Peter Thiel Is Bankrolling an Unapproved Offshore Herpes Vaccine Trial
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Excerpts:
>“Many of the virus vaccines we currently put in our kids — chickenpox, mumps, measles and rubella — were developed using live-attenuated viruses in the ’50s, ’60s and ’70s when the regulatory landscape was more relaxed,” he says, “and they have worked remarkably well.”
In the United States, a noticeable shift in research focus occurred around the time of the Belmont Report, published in 1978, which summarized ethical principles and guidelines for research involving human subjects. The FDA began erring on the side of caution, and expediency became a casualty of the government’s procedures.
>Dr. Halford feels the relative risk is fairly clear-cut.
“Relative risk is not a new concept,” says Halford. “Our technology is much better today, yet within first-world countries the mindset for developing vaccines has moved away from relative risk and toward the legal approach that asks ‘Is there any risk whatsoever?’” Dr. Halford smiles. “There’s risk when you walk out the door each day.”
He believes the more humane, common-sense approach weighs the risk of testing a vaccine candidate versus the risk of doing nothing.
“For example, in 2016 we know that about 60 million people will get newly infected by HSV-1 and 2—about a million people per week—and 2 to 3 percent are going to progress to a lifetime of chronic disease,” he says. “Many of those people will face a lifetime of never-ending isolation and pain caused by a chronic herpes infection. These can also have devastating effects on the psyche of patients.”
“So, do we run a small trial using something that’s been proven safe on animals for the past 20 years or do we sit on the sidelines?” he asks. “If we sit on the sidelines, people suffer.”
The sentence below seems to imply that this was all they could afford:
After he failed to secure federal funding and an [institutional review board], Halford moved ahead with the trial offshore.
But with Peter Thiel as an investor, I assume that money (within reason) wasn't the primary motivator.
In general, I'm dismayed by the breathless, sensationalistic tone of this article. The people involved don't seem stupid or malevolent, so I'd like to understand better their rationale for what they're doing.
From an academic standpoint this is ethically questionable. From a purely moral standpoint this is disgusting.
It is only morally disgusting if the study participants are purposefully _misled_ or _forced_ to submit to the study. This is absolutely NOT the case here.
The entire article is literally about why they took they approach they did, and why they couldn't do it in the US. The first line of the article is:
>Defying U.S. safety protections for human trials
Then:
>Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks.
>...But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.
And as to why not deal with the FDA:
>The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.
>“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”
This trial was part of a larger political push to weaken FDA research oversight, as the article clearly and fully explains.