Over the past two years, more than 200 patients have flocked to see after learning that two drugs he prescribes could possibly stave off aging. One 95-year-old was so intent on keeping her appointment that she asked her son to drive her from Maryland after a snowstorm had closed the schools.

Green is among a small but growing number of doctors who prescribe drugs “off-label” for their possible anti-aging effects. Metformin is typically prescribed for diabetes, and rapamycin prevents organ rejection after a transplant, but doctors can prescribe drugs off-label for other purposes — in this case, for “aging.”

Rapamycin’s anti-aging effects on animals and metformin’s on people with diabetes have encouraged Green and his patients to experiment with them as anti-aging remedies, even though there’s little evidence healthy people could benefit.

“Many of [my patients] have Ph.D.s,” said Green, who is 76 and has taken the drugs for three years. “They have read the research and think it’s worth a try.”

In fact, it’s easier for patients to experiment with the drugs — either legally off-label or illegally from a foreign supplier — than it is for researchers to launch clinical trials that would demonstrate they work in humans.

No rigorous large-scale clinical trials have been conducted aimed at aging. The FDA so far has not agreed that a treatment could be approved for delaying the onset of aging or age-related diseases, citing questions about whether research can demonstrate an overall effect on aging rather than just on a specific disease.

Given such reservations, pharmaceutical companies have little incentive to fund costly, large-scale trials. Also, both metformin and rapamycin are generic and relatively cheap.

“There’s no profit,” said , a professor of pathology at the University of Washington medical school whose team received a $15 million grant from the National Institutes of Health to study the effects of rapamycin in dogs, but has noted the lack of funds for studies in people. “Without profit, there’s no incentive.”

Supplements with purported anti-aging effects routinely enter the market with little scrutiny and less evidence.

Yet, late last year, the NIH rejected a $77 million grant by a prominent group of researchers to determine whether metformin could target multiple age-related diseases at once. It was the second rejection of the ambitious but unorthodox bid.

“We’re going to keep trying,” said a lead author of the metformin proposal, Stephen Kritchevsky, a co-director of the Sticht Center for Healthy Aging and Alzheimer’s Prevention. “These things take time.”

Less is known about rapamycin’s anti-aging effects and its possible side effects in the general population, including the possibility it could lead to insulin resistance. Yet a litany of studies show that rapamycin extends animal life spans. It also has been shown in such studies to stave off age-related diseases, from cancer to cardiovascular diseases to cognitive diseases.

“There should have been a clinical trial for rapamycin and Alzheimer’s disease years ago,” said Kaeberlein, who has publicly urged NIH to use a historic boost in Alzheimer’s funding to . “But the fact is, the clinical trials are really hard and expensive.”

Alexander Fleming, a former FDA official and advocate for the metformin proposal, said he believed it was difficult for regulators and funders to grasp that aging can be tackled as a whole — not just one disease at a time.

In fact, NIH reviewers who rejected the metformin proposal cited problems with the project’s aim of testing multiple age-related diseases at once. The researchers considered appealing the decision, asserting those reviewers were biased against studying aging as a whole. NIH, which declined to comment, discouraged the attempt.

, director of the National Institute on Aging’s division of geriatrics and clinical gerontology, told Kaiser Health News that NIH is not ruling out funding projects that target aging, saying such proposals are still “of interest.”

The FDA also is open to considering such efforts “based on the scientific evidence presented to us,” said FDA spokeswoman Amanda Turney.

Fleming, who oversaw the controversial FDA approval of metformin for Type 2 diabetes, said an argument could be made that it could approve a drug like metformin for preventing age-related diseases instead of just treating them. He points to now widely used statins, which were approved to prevent heart disease.

“There is some kind of belief that the FDA can’t approve a therapy to reduce the progress of aging or age-related conditions,” said Fleming, an endocrinologist. “It’s just not true.”

Given the lack of consensus, other researchers have moved ahead with clinical trials focused on specific age-related conditions.

Researchers have shown that a “cousin” of rapamycin boosts the effectiveness of flu shots and lowers the incidence of upper respiratory infections in seniors by up to 30 percent. This group, led by Dr. Joan Mannick, has licensed it from Novartis and is now working on getting approval to target Parkinson’s disease.

“We’re trying to be pragmatic,” Mannick said of .

Some doctors and patients have decided not to wait. At a recent scientific forum on aging, one of the researchers on the NIH proposal asked the 300 or so people in attendance to raise their hands if they were already taking metformin for aging.

“Half the audience raised their hands,” recalled the researcher, director of the Institute for Aging Research at the Albert Einstein College of Medicine, who said a pharmaceutical rep recently estimated that metformin sales are up 20 percent.

