THE MEDICAL INDUSTRY CANNOT REGULATE ITSELF
DOCTORS RELY ON DRUG COMPANY FLASHY BROCHURES
Drug companies spend billions each year to encourage doctors to prescribe their drugs. Doctors and their staff get visited by drug sales reps right in the office during patient care hours. Doctors are flooded with advertisements through direct mail and e-mailing and advertising in the medical journals they rely on.
What makes direct physician advertising so sneaky but effective is that doctors consistently underestimate the influence it has on their prescribing practices. They also can’t tell the facts from lies in the flashy brochures provided by the drug reps.
Brochures, fact sheets and graphs that the drug reps bring to the doctor’s office were the focus of a study by the Institute for Evidence-Based Medicine, a private independent research institute. They evaluated 175 brochures containing information on 520 drugs:
- 15% of the brochures did not contain any references to actual medical studies to back up their ad claims.
- The references that were listed in another 22% could not be found. In other words they were made up.
- In the remaining 63% the information was correctly connected with real research articles, but the brochure ( all the other brochures lied? Also, emphasis) lied about the study results.
- Only 6% of the brochures contained statements that were scientifically supported by real medical articles.
Believe it or not, this is what your doctor depends on instead of the actual scientific studies.
PRIVATE INFORMATION IS FOR SALE
Drug sales representatives are armed with very specific physician information. The pharmaceutical manufactures hire information companies who provide detailed data on exactly who prescribes what.
The largest of these information companies, IMS, purchases electronic records of prescriptions from pharmacies and other sources. They link the pharmacy records with information they obtain about doctors in the Physician MasterFile that is maintained by the American Medical Association (AMA).
The AMA licenses IMS and others to use the MasterFile. In fact the AMA was paid $44.5 million in 2005 alone for selling doctor information. The MasterFile includes data on members and non members as well as paramedical personnel like nurses and physician’s assistants.
This billion dollar advertising machine is very effective at convincing doctors to prescribe all the latest and most expensive drugs. These are the very treatments that don’t have a long term safety record yet.
FREE SAMPLES ARE NOT SO FREE
Free drug samples are the number one way to influence doctors prescribing habits. When doctors have free medication samples it definitely influences what they are most likely to prescribe. Researchers from the University of Minnesota reported that when doctors in training have access to free drug samples, they are more likely to choose the advertised drugs than other training doctors who did not have access to free samples. When free samples of prescription drugs were available, physicians were less likely to choose cheap generics or effective over-the-counter drugs to treat the same conditions.
Even when their stock of free samples ran out, these doctors continue to prescribe “the latest”, recommending that their patients take the more expensive drugs that have an unproven safety record. When doctors in training rely on the latest new advertised drug, it drastically increases the cost of treatment because they keep writing prescriptions long after all of the free samples are gone. In other words, what is “free” up front causes long term higher costs.
In another study, 95% of physicians who gave free drug samples to treat urine infections admitted that the free sample of the newest drug was not the best medication for the condition. In other words, they gave the drug just because it was in their free sample closet. 91% of samples given for high blood pressure were not the best drug for the patient. 49% of samples given for depression were not the drug they would have prescribed if samples had not been available. Whether they are aware of it or not, doctors are heavily influenced by the freebies given by drug reps.
An article in the Journal of the AMA found that when medical training centers had drug industry funding, it was found to be the key factor that set up lifelong habits for how the doctor prescribes. Those habits will follow the doctor-in-training into practice, where the effects of manufacturer influence will continue.
Clinic doctors and medical training hospitals are not the only ones to be targeted by drug makers. Even pharmacists are willing to be paid off for pushing certain drugs on you. One pharmaceutical manufacturer developed a program to generate loyalty among pharmacists. Their “YOUnique club”, allows a pharmacist to accumulate points toward the award of prizes every time they gave the company’s brand of medication. This is fine for an individual person racking up frequent flier miles, but not when trusted professionals are playing around with peoples’ health.
