Overdosed America (20 page)

Occasionally, the drug industry pays lip service to complaints of its marketing excesses. In 2002, Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry’s trade association, voluntarily changed its guidelines regarding CME.
Permissible offerings
are now limited to meals that are “modest as judged by local standards” and occur “in a venue and manner conducive to informational communication and provide scientific or educational value.” A study done over the following six months monitored CME for doctors during their residencies (the most formative years for establishing patterns of interaction with the drug industry) to determine whether the drug industry’s self-imposed guidelines were being followed. The study concluded: “Findings at our institution suggest poor compliance with the spirit of the PhRMA guidelines in the first 6 months of their inception. Dinners were frequently held at high-priced restaurants that are known to be among the best.”

The president of PhRMA,
Alan Holmer, claims that the drug industry
provides a much-needed service to doctors: “Industry-supported conferences, seminars, and symposia are helping physicians to provide the best, most appropriate, and most up-to-date health care to their patients. They help to ensure the widespread adoption of new medicines and technologies that save lives, cure disease, relieve pain, and allow individuals to lead longer, healthier, and more productive lives.” He’s certainly right about one thing: Industry-supported CME definitely accelerates widespread adoption of new developments in medicine. The net effect on Americans’ health, however, is not so clear.

Who’s to blame for the commercial takeover of the education that keeps doctors up to date on the latest in medical science? It’s too easy to lay all the blame on the drug and medical-device companies and the medical education and communication companies. Doctors who allow their reputations and academic positions to be leveraged by drug companies for commercial purposes provide a crucial link in the chain of corporate influence. Most insist that these financial relationships do not color their opinions, but a
review article published in JAMA
titled, “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” shows that drug company–sponsored lectures are two-and-a-half to three times more likely to mention the sponsor’s drug in a positive light and the competitors’ drugs in a neutral or negative light. Doctors who receive honoraria for speaking and research support from a drug company are four and nine times more likely, respectively, to support the use of that company’s drug in their hospital. Meanwhile, doctors practicing on the front lines of medicine, drilled to believe new information when it comes from sources they’ve been taught to accept as legitimate, are unwittingly and effectively influenced by the underlying commercial agenda of the majority of their continuing “education.”

Doctors in training are gradually eased into the process so that it seems like a normal part of their educational environment. The
gifts and meals start in medical school
, but really come into play during residency training, when doctors are developing their prescribing and information-gathering habits. An editorial in
The Lancet
sheds light on how this process evolves: “It starts slowly and insidiously, like an addiction, and can end up influencing the very nature of medical decision-making and practice. It first appears harmless enough: a textbook here, a penlight there, and progresses to stethoscopes and black bags, until eventually come nights ‘on the town’ at academic conventions and all-expenses-paid ‘educational symposia’ in lovely locales.” It doesn’t take long before doctors and drug reps are on a first-name basis.

A 2001 study published in the
American Journal of Medicine
looked at residents’ interactions with drug salespeople and their opinions about accepting gifts and attending drug company–sponsored educational activities.
Eight out of 10 medical residents
saw the inclusion of such sponsored education and interaction with drug reps as “appropriate.” This shows how seamlessly drug company infomercials have become integrated into medical training, even in the very best medical centers, just as soft drink and snack machines gradually have become accepted as a normal part of the public school environment. The study commented on the “ubiquity of the [drug] industry’s presence” in the residents’ environment and on the lack of formal education for residents about the effect of relationships with drug industry salespeople. Eighty-four percent of residents in the study thought that their colleagues were influenced by drug-company promotions, but only 39 percent felt that the same could be said of themselves. A 2003 article in the
British Medical Journal
succinctly summarized these issues:
“Twisted together like the snake
and the staff, doctors and drug companies have become entangled in a web of interactions as controversial as they are ubiquitous.”

Anyone who has spent any time in a doctor’s office will have noticed the constant parade of attractive and well-dressed drug company sales representatives giving away trinkets to the staff and trying desperately to get a moment of the doctor’s time. The
number of reps making sales pitches
in doctors’ offices has
tripled
over the past 10 years. There is now one full-time drug rep for every four and a half office-based doctors. In 2001, drug companies spent $4.7 billion “detailing” (“industry speak” for drug reps’ sales calls) to the 490,000 office-based doctors in the United States, or about $10,000 for each doctor per year. And that doesn’t include the cost of the drug samples the reps left.

It is difficult for doctors to avoid dealing with sales reps. They are usually pleasant people who are convinced that they are providing a useful service. They are also experts in the art of getting doctors’ attention: finding a place to sit or stand from which eye contact with the doctor cannot be avoided, starting their sales pitch when the doctor comes within view, and skillfully creating situations in which the only way to contain their influence is to be uncomfortably and blatantly impolite—often in front of patients. They come bearing free drug samples and many enticing gifts.

I, too, have accepted some of their offerings. A Swiss Army penknife bearing the name of a now forgotten antihistamine was irresistible. Drug companies were very generous in donating medicine for my medical trip to the Amazon, with no strings attached. Once, I accepted a $1000 grant to fund a small trial of alternative healing in my office. (I wanted to see if these services would help my patients, but I didn’t feel right charging for therapies that I wasn’t sure would be effective.) The quid pro quo for this grant was that I agreed to listen to the drug reps sales pitches three times. They lost interest after the first meeting took a contentious turn: I asked if they honestly believed that I should use their powerful antibiotic for routine infections or if they were just trying to persuade me to do this because it was their job.