Barzilai is concerned about the off-label trend, although he sees metformin as promising. He contends that researchers in the longevity field first need to set up a framework for testing in clinical trials. Even if metformin doesn’t pan out as the most effective drug, he asserts a model like the metformin proposal is needed for any major clinical trial to proceed. His group is now trying to secure about half the amount of funding it requested from NIH from a mix of nonprofit and private investment.

“Much of the aging field is charlatans,” Barzilai said. “They tell you take this or that and you’ll live forever. But you have to do a clinical trial that is placebo-controlled and only then can you say what it really is and whether it’s safe.”

Green nonetheless said he plans to continue prescribing. He estimates about 5 percent of his patients are doctors themselves. Others have backgrounds in science or are in the upper-income bracket. According to his website, he charges $350 for an initial visit and does not accept insurance.

“They fly to see me on their own planes,” he said.

But other doctors who are open to prescribing metformin are holding off on rapamycin, given side effects in higher doses in sick patients.

“I need to see more evidence,” said Dr. Garth Denyer, a doctor in The Woodlands, a wealthy Houston suburb, who said he prescribed metformin to a small number of patients but is waiting on rapamycin. “I’m hoping to see more data on safety.”

Michael Slattery, who has been HIV-positive since 1983, said he is taking both drugs because the virus is likely to shorten his life expectancy.

So far, he has not noticed any side effects or benefits. His partner, however, who is also HIV-positive, stopped taking rapamycin after getting kidney infections.

“I feel I have nothing left to lose,” said Slattery, a retired biotech consultant.

Other patients remain hopeful, even though the evidence is unlikely to be definitive anytime soon.

Linda Mac Dougall, 70, of Port Hueneme, Calif., said she participated in a small study that did not have a placebo control. She’s uncertain whether it had any effect on her.

“I really haven’t noticed anything, but that doesn’t mean it didn’t work,” said Mac Dougall, a massage therapist for seniors. She has slightly more confidence in the wide array of supplements she takes, she said: “If I live until I’m 110, we’ll know.”

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What’s the 49-year-old’s secret? He says his daily regimen includes ingesting a molecule his own research found improved the health and lengthened the life span of mice. Sinclair now boasts that he has the lung capacity, cholesterol and blood pressure of a “young adult” and the “heart rate of an athlete.”

Despite his enthusiasm, published scientific research has not yet demonstrated the molecule works in humans as it does in mice. Sinclair, however, has a considerable financial stake in his claims being proven correct, and has lent his scientific prowess to commercializing possible life extension products such as molecules known as “NAD boosters.”

His financial interests include being listed as an inventor on a patent licensed to Elysium Health, a supplement company that sells a NAD booster in pills for $60 a bottle. He’s also an investor in the company that he says measured his age.

Discerning hype from reality in the longevity field has become tougher than ever as reputable scientists such as Sinclair and pre-eminent institutions like Harvard align themselves with promising but unproven interventions — and at times promote and profit from them.

Fueling the excitement, investors pour billions of dollars into the field even as many of the products already on the market face fewer regulations and therefore a lower threshold of proof.Ìý

“If you say you’re a terrific scientist and you have a treatment for aging, it gets a lot of attention,” said Jeffrey Flier, a former Harvard Medical School dean who has been critical of the hype. “There is financial incentive and inducement to overpromise before all the research is in.”

Elysium, co-founded in 2014 by a prominent MIT scientist to commercialize the molecule nicotinamide riboside, a type of NAD booster, highlights its “exclusive” licensing agreement with Harvard and the Mayo Clinic and Sinclair’s role as an inventor. According to the company’s , the agreement is aimed at supplements that slow “aging and age-related diseases.”

Further adding scientific gravitas to its brand, the website lists and 19 other prominent scientists who sit on its scientific advisory board. The company also advertises with Harvard and U.K. universities Cambridge and Oxford.

Some scientists and institutions have grown uneasy with such ties. announced in 2017 it would receive funding from Elysium, cementing a research “partnership.” But after hearing complaints from faculty that the institute was associating itself with an unproven supplement, it quietly decided not to renew the funding or the company’s membership to its “innovation” board.

“The sale of nutritional supplements of unproven clinical benefit is commonplace,” said Stephen O’Rahilly, the director of Cambridge’s Metabolic Research Laboratories who applauded his university for reassessing the arrangement. “What is unusual in this case is the extent to which institutions and individuals from the highest levels of the academy have been co-opted to provide scientific credibility for a product whose benefits to human health are unproven.”

The bottom line is I don’t try any of these things. Why don’t I? Because I’m not a mouse.

Felipe Sierra, the director of the division of aging biology at the National Institute on Aging at NIH

The Promise

A generation ago, scientists often ignored or debunked claims of a “fountain of youth” pill.

