Who decides whether a drug is licensed and remains licensed should problems turn up later? The answer is organizations such as the Food and Drug Administration (FDA) in the US and its European counterpart, the European Medicines Agency (EMA). These bodies supposedly act in our interests to protect us against, among other things, worthless or hazardous pharmaceutical agents. Or that’s the theory, anyway.
Because both of these organizations have come under repeated criticism for apparently working harder to protect the interests of pharmaceutical companies than our own . Recently, I was reading a piece in the Journal of the American Medical Association that highlighted some worrying examples.
Earlier this year, for example, researchers based in Denmark wrote in the British Medical Journal how its request for unpublished data on two weight loss drugs from the EMA was anything but straightforward. One of these drugs (rimonabant) has subsequently been withdrawn when it was discovered it could caused severe adverse effects depression and suicidal thoughts. The other drug (orlistat) has been claimed by consumer advocacy group Public Citizen to be of limited effectiveness and also potentially hazardous. The EMA refused to release clinical trial data on these drugs, arguing that to do so would undermine commercial interests. It eventually yielded the data only when compelled to do so by the European ombudsman.
Because of the seeming cosy relationship which the EMA has with pharmaceutical companies, the European Parliament has refused to sign off on the agency’s accounts, and has ordered a special investigation of the EMA over its funding sources and hiring practices.
The FDA has not been immune to criticism either. The JAMA piece recounts a sorry tale concerning the drug valdecoxib. This drug was licensed in 2001, but the manufacturer asked the FDA to withhold data on it. The FDA argued that such data was a trade secret. Public Citizen finally forced the data out of the FDA by initiating legal action, and discovered that valdecoxib could cause serious adverse effects including, err death. The drug was subsequently withdrawn.
According to Dr Steven Nissen, chair of the department of cardiovascular medicine at the Cleveland Clinic: “The FDA is now somewhat more transparent, but it’s not transparent enough. For reasons I can’t understand, it still keeps information secret.”
Talk from the FDA and EMA about protecting ‘commercial interests’ and trade secrets leaves me utterly cold. For me, there’s something deeply and troublingly unethical and immoral about withholding information that can cost people dearly in terms of the health and even with their lives. At least such misdeeds are coming to light and organizations such as the FDA and EMA are being more held to account.
1. Hampton T. European Drug Agency Under Fire – Critics Charge That Trial Data Are Too Inaccessible. JAMA 2011; 306(6): 593-595
2. Gøtzsche PC, et al. Opening up data at the European Medicines Agency. BMJ. 2011;342:d2686