The wsj starts off with a good review on Thalidomide, but later cannot help itself...

 

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. 

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/

So, what will the FDA's secret hidden database lay bare?

NOTE: By now, if you haven't heard of the secret database the FDA has been keeping to help companies hide adverse events, I'd say you are not keeping up! I will supply a couple of links for you to peruse to get yourself up to speed.

ON THE ETHICS: It is key to discuss the ethics or rather their absence, in detail. However, I want to focus on something else for now. I am curious about what we will learn, and I want to focus on that. However, I will leave you with a couple of points to ponder:

1. It is typical for controversies to take a political bent. But here is an alarming example of something that started with one administration, and sustained through several.

2. There are something like 780+ federal agencies, that we know of. Just the potential of the spread of this type of bold unethical behavior, that will go unpunished is just jarring!

3. Congress is completely asleep at the wheel!

4. THIS ONE IS KEY: How many company executives know about this, have participated in this, and what are the implications of all this?

What I Expect We Will Learn

1. Just how many medical devices and their manufacturers been accessing the database?

2. What type of adverse events were being hidden?

3. The relationship between adverse events that we were made aware of, previously and what was in the database. Do we get a chance to just sum them up and say, "well, we thought this device had 5 adverse events per year, and now we know it was 25 per year because we found thata on an average, 20 were being hidden per year?"

4. What if certain types of adverse events were hidden from us?  What if injuries were made public, but deaths hidden?

5. What if companies got preferential treatment in terms of access to the database and how was this decided?

6. To what extent can we answer the question: how far was the true harm to patients?

Lost Opportunities

1. Imagine how many start ups could have germinated to solve issues caused by devices that people falsely believed to be better than they are!

2. Imagine how many patients could have chosen alternate treatments or devices. One also has to wonder how many credible lawsuits were not filed owing to the fact that the evidence was hidden!!

3. Doctors could have better cared for their patients, and provided them with adequate warnings, alternates or protection.

4. The FDA is meant to protect us. Medical Device Companies are supposed to be ethical. And now, it is anyone's guess how deep the loss of credibility is going to go!!!



There is more to come

This database raises far more questions and alarms. I am sure in the days, weeks and months to come, we will discuss more of these issues, as details become apparent. Currently, we know something like 3X the data was hidden, in just a year, per Star Tribune. Who knows what the real depth of the problem is.

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References:

1.Star Tribune: http://www.startribune.com/fda-says-it-will-make-more-info-available-on-medical-device-problems/507788372/

2.The Kaiser Health News Report: https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/

3. Image of Woman: https://www.pexels.com/photo/black-and-white-black-and-white-depressed-depression-568025/

4. Image of Right and Wrong: https://pixabay.com/photos/ethics-right-wrong-ethical-moral-2991600/

5. Image of Seated Person: https://stocksnap.io/photo/95TESM9499