By Jake Rossen
By Jesse Marx
By Michelle LeBow
By Alleen Brown
By Maggie LaMaack
By CP Staff
By Jesse Marx
A Canadian study found that a number of women who took Paxil during the last trimester of their pregnancies gave birth to babies that went through withdrawal. Many of the researchers concluded that the withdrawal symptoms could be mistaken as physical illness or a relapse into depression. Warnings about the withdrawal symptoms were placed on Paxil's label in several European nations.
Yet, even as the research was suggesting that SmithKline should both change Paxil's label and work to educate doctors about its withdrawal symptoms, the drug company seemed to be more interested in damage control. For example, in 1997, a report on more than 13,000 British patients' experience with SSRIs concluded that Paxil was far more likely to cause withdrawal than its competitors. According to a class-action lawsuit filed against SmithKline, the company reacted by ordering its sales representatives to tell U.S. physicians that the damning study had found no difference between Paxil's withdrawal rates and those of other antidepressants.
The company may, in fact, have known about the withdrawal symptoms much earlier, according to the suit. One hundred and eight patients who dropped out of a clinical trial of the drug told the manufacturer that they had experienced withdrawal. When it reported on the trial to the FDA, the suit alleges, the drug company reclassified these patients as having relapsed. (Typically the FDA uses only the data submitted by a pharmaceutical company when considering whether to approve a new drug.)
The watchdog organization Public Citizen has warned that the FDA is increasingly dependent on the pharmaceutical industry for funding. In 1992, under pressure from AIDS activists and drug companies, Congress passed the Prescription Drug User Fee Act, which allows manufacturers to pay the agency to review products more quickly. The move has cut the average length of time it takes to bring a new drug to market from 30 months to 15. At the same time, however, there's been an increase in the number of drugs the agency has had to take off the market, according to the Washington, D.C.-based nonprofit.
In May, Congress increased the share of the agency's funding that comes from drug companies. The provision was neatly hidden in a rider to the $3 billion Bioterrorism Preparedness Act. Sen. Ted Kennedy, author of the rider and head of the Senate Health, Education, Labor, and Pensions Committee, failed to hold a hearing on the controversial law. The pharmaceutical concerns did have to make one small concession: Recognizing that the FDA was ill-equipped to track drugs once they had hit the market, Congress ordered that some of the fees be used to monitor new drugs.
The wing of the agency that tracks adverse drug effects operates with a shoestring budget of $15 million and a staff of 72 and depends on voluntary and unreliable reporting by doctors, according to a May 2000 article in Washington Monthly. By comparison, the portion of the FDA that approves and monitors new drugs has some 1,300 employees and a budget of roughly $290 million.
It's a far cry from the systems other countries have in place to monitor the safety of new and popular drugs. "What the Brits and the Aussies do is ask healthcare professionals to pay particular attention to possible adverse effects of both new drugs and those that are widely distributed or they are interested in," says Larry Sasich, a research pharmacist with Public Citizen's Health Research Group. "And they give healthcare professionals a lot more information, via a newsletter, for instance....Of course, gathering data is certainly easier in countries with national healthcare systems, because prescriptions can be tracked."
Last December, nine years after Paxil came on the market, the FDA ordered GlaxoSmithKline to begin warning consumers that they might have trouble discontinuing Paxil. Ever PR-savvy, the company rewrote the label to note that the drug sometimes causes "discontinuation effects." Even as it was drafting the warning, GlaxoSmithKline argued that Paxil isn't addictive. In the company's view, in order for a substance to be deemed addictive it must cause withdrawal symptoms that produce "drug-seeking behavior." And who ever heard of someone jonesing badly enough to steal Paxil from their neighborhood drugstore?
Nonetheless, on August 16 Mariana Pfaelzer, the federal judge hearing Murphy's and Morrison's case, ordered GlaxoSmithKline to stop advertising Paxil as non-habit-forming.
"We are very disappointed in the ruling," said David Stout, president of U.S. Pharmaceuticals at the company. "The U.S. Food and Drug Administration--and not the courts--has the expertise and responsibility for reviewing and regulating pharmaceutical ads." The company had submitted the ad in question to the agency for review, he noted, and heard no objections.
"GSK is strongly behind the safety and efficacy of Paxil," he continued. "Physicians' organizations like the American Psychiatric Association have stated that antidepressants are not habit-forming. It is also important to note that the court has made no finding that Paxil is addictive or induces dependency."
The company contacted the FDA, and two days later the agency demanded that the judge lift the ban, arguing that the court had no authority to order GlaxoSmithKline to pull the ads. The agency wanted to reserve that power for itself. Last week, Judge Pfaelzer reversed herself and allowed the company to continue airing the ads.