Fw: Subject Reference: OVERDOSE: The Case Against Drug Companies / Part I

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Subject: Subject Reference: OVERDOSE: The Case Against Drug Companies / Part I

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Over Dose: The Case Against the Drug Companies

By Jay Cohen, M.D.

Part 2 of 2 (Part 1)

Over Dose: The Case Against the Drug Companies: Prescription Drugs, Side Effects, and Your Health

The PDR is not only the leading drug reference among physicians, but it is also purchased by thousands of consumers each year. Moreover, the PDR is the source for the bulk of information contained in other consumer drug references. Yet, as I have written in multiple professional publications, because the PDR is mainly a collection of drug-company written package inserts, it omits a great deal of important information.

The PDR omits or underreports many serious side effects. It frequently omits information about proven-effective medication dosages that are lower and safer than the doses recommended by drug companies or usually prescribed by doctors (54-58). Many new, important uses of medications are not even mentioned in the PDR.

Nor does the PDR provide any guidance whatsoever in selecting between the many drugs that might be used for medical conditions. And, although a new PDR is published each year, many drug descriptions are not updated. Some of these descriptions contain information that is decades old.

A glaring example was provided in a 1997 article in the ls of Emergency Medicine (59). This article examined drug company guidelines in the PDR for handling overdoses of 20 drugs commonly seen in overdose situations in emergency rooms.

The study found that for 80% of the drugs studied, the PDR guidelines for handling overdoses were inadequate. For overdoses with nearly half of these drugs, the PDR recommended "ineffective or frankly contraindicated" treatments that could worsen the situations or cause unnecessary deaths.

The drug companies' influence even extends to the FDA, which we will explore in Chapter 11. The FDA is required to ensure the effectiveness and safety of medications, but changes in the law and political pressure from Congress, as well as a massive shortfall in funding, has led to weakened FDA standards. Furthermore, some of the FDA's own policies make matters worse (60). Funding for the FDA's monitoring of newly approved drugs is so limited that some drug toxicities weren't identified by the agency, but by investigations conducted by newspapers or health interest groups. Limited funding also hampers the ongoing monitoring of important drugs with recognized risks.

After Viagra was on the market for seven months, the FDA reported receiving 230 cases of deaths associated with the drug (61). The FDA responded, as usual, with required changes in Viagra's labeling -- yet, the agency hasn't provided any follow-up reports on Viagra-related deaths or any analysis of whether the labeling changes have helped. Experts with drug company ties fill many important advisory positions at the FDA. An investigation by USA Today found that more than half of the experts on FDA advisory committees "have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions (62)."

Today, the FDA approves drugs much faster, and sometimes on fewer studies, than required ten years ago (63-65), and FDA oversight wasn't exactly robust then, as multiple drug withdrawals in the 1980s demonstrated. Since 1997, more drugs have proven toxic and been withdrawn than ever before.

Some of these withdrawn drugs - Redux, Seldane, Propulsid, Rezulin -- were prescribed millions of times. According to Dr. Alastair J.J. Wood, Assistant Vice Chancellor for Research at the Vanderbilt University Medical Center (66), "a staggering 19.8 million patients (almost 10% of the U.S. population) were estimated to have been exposed" to just five of the ten drugs withdrawn in this period.

Dr. Wood added, "None of the drugs was indicated for a life-threatening condition nor, in many cases, were they the only drugs available for that indication (67)." Safer alternatives to these drugs existed, but intense marketing convinced physicians to prescribe them anyway -- and to continue prescribing them even as the FDA prepared to withdraw them.

Drug companies can profit handsomely on such drugs. Seldane, the top-selling antihistamine in the world for more than a decade, was on the market for thirteen years until the FDA removed it in 1997, seven years after the drug's cardiac toxicities were identified in 1990 (68). ============================================================

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