From a consumer’s point of view, clinical trials seem abstract, someone else’s concern. After all, isn’t it the FDA’s job to worry about clinical trials? Or the NIH or one of the government agencies? It is. Pharmaceutical companies run clinical trials on drugs for drugs that are being developed for the US market to learn if they work, if they work better than drugs already available, and if their side effects (because all drugs have side effects) are mild enough to be considered safe, or at least less worse than not taking the drug.
The catch is that many trials are stopped when the early feedback indicates the trial will have a bad outcome. I imagine the drug company then adjusts the formulation or the dosage and tries again. It costs a LOT of money to develop a drug for market, and drug companies are motivated to make it work. As a capitalist and a believer in the free market system, I don’t object to any company that develops a product tinkering with it to make it work or work better. R&D for drug companies is hugely expensive and when a successful drug is developed the company and its shareholders deserve a good financial return. However, the pressure to profits can push some (a few) drug companies to ignore warning signs or to go so far as to suppress important information that comes from the trials or from internal research. For example, it seems that J&J crossed that line with their hip implant systems.
In an OpEd piece in the NYTimes on Saturday, Feb. 2, 2013, Health Care’s Trick Coin, Ben Goldacre details the blatant flaunting of the FDA requirement that every clinical trial conducted post results at clinicaltrials.gov within a year. The fine is $10k a day for noncompliance, but there have never been any fines levied (here’s a way to balance the budget Mr. President!). According to Goldacre, only 20% of the trials that should have been reported were.
Why care? Because hiding bad trial outcomes means that the FDA isn’t working with all the information. Some drug side effects may not be apparent, the efficacy of the drug may appear higher than it actually is. Most importantly, the FDA might approve a drug that will have a bad outcome on you.
Until recently I thought an FDA approval on a drug meant it was safe and effective. I believe that many people have the same impression – after all, isn’t that why the FDA was started? However there are flaws with the system — clinical trials disappear without review, the FDA doesn’t get all the data that a pharmaceutical company gathers, comparative efficacy of drugs is often not made clear on drug labels.
Requiring pharmaceutical companies to follow the law and register all drug trials is a good, and easy, step towards making sure the FDA and your doctor, has all the information available. Sign the petition at www.alltrials.netto support requiring all drug companies to register all clinical trials.
