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MDs distrust industry-funded studies

Posted by medconsumers on September 27, 2012

Here’s an interesting turn of events. A new survey shows that physicians will distrust the results of a study, once they see that it was funded by the pharmaceutical industry.  In fact, many physicians were more likely to trust research funded by a government agency like the National Institutes of Health. But here’s the twist: Many industry-funded studies are of very high quality and some taxpayer-funded studies can be of lesser quality.

If physicians’ prescribing decisions are not guided by the quality of the research, then we’re all in trouble.  But then again, maybe we’re all in trouble, anyway, given the fact that most drug studies are funded by industry. We already know that industry-funded trials tend to produce results that favor their products—and the studies that fail to do so never see the light of day. The latter problem has been resolved—somewhat— for new drugs.  Trials initiated after 2007 are mandated to register on a publicly accessible website so that everyone knows of their existence and goals.

But I digress. The surveyed physicians were given only the abstracts (summaries) of hypothetical clinical trials of three different drugs. The trials were of high, medium or low quality.  Each abstract disclosed whether the study had support from a pharmaceutical company, the National Institutes of Health, or made no mention of support. The follow-up questions determined physician understanding of the trials’ quality, their confidence in the results, and their willingness to prescribe the drugs.

“We found that respondents downgraded the credibility of industry- funded trials, as compared with the same trials randomly characterized as having NIH funding or having no source of support listed,” concluded Aaron S. Kesselheim, MD, Harvard Medical School, and colleagues who developed the survey, published recently in The New England Journal of Medicine.  Ironically, 75% of the surveyed physicians reported “accepting at least one type of industry support.”

What to make of all this?  I have to admit that I was somewhat surprised by the survey results. I didn’t think practicing physicians were that jaded, especially physicians who themselves take industry money. This survey is important, but there’s a far larger problem related to pharmaceutical industry funding. It was addressed by one memorable speaker at a conference held last year by the Cochrane Collaboration. “Many of the clinical trials conducted by the pharmaceutical industry are very well-designed, but they do not answer the questions we want answered,” said John Ionnaides, MD. “We want to know whether the new drug is safer and more effective than the older drugs,” he said.  The “we” he was describing are the physicians who prescribe the drugs as well as the people who take them.

Dr. Ionnaides, an internationally respected researcher, went on to explain that no drug company wants to risk a head-to-head comparison trial, which could find an older, cheaper off-patent drug is better than their new expensive drug. Instead, a new drug goes on the market having proven to the FDA’s satisfaction that it is better than nothing (a placebo). And that’s exactly the way the drug makers want it to be (and lobby Congress to make sure things go their way).

This research gap goes far beyond drugs. No head-to-head comparison study, for example, has been done to guide men through the thicket of treatment options for prostate cancer.

Perhaps information gaps like this can be tackled successfully by the comparative effectiveness research efforts that have emerged as a result of the Affordable Care Act. But wouldn’t it be better if taxpayers did not have pay for this important research? Isn’t it about time to take seriously an idea that bubbles up every now and then:  Make the drug and device companies contribute to a large research fund; and then make them step back to let independent researchers conduct the head-to-head comparison trials.

Maryann Napoli, Center for Medical Consumers©

Posted in Conflict of Interest, Doctors, Drugs | Tagged: , , , , , , , , , | 1 Comment »

How prescription drug harms can go unnoticed

Posted by medconsumers on July 12, 2012

Twelve years ago, the American public first heard the shocking news that deaths due to medical care constitute the third leading cause of death in the U.S.—after deaths from heart disease and cancer. Sadly, the death of the research physician who introduced this statistic has recently been attributed to her medical care. Implicated is the commonly prescribed and widely advertised drug Plavix.

The circumstances surrounding the death of Barbara Starfield, MD, of the John Hopkins School of Hygiene and Public Health, were described online first at the Archives of Internal Medicine. The story is told by her husband, also a physician, who has raised critical issues about how common but serious harms of prescription drugs can go unreported.  He calls on doctors and the general public to be vigilant about reporting adverse effects to FDA. His wife had published many papers about improving the quality of medical care.

Neil A. Holtzman,MD, got more information than usual because an autopsy was required for his wife. She died while swimming alone in a pool. Although the immediate cause of death was “pool drowning,” Dr. Holtzman wrote that he was stunned by the description of “cerebral hemorrhage” as the underlying condition. “The pathologist attributed the massive hemorrhage to cerebral amyloid angiopathy (CAA), listing “anticoagulation therapy” on the death certificate under “other significant conditions.” CAA is not so rare, says Dr. Holtzman who learned that it is present in about 8% of everyone over age 75, which includes his wife.

Plavix is the “anticoagulation therapy” mentioned in the autopsy report.  Dr. Holtzman explained that his wife had been diagnosed with a heart condition called coronary insufficiency three years before her death.  Initially, she was put on aspirin therapy, but six months later a stent was implanted to open the right main coronary artery.  Plavix is the standard open-ended treatment thereafter.

Unfortunately re the “thereafter” part, only two aspirin vs. Plavix clinical trials had been conducted in people who had stents implanted. (Not incidentally, both trials were industry-sponsored.) Neither lasted more than one year; yet many cardiologists prescribe Plavix beyond one year after stent placement, as did his wife’s cardiologist.

(Forgive me for inserting myself into this story, but my husband and I discovered the same gap in research information after he had a drug-coated stent implanted during a “possible heart attack.”   We too noticed the short duration of the two Plavix vs. aspirin trials.  And we were disturbed by the higher rate of major bleeding shown for Plavix plus aspirin compared to aspirin alone in one study of unstented people post-heart attack.  With his cardiologist’s approval, my husband stopped the Plavix  15 months after his stent was implanted and stayed on the 325 mg dose of aspirin. None of this bad news about Plavix was explained to us by the cardiologists, by the way, we found it on our own.)

