28 August 2017

What an Evil Little Sh%$!

I am referring, of course, to a Silicon Valley type, who have honed the little sh%$ to a fine edge.

Specifically, I am referring to to Peter Thiel, who is literally a vampire who wants to use the blood of the young to extend his lifespan.

The latest bit of evil is his funding "patently unethical" human experimentation, specifically testing a live virus vaccine without any regulatory oversight on the island of St. Kitts:
Heavyweight tech investor and FDA-critic Peter Thiel is among conservative funders and American researchers backing an offshore herpes vaccine trial that blatantly flouts US safety regulations, according to a Monday report by Kaiser Health News.

The vaccine—a live but weakened herpes virus—was first tested in a 17-person trial on the Caribbean Island of St. Kitts without federal oversight or the standard human safety requirement of an institutional review board (IRB) approval. Biomedical researchers and experts have sharply rebuked the lack of safety oversight and slammed the poor quality of the data collected, which has been rejected from scientific publication. However, investors and those running the trial say it is a direct challenge to what they see as innovation-stifling regulations by the Food and Drug Administration.

………

Madden, Thiel, and other investors have invested $7 million into the vaccine’s development, according to Rational Vaccines, the company orchestrating the trial. Though Thiel could not be reached for comment, he has been openly critical of the FDA’s review process. At one point, he claimed that the agency’s processes were so overbearing that “you would not be able to invent the polio vaccine today.”

The lead researcher behind the vaccine, William Halford, formerly of Southern Illinois University, made similar claims. In a positive university press release, Halford was quoted as saying: “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… and they have worked remarkably well.”

He went on to suggest that the FDA has made “barriers too high” and that countries with less regulation were better for vaccine and drug development. “There are governments around the world that the WHO [World Health Organization] has approved for vaccine development,” he said. “We’re talking to those types of governments.”

………

Other researchers and experts strongly disagreed with Halford's stance and handling of a live, attenuated virus vaccine, which can cause infections in the uninfected or severe side-effects in those already infected. “What they’re doing is patently unethical,” Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division, told KHN. “There’s a reason why researchers rely on these protections. People can die.”

Robert Califf, who served as FDA commissioner during the Obama era, agreed. “There’s a tradition of having oversight of human experimentation, and it exists for good reasons,” he said. “It may be legal to be doing it without oversight, but it’s wrong.”

………

A spokesperson for Southern Illinois University, one of the vaccine’s patent holders, said that the university has no legal responsibility to ensure proper safety protocols for the trial. However, after questions about the lack of IRB [Institutional Review Board] approval (a federal requirement), the spokesperson said that the university would “take this opportunity to review our internal processes to ensure we are following best practices.”
(emphasis mine)

In addition to the quality of the study being so poor that it was refused for publication, there are also reports of skin lesions from a study size of only 17 patients.

I would have thought that this would have merited a visit from the FDA, and possibly an FBI investigation for conspiracy, but it appears that the rules do not apply to rich people, which is an even bigger problem.

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