“Until about the early 1990s, it was kind of laughable that you could develop a pill that would slow aging,” said Richard Miller, a biogerontologist at the University of Michigan who heads one of three labs funded by the National Institutes of Health to test such promising substances on mice. “It was sort of a science fiction trope. Recent research has shown that pessimism is wrong.”

Mice given molecules such as rapamycin live as much as 20 percent longer. Other substances such as 17 alpha estradiol and the diabetes drug Acarbose have been shown to be just as effective — in mouse studies. Not only do mice live longer, but, depending on the substance, they avoid cancers, heart ailments and cognitive problems.

But human metabolism is different from that of rodents. And our existence is unlike a mouse’s life in a cage. What is theoretically possible in the future remains unproven in humans and not ready for sale, experts say.

History is replete with examples of cures that worked on mice but not in people. Multiple drugs, for instance, have been effective at targeting an Alzheimer’s-like disease in mice yet have failed in humans.

“None of this is ready for prime time. The bottom line is I don’t try any of these things,” said Felipe Sierra, the director of the division of aging biology at the National Institute on Aging at NIH. “Why don’t I? Because I’m not a mouse.”

The Hype

Concerns about whether animal research could translate into human therapy have not stopped scientists from racing into the market, launching startups or lining up investors. Some true believers, including researchers and investors, are taking the substances themselves while promoting them as the next big thing in aging.

“While the buzz encourages investment in worthwhile research, scientists should avoid hyping specific [substances],” said S. Jay Olshansky, a professor who specializes in aging at the School of Public Health at the University of Illinois at Chicago.

Yet some scientific findings are exaggerated to help commercialize them before clinical trials in humans demonstrate both safety and efficacy, he said.

“It’s a great gig if you can convince people to send money and use it to pay exorbitant salaries and do it for 20 years and make claims for 10,” Olshansky said. “You’ve lived the high life and get investors by whipping up excitement and saying the benefits will come sooner than they really are.”

Promising findings in animal studies have stirred much of this enthusiasm.

Research by Sinclair and others helped spark interest in resveratrol, an ingredient in red wine, for its potential anti-aging properties. In 2004, Sinclair co-founded a company, Sirtris, to test resveratrol’s potential benefits and declared in an interview with the journal Science it was “as close to a miraculous molecule as you can find.” GlaxoSmithKline bought the company in 2008 for $720 million. By the time Glaxo halted the research in 2010 because of underwhelming results with possible side effects, Sinclair had already received $8 million from the sale, according to Securities and Exchange Commission documents. He also had earned $297,000 a year in consulting fees from the company, according to The Wall Street Journal.

At the height of the buzz, Sinclair accepted a paid position with Shaklee, which sold a product made out of resveratrol. But he resigned after The Wall Street Journal highlighted positive comments he made about the product that the company had posted online. He said he never gave Shaklee permission to use his statements for marketing.

Sinclair practices what he preaches — or promotes. On his LinkedIn bio and in media interviews, he describes how he now regularly takes resveratrol; the diabetes drug metformin, which holds promise in slowing aging; and nicotinamide mononucleotide, a substance known as NMN that his own research showed rejuvenated mice.

Of that study, he said in a video produced by Harvard that it “sets the stage for new medicines that will be able to restore blood flow in organs that have lost it, either through a heart attack, a stroke or even in patients with dementia.”

In an interview with KHN, Sinclair said he’s not recommending that others take those substances.

“I’m not claiming I’m actually younger. I’m just giving people the facts,” he said, adding that he’s sharing the test results from InsideTracker’s blood tests, which calculate biological age based on biomarkers in the blood. “They said I was 58, and then one or two blood tests later they said I was 31.4.”

InsideTracker sells an online age-tracking package to consumers for up to about . The company’s Sinclair’s support for the company as a member of its scientific advisory board. It also touts a study that describes the benefits of such tracking, which Sinclair co-authored.

Sinclair is involved either as a founder, an investor, an equity holder, a consultant or a board member with 28 companies, according to a of his financial interests. At least 18 are involved in anti-aging in some way, including studying or commercializing NAD boosters. The interests range from longevity research startups aimed at humans and even pets to developing a product for a to advising a longevity investment fund. He’s also an inventor named in the patent licensed by Harvard and the Mayo Clinic to Elysium, and one of his companies, MetroBiotech, has filed a related to nicotinamide mononucleotide, which he says he takes himself.

Sinclair and Harvard declined to release details on how much money he — or the university — is generating from these disclosed outside financial interests. Sinclair estimated in a 2017 interview with Australia’s Financial Review that he raises $3 million a year to fund his Harvard lab.

Liberty Biosecurity, a company he co-founded, estimated in Sinclair’s online bio that he has been involved in ventures that “have attracted more than a billion dollars in investment.” When KHN asked him to detail the characterization, he said it was inaccurate, without elaborating, and the comments later disappeared from the website.

