Why Trump's 'Cure' Isn't Ready for Approval

Shortly after President Trump touted Regeneron Pharmaceuticals’ experimental antibody cocktail treatment for COVID-19 as a “cure”, both Regeneron and Eli Lilly and Company filed with the US government to make their antibody treatments available to the public.

The drugs from the two companies work similarly. Neither company has completed their clinical trials to date, but both argue that the pandemic is so urgent that treatments should be available immediately.

Regeneron’s treatment, REGN-COV2, contains two antibodies: one from a person who has recovered and the other from a mouse that has been genetically modified to have a human immune system. Eli Lilly’s treatment, LY-CoV555, uses an antibody from one of the first patients in the US to recover.

Both treatments contain antibodies that are supposed to bind to the “spike protein” of the SARS-CoV-2 virus. (A spike protein mediates entry of the virus into the cells.)

Antibodies are proteins that our immune and B cells make to fight off infection. Months ago, there was a big surge in “convalescent plasma” – a plasma donated by people who have recovered from COVID-19 – in the hope that the antibodies their bodies developed to fight the virus could be shared with people current infections from transfusions could help. However, as researchers learn more about COVID-19, they try to select and develop the key antibodies that will attach to the virus to make them more effective.

However, Aruna Subramanian, MD, an infectious disease doctor at Stanford Health Care and principal researcher on a number of COVID-19 drug trials, is skeptical about this. She told Medical Daily that both treatments are considered effective, but that they are still “under a lot of research”. And she would know, considering that she is the lead researcher for Stanford’s inpatient study of Regeneron antibody cocktails.

“We’re looking at three arms,” ​​she said. “People get either the high dose of the monoclonal antibody, the lower dose, or the placebo. And they are blind – we don’t know what they’re getting and the patient doesn’t know what they’re getting. And then we track the viral load by swabbing nasal passages and blood counts. “

The data that both companies have so far come from outpatients with mild to moderate illnesses. The inpatient studies have not yet included enough patients or analyzed data to report results. Dr. Subramanian said her study so far included a few hundred patients, not all of whom survived, and she doesn’t know who was on medication (or what dose) versus placebo.

There is currently initial evidence that both drug treatments will help patients with mild to moderate cases: their viral load drops faster, symptoms resolve faster, and they are less likely to need to be hospitalized. The treatments were most helpful in patients whose immune systems had not yet responded to the virus. Nobody is yet aware of the effects on the more severe cases or the long-term side effects of the drugs, but the infusions themselves have not caused any serious immediate side effects.

Dr. Subramanian said the evidence that will be available to the U.S. Food and Drug Administration (FDA) to evaluate these emergency applications is sparse. “What was published? [from Regeneron] is only 275 patients, and even that is just top-line results. The full FDA approval process is a much more in-depth process. For this application they look superficial and decide whether the issuance of such a contingent emergency permit will bring sufficient benefit to society. “

The FDA does not need to issue blanket approval. For example, the antiviral drug Remdesivir has only been granted emergency approval for inpatients. Dr. However, Subramanian hopes that this won’t happen with the new applications.

For one, if they are approved for emergency use, it becomes much more difficult to enroll patients in clinical trials where they do not know what treatment they are receiving. Why would someone sign up to possibly get a placebo or an unknown dose in a study when they can only get a prescription for the drug after it’s approved?

Loss of participants for further studies would hamper the researchers’ efforts to gather important information: how effective (or not) each drug is, in what dose, with what side effects, in what populations, and at what time and with what frequency ? For example, it is not known at this point whether the high doses are needed or whether the low dose is as effective.

She understands that President Trump’s bold remarks after his successful treatment propelled this urgency request, but warns that important drug decisions should never be based on a person’s outcome. In addition, there are too many variables in this case to be able to say with certainty whether or how much Regeneron’s treatment helped.

“We don’t know when [the president] last tested negative; We don’t know when it started. He received other treatments, they never told us what his lung image scans were like or how severe his case was, and all of these are things that need to be looked into. “

Dr. Subramanian hopes the FDA will deny the applications for the time being, so the studies can continue for a few more months so the data can be properly collected and reviewed.

“Let’s investigate this further and see where it really belongs before we push something through. I think that would be the most responsible thing, ”she said.

Jenna Glatzer (www.jennaglatzer.com) is the author or ghostwriter of more than 30 books, including the Celine Dion authorized biography. Her latest work is Gratitude on the Move: A True Story of Hope, Determination, and the Everyday Heroes around Us with Colleen Kelly Alexander.