DRUG MAKERS INFLUENCE SCIENTIFIC REPORTING
A less obvious source of biased information is found in medical journal articles. Most medical journals have some sort of conflict of interest policy that applies to authors, but the majority do not have any rules about conflicts of interest for their reviewers, editors or publishers. That means that the people who actual control the content of the journal are themost prone to have undisclosed conflicts of interest. These are the people that the drug companies can count on to publish what they want (and to refuse to publish article sthat would make their durgs look bad). Journal publishers make a lot of money when they are paid to print “special edition journal supplements” that are entirely sponsored by a drug maker. These articles only tell the “good news” about their drug, and don’t tell the whole story. This is like a slick infomercial in print.
Medcial journals are no different from other media businesses – they rely on their advertisers to saty in print. But their advertisersa re not Toyota and Pepsi, they are the makers of the very treatments that the journal authors are supposed to be investigating.
Medical journals that publish studies that show the bad news about a drug can see the company’s ads pulled, and a big drop in funding. Richard Smith, editor with the British Medical Journal for 25 years, says that medical journals are nothing more than an extension of the marketing arm of pharmaceutical companies.
Sometimes it takes a little digging around to find the manufacturer influence. It might not be obvious when the authors are from academic centers and the research support has been funneled from the drug maker through government health institutions. Medical experts may well “know best”, but they are often in the pay of the sponsoring company and they can be counted on to give only good news about the drug made by the company who pays.
When a research project is done, the drug company that sponsors it requires every researcher to sign an agreement. The legal agreements say that the company has the right to say what results will be published (any results that make their drug look good) and what will never see the light of day (less favorable results or downright damaging information). This leads to the practice of covering up bad side effects, witness Vioxx, FenPhen, etc….
A more stealthy practice is called ghost authoring. An article that is ghost authored is written entirely by a company writer. Then it is shopped around for a likely university-associated doctor to be the “author”. The doctor is given a fee for the use of his name, but has not written a word of the article. The sponsoring company then purchases journal space for the article.
MEDICAL GUIDELINES SELL DRUGS
National advisory panels, government medical institutions support groups are all sources of guidelines and recommendations. They are often stacked with experts who have significant conflicts of interest. For example, in 2004 the National Institute of Health’s National Cholesterol Education Program issued new lower cholesterol recommendations (from blah to blah) based on unimpressive scientific data. The data came from studies that were largely funded by pharmaceutical firms. Eight of the nine authors of the new cholesterol guidelines were found to have financial ties to four statin manufacturers (makers of drugs like Lipitor and Crestor).
Similarly, in 2005 the FDA held an Advisory Committee meeting to discuss the risk of heart attack from Vioxx and similar drugs, called “cox-2 inhibitors”. The panel voted to keep all three cox-2 inhibitors on the market, though with heightened warnings about the dangers posed by this class of drugs. Of the 32 scientific experts chosen by the FDA to evaluate these drugs, ten had affiliations with one or more of the manufacturers of cox-2 inhibitors. Another 17 scientists had other ties to drug manufacturers, though not the three with products under consideration at the meeting. The drugs were later taken off the market, but not until the companies had made millions more and injured more unsuspecting patients.
A look at voting records on FDA Advisory Committee recommendations compared to financial support reveals that financial conflicts of interest are very much related to voting patterns. 73 percent of advisory committee members have conflicts of interest. Only one percent of those with conflicts are routinely excluded.
New FDA guidelines would limit the influence of industry by excluding anyone from sitting on an advisory panel that has $50,000 or more manufacturer interest in the preceding 12 months. Panelists with some conflict but less than $50,000-worth would be allowed to influence panel discussions but would not have voting power. However “waivers” are often granted, letting business go on as usual.
