The Political Discreditation of Hydroxychloroquine

 

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.

Who Gets the Credit for the Vaccines?

The greatest news in the world today is the availability of not one, but two vaccines for the Covid-19 pandemic. Who gets the credit for this remarkable achievement?

All the scientific experts made fun of President Trump when he promised a new vaccine before the end of the year. Nine months ago, Dr. Anthony Fauci, the recognized expert on the Corona Virus Task Force, stated, “It will take at least a year and a half to have a vaccine we can use.” The health community dismissed even this statement as a fantasy.

Dr. Paul Offit, co-inventor of the rotavirus vaccine, confessed, “When Dr. Fauci said 12 to 18 months, I thought that was ridiculously optimistic.” A New York Times vaccine timeline went further, declaring: the grim truth behind this rosy forecast is that a vaccine probably won’t arrive any time soon.” All these naysayers were wrong.

Graham T. Allison, professor of government at Harvard, writes his opinion in The Wall Street Journal. He asks readers to answer a short quiz as to who should get the most credit for this rapid development of a vaccine to this new coronavirus. Here are the possible answers:

  • World organizations – The initiative forwarded by the United Nations, Group of 20, World Health Organization (WH0), and COVAX – an affiliate of WHO and the Coalition for Epidemic Preparedness Innovations (CEPI) that called for “a people’s vaccine available and affordable for everyone, everywhere,” in the words of U.N. Secretary-General Antonio Guterres.
  • Foundations and Donors – The Gates Foundation that established CEPI (the “alliance to finance and coordinate the development of new vaccines” at Davos, Switzerland in 2017.)
  • Leaders and Federal Agencies ­– The directors of the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and the National Institute of Allergy and Infectious Diseases (NIAID), the Health and Human Services (HHS) secretary and the assistant secretary for health.
  • Medical and Public Health Schools – The hundreds of medical and public health schools, their associated research labs and hospitals, and the tens of thousands of epidemiologists, virologists and other experts who have been talking endlessly about this plague.
  • President Trump’s Operation Warp Speed – Led by Moncef Slaoui, a controversial former head of vaccine development at the pharmaceutical company GlaxoSmith Kline, which has delivered more vaccines than any other company in the world – which gave billions of taxpayer dollars to biotech and pharmaceutical companies to speed vaccine development and manufacture doses in advance in case a vaccine proved effective.
  • Private, profit-seeking corporations – Pfizer, BioNTech, Moderna, AstraZeneca, Novovax, Johnson & Johnson, and others.

 

Which of these should you be thanking when you receive your vaccine soon?

Professor Allison says the answers are clear but may be uncomfortable for some readers.

Here is his answer, “Had the WHO and the Gates Foundation not existed, there would have been little difference in the availability of the vaccine. Had all of the departments and agencies in the U.S. government been on autopilot, this miraculous development would never have happened. This bureaucracy – including the CDC, FDA, and HHS – was unable to provide a coronavirus test for several months after South Korea, Singapore, and others were conducting extensive testing under their public-health responses.”

“Universities are rightly claiming to have built the foundations of knowledge without which other researchers couldn’t have sequenced the virus’s genome or developed mRNA delivery systems necessary to Pfizer and Moderna’s vaccines. But holding the pre-Covid base of knowledge constant, these scholarly researchers could have slept through the pandemic and it would have made little difference.”

That leaves us with only two choices to give the credit, according to Allison:

  • First – CapitalismThe capitalist system, which facilitated competition between private, profit-seeking biotech and pharmaceutical companies to produce a lifesaving product. Charities, universities, government agencies all want to do good, but the for-profit corporations, like Pfizer and Moderna, have been racing to the pot of gold at the end of the rainbow. Allison says, “There would be no Covid-19 vaccine today had there been no venture capitalists prepared to invest before a product or profit was visible, no corporate leadership willing to double down with the companies’ own money in the spring to fund a crash effort to produce a vaccine by year-end, and no researchers pursing a dream about mRNA as an unprecedented route for vaccines.

 

  • Second – Operation Warp SpeedPresident Trump deserves the credit for creating this initiative. Allison says, “Had Mr. Trump not created the initiative, appointed as its leader a man who knows the vaccine development world, and given him license to spend $10 billion outside normal contracting procedures, Covid-19 vaccines would still be only works in progress. Even after they were finally approved, the vaccines’ distribution could have been long delayed. Imagine a world in which Mr. Trump had not appointed as deputy head of the operation a general who knows logistics and had the authority to write contracts with FedEx and UPS to book space on their airplanes and in their network of distribution centers.”

