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Pharmaceutical Industry to Public: Drop Dead

Posted by medconsumers on May 1, 2008

The Pre-emption Shield Explained

The scenario has become depressingly repetitive: A heavily promoted drug prescribed to millions over the years is found to have potentially fatal adverse reactions; a hundred or so deaths are linked to the drug; the drug maker acts as if it just learned of the harm; a lawsuit precipitates the release of in-house documents showing that company officials knew of the dangers long before its drug went on the market; the injured patients have their day in court.

The last phase of this scenario, the one where people go to court to seek compensation for their injuries, will be eliminated if the pharmaceutical industry gets its way. The industry takes the position that a drug’s safety must be proven to the FDA’s satisfaction before it is allowed on the market; therefore, the drug maker should be held harmless for anything that happens thereafter. “The FDA should not be second guessed by the courts” goes the pharmaceutical industry’s legal argument for what is called pre-emption. Not surprisingly, it has the strong backing of the Bush Administration.

Proof of Safety Inadequate

The presumption that the FDA approval process guarantees safety is absurd. The two clinical trials required by the FDA are usually short-term and always conducted by the drug makers themselves. Rare or uncommon serious adverse reactions to drugs are typically not apparent until hundreds of thousands of people take the drug over the course of many years. Worse of all, drug companies are known to withhold negative trial results from the FDA.

And if that’s not bad enough, a bipartisan Congressional panel recently confirmed what has been known for years: The FDA’s ability to protect the public’s interest is obstructed by the fact that it is seriously underfinanced. This affects everything from the agency’s inability to vet all drug advertising for misleading claims to its drug-safety monitoring system that, according to the nonpartisan Government Accountability Office, captures less then 10% of all serious adverse reactions to drugs after they go on the market.

Most Recent Industry Crimes

Within a recent three-week period alone, the national media spotlighted three cases in which pharmaceutical giants misled the FDA about the safety of their products. Eli Lilly and Alaska agreed to a $15 million settlement on behalf of the state’s Medicaid patients who developed diabetes as a result of Lilly’s antipsychotic drug Zyprexa. The company hid the risks (e.g., deaths, strokes, pancreatitis) and exaggerated the benefits of Zyprexa while encouraging primary care doctors to prescribe it for unapproved uses.

Another case involved the bestselling pain-reliever Vioxx withdrawn in 2004 by its maker Merck because it increased the risk of heart attacks and strokes. And lastly, there’s Johnson & Johnson’s birth control patch, now known to cause blood clots, strokes and deaths. In all three cases, the dangers would have remained unknown—and people would continue to be injured—had it not been for lawsuits.

Among the e-mails, letters and other internal documents released during the Vioxx litigation was damning evidence that Merck knew of the drug’s dangers early-on. The company’s initial research made “the surprising discovery” that “Because selective COX-2 inhibitors [Vioxx, Celebrex, Bextra] do not affect platelet function whereas standard NSAIDs [aspirin, ibuprofen, etc] do, it was hypothesized that selective COX-2 inhibitors might…increase the risk of cardiovascular events.” This warning was repeated twice (at a meeting and in a memo), according to Merck documents—all dated prior to Vioxx’s approval by the FDA in 1999.

Vioxx made news again recently when the most comprehensive study of Merck’s internal documents released during the Vioxx litigation revealed the manipulation of the company’s clinical trial results. One example: Merck conducted several trials trying to prove that Vioxx slows the progression of cognitive impairment in people with dementia. The company’s early analysis of these trials showed “a significantly increased mortality risk” among the participants assigned to take Vioxx (their death rate was more than twice that of the placebo group). This, however, was not the way Merck reported the results to the FDA. Instead, Merck minimized the death risk by using a less-valid type of data analysis of the same trial results and concluded that Vioxx was “well tolerated.”

When the study of the Merck documents was published last month in the Journal of the American Medical Association, the accompanying editorial made it clear that the manipulation of trial results is not the sole purview of one company. The editors also noted that the evidence necessary to demonstrate Merck’s misdeeds became public—and publishable—only because of litigation. Last fall, Merck agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits filed by former Vioxx patients or their families.

This is not likely to be the way things will turn out for the young women injured by Johnson & Johnson’s popular Ortho Evra birth control patch. The patch delivered far more estrogen into the bloodstream than standard oral contraceptives, increasing the risk of potentially fatal blood clots. More than 3,000 women and their families have sued Johnson & Johnson claiming that the patch caused heart attacks, strokes and at least 40 deaths. Documents made public by this lawsuit showed that Johnson & Johnson’s own trial revealed these risks in 1999. The company, as The New York Times put it, “obscured the finding in a 435-page report to the FDA.”

The Pre-Emption Dodge

The Ortho Evra plaintiffs are now on hold while a similar lawsuit against yet-another drug company (Wyeth) becomes the test case for the pre-emption shield when it goes to the Supreme Court in November. The Court is expected to rule in favor of industry and make pre-emption the legal standard. A precedent was set in February when the Court ruled that the device industry is immune from damage suits filed by people injured by defective pacemakers, stents, etc.

Pre-emption is just the latest in a series of outrages perpetrated by the pharmaceutical industry against the public. At a time when criminal charges should be brought against company officials who withhold evidence of harm, the industry wants a pass. And it’s likely to get just that given the pro-business, anti-consumer Supreme Court decisions over the last few years.

In the meantime, if you are scheduled for a knee replacement or stent or a new heart valve, be aware that medical devices now come with an invisible warning from industry:

In event of a major defect or other serious harm: You’re on your own.

Maryann Napoli, Center for Medical Consumers © May 2008

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