Now, this truly does not sound like the way to run a clinical trial. Dr. William Halford of the Rational Vaccines company invited 20 patients to St. Kitts for a trial of a putative herpes vaccine. The consent forms explicitly stated that this was done to evade the jurisdiction of the US Food and Drug Administration, and so he did. According to the Kaiser Health News, no one knows where the vaccine was manufactured or how. There was no review board oversight. And Halford gave booster shots (whose content and provenance is likewise uncertain) to patients after they arrived back in the US.
Normally, this sort of thing would be inviting prosecution. But Dr. Halford died last summer, of cancer that was diagnosed back in 2011. He seems to have decided to break loose of regulatory boundaries in his herpes vaccine work around that time, self-experimenting with several variants of his vaccine ideas. Some of the patients reported side effects from the treatment, but it’s not like we have any detailed records of such things, because Halford doesn’t appear to have kept any. He did try to publish a manuscript on the whole effort in Future Virology, but the review process did not go well, as you might imagine:
4. The author presents results of 2 experiments on humans, the first one a safety study that he conducted on himself. While self-experiments are generally permitted, these still require IRB review. Please provide assurance that this protocol was IRB reviewed and that the participant signed an informed consent. Unfortunately, data on 1 person does not prove safety of a product.
5. The subsequent Phase 1 study was conducted on a Caribbean island nation. Again, no information about IRB for this study is provided, and the trial does not seem to be listed on clinicaltrials.gov. The data on efficacy are based on self-report on participants who were questioned by the author and other staff before and after. As the author states, “self-reported cessation of genital herpes. . .should be viewed with skepticism. Agreed.
6. On Figure 8, there is an impressively small p value. However, how it was derived is not shown. Given that there were only 17 persons in this study, it is unlikely that an appropirate statistical test was performed to obtain this result.
Back in April, Halford and his associates press-released an investment in Rational Vaccines by Peter Thiel’s investment fund. That has generated a lot of headlines about “Peter Thiel funds illegal human trial!” and so on, but (as much as I’m skeptical about his pharma ideas), this coverage is unfair. The investment occurred after the offshore trial had already taken place, and in fact, Thiel’s people insisted that further work on the vaccine be done in a more, well, rational manner. According to the co-founder of the company, Agustin Fernandez:
But (Fernandez) said that this past spring — about six months after the first trial was concluded — when Halford and he met with Thiel’s representative to discuss Thiel investing in the vaccine’s development, the representative “yelled” at Halford for arguing that his decision to do the testing without FDA monitoring was motivated by a desire to help herpes sufferers without unnecessary delay.
Thiel’s rep “said, ‘We want to help people too, but we want to help a billion people, and we need to go through the FDA,’ ” Fernandez recalled.
The PayPal co-founder Thiel and a group of other investors committed $7 million to Rational Vaccines on Aug. 23, with the condition that future testing of the vaccine comply with FDA standards. . .
Good for them. I’d be leery of backing these folks, but Thiel won’t miss $7 million, and I’m sure he funds a number of long shots. A herpes vaccine would indeed be a good thing, but it’s not going to be easy to realize, especially by means like these. Overall, it looks like Thiel’s group is actually trying to yank these folks back to something like reality. I hope they realize what they’re getting into. It sounds like a good deal of the work done so far on this vaccine is not going to enhance the regulatory package very much. It may well be that when you actually do a reasonable, controlled trial of the stuff that it doesn’t do much good at all, but there’s no way of knowing that until you, y’know, do such a trial. Which is how things should have been done in the first place. All of Halford’s vaccine-cowboy stuff, instead of speeding things up, has only slowed the process down.