JUST NOW AND AGAIN, specialized journalism scores a bull’s-eye hit that the mainstream media can overlook – but certainly shouldn’t.

I want to commend some dogged reporting by Marisa Taylor of Kaiser Health News, who for the past year and more has been on the trail of an egregious case of illicit medical experimentation.     

Taylor (pictured below right) has highlighted practices that we may have thought were consigned to history’s dustbin, like the notorious Tuskegee Syphilis Experiments, or those carried out in Guatemala by American researchers in the 1940’s, which some argue were even worse than Tuskegee. Today’s diligent reporting has been pursued against an ominous background. Institutional regulations in medical science are undergoing one of their periodic assaults launched by proponents of greater freedom in research. These proponents argue (many of them in entirely good faith, I should stress – and some with less benign intent) 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, medical breakthroughs.

READ another version of this article at PBS‘s new site: CHAPTER AND VERSE

But Taylor’s recent news-breaking revelations  – a remarkable combination of science and investigative journalism – have brought the sometimes high-flown debate back down to the nitty-gritty level of criminality. She revealed that the federal Food and Drug Administration (though its staffers won’t officially confirm this, because they never do) is pursuing criminal inquiries into the distressing case of Professor William Halford (below left).

Halford was a microbiologist who embarked on some self-styled drug ‘trials’ – which were apparently a last-ditch effort for him, since he knew he was dying from an incurable cancer. He devised 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. He did this illicitly in off-shore locations and in hotel rooms on American soil.

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 adverse reactions.

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. (I also review the case at my new online venue “Chapter and Verse” – the ethics and belief platform freshly erected by WNET, the New York PBS station.)

A company Halford formed, Rational Vaccines – and which is now of course 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” (sic) 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 off Gawker, the gossip and investigative journalism site.)

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 uncovered 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, Ill.

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 that evidently 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 University 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.”

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 that 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“.

THIS STORY ALSO APPEARS AT the new PBS/WNET website “Chapter & Verse” – where I will be contributing occasional Essays on Ethics.