FDA vs Attorneys: Who Really Protects Us?

September 27th, 2010. By janem

There’s always some whining going on about how much money lawyers make from pharmaceutical class actions. But do those whiners ever think about how safe we would be were it not for the lawyers, lawsuits and the courts? Let’s add advocacy and consumer groups too—their actions have also kept us safe from dangerous drugs and their side effects.

Relying on the FDA for post-market surveillance once it has approved a drug reminds me of this old adage: Close the stable door after the horse has bolted. All too often it takes consumers and their attorneys—like a band of Davids against the Goliath drug company—to resolve adverse drug events that occur by underhanded tactics such as off-label promotion and false advertising.  Case in point: the diabetes drug Byetta.

The FDA received reports of adverse health events (kidney problems and pancreatitis) from Byetta users since the beginning of 2005 but they did diddly squat until last November, when in their infinite wisdom, finally said, “Byetta can heighten the risk of kidney problems, including kidney failure, in people suffering from type 2 diabetes.” But not before attorneys were filing class action lawsuits against the manufacturer.

And what about Avandia? In 2007, a report in the New England Journal of Medicine, linked Avandia to a 43 percent increased risk of heart attack, and more than 700 lawsuits—with GlaxoSmithKline agreeing to a $60 million settlement. Yet it took the FDA until September 2010 to severely restrict sales of the drug (sales have been completely suspended in Europe).

And let’s consider Zyprexa. Class action lawsuits alleged that the manufacturer, Eli Lilly and Co., negligently made, marketed and sold Zyprexa without properly warning of the risks prior to June 6, 2007. Eli Lilly paid out approximately $1.5 billion to settle civil and criminal claims alleging illegal marketing—promoting the drug for use in seniors with dementia when it is not approved for that use.

As well, Eli Lilly paid millions of dollars to settle claims alleging the increased risk of diabetes and related health problems, but the settlement does not imply liability or wrongdoing, so are we safer as a result? The drug is still sold, but with the labeling clearly showing diabetes-related side effects. But Zyprexa treats psychosis—how many people with schizophrenia or bi-polar disorder are going to read the label? Attorneys have taken the drug company to court; now isn’t it up to the FDA to take the drug off the market? Or at the very least, the agency should be more diligent with post market surveillance.

Tags: Avandia, Byetta, Zyprexa

This was posted on Monday, September 27th, 2010 at 11:16 am and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.