Medical Groups Can Fight Possibly Deadly COVID-19 Vaccine; Administering Insufficiently Tested Vaccine Could Create Legal Liability
Public May Not Trust An Untested COVID-19 Vaccine
WASHINGTON, D.C. (September 1, 2020) - Worried that emergency approval of a COVID-19 vaccine by the beleaguered FDA, before full-scale trials have even been completed, might not be trusted by the public, and perhaps that such an untested vaccine might not be effective and could even be harmful, some medical experts have begun calling for a completely independent body to make its own determination before any vaccine is distributed.
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This comes in response to a statement by FDA Commissioner Stephen Hahn that the FDA could consider emergency use authorization or approval for a COVID-19 vaccine before phase three trials are complete.
While such pleas are unlikely to be effective at an agency which - unlike independent federal agencies such as the FCC, FTC, etc. - is headed by a commissioner who serves at the pleasure of the President and can be fired by him at any time, there is a way to protect the public from a possibly ineffective or even harmful COVID-19 vaccine, notes public health activist and expert John Banzhaf, a professor of public interest law.
Indeed, he points out that any physician, hospital, medical insurance company, or other entity which took part in administering a COVID-19 vaccine which had not been fully tested - and where there was reason to suspect that any premature FDA authorization was rushed for political reasons and not based upon established medical testing procedures - could be held legally liable if a person receiving the vaccine suffered an adverse reaction (including coming down with COVID-19 as a direct result), or whose reasonable reliance on the vaccine caused them to risk exposure to the virus which then turned out to be harmful if not deadly.
These potentially very costly legal risks are multiplied many times by recent medical findings that, in addition to killing a tiny percentage of those who become infected, many if not most who experience symptoms of COVID-19 suffer permanent medical problems - including some disabilities - because of damage to their hearts or lungs, and perhaps also to kidneys and even brains (now being called "brain fog").
If one or more major medical organizations - such as the American Medical Association, American College of Physicians, American Academy of Family Physicians, National Medical Association, etc. - were to announce that it would recommend that its members not administer any vaccine which had not fully completed phase three trials unless a responsible body independent of the federal government and the President had endorsed it, it would probably force the FDA to permit such a review, argues Banzhaf.
The same result would probably occur if several of the major hospital chains, or large health insurance carriers, were to take the same position, he adds.
Reasons To Distrust The FDA
Among the many reasons for many reasonable members of the public to distrust the FDA and its head regarding the pandemic, Banzhaf lists the following:
- the very name of the COVID-19 vaccine program - "Operation Warp Speed" - strongly suggests rushing to judgment at all costs, and possibly not insisting upon sufficient testing for safety and effectiveness
- the FDA bungled getting COVID-19 tests on the market, and then allowed antibody tests which proved inaccurate to be made available
- it hastily approved hydroxychloroquine as a treatment after being touted by the President but before it was fully tested, and then had to withdraw the authorization only two months later
- it authorized the use of convalescent plasma, likewise strongly recommended by the President, despite the reservations of many medical experts
- FDA Commissioner Hahn made a clearly misleading statement which greatly overstated the effectiveness of the plasma in treating COVID-19
- the agency changed its testing guidelines in ways which upset many experts, and without even consulting infectious disease expert Dr. Anthony Fauci
- many observers have suggested that it appears that top governmental pandemic experts are being pressured to take unjustified positions favored by the President
To counter the call for a new independent commission, the FDA has argued that it "has committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public."
But critics Kathryn Stephenson of Harvard Medical School, bioethicist Arthur Caplan of NYU, and others say that a public already skeptical about both vaccines and the FDA is unlikely to trust the existing advisory committee within the agency because some of its members work for pharmaceutical companies and government agencies, and thus are subject to pressure from the President.
Approval Process For A Vaccine Was Influenced By Politics
Indeed, in a recent survey, 78% of respondents said they were worried that the approval process for a COVID-19 vaccine was being influenced more by politics than by science.
While getting a vaccine as early as possible is obviously important, virtually all of the experts said that it would almost certainly not be ready before the end of the year.
To now rush it for release prior to election day, without completing the trials to show whether it is both safe and effective, would only increase the existing distrust of the public regarding the government's handling of the entire crisis, and could substantially prolong the hardship of the pandemic if even more people simply refused to be vaccinated, says Banzhaf.
Public Citizen agrees, arguing that such a rush to prematurely approve a COVID-19 vaccine could fuel existing vaccine hesitancy.
It could also make it more difficult to find people willing to participate in any more clinical trials because participants might not want to take the risk of getting a placebo, offering no protection, when they could get a shot of an arguably effective vaccine.
So Banzhaf suggests that it would be appropriate for major medical organizations, large hospital chains, and big medical insurance companies to consider what their role should be regarding any approval of a COVID-19 vaccine without the satisfactory completion and unbiased evaluation of phase three clinical trials, he argues.