Perhaps, Recall the Thalidomide Disaster, etc. while Searching for a Covid Vaccine
There is a big push by trump and Republicans to bring a Covid to market quickly.
Remember the Thalidomide Disaster, The Morning Call, May 12, 2020
In the rush to find a vaccine or treatment for the coronavirus, let’s not forget the bitter lesson learned in the 1950s and ’60s when thalidomide was prescribed to pregnant women for morning sickness. Thalidomide was approved for European use in 1957 although it was never tested on pregnant women.
Our Food and Drug Administration never approved the drug, but 20,000 pills had been given to doctors for distribution to patients in clinical trials. After reports surfaced about babies born with birth defects to mothers who had taken the drug, thalidomide was taken off the market.
Worldwide, an estimated 10,000 to 20,000 babies were born with deformed or shortened limbs; about 40% died around the time of birth. Children who didn’t die in infancy suffered from eye, ear, heart, and urinary tract problems.
Thalidomide was taken off the market in 1961. In the years since the tragedy, several countries, including the U.S., have tightened their drug regulations.
“The Thalidomide Tragedy: Lessons for Drug Safety and Regulation,” Helix, Bara Fintel, Athena T. Samaras, Edson Carias, September 2009
It has only been recently, drugs used by women were trialed using women. I had written about such here; A Woman’s Right to Safe Healthcare Outcomes when asked to do so by one organization. The driving factor for the lack of women in tests was not necessarily driven by bias as much as a lack of knowledge of the biological differences (then) determining how disease symptoms may present in each gender. A broad-based assumption was made of the test findings for men, the results of which could also be applied to women. The testing of men was simpler as men are not subject to the hormonal fluctuations of women. As sound(?) as this reasoning “may” be in minimizing the number of trials only, this appears to be more of a financial decision without considering the biological differences between the genders and the impact of not trialing a drug utilizing both sexes.
In itself, women experienced adverse reactions to various drugs.
Essure is a permanent female sterilization device consisting of metal coils which eventually embed into a woman’s fallopian tubes creating scar tissue blocking sperm access to a woman’s eggs. Insertion of it is reversible only through surgery. In February 2016, the FDA designated Essure to have a “boxed warning” which is meant to alert doctors to the hazards of the device.
In February 2018, a group of women calling themselves the E-Sisters met with former FDA Commissioner Scott Gottlieb. The E-sisters believe Essure has caused themselves and tens of thousands of others health problems, from bleeding, bloating, and pelvic pain to more obscure symptoms such as rashes, tooth loss, joint pain and fatigue associated with an allergic or autoimmune reaction. They brought with them a photo album of other E-Sisters who had suffered because of Essure and also Madris Tomes, a former FDA analyst. Ms. Tomes’s software company tracks adverse medical events reported to the FDA and had logged 26,000 events caused by Essure.
The original manufacturer Conceptus put Essure through a Level III approval process and presented its data to a FDA advisory committee “touting its near-perfect effectiveness in preventing pregnancy and its high levels of satisfaction among women.” Later studies challenged those studies and the effectiveness of the device. A Yale study challenged the rigor of the Level III process. a JAMA study reported 5% of all women using these devices required follow up surgery, and a third study claimed women using Essure were 10 times more likely to require surgery.
After November 2017, the U.S. was the only country in the world where Essure was still available after new owners Bayer removed Essure from every other market for “commercial reasons” and not because of safety. Bayer announced in July 2018, it would also remove the device from the US market after December 31st, 2018 due to declining sales.
The FDA has only removed several items from the market completely in its history. When asked to do so, FDA Commissioner Scott Gottlieb did not.
Each example detailed “briefly” here gives reason to perhaps take some time to analyzed the impact of each candidate drug on humans carefully before rushing to market with a vaccine.
“Should We Cheer or Boo the 21st Century Cures Act?,” Brains Explained, December 2016
“Real world” evidence is not better than science. I have watched the FDA flop around in a politicized environment brought about by a Republican supported president attempting to bring about the introduction of various drugs to fight Covid and bypass much of the clinical trials normally done by utilizing real world evidence of efficacy. All before the November elections. Simply speaking, “the gold standard for demonstrating a drug’s effectiveness is a randomized controlled trial. Randomly a group of patients is divided into two groups, give half the patients a drug, give the other a placebo (pill with no active drug) or another form of non-treatment, and then compare the two groups.”