Searching the medical literature for current Plavix data, Dr. Holtzman found two trials published after his wife’s death that showed a significant increase in major bleeds.  All but one of the Plavix studies were published before his wife died, but their alarming results seemed to be ignored by most cardiologists, he wrote. “Neither the American Heart Association nor the FDA issued an alert on prolonged use of the drug.”

Dr. Holzman observed that the studies on Plavix following coronary stent placement reflect the focus of the cardiologists who are largely concerned with the short-term effects of a drug following stent implants. The patient, on the other hand, would want to know about bleeding risks throughout entire duration of drug treatment.

The autopsy showed a bruise on Dr. Starfield’s scalp but no skull fractures. Her husband suspects that a bump against the bend in the side of the pool could have precipitated the cerebral hemorrhage. He knew that she had informed the cardiologist that she bruised more easily while taking Plavix and bled longer following minor cuts. Had cardiologists known to look for cerebral amyloid angiopathy, the “significant condition” listed on Dr. Starfield’s death certificate along with “anticoagulant therapy” perhaps a connection would have been made to the strokelike symptoms she experienced in her last weeks.

Ironically, Dr. Starfield’s death would not have been counted in the third leading cause of death statistic. When she identified the sources for this statistic back in 2000, she was careful to note that it is probably an undercount, given the fact that the studies looked only for iatrogenic deaths in hospitalized patients.  It doesn’t take into account people who die of medical treatment outside of a hospital.

Maryann Napoli, Center for Medical Consumers©

Related info: Report adverse drug reactions to the FDA’s Medwatch Program (for consumers) and (for health professionals).  Sign up for FDA drug alerts and recalls.  Read Dr. Starfield’s 2000 commentary in the July 26, 2000 issue of JAMA (Is US Health Really the Best in the World?).

Related post: Angioplasty overuse and Bill Clinton  2010 post about overuse of stents.

Stents vs drugs from one of our favorite websites.

Read this 2012 article by ProPublica Why can’t medicine fix simple mistakes?

Posted in Aspirin, Conflict of Interest, Doctors, Drugs, Heart, heart disease | Tagged: , , , , , , , , , | 4 Comments »

Weight loss won’t prevent diabetes

Posted by medconsumers on January 15, 2012

Rare is the public announcement that a long-standing medical recommendation has been found to be impossible to follow. That’s what happened—albeit unofficially— at a recent press briefing when Richard Kahn, PhD, announced that weight loss is not the sure-fire preventive measure for avoiding diabetes 2. Studies show that hardly anyone can lose enough weight to meet the universally recommended goal. And even those who get there halfway usually regain the weight within a few years.

That won’t come as a surprise to anyone has ever tried dieting. What made this press briefing noteworthy, however, is the fact that Dr. Kahn was the chief scientific and medical officer of the American Diabetes Association for 25 years. His study raises questions about the centerpiece of the ADA’s standard diabetes prevention message: “Maintain a healthy weight “(along with increased physical activity). This is the advice that is also given to people diagnosed with prediabetes, a newly created “disease” that indicates they almost have diabetes 2 (more on that later).  According to the ADA, which receives funding from the pharmaceutical industry, there are 79 million Americans who have prediabetes. All are likely to be put on long-term drug therapy once the weight-loss attempts fail or never get off the ground.

At the press briefing, Dr. Kahn, now a professor of medicine at the University of North Carolina, Chapel Hill, described his paper in this month’s issue of the public policy journal Health Affairs, which is primarily devoted to diabetes.  He has based his conclusion about weight loss on the very clinical trials that set the standard for diabetes prevention. Perhaps Dr. Kahn is the first to notice that most of the study participants, all of whom were initially either overweight or obese, regained the weight after the trials were over.

“When you look at the published studies, you see that a substantial amount of weight loss is necessary and hardly anyone can meet the intended goal, explained Dr. Kahn.  “People who participate in the standard community weight loss programs lose about 3-4% of their body weight, but they don’t get an appreciable delay in the onset of diabetes until they reach 7.5% weight loss. So you see they are not coming close to delaying or preventing diabetes.”

Based on the best of the diabetes prevention trials, here’s an estimate from Dr. Kahn’s paper for what a 4% weight loss would actually do for people in terms of health and cost-effectiveness: “If overweight or obese people could maintain for life a 4% reduction in weight at minimal financial cost, there would be a modest 1% reduction in heart attacks and strokes after 20 years. Rates of some microvascular complications [e.g., blindness, neuropathy, foot amputations] would also decline, but it would take at least 20 years—during which time weight loss was continuously maintained—for such an intervention to achieve cost-effectiveness.”

Dr. Kahn was the only author at the press briefing whose paper was not favorable to prevention. Several promoted a nationwide diabetes prevention program. “This would be a waste of resources,” said Dr. Kahn. “Instead we need a better understanding of the biological processes that cause so many people to put on weight.  I don’t think we know enough about energy balance, specifically energy intake vs. energy expenditure. Our bodies regulate that very, very closely, and we just don’t know enough about the components of that [process], or why this imbalance occurs in some people and not others. We eat all the time, food is all around us, food is cheap and maybe our bodies can’t adapt to this environment.”

Until obesity researchers come up with answers, drug therapy is the way to go once diabetes develops, according to Dr. Kahn’s paper,  “We can greatly reduce the likelihood of serious complications through early detection and proper medical management.” (Novo Nordisk, the company that makes diabetes drugs, was thanked by the editor of Health Affairs for partially funding this month’s issue.) However, Dr. Kahn expressed reservations about putting people on drug therapy when they are diagnosed with prediabetes,  “The use of metformin or other glucose-lowering medications might help prevent diabetes, but initiating such therapy prior to the onset of diabetes is basically equivalent to diagnosing the disease at a lower glycemic [i.e., blood sugar level] threshold and therefore deserves more discussion.”

