Human Challenge Trials and Hydroxychloroquine

Stage III vaccine testing is being done by administrating the vaccine or a placebo to around 30,000 people.  Then the number taking the vaccine or the placebo who develop COVID-19 are counted.  If the vaccine is good, statistically, fewer in the vaccine group will catch the disease compared to the placebo group.  If too few people in the trial catch the disease, the numbers will be too small to come to a statistically strong conclusion.  It may take a long time for enough cases to accumulate.  A lot of time will be wasted on extensive paperwork designed to ward off lawyers trying to profit from others' misery.

A human challenge trial is a much simpler and faster method of testing a vaccine.  Volunteers are infected deliberately with live virus after having been vaccinated.  A placebo group, vaccinated with fake vaccine, is also infected to make sure that the infection works and perhaps answer other questions such as whether many people are innately immune to the virus.  Within a week or two after the infection is made, it will become obvious if the vaccine is working.

Younger, healthy adults are not likely to suffer or die from the virus.  A much smaller number of people are needed in human challenge trials because exposure to the virus is assured, rather than waiting around until enough of the cohort catch it from the environment.

The participants in the trial would of course be volunteers, and probably they would be paid, but nothing exorbitant.  They would have one clear benefit, after the trail is over, they would be immune, either from catching the virus or because the vaccine works.

People risk their lives all the time in many ways — for example, enlisting in the armed forces or walking through a bad neighborhood in Chicago.  Why should there be a problem if they volunteer to take the small risk of participating in a human challenge trial?  About 1,000 people a day are dying from the virus while we wait around for stage III tests that take forever.  It is unlikely that even one person will die in a carefully conducted human challenge trial.  In New York City, the death rate from COVID-19 for people aged 18–45 is 21 per 100,000 cases.  If the volunteers are in their twenties and screened, the death rate might be 10 times less than this.  If 1,000 volunteers are infected, the expected number of deaths would be very close to zero.

A group of scholars have written a paper, "Evaluating use cases for human challenge trials in accelerating SARS-CoV-2 vaccine development."  The World Health Organization has also produced a document discussing regulatory issues with human challenge trials: "Human Challenge Trials for Vaccine Development: regulatory considerations."

Political considerations have overwhelmed science in dealing with COVID-19.  Trump's enemies include most of the media, academia, provincial Silicon Valley types, and of course the Democrats.  If you listen to NBC News, every day, it attempts to unjustifiably scare people with the virus, obviously to undermine Trump.  We are lucky that the virus is not smallpox or the 1918 flu.  It is incredible and comforting that children are, in Trump's words, "almost immune."  Most of the people dying are fragile old people.  That is not OK, but imagine how much worse the effect on the collective psyche would be if the virus preferentially killed young children.  We are programmed to protect young children, an instinct that is incredibly strong among parents.  The polio epidemics of the 1950s created overwhelming fear among parents.

There is a strong case that hydroxychloroquine combined with zinc and azithromycin, given early in the course of the disease, makes the disease much milder.  Hydroxychloroquine is a safe drug used for over 50 years.  The theory behind this is that the HCQ makes it easier for zinc to pass into cells.  Zinc inhibits the reproduction of the virus.  Slowing down the multiplication of the virus gives the patient's immune system more time to develop immunity before the virus overwhelms the patient, making him very sick or even killing him.  The HCQ treatment must be given early.  It is not useful for patients who are already deathly sick.

Quite a few doctors and scientists have advocated the use of HCQ based on clinical experiences and various studies.  Recently, Dr. Harvey A. Risch, a professor of epidemiology and a medical doctor at Yale, wrote a review paper.  He even published an op-ed in Newsweek.

Dr. Risch is eminently qualified to write about HCQ.  The reaction to his articles was virulent hatred and an apparent attempt to get him fired.  Supporting Trump by promoting a treatment suggested by Trump is an unforgivable sin among Trump-hating academics.  The science does not matter, only the politics.  The dean of the Yale School of Public Health felt it necessary to write that it is not his job to suppress the opinions of academics working at this school.  A letter signed by 21 Yale academics denounced Dr. Risch.

In his Newsweek editorial, Dr. Risch states: "I myself know of two doctors who have saved the lives of hundreds of patients with these medications but are now fighting state medical boards to save their licenses and reputations.  The cases against them are completely without scientific merit."

In my own state of Nevada, the governor has outlawed HCQ except for hospitalized patients.  By the time the patient is hospitalized, it is too late.  Maybe a new approach to finding a workable vaccine will make a difference.

Norman Rogers is the author of the book Dumb Energy: A Critique of Wind and Solar Power. He often writes on the political distortion of science.

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