Lyle Bootman, the University of Arizona's pharmacy dean, who co-chaired the IOM probe.

"We're paid whether these errors occur or not," lamented Bootman, who recently experienced the threat firsthand as his son-in-law dodged some drug near-misses while in intensive care in a reputable hospital.

The new probe couldn't say how many of the injuries are serious, or how many victims die. A 1999 estimate put deaths, conservatively, at 7,000 a year.

Even the total injury estimate is conservative, Bootman stressed. It includes drug errors in hospitals, nursing homes and among Medicare outpatients, but it doesn't attempt to count mix-ups in most doctors' offices or by patients themselves.

There have been efforts to improve patient safety in the six years since the IOM first spotlighted medical mistakes of all kinds, including recent bar-coding of drugs to minimize mix-ups in hospitals and pharmacies.

But clearly more are needed, and the new report highlights how the nation's fragmented health care system is conducive to drug errors, said Dr. Donald Berwick, a Harvard professor who heads the nonprofit Institute for Healthcare Improvement.

"This isn't a matter of doctors and nurses trying harder not to harm people," Berwick cautioned. "Safety isn't automatic. It has to be designed into the system."

Medications' sheer volume and complexity illustrate the difficulty. More than 10,000 prescription drugs are on the market, and 300,000 over-the-counter products. It's impossible to memorize their different usage and dosage instructions, which may vary according to the patient's age, weight and other risk factors, such as bad kidneys.

Plus, four of every five U.S. adults take at least one medication or dietary supplement every day; almost a third take at least five. The more you use, the greater your risk of bad interactions, especially if multiple doctors prescribe different drugs without knowing what you already take.

Add doctors' notoriously bad handwriting and sound-alike drug names: Was that order for 10 milligrams or 10 migrams? The hormone Premarin or the antibiotic Primaxin?

Moreover, consumer instructions are woefully inadequate, the report concludes. One study found parents gave their children the wrong dose of over-the-counter fever medicines 47 percent of the time.

Then there was man with newly diagnosed asthma wondering why his inhaler didn't work. Asked how he used it, the middle-age man squirted two puffs into the air and tried to breathe the mist. His original doctor had demonstrated the inhaler without telling him to spray it inside his mouth.

Among the report's recommendations:

•The government should speed electronic prescribing, including fostering technology improvements so that the myriad computer programs used by doctors, hospitals and drugstores are compatible.

Fewer than about 20 percent of prescriptions are electronic, said report co-author Michael Cohen, president of the Institute for Safe Medication Practices. E-prescribing does more than counter bad handwriting. The computer programs can be linked to databases that flash an alert if the prescribed dose seems high or if the patient's records show use of another drug that can dangerously interact.

•The government should speed electronic prescribing, including fostering technology improvements so that the myriad computer programs used by doctors, hospitals and drugstores are compatible.

Fewer than about 20 percent of prescriptions are electronic, said report co-author Michael Cohen, president of the Institute for Safe Medication Practices. E-prescribing does more than counter bad handwriting. The computer programs can be linked to databases that flash an alert if the prescribed dose seems high or if the patient's records show use of another drug that can dangerously interact.

•Patients and their families must be aggressive in questioning doctors, nurses and pharmacists about medications. Get a list of each drug you're prescribed, why and the dose from each doctor and pharmacy you use, and show it at every doctor visit.

"Take active steps to make sure you know what you're getting, and is it what you need," said report co-author Dr. Wilson Pace of the University of Colorado.

•The nation should invest about $100 million annually on research into drug errors and how to prevent them. Among the most-needed studies is the impact of free drug samples, which often lack proper labeling, on medication safety.

•The Food and Drug Administration should improve the quality of drug information leaflets that accompany prescription drugs, but often have incomplete information or are written in consumer-confusing jargon.

•The government should establish national telephone hotlines to help patients unable to understand printed drug information because of illiteracy, language barriers or other problems.


