By David Tereshchuk
Institutional regulation in science – including medical science – is undergoing one of its periodic assaults by proponents of greater freedom in research. These proponents argue (most of them in entirely good faith, I should stress) that experimentation is often needlessly hampered by too much official control. Formal constraints, they say, can cramp the kind of spontaneous improvisation that leads to unexpected, sometime spectacular, breakthroughs.
As reported by Marisa Taylor of Kaiser Health News, it has been revealed that the federal Food and Drug Administration (who won’t officially confirm this) is pursuing criminal inquiries into an egregious case of medical experimentation – conducted illicitly in off-shore locations and in hotel rooms on American soil.
The procedures under investigation were self-styled drug ‘trials’ – apparently a last-ditch effort by a university professor of microbiology, William Halford who – knowing he was dying from an incurable cancer – evidently threw both professional caution and ethics to the winds. He embarked hell-bent on a test-program for a herpes vaccine he’d invented, but for which he hadn’t gained FDA approval – a program that involved injecting it into human subjects.
Halford died a year ago (June 2017) but not before he inflicted some still-resounding blows on the medical world’s ethical and regulatory framework. And he may have also inflicted adverse side-effects on at least some of his experimental subjects. Given the shady way he operated, though, it is difficult to find all his subjects and to accurately assess what medical damage he may have caused. Some of the few participants who have been successfully located say they have experienced distressing reactions.
The generally accepted medical science procedure is, in essence, to first conduct toxicity and safety tests on animals … and only then — and only if the experimental results pass muster with the FDA — will researchers move on to human trials. This is clearly far from what Halford did. He may be dead but associates who worked with him could now be at risk of prosecution. More broadly, the case raises fundamental questions of scientific and medical ethics.
A company he formed, Rational Vaccines – which is now under the investigators’ scrutiny – has declined to comment on the case, apart from saying it will cooperate with the federal inquiries, and is now adopting a more “classical” approach to product development. It has also shut down its website. One of the company’s biggest investors is Silicon Valley billionaire Peter Thiel, who supports libertarian activists who want to cut back governmental regulation of scientific research. (He also is known for funding the multi-million dollar 2016 lawsuit that effectively killed Gawker, the gossip and investigative journalism website.)
Halford’s university, Southern Illinois (SIU), shared in a patent on the prospective vaccine with the Rational Vaccines company, but initially denied any responsibility in the matter of overseas experimentation. Taylor’s reporting found not only the off-shore efforts (in the Caribbean islands of St Kitts and Nevis), but in addition the discomforting fact that herpes sufferers had also been injected in rooms at a Holiday Inn Express and a Crowne Plaza hotel just a few miles off-campus in Springfield, Illinois.
The university then admitted there had been “serious noncompliance with regulatory requirements and institutional policies and procedures.” Again, as with the company, any criminal responsibility among Halford’s university colleagues will be for the FDA’s officials to assess.
Whatever the legal outcome may turn out to be, the story has alarmed both ethicists and medical practitioners. “Furtive, unregulated live virus vaccine injections in a Holiday Inn? This is really, really out there,” was the reaction of Dr Jonathan Zenilman, who specializes in sexually transmitted diseases at Johns Hopkins University. He was also disturbed to learn that no effort was made to obtain signed Informed Consent forms from the ‘patients’, which is normal and required practice.
Nita A. Farahany, a professor of law and philosophy at Duke Law School said: “Conducting clandestine research experiments and intentionally circumventing research approval and oversight practices is unethical, unwise, and does not enable adequate validation of science.”
It often seems like we’ve have come a long way since the notorious Tuskegee Syphilis Experiment that extended over a now-incredible four decades during the mid-twentieth century. That prolonged and appalling abuse of African-American patients’ rights finally resulted in the National Research Act of 1974 being passed, the beginnings of our present legal apparatus known more fully as ‘Protection of Human Subjects of Biomedical and Behavioral Research’. Now, 44 years later, the Halford case must give us pause.
Any criminal proceedings that result from the current probe are unlikely to be cut-and-dried. Rational Vaccines, for instance, may be able to claim Halford was acting independently of them – as indeed might the University (even though many of Halford’s interactions with his subjects were conducted through his academic email account – and he clearly used other school resources as well).
In the realm of ethics – as well as the law – it can and will be argued that the matter is not simple.
In our fast-changing society, we’re told, our ethical landscape is being transformed. Formal structures and institutions are losing their authority and power. Just for one indicator, perhaps – we could ask how exactly was Halford able to recruit his test subjects? Not through a hospital, nor a network of accredited doctors … but online, primarily through Facebook – specifically, via a members-only account.
The argument will doubtless continue, and meanwhile ethicists will remain deeply troubled by the Halford case, like Arthur Caplan, director of ethics at New York University’s Medical School. He commented: “This is experimentation in the 21st century – heavily embedded in social media and combined with a hostility to regulatory oversight“.
David Tereshchuk has reported on ethics and belief for PBS’s Religion and Ethics NewsWeekly and The PBS NewsHour Weekend. He writes the international multimedia commentary on TheMediaBeat.US which also appears on Huffington Post.