Header Ads

Breaking News

Trump’s Convention Push for a Coronavirus Cure Puts Politics Before Health


The Food and Drug Administration has again failed to adhere to the scientific standards that the agency has always sought to uphold. On Sunday, the agency granted emergency-use authorization for doctors to treat COVID-19 with blood plasma from recovered patients, though it was unable to provide sufficient data to determine how effective the treatment will be. President Trump, in a tweet on Saturday, blamed “deep state” elements at the F.D.A. for slowing the approval of drugs and vaccines until after the election. Earlier in the week, federal scientists, including the infectious-disease expert Anthony Fauci, and his boss, Francis Collins, the director of the National Institutes of Health, had urged the F.D.A. to delay the emergency-use authorization. They did not think there was enough data to support it.

Trump is not a man to let a lack of data interfere with his political needs, however. So at a briefing on Sunday, on the eve of the Republican National Convention, he called the treatment “a historic breakthrough,’’ with “an incredible rate of success.” He added that the F.D.A. had made “the independent determination’’ that the treatment is “very effective” and has reduced mortality rates by “thirty-five per cent.” Not one of those assertions is true. Yet the F.D.A. Commissioner, Stephen Hahn, ignored the advice of Fauci, Collins, and others, and apparently made this significant scientific decision based on the wishes of a President who ignores science and denigrates researchers.

Trump’s trade advisor, Peter Navarro, who frequently offers inaccurate judgments about COVID-19 therapies, has said that the odds of blood plasma helping a COVID-19 patient are “close to a hundred percent.” There is no evidence that the treatment has cured anyone.

Public-health officials expressed deep concern over the decision. On Monday morning, on NPR, Margaret Hamburg, who was the commissioner of the F.D.A. for six years, under Barack Obama, said, “What we don’t know is how it works in this case. Is it truly effective? When in the course of disease might it be most effective, and for which patients?’’ She added that, based on the preliminary data that are available, the treatment “probably has some marginal benefit, but it’s probably not much.’’ Even Trump’s assertion that the F.D.A.’s authorization “will dramatically expand access to this treatment’’ is almost certainly wrong, since that will depend on tens of thousands of recovered patients donating blood.

Sunday’s decision was not as egregious as the agency’s similar emergency-use grant, in March, for hydroxychloroquine, the malaria drug that President Trump touted as a miracle cure. He even announced at a nationally televised briefing that he was taking the drug as a preventative—a claim he repeated at the Convention on Monday night. Not only did hydroxychloroquine prove to be ineffective against the coronavirus; in some cases, it endangered people’s lives. The agency was forced to withdraw the authorization earlier this summer and replace it with warnings about the drug’s dangers. For the F.D.A. that was a stunning reversal. (Trump’s latest COVID-19-treatment infatuation comes from Mike Lindell, the C.E.O. of My Pillow, Inc., who has been pushing oleandrin, a botanical supplement made from the poisonous oleander plant.)

Convalescent plasma has been undergoing clinical trials for months. The concept itself has been in use for more than a century, treating everything from bacterial infections to the Ebola virus. We do not know how well it will work with COVID-19, but its long track record suggests there is little danger the treatment will cause harm. The idea behind it is simple: infusions of antibody-rich plasma taken from people who have recovered from the disease can be injected into patients. That should boost recipients’ immune systems, helping them to fight the virus until they generate their own antibodies. In June, the Mayo Clinic, after transfusing more than twenty thousand COVID-19 patients, released data showing that the treatment is safe. The study did not include placebo controls, however, so it was impossible to fully judge its effectiveness. Thousands of physicians have administered plasma to COVID-19 patients, and some feel that it has helped them. But I have neither spoken to nor read of any doctors who view it as anything more than a tool that may be of limited use until something better is developed.

The agency’s willingness to accede to Trump’s wishes raises an even more serious concern: What will happen as the President continues his campaign to force the F.D.A. to approve a vaccine before the election? Several vaccines look promising, and, thanks to massive infusions of money, as well as genuine scientific advances, their development has been remarkably swift. Yet no serious public-health official thinks that one will be approved for general use before the end of this year, at the earliest.

Trump may be motivated by electoral politics, but Americans, in fact, have long bristled when their access to experimental remedies has been restricted—and the F.D.A.’s authority to do so has not come easily. Snake-oil cures and worse were common before 1906, when Congress passed the Pure Food and Drug Act. The act permitted the Bureau of Chemistry, which preceded the F.D.A., to insure that labels contained no false or misleading advertising.

It has usually taken a disaster to persuade Congress to adopt strict regulations.

For years, sulfanilamide, a drug prescribed to treat streptococcal infections, was used safely and effectively in tablet and in powder form. Most children can’t swallow pills, though, and, in June, 1937, researchers at one company found that the drug would dissolve in diethylene glycol. They tested the mixture for flavor, appearance, and fragrance—but not for toxicity—and then shipped it all over the country. They overlooked an important characteristic of the solution: diethylene glycol, normally used as an antifreeze, is a deadly poison. Within weeks, scores of children were dead. The next year, after more than a hundred deaths, Congress passed the Food, Drug, and Cosmetic Act, which finally gave the F.D.A. the authority it needed to regulate such products, and in the years since it has done so with vigor.

But Sunday’s action, coming after other recent instances of federal-health officials capitulating to Trump, has vaccine experts deeply worried. Bruce Gellin, the president of global immunization at the Sabin Vaccine Institute, told me that “despite reassurances from Francis Collins and others that moving at warp speed won’t cut corners, if FDA’s gold standard of data-driven decision making can be trumped by politics, then I worry about how confident Americans will be about any product that the FDA approves.’’

This is hardly a theoretical concern. On Monday, the Financial Times reported that the Trump Administration is “considering bypassing normal US regulatory standards” to approve an experimental British vaccine for use in this country before the election. If that happens, the F.D.A. will risk losing its hard-won credibility for good.


More on the Coronavirus

Source link

No comments