Sinclair cited confidentiality agreements for not disclosing his earnings, but he added that “most of this income has been reinvested into companies developing breakthrough medicines, used to help my lab, or donated to nonprofits.” He said he did not know how much he stood to make off the Elysium patent, saying Harvard negotiated the agreement.

Harvard declined to release Sinclair’s conflict-of-interest statements, which university policy requires faculty at the medical school to file in order to “protect against any faculty bias that could heighten the risk of harm to human research participants or recipients of products resulting from such research.”

“We can only be proud of our collaborations if we can represent confidently that such relationships enhance, and do not detract from, the appropriateness and reliability of our work,” the policy states.

Elysium advertises both Harvard’s and Sinclair’s ties to its company. It was co-founded by Massachusetts Institute of Technology professor , Sinclair’s former research adviser and an investor in Sinclair’s .

Echoing his earlier statements on resveratrol, Sinclair is quoted on Elysium’s website as describing NAD boosters as .”

Supplement Loophole?

The Food and Drug Administration doesn’t categorize aging as a disease, which means potential medicines aimed at longevity generally can’t undergo traditional clinical trials aimed at testing their effects on human aging. In addition, the FDA does not require supplements to undergo the same safety or efficacy testing as pharmaceuticals.

The banner headline on Elysium’s website said that “clinical trial results prove safety and efficacy” of its supplement, Basis, which contains the molecule nicotinamide riboside and pterostilbene. But the did not demonstrate the supplement was effective at anti-aging in humans, as it may be in mice. It simply showed the pill increased the levels of the substance in blood cells.

“Elysium is selling pills to people online with the assertion that the pills are ‘clinically proven’” said O’Rahilly. “Thus far, however the benefits and risks of this change in chemistry in humans is unknown.”

“Many interventions that seem sensible on the basis of research in animals turn out to have unexpected effects in man,” he added, citing a large clinical trial of beta carotene that showed it increased rather than decreased the risk of lung cancer in smokers.

Elysium’s own research documented a “small but significant increase in ,” but added more studies were needed to determine whether the changes were “real or due to chance.” One independent has suggested that a component of NAD may influence the growth of some cancers, but researchers involved in the study warned it was too early to know.

Guarente, Elysium’s co-founder and chief scientist, told KHN he isn’t worried about any side effects from Basis, and he emphasized that his company is dedicated to conducting solid research. He said his company monitors customers’ safety reports and advises customers with health issues to consult with their doctors before using it.

If a substance meets the FDA’s definition of a supplement and is advertised that way, then the agency can’t take action unless it proves a danger, said Alta Charo, a former bioethics policy adviser to the Obama administration. Pharmaceuticals must demonstrate safety and efficacy before being marketed.

“A lot of what goes on here is really, really careful phrasing for what you say the thing is for,” said Charo, a law professor at the University of Wisconsin. “If they’re marketing it as a cure for a disease, then they get in trouble with the FDA. If they’re marketing it as a rejuvenator, then the FDA is hamstrung until a danger to the public is proven.”

“This is a recipe for some really unfortunate problems down the road,” Charo added. “We may be lucky and it may turn out that a lot of this stuff turns out to be benignly useless. But for all we know, it’ll be dangerous.”

The debate about the risks and benefits of substances that have yet to be proven to work in humans has triggered a debate over whether research institutions are scrutinizing the financial interests and involvement of their faculty — or the institution itself — closely enough. It remains to be seen whether Cambridge’s decision not to renew its partnership will prompt others to rethink such ties.

Flier, the former dean of Harvard Medical School, had earlier heard complaints and looked into the relationships between scientists and Elysium after he stepped down as dean. He said he that many of the board members who allowed their names and pictures to be posted on the company website knew little about the scientific basis for use of the company’s supplement.

Flier recalls that one scientist had no real role in advising the company and never attended a company meeting. Even so, Elysium was paying him for his role on the board, Flier said.

Caroline Perry, director of communications for Harvard’s Office of Technology Development, said agreements such as of research funds from Elysium comply with university policies and “protect the traditional academic independence of the researchers.”

Harvard “enters into research agreements with corporate partners who express a commitment to advancing science by supporting research led by Harvard faculty,” Perry added.

Like Harvard, the Mayo Clinic refused to release details on how much money it would make off the Elysium licensing agreement. Mayo and Harvard engaged in “substantial diligence and extended negotiations” before entering into the agreement, said a Mayo spokeswoman.

“The company provided convincing proof that they are committed to developing products supported by scientific evidence,” said the spokeswoman, Duska Anastasijevic.

Guarente of Elysium refused to say how much he or Elysium was earning off the sale of the supplement Basis. MIT would not release his conflict-of-interest statements.

Private investment funds, meanwhile, continue to pour into longevity research despite questions about whether the substances work in people.