Additional  information about prediabetes and exercise

More and more physicians have begun to treat prediabetes with drug therapy, though there is no evidence to show that this is safe or effective.  One can see tacit support for this practice on the ADA website which states, “Before people develop type 2 diabetes, they almost always have prediabetes—blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes.”  Read this about the pharmaceutical industry’s role in expanding the definition of diabetes 2 and why the current threshold for starting drug therapy is dangerously low for people with diabetes 2.  click here   And this about exercise, “You can be fat and fit.” 

Maryann Napoli, Center for Medical Consumers©

Posted in Conflict of Interest, Diabetes 2, Diet & Exercise, Drugs, exercise, Type 2 Diabetes | Tagged: , , , , , , , | 8 Comments »

Whistleblower’s story: New book reviewed

Posted by medconsumers on October 5, 2011

“Blood Feud: the man who blew the whistle on one of the deadliest prescription drugs ever” (NY: Dutton, 2011)  by Kathleen Sharp 

This is the true story of an expensive anti-anemia drug that came on the market for one purpose; was heavily promoted for several unproven uses; and how the drive for profits led two drug companies to commit fraud. Kathleen Sharp, a veteran investigative reporter, describes what happened from the perspective of a drug salesman whose company pressured him into achieving higher and higher sales targets. The drug maker provided a playbook of tactics known to manipulate physicians into writing more prescriptions and at higher, more dangerous, doses. Eventually, the drug salesman-turned-whistleblower comes to the horrifying conclusion that over a half a million people have died as a result of this drug. Its benefits, if any, remain unclear; its safety never established.  It is still on the market.

Central to the story is one of the first biotech drugs to go on the market. Erythropoietin is the man-made version of human erythropoietin, which is produced naturally in the body and stimulates the bone marrow to make red blood cells. Epo, as it is called, became known as a “blood booster,” sold by Amgen and Johnson & Johnson under the brand names: Procrit, Epogen, Aranesp, and Eprex (Europe).

Epo received FDA approval in 1989 to reduce cancer chemotherapy patients’ need for blood transfusions after it became known that the nation’s blood supply was infected with the HIV virus. In time, epo would be heavily promoted as an instant cure for chemotherapy-related fatigue and for anemia in kidney dialysis patients. (Disclosure: I am quoted in the book, speaking before the FDA Oncologic Drug Advisory Committee against J&J’s fraudulent direct-to-consumers advertising campaign for Procrit.)

The whistleblower ‘s story begins in 1992 when Mark Duxbury became a Procrit sales rep at J&J’s new biotech division, Ortho. Initially, Duxbury believed that he was selling an important quality-of-life enhancing drug for cancer patients suffering the debilitating effects of chemotherapy. Procrit, so he thought, would allow them to complete the treatment regimen.

The methods used by J&J to get its sales reps to turn Procrit into a blockbuster drug make for fascinating, though appalling, reading. Doctors were easily manipulated into prescribing more epo with rebates, secret discounts, honoraria, and other kickbacks.  In time, the entire Procrit sales force was encouraged by J&J to break the company’s own product license agreement with its partner Amgen. This agreement stipulated that J&J would stay away from the kidney dialysis market. (Amgen, maker of Aranesp, was the start-up company that did the original epo research.)

By 1993 Duxbury was a company award-winner for the greatest overall growth in sales in the western region of the U.S. He was rewarded with a higher income and an all expenses paid trip to a luxury resort. Still, J&J didn’t let up on the pressure to increase sales, making Duxbury conclude that the only way to meet his escalating quota was to “steal dialysis business”.

Doctors were encouraged to prescribe Procrit in high doses, particularly for cancer patients, because this would increase sales by hundreds of millions of dollars. That the deaths of about a dozen high-profile European cyclists were already linked to high dosing with epo (accessed via the black market) should have served as a warning.

This book is a goldmine of information about how the nation’s pharmaceutical companies inflate the cost of medicines while hiding the true cost from consumers as well as the government payers. What’s more, the drug makers in this story monitor doctors’ prescribing habits to determine the marketing strategies that work best; violate patient confidentiality laws by encouraging sales reps to troll medical records for the best drug-testing candidates; and use study participation to get doctors to prescribe epo for dangerous off-label purposes. Such tactics are not confined to the selling of epo.

Duxbury’s sterling career started to go downhill when he was deposed as a result of a lawsuit initiated by Amgen against J&J. (Depositions conducted over the course of several years serve as a major source for this book.) As a result, his own in-office memos revealed J&J’s orders to encroach on Amgen’s kidney dialysis territory.

Duxbury soon became a liability to his own company, which turned on him as if he were the one who thought up the illegal sales tactics.  He was fired in 1998. Many of the reps who had been instructed to sell Procrit for dialysis were also fired or resigned. Many would not learn—until years later—that their order to promote Procrit as an anti-anemia drug for kidney patients was an off-label use (unproven) use and thus a federal crime. (The FDA had approved Procrit to treat anemia only in cancer patients.)

The rest of the story involves Duxbury’s downward spiral— unemployment, lawsuits, depression, and self-destructive behavior—as he tried to alert the public about the dangers of epo.  The sinister way the Ortho division of J&J treated its own employee who, after all, was just following orders, should confirm your worst fears about corporate misbehavior. As Duxbury put it after his own lawsuit for wrongful termination turned up information new to him. “I was shocked to learn that everything I did at Ortho was illegal. They cheated not just the government but their own people too!”

