When Regulators Save Lives: 46 Countries Approved Thalidomide but not the United States
There are numerous drug topics in the headlines these days and many of them are of great interest, including all the buzz about Wegovy, Ozempic, and Mounjaro. Some of these headlines are quite dramatic, “Wegovy and Ozempic Spark a Gold Rush for Drugmakers” as well as “Employers Cut Off Insurance for Obesity Drugs.”
What seems clear is that these drugs work well for diabetics and those with severe obesity. The drugs are still fairly new and expensive, however, and may require users to be on them for life. They also present with unpleasant side effects.
We apologize to those for whom these drugs are doing so much good for pairing them with an article about Thalidomide but we are attempting to make an important point. There are risks taking drugs which are fairly new to the marketplace. The media attention surrounding these drugs seems quite extraordinary and since the U.S., unlike most countries, allows direct to consumer advertising, substantial consumer demand is likely.
Certainly there are times when rushing a drug or vaccine to market makes sense. The quick development and distribution of COVID vaccines is a perfect example. But let’s remember that it wasn’t that long ago that Big Pharma promoted drugs for aches and pains that resulted in tragic and large-scale opioid addiction and overdose deaths. Anyway, the use of these new drugs to help shed some weight may be a bit premature since the experts admit they don’t know how the drugs actually work. Thinking about the opioid crisis and relevant history reminded us of the shocking and earlier 20th century tragedy of Thalidomide and the fascinating career of Dr. Frances Oldham Kelsey, who was instrumental in preventing Thalidomide from being approved by the FDA. Too bad there wasn’t someone as uncompromising when Purdue Pharma sought Oxycontin approval. Perhaps widespread use would have been avoided if a more cautious approach had been taken.
Thalidomide, which was prescribed to pregnant women in the 50’s and early 60’s for morning sickness and nausea, was approved for use in 46 countries. There was only limited circulation of the drug in the U.S. because at that time only doctor’s offices had access to a drug prior to a drug being FDA-approved. Thalidomide was never approved by the FDA for use in the U.S. because Dr. Kelsey and her colleagues resisted those efforts citing that the drug remained unproven. It is estimated that some 10,000 children were born with severe deformities in those 46 countries where Thalidomide was approved as well as thousands of resulting miscarriages. Please read about Dr. Kelsey’s fascinating career using the link above or another one here. I was delighted to see Dr. Kelsey included in the Women’s History Museum in Washington, D.C., which a number of my friends and colleagues have worked to make a reality.
In summary, drugs save lives. However, it’s probably wise to have more experience with these new drugs and how they work before rushing to take them for modest weight loss. We know journalists have to produce copy but the predictions that Weight Watchers and other major players in the weight loss industry might close down due to the introduction of very new drugs seems rather premature. Please watch the video and make your own judgment.