There are drugs out there with obvious risks. Thalidomide comes to mind. It is a drug that, invented a long time ago, was banned because of the serious risks attendant in taking it to unborn children. Yet, many years after the ban, it was brought back, because there were accompanying benefits that made it desirable that people be allowed to access the drug. I was a speaker at the two day NIH conference held in September 1997 that discussed the risk management involved in bringing thalidomide back.
Consider the case of Accutane. The various makers of Accutane, which is now generic, are involved in a risk management program called iPledge, which has multiple safeguards, registries, passwords and elements meant to control who prescribes and who uses the drug. The FDA has a part of its Web site devoted to Accutane. So does the American Academy of Dermatology. That is because there are risks alleged with Accutane that involve harm to unborn children as well as alleged psychiatric events. But has the cure proven as bad as the risk? That was the subject of a Washington Post story on Accutane risk management yesterday.
No one wants unnecessary risk. But likewise, no one should want the benefit of a drug intervention to be completely overshadowed by risk management efforts. According to the article in the Washington Post, and to materials on the Website of the American Academy of Dermatology, the risk management plan for Accutane, named iPledge, has resulted in 9 out of 10 physicians having trouble prescribing the drug because the system housing the multiple safeguards doesn’t work properly. That has meant that patients who need the drug have had great difficulty getting it.
Risk management programs cannot manage away all risk, but likewise, they should not manage away the benefit while addressing risk. It also means that before programs are put into place, there should be some effort to ensure that they work smoothly and some method of quality assessment, with adjustments to the program reflecting that input.
Accutane is an extreme example, but the lesson here is that the theoretical application of a program has to match up with the real world, practical method of delivery, which in turn should address the real, as opposed to perceived causes of risk. It is perhaps one argument in favor of drug sponsors who have a product with obvious risk issues, be prepared before FDA approval to work out a risk management program with solid tools, evaluation and communications built into it.