Opinion column: Don’t move too fast on vaccine testing


The idea of moving at “warp speed” probably resonates with Star Wars fans. A galactic empire is impossible if it takes 100 years for a signal, much less a warship, to move from one system to another at the universal speed limit, 186,000 miles per second, the speed of light

Serious science fiction lovers know that the warp drive does not traverse space at faster-than-light speeds. It warps space, or leaps through another dimension—it takes a massive shortcut.

So, what’s the shortcut for vaccine development?

Safety testing? It is impossible to test for long-term consequences without observing recipients for a long time—not a few days or weeks. If experts are worrying about long-term effects of having the disease, why not about the vaccine? If one consequence might be a massive immune over-reaction to a later exposure to the coronavirus, we’d need to await another outbreak.

Efficacy testing? One way to test for efficacy is to find an animal model. See whether unvaccinated animals get the disease when deliberately exposed, while vaccinated ones are protected. If this works, you still need to test humans: vaccinate one group, give one group a placebo, and see whether a larger proportion of the unvaccinated get sick. Normally, you would wait to see how the subjects fare in the real world, where they might get naturally exposed during their usual activities. This takes time. You could speed this up by giving them all a dose of the virus, which might kill some of them. That would be unethical—wouldn’t it?

One could test for antibodies, but do they work? Some are asserting that the antibodies that survivors have might not protect them. Why would the vaccine antibodies be better? For one thing, the virus might mutate. Maybe it already has.

Then what about production and distribution?

How about sinking hundreds of millions of dollars into producing various vaccine candidates, just in case they work? Then you could just waste it all if they don’t.

For distribution, why not mobilize the armed forces to quickly vaccinate 300 million people? Our furloughed medical workers might not be up to the job. Might arms be needed if people resist? Incidentally, if everybody gets the vaccine, there’s no control group. Doesn’t the scientific method call for one?

Why the hurry?

One reason for hurry is that the epidemic might be gone, and the vaccinators couldn’t take the credit. We have no vaccine for the “Spanish” flu of 1918, the “Asian” flu of 1958, or the “Hong Kong” flu of 1968, all of which killed far more than the current pandemic, and all of which went away. A speedy vaccine, which was developed for the predicted 1976 mass extinction/swine flu pandemic that never was, resulted in deaths and Guillain-Barré syndrome.

Humanity survived many waves of far more deadly pestilence before vaccines. The smallpox vaccine may have finally eliminated smallpox, but smallpox lesions were identified in Egyptian mummies from the 3rd century B.C., but not in earlier or later mummies. It re-emerged in the 6th and 7th centuries A.D., disappeared until the 11th century, then after being almost absent for about 300 years re-emerged in the 15th century.

In 2020, much has happened with amazing speed: the flattening of the economy, the suspension of civil liberties, the destruction of medical practices. Censorship of any information that the World Health Organization (WHO) doesn’t like, for example about potential game-changers like vitamin D and high-dose vitamin C. The declaration of a new drug remdesivir as the “standard of care” after an underwhelming study was prematurely stopped. The sequencing of the coronavirus genome. Revolutionary experimental DNA and RNA vaccine technologies.

Those who were seemingly prescient about the potential of coronavirus—Bill Gates holds a 2015 patent on a coronavirus created with recombinant gene technology, and the Gates Foundation held a crisis simulation modeled on a coronavirus in October 2019 — did nothing to shore up preparedness measures such as equipment stockpiles.

Fear spreads at the speed of light. After 70 years and 100 million users of antimalarial drugs with remarkable safety, FDA is inspiring fear of heart problems from using hydroxychloroquine or azithromycin for COVID-10 … but don’t worry if it’s for lupus, rheumatoid arthritis, or malaria.

We need an immediate return to letting doctors practice and letting people work. They need accurate information, so they can make prudent decisions about protecting themselves and their loved ones. We need an immediate end to the dictatorial influence of a few long-entrenched “experts” or media giants, and investigations of conflicts of interest with all deliberate speed.

What we do NOT need is panic-inspired warping of safety testing.

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Jane M. Orient, M.D. has been in solo private practice since 1981 and has served as Executive Director of the Association of American Physicians and Surgeons (AAPS) since 1989. She is currently president of Doctors for Disaster Preparedness and managing editor of the Journal of American Physicians and Surgeons. Reach her at doctorjaneorient@gmail.com

Jane M. Orient, M.D. has been in solo private practice since 1981 and has served as Executive Director of the Association of American Physicians and Surgeons (AAPS) since 1989. She is currently president of Doctors for Disaster Preparedness and managing editor of the Journal of American Physicians and Surgeons. Reach her at doctorjaneorient@gmail.com