One key Elysium is the Morningside Group, a private equity firm run by Harvard’s top donor, Gerald Chan, who also gave

Billionaire and WeWork co-founder Adam Neumann has invested in Sinclair’s Life Biosciences.

An investment firm led by engineer and physician Peter Diamandis gave a group of Harvard researchers $5.5 million for their startup company after their research was publicly challenged by several other scientists.

In its announcement of the seed money, the company, Elevian, said its goal was to develop “new medicines” that increase the activity levels of the hormone GDF11

It described research by its founders, which include Harvard’s , as demonstrating that “replenishing a single circulating factor, GDF11, in old animals mirrors the effects of young blood, repairing the heart, brain, muscle and other tissues.”

Other in the field have either failed to replicate or contradict key elements of their observations.

Elevian’s CEO, Mark Allen, said the early scientific data on GDF11 is encouraging, but “drug discovery and development is a time-intensive, risky, regulated process requiring many years of research, preclinical [animal] studies, and human clinical trials to successfully bring new drugs to market.”

Flier worries research in the longevity field could be compromised, although he recognizes the importance and promise of the science. He said he’s concerned that alliances between billionaires and scientists could lead to less skepticism.

“A susceptible billionaire meets a very good salesman scientist who looks him deeply in the eyes and says, ‘There’s no reason why we can’t have a therapy that will let you live 400 or 600 years,’” Flier said. “The billionaire will look back and see someone who is at MIT or Harvard and say, ‘Show me what you can do.’”

Despite concerns about the hype, scientists are hopeful of finding a way forward by relying on hard evidence. The consensus: A pill is on the horizon. It’s just a matter of time — and solid research.

“If you want to make money, hiring a sales rep to push something that hasn’t been tested is a really great strategy,” said Miller, who is testing substances on mice. “If instead you want to find drugs that work in people, you take a very different approach. It doesn’t involve sales pitches. It involves the long, laborious, slogging process of actually doing research.”

KHN senior correspondent Jay Hancock contributed to this report.

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Among the most prominent: Dr. Robert Redfield, director of the Centers for Disease Control and Prevention. Smith said he enthusiastically urged administration officials to pick his longtime friend and associate, who now oversees one of the agencies that fund the multibillion-dollar international prevention and treatment program known as the President’s Emergency Plan for AIDS Relief (PEPFAR).

And within the White House itself are certain aides the activist has known for years, as he acknowledged during a series of interviews with Kaiser Health News. They include Katy Talento, a leading conservative voice on health care policy, and staffers in Vice President Mike Pence’s office who court religious conservatives on a variety of issues.

Even Smith’s wife, who has had her own high-profile activism over the years, is working on abstinence efforts within the administration. Anita Smith was hired recently as a part-time PEPFAR consultant by one of the couple’s longtime allies.

“This is the new in crowd,” said Paul Zeitz, an expert on global AIDS epidemic control who worked for the State Department from mid-2014 until last August. “These are the people who are likely to be influencing how we spend taxpayer money on AIDS efforts for the rest of the administration.”

Such connections signal a resurgence of religious conservatives’ influence over health care issues well beyond abstinence education. Last year, President Donald Trump announced that PEPFAR must now follow the , which bans foreign, non-governmental organizations from using their funds for abortion-related services such as counseling.

The origins of Shepherd Smith’s high-profile contacts are detailed in memos, letters and military documents in an archive of KHN examined hundreds of pages there to help assess the Trump administration’s approach to health policy and AIDS treatment and prevention.

While PEPFAR is credited with saving millions of lives in Africa and elsewhere, several of its programs, especially those encouraging abstinence, have been criticized by scientists and relief experts as ineffective and impractical.

In the late 1980s, Smith developed relationships with government scientists even as other religious leaders balked at the idea of getting involved in AIDS prevention efforts. That included recruiting Redfield, at what was then Walter Reed Army Medical Center, to join the advisory board of the Smiths’ fledgling Americans for a Sound AIDS/HIV Policy. The now-defunct organization strongly supported abstinence education.

“We sought [the scientists] out because we thought they were doing the right thing,” the 73-year-old Smith told KHN. “It’s not rocket science. We figured out a plan for our message to become important.”

Redfield also served as chairman and an advisory board member of another organization that Smith and his wife later founded. He stepped down from Children’s AIDS Fund International, which also backs abstinence education, only to comply with government ethics rules after he joined the CDC in March.

In recent media interviews, the physician-researcher said he has rethought his opposition to promoting condom use in the fight against AIDS. He elaborated on that in a statement in July to KHN, saying he supports programs that encourage people who are not sexually active to delay sex and have fewer partners — an approach hailed by conservative activists.

“We know that abstinence is the only 100 percent effective way to prevent HIV and other transmitted diseases,” he noted in the statement.