Author Sharp says that the safety tests were never conducted for epo drugs, though such testing was required by the FDA contingent on approval. By the late 1980s, she states, “scientists knew that boosting red blood cells also thickened the blood, which increased the risk of clotting. Blood clots lead to strokes, heart attacks, and brain aneurisms.” What’s more, she writes, “No one could be sure that Procrit was safe at even recommended doses, according to several sources.”

In 2007 the FDA finally got around to protecting the public. The agency issued a warning about all epo drugs which by this time were also marketed for AIDS patients. New studies showed epo drugs associated with an increase in death, heart attack, stroke and tumor growth in subgroups of people with cancer and those with chronic kidney failure. Click here

Epo drugs continue to generate billions in annual revenues.  Duxbury’s whistleblower case is still making its way through the courts.

Maryann Napoli, Center for Medical Consumers©

Posted in Advocacy, Book Reviews, Cancer, Conflict of Interest, Doctors, Drug ads, Drugs, unnecessary treatment | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , | 3 Comments »

Risks of treating diabetes 2

Posted by medconsumers on August 8, 2011

In keeping with the theme of this website—reporting the lack of evidence for common medical treatments—attention this week goes to drugs for type 2 diabetes. A new meta-analysis of the best studies on this topic shows strong hints that these drugs may cause more harm than good when intensive glucose (blood sugar) lowering is the goal. At best, there is a small reduction in non-fatal heart attacks among people treated intensely, at worst, an increase in cardiovascular deaths and deaths from all causes. All because blood sugar was intentionallly reduced to extremely low levels—ironically, in an effort to save type 2 diabetics from an early demise.

The meta-analysis included 13 randomized controlled trials with a combined total of over 33,000 type 2 diabetics given drugs to get their glucose levels down to what is defined as normal. The analysis of these trials was conducted by an international team of researchers and published recently in the British Medical Journal. To make sense of the findings, I turned to one of its co-authors, James M. Wright, MD, PhD, University of British Columbia, Vancouver, who acknowledged they were surprising. “One would expect that lowering glucose levels to normal [with drugs] would make people live longer; but we could find no reduction in mortality in these trials,” he explained. “If anything, mortality was increased by 4% in the people treated intensively [below normal].”

What exactly is “normal” and why was intensive lowering of glucose levels considered a treatment goal? To put the new findings in perspective, here’s the back-story for how type 2 diabetes became a common diagnosis:

-In 1998, the definition of diabetes was changed from a fasting blood sugar of 140 mg/dL to a blood sugar of 126 mg/dL, thus making millions of formerly healthy Americans into type 2 diabetics overnight and, not incidentally, candidates for long-term drug therapy. In time the A1C blood test, which provides a three- to four-month picture of past glucose levels, would be considered the better measure for assessing type 2 diabetes and the need for treatment.

-Most of the physician experts who served on the panel that expanded the definition of type 2 diabetes had financial ties to companies that make drugs for the condition. click here By 2009, an equally conflicted international panel of experts announced “the goal of therapy is to achieve a hemoglobin A1C of 6.5% or less.” click here  Unfortunately, there is no evidence to prove this current recommendation is safe or effective.

-Lowered thresholds for normal initially seemed to make sense. Observational studies showed type 2 diabetics die of heart disease at rates two to four times higher than people without it. Diabetics also have more heart attacks and strokes. What’s more, risks start to increase at glucose levels lower than what had previously been defined as normal.

-Will glucose-lowering drugs also lower the chances of dying a premature death or having a heart attack or stroke? The first clinical trial designed to answer that question, the ACCORD trial, had to be stopped 18 months ahead of schedule in 2008. More deaths had occurred in the participants treated intensively, compared to those treated to normal blood glucose levels. There was also higher rate of hypoglycemia in the intensively treated people, 10% of whom required medical care.

This disturbing recent history brings us full circle to the new meta-analysis of the 13 clinical trials (one of which is the ACCORD). The 18,315 study participants of these trials who had been treated intensively (to A1C of 6.6%) were compared with the 16,218 treated less intensively (to A1C of 7.5%). All participants were taking the usual drugs prescribed for type 2 diabetes; those treated intensively were more likely to use combinations of drugs and higher doses. The meta-analysis produced this alarming conclusion: “The overall results do not show a benefit of intensive glucose lowering treatment on all cause mortality or cardiovascular death. A 19% increase in all cause mortality and a 43% increase in cardiovascular mortality cannot be excluded.”

Dr. Wright, co-author of the meta-analysis and practicing physician, was asked how he treats his patients. “My target is a HbA1C of 7% to 8%, never lower,” he responded. “If a patient comes to me with a 7.9% A1C test result, I would say that’s fine. “When someone on drug treatment has a 6.5% A1C, I would stop one of the drugs. When you get into the lower range—that is, below 7% there’s an increased risk of causing hypoglycemia, which can be severe and life threatening. The only exception would be the person on diet alone where hypoglycemia is not a risk and where you would encourage the patient to continue their diet and exercise to maintain the level of 6.5%.”

Added September 22, 2012 : Soon after this post went up on our website, this review was published in the Cochrane Library. It did not find any significant reduction in either death from any cause or death from heart disease when intensive glycaemic control  was compared with conventional control.

Maryann Napoli, Center for Medical Consumers©

For more on this topic, read “Diabetes 2 drugs: risks without benefits”. and this “How risky is having diabetes 2?”.

Posted in Conflict of Interest, Diabetes 2, Diet & Exercise, Drugs, Heart, Type 2 Diabetes | Tagged: , , , , , , | 2 Comments »

MDs OK with industry gifts

Posted by medconsumers on July 19, 2010

One thing that adds to the inefficiency of our medical care system is the distorting influence of the pharmaceutical industry’s marketing techniques. A new survey of 600 doctors, surgeons, and medical students found that most have positive attitudes towards the marketing activities of the drug companies. Unfortunately, most seem to miss the fact that marketing is all about getting them to prescribe the most expensive drugs.

