October 26

How Pharma Took Over Medicine: Research and Practice – BMJ / NYT

How Pharma Took Over Medicine: Research and Practice – BMJ / NYT

Fri, 3 Jan 2003

In today’s New York Times Dr. Erin Marcus writes: “Medicines aren’t like shampoo or perfume.” But they’re being hawked on TV as if they were just another ‘enhancer’–when in fact, they come with glossed over risks of harm.

1997 was a watershed for the pharmaceutical industry: it succeeded in redirecting medicine from its scientific evidence based practice to one driven by marketing. The drug industry launched an aggressive advertising campaign directed at consumers. The FDA, the agency that is supposed to regulate the industry, sat idly by as fraudulent claims, lies and disinformation spread over the air waves. Indeed when a judge recently tried to pull a Pfizer advertisement, the U.S. Justice Department intervened, claiming FDA has jurisdiction, not the courts! The US government thereby exempted drug companies from “truth in advertising statutes.”

In 1997 drug companies also embarked on a collaboration with academic researchers set about creating “diseases” for their products. They labeled fleeting problems as “dysfunctional conditions”, and pre-emptively labeled people–including children– as “at risk” of a “condition” for which a prescription drug was either in need of a market or about to be launched.

And the drug industry took over the function of “educating” doctors about drugs. This marketing strategy has trivialized, if not debased the practice of medicine, undermined the physician-patient relationship, depleted healthcare budgets with drugs whose advertising costs was passed on to consumers. But the strategy has reaped enormous riches to the pharmaceutical industry. No wonder this industry spends billions on bringing physicians into the fold and billions more to influence consumers: “A recent report by the General Accounting Office estimates that every year at least 8.5 million Americans request and obtain specific prescriptions after seeing or hearing ads for particular drugs. In 2001 drug companies spent about $2.7 billion on such advertising, a 150 percent increase since 1997, when the F.D.A. loosened its rules on advertising.

An investigative report in The British Medical Journal sheds light on one example of the collaborative effort between drug companies and doctors who can’t say no to $$$. This unholy alliance conceived of a scheme to convince women they’ve sexually dysfunctional and in need of a pill: “The Making of a Disease: Female Sexual Dysfunction” by Ray Moynihan, journalist BMJ 2003;326:45-47 ( 4 January ): http://bmj.com/cgi/reprint/326/7379/45.pdf

“Perhaps the greatest concern comes from the flip side of inflated estimates of disease prevalence the ever-narrowing definitions of “normal” which help turn the complaints of the healthy into the conditions of the sick. These revelations about female sexual dysfunction should spark a more widespread and rigorous investigation into the role of drug companies in defining and promoting new diseases and disorders.”

In an Op Ed article in The New York Times (below), Dr. Erin Marcus, a University of Miami internist decries FDA’s relaxing of the drug advertising rules in 1997.



January 3, 2003

When TV Commercials Play the Doctor


MIAMI – Several months ago, a woman walked into a clinic where I work and asked for Prempro, a hormone replacement drug. She wasn’t bothered by hot flashes or interested in preventing bone loss – the usual reasons we would have prescribed this drug. She just wanted to look like Patti LaBelle. Back then Ms. LaBelle, along with Lauren Hutton, was an official Prempro spokesperson, promoting the drug in television advertisements in which she sang of her “new attitude.”

Last summer, Wyeth, the manufacturer of Prempro, stopped running the ads after a major federal study found that women taking the drug for four years or more had a higher risk of breast cancer than those who took a placebo. Patients have stopped asking for Prempro but they continue to ask about other heavily promoted drugs, like Vioxx, a pain medicine whose ads feature Dorothy Hamill skating lithely around a rink.

Since the Food and Drug Administration relaxed its rules governing advertising of prescription drugs five years ago, I’ve seen a steady increase in the number of patients asking for certain expensive new medicines. Often these patients don’t really know the purpose of these drugs or their risks or side effects — they’ve just seen a nice ad on TV or in a magazine. While I’ve usually found that I can convince patients that they don’t need these drugs (if they’re inappropriate), it can be very hard to persuade patients to try pain relievers other than Vioxx and Celebrex, since often patients in pain are looking for anything that will help, and these drugs are effective and well known.

A recent report by the General Accounting Office estimates that every year at least 8.5 million Americans request and obtain specific prescriptions after seeing or hearing ads for particular drugs. In 2001 drug companies spent about $2.7 billion on such advertising, a 150 percent increase since 1997, when the F.D.A. loosened its rules on advertising. This is still less than the amount drug companies spent promoting their drugs to doctors (and I’ll admit, I’ve listened to their talks and eaten their sandwiches). But most doctors, unlike patients, make their decisions based on clinical experience, and at least where I work, doctors usually greet these drug promotions with a dose of skepticism.

Perhaps the most unsettling finding of the accounting office report is that many of the prescription drug ads are misleading and are seen by millions before the government even considers stopping them. The F.D.A. is not required to review the ads before they hit the airwaves. Often, by the time the agency sends out letters telling companies to stop a particular ad, it has already run for months and been taken off the air.

Some have blamed a new step in the F.D.A.’s review procedure for the slowdown in removing misleading advertisements from the airwaves. Even so, the regulation of prescription drug ads aimed at consumers was limited already. The agency requires that these ads include balanced information about a drug’s risks and benefits but allows them to greatly summarize side effects.

The new director of the F.D.A., Dr. Mark B. McClellan, has said he plans to set new standards for the ads and toughen enforcement. But many of us who have to answer patients’ questions every day wonder whether these commercials should be on the air at all.

Medicines aren’t like shampoo or perfume. They’re things people need to maintain health, not discretionary products a person can use or throw away on a whim. I’m all for educating patients so they can make informed decisions about treatment. But these ads aren’t educational tools, they’re sales pitches — and as hard as we doctors try, it’s tough to compete with the likes of Patti LaBelle and Dorothy Hamill.

Erin N. Marcus is a general internist and assistant professor of clinical medicine at the University of Miami School of Medicine.

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