FDA launch­es crim­i­nal probe in­to unau­tho­rized her­pes vac­cine R&D backed by Pe­ter Thiel

The Food and Drug Ad­min­is­tra­tion has launched a crim­i­nal in­ves­ti­ga­tion in­to re­search by a South­ern Illi­nois Uni­ver­si­ty pro­fes­sor who in­ject­ed peo­ple with his unau­tho­rized her­pes vac­cine, Kaiser Health News has learned.

SIU pro­fes­sor William Hal­ford, who died in June, in­ject­ed par­tic­i­pants with his ex­per­i­men­tal her­pes vac­cine in St. Kitts and Nevis in 2016 and in Illi­nois ho­tel rooms in 2013 with­out safe­ty over­sight that is rou­tine­ly per­formed by the FDA or an in­sti­tu­tion­al re­view board.

Ac­cord­ing to four peo­ple with knowl­edge about the in­quiry, the FDA’s Of­fice of Crim­i­nal In­ves­ti­ga­tions is look­ing in­to whether any­one from SIU or Hal­ford’s for­mer com­pa­ny, Ra­tio­nal Vac­cines, vi­o­lat­ed FDA reg­u­la­tions by help­ing Hal­ford con­duct unau­tho­rized re­search. The probe is al­so look­ing at any­one else out­side the com­pa­ny or uni­ver­si­ty who might have been com­plic­it, ac­cord­ing to the sources who asked not to be iden­ti­fied be­cause of the sen­si­tiv­i­ty of the mat­ter.

The FDA rarely pros­e­cutes re­search vi­o­la­tions, usu­al­ly choos­ing to ad­min­is­tra­tive­ly sanc­tion or ban re­searchers or com­pa­nies from fu­ture clin­i­cal tri­als, le­gal ex­perts said. Even so, the agency is em­pow­ered to pur­sue as a crime the unau­tho­rized de­vel­op­ment of vac­cines and drugs — and some­times goes af­ter such cas­es to send a mes­sage.

In this case, hu­man-sub­ject vi­o­la­tions would be deemed es­pe­cial­ly se­ri­ous giv­en Hal­ford was not a med­ical doc­tor and had in­ject­ed peo­ple with his ex­per­i­men­tal vac­cine with­out any rou­tine over­sight, ex­perts said.

“Since the re­search ap­pears to be an ef­fort to to­tal­ly evade FDA over­sight and is egre­gious, it makes sense the FDA would in­ves­ti­gate it as a crim­i­nal mat­ter,” said Pa­tri­cia Zettler, a for­mer FDA lawyer who was told of the crim­i­nal in­ves­ti­ga­tion by KHN. “There is a de­ter­rent ef­fect for oth­ers who might con­sid­er this a very brazen way to get out of hu­man sub­ject and FDA re­quire­ments.”

The FDA de­clined to com­ment. Ra­tio­nal Vac­cines did not re­spond to re­quests for com­ment. An SIU spokes­woman said, with­out elab­o­ra­tion, “The gov­ern­ment is in­ves­ti­gat­ing and we are co­op­er­at­ing.”

Any re­sult­ing crim­i­nal pros­e­cu­tion from the in­ves­ti­ga­tion could have po­lit­i­cal ram­i­fi­ca­tions.

Ra­tio­nal Vac­cines was co-found­ed with Hol­ly­wood film­mak­er Agustín Fer­nán­dez III and the com­pa­ny re­ceived mil­lions of dol­lars in pri­vate in­vest­ment from in­vestors af­ter the Caribbean tri­al, in­clud­ing from bil­lion­aire Pe­ter Thiel.

Thiel, who for months has re­fused to re­spond to ques­tions from KHN, con­tributed to Pres­i­dent Don­ald Trump’s cam­paign and is a high-pro­file crit­ic of the FDA. Thiel is part of a larg­er lib­er­tar­i­an move­ment to roll back FDA reg­u­la­tions to speed up med­ical in­no­va­tion.

The sources fa­mil­iar with the in­quiry said the FDA’s Of­fice of Crim­i­nal In­ves­ti­ga­tions, which has dozens of of­fices across the coun­try, be­gan to ag­gres­sive­ly pur­sue the case weeks ago.

