Breaking News
March 24, 2018 - New findings highlight need to reconsider cervical cancer screening guidelines
March 24, 2018 - Smartwatch App Might Help Detect A-Fib
March 24, 2018 - TAVR Reasonable for Low-Flow, Low-Gradient Aortic Stenosis
March 24, 2018 - Kids with severe brain injuries may develop ADHD: study
March 24, 2018 - Researchers explore ways to help older adults taper off and stop using sedatives
March 24, 2018 - Back pain being mismanaged globally
March 24, 2018 - Fingerprint test accurately and noninvasively detects heroin, cocaine users
March 24, 2018 - Leading experts to promote cardiovascular health at EuroPrevent 2018
March 24, 2018 - A Role for Rituximab in Lupus?
March 24, 2018 - New osteoarthritis genes discovered
March 24, 2018 - Maternal intake of DHA supplement linked to higher fat-free body mass in children
March 24, 2018 - Royal College of Pathologists‘ bulletin provides summary of Tissue Handling Workshop
March 24, 2018 - Maternal alcohol use early in pregnancy may be risk factor for infant abdominal malformation
March 24, 2018 - Savara Initiates Phase 2a Clinical Study of Molgradex for the Treatment of NTM Lung Infection
March 24, 2018 - Accelerated WBI Should be the Norm for Most Breast Cancers
March 24, 2018 - Experts seek to standardize treatments for childhood rheumatic diseases
March 24, 2018 - Foil-based measuring chip rapidly detects Legionella
March 24, 2018 - Bariatric surgery linked to positive outcomes in very obese adolescents with type 2 diabetes
March 24, 2018 - Are there risks from secondhand marijuana smoke? Early science says yes.
March 24, 2018 - New University of Bath project seeks to make injections safer
March 24, 2018 - Higher-dose RT does not improve survival but reduces recurrence risk for prostate cancer patients
March 24, 2018 - Researchers examine link between knee pain and depression in older adults
March 24, 2018 - FDA Alert: BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall
March 24, 2018 - Daytime Sleepiness Linked to Amyloid Accumulation Without Dementia
March 24, 2018 - Energy storehouses in the brain may be source of Alzheimer’s, targets of new therapy
March 24, 2018 - Praising people with autism shows promise for producing more exercise
March 24, 2018 - Using harmless red or infrared light to diagnose breast cancer
March 24, 2018 - Clash over abortion hobbles a health bill. Again. Here’s how.
March 23, 2018 - Virtual nature environment could be new way to recover from stress
March 23, 2018 - New study identifies key cellular mechanisms behind vascular aging in mice
March 23, 2018 - Nightmares Common Among U.S. Troops, But Seldom Reported
March 23, 2018 - Another Record Low for Tuberculosis in U.S.
March 23, 2018 - Changes in the eye connected to a decline in memory
March 23, 2018 - Radiologist creates dramatic teaching tool using power of VR
March 23, 2018 - Grilled meat could be raising the risk of hypertension finds study
March 23, 2018 - Mutations found in bassoon gene may help explain cause of rare brain disorder
March 23, 2018 - Childhood Brain Injuries May be Linked to ADHD Years Later
March 23, 2018 - Why treating addiction with medication should be carefully considered
March 23, 2018 - Researchers make key discovery about cellular pathway linked to myriad of diseases
March 23, 2018 - Researchers uncover cause of rare childhood neurodegenerative disease
March 23, 2018 - Measles infection in early childhood could contribute to later COPD
March 23, 2018 - Opioid painkiller is top prescription in 11 states
March 23, 2018 - Sienna Biopharmaceuticals Announces First Patient Dosed In Proof-of-Concept Trial of Topical By Design™ JAK Inhibitor SNA-125 for Atopic Dermatitis
March 23, 2018 - In Teen Girls, Neural Patterns May Drive Emotional Resilience
March 23, 2018 - Gene-based test for urine detects, monitors bladder cancer
March 23, 2018 - BD to introduce new digital solution for IV chemotherapy administration process at EAHP 2018
March 23, 2018 - New computational method helps to identify tumor cell mutations with greater accuracy
March 23, 2018 - Researchers identify potential obesity treatment in freezing hunger-signaling nerve
March 23, 2018 - Wales participates in the 100,000 Genomes Project
March 23, 2018 - 24-Hr Paging Cuts ED Visits for Kids with Endocrine Issues
March 23, 2018 - The brain learns completely differently than we’ve assumed since the 20th century
March 23, 2018 - Less nutritious diet mainly contributes to Type 2 diabetes among U.S.-based South Asians
March 23, 2018 - Stony Brook Medicine expert provides tips for healthy diet to decrease cancer risk
March 23, 2018 - New findings could have revolutionary impact on quality of life of older people
March 23, 2018 - Restoring enzyme may help reverse effects of vascular aging, study shows
March 23, 2018 - Protein profiling reveals new prostate cancer mechanisms
March 23, 2018 - Depression may be linked to increased risk of atrial fibrillation
March 23, 2018 - FDA Takes Aim at Flavored Tobacco
March 23, 2018 - SMART Strategy Lowers Asthma Exacerbation Risk
March 23, 2018 - Cold open water plunge provides instant pain relief
March 23, 2018 - Portable and wearable technology supports future of military medical devices
March 23, 2018 - Patients with vascular malformations have poor health-related quality of life
March 23, 2018 - Researchers develop unique technology to overcome global antibiotic resistance crisis
March 23, 2018 - New DOD grant to support testing of promising therapy for triple-negative breast cancer
March 23, 2018 - Novel vaccine technologies can help better prepare for future infectious disease threats
March 23, 2018 - OncoBreak: Colonoscopy TV; Coverage for Genomic Testing; Care for Caregivers
March 23, 2018 - For some surgeries, nerve blocks mean better outcomes, fewer opioids
March 23, 2018 - Maternal obesity and androgen excess induce sex-specific anxiety in offspring, study suggests
March 23, 2018 - The tale of Theranos and the mysterious fire alarm
March 23, 2018 - USC researchers create algorithm to optimize substance abuse intervention groups
March 23, 2018 - Impulsivity may be associated with greater weight loss during treatment in obese children
March 23, 2018 - CTI BioPharma Announces Publication of Pacritinib Phase 3 PERSIST-2 Clinical Trial in JAMA Oncology
March 23, 2018 - Senate Panel Addresses Native Americans’ Opioid Troubles
March 23, 2018 - Brain connections in schizophrenia
March 23, 2018 - Mental health assessment in health checks can help detect psychologically vulnerable people
March 23, 2018 - New test for urothelial cancers offers less invasive, more accurate detection
March 23, 2018 - Groundbreaking 100,000 Genomes Project achieves important milestone to transform NHS care
March 23, 2018 - Mice getting a new lease of life with anti-aging pills
March 23, 2018 - Obesity kills taste buds and dulls taste sensation finds study
March 23, 2018 - Medical students get less formal education in radiation oncology, study finds
Unregulated herpes experiments expose ‘black hole’ of accountability

