Breaking News
June 22, 2018 - AAA doses first patients in two clinical studies with PSMA-R2 for prostate cancer
June 22, 2018 - Pelvic pain a major issue for women nearing mid-life, research reveals
June 22, 2018 - Researchers develop reliable DNA barcodes for biomedical research
June 22, 2018 - New risk-prediction model may help identify diabetic patients at high risk of pancreatic cancer
June 22, 2018 - Study reveals how mTORC1-driven changes in crowding could influence major diseases
June 22, 2018 - Researchers uncover new therapeutic opportunity in the treatment of malignant melanoma
June 22, 2018 - UC Riverside researcher receives grants to advance cancer, ALS research
June 22, 2018 - Radiation therapy alone may be enough to treat older, sicker patients with anal cancers
June 22, 2018 - Technical report describes how to make accurate particle size measurements on carbon black samples
June 22, 2018 - Nocdurna (desmopressin acetate) Approved by FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria
June 22, 2018 - Neuroscientists locate neurons in the brain that respond when a visual target is found
June 22, 2018 - First human Keystone virus infection reported
June 22, 2018 - New study reveals how ‘good’ bacteria help in regulating our metabolism
June 22, 2018 - Osteopathic manual therapy affecting the diaphragm improves chronic low back pain
June 22, 2018 - Researchers create revolutionary model to study pulmonary diseases
June 22, 2018 - Diagnosing Heart Disease Using AI
June 22, 2018 - Increasing biodefense risks posed by synthetic biology
June 22, 2018 - Many Women Report Vasomotor Symptoms in Their 60s
June 22, 2018 - Rare mutation of gene carried by Quebec family gives insight into how the brain is wired
June 22, 2018 - Chemists find new way to make enzymes do a non-natural reaction
June 22, 2018 - Summer is good time to check for signs of skin cancer
June 22, 2018 - Innovative method can help identify patients with spastic cerebral palsy
June 22, 2018 - Exercise alters characteristics of blood to reduce inflammation in obese people
June 22, 2018 - Researchers examine complications across different types of breast reconstructive surgeries
June 22, 2018 - Rhesus macaque model could be useful to test therapies for congenital Zika virus syndrome
June 22, 2018 - AHA: New Insights Into Sickle Cell and Stroke Risk
June 22, 2018 - Doctors prescribe opioids at high rates to those at increased overdose risk
June 22, 2018 - Reduction in US cigarette smoking rates
June 22, 2018 - Preconception binge drinking may have negative effect on future offspring
June 22, 2018 - FDA expands approval of novel diabetes management device to include younger pediatric patients
June 22, 2018 - Researchers confirm weight loss benefits of the 16:8 diet
June 22, 2018 - FDA approves Eversense CGM system for use in adults with diabetes
June 22, 2018 - State opioid monitoring programs are not created equal
June 22, 2018 - Autistic teens who are bullied have higher rates of depression
June 22, 2018 - Penn Medicine team launches universal stroke awareness program
June 22, 2018 - Scientists discover the molecular trigger of necroptosis
June 22, 2018 - Researchers report unusually high levels of herpesvirus in the brains of people with Alzheimer’s disease
June 22, 2018 - Theoretical models predict how juveniles evolve to be more susceptible than adults to infection
June 22, 2018 - USC study reveals how the cell launches emergency response to repair damaged DNA
June 22, 2018 - $1.9 million grant aims to enhance behavioral health services in community-based settings
June 22, 2018 - New 3D imaging technique could improve arthritis treatment
June 22, 2018 - Cytokinetics Announces Data From Phase 2 Clinical Study of Reldesemtiv in Patients With Spinal Muscular Atrophy
June 22, 2018 - Polarized cells give the heart its fully developed form
June 21, 2018 - Stem cells appear to help fight obesity in animal models
June 21, 2018 - Harnessing Pediatric Cancer Genomic Data in the Cloud
June 21, 2018 - Training nursing students with cost-effective 3D-printed task trainers
June 21, 2018 - Study provides insight into how planned and spontaneous movements are processed in the brain
June 21, 2018 - Suicide Prevention | SAMHSA – Substance Abuse and Mental Health Services Administration
June 21, 2018 - From designer microbes to stem cells, researchers are investigating new strategies to treat bowel disease
June 21, 2018 - Study suggests state-of-the-art genomic testing for routine autopsy of stillbirths
June 21, 2018 - Christiana Care Health System opens first Epilepsy Monitoring Unit in Delaware
June 21, 2018 - CDC: Obesity Prevalence Higher in Non-Metropolitan Counties
June 21, 2018 - Youths Treated for Non-Suicidal Self Harm at Increased Risk of Suicide Within a Year
June 21, 2018 - WVU researchers increase colorectal cancer screening rates in West Virginia
June 21, 2018 - Pediatric kidney recipients often have subclinical inflammation
June 21, 2018 - OHSU Knight Cancer Institute Director wins 2018 Tang Prize in Biopharmaceutical Science
June 21, 2018 - Researchers study broader effects of neonics on wildlife
June 21, 2018 - Study provides new insight on how antibiotics affect the gut microbiome
June 21, 2018 - InHealth Technologies becomes exclusive distributor of RENÚ Voice, RENÚ Gel in the United States
June 21, 2018 - New analysis links higher BMI to lower breast cancer risk for younger women
June 21, 2018 - Interactive preclinical PET-MR workshop demonstrates benefits of multi-modality imaging
June 21, 2018 - Gene signature could improve early diagnosis of TB
June 21, 2018 - Psychiatric Drug Lithium Tied to Birth Defect Risk
June 21, 2018 - Preclinical study suggests ARID1a may be useful biomarker for immunotherapy
June 21, 2018 - Risks of cancer and mortality found to be lowest in light drinkers
June 21, 2018 - Fetal immune cells are fast-acting first responders to microbes in adulthood
June 21, 2018 - Researchers invent medical device for proliferation, differentiation of neural stem cells
June 21, 2018 - Study explores current understanding of human physiology, pathology, trauma and surgery in space
June 21, 2018 - Scientists explore interactions between chromosomes 12 and 17
June 21, 2018 - People with severe obesity constantly try to reduce or control their weight
June 21, 2018 - Relaxing ‘brain tingles’ may have benefits for both mental and physical health
June 21, 2018 - Breakthrough discovery reveals brain metals that may drive progression of Alzheimer’s disease
June 21, 2018 - New methods of fragment-based lead discovery to identify potential antibiotics
June 21, 2018 - Recovery and Treatment | NIH MedlinePlus the Magazine
June 21, 2018 - Study finds cell-free DNA profiling as versatile method to monitor UTIs
June 21, 2018 - ‘Hidden’ driver discovered that helps prime the anti-tumor immune response
June 21, 2018 - Groundbreaking discovery could be key to preventing cancer metastasis
June 21, 2018 - Impulse control disorders found to be more common in people taking Parkinson’s drugs
June 21, 2018 - Study finds possible link between Type 2 diabetes and common white pigment
June 21, 2018 - Most emergency department patients wish to be involved in medical decision-making
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 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