Concerns Mount – FDA May Approve Deadly Vaccine

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Concerns Mount – FDA May Approve Deadly Vaccine; But Major Medical Organizations Can Help Protect Public Health

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The FDA May Approve A Vaccine Too Quickly

WASHINGTON, D.C. (September 16, 2020) - Concerns are mounting that the FDA may approve a vaccine too quickly and without adequate testing - which could be deadly if there are adverse reactions and/or people rely upon it but it provides inadequate protection - but there is a remedy if major medical associations are willing to play a role, says public interest law professor John Banzhaf.

Adding to the recent growing concerns by experts and others that the FDA will rush to approve the release of a vaccine because of political pressure, Politico just disclosed that HHS Secretary Alex Azar not only "led an escalating pressure campaign against his own Food and Drug Administration this spring and summer, urging the agency to abandon its responsibility for ensuring the safety and accuracy of a range of coronavirus tests as the pandemic raged," but ultimately "overriding objections from FDA chief Stephen Hahn, Azar revoked the agency's ability to check the quality of tests developed by individual labs for their own use, according to seven current and former administration officials with knowledge of the decision."

This comes on top of Hahn's recent announcement that he is willing to consider bypassing the usual approval process to get a vaccine out to the public quickly, perhaps before Election Day as the President has suggested.

Among other things, if he uses the emergency use authorization [EUA] process which he suggested, it will mean a very significant lowering of the standards from the usual - that there is "substantial evidence" that the vaccine is safe and effective - to the much weaker "may be effective" given the "totality of scientific evidence standard," notes Banzhaf.

Reasons To Distrust The FDA

Even before these recent developments, there was growing concern among experts and members of the public that the FDA could be counted on during the pandemic, and with increasing pressure from the President, to provide adequate protection to the public. The reason for this distrust included, says Banzhaf.

  • the very name of the vaccine program - "Operation Warp Speed" - strongly suggests rushing to judgment at all costs, and possibly not insisting upon sufficient testing to fully establish safety and effectiveness
  • the FDA bungled in initially getting COVID-19 tests on the market, and then allowing antibody tests which proved inaccurate to be made available
  • it hastily approved hydroxychloroquine as a treatment after it was touted by the President but before it was fully tested, and then had to withdraw the authorization only shortly thereafter
  • it authorized the use of convalescent plasma, likewise strongly recommended by the President, despite the strong and continuing reservations of many medical experts
  • FDA Commissioner Hahn just made a clearly misleading public statement which greatly overstated the effectiveness of the convalescent plasma in treating COVID-19
  • the agency recently changed its testing guidelines in ways which concerned many public health 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 scientifically unjustified positions because of pressures from the White House

As a result, there is now a growing chorus within the medical community - as reported by CNN, the Washington Post, CBS, WebMD, STAT, The Independent, and others - calling for an independent commission, free from bias, including pressure from the President - to review the safety and effectiveness of any vaccine before it is widely distributed.

Countering Calls For A New Independent Commission

To counter these calls 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" - although its recommendations are not binding and can be ignored by the agency, notes Banzhaf.

But critics such as Dr. Kathryn Stephenson of Harvard Medical School, bioethicist Arthur Caplan of NYU, and others say that a public already skeptical about vaccines and the FDA itself is unlikely to trust this FDA advisory committee because some of its members work for pharmaceutical companies or government agencies, and thus are subject to pressure from the President and others.

But, suggests Banzhaf, 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 consider recommending 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, that announcement would probably force the FDA to permit such a review, or effectively prevent premature widespread distribution of a potentially deadly vaccine, argues Banzhaf.

The recent pledge by nine vaccine makers that they will hold back seeking FDA approval until their product is proven to be both safe and effective is unlikely to persuade either the public nor a growing number of spectacle experts, says Banzhaf, who predicts that it will be seen like an assurance from the NRA that gun owners will use assault rifles responsibly, or from the Hell's Angles that its members will obey traffic regulations.

So Prof. Banzhaf suggests that it would be appropriate and perhaps necessary for major medical organizations to consider what their role should be regarding the distribution and administration of any vaccine without the satisfactory completion and unbiased evaluation of clinical trials, and not stand by passively in view of this growing concern and danger.

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