Breaking News
May 27, 2018 - Breast cancer survivors do not receive recommended level of screening after surgery
May 27, 2018 - Recommendations Developed for Managing Postpartum Pain
May 27, 2018 - Rheumatoid Arthritis (RA) | Arthritis Basics | Arthritis Types | Arthritis
May 27, 2018 - ‘Life support’ for transplant livers better than freezing: study
May 27, 2018 - Tree nut consumption linked to improved type 2 diabetes health
May 27, 2018 - Income and education gap causes racial differences in health behaviors, study shows
May 27, 2018 - Even at ‘Safe’ Levels, Air Pollution Puts Seniors at Risk
May 27, 2018 - Obstructive sleep apnea linked to thinning of calvaria, skull base
May 27, 2018 - Epigem’s Managing Director sets the bar for life sciences industry at VentureFest
May 27, 2018 - CPAP may reduce resting heart rate in prediabetic patients
May 27, 2018 - Study reveals striking disparities in health care access and quality across most nations
May 27, 2018 - The Yogi masters were right—meditation and breathing exercises can sharpen your mind
May 27, 2018 - SLU researcher aims to find solutions for diabetes patients at risk of hypoglycemia
May 27, 2018 - Scientists uncover the cause of insulin resistance in obesity
May 27, 2018 - $2.3 million NIH grant to support new project on oxytocin neurons and social behavior
May 27, 2018 - Less Driving Tied to Lower Cardiovascular Disease Risk
May 27, 2018 - Genetics Home Reference: LMNA-related congenital muscular dystrophy
May 27, 2018 - Long-term psychological study confirms time is the best medicine against homesickness
May 27, 2018 - Study explores if CPAP treatment can improve sexual QOL for sleep apnea patients
May 27, 2018 - Study investigates role played by brain in prosocial behavior
May 27, 2018 - New Guidelines Mean 1 in 3 Adults May Need Blood Pressure Meds
May 27, 2018 - Cerebrospinal Fluid (CSF) Analysis: MedlinePlus Lab Test Information
May 27, 2018 - Kids in tough neighborhoods head to ER more often
May 27, 2018 - Exercise alters brain’s dopamine system to help treat addiction, study finds
May 27, 2018 - Sepsis patients treated and released from ED for outpatient follow-up experience good outcomes
May 27, 2018 - Initiative cuts overuse of tests, treatments for bronchiolitis
May 27, 2018 - Study links ‘sleep spindles’ to memory reactivation
May 27, 2018 - Scientists develop new method to speed up genome evolution of baker’s yeast
May 27, 2018 - Sunscreen pills are fake says FDA
May 27, 2018 - Study finds increasing wealth gap between households of seniors and families with children
May 27, 2018 - Link between tuberculosis and Parkinson’s disease discovered
May 27, 2018 - Doctors call on health authorities for permission to provide stroke patients with life-saving treatment
May 26, 2018 - Couples who eat seafood-rich diet tend to get pregnant faster
May 26, 2018 - NIH summit presents recommendations to accelerate treatment development for Alzheimer’s disease
May 26, 2018 - Medication-related harm found to be common among older adults, but preventable
May 26, 2018 - Lunaphore and Vitro announce partnership to develop ISH protocols for RNA, DNA targets
May 26, 2018 - Cryoablation Efficacious for Cancer Pain, Review Finds
May 26, 2018 - Link between IBD and Parkinson’s might allow doctors to slow down condition
May 26, 2018 - Study finds fewer than 5% of low-income, urban mothers use prenatal vitamins before pregnancy
May 26, 2018 - California hospitals urge moms to favor breast milk over formula
May 26, 2018 - Most concussion patients do not receive follow-up care after hospital discharge, says study
May 26, 2018 - Lifetime risks of developing Alzheimer’s dementia vary by age, gender
May 26, 2018 - Researchers find novel ways to improve participation in clinical research
May 26, 2018 - Researchers develop methods for measuring free-base nicotine levels in e-cigarettes
May 26, 2018 - AHA: Preterm Birth Could Warn of Mom’s Future Heart Risks
May 26, 2018 - Some calories more harmful than others
May 26, 2018 - Study links cell size with commitment to division
May 26, 2018 - Researchers develop new, rapid blood test to detect liver damage
May 26, 2018 - Researchers discover cascade of immune processes linked to poor outcomes in aggressive breast cancer
May 26, 2018 - New research will use mathematics to solve mysteries in cell biology
May 26, 2018 - Proposed National Resilience Strategy to reverse catastrophic increases in ‘deaths of despair’
May 26, 2018 - Mice remain slim on burger diet
May 26, 2018 - BMC receives $13.5 million award to test methods for delivering childhood anxiety treatment
May 26, 2018 - ‘Right to Try Act’ will not benefit terminally-ill patients
May 26, 2018 - Study reveals novel statistical algorithm to identify potential disease genes
May 26, 2018 - Two genes play vital roles in malignant brain cancer
May 26, 2018 - Study explores link between groundwater lithium and diagnoses of bipolar disorder, dementia
May 26, 2018 - Researchers reveal stimulatory effects of myelin on young neural cells
May 26, 2018 - Small part of cellular protein that helps form long-term memories also drives neurodegeneration
May 26, 2018 - Four-legged friends can have heart issues, too
May 26, 2018 - Scientists create small, self-contained spaces inside mammalian cells
May 26, 2018 - Better Social Support Network Protects Black Men Against HIV
May 26, 2018 - National Heart, Lung, and Blood Institute (NHLBI)
May 26, 2018 - Burnout, depression can affect ophthalmology residents, study finds
May 26, 2018 - Latinos and African Americans more likely to experience serious depression than Whites
May 26, 2018 - Data from past epidemic could help improve response to future Ebola outbreaks
May 26, 2018 - Researchers provide insight into how the memory molecule limits brain plasticity
May 26, 2018 - OSU biologist describes ‘restoration ecology’ approach toward patient health
May 26, 2018 - New approach to study brown fat could aid in finding treatments for obesity
May 26, 2018 - UCI Center on Stress & Health receives NIH funding to develop digital health interventions
May 26, 2018 - Could More Fish in the Diet Boost Sex Lives and Fertility?
May 26, 2018 - NTU Singapore and SERI invent new scope to diagnose glaucoma
May 26, 2018 - Cancer cells co-opt pain-sensing ‘neural channel’ to increase tolerance against oxidative stress
May 26, 2018 - Study uncovers why pesticide exposure increases Parkinson’s disease risk in some people
May 26, 2018 - Study finds link between lead exposure and fertility rates
May 26, 2018 - Causes and treatment of acute heart failure vary by region, registry shows
May 26, 2018 - Delivery of standardized diabetes care could help achieve equitable health outcomes for all patients
May 26, 2018 - FDA authorizes marketing of OsteoDetect software for detecting wrist fractures
May 26, 2018 - HSE experts suggest new way of looking at infantilism
May 26, 2018 - Children and adolescents growing up in extreme societal conditions more likely to resort to violence
University was tipped off to possible unauthorized trials of herpes vaccine

University was tipped off to possible unauthorized trials of herpes vaccine

image_pdfDownload PDFimage_print

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 U.S. hotel rooms in 2013 without any safety oversight and in violation of U.S. 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.

KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Gordon and Betty Moore Foundation

Kaiser Health NewsThis article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Tagged with:

About author

Related Articles