TIL an FDA official saved the US from a generation of children with birth defects such as flipper-like arms and feet by repeatedly blocking the authorization of a drug, already approved in Europe, known as Thalidomide.

Here's the reality though. The FDA is a political entity, subject to intense pressure from Congress and media. There is a huge difference between the FDA's two choices in approving new drugs: If the FDA approves a drug that turns out to be disastrous, people will suffer; if it delays or denies a needed drug, people will also suffer. Both mistakes are medically harmful.

But from a political standpoint, there is a huge difference between them. Those injured by an incorrectly approved drug will often know that they are victims of FDA mistakes. Their stories make riveting news, and their testimony, or that of their surviving families, is powerful. But for victims of incorrect FDA delays or denials, who are prevented from using drugs that could have helped them, the situation is far different. All they know is that their doctors told them that nothing more could be done to help them. Only a fraction of these people will understand the reason for this—namely, that a useful drug was bottled up at the FDA.

Unlike in the first scenario, these people do not realize that they too are victims of FDA mistakes. Their suffering or death is simply viewed, by them and others, as reflecting the state of medicine rather than the status of an FDA drug application. In short, victims of incorrect FDA approvals are highly visible, while victims of incorrect FDA delays or denials are practically invisible.

For example, consider the FDA's incredibly long delay in approving beta-blockers to reduce the risk of second heart attacks. By the mid-1970s this had been documented in clinical trials, and a number of beta-blockers were approved for this use in Europe. But in the U.S., the FDA imposed a moratorium on beta-blocker approvals due to the drugs' carcinogenicity in animals. In effect, the FDA was denying needed cardiac drugs to people at high risk of heart attacks because of the unproven possibility that those drugs might cause cancer years in the future. Finally, in 1981 the FDA approved the first such drug, boasting that it might save up to 17,000 lives per year. That meant, of course, that as many as 100,000 people may have died waiting for the FDA to act—an explosive point, but one that very few journalists pursued. For all practical purposes, these people were invisible in a very literal sense—we've all seen photographs of thalidomide victims, but I suspect that not one of us has ever seen a photograph of someone who suffered or died because of the FDA's beta-blocker moratorium.

/r/todayilearned Thread Parent Link - npr.org