FAKE GRASS ROOTS GROUPS
Non profit support groups seem to be made up of well-meaning patients and families. They would appear to have no conflicts of interest. However they are not always what they seem. This is especially true for conditions that have recently been named, and then made popular. The Restless Legs Syndrome (RLS) Foundation, for instance, received over half a million dollars in 2005 from manufacturers of RLS drugs.
The New York Times reported on Midwest Heart Foundation, where medical device manufacturers liberally donated to the nonprofit medical group. The generous device maker was “re-paid” by the clinic doing a study of the company’s own heart device. This gave handsome profits for the doctors and their clinic. On their website Midwest brags that their Foundation “gives patients access to medical advances before they come to market.” In other words, “We’re experimenting on you.”
Documents that came out in the lawsuits over the diet drug combination FenPhen (fenfluramine-phentermine) uncovered some dirty business. The manufacturers of diet pills provided the principle financial support for several “advocate groups”, such as the American Obesity Association. In exchange, the Association pushed the use of FenPhen. Drug makers even funded the start up of brand new groups to promote their diet drug, with names like the American Association for the Study of Obesity.
These company groups operated as non profits. They sponsored mass mailings about the benefits of FenPhen to physicians and patients, and were given free spots on public service announcements that helped them advertise FenPhen. This was totally free advertising. They went beyond warning about the health effects of obesity by making up their own statistics about obesity, and emphasizing diet drug treatment. Their spokespeople included physicians, researchers and celebrities who were in the pay of the manufacturers. These conflicts of interest were not required to be disclosed when they spoke on news and talk shows across the country.
THE MEDICAL INDUSTRY CANNOT REGULATE ITSELF
Studies on the psychology of gift-giving definitely show that the drug industry and medical centers cannot regulate themselves to do what’s best for patients. Money changes people.
The AMA has an “ethical guideline” that says doctors are not supposed to accept gifts of substantial value (worth more than $25). But hardly anyone pays attention to this. Drug companies pay for physician travel to company-sponsored meetings, and they pay doctors to be part of their speaker’s bureaus. When it comes to ghostwriting and consulting, the drug maker writes up the articles and then pays the doctor to put his name on it as if he wrote it.
These financial arrangements set up the doctor to have conflicts of interest, where they are likely to recommend an advertised drug instead of nutrition, life style change, or an equally effective over the counter drug, or a cheaper and safer generic. Some doctors are calling for stricter rules about accepting gifts. Doctors should be more open with their patients, and tell them about the persuasive gifts they get from sales reps.
In the early days, drug sales reps were often grisly old retired pharmacists or studious-looking elder professor types. These days the drug rep’s sex appeal is more important than knowledge about the drug. Some of the “freebies” the docs get are not just drugs, either.
Drug companies sponsor medical meetings and health fair events to promote their products. Money for these events is written off by the drug makers as “charitable contributions” when it is really advertising. Drug manufacturers are allowed to fund the conference, pay the speakers and get them to essentially advertise their products. Drug sales reps are limited by regulations about what they can and cannot say about their product, but at medical meetings the company-paid doctor can say whatever he wants (or is told to say).
The pharmaceutical industry provides at least half of continuing medical education conference money to medical schools. Beyond medical schools, more than half of medical conferences are funded by pharmaceutical or biological device firms. It is common for pharmaceutical manufacturers to create “non profit” medical education companies, who then get accredited by the Accreditation Council of Continuing Medical Education (ACCME).
So who is regulating the accrediting agency to watch for conflicts of interest? ACCME has its own watchdog, Task Force on Industry-Professional Collaboration. Half of Task Force members are from the pharmaceutical industry!
BE A SMART HEALTH CARE CONSUMER
You have a right and a responsibility to be fully informed before accepting a treatment recommendation. Ask about the conflicts of interest of your doctor, hospital or medical center. Look around to see who is funding the groups or internet sites that you use for medical information. Subscribe to SmartMEDinfo.com for unbiased medical information with no financial conflicts of interest.
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