The in­ves­ti­ga­tors have in­ter­viewed wit­ness­es across the coun­try, ask­ing them to iden­ti­fy Hal­ford’s as­so­ciates, and have de­scribed his ac­tions as pos­si­ble vi­o­la­tions of hu­man-sub­ject guide­lines and of FDA reg­u­la­tions, the sources told KHN.

The in­ves­ti­ga­tors al­so have ex­pressed in­ter­est in whether Hal­ford’s for­mer as­so­ciates at the uni­ver­si­ty or oth­er re­searchers and med­ical pro­fes­sion­als out­side the uni­ver­si­ty might have helped or known about his con­duct, the sources said. They al­so have raised ques­tions about the com­pa­ny’s knowl­edge of the vi­o­la­tions.

Ra­tio­nal Vac­cines helped over­see the Caribbean tri­al, but the 2013 ho­tel in­jec­tions took place be­fore the com­pa­ny was formed.

Un­der a Supreme Court rul­ing, a cor­po­rate of­fi­cial may be pros­e­cut­ed for a crim­i­nal mis­de­meanor of­fense un­der the Fed­er­al Food, Drug and Cos­met­ic Act even with­out proof that the of­fi­cial act­ed with in­tent or ac­tu­al knowl­edge of the of­fense.

Ini­tial­ly, uni­ver­si­ty of­fi­cials and Ra­tio­nal Vac­cines pub­licly de­fend­ed Hal­ford’s re­search. Ra­tio­nal Vac­cines has said it con­sid­ered the 2016 tri­al a suc­cess — though it is un­clear what da­ta it used to sup­port that claim.

Af­ter KHN’s in­ves­ti­ga­tion re­vealed that Hal­ford in­ject­ed peo­ple in the Unit­ed States, not just in the Caribbean, Ra­tio­nal Vac­cines took down its web­site, al­though it had vowed to con­tin­ue re­search.

SIU, a state uni­ver­si­ty with a med­ical school in Spring­field, IL, ini­tial­ly said it bore no re­spon­si­bil­i­ty for the ex­per­i­ments be­cause Hal­ford con­duct­ed the re­search in­de­pen­dent­ly and over­seas.

Af­ter Kaiser Health News raised ques­tions about Hal­ford’s prac­tices, the De­part­ment of Health and Hu­man Ser­vices asked the uni­ver­si­ty to de­ter­mine whether his ac­tiv­i­ties vi­o­lat­ed the in­sti­tu­tion’s pledge to HHS to fol­low hu­man-sub­ject safe­ty pro­to­cols for all re­search. SIU’s med­ical school re­ceives about $9 mil­lion a year in fed­er­al re­search dol­lars.

SIU has since ac­knowl­edged that Hal­ford’s con­duct vi­o­lat­ed uni­ver­si­ty rules and US laws. Uni­ver­si­ty of­fi­cials have de­nied know­ing about his mis­con­duct, an as­ser­tion that FDA in­ves­ti­ga­tors are still prob­ing, the sources said.

Hal­ford’s ac­tions al­ready raised un­usu­al le­gal ques­tions be­cause the FDA would not or­di­nar­i­ly have ju­ris­dic­tion over clin­i­cal tri­als when they oc­cur over­seas and the re­searchers have not sought FDA ap­proval.

It’s al­so un­clear where Hal­ford man­u­fac­tured the vac­cine.

If it was man­u­fac­tured in the Unit­ed States, the FDA like­ly has ju­ris­dic­tion, said Zettler, a law pro­fes­sor at Geor­gia State Uni­ver­si­ty.

The OCI of­ten goes af­ter such cas­es of con­t­a­m­i­nat­ed food, coun­ter­feit or off-la­bel phar­ma­ceu­ti­cals. The of­fice was cre­at­ed in the wake of a 1988 scan­dal in which phar­ma­ceu­ti­cal ex­ec­u­tives bribed FDA of­fi­cials in ex­change for speed­ing up gener­ic drug ap­provals.

While rare, the OCI oc­ca­sion­al­ly pur­sues re­search abus­es as a crime. A Glax­o­SmithK­line re­searcher, for in­stance, plead­ed guilty in 2010 to charges re­lat­ed to her fab­ri­ca­tion of da­ta in a study of chil­dren tak­ing the an­ti­de­pres­sant Pax­il. Glax­o­SmithK­line lat­er agreed to plead guilty and to pay $3 bil­lion to re­solve its crim­i­nal and civ­il li­a­bil­i­ty in the case.

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.

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