Bush Protects Corporations from Consumers

By Sam Uretsky

On July 24, the New York Times reported that the Bush administration, as part of its ongoing effort to (1) protect the pharmaceutical industry that has given $6,549,328 to Republicans this year (compared to $3,321,117 to Democrats), while (2) hurting the trial lawyers who gave $69,617,882 to Democrats compared to $27,977,881 to Republicans, proposed that pharmaceutical manufacturers be exempt from lawsuits as long as their products were approved by the Food & Drug Administration. This would protect the innocent multinational corporations from the rapacious citizenry who like nothing better than to turn their injuries and disabilities into cash, and the trial lawyers who aid and abet them.

There is some justification for this policy, but only some. The drug companies are required to include a package insert, also known as a "full disclosure" with every package of medication. This lists the reported side effects and adverse reactions of every drug. In theory, every patient has knowledge of the risks inherent in taking a drug, and can make an informed decision whether the risks outweigh the benefits. Pharmaceutical sales representatives leave copies of the package inserts with physicians to assure that every MD has the requisite information before prescribing the drug. It's argued that the drugs save more lives than they harm, and the hazards are clear. Lawsuits, the administration says, just get in the way of drug companies who wish to make life-saving drugs. The FDA is giving citizens all the protection they need.

Well, yeah. Except that in 1982, while Ronald Reagan was president, the FDA issued a statement that it was legal for prescribers to use drugs in ways not approved by the package insert. Until then, the PI was the absolute standard for drug use, and could limit the dose and duration of treatment. The rule might be flouted a lot, and the FDA was simply acceding to reality, but you could fish for a lifetime with the worms in that can.

Under the new rules, it was perfectly okay to prescribe a drug for any use, in any dose, for any duration that was backed up by the professional literature. The studies required to get approval for marketing have to be good ones, because they have to be reviewed by a panel of experts. After that, the studies don't have to be the same quality, and frequently they're not. It's easy to design a biased study using methods that favor one drug over another, and it happens.

Beyond that, New York's attorney general reported that at least some pharmaceutical manufacturers were suppressing publication of studies with unfavorable results. If a drug company sponsors a study that has favorable results, they rush to get it published. If the results aren't favorable, nobody has to know. On June 2, Attorney General Elliot Spitzer issued a press release that said: "Specifically, (GlaxoSmithKline) conducted at least five studies on the use of Paxil in children and adolescents. However, GSK only published and disseminated one of these studies, which showed mixed results on efficacy. The lawsuit alleges that the company suppressed the negative results of the other studies, which failed to demonstrate that Paxil is effective and which suggested a possible increased risk of suicidal thinking and acts."

GlaxoSmithKline isn't the only drug company which has suppressed publication of unfavorable results. Last year, the British Medical Journal, also known as BMJ, published a review that showed drug manufacturers in general manage to keep unfavorable results out of the medical journals.

On July 21, the New York Times reported that some drug companies have been permitted to state "use in pediatrics has not been established" when the tests have been conducted and the results raised doubts about the wisdom of using the drug. If the tests have been run, prescribers and the patients who are the ones directly at risk are entitled to know the results. On the 25th, the Washington Post reported that Jannsen Pharmaceuticals had minimized potentially fatal risks from its $2.1 billion a year antipsychotic medication, Risperdal.

The Republican Party has done its best to demonize trial lawyers, in this case to paint them as opposing the manufacturers of life-saving drugs. It's not so. Not that all trial lawyers are models of virtue, but they serve as the natural inheritors of The Green Hornet "He hunts the biggest of all game, public enemies that even the G-Men cannot reach." It's clear that the G-Men, or at least the FDA men and women, can't do the job with current resources. The trial lawyers represent a strong second line of defense against corporate greed. The Bush administration wants to protect the pharmaceutical manufacturers' right to withhold information. Why should a

bunch of sick and injured people stand in the way of corporate profits?

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y.

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