Infection doesn’t deter President from tub-thumping for yet another unproven drug

antibodiesregeneron-300x157Well, there he goes again (as President Reagan used to say): President Trump, whose White House has become a coronavirus hot spot and who has clearly played a role in a super spreader event, is hyping yet another medical treatment for Covid-19.

He has referred to his own viral infection as “a blessing from God,” used the C word (as in “cure”) and has called an incipient therapy used on him as a “miracle.” So, now Americans may be racing to reference works to learn more about coronavirus care with monoclonal antibodies, specifically those developed by the Big Pharma firm Regeneron. It is headed by Dr. Leonard Schleifer, and as CNN reported:

[Schleifer] and President Trump are acquainted: The CEO has been a member at Trump’s golf club in Westchester, New York, and his company also received $450 million in government funding in July as part of the president’s Operation Warp Speed plan to quickly develop a vaccine and other treatments for Covid-19 … Trump also recently owned shares of Regeneron (REGN) [as] listed as assets on Trump’s 2017 filing with the U.S. Office of Government Ethics, though [not] on the president’s most recent filing for 2020.”

Trump’s doctors, after he was hospitalized at Walter Reed medical center, reached out to Regeneron and asked for its “REGN-COV2 antibody cocktail,” which the company supplied on the basis of the “compassionate request.”

What is it? As CBS News reported (see illustration above):

“REGN-COV2 is described as a drug cocktail because it consists of two antibodies [blood proteins] designed to be particularly attractive to the coronavirus. The idea is that the antibodies will bind to the surface of the virus, stopping it from attaching to other healthy cells in the body. One of the antibodies comes from people who have contracted Covid-19 and recovered; the other comes from mice that have been injected with Covid-19.”

There is more to this immune system-boosting therapy, as multiple news organizations have reported, notably the history of its development. The treatment might be controversial and unacceptable to those with strong religious beliefs, because, as the New York Times reported:

“When the Trump administration suspended federal funding in 2019 for most new scientific research projects involving fetal tissue derived from abortions, officials argued that whatever the scientific benefits, there was a pressing moral imperative to find alternative research methods. ‘Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration,’ the Department of Health and Human Services said in a statement released at the time. Yet the treatment for Covid-19 received by Mr. Trump — a cocktail of monoclonal antibodies he described as a ‘cure’ in a celebratory video posted on Twitter — was developed using human cells derived from a fetus aborted decades ago.”

White House officials have tried to distinguish this scientific reality from their policy action by saying the Regeneron cells pre-dated the Trump decisions.

Dearth of rigorous data

The blow-up over the treatment’s genesis may not pull the spotlight, too, from the absence at present of clinical information about monoclonal antibodies and the coronavirus. That is because the therapy still is firmly in the clinical trial phase, with Trump becoming one of a handful of people on the planet to get it.

Regeneron and Eli Lilly have raced to develop, test, and bring to market this therapy, which has been well-tolerated by the few patients who have gotten it. The scant data suggests monoclonal antibodies may become another treatment resource in coronavirus care.

It is not, as of now, factually correct to call it that C word.

Regeneron and Lilly both have asked the federal Food and Drug Administration for emergency authorization to use their products in coronavirus cases. That procedural step has been boosted, in Regeneron’s case, by calls from the White House to the FDA. Inappropriately, critics say.

Surprise, Big Pharma execs already are profiting, handsomely, from the focus on monoclonal antibodies.

The rest of us still don’t know: How much this care might cost, how available it might be, and how soon. The cocktail reportedly is not easy to make, nor is it easy to scale. Officials have said they 50,000 doses available — an amount that might give a day’s newly infected patients in the U.S. one dose (and the treatment might require several).

A record of medical hype

Facts have not stopped the president from falsely asserting that he will ensure all patients who need monoclonal antibodies, as well as the anti-viral drug Remdesivir, will get them, affordably and maybe even free. How many Americans, however, can get the elite and expensive care offered to a president — treatment that likely cost more than $100,000 for a short stay.

These claims come from the same president who, with those in his evidence-free orbit, have:

The administration also has shown the calamitous outcomes of its D-driven pandemic response: downplay, denigrate, deny, and defy public health and medical scientists’ evidence-based recommendations. Not only has the president contracted the coronavirus and required advanced medical care, dozens around him have tested positive (with some falling ill), and thousands have been exposed. Trump has declined to say when he first tested positive and, even as he shoves to return to normality, he will not say if he has tested negative. He says he is symptom- and medication-free now.

Trump — who got himself sick by resisting face covering and distancing recommendations — plans to resume campaigning at mass events, quickly.

Not good. In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles to access and afford safe, efficient, and excellent health care. This has become an ordeal due to the skyrocketing cost, complexity, and uncertainty of treatments and prescription medications, too many of which turn out to be dangerous drugs.

The president, no matter his health, insists on dominating the daily news. He has become, studies show, the top source of misinformation with his flood of falsehoods, notably about the pandemic and Americans’ health. This was bad news for clinicians and patients gulled into buying and using hydroxychloroquine, shorting its supplies for those with proven need for it. It was not useful for determining the good use of convalescent plasma, and it may similarly affect monoclonal antibody therapies. These medical interventions can be best shown to be safe and effective with rigorous clinical trials, which include randomized and blinded research and stringent controls (with some participants getting placebos and others the test treatment or drug). When novel care gets premature hype or is rushed into wide use, this can avert potential test subjects from participating in trials that can show what works and what doesn’t.

And we’re all the worse for it. We can’t know whether therapies or medications are safe and effective without, frankly, risky trial and lots of error.

We’ve got a lot of work to do, especially in the next few weeks when it seems clear that politicians’ behaviors and comments may get wildly evidence free. Facts matter. Be skeptical and discerning. And breathe and please vote.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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