Thalidomide, The FDA and Type I & II Errors

Thalidomide was sold to pregnant women in the 1950s and early 1960s to cure morning sickness. It was made by the German company Grunenthal. It caused serious birth defects before being taken off the market.

Thalidomide used to come up in my micro classes since we sometimes read a chapter from the book The Economics of Public Issues that discussed the dilemma the FDA faces in approving drugs.

There is a danger that the FDA will make a Type I error, meaning an unsafe drug is allowed onto the market. To try to avoid that, they can test a new drug for a long time to make sure it is safe. But in the mean time people might be dying because they cannot get the drug. When that happens, it is called a Type II error. This happened with Septra, an antibiotic. 

The book reports that "in 2006, the FDA gave physicians the OK to use it (thalidomide) in treating bone marrow cancer.

Now there is a new book about Thalidomide & the FDA. It was reviewed recently in The WSJ. See ‘Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide’ Review: The Noble Bureaucrat by Sam Kean. The book he reviews is by Cheryl Krasnick Warsh. Excerpt:

"As Ms. Warsh makes clear, Kelsey’s stand against thalidomide helped transform the FDA’s regulation process, and the larger world of medicine. After thalidomide, the FDA instituted far more onerous requirements for drug applications. By 1969, Ms. Warsh notes, “submissions comprised an average of four volumes, each the size of a metropolitan area telephone book.” One application was said to be seven feet thick, a claim Kelsey at once laughed off as a “wild rumor.” But by the 1990s, applications often did reach 250 volumes. Not surprisingly, the approval process for new drugs has slowed drastically.

Ms. Warsh fails to discuss the tradeoffs of the glacial approval process—while we’re certainly spared some thalidomide-like tragedies, beneficial new drugs also take years longer to reach sick patients. During her career, Kelsey often quoted a lawyer who shepherded a drug-reform bill through Congress in 1938: “Conservatism in a scientific world may occasionally deprive the public and delay the acceptance of important discoveries. This loss is more than overbalanced by the immense social harm resulting from undisciplined and unsupported . . . curative claims.” I wonder whether AIDS activists in the 1980s—who excoriated the plodding FDA while waiting for potential treatments—would have agreed about what the true “social harm” was. There may not be any simple answers, but Ms. Warsh never broaches the subject.

To be fair, this book is a biography, not an analysis of drug regulation. But after the drama of the thalidomide scandal, Ms. Warsh’s account starts to read like what it is: the life of a bureaucrat. I was hungry for more analysis of Kelsey’s legacy—mostly positive, but not uniformly so. In the 1960s, Kelsey became a national star: President John Kennedy awarded her a medal at the White House in a ceremony attended by astronauts John Glenn and Alan Shepard. Since then, the sun has clearly set on Kelsey’s fame. But sunset is the time we cast the longest shadows."

Related posts:

 

Immigration & Asylum meet Type I & II Errors (2023)

Solar Panels, Tradeoffs and Type I & II Errors (2022)

Remdesivir and Type I & Type II errors (2020)

Do FAA drone regulations illustrate the tradeoff between Type I & Type II errors (2018)

Maker Of Thalidomide Apologizes (2012)

The Paycheck Protection Program and and Type I & Type II Errors (2020)

The FDA, Masks and Type I & Type II Errors (2020)

Fraction of Covid-19 Rental Assistance Reaches Tenants and Landlords (follow up to a post on June 11) (2021)

Zombies might return and fighting them is art as well as science (2021)

Accommodations for disabled people and Type I & II Errors (2023)