A very interesting memo has seen the light of day that provokes serious reflection on a fundamental issue of commercial life. It concerns the question of whether industry can police itself for the quality and effectiveness of its products. On the face of it, there is every incentive to do so. A poor product is found out in the course of use and this hurts profits. In reality, this straightforward system breaks down.
The memo in question comes from the head of the Food and Drug Administration to the head of the National Institutes of Health and the head of the National Institute for Allergy and Infectious Diseases. These three are at the top of the regulatory structures on which we rely for quality assurance.
Here is what Janet Woodcock wrote to Francis Collins and Anthony Fauci on May 27, 2021 in the early morning.
“I have been contacted by a number of people who have experienced adverse events post COVID-19 vaccination (from all three of the current vaccines),” she wrote. “Many are healthcare professionals, some of whom I know. The symptoms do not fit together into a distinctive syndrome and most are not easily quantifiable or evaluated with standard laboratory testing.”
“These problems are not the sort that a system like VAERS would be able to detect,” she continued, “or even a more sophisticated population-based active followup such as CDC has, or a medical record based system such as BEST. I think it would be worthwhile to do a study and evaluate a cohort of these individuals. But of course $$ need to be made available, and you would need an investigator who is interested in ‘medical mysteries.’”
Then she says what I find most intriguing of all.
“I doubt the industry would support, for obvious reasons. But my experience is, that if you let a problem fester, then it will come back to bite you later and you are not prepared.”
It’s more than a little odd that the head of the FDA would say that if they are studying and evaluating drug safety, they will need extra money. Isn’t that the whole point of the agency? I mean, the agency has a $6 billion budget, while the NIH spends $48 billion. You might think they could dig around for the funds to perhaps examine the impact of a product the agency authorized for the entire population.
On the face of it, it is wholly bizarre that this suggestion would need to be made at all. But then she continues and says, without even having to justify her intuition, that industry itself would not support such an investigation. She adds that this is for “obvious reasons,” namely, one supposes, that they don’t want knowledge that their products are harmful to hurt profitability.
I do not get this at all. If McDonald’s was suspected of serving poison fries, they would certainly want to know because knowledge of that would devastate their business. It’s true with car manufacturers too. They need to know that their cars are safe. The grocery across the street from me is super scrupulous about removing products once they expire, not because of the regulations but because they care about customer retention.
It’s the same with electronic goods. Before going to market, manufacturers send their products to the Underwriters Laboratory for testing and certification. This is not a government agency. It is a private nonprofit established more than a century ago. It is a neutral voice designed to assure quality in ways that benefit both the consumer and the producer.
In other words, this is not a difficult problem. It’s simply not the case that food makers want to poison their customers or electronic makers want their products to blow up. Everyone has an interest in quality. The drug industry is unique in not wanting rigorous testing for safety and effectiveness. Why might this be so?
The answer comes down to liability. The drug industry and vaccines in particular are beneficiaries of a special system that grants them liability protection. It is meant to assure availability and minimized entanglements in the court system that would inhibit production and distribution. In reality, it creates a kind of moral hazard: it invites companies to produce and distribute unsafe products that are indemnified.
The COVID-era vaccines benefited from yet a second layer of protection. They were produced and distributed under a provision called emergency use, one made possible by a special act administered by the Department of Health and Human Services. The idea is that if the need is intense enough, the normal high standards of quality and safety could be bypassed in the public interest.
This is why Woodcock could confidently say that the industry itself would not want to pay for safety examinations. The “obvious reason” was that such could hurt profitability. It is intriguing that she knows this and states it without a thought or any curiosity as to why that might be the case.
Implicitly, then, she is admitting what she suggests they seek to discover; namely that the products are not safe, that these shots have myriad side effects that are unwelcome and not easily discovered by the normal monitoring systems. Indeed the systems are designed to mask and hide such adverse events.
In Woodcock’s views, it would be dangerous for everyone to ignore all the signs from health professionals that these shots were harmful. Not doing a close examination “it will come back to bite you later.” Indeed that is precisely what is happening.
We are now flooded with evidence that the people in charge had plenty of warnings. From long before the shots were even widely available to the public, Anthony Fauci received credible information that they were not effective on new variants. He ignored such warnings. Later he was presented with evidence that they could lead to more miscarriages. He recommended them to expectant mothers in any case.
Under normal standards of liability and market rules concerning feedback, quality assurance generally takes care of itself. Indeed, the market has built many systems that are highly sensitive to customer input. When you buy a book from Amazon, you read the reviews. It’s true for any product on the market.
But pharmaceuticals have constructed a special set of rules that apply to them and them alone. The result is a plethora of products on the market that don’t pass muster. They are even actively dangerous. This is because they have bypassed the normal system that guarantees quality in every other sector.
The old ideological question has always been the same. Is profit-making business good or bad for society? The answer is: it depends. The systems have to be in place to provide external policing of products, whether in the form of consumer feedback, liability risk, or industry-organized standards. None of these exist for many of the most common pharmaceuticals. That is leading to the current revolt.
Woodcock’s prediction is coming true. The failure to examine these products for the downside is coming back to bite both the regulatory agencies and the industries that make them.