The most disturbing finding in this survey, published in Archives of Surgery, is the 58% of respondents who said they believe that drug samples improve patient care. Free drug samples to doctors—one of the pharmaceutical industry’s most effective marketing strategies—are all about increasing the sales of brand-name drugs. They tend to be the newest, most expensive drugs, offered to patients in this way, “Try this free drug sample and see how you do.” The patients who do just fine continue with the expensive drug, which may very well have a less expensive alternative that is just as good…or safer. So far, no one has come up with any good evidence that free samples improve patient care.

The pharmaceutical indstry would have us believe that the free drugs go to low-income patients, but that didn’t hold up once researchers took a hard look. They found that the people most likely to receive free drug samples from their physicians are the financially well off and the insured. (Click here) Another study showed that the people who get free samples wind up with significantly more out-of-pocket expenditures than those who don’t.

Three-fourths of the doctors in the new survey believe that accepting free gifts and free lunches did not influence their own prescribing practices, but 52% said other doctors are likely to be swayed by such marketing tactics.

I think we can safely assume that the pharmaceutical marketing pros know exactly what works in terms of gifts to doctors, be it a free mug with drug company logo or a lavish dinner at the local French restaurant. One anti-drug industry documentary featured a former drug saleswoman turned whistle-blower. She said that her company could clock an uptick in drug prescriptions after something as seemingly minor as bringing a $10 take-out Chinese lunch for each person on the doctors’ staff.

You have no way of knowing how much marketing influences your own doctor’s prescribing behavior. A doctor too ready to prescribe the newest drug is a bad sign. So is the doctor whose waiting room often includes a well-dressed drug sales representative (usually female) and/or an office that is heavy on the industry-generated posters, pens, mugs, and brochures. One friend noticed the place she was expected to place her feet on the scale in her doctor’s office had a paste-on ad for Meridia, the weight-loss drug.

Revealing as this survey is, it centers on marketing tactics that are small potatoes compared to what’s happening at academic medical centers and is largely hidden from public view. It’s the fact that half of all continuing medical education is funded by industry. It’s the large consulting fees paid to key opinion leaders to “educate” their peers about the latest drugs. (For the definitive article describing how this works, click here.) Things have gotten so bad that medical students at Harvard are reportedly asking hard questions about which of their professors are paid consultants for the pharmaceutical industry (click here).

Reforms are on the way but still relatively new. Under a new federal law, drug and device companies will soon have to disclose, on a publicly accessible website, the names of doctors who accept speaking fees, as well as the value of all gifts. We already know that this will have an immediate effect. Vermont is one of three states that lead the way and put this law into practice in 2002. Early this year, the attorney general of Vermont released data showing that total payments to doctors in Vermont dropped 13% in 2009 to $2.6 million. Vermont now plans to improve its law with an outright ban on most gifts, including food, which amounts to $800,000 of the 2009 total.

Several years from now we can look forward to another survey to see how doctors react to the new federal law.

Maryann Napoli, Center for Medical Consumers©

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Posted in Conflict of Interest, Doctors, Drug ads, Drugs | Tagged: , , | 2 Comments »

WHO & Pharma under fire over swine flu

Posted by medconsumers on April 2, 2010

Before the faux swine flu pandemic fades from memory, consider this: One country—Poland—made the decision not to knuckle under to the pharmaceutical industry and buy H1N1 swine flu vaccines for its citizens. Dr. Ewa Kopacz, who is Poland’s minister of health, decided against a national vaccination campaign for several good reasons. She was not convinced that the vaccines were completely safe. Furthermore, the H1N1 flu appeared to be relatively mild in the countries of the southern hemisphere where the flu season was coming to an end. But it was the “conditions of purchase” that confirmed her decision. She was told by the vaccine companies that only the government could purchase their products—-vaccines would not be sold to clinics or anyone in Poland.

The price of each vaccine would be two to three times the cost of the yearly seasonal vaccine, though Dr. Kopacz knew the H1N1 vaccine is based on exactly the same technology. What’s more, it was not known at the time whether people would need one or two vaccines for full protection. And most outrageous: the Polish government was expected to sign a contract, stating that anyone injured by a vaccine would be the government’s responsibility. (Note: the U.S. government had long ago accepted this one-sided agreement.) Poland had fewer swine flu deaths this season and the virus was less virulent than in other countries. Though only half the vaccines in the U.S. were used, the estimated number of U.S. flu deaths this season was the lowest in years.

For standing up to the vaccine companies’ threats of dire consequences of her decision, Dr. Kopacz was the star of a hearing conducted on Monday by the Council of Europe in Paris, and attended by members of parliament. The gathering aimed its initial ire at the World Health Organization (WHO) for its changing definitions of pandemic and its alarmist warnings that were described as a “monumental mistake.” The result: a huge waste of money, unnecessary fear and anxiety; and a distortion of health services. Several speakers listed other pandemics like SARS, Creutzfeldt-Jakob disease (“mad cow”) and the avian (bird) flu that never lived up to the threat level announced by WHO. “Not a single person died from the avian flu in my country,” said the professor who was the former head of the French Red Cross. It is like the boy who cried ‘wolf,’ warned Paul Flynn, MP from the U.K, “If a truly dangerous virus does emerge some day, few people will take notice of it. The trust in the WHO has been undermined and it must be rebuilt.”