Anita Smith is now a consultant within PEPFAR to Deborah Birx, a physician and ambassador-at-large who oversees the program’s estimated $5 billion annual budget. Birx is also a former board member of Children’s AIDS Fund International and served until she was hired by the CDC in 2005, a PEPFAR spokesman said. (The organization received PEPFAR grants between 2004 and 2008 despite an early evaluation from experts who deemed it “not suitable for funding,” at the time.)

Smith’s hiring earlier this year was part of a strategy to improve prevention programs aimed at preteen girls, including support for “decision-making around whether to delay, abstain or protect,” according to a statement from Birx’s office.

“The administration is trying to put sweeteners in there for religious conservatives,” said Heather Boonstra, director of public policy at the Guttmacher Institute, a nonprofit focused on reproductive health. “It’s not as if these concepts are a problem if they are included as part of a whole array of programs. The concern is that these changes are opening the door for a greater number of programs that focus solely on abstinence.”

Through her husband, Anita Smith declined to answer any questions. “My wife is an expert on these types of programs,” he said, “so it’s not surprising she would be asked to weigh in.” She remains president of the children’s AIDS organization, which is based in Sterling, Va. Shepherd Smith no longer has an official position there.

Birx’s statement explained her connection to the couple, noting that she became involved in the children’s organization through an annual Christmas event of gift-wrapping presents for families affected by HIV. “When they asked me to join their board, I did so to show my support for the concept of services to others in need,” she said.

Shepherd Smith’s alliances can be traced through the University of Michigan archive. It was set up by science writer Jon Cohen, whose 2001 book, “” examined what went wrong in the epidemic’s early years. According to a government transcript there, Smith sized up Redfield swiftly when they first met. “He was as happy to see us, as we were him,” Smith said in an interview with military investigators. Their relationship deepened as the activist and scientist rose in prominence, Smith’s letters to Walter Reed officials suggest.

Smith, who secured CDC dollars for Americans for a Sound AIDS/HIV Policy (ASAP) in the 1980s, regularly stopped by Walter Reed to see Redfield and others who joined the organization’s board, according to military records in the archive. Under Smith’s direction, ASAP touted Redfield’s vaccine research as being “the most important scientific advancement in the epidemic to date.” In turn, as ASAP chairman, Redfield called the group “the most effective AIDS/HIV organization I know” in its 1991 annual report.

The archive reveals that some Walter Reed scientists complained to Army officials about the organization’s possible influence with Redfield. The complaints triggered an inquiry into allegations that Smith was pressuring researchers to skew Redfield’s vaccine data to help secure congressional funding.

Though Redfield insisted he did not give Smith preferential treatment, a military investigator found that the researcher violated military rules and recommended the “close relationship” between Walter Reed and ASAP be “severed so there is not an appearance of endorsement or favoritism.” A separate inquiry concluded that Redfield had publicly overstated his data but cleared him of scientific misconduct charges.

In 1996, Redfield left the military and helped to establish the University of Maryland’s Institute of Human Virology.

To this day, Smith remains a fierce supporter. After controversy stirred over Redfield’s $375,000 salary — significantly more than previous CDC leaders earned — Smith told KHN the amount was well deserved. It ultimately was reduced to $209,700.

Smith describes himself as still pushing others hard for both information and action to stop the AIDS epidemic, but he demurred when asked how regularly he contacts administration officials, including the CDC director.

“I have no control over the guy,” Smith said when asked whether he expected Redfield to implement policy changes he supports. “I can only hope we’ll have a little more balance than we’ve seen in the last few years.”

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Previously, the administration’s “zero-tolerance” immigration stance meant splitting children from parents.Ìý Immigration authorities acknowledged that during that policy 2,322 children 12 and under Ìýwere detained and placed in facilities run by the Department of Health and Human Service.

The policy of detaining families “during the pendency of their immigration cases” was announced Friday night in a . But experts and former government officials warn the new approach — which places parents and children in the custody of the Department of Homeland Security for months or even longer — won’t improve the situation.

The DOJ declined to comment. DHS did not immediately respond to requests for comment.

“We’re seeing a repeat pattern of this administration,” said Sarah Pierce, a policy analyst with the Migration Policy Institute and former immigration attorney. “The president makes laws and policies and the administration then struggles to implement what he does.”

For longer detentions, DHS will need resources for young children that the agency doesn’t generally set up, such as educational facilities.

“They even need diapers, formula and bottles,” Pierce said. “We’re talking about the basics for caring for children.”

Making matters more complicated, DHS’ family facilities under the indefinite detention policy. The White House has also asked the Department of Defense to make detention facilities available.

“DHS’ primary focus — [its facilities] were designed to hold these people, and not let them out,” said Peter Boogaard, a former DHS spokesman under the Obama administration. “It is not in any way designed to protect the health and well-being of families and young children.”

