Double Standard On Drugs

The Food and Drug Administration just issued a warning on RU-486 – the drug used to cause medical abortions – after two women died from secondary infections after taking the pill to end their pregnancies. But the FDA waited until about 27,000 people had died from heart attacks and strokes while taking arthritis drug Vioxx before pulling that drug. Why the discrepancy?

The FDA is not exactly known as a Johnny-on-the-spot agency. "Slow" and "careful" are its middle names – slow to approve generic drugs that might cut into the profits of large pharmaceutical companies, and careful not to do or say anything that could hurt the sales of those companies' hot sellers. The bodies have to really pile up before the FDA pulls the plug on a popular drug.

Which is what made the Nov. 15 FDA announcement so unusual. The death of one woman last January prompted the FDA to issue a warning notice on the so-called abortion pill, RU-486. The woman did not die as a direct cause of the medication, but rather a secondary infection that set in afterward. It was only the second such case reported after using RU-486.

Compare that FDA response to its handling of Merck's hot-selling arthritis pill, Vioxx. Warnings on that pill have been flooding in from around the world for more than two years – warnings the FDA ignored. The pill worked fine at alleviating pain – especially for the estimated 27,000 users it killed. It seems Vioxx had some nasty side affects: heart attacks and strokes.

Why did it take so long for the FDA to pull the plug on Vioxx, even though it had hard proof the drug was killing thousands of people every year? And, conversely, why was it so quick to issue a warning on RU-486 based on two deaths not even directly connected to the drug?

Would money surprise you? Merck was a big contributor to GOP coffers, and they make sure they hire lobbyists with strong ties to the Bush camp.  Meanwhile, RU-486 contributed nothing. The company that produces it is not even American, but French. And that company has been the target of anti-choice forces since the day RU-486 first hit the market.

The anti-choice Christian right has had some limited success in curtailing the drug's availability, even for medical research into the drug's other possible applications. Anti-choicers were temporarily successful in blocking the drug in the United States, gaining an FDA order that banned the import of RU-486 from 1989 until 1993. Opponents have also launched boycotts against French pharmaceutical company Roussel-Uclaf; the drug maker's German parent company, Hoechst A.G., as well as their American affiliates; and have threatened to boycott any other pharmaceutical company that makes RU-486 available.

But RU-486 is so safe and effective, its use in the United States has grown steadily. Then came George W. Bush's re-election on the backs of the Christian right, and two weeks later, the FDA issued its warning on RU-486.

Bush always says he wants to see "the good science" before making tough decisions on such matters. So let's see how the science works out on this:

• Merck was pulling in around $2.5 billion a year from Vioxx sales.
• Merck shared some of this drug booty with the Bush re-election campaign and other GOP candidates up for re-election. (In all, drug companies pumped $13 million into various campaign coffers; two-thirds of it went to Republicans.)
• The FDA knew for two years that there was hard data showing that Vioxx was killing some of its users, but did nothing.
• Once the body count reached 27,000 and became impossible to hide or deny any longer, the FDA ordered Merck to pull Vioxx off the market.
• The company that produces RU-486 is foreign and therefore not allowed by federal law to contribute to American campaigns.
• The Bush campaign and the GOP has not, and never will, get a dime from RU-486 sales.
• Unlike Vioxx, RU-486 is remarkably safe – safer than Vioxx, for sure, and a lot safer than illegal abortions. Deaths following RU-486 use were 1 in every 200,000 compared to 1 in every 3,000 illegal abortions.