Fines are even less effective when it comes to preventing patients from being physically harmed. GSK is accused of illegally marketing two antidepressants -- Paxil for depression in adolescents, and Wellbutrin for weight loss, substance addiction, ADHD and other problems. Paxil has been shown to have significant side-effects, including triggering suicidal thoughts and behavior in some patients, and neither antidepressant is much more effective than a sugar pill in the vast majority of patients with depression. Fining the company after the fact doesn't do much for the patients who have already been hurt by their marketing practices.
That's even more the case for GSK's egregious behavior regarding its diabetes drug Avandia. When a new drug comes on the market, sometimes the FDA will ask or require that the manufacturer to do a study, called a post-marketing trial, to look for rare side effects and establish whether the drug is safe over the long term. That's important because often the clinical trials that are done before a drug is approved aren't big enough, and don't last long enough, to say whether a drug is safe to use over a long period.
With Avandia, GSK fudged the results of those post-marketing trials. The company claimed that its RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) trial showed no evidence that Avandia caused heart attacks or other cardiac diseases. But when outside researchers looked at the data they found massive irregularities and plenty of cases of harm, including patients who died and then mysteriously disappeared from the clinical trial records.
GSK hasn't admitted anything more than "inadvertently" failing to inform the FDA of problems, and the fine isn't going to protect patients from future Avandias. What we really need is a better system for tracking drugs once they are on the market.
Right now, we leave this crucial task to the very companies that have every reason to fudge data, ignore problems -- even deaths -- and keep doctors and patients in the dark, because they are making too much money to do otherwise. At its peak, Avandia earned GSK $2.2 billion a year. It was a phenomenally lucrative drug. The $250 million levied against the company for that part of the fine amounts to less than a slap on the wrist.
The solution isn't stiffer punishments for fraud -- we should take away the power to do harm in the first place. That means we need to stop giving drug companies the opportunity to sell out patient safety in exchange for another few months or years on the market. The simplest way to do that is to have automatic, external post-market surveillance for all new drugs.
Any new drug should be considered by both patients and doctors to be experimental for the first few months, or even years it is on the market, and the FDA should treat the approval of the drug as provisional. (The same goes for new medical devices.) For at least two years, any patient who might receive a new drug or medical device has to be fully informed of its known side effects, and of its experimental status. Data on those patients should be tracked (anonymously), and compared to patients receiving other treatments. Most importantly, automatic algorithms can search those data for patterns revealing any negative effects of the new product, so safety problems can be caught quickly.