The WHO was the proverbial empty chair at this meeting because it declined the invitation and, the MPs said, had cloaked itself in secrecy at a prior meeting which was the first attempt to get answers to questions like: who decides that something is a ‘phase-6 pandemic’? And based on what evidence? (Another meeting, this time with WHO representatives, is planned for April 15 in Geneva.) Dr. Tom Jefferson of the Cochrane Collaboration spoke of how little reliable scientific evidence there is—not only to support vaccine use but also for understanding influenza itself. “The randomized trials that have been conducted are too small and too short [in duration],” he said, referring to vaccine trials that are usually funded by companies that make the vaccines. “The harms are not even looked for. We can’t answer the question of whether vaccines are safe.” Dr. Jefferson called for a large taxpayer-funded multi-country vaccine trial to fill the serious information gaps about vaccine effectiveness and possible harms.

As the hearing went on, the pharmaceutical industry became the major target. Several speakers called for more scrutiny of the pharmaceutical industry’s influence on health policy. They know that billions of pounds and Euros were spent on vaccines and unproven antiviral drugs like Tamiflu, and now they want to know who profited from WHO decisions. There must be more scrutiny of WHO’s key opinion leaders, especially those who fanned the flames of pandemic fears while taking pharmacuetical industry consulting fees. (Though unmentioned at this hearing, one H1N1 key advisor to WHO has been under investigation for personally profiting from the vaccination. Click here for more.)

Dr. Marek Twardowski, Poland’s undersecretary of state, ministry of health, brought the discussion back to the vaccine companies’ preposterous contract that his country was expected to sign. “Your governments did in fact sign contracts that shifted the responsibility for vaccine-related harm to your governments, and these agreements were made in confidence [i.e., secret],” he told the MPs. “As of March of this year, none of the vaccine companies brought their products into your countries under normal marketing conditions. Can you imagine if car companies like Toyota decided that they will only sell their cars to a government and then when a serious defect shows up like the Toyota’s accelerator problem, the taxpayers are expected to pay for it?” This is an “extremely dangerous precedent,” he said. “And I hope that today’s deliberations result in this never happening again.”

It’s hard to imagine such a conversation taking place in the U.S. Congress, which is bought and paid for by the pharmaceutical industry. And it’s unlikely many Americans know that vaccine companies already made sure the government pays for injuries caused by their products. In the wake of 9/11, Congress passed a federal law that allows vaccine companies to be protected from liability in the event of a vaccine-related injury. Authorities need only declare a public health emergency for the protection to go into effect. And if you think that the vaccine companies need protection from lawsuits to continue making vaccines, see this Bush-era press release from Public Citizen: “Flu Vaccine Shortage: Another Example of How Bush Dis-Torts the Truth About Lawsuits”

Click here to see the Webcast of the March 29 Council of Europe hearing.

Maryann Napoli, Center for Medical Consumers©ISSN 2155-1480

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Vaccine-Autism study retracted

Posted by medconsumers on February 25, 2010

A prestigious British journal has retracted a 1998 study that purportedly showed a link between autism, inflammatory bowel disease, and the combination measles-mumps-rubella (MMR) vaccine. This now-discredited study spread fear among parents in the U.S. and other countries where autism is on the rise. Many parents either refused to let their children receive the MMR vaccine or demanded that each of the three vaccines be given separately and at wide intervals to reduce any possible risk.

The February 3 retraction by The Lancet is the culmination of an investigation of the work of British gastroenterologist Andrew Wakefield, MD, who is the lead author of the study that found a persistent live measles viral infection in the intestines of vaccinated autistic children. The same viral infection was not found in the intestines of vaccinated children who are not autistic. Although the study included only 12 children, its impact on the public was all out of proportion to its size. There is no confirmed cause of autism, and Dr.Wakefield’s findings suggested environmental (i.e., external) factors could be involved.

Autism spectrum disorders (ASD), as it is now called, is “an urgent public health concern,” according to the U.S. Centers for Disease Control and Prevention. Twenty years ago, autism occurred in one of every 10,000 children in the U.S.; the ASD rate was recently estimated to be one in 100 children by Health and Human Services Secretary Kathleen Sebelius.

The Lancet’s retraction of Dr. Wakefield’s study means it is withdrawn from the published medical literature and electronic databases. The decision was based on the findings from Britain’s General Medical Council, which licenses physicians and regulates their practice. The Council concluded that Dr. Wakefield and his co-authors had acted “dishonestly and irresponsibly.” They were described as acting with “callous disregard” for the children—subjecting them to invasive and unnecessary procedures such as lumbar punctures and colonoscopies.

While the apparent deceptions of Dr. Wakefield and colleagues deserve condemnation, they do not close the door on a possible link between vaccines and ASD. (The General Medical Council made it clear that it was looking solely at this one study.) Nor should it stop researchers from looking into other possible environmental causes. Like the many untested chemicals in the environment and the drugs given during pregnancy and childbirth.

As more and more children are diagnosed with ASD, the standard explanation—doctors are just getting better at recognizing the disorder—becomes less believable. And it’s hard for parents not to see a vaccine connection when their child goes from developing normally to abrupt regression after an MMR shot. (This is dismissed as coincidence because ASD symptoms usually show up at age 15 to 18 months when the shot is typically administered.) The debate over vaccine safety is not going away as long as there is no understanding of the cause or causes of ASD.

Another major reason for keeping the vaccine-ASD debate alive is the Hannah Poling case. In 2008, this nine-year-old child won a judgment in the federal vaccine court, set up specifically for those who claim vaccine-related injury. This case is noteworthy because it was the first time that the federal officials acknowledged a connection between her autistic symptoms and the vaccines she received. The child had an undiagnosed and uncommon disorder affecting her mitochondria. This may have either aggravated or caused the autistic symptoms that appeared soon after one doctor visit in 2000, when Hannah Poling, then a toddler, was given five shots against nine different diseases. Click here for more about this case.