The rule in my office was that the drug reps could talk to the nurses to find out if we needed samples, but not to me. Looking back, I think that the drug reps were quite supple—if not brilliant—in accommodating my anticommercial bias and actually leveraging it to their advantage. We doctors tend to remember the dose, timing, and side effects of only two or three drugs in each class. The drug companies knew this, of course, and were willing to give me a steady supply of samples in order to make sure that I was familiar with their drug instead of a competitor’s. With free samples to give out to people who needed them, I felt like Robin Hood. And they (I now realize) felt like very effective drug reps.

You may wonder why 80 to 90 percent of doctors—with all their training and clinical experience—are willing to listen to drug reps at all. Moreover, you may wonder how self-respecting doctors could possibly allow themselves to be influenced by the sales pitches from people with so much less understanding of the complexities and pitfalls of medical practice, and with such obvious commercial motives. The drug reps provide what can seem to busy doctors like a useful service. Along with their trinkets, doughnuts, and free lunches, they arrive with reprints of articles from medical journals and the drug company’s own educational materials summarizing the latest medical research. Like CliffsNotes, the drug reps provide doctors with easy-to-read versions of the latest research (that supports their product), allowing the doctors to feel up to date. How accurate is this so-called educational material? According to an article in the
Journal of General Internal Medicine
published in 1996,
42 percent of the material given to doctors
by drug reps made claims that were in violation of FDA regulations, and only 39 percent of the material provided scientific evidence to support its marketing claims.

Most doctors firmly believe that their opinions about drugs and scientific evidence are not compromised by these interactions. The research shows otherwise. A review of doctor–drug company interactions, published in JAMA, shows that these interactions have a
mostly negative effect
on the quality of medical care. For example, more interaction with pharmaceutical company marketing people, as well as
having drug samples on hand
, increases the likelihood that doctors will prescribe newer, more expensive drugs and fewer generic drugs. The more a doctor sees a sales rep, the less likely the doctor is to identify false claims about the drug, and the greater the doctor’s tendency to prescribe more drugs overall.
Doctors who interact with drug companies
are also about 15 times more likely to request that drugs manufactured by specific companies be stocked in hospital pharmacies.

How do the drug reps and their bosses know that their sales pitches are working? It’s easy to keep track of how many doctors meet with each rep; how many offices accept samples; how many offices load up on trinkets (pens, notepads, coffee cups, calenders, clocks, and wall posters that broadcast the message that commercialism is okay); and how many docs can be rounded up for an “educational” dinner meeting.

But most important, the drug companies purchase from local pharmacies individual doctors’ prescribing information, so they know exactly what we prescribe, and can precisely measure the effect of their reps’ office calls and enticements. (I am happy to report that the small-town family-owned pharmacy near my office has not succumbed to the temptation to sell this information.)

The upshot is that the drug companies now know much more about doctors’ prescribing habits than doctors know themselves. They also understand that it doesn’t really matter that drug reps don’t know as much about medicine, or that their materials fail to present the whole truth. The only thing that matters is how to influence doctors. Clearly, that’s the one thing drug reps have down to a science. This raises an important question: Is that the way you want your doctor to keep informed about the best medical care for you?

There is one area that has been neglected in all the education provided to doctors by the drug companies: doctors have surprisingly little awareness of the cost of drugs.
Nine out of 10 doctors
think that brand-name drugs cost less than they actually do, and an equal proportion think that generic drugs cost more than they actually do. Most important, in terms of the cost of health care, the drugs for which doctors are most likely to underestimate the cost are those that are most widely prescribed.

Recognizing that no doctor can keep up with the deluge of medical research about all of the different clinical conditions, the medical profession regularly develops clinical practice guidelines to establish the standards that define good medical care. These guidelines are created by panels of nationally recognized clinical experts, and are usually sponsored by nonprofit organizations (such as the American Heart Association, the National Osteoporosis Foundation, or the National Stroke Association), professional societies (such as the American Colleges of Gastroenterology, Psychiatry, or Rheumatology), or governmental agencies.

Clinical guidelines provide expert review of the research and allow doctors to be confident that their decisions regarding patient care reflect the best available scientific evidence. Guidelines also provide benchmarks by which the quality of a doctor’s care can be evaluated, and (always lurking in the background of a doctor’s thoughts) they are admissible as evidence of the accepted standards of care in medical malpractice cases.

A study published in JAMA in 1999
evaluating the quality of the guidelines
showed, ironically, that they often fall short of established standards. The following year
The Lancet
published a report that found that
only one out of 20 clinical guidelines
examined met established standards of quality for three simple criteria: description of the professionals involved in formulating the guidelines; description of the sources of information used to find the relevant scientific evidence; and grading of the evidence used to support the main recommendations.

In 2000, Canadian researchers from the British Columbia Office of Health Technology Assessment evaluated the quality of the guidelines that addressed the testing of cholesterol levels. They found that
four out of five of these guidelines
did not reflect the best scientific evidence available. The Canadian researchers also found that “the greater the involvement of clinical experts in the development process of the clinical practice guidelines, the less the recommendations reflected the research evidence.”

Then, in 2002, JAMA published
the most damning study of all
. The study found that four out of five experts who participate in the formulation of clinical practice guidelines have financial relationships with drug companies, averaging more than 10 such relationships each. A whopping
59 percent
of the experts “had relationships with companies whose drugs were considered in the guideline they authored.” This would be the equivalent of a judge’s having an ongoing financial relationship with one of the litigants in a case he was hearing, or a stockbroker’s recommending his uncle’s IPO. More than half of the guidelines examined in the JAMA study had not even established a formal process for declaring participants’ relationships with drug companies.