Thalidomide's Gift to Public Policy

Rah, rah, rah! Three cheers for Thalidomide! Three cheers for the morning sickness pill of the 1950's that led to thousands of birth defects.

Three cheers? Yes, because if it were not for the tragedy of Thalidomide, we wouldn't have the regulations we have today for new pharmaceutical drugs. And we certainly wouldn't be aware of the practice of withholding relevant and crucial information by pharmaceutical drug companies trying to pass their products off at any and all costs. Please take the time to read the history of Thalidomide here, and of the lone voice who refused to approve the drug for sale in the United States, FDA reviewer Frances Oldham Kelsey. When you do, you'll see how lax our earlier laws were concerning drug approval.

At that time, pharmaceutical companies needed only to show that a drug was safe, and with a little trickery, it was easy to get things through. After the Thalidomide tragedy, though, the FDA changed the rules and required drugs to be both safe and effective. That means that manufacturers had to show that the drug actually did something beneficial--this prevented drugs from being "tried" on the public, as Thalidomide was in the U.S. Although it was never approved for sale, about 20,000 Americans received Thalidomide on a trial basis, including several pregnant women. Most birth defects were seen in Europe, but there were seventeen Americans born with birth defects caused by this drug.

We also have to thank Thalidomide for keeping us on our toes today. It's exactly what I think about when I hear of antidepressant manufacturers hiding results. If you've got to hide 'em, there has got to be something terribly wrong. As I've said a thousand times over--when there's big money involved, don't count on human decency to make right decisions. And if it weren't for Thalidomide...we might not know the full extent of that statement. So thank you Thalidomide for opening our eyes.