While the Obama administration grappled with a sudden influx of families in 2014, the detention of families triggered litigation under the agreement, which required that families be detained together at DHS facilities and the children be released within 20 days. The Obama administration then began releasing the families under the agreement.

“Most of these families were released before the 20 days were up,” Pierce said.

The has also requested the Flores settlement be modified to permit longer detention of families being prosecuted, including children.

People who are stopped by the U.S. Border Patrol receive some baseline health screenings. And the Office of Refugee Resettlement, the HHS program in charge of “unaccompanied alien children,” typically provides some medical care for children detained at the border, including consultations with child psychologists and social workers.

In recent weeks, ORR — which took responsibility for children who had been separated from their parents — has come for providing reportedly substandard care, including reports that children’s psychiatric records and case files were being used in immigration court. Many experts have also suggested ORR couldn’t handle the number of kids being detained, and lacked expertise in caring for the many 12-and-under children detained who were separated from their families.

Still, unlike DHS, many noted, ORR has some expertise in providing children’s health services. Boogaard said he was unfamiliar with any protocols to ensure kids receive adequate vaccinations, or consultations with child psychologists and social workers.

“They are not resourced and not staffed to be able to deal with the unique challenges of dealing with children,” he said.

U.S. Immigration and Customs Enforcement, the DHS agency that operates detention centers, redirected questions to on standards for family centers. It says residents will have access to “health care education and maintenance services that are determined by the health care authority to be necessary and appropriate,” including “prevention, diagnosis, and treatment of medical, dental, and mental health conditions.”

Advocates and watchdog organizations, though, suggest that hasn’t been the case.

A argued “dangerously substandard medical care” had contributed to eight out of the 15 deaths documented in records released by ICE from December 2015 to April 2017. Medical reviewers also noted instances of poor medical care in six of the other deaths.

“ICE’s record of providing inadequate care to adults does not bode well if the agency is put in charge of providing care to increasing numbers of children,” said Alison Parker, who directs HRW’s U.S. program.

Meanwhile, children currently crossing the border have particularly intense health needs — in no small part because many are fleeing violent circumstances. Lengthy detention can add to that trauma, experts said.

“Historically thinking about what family detention has looked like in this country, we have reason to be concerned,” said Shadi Houshyar, who directs early childhood and child welfare initiatives at Families USA, an advocacy group. “Detention is no place for children.”

Prior to the 2015 ruling, she added, children in detention facilities were found “dehydrated, and not eating, and having intestinal problems.” Many new mothers, she added, experienced depression and trouble nursing.

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The Trump administration has detained 2,322 children 12 years old or younger amid its border crackdown, a Department of Health and Human Services official told Kaiser Health News on Wednesday. They represent almost 20 percent of the immigrant children currently held by the U.S. government in the wake of its latest immigrant prosecution policy.

Their welfare is being overseen by a small division of the Department of Health and Human Services — the Office of Refugee Resettlement (ORR) — which has little experience or expertise in handling very young children.

The number of children has exploded in the past six weeks since the Trump administration moved to stop parents and their children at the U.S. border and separate and detain them in different facilities. A total of 11,786 children under age 18 are currently detained, the official said.

President Donald Trump signed an Wednesday that seeks to detain parents and children together. The order also changes oversight of detention from HHS to the Department of Homeland Security. But it’s unclear whether the children currently detained by HHS will be transferred and whether the order will comply with a court standard for the treatment of children in custody, known as the Flores agreement.

Since 2003, ORR has been charged with sheltering and finding suitable homes for “unaccompanied alien children” — generally teenaged immigrants who reach the United States without a parent or guardian.

But its responsibilities have morphed and multiplied since April because the immigration crackdown means that the ORR is now responsible for detaining not only more children, but minors who are far younger than those who had arrived in the past, experts said.

Beyond specialized medical care, younger children have different food and housing needs, and require more personal attention.

“The children are younger and will be there for a longer time and are deeply traumatized by being forcibly separated from their parents,” said Mark Greenberg, a former administration official at HHS’ Administration for Children and Families, which oversees the ORR. “All of that makes it much more difficult to operate the program.”

The complex crisis is magnified by the inexperience of some of the political appointees leading the response, said critics who include former officials from both Republican and Democratic administrations of the past decade.

ORR Director Scott Lloyd is a lawyer whose career has been focused on anti-abortion efforts. He led the Trump administration’s legal efforts to prevent abortions for detained teen immigrants. Lloyd’s main immigration experience before leading ORR was research for a report on refugees for the Knights of Columbus, a Catholic service organization with an anti-abortion stance,

Kenneth Wolfe, the HHS spokesman who provided the figures, declined to address how many people are currently working at ORR or whether ORR had secured additional staff or expertise to cope with the influx of young children. He also would not say how many of the 2,322 children 12 and younger have been separated from their families.

