Government Doublespeak and Abundance of Caution: FDA Approval of Covid Vaccines

 

                                                                          

Obadiah Youngblood

                 

Today's New York Times carries a letter to the editor from Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, the group which gives or withholds approval for new drugs or vaccines.

He says:

"Any vaccine approval without completion of the high quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.'s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.

This approach helps to ensure that the F.D.A. has all the available data from clinical studies and provides the public with trust and confidence in the quality, safety and effectiveness of any vaccine that the agency approves." 

So what is the FDA saying here? We do not yet have confidence in the quality of the vaccines? Is it saying it has doubts about the safety of the vaccines?  Or is it saying something very different: That the jury is still out about the safety?  Is it saying "we are the jury and we are still deliberating?" Which is to say: we haven't heard enough yet to make a judgment.

And if the FDA says it is still unsure of the safety, then why should any citizen or parent be willing to take action and get the vaccine? 

Reading this I thought immediately of a conversation I had with a patient and his wife yesterday when I asked why he had not got his vaccine and he said, "It's not FDA approved."

He was angry at me because I refused to see him in the office because he was not vaccinated. What he argued, of course, was I was insisting he take a vaccine which even the federal government had not yet said was safe and effective. He was correct, too. The FDA has not yet given it's seal of approval, so how could I as an employee of a private company, or a public hospital insist employees of the health care facilities or patients being treated there take a vaccine not yet certified as safe?

We have a dietician in the office who refuses to get vaccinated for the same reason.

Of course, if you probe a little more, you understand this is just a legalistic argument which fronts for a world of conspiracy theory, the government-always-lies and Hillary- runs-a-pedophile-ring thinking, but it is difficult to deny the government is saying the FDA watch dogs have not yet become convinced this vaccine meets all the safety requirements.

Is should not be lost on anyone that the very same people who now point to the FDA, who so vociferously claim "The FDA has doubts, so should we!" are the people who in the next breath will tell you you cannot trust anything the government tells you about anything. (As my patient did, in the next sentence. So he believes the government--the FDA--when it suits his paranoid view, but not when the government says something which conflicts with his paranoid view, like wearing a mask and avoiding indoor crowds is a good idea. Government taking my freedom!)

A letter from a professor of pharmacy at the University of Maryland appearing in the British Medical Journal says, 

If the FDA listens to us, they won’t give serious consideration to approving a covid-19 vaccine until 2022. Our first request is that the FDA require manufacturers to submit data from completed Phase III trials—not interim results. Trials by vaccine manufacturers were designed to follow participants for two years, and should be completed before they are evaluated for full approval, even if they are now unblinded and lack placebo groups. These Phase III trials are not simply efficacy studies; they also are necessary and important safety studies (as the study titles say), and all collected data remain invaluable.

We also call on FDA to require a more thorough assessment of spike proteins produced in-situ by the body following vaccination—including studies on their full biodistribution, pharmacokinetics, and tissue-specific toxicities. We ask the FDA to demand manufacturers complete proper biodistribution studies that would be expected of any new drug and request additional studies to better understand the implications of mRNA translation in distant tissues. We call on data demonstrating a thorough investigation of all serious adverse events reported to pharmacovigilance systems, carried out by independent, impartial individuals, and for safety data from individuals receiving more than two vaccine doses, in consideration of plans for future booster shots. We ask the FDA to request necessary studies in specific populations, including those previously infected with SARS-CoV-2, pediatric subjects, and those with immunological or other underlying medical complexities. Given the nature of the novel vaccine platforms, our petition asks for experts in gene therapy to be included among the external committee advising the FDA.

What all this is saying is there may be troubles with the vaccines which do not become apparent for two years.

Photo: Mary McCarthy

Of course, as Charity Dean, MD, the intrepid public health officer of Santa Barbara, California noted, by the time the CDC was ready to act, anything it decided to do would be too late. She was speaking about a variety of actions she needed the CDC to take during the first weeks of COVID 19 rampaging on the West Coast,  like allowing and approving tests to detect COVID 19 which had been created at a University of California (SF) lab which she needed immediately to track and trace the epidemic, and to prevent it from spreading. She ultimately forbade her staff to deal with the CDC because that institution was worse than useless, acting like a university which was only interested in science, in proceeding, plodding through to an answer with unassailable results when people were dying in California and the public could not afford to wait for the results of a scientifically pure study. 

Charity Dean, MD

When a fire is raging along the street, you cannot wait to open the fire hydrants and hook up the hoses until the inspection tags on the hydrants have certified there are no leaks in the hydrants and the water used is free of environmental risks.

