18. Pharmaceutical Companies Mass Market Drugs

Source: THE WASHINGTON MONTHLY Title: "Pill Pushers," Date: April 1997 Author. Greg Critser

SSU Censored Researchers: Jacqueline Lichstein and Judith Westfall
SSU Faculty Evaluator: Paul Benko, Ph.D.

Profit-hungry pill companies are ignoring responsible medical practices and taking advantage of a growth economy to booster and advertise prescription medications directly to the public. The rush to high sales has companies promoting some medications that have not been fully tested or approved by the FDA. As doctors can prescribe any medication they choose (even unapproved ones), drug companies are using this loophole in the law to convince patients and doctors that they should be using specific drugs even before FDA approval.

In 1990, as the success of antidepressant Prozac proved that psychiatric drugs could create new mass markets, Abbott Pharmaceutical decided to re-register Depakote (originally a medication for epilepsy) as a treatment for bipolar disease, the diagnostic term for manic depression. Abbott filed the requisite forms with the FDA and began clinical trials, but did not wait for the FDA to render decisions about Depakote's efficacy -- as required by law. Instead, they began hyping away. Using a medical education program on bipolar disease for doctors, they began to promote Depakote illegally. They were eventually caught and cited by the FDA for promoting Depakote and for collecting information about how doctors prescribed certain medications.

Over the past few years, the FDA has issued dozens of warning letters to pharmaceutical giants for promoting so-called "off-line uses." In 1996, the drug giant Pfizer received a warning letter from the FDA for promoting its antidepressant Zoloft as a treatment for "Premenstrual Dysphoric Disorder," a form of depression that accompanies premenstrual syndrome (PMS) for a small percentage of women. The FDA considered the practice of "off-line" promotions so severe at Pfizer that it sent an eight-page warning letter to William Steere, the company's chairman.

FDA Commissioner Mary Pendergast stated in 1994, "Promotion of unapproved use by company sales represent-atives is a major problem." The FDA has a unit specifically empowered to police drug company hype, but that arm, the Division of Drug Marketing, Advertising, and Communications (DDMAC) is increasingly understaffed and overworked, with only 29 employees nationwide.

Doctors were once the traditional gatekeepers of the public's health. However, physician-prescribing habits are increasingly circumscribed by HMOs, who prod them to prescribe more drugs, and by pharmaceutical benefits managers, who tell doctors which drugs insurance companies will cover. Doctors are losing control of their prescription writing franchise, and are under increasing pressure from an ad-stimulated public and "off-line" drug company sales promotions. In 1996, there were over $4 billion in medical costs for treating adverse drug reactions in patients in the U.S.

UPDATE BY AUTHOR GREG CRITSER: "This story grew out of an on-going journalistic question: How do drug companies get their pills into your belly, and how do they get paid for it? One way is to market drugs to physicians for non-approved, or 'off-line' uses. This is accomplished by aggressively exploiting FDA loopholes and staffing weaknesses. At the time I wrote this article, all such efforts violated the Food and Drug Act.

"But this is no longer the case. In 1997, President Clinton signed new legislation which, among other things, gives pharmaceutical companies permission to market drugs to doctors for uses that they have not been approved for by the FDA. This legislation was passed under the ongoing effort to 'reform' the FDA. But the reform cuts only one way -- in favor of drug companies and against independent government oversight. The new law permits drug companies to use private firms to evaluate new drugs instead of being evaluated by FDA staff. This means that the agency Americans believe is the last word in product safety and efficiency is increasingly unable to do that job independently. Witness the recent recall of the diet drug Redux.

"There was no mainstream response to the Washington Monthly article. To find out more, you may want to explore the Web site of the FDA, which posts all enforcement actions. All of the major pharmaceutical companies have extensive Web sites. The trade publication Medical Advertising News provides a varnished, but nevertheless revealing, look at marketing practices. Of the big three national newspapers, only The Wall Street Journal is worth reading on this subject."