Any sensible person who reads the wsj knows the publication is a double-edged sword at best. You mostly read it for the financial news and hope they are not lying through their teeth. And, like diamonds in the rough, or other undesirable places, every now and then, they do manage to write about things in a meaningful manner.
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It was with this sort of pleasant surprise that I started to read a Review of the book titled "Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide". It is a poorly kept secret that the FDA was provided with ammunition at the most opportune of times, with which it prevented much death and dismemberment. It is also well-known that in today's political environment, such powers would be quite tough to come by, as this article linked below will demonstrate.
The earlier part of the review
The earlier part of the review is pretty cool. Thalidomide, prescribed as a sleep aid, would have escaped review were it not for Frances Oldham-Kelsey's keen scientific eye and healthy apprehension for something that appeared too good to be true. Having worked on a drug that had a deleterious effect on fetii, she stepped up at the right time and required William S. Merrell Pharmaceuticals to provide more data. The ensuing saga, even in the short review, reads like a B-movie plot, and I leave all that up to you. I definitely recommend the review, and I personally put the book on my list of must-reads.
The ignorant whiny part
Just when I was about to fool myself into thinking, "Wow, the wsj is about to become the WSJ in my eyes!", the review slipped into the well-branded, stereotypical, tone deaf part: "Ms. Warsh fails to discuss the tradeoffs of the glacial approval process"
You know what the tradeoff is? STAYING ALIVE and HEALTHY. It is remarkable that in the same review about a book that shows how one scientist stood in the way of unknown thousands of mutilated fetii and a good drug review process and created a revolution that now the world has started to embrace (with the EU pulling ahead of us), the review author irresponsibly caters to wsj's baser instincts.
Conclusion: How to do approvals right
Drug and device approvals are quite tough to get right, even when the FDA is acting ethically, and not colluding with surgical supplies companies (I will link a post in which I touch upon the bad governance below), things slip by. Thus we end up with bad metal implants, knees, hips, you name it, questionable Azheimer's drugs and much more.
Then, as with Aduhelm, (story below), the FDA realizes its mistakes, especially in bowing to political pressure from unscrupulous convicted felons, their friends, and others, and overclocks in the other direction. This then results in events like the one from last week, when MDMA was denied for PTSD treatment. Now it will take us forever to find out if the rejection was justified.
Thus what we need are smarter, scientific reviews that don't arise from undue political pressure and self-destructive book reviews. At the end of the day, I am sure, Califf is not scanning unscrupulous publications for book reviews to worry about the pace at which his agency should approve drugs or devices. At least, I hope he has better things to read.
Using machine learning techniques, better clinical data, honest reviews, dedicated panels of humans and other commonsense approaches, glacial or not, the FDA can strive to keep patients alive in the decades to come! There will be plenty of time to discuss these techniques, and for now, I urge you to stick to the "glacial" timelines in an era where the glaciers are melting.
References:
1. The self-destructive book review on wsj: https://www.wsj.com/arts-culture/books/frances-
oldham-kelsey-the-fda-and-the-battle-against-thalidomide-review-the-noble-bureaucrat-7f1fc379
2. The book:https://www.amazon.com/Frances-Oldham-Kelsey-against-Thalidomide/dp/0197632548
3. The FDA's aduhelm misadventure: https://www.nbcnews.com/health/health-news/fda-broke-protocols-approving-biogen-alzheimers-drug-congressional-rep-rcna63662
4. The FDA colludes with your favorite surgical device manufacturers: https://chaaraka.blogspot.com/2019/04/so-what-will-fdas-secret-hidden.html
5. The FDA's sudden repugnance for MDMA: https://www.nbcnews.com/health/health-news/fda-panel-rejects-first-mdma-treatment-deep-concerns-flawed-trials-rcna155325
6. The cover image for the blog post: https://www.pexels.com/photo/selective-focus-photo-of-pile-of-assorted-title-books-1148399/
This post first appeared on Medical Devices, Biotechnology, Bioengineering And The Like, please read the originial post: here
