Thalidomide goes on market: Oct. 1, 1957
A “wonder drug” named thalidomide goes on the market in Germany. It’s a sedative—without barbituates—and is considered so safe that it’s soon being sold over-the-counter in many countries, primarily in Europe and Australia. In fact, its inventors had bragged that “they could not find a dose high enough to kill a rat.” By 1960, thalidomide was almost as popular as aspirin, in terms of sales.
Many doctors were so convinced of thalidomide’s safety that they began prescribing it “off-label” as a treatment for morning sickness in pregnant women. But then, those doctors, to their horror, started seeing their patients having babies with awful birth defects, particularly a condition called phocomelia, in which the infants’ arms never developed, and instead hands grew from their upper arms like flippers.
After a German newspaper reported an apparent link between thalidomide use and 161 babies born with birth defects, the German government ordered the drug off the market. Other countries followed suit and by 1962, thalidomide was banned in most countries.
But not before more than 10,000 “thalidomide babies” with defects were born around the world. Research found that the drug’s molecules crossed the placental wall during pregnancy, especially during the first trimester, and that could cause profound problems in the growth of the fetus.
In the U.S., however, the damage from thalidomide was much more limited, thanks largely to efforts of one woman on her first assignment in the Food and Drug Administration (FDA). Her name was Frances Kelsey and she was part of a new wave of scientists who believed that drugs should not receive FDA approval unless the manufacturer could provide clear evidence that they were safe and effective. At that point, Congress hadn’t given the FDA that authority and Kelsey came under tremendous pressure from the drug company to give thalidomide a green light. But she resisted, concerned that there wasn’t enough data proving that the drug wouldn’t cross the placental wall.
She was shown to be right, and in the summer of 1962 President John F. Kennedy awarded Kelsey the highest honor given to a U.S. civilian—the President’s Award for Distinguished Federal Civilian Service. She was only the second woman to receive it.
That same year, primarily in response to the thalidomide crisis, Congress gave the FDA much more power in regulating the release of drugs in the U.S. Among the key changes was to give the FDA oversight of clinical trials. Previously, “clinical trials” involved not much more than pharmaceutical companies passing out drugs to doctors who had their patients “test” them. Manufacturers could put their medications on the market only 60 days after notifying the FDA. But after what happened with thalidomide, the process, designed by Kelsey herself, became much more comprehensive and demanding, Today, it can take longer than 10 years for a drug to be approved.
While it no longer is permitted to be used as a sedative, thalidomide has been found to be an effective treatment for both leprosy and multiple myeloma, a deadly blood cancer. In 2010, the FDA created the Kelsey Award. It’s given to a different FDA employee every year. Frances Kelsey, now 99, received that first one.
Published On: Oct 4th 2013