Vaccines are a multi-billion industry and financial ties to vaccine companies are common among physicians who serve on panels that evaluate vaccines and set policy (click here). Many parents are justifiably uneasy about the sheer number of vaccines that have become mandatory over the last 40 years. A baby born this year is expected to receive at least 30 vaccines against 11 infectious diseases before the age of six. By age 18, the child will have received an additional 21 vaccines against six infectious disease. Even more vaccines are recommended for the child with a serious underlying medical condtion and the child at high risk for one.

More information

Click here for information about a new government-financed study called the National Children’s that will follow unborn children and their parents for 21years. The New York Times says, “It will examine how environment, genes and other factors affect children’s health, tackling questions subject to heated debate and misinformation. Does pesticide exposure, for example, cause asthma? Do particular diets or genetic mutations lead to autism?” This study intends to enroll 100,000 pregnant women in 105 countries.

Click here for the blog of Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, who continues to defend Dr. Wakefield’s work. Although her organization is often mischaracterized as anti-vaccination, it is against mandatory vaccination without informed consent. (In the U.K. and Canada, childhood vaccinations are not mandatory.) National Vaccine Information Center’s mission is vaccine safety. Read this: “If you vaccinate ask eight questions.”

Maryann Napoli, Center for Medical Consumers(c)

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Tamiflu: serious questions remain

Posted by medconsumers on January 23, 2010

We recently reported that Tamiflu lowers a healthy person’s chances of getting the flu by 4 percentage points (see How good is Tamiflu?). Now a cloud doubt hovers over this drug’s safety and its vaunted ability to prevent severe complications, according to a newly updated Cochrane review published last month in the BMJ (British Medical Journal). Tamiflu was approved by the FDA to shorten the duration of seasonal flu by about one day and to prevent the seasonal flu in healthy adults and children. Soon after the H1N1 influenza outbreak of April 2009, Tamiflu morphed into a drug that is also good at preventing swine flu, though no studies had provided proof. [Note: Tamiflu is named throughtout this article because it is the best known drug in a class called neuraminidase inhibitors, which also includes Relenza. The findings from this newly updated Cochrane review apply to both drugs.]

What takes the Tamiflu story beyond the usual expensive-drug hype is the fact that it is an international public health story. Countries around the world, including our own, began to stockpile Tamiflu several years ago, spending billions annually. Roche, the company that makes Tamiflu, “bought” the World Health Organization’s brand loyalty in much the same way drug companies encourage doctors to prescribe expensive drugs with free samples. In a 2005 press release, the World Health Organization “welcomes Roche’s donation of three million treatment courses of its antiviral oseltamivir [Tamiflu] to a WHO international antiviral stockpile.” At the time, Tamiflu was regarded as the drug for avian (bird) flu, though no studies had provided proof. Central to the widespread confidence in Tamiflu was the claim that it lowers the risk of serious flu-related complications like pneumonia.

That claim and reports of Tamiflu’s severe adverse reactions became the impetus for the newly updated Cochrane review led by Dr. Tom Jefferson. In a nutshell, here’s what the authors found: the original studies that showed benefits to Tamiflu are now suspect where it concerns influenza complications and adverse reactions to the drug itself. About half of the studies were never published and are therefore unavailable for the in-depth analysis that is the hallmark of a review from the Cochrane Collaboration. All were sponsored by Roche, maker of Tamiflu, and most troubling, no independent studies of Tamiflu have ever been conducted. The hard-hitting editorial that accompanied this Cochrane review observed that the new findings have broad implications because they cast “doubt not only on the effectiveness and the safety of Tamiflu but on the system by which drugs are evaluated, regulated, and promoted.”

The review seems to confirm Tamiflu’s ability to shorten the duration of the seasonal flu by one day, if taken within 48 hours of first symptoms. However, the crucial question about the drug’s purported ability to reduce influenza-related complications like pneumonia could not be answered because of the unavailable data from the Roche-sponsored studies. And for the same reason, Jefferson and colleagues were not able to determine whether the reports of Tamiflu-related deaths and neuropsychiatric reactions, such as hallucinations and delirium, are actually rare occurrences. Nausea, vomiting, and retching are acknowledged to be common side effects of Tamiflu.

In a telephone interview, Dr. Jefferson, who is an internationally recognized influenza expert, took full responsibility for his role in advancing the Tamiflu hype. He was the lead author of the 2005 Cochrane review that lent credence to Tamiflu’s efficacy in preventing and treating the symptoms and complications of influenza. “We made a mistake in 2005,” he admits, “We took the data from the Roche-sponsored meta-analysis [of ten Tamiflu studies] on trust without checking the sources of the data. Had we done that, we would have realized that eight of ten studies were unpublished. And in over half of these studies, everyone except the lead author was either a Roche employee or a [Roche-paid] consultant. This shows that we trusted the data, irrespective of funding, a charge that is sometimes leveled at the Cochrane Collaboration.”

Dont expect any similar acknowledgement of mistakes or public soul-searching from the U.S. Centers for Disease Control and Prevention which was in the forefront of the enthusiasm for Tamiflu, as well as all flu vaccines. Dr. Jefferson, a long-time critic of the influential agency’s “evidence-free recommendations like flu vaccines for two-year-olds,” explains why. “The CDC is both the promoter and the evaluator of influenza drugs and vaccines…and guess what…they’re never wrong.” The agency, he continued, can’t think beyond the pharmaceutical model, he continued, citing what his research shows are the safest, most reliable methods of preventing the spread of influenza—frequent handwashing, quarantine measures, and barrier methods like wearing masks and gloves.

For more information
Click into this link for the story behind this Cochrane review and the contradictory statements about the potential benefits of Tamiflu made over the last ten years by Roche, the FDA and the drug-regulatory agencies of other countries. And click into the editorial that accompanied the review. And here’s our 2011 follow-up post on the controversey.

