TheStreet Profiles Dr. Henry Miller on FDA Woes

TheStreet Profiles Dr. Henry Miller on FDA Woes

Ex-FDA Doc: Agency Suffering ‘Unprecedented’ Loss of Trust
By Adam Smith

Early this year, when the novel coronavirus that was devastating China began to spread to other countries, hope came in the promise of a quick vaccine, one that doctors and scientists bet could be created in just a year and a half if all went well.

But some were cautious, such as Dr. Henry I. Miller, who for many years worked at the Food and Drug Administration and who was a founding director of the agency’s Office of Biotechnology. As media reports told of how quickly a coronavirus shot could arrive, Miller was reminding those who would listen of what happened with the speedy creation of the swine flu vaccine in the 1970s that led to hundreds of cases Guillain-Barre, an otherwise rare, but potentially deadly, syndrome.

While Miller sees a vaccine as critical to escaping the grip of Covid-19, he also warns of when vaccine creation goes wrong. In addition to the swine flu shot fiasco, a failed vaccine for respiratory syncytial virus that was tested in 1966 was blamed for the deaths of two children and ended up making kids sicker after infection than they would have been if they never had gotten the shot. Then in 2009, hundreds of people again came down with Guillain-Barre after taking an H1N1 shot.

Now, caution is turning to warning after, in late August, the bombshell report landed in The Financial Times: The Trump administration was looking to score a shot in less than half the predicted timeline by fast-tracking a vaccine in time for the November election. 

“The perception of vaccines being rushed is fanning the passions – and actions – of the ‘anti-vax’ movement, and encouraging skepticism about vaccines. If that were to lead to poor public uptake of Covid-19 vaccines once they’re available, that could extend the pandemic indefinitely,” Miller told TheStreet.

The FDA reportedly tried to regain control over the approval process for a Covid shot last week, but the damage to public trust may prove hard to reverse, says Miller, an outspoken physician and molecular biologist. In an interview with TheStreet over the past few days, Miller expressed concern over politicians’ arm twisting at the FDA and CDC, and called the injury caused to the agencies’ reputations “unprecedented.”

Following is a lightly edited interview with Miller.

TheStreet: Back in late February, I asked what you thought about the 18-month time-frame that was widely discussed for developing a vaccine. You said it was possible, but noted the swine flu vaccine’s problems in the 1970s. Do you think that example is even more relevant now that we hear proposals for fast-tracking the approval process, which was not discussed back then?

Miller: Yes, and there are other examples of vaccines gone awry, including the respiratory syncytial virus vaccine and an H1N1 flu vaccine. The FDA did just announce that it will issue more stringent guidance for emergency-use authorizations for a Covid-19 vaccine. They continue to try to build a rhetorical and legal barrier against political pressure.

TheStreet: On that note, in a recent column, you wrote about your concern of the potentially “damaging action” of carrying out a pre-election emergency-use authorization for a Covid-19 vaccine. Even if a vaccine comes after Trump’s promises of early November and the FDA holds steady, has this mix of politics and  vaccine creation already damaged public trust in a vaccine, whether or not the vaccine that becomes available completes all clinical trials?

Miller: I think so, especially President Trump’s coy references to a vaccine becoming available “before a very special date.” The perception of vaccines being rushed is fanning the passions – and actions – of the “anti-vax” movement, and encouraging skepticism about vaccines. If that were to lead to poor public uptake of Covid-19 vaccines once they’re available, that could extend the pandemic indefinitely. If we are to blunt the spread of Covid-19, we desperately need vaccines, in addition to people continuing to wear masks, maintain social distance, practice good hygiene, and avoid poorly ventilated, crowded indoor spaces.

TheStreet: Another side-effect, it seems, of the Covid-19 pandemic has been increasing mistrust in the FDA and CDC. Have you seen any other time in history when public trust in these agencies has been so in question?

Miller: This is unprecedented. The CDC has been a mess from the start – first sending out flawed tests and then, after a month’s delay, sending out a second test that required a component that was in short supply. It then screwed up on whether testing for the virus should be done on asymptomatic contacts of infected people. Now this: The CDC updated its guidance (last) Friday for coronavirus transmission to say that the virus can be transmitted via aerosols as well as larger droplets, but then walked it back again by Monday.

The FDA has been in disarray at times, as well. It was bullied to issue an emergency use authorization for hydroxychloroquine and convalescent plasma. The FDA in addition allowed coronavirus PCR tests and antibody tests to be marketed without the vetting of their validation data. This resulted in allowing hundreds of flawed tests to be marketed.

TheStreet: Do you feel that people should look to additional guidance from prominent scientists, doctors and researchers currently outside of those agencies when a vaccine does come out, assuming one does, on whether it would be reasonable to take it?

Miller: Yes, but I think what might make getting reliable advice somewhat problematic is that there might be a wide spectrum of opinion about the vaccine. …

TheStreet: So, having all these voices weigh in might just add to the confusion already felt by many in the U.S….

Miller: Yes, but I’d probably go with National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci’s viewpoint – along with reading for myself the FDA’s “Summary Basis of Approval” — their interpretation of the data and rationale for the approval.

TheStreet: Finally, back in February could you ever have imagined that the U.S. would by now be surpassing India and Brazil and the rest of the world in Covid-19 cases and deaths? (By Sunday, the U.S. had surpassed 7 million total diagnoses of the disease.)

Miller: No, certainly not. But while I agree with your point, I doubt the accuracy of case and death statistics from countries like India and Brazil, and for China and Russia and others. I think it’s highly unlikely that those countries are doing sufficient testing that would provide an accurate count of cases. Russia, China and Brazil also have authoritarian leaders who would not hesitate to distort data, including numbers of coronavirus-caused cases and deaths, for political reasons.

This story has been updated with edits to the first few paragraphs.

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