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Monday, May 29, 2006

Medical Guesswork

Medical Guesswork

From heart surgery to prostate care, the health industry knows little about which common treatments really work

By John Carey, BusinessWeek, May 29, 2006

The signs at the meeting were not propitious. Half the board members of Kaiser Permanente's Care Management Institute left before Dr. David Eddy finally got the 10 minutes he had pleaded for. But the message Eddy delivered was riveting. With a groundbreaking computer simulation, Eddy showed that the conventional approach to treating diabetes did little to prevent the heart attacks and strokes that are complications of the disease. In contrast, a simple regimen of aspirin and generic drugs to lower blood pressure and cholesterol sent the rate of such incidents plunging. The payoff: healthier lives and hundreds of millions in savings. "I told them: 'This is as good as it gets to improve care and lower costs, which doesn't happen often in medicine,"' Eddy recalls. "'If you don't implement this,' I said, 'you might as well close up shop."'

The message got through. Three years later, Kaiser is in the midst of a major initiative to change the treatment of the diabetics in its care. "We're trying to put nearly a million people on these drugs," says Dr. Paul Wallace, senior adviser to the Care Management Institute. The early results: The strategy is indeed improving care and cutting costs, just as Eddy's model predicted.

For Eddy, this is one small step toward solving the thorniest riddle in medicine -- a dark secret he has spent his career exposing. "The problem is that we don't know what we are doing," he says. Even today, with a high-tech health-care system that costs the nation $2 trillion a year, there is little or no evidence that many widely used treatments and procedures actually work better than various cheaper alternatives.

This judgment pertains to a shocking number of conditions or diseases, from cardiovascular woes to back pain to prostate cancer. During his long and controversial career proving that the practice of medicine is more guesswork than science, Eddy has repeatedly punctured cherished physician myths. He showed, for instance, that the annual chest X-ray was worthless, over the objections of doctors who made money off the regular visit. He proved that doctors had little clue about the success rate of procedures such as surgery for enlarged prostates. He traced one common practice -- preventing women from giving birth vaginally if they had previously had a cesarean -- to the recommendation of one lone doctor. Indeed, when he began taking on medicine's sacred cows, Eddy liked to cite a figure that only 15% of what doctors did was backed by hard evidence.

A great many doctors and health-care quality experts have come to endorse Eddy's critique. And while there has been progress in recent years, most of these physicians say the portion of medicine that has been proven effective is still outrageously low -- in the range of 20% to 25%. "We don't have the evidence [that treatments work], and we are not investing very much in getting the evidence," says Dr. Stephen C. Schoenbaum, executive vice-president of the Commonwealth Fund and former president of Harvard Pilgrim Health Care Inc. "Clearly, there is a lot in medicine we don't have definitive answers to," adds Dr. I. Steven Udvarhelyi, senior vice-president and chief medical officer at Pennsylvania's Independence Blue Cross.

What's required is a revolution called "evidence-based medicine," says Eddy, a heart surgeon turned mathematician and health-care economist. Tall, lean, and fit at 64, Eddy has the athletic stride and catlike reflexes of the ace rock climber he still is. He also exhibits the competitive drive of someone who once obsessively recorded his time on every training run, and who still likes to be first on a brisk walk up a hill near his home in Aspen, Colo. In his career, he has never been afraid to take a difficult path or an unpopular stand. "Evidence-based" is a term he coined in the early 1980s, and it has since become a rallying cry among medical reformers. The goal of this movement is to pierce the fog that envelops the practice of medicine -- a state of ignorance for which doctors cannot really be blamed. "The limitation is the human mind," Eddy says. Without extensive information on the outcomes of treatments, it's fiendishly difficult to know the best approach for care.

The human brain, Eddy explains, needs help to make sense of patients who have combinations of diseases, and of the complex probabilities involved in each. To provide that assistance, Eddy has spent the past 10 years leading a team to develop the computer model that helped him crack the diabetes puzzle. Dubbed Archimedes, this program seeks to mimic in equations the actual biology of the body, and make treatment recommendations as well as figure out what each approach costs. It is at least 10 times "better than the model we use now, which is called thinking," says Dr. Richard Kahn, chief scientific officer at the American Diabetes Assn.