Maryann Napoli, Center for Medical Consumers(c)

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Type 2 diabetes drugs: risks w/o benefit

Posted by medconsumers on December 14, 2009

Yet another study, this one conducted in the U.K, has shown that the oral drugs typically prescribed for people with type 2 diabetes are killing some of them; and many more have suffered heart attacks and congestive heart failure while on the drugs. Ironically, these are the very conditions that the drugs are intended to prevent. The British Medical Journal recently published findings from a 15-year database of more than 91,000 people with type 2 diabetes. The drugs they were taking—Avandia, Actos, Glucophage, and Amaryl—will be familiar to Americans. This is the eleventh published study to acknowledge the fact that oral hypoglycemic drugs are associated with an increased risk of serious harms. This one shows that some are riskier than others.

For those of you who are on one of these drugs, I provide access to the new study and leave it to your doctor to explain. I want to move on to the larger issue of why doctors continue to prescribe these dangerous drugs and how they got on the market in the first place. That last point is more easily addressed. Drugs most often receive FDA approval on the basis of what researchers call surrogate endpoints, for example, blood sugar levels are controlled, blood pressure or cholesterol is lowered, etc. The studies are usually too short in duration to prove what matters most to the people taking the drugs—i.e., they cut the chances of heart attack, stroke, etc.

I put the question of why doctors continue to prescribe these drugs in the face of so much proven danger to Nortin M. Hadler, MD, whom I consider the informed-skeptic-in-chief on this topic. Dr. Hadler is a professor of medicine and microbiology/immunology at the University of North Carolina, Chapel Hill. He is the author of two books, each with excellent sections devoted to type 2 diabetes (see below). Of course, the place to start questioning Dr. Hadler is the very definition of type 2 diabetes, which has been expanded over the years to include more and more people.

Dr. Hadler had a ready answer, “I don’t think America realizes how much input industry has on the medical organizations and their thought leaders who are involved in writing these definitions and treatment guidelines. Several of these entities are so heavily underwritten as to be almost wholly owned subsidiaries of the pharmaceutical industry. Professional meetings have much more the tone and the feel of the marketplace than they do of the academy. And all of this happened in the last 20 years.

“There are several pharmaceutical industry-supported medical groups that compete to establish standards of care for type 2 diabetes and related conditions. Some endocrinologists believe that type 2 diabetes, obesity, high blood pressure, and high cholesterol—all cluster together because they are parts of a single metabolic syndrome, which responds poorly to the treatment of its components. Others argue strenuously for the treatment of one or the other components [of metabolic syndrome]. Rather than choosing meaningful effectiveness as their battle cry, they are more interested in turf wars. The cardiologists are averse to this metabolic syndrome notion and want to pull out cholesterol and maybe hypertension as the most important risk factors to treat. The Endocrine Society and the American Diabetes Association finally got together and came out with their definition of type 2 diabetes and guidelines for lowering blood sugar.

“All of this is driven by the belief that if we normalize cholesterol or blood sugar we will improve longevity and decrease the incidence of blindness, kidney failure, stroke, heart attacks and leg ulcers. The thought leaders are so convinced of their belief that they focus on treating the blood sugar and to question whether they are treating the patient seems unnecessary. Their shortsighted efforts are rewarded with renown by the pharmaceutical industry. Almost all the thought leaders are heavily involved in drug trials where they are paid for studying the drugs. And almost all are vying for a place on the committees that set treatment guidelines.

“We now have three randomized controlled trials of oral hypoglycemic drugs in the treatment of type 2 diabetes and based on these three, we doctors cannot offer any meaningful assurance whatsoever that taking these drugs will decrease the likelihood of having a stroke, death before your time, amputation, renal failure, blindness. Anybody who tells you otherwise is exercising firm beliefs in the face of the evidence. They are wont to argue that oral hypoglycemics might have proven effective if we had done a bigger and/or longer trial. Such an argument is on the thinnest of ice. The available trials are impressive for their duration (measured in over a decade for two of the trials) and their size. Little of importance, if anything, has been missed.

“Maybe it’s time to address the other aspect of the metabolic syndrome that is too long and too often ignored. Most people who fall into the metabolic cluster are facing serious socioeconomic challenges in our society for which type 2 diabetes is one surrogate measure and for which pharmaceuticals are irrelevant.”

When I asked Dr. Hadler about metformin, the oldest and some doctors believe the safest diabetes 2 drug, he was unmoved by the British study that showed it to be effective at reducing the risk of heart attack, stroke, etc. “When you look carefully at that study, you will see the finding [of effectiveness] was not statistically significant [which means it could be due to chance].” As someone who has done an in-depth assessment of this landmark study, called the United Kingdom Prospective Diabetes Study, Dr. Hadler states, “…we doctors cannot offer any meaningful assurance whatsoever that taking these drugs will decrease the likelihood of having a stroke, death before your time, amputation, renal failure, blindness.”

Dr. Hadler is the author of The Last Well person. How to stay well despite the health-care system and Worried Sick. A prescription for health in an overtreated America, each has a strong section on type 2 diabetes. He appears frequently on National Public Radio.

For More Information:
Type 2 diabetes is largely due to lack of exercise and poor eating habits. See our 2008 interview with Dr. Steve Blair on the importance doing at least one-half hour of brisk walking five or more times a week. And to learn how to eat well and lower your risk of type 2 diabetes and other chronic conditions, read Michael Pollen’s new book entitled, “Food Rules.”

If you would like to know more about how the pharmaceutical industry brings the thought leaders around to its way of thinking, read Our Daily Meds by former New York Times business reporter Melody Petersen.

Maryann Napoli, Center for Medical Consumers(c)

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