Deregulating Covid-19 Treatment Sets Dangerous Precedent for Vaccine Approval

(Posted on Thursday, August 27, 2020)

The current Administration in Washington is gambling on deregulation of the Food and Drug Administration. Regulations on Covid-19 testing meant to keep Americans safe are weakened by the Administration in a recent executive order. This change could result in unreliable tests being released, which only adds to the testing woes present in the United States. Unverified tests and fast-tracked treatments could lead to more, not less, spreading of the disease.

The FDA expedited the approval of a Covid-19 treatment—convalescent plasma—against the advice of its internal experts and those at the National Institute of Health. Were the federal government to continue this theme, one could expect the approval of an underregulated Covid-19 vaccine in the coming months, regardless of definitive proof, safety, or efficacy, something both the governments of China and Russia appear to have done.

Sunday’s emergency use authorization for convalescent plasma was issued as a therapy, which has been used to treat 70,000 Covid-19 patients. Its benefits are still unknown, as there has been no randomized controlled study on the effect of the treatment compared to a placebo. FDA Commissioner Stephan Hahn has even admitted to overstating the effectiveness of the treatment in a news conference by tenfold.

To quote Hahn, “A 35% improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — 100 people who are sick with Covid-19, 35 would have been saved because of the administration of plasma.” The study in question suggests that closer to 3-5 people would be saved by convalescent plasma. Even that estimation is in question as the researchers did not compare plasma infusions to a control group. The result was pulled by comparing those who received a lot of antibodies early to those who received only a few later on.

We have seen this type of behavior before in a failed emergency use authorization for hydroxychloroquine. Once touted as a “game changer”,  the drug has now been noted to cause serious heart rhythm issues. The Infectious Diseases Society of America argues against the use of the drug in any setting as a treatment for Covid-19. Despite these warnings, people continue to take hydroxychloroquine. They assume it is an effective treatment, while it is actually damaging to their health. This carries dangerous implications for potentially fast tracked vaccines.

Were the federal government to fast track vaccines to market, what would be the damage? The most immediate and obvious answer is that vaccines would be untested, unproven, and potentially harmful, as previously seen by the damaging effects of hydroxychloroquine. The more complicated and storied answer is that of trust in the efficacy of vaccines.

A recent survey found that if a Covid vaccine were to be approved and available by the end of the year, thirty five percent of voters would be unlikely to get it. People are already hesitant about being vaccinated for Covid-19 and an expedited, unregulated production would likely entrench their hesitation.

These hesitations are not entirely unfounded, as in the African American community. From J Marion Sims operating on and mutilating unconsenting enslaved Black women to further his gynecological research to the Tuskegee Experiments, Black people have been the subject of abuse by medical professionals for decades and continue to be more poorly treated and cared for than their Caucasian counterparts.

Paired with the distrust of medications and the professionals who administer them is another stumbling block: the close association between new vaccines and corporate profits. After receiving almost half a billion dollars from the US government, one company suggested it would not sell a developed vaccine for Covid-19 at cost of production. How can people be expected to trust the efficacy of a vaccine if they were fast-tracked through the approval process or regulatory processes for these vaccines were stripped based on politics and profits rather than sound public health advice?

We have seen what happens to the infection when behavior changes: infections and death skyrocket, as has happened with the economic reopening. Approval of vaccines with unknown effectiveness and safety could lead to even more infection and death. The damage to the FDA’s long term regulatory processes are massive. The sale of ineffective medicines, lack of confidence in medicines that do work, and political corruption of the medical field will lead to the further spreading of this disease. Were people to take vaccines they believe to be effective, they may return to society with the idea they are immune.

Trust in the FDA is tainted when the public associates the agency with the politics of Washington. Vaccines are meant to be innovations by the scientific community, not devices of political gain. When FDA regulations are undermined by the current Administration for political gain, distrust in medical breakthroughs are sewn. The Administration’s attempt to find a vaccine for the disease before the election is a dangerous gamble.

While finding a vaccine remains a top priority, throwing away the regulatory practices that ensure the efficacy of a vaccine is not a risk worth taking. We are moving back into the era of snake oil and patent medicine. We are opening the doors wide open to corruption. Where politicians for electoral, or personal gain, can approve or disapprove of medication. This is an extraordinarily dangerous situation.

Read original article on the Forbes website (published August 27, 2020)