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.