Kaiser Health Network reports on the disconcerting activities of Rational Vaccines co-founder William Halford, Ph.D., in 2013, prior to forming the company. According to participants, Dr. Halford, a microbiologist, injected eight people with a live herpes virus formulated as a vaccine. He did this in a Holiday Inn (!), without physician supervision, without formal written consent, and without the approval of an ‘independent’ institutional review board (IRB). This is criminal behavior, though Dr. Halford died earlier this year so he can't be pursued. The university is again claiming they were not aware of his activities, though they share a patent on the prospective vaccine with Rational Vaccines, which was formed to market and research the product.
For those of you new to the tangled story, here is a quick summary. Rational Vaccines was founded by Dr. Halford and Augustin Fernandez and built upon Dr. Halford’s work at Southern Illinois University (SIU) to develop a vaccine for herpes. SIU is therefore an investor, as is recently Facebook investor and billionaire Peter Thiel. There was initial concern about Rational Vaccines because they chose to circumvent FDA protocols requiring study oversight by an IRB. Rational Vaccines instead opted to perform their safety studies off-shore in St. Kitts and with hand-selected subjects and without outside supervision. The data were never published but they claimed a huge success and raised money to do a trial in Mexico.
Institutional Review Boards are a requirement for federal research because of the infamous Tuskegee Study of Untreated Syphilis in the Negro Male, a study in which patients with known syphilis went untreated and uninformed about their condition.
Herpes patients represent a united, vocal online community but due to the nature of the disease it is hard to know if they could really offer true informed consent outside legitimate trials. The hope that Rational Vaccines has claimed to offer has been enthusiastically embraced by that community, because there are few other options on the horizon. The concern is that this hope in Rational Vaccines that gave them far too much power in their relationship with patients. A scientist offering a vaccination lifeline can too easily manipulate desperate patients.
In emails, Halford invites patients for dinner and drinks and states that it would be “suicide for me to admit on camera what we are doing here.” That one sentence crystallizes the purpose of an independent IRB, to make sure that patients have an informed understanding of what is being asked of them, the risks and the benefits – an IRB levels out that power relationship, it makes patients closer to equals with investigators, not supplicants. While he took no money from his test subjects - because Halford told them “it would get him in more trouble if he was ever caught” - he told people they could donate money to SIU for his research. SIU set up a business account for donations to Halford refuses to disclose how the money was used.
As you expect, with a potential legal issue on their hands neither SIU nor Rational Vaccines are commenting. For their part, Southern Illinois University, the holder of two patents used by Rational Vaccines, said they “had no legal responsibility to ensure safety measures were in place because the university has an arms-length relationship with Rational Vaccines.” When the story broke in August, they said they would “take this opportunity to review our internal processes to assure we are following best practices.”
That investigation is on-going but they deny any responsibility for Dr. Halford’s actions as Medical Director for Rational Vaccines. Two of the patients treated in 2013 and 2015 reported to FDA that they have side effects from their participation.
The lack of outside oversight for Rational Vaccines’ St. Kitts adventure was an ethical dilemma and cast their claims into doubt but the latest revelations make Dr. Halford’s actions criminal.
“We’re not allowed to do this to guinea pigs in this country let alone human subjects,” University of Washington herpes researcher Anna Wald told Marisa Taylor at Kaiser Health News.