 

As we celebrate this Christmas, we should all be thankful for a system of capitalism that made this achievement possible, and a president from the business world who knew how to get things done quickly. Those conclusions may make many Americans cringe who favor socialism and hate Trump, but they are strong arguments against their way of thinking.

Take the Vaccine!

Some people have irrational fears. Take the fear of flying, for instance. Some people would rather drive a thousand miles than get on an airplane because they have a fear of flying.

According to Dr. Arnold Barnett, of the Massachusetts Institute of Technology (MIT), the death risk per flight is one in seven million. It doesn’t matter whether you fly once every three years or every day of the year. In fact, based on this incredible safety record, if you did fly every day of your life, probability indicates that it would take you nineteen thousand years before you would succumb to a fatal accident!

Compare these statistics to driving. One hundred and thirty people are killed every day on average in auto accidents. That’s 47,000 killed in auto accidents every year. Dr. Barnett calculates you are nineteen times safer in a plane than in a car. Yet famous football coach John Madden insisted on avoiding planes, preferring his customized bus instead.

How about a train? The risk of dying on a transcontinental train ride is one in a million. That’s pretty good. But you are ten times safer in a plane than on a train.

Which brings me to vaccines. According to the latest polls, about 60% of Americans plan to get a Covid-19 vaccine. This paltry number is actually an improvement since September when only 51% said they would get the vaccine. The Pew Research Center reports only 29% will definitely get the vaccine, and 31% will probably get it. But 21% probably won’t be vaccinated and 18% definitely refuse to get it. These statistics are shown graphically below:

This is particularly difficult to understand at a time when the number of infected Americans is rising rapidly and 71% of Americans say the worst of the pandemic is “still to come.” This is depicted in the next graph:

According to the Pew Research survey, concerns about the vaccines fall into three categories:
Personal concern about getting a case of COVID-19 that would require hospitalization. Those most concerned about getting a serious case of the coronavirus indicate a higher likelihood of getting a vaccine. Those who see little personal need by this metric are closely divided over whether they would get vaccinated.
Trust in the vaccine development process. Expressing confidence that the research and development process will yield a safe and effective vaccine is tied to higher levels of intent to get vaccinated.
Personal practices when it comes to other vaccines. Those who say they get a flu shot yearly are much more likely than those who rarely or never do so to say they would get a vaccine for the coronavirus if one were available.

Some of these fears fall along racial lines. Even though black Americans have a higher rate of infection and death, they are less inclined to get vaccinated than other racial and ethnic groups: 42% would get vaccinated compared to 63% of Hispanic and 61% of white Americans. Asian Americans, however, say 83% plan to get the vaccine.

Fortunately, among older Americans, who are at the highest risk, 75% plan to get vaccinated, while only 55% of those under age 30 plan to do so. Many of those opposed, about half (46%) say they would consider being vaccinated once others receive the vaccine and more information on safety is available. But 21% remain firmly against the vaccine, no matter what happens.

These fears are irrational, just like the fear of flying. For the last ten months not only our country, but the whole world, has been paralyzed by the impact of this novel coronavirus scientists now call SARS CoV-2 or Covid-19. As of this writing, the global impact has been 77,432,103 cases and 1,704,065 deaths. The U.S. statistics are 18,042,120 cases and 319,457 deaths. With these sobering numbers, you would think people would be dancing in the streets at the news that vaccines are now available to rid us of this plague!

The vaccines are the perfect gift to the world this Christmas. Take the vaccine! I did yesterday. As a healthcare provider, I was offered the opportunity to get the vaccine in the early priority group. The shot was nearly painless and the muscle soreness in my arm was less than a flu shot. I’ve had no other side effects. I took the vaccine for three reasons; to protect my patients, to protect my wife (who is in a high-risk category) and to protect myself. I can’t help anyone if I’m ill, or even just an asymptomatic carrier. A 14-day quarantine if I become infected isn’t good for me, my family, or my patients.

If we’re ever going to return to some semblance of normal in this country, and the world, we need people to step up and get the vaccine. Be thankful we live in a world where modern technology, with the help of the Trump administration’s Operation Warp Speed, has made a safe, effective vaccine available in the record time of less than a year. The usual time is 4-5 years. There were many naysayers who said that was impossible, but it happened and we should all be grateful. But this rapid development of a new vaccine didn’t cut corners when it comes to safety. This historic scientific breakthrough should be cheered by all, and taken advantage of by all, unless their doctor believes they have a medical condition that makes it unsafe for them. The rest of you need to get vaccinated!