House of Cards

Patricia Nell Warren’s Left Field

Sooner or later, a house of cards falls. The higher you build it, the greater the chance that its construction dynamics will fail.

For twenty years, the pharmaceutical industry and the FDA have been building a skyscraper of cards. Their construction materials: the research pipeline and its flood of new drugs. It started with the FDA’s 1987 decision to fast-track AZT for AIDS treatment. In turn, the release of AZT opened the fast track to dozens of other drugs.

By 1999, despite ominous murmurs about serious side effects of some drugs, and a few high-profile withdrawals, the FDA still insisted, “Speedier drug approval has not compromised public safety in the U.S.” The director of the Tufts Center for the Study of Drug Development, Kenneth I. Kaitin, said: “If the public wants new drugs—and wants them more quickly, they must be willing to accept a certain degree of risk.”

But that house of cards is falling. Some government officials, researchers, and pharmacorps have evidently swept negative risk data under the carpet, in order to protect policy and profits. Their cover-ups are hitting the news.

According to an article in the Washington Post, a survey of some 400 scientists at the FDA two years ago revealed that “a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency’s ability to assess the safety of a drug.” During Senate hearings, FDA safety officer Dr. David Graham admitted that “scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated.”

Recently we learned that our government was allegedly party to a cover-up on liver complications and other problems with nevirapine. Sold in the U.S. as Viramune, it stars in the Bush administration’s plan to sell cheap AIDS drugs to Africa. Dr. Edmund Tramont, head of the AIDS division at the National Institutes of Health (NIH), was fingered by another NIH AIDS researcher, Dr. Jonathan Fishbein, for altering the report on a sloppily run African drug trial. According to freelance reporter Liam Scheff, “Documents obtained by the Associated Press show that Tramont censored reporting of thousands of toxic reactions and at least 14 deaths in the ongoing Nevirapine study in Uganda.”

The news reverberated around the world. In South Africa, outraged officials accused the U.S. of treating Africans like “guinea pigs.”

But this news wasn’t any revelation. Five years ago, nevirapine’s ability to cause lethal liver damage in some people was already aired in the U.S. (I reported this in my April 2001 Left Field.) At that time the FDA compelled the drugmaker, Boehringer Ingelheim, to put a black-box warning label on nevirapine.

If fourteen people died in just one Ugandan study, how many Americans have perished? Recently in Tennessee a woman named Joyce Ann Hafford died during a clinical trial involving AIDS drugs. Her relatives allege that Hafford was not given “informed consent” on possible complications; they are suing principals involved in the study. The Associated Press got her case file—and her family learned that NIH had already concluded nevirapine may have been the culprit.

But Hafford is only one of thousands of Americans treated with nevirapine since it was released in 1996. Its advocates insist that the drug is saving lives, but I think we deserve to know the ratio of deaths to lives saved. How many gay men were logged as “dying of AIDS” when their doctors knew they died of nevirapine-related complications? At Incarnation Children’s Center in New York, where over 100 child wards of the state were experimented on with nevirapine and other drugs, how many died? The ICC scandal has been in the news for a year now, but the question has not yet been answered.

As cards keep falling from the sky, aDrugRecall.com now lists dozens of drug names. During Senate hearings, one of the FDA’s own people—the aforementioned Dr. David Graham—testified that both the FDA and Merck knew for years that Vioxx can cause heart attacks and strokes.

If individual Americans choose to take the risk of new drugs—as many PWAs have done—that’s their right. But they also have the right to “informed consent,” meaning they should be told all the risks. And it’s also their right to demand that officials, executives, and researchers who put people’s lives at risk with their cover-ups should be criminally prosecuted.