Uni­ver­si­ty was tipped off to pos­si­ble unau­tho­rized tri­als of her­pes vac­cine

WASH­ING­TON — The uni­ver­si­ty that em­ployed a con­tro­ver­sial her­pes vac­cine re­searcher has told the fed­er­al gov­ern­ment it learned last sum­mer of the pos­si­bil­i­ty of his il­le­gal ex­per­i­men­ta­tion on hu­man sub­jects. But South­ern Illi­nois Uni­ver­si­ty did not pub­licly dis­close the tip or its find­ings about re­searcher William Hal­ford’s mis­con­duct for months, ac­cord­ing to a memo ob­tained by Kaiser Health News.

Last week, Kaiser Health News re­port­ed that Hal­ford con­duct­ed an ex­per­i­ment in which he vac­ci­nat­ed pa­tients in US ho­tel rooms in 2013 with­out any safe­ty over­sight and in vi­o­la­tion of US laws, ac­cord­ing to pa­tients and emails they pro­vid­ed to KHN to sup­port their al­le­ga­tions.

They told KHN those in­jec­tions oc­curred three years be­fore Hal­ford test­ed a her­pes vac­cine he cre­at­ed on hu­man sub­jects in a house in St. Kitts in 2016, again with­out rou­tine safe­ty over­sight. Hal­ford died of can­cer at the end of June.

While the uni­ver­si­ty has re­fused to re­spond to ques­tions about the 2013 in­jec­tions, an Oct. 16 memo to the fed­er­al gov­ern­ment ob­tained by KHN un­der open-records law shows that SIU learned of such pos­si­ble ac­tiv­i­ty at the end of Ju­ly. Ac­cord­ing to the memo, Ra­tio­nal Vac­cines, the com­pa­ny that Hal­ford co-found­ed, and an­oth­er SIU pro­fes­sor dis­closed that “hu­man sub­jects re­search might have oc­curred pri­or to the … clin­i­cal tri­al in St. Kitts.”

SIU re­port­ed in the memo to the De­part­ment of Health and Hu­man Ser­vices and the Food and Drug Ad­min­is­tra­tion that its in­sti­tu­tion­al re­view board, or IRB, found Hal­ford’s ac­tiv­i­ties to be a “se­ri­ous non­com­pli­ance” and said it rec­om­mend­ed the uni­ver­si­ty con­duct a “con­fi­den­tial” in­ves­ti­ga­tion to de­ter­mine if he com­mit­ted any oth­er mis­con­duct.

“Dr. Hal­ford will­ful­ly and in­ten­tion­al­ly en­gaged in hu­man sub­jects re­search with­out the ap­proval and over­sight of the IRB, in vi­o­la­tion of IRB poli­cies and in vi­o­la­tion of ap­plic­a­ble law and reg­u­la­tion,” SIU wrote in the memo.

Pre­vi­ous­ly, the uni­ver­si­ty had said it was not re­spon­si­ble for Hal­ford’s St. Kitts tri­al be­cause he con­duct­ed it in­de­pen­dent­ly through Ra­tio­nal Vac­cines.

Be­fore re­leas­ing the memo to KHN, the uni­ver­si­ty blacked out some of the de­tails. It’s un­clear whether the “se­ri­ous non­com­pli­ance” in­volved the 2013 in­jec­tions or some oth­er unau­tho­rized hu­man sub­ject re­search.

“This is a very se­ri­ous mat­ter for the uni­ver­si­ty,” said Robert Kl­itz­man, a doc­tor and di­rec­tor of the mas­ter’s pro­gram in bioethics at Co­lum­bia Uni­ver­si­ty in New York.

Kl­itz­man said the Of­fice for Hu­man Re­search Pro­tec­tions (OHRP), the HHS di­vi­sion that over­sees com­pli­ance with rules on hu­man tri­als, could halt all of the uni­ver­si­ty’s re­search as a re­sult of the find­ing. The Na­tion­al In­sti­tutes of Health could al­so freeze its fund­ing to SIU, he added, even though Hal­ford’s re­search was not fed­er­al­ly fund­ed.

OHRP and the FDA said they have poli­cies of not dis­cussing po­ten­tial or on­go­ing in­ves­ti­ga­tions. SIU did not re­spond to ques­tions.

Sev­er­al par­tic­i­pants from both tri­als told KHN they have asked SIU for help.They said Tues­day that they felt the uni­ver­si­ty should be in­form­ing them of its in­ves­ti­ga­tion in­to unau­tho­rized ex­per­i­ments and its find­ings.

“Hal­ford test­ed his vac­cine on hu­mans us­ing SIU’s fa­cil­i­ties and re­sources,” said one Col­orado woman who has tried to talk to the uni­ver­si­ty about her ex­pe­ri­ence in the St. Kitts tri­al. “They [SIU] de­ny know­ing any­thing about it. SIU hasn’t been very forth­com­ing.”

Kl­itz­man said the uni­ver­si­ty did have a re­spon­si­bil­i­ty to the par­tic­i­pants who were in­ject­ed with Hal­ford’s vac­cine. Two of them — in­clud­ing the Col­orado woman — have filed so-called ad­verse event com­plaints with the FDA, say­ing that Hal­ford’s vac­cine may have caused side ef­fects.

“Eth­i­cal­ly, the uni­ver­si­ty should con­tact the par­tic­i­pants to let them know that some par­tic­i­pants have de­vel­oped ad­verse events,” he said.

By Marisa Tay­lor. Orig­i­nal­ly post­ed at Kaiser Health News, a na­tion­al health pol­i­cy news ser­vice that is part of the non­par­ti­san Hen­ry J Kaiser Fam­i­ly Foun­da­tion.

Martin Shkreli [via Getty]

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I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Hal Barron. GSK

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Brian Kaspar. AveXis via Twitter

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

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We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

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