The recently passed Cures Act undermines randomized control trials, (again) the gold standard for evaluating medical therapies. It allows drug companies to take short cuts in evaluating the effectiveness of a treatment by using “real world” evidence, which is defined as anything other than a proper clinical trial, and as opposed to going through the lengthy clinical trial process. This commonly includes simply observing individual patients without any a basis to measure the treatment against a control group, which can lead to spurious conclusions. Some companies such as Moderna with mRNA appear to be doing extensive trials of the drug before going to market after the November elections. The policies within the Cures act would significantly lower the bar for evaluating whether a drug or medical device is safe and effective.
This is a good article discussing Michigan Congressman Fred Upton’s sponsored 21st Century Cures Act and worth doing an analysis of later. Fred walked away with $millions in political donations. The article does point out issues with the Act which are coming to light with the push of a Covid vaccine.
What I have tried to do is initially establish some reasons why you should take the longer route to get to the conclusion of which drug actually works without causing harm.
The definition of the word “effectiveness” for a human SARS-CoV-2 vaccine trial is challenging. It is easy to measure antibody titer, but effective in blunting the symptoms of a viral infection? As I understand it, the Moderna mRNA vaccine provided protection in an animal model (don’t recall the details), but no in-human challenge trials have been done or are currently contemplated. The huge number of enrollees for the phase III trial virtually assures a significant number of infections in the vaccine and control arms, and the plan is to track these cases to look for different outcomes.
I’m in the vaccine arm of the Moderna trial, with a robust IgG response to the spike protein. I don’t plan to seek out an infection. Since it’s just my wife and me, our household hasn’t achieved herd immunity, since the threshold is 80%.
Picked up 5.5 hours of sleep and will probably lay down again. The mind is a marvelous thing. I just wish it would quiet down once an a while letting me rest unhindered.
To your point, I was thinking similar. How much anti-body does one need not to catch Covid or hinder it to the level of a headache and a minor temperature. Is success measured by the former or the latter? We have one example claiming antibodies, running around and exposing himself to various levels of contagion, and perhaps even mutations of the same. It mutated once in going from animal to human. It would be nice to disprove his nonsense as he is enabling those who do not know better including some who comment here.
Even with the vaccination, why risk it? It is just my wife and I now in a nice 2500 sq. foot home which is ready for a young family and nicely priced. The realtor world has changed since when I could sit down with one and actually believe what they tell us, if they have something to tell, and they claim ignorance. The ones bringing buyers are supposed to show off the home and represent the seller in order to obtain their commission POC. For the last 6 weeks, we have bugged the house so we can get an idea of what was going on as the information coming back was scant and dubious. Another story for later and maybe a topic.
We could have emerged from a lockdown if people were to observe safe distances and wore face masks on a regular basis like I have seen in Asia pre-Covid. They will not even do the simplest of precautions and expect others to take the risk so society can open up. I guess we could if people observed the precautions. They won’t. By the election, we may be at 250,000 dead.
Each morning I am up early. Open the doors and air out the place. And then shut down. On our 2.srds of an acre of land we are far enough away from neighbors to avoid contact except from a safe distance. We do not eat indoors at restaurants, we do carryout, and eat outside at establishments. May paranoid wife of 49 years keeps after us and on this I agree.
My favorite drug trial story was a male birth control pill, WIN 18446, developed back in the 1960s. It turned off sperm production. It was tested on prisoners, volunteers, in Washington and Oregon, and it worked very well with no serious side effects. It turned out, there was one, it interacted horribly with alcohol. Apparently, it blocked sperm production, but it also blocked a liver enzyme that breaks down ethanol.
Drug trials are an absolute pain in the ass to run. The signal is massively noisy, and then, the results can be confounded in an instant by real life, post trial. I consider this whenever I hear arguments for testing a COVID vaccine with challenge trials. We have very little idea of what would comprise a realistic challenge.
Joel has been inoculated with Moderna’s rMNA. We were just talking about such. It is supposed to produce antibodies. The issue being how much is enough to resist Covid 100% or to some degree. He can answer more questions if you pose them. I believe he would talk about it.