August Macke 

When Alexandre Yersin developed a vaccine against the Black Plague (Yesinia pestis) at his clinic in Vietnam in 1895, he did not submit it to an FDA panel. People were dying all around him and he saved the village of Nha Trang.

The FDA has faced the need for urgent action since at least the HIV epidemic, when people dying of a lethal disease demanded it allow the use of AZT early on, because if it took 2 years to be sure it was safe and effective thousands would die who might have lived. So the FDA made an accommodation, as it did with the "Emergency Use Authorization" for the current COVID vaccines.

The EUA was issued because the FDA and the CDC realized the country did not have the luxury of time.

But now we have people saying "Well, if there are still questions about the vaccine in the mind of the FDA, why should I risk taking it or allow my kids to take it, if 2 years from now something bad may happen?"

What you want to ask the pharmacists who wrote the BMJ is: what exactly do you expect might happen in 2 years?  The experience with the swine flu vaccine comes to mind: In 1976, after 100 million people were vaccinated for swine flu to head off what was expected to be a devastating pandemic. 300 people got Guillain Barre syndrome, a sort of month long polio like paralysis. This is the classic example of a fools rush in scenario which actually is not what it has been said to represent. 

The fact is swine flu itself causes Gullain Barre, and by the numbers fewer cases were seen in the vaccinated group than in the non vaccinated group; so far from causing GB, the vaccine may have protected against it. But the big fact is that apart from one vaccine, every adverse effect of vaccines going back to the first vaccines occur within 6 weeks of vaccination, so a 2 year waiting period is not justified by experience.

The exception is the vaccine against Respiratory Syncytial Virus in some patients actually enhanced the severity of disease in some children receiving the vaccine rather than diminishing the severity of the disease. This remains the cautionary tale of vaccinology, but nothing like this has been seen in COVID vaccination and we have had enough time and cases to see it if it occurs.

Obadiah Youngblood 

The pharmacists who authored the letter asking for delayed approval until 2022 wanted to see more data on "bio-distribution" of the vaccine within the body, which is nice to know about most drugs: does the drug cross the blood brain barrier, does it get into the gut, does it penetrate the heart? But what practical difference could this information possibly make in the decision to deliver the vaccination to a population? There is an old clinical adage: Don't do a diagnostic test if there is no therapeutic implication. The same applies here, mostly. Yes, we need to continue to study what happens long term to patients getting the vaccine, just as we do "post marketing" studies on most drugs, to see if 5 or 10 years later we see things we hadn't expected.

Metformin, a diabetes drug, has been used since 1969 but only in the past few years has it been recognized it may have an anti-cancer effect; cholesterol lowering statin drugs may increase bone density. Who woulda thunk?  Does that mean we should have delayed the use of metformin or statins until we knew these things?

But these are drugs which are taken every day for years; the vaccines are administered but once or twice. Of course, vaccines interact with the immune system, which is a memory system, and which, hopefully will continue to have ongoing effects.

The fact is, we have loads of examples of the good things vaccines do: Measles killed more than many battles during the Civil War; influenza killed more people in 1918 than all the battles of World War I; diphtheria, tetanus killed thousands and are now seen only in the unvaccinated. And even today, the images of wards filled with children in iron lungs keep the idea of polio vaccine fresh.

TWiV Team

In fact, polio was rushed to market far more precipitately than COVID vaccines. Jonas Salk gave it to himself and his children without FDA approval. The first polio vaccines were "inactivated" or "live" viruses and there was an incident where one factory failed to inactivate the virus enough and children given the vaccine got polio. Even the oral vaccine, which lives in the guts of its recipients can "revert" back to virulent polio occasionally, and there are some vaccine associated outbreaks of polio, but rarely.

No thing made by man is without potential for failure or mischief.

So what does the FDA mean when it says it would be failing in its mission if it gave approval before all the usual steps had been completed? Is this not an agency publicly stating it cares more about "Cover Your Ass" than about the public health?

As far as I can see what the FDA is saying is "Our mission is not public health. Our mission is to certify the safety and efficacy of the drugs presented to us, dispassionately, without regard to the urgency or need for action. But once our seal of approval is affixed, you can be sure the vaccine is safe. If thousands die, awaiting that process to play out, that is not our concern. We are focused on one thing, not the other."

If we approve of that fire hydrant, then when the firemen hook it up we and they can be sure the hydrant will work, the water flowing out is clean and when you shut off the hydrant, it will stop. 

Nice to know. 

But when your house is on fire, all you want is access to that hydrant.