Unregulated herpes experiments expose ‘black hole’ of accountability

image_pdfDownload PDFimage_print

Recent revelations that a U.S. researcher injected Americans with his experimental herpes vaccine without routine safety oversight raised an uproar among scientists and ethicists.

Not only did Southern Illinois University researcher William Halford vaccinate Americans offshore, he injected other participants in U.S. hotel rooms without Food and Drug Administration oversight or even a medical license. Since then, several participants have complained of side effects.

But don’t expect the disclosures after Halford’s death in June to trigger significant institutional changes or government response, research experts say.

“A company, university or agency generally does not take responsibility or take action on their own to help participants, even if they’re hurt in the trial,” said Carl Elliott, a professor in the Center for Bioethics at the University of Minnesota. “These types of cases are really a black hole in terms of accountability.”

The federal government once scrutinized or even froze research at universities after learning of such controversies. Now, experts said, the oversight agencies tend to avoid action even in the face of the most outrageous abuses.

Experts said the U.S. regulatory agencies are especially unprepared to deal with off-the-grid experiments like Halford’s. He recruited subjects through Facebook and in some cases didn’t require signed consent forms, or informed participants outright that the experiments flouted FDA oversight. These patients, many who struggle with chronic, painful herpes, proceeded anyway in their quest for a cure. After Halford’s offshore trial, Peter Thiel, a libertarian and adviser to President Donald Trump, pitched in millions of dollars for future research.

“This is experimentation in the 21st century: heavily embedded in social media and combined with a hostility to regulatory oversight,” said Arthur Caplan, director of the Division of Medical Ethics at New York University’s School of Medicine. “How is the government going to manage subjects, researchers and investors who don’t like regulations?”

SIU officials initially brushed off any questions about Halford’s methods, saying the university did not have responsibility for the offshore vaccinations of the 20 participants in the trial because he formed an independent company to conduct the trial in St. Kitts and Nevis.

SIU eventually launched an inquiry last August, more than a month after Kaiser Health News began asking questions about Halford’s methods. The investigation is ongoing, although a preliminary inquiry found Halford’s methods to be in “serious noncompliance” with university rules and U.S. regulations.

