As the number of U.S. deaths approaches 300,000 you would think everyone would be anxious to find ways to fight the virus. But unlike the tragedy of 9/11, not everyone has the same national interest.
My greatest sorrow in this year of many sorrows is the politicization of the Covid pandemic. At a time when the nation should be pulling together to fight this virus, we are instead pulling apart. We are divided along political lines rather than united behind the science of the virus and the therapeutics to provide treatment.
The best example of this division is the drug hydroxychloroquine. Earlier this year, when this novel coronavirus was just making its way to the U.S. from Wuhan, China, there were reports from China that hydroxychloroquine might offer some protection and early mitigation of the virus. Chinese doctors reported no cases of the virus in those patients taking hydroxychloroquine for other diseases such as lupus. I reassured someone in my own office who was taking the drug for lupus that she had protection from the virus.
Reports began coming in from France that a combination of hydroxychloroquine and azithromycin was effective in treating the virus. A doctor in upstate New York reported success with the same combination in all of his patients. My next-door neighbor, an ICU physician, told me of great success with her patients. There was real enthusiasm building in the medical community.
Then something happened that changed everything – President Trump championed the drug in his Corona Virus Task Force press conferences. All of a sudden hydroxychloroquine was the enemy of the people. Now the media, and those in the medical community who hated Trump, were out to prove him wrong.
Dr. Marc Siegel, internist and medical expert for Fox News and professor of medicine at NYU Langone Medical Center, has recently published a new book called Covid: The Politics of Fear and the Power of Science. Siegel tells the story of his own 96-year-old father with heart disease who was placed on hydroxychloroquine and azithromycin by his cardiologist when he developed shortness of breath and a fever. One day later he was greatly improved and later serologic testing confirmed he had Covid antibodies.
Siegel reviews the history of the politicization of hydroxychloroquine in his book. He says the FDA approved the drug for Emergency Use Authorization (EUA) on March 28th after a study published in Nature demonstrated hydroxychloroquine anti-viral activity against the Covid virus. There was also long-time evidence that the drug decreased the inflammation that could lead to the “cytokine storm” responsible for severe damage to the lungs in Covid patients. Since this drug had been used for 65 years for other diseases and had a good safety record, there was real reason for optimism.
But after the Trump championing of the drug in April, the opposition began. First, the Journal of the American Medical Association (JAMA) published a report that the drug wasn’t effective against Covid, at least very late in the game when the patient was dying. Then soon after Trump admitted taking the drug as a prophylactic, the FDA revoked its EUA on June 15th. Another study from England published in Lancet showed the drug to be ineffective when given to very sick patients. But then that study was discredited when the data was found to be from a questionable source. (see Lancet Gets Research Wrong Again)
An exception to this trend came from the Henry Ford Health System in Detroit which released a study where the drug was given very early in the hospitalization. They looked at 2,500 patients and found that the use of hydroxychloroquine alone cut the death rate in half from 26 percent to 13 percent. They believed the key to success was using the drug early, before significant inflammation occurs.
But others continued to discredit the use of the drug. The University of Minnesota published a study in Annals of Internal Medicine that reported hydroxychloroquine did not work to decrease symptoms in mild to moderate cases among outpatients. But Dr. Siegel interviewed the researchers and learned they did not confirm the patients were actually diagnosed with Covid, but went by symptoms alone. A randomized study from Brazil, published in the highly regarded New England Journal of Medicine, showed no effect against Covid in mild to moderate hospitalized patients. The critics all said this was the final nail in the coffin that discredited hydroxychloroquine. But careful analysis revealed they didn’t start their patients on the drug until seven days after hospitalization, much too late to be of any real effectiveness.
Yet many doctors stopped using the drug due to this study and the withdrawal of the FDA authorization. While doctors may legally use a drug without FDA authorization, they open themselves up to liability claims in such cases. For many doctors this just wasn’t worth the risk.
Dr. Siegel interviewed FDA Commissioner, Dr. Stephen Hahn, to ascertain his reason for withdrawing EUA for hydroxychloroquine. He said the original purpose of the EUA was to get access to a stockpile of the drug in Pakistan produced by Bayer Pharmaceutical. But the FDA made the mistake of applying the EUA to across-the-board hospital use when it was never really needed. When it was discovered there was plenty of drug available in the U.S. (50 million doses from Teva), the EUA was withdrawn. But this sent the wrong message that the drug was ineffective and many doctors stopped using it.
Dr. Siegel concludes the entire battle over hydroxychloroquine was over politics, not science. He says, “The end result was to make the public more afraid, one group (mostly on the right politically) championed hydroxychloroquine and advocated its use, even as it became restricted in more states and more pharmacies across the country. The political left, on the other hand, denounced the drug based on flawed science and continued to ridicule President Trump for having used it himself.”
He is not alone in that opinion. Myron S. Cohen, M.D., Director, Institute for Global Health & Infectious Diseases, University of North Carolina, says, “So, what are we to do with the results of this trial? The advocacy and widespread use of hydroxychloroquine seem to reflect a reasonable fear of SARS-Co-V-2 infection (Covid). However, it would appear that to some extent the media and social forces – rather than medical evidence – are driving clinical decisions and the global Covid-19 research agenda.”
We are in real trouble, America, when we allow the media and social forces to determine our medical decisions.