Can one computer program offset all the ill-advised treatment options for a whole range of different diseases?

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Wednesday, April 26, 2006

Drugs companies 'inventing diseases to boost their profits' - World - Times Online

Drugs companies 'inventing diseases to boost their profits'

Drugs companies 'inventing diseases to boost their profits'

By Mark Henderson, Science Correspondent, The Times, April 11, 2006

Pharmaceutical companies are systematically creating diseases in order to sell more of their products, turning healthy people into patients and placing many at risk of harm, a special edition of a leading medical journal claims today.

The practice of “diseasemongering” by the drug industry is promoting non-existent illnesses or exaggerating minor ones for the sake of profits, according to a set of essays published by the open-access journal Public Library of Science Medicine.

The special issue, edited by David Henry, of Newcastle University in Australia, and Ray Moynihan, an Australian journalist, reports that conditions such as female sexual dysfunction, attention deficit hyperactivity disorder (ADHD) and “restless legs syndrome” have been promoted by companies hoping to sell more of their drugs.

Other minor problems that are a normal part of life, such as symptoms of the menopause, are also becoming increasingly “medicalised”, while risk factors such as high cholesterol levels or osteoporosis are being presented as diseases in their own right, according to the editors.

“Disease-mongering turns healthy people into patients, wastes precious resources and causes iatrogenic (medically induced) harm,” they say. “Like the marketing strategies that drive it, disease-mongering poses a global challenge to those interested in public health, demanding in turn a global response.”

Doctors, patients and support groups need to be more aware that pharmaceutical companies are taking this approach, and more research is needed into the changing ways in which conditions are presented, according to the writers.

Disease-awareness campaigns are often funded by drug companies, and “more often designed to sell drugs than to illuminate or inform or educate about the prevention of illness or the maintenance of health”, they say.

Particular conditions that are highlighted in the journal include sexual function in both men and women. The prevalence of female sexual dysfunction, one paper claims, has been highly exaggerated to provide a new market for drugs, while the makers of anti-impotence medicines, such as Viagra and Cialis, have been involved with their presentation as lifestyle drugs that can boost the sexual prowess of healthy men.

Ordinary shyness is routinely presented as a social anxiety disorder and treated with antidepressants, while newly identified conditions such as “restless legs syndrome” — a constant urge to move one’s legs — are presented as being much more common than they really are.

Richard Ley, of the Association of the British Pharmaceutical Industry, rejected the accusations, pointing out that Britain has firm safeguards against disease-mongering. Many of the authors’ criticisms, he said, were aimed squarely at countries such as the United States, where pharmaceuticals can be openly advertised directly to patients.

“Drug companies are not allowed to communicate directly with patients, and we do not invent diseases,” he said.

“We provide information that there are treatments out there that might help certain conditions, but at the end of the day it is down to health professionals to decide if they are appropriate.

“The best safeguard is that the doctor who knows the product and knows the patient’s history is the one who decides what to prescribe.”

TRICK OR TREAT?

MENOPAUSE
Symptoms include hot flushes, night sweats and loss of libido
Criticism too often “medicalised” as part of a “disorder” when it is a normal phase of life

IRRITABLE BOWEL SYNDROME
Symptoms include constipation, cramps and diarrhoea
Criticism promoted by drug companies as a serious illness needing therapy, when it is usually a mild problem

SEXUAL DYSFUNCTION
Symptoms impotence in men, lack of libido or difficulty becoming aroused in women
Criticism drugs such as Viagra marketed not only for treating genuine erectile dysfunction caused by medical problems but as lifestyle improvers

OSTEOPOROSIS
Symptoms thinning of the bones, particularly among postmenopausal women
Criticism portrayed as a disease in its own right, when it is really a risk factor for broken bones

RESTLESS LEGS
Symptoms urge to move legs because of unpleasant feelings, often at night
Criticism prevalence of a relatively rare condition exaggerated by the media, along with the need for treatment

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