Experts say the university should contact all participants who were injected with the vaccine and offer help to those who are suffering from side effects. But they point out that the university has potential conflicts of interest when scrutinizing its role in Halford’s research. SIU shared in the vaccine patent with Halford’s company, and medical school administration officials touted his work when Rational Vaccines benefited from Thiel’s investment.

In ongoing reporting, KHN learned that Halford injected a group of people in two hotel rooms near his lab in Springfield, Ill., in 2013, three years before he began experiments offshore. According to emails and one of the participants, many email exchanges with participants were sent from Halford’s university email account. He used the university phone and referred to a graduate student as assisting in the experiment and using the lab.

One participant has told the FDA he believes he suffers from adverse effects from the vaccine.

Yet Rational Vaccines continues to assert the vaccine is safe and effective, even though Halford’s data from his human subject experiments have not been published in a reputable scientific journal. Since the controversy, the company has taken down its website.​

“This researcher basically violated all of the regulatory requirements and ethical principles guiding human subject research,” said Michael Carome, a doctor who directs the health research group for the nonprofit advocacy group Public Citizen. “Unfortunately, it seems everyone is trying to distance themselves here to avoid legal liability and a public relations embarrassment.”

The FDA, which has declined to comment on this case, could have jurisdiction, but it rarely takes aggressive action on behalf of human subjects, experts said. The FDA has had limited contact with two participants who have filed complaints alleging side effects from the vaccine.

“The FDA is just not set up to handle this,” NYU’s Caplan said.

The federal Office for Human Research Protections (OHRP), which monitors how human subjects are treated in trials, could choose to conduct an independent investigation. The agency would have jurisdiction because the university had pledged to follow human subject safety protocols for all research, even if it was funded privately.

Experts, however, remain skeptical that OHRP, an agency in the Department of Health and Human Services, would assume a prominent role in investigating the case based on the agency’s track record.

OHRP asked the university for an explanation after KHN first reported that Halford didn’t ask for routine safety oversight from an institutional review board.

OHRP once took on human subject violations that occurred during non-federally funded research and in cases where the FDA asserted jurisdiction, Carome said.

Now, the agency often chooses to stay out of non-federally funded trials and defers to the FDA, he said.

As a result, its public response to allegations of research abuse has plummeted, experts said.

The agency’s public assessments of research misconduct peaked in 2002, when it issued more than 100 “determination letters.”  That number has steadily declined. This year, it has issued one.

“A single letter in one year is extraordinary,” said Carome, who was the agency’s associate director for regulatory affairs from 2002 to 2010. “OHRP’s compliance oversight activities are moribund.”

“The end result is the federal watchdog for human subject protections is ineffective in its role in investigating complaints” and preventing violations, he said.

OHRP maintains it has been using other “more efficient” approaches. Rather than automatically opening a case and issuing a determination letter, the agency is “working more closely with complainants and institutions to address some of the concerns raised about human subject research,” said an HHS spokesperson, who declined to be named citing agency policy.

“But … in situations where something seriously wrong occurred, or subjects were harmed, OHRP does take action,” the spokesperson said.

OHRP hasn’t taken high-profile, aggressive action in years, said experts who pointed to the government’s suspension of federally funded research at Duke University and Johns Hopkins University more than a decade ago.

The federal government’s unresponsiveness in cases of privately funded research became more pronounced under the Obama administration, experts said.

In the waning days of the Obama administration, the federal government approved the first major overhaul of regulations surrounding human trials in 40 years. The resulting changes to federally funded trials included making consent forms more concise and clear.

Laura Stark, associate professor at Vanderbilt University’s Center for Medicine, Health and Society, said that in federally funded trials the measure “shifts the balance towards protecting research participants rather than protect[ing] institutions against liability.”

However, the rule does not address privately funded trials.

“If [the] organization and studies are privately funded, then they are not beholden to the law,” Stark said

As more universities began dropping their pledges to follow safety protocols for all research, it had already become difficult for the agency to assert jurisdiction. Meanwhile, OHRP’s compliance staff dwindled from six employees in 2008 to two in 2017. The lack of accountability for privately funded research is unlikely to change, experts say.

Stark called Halford’s research “a potential harbinger of the future of medical research given the increase in private funding and the unlikely prospect of updating the regulations again anytime soon.”

Compounding the problem, the United States is the only developed nation that does not guarantee medical care for those injured in clinical trials, experts said.

When participants claim injury, they often are told to file claims with their insurance companies, an impossible endeavor, said NYU’s Caplan.

“We still haven’t figured out how to compensate people who say they are injured in research,” he said. “In cases like these, in which subjects are claiming harm from a cuckoo experiment, the system is set up to punish the institution rather than give redress to the subject. Their only route then is to sue.”

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

Kaiser Health NewsThis article was reprinted from 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