The administration had previously refused to provide the ages of the children separated from their families — saying only that about 2,300 children have been separated and detained since the policy took effect.

The detention conditions, which include children being held in chain-link holding pens and “tent cities,” have ignited a political firestorm over possible abuse in the treatment of children as young as 4. Some of these younger children — including toddlers — are being sent to “tender age” shelters, according to media reports. The care is also costly: Tents alone cost HHS $775 per person per day, according to media reports.

Republicans, including former , have called on the administration to stop the policy. Trump has blamed Congress for the detentions, but top White House advisers were actively promoting family separations as a policy shift.

have described children as young as 5 being scolded for playing, one teenager teaching others how to change a small child’s diaper, and caretakers not being permitted to touch children. ProPublica reported that detained are younger than 4.

ORR, experts add, is already at a disadvantage.

“It’s significantly challenging to create that capacity, and quite expensive,” noted Robert Carey, a former ORR director from the Obama administration. “All the aspects of care are dramatically different based on age. … You need people who are trained in early childhood development or care.”

That’s a heavy lift for an office that, experts stress, was never built to serve as a long-term housing system.

It’s not clear, Carey and others said, that the administration has had sufficient time or support to adapt.

Many ORR employees, Carey added, are career staffers with deep knowledge about immigration and child welfare, with whom he frequently worked while in office.

“The kids are going into the custody of ORR without adequate resources,” said Shadi Houshyar, who directs early childhood and child welfare initiatives at Families USA, an advocacy group. “It’s definitely going to result in some potentially damaging decisions being made. The capacity, training and fundamental orientation — while understanding the needs of children — is not the orientation that ORR has.”

While ORR has a history of placing teenagers who arrive on their own with relatives of families in the U.S., that challenge is heightened by the policy of separating children, who are young and may understand little of the experience or be able to identify relatives who could take them in.

Making matters more complicated, when families are separated, parents and children are tracked by different federal agencies — the parents by the U.S. Department of Homeland Security, and the children by ORR. Children are also tracked and treated the same as minors who arrived on their own. Together, that makes reunification more difficult. And that’s a problem experts worry will persist, even if family separations cease.

“It does not look like they’ve figured out this process,” said a former HHS official, who requested anonymity because she could face professional ramifications for speaking publicly. As a result, she added, “the time the child stays in ORR could be significantly longer” — which in turn adds to trauma and causes other long-term problems.

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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.”

Sen. Chuck Grassley (D-Iowa), the chair of the Judiciary Committee, applauded the FDA’s action after he had called on the agency to look into the matter, citing Kaiser Health News’ investigation.

“We ought to find out if the research was done with the knowledge of those who should’ve acted to stop it instead of turning a blind eye …” he said in a statement. “This research broke just about every rule in the book and put human subjects at extreme health risk.”

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,Ìý, 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 , a corporate official may be prosecuted for a criminal misdemeanor offense under the 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, Ill., 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 U.S. 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 , for instance, pleaded guilty in 2010 to charges related to her fabrication of data in a study of children taking the antidepressant Paxil. later agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability in the case.

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For four years, her doctor prescribed the 61-year-old a wide range of opioids for her transverse myelitis, a debilitating disease that caused pain, muscle weakness and paralysis.

The drugs not only failed to ease her symptoms, they hooked her.

When her home state of New York legalized marijuana for the treatment of select medical ailments, Owens decided it was time to swap pills for pot. But her doctors refused to help.

“Even though medical marijuana is legal, none of my doctors were willing to talk to me about it,” she said. “They just kept telling me to take opioids.”

While 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Owen who use marijuana and the doctors who treat them are caught in the middle of a conflict in federal and state laws — a predicament that is only worsened by thin scientific data.

Because the federal government classifies marijuana a Schedule 1 drugÌý— by definition a substance with no currently accepted medical use and a high potential for abuse — research on marijuana or its active ingredients is highly restricted and even discouraged in some cases.

Underscoring the federal government’s position, Health and Human Services Secretary Alex Azar recently pronounced that there was “no such thing as medical marijuana.”

Scientists say that stance prevents them from conducting the high-quality research required for FDA approval, even as some early research indicates marijuana might be a promising alterative to opioids or other medicines.

Patients and physicians, meanwhile, lack guidance when making decisions about medical treatment for an array of serious conditions.

“We have the federal government and the state governments driving a hundred miles an hour in the opposite direction when they should be coming together to obtain more scientific data,” said Dr. Orrin Devinsky, who is researching the effects of cannabidiol, an active ingredient of marijuana, on epilepsy. “It’s like saying in 1960, ‘We’re not going to the moon because no one agrees how to get there.’”

The problem stems partly from the fact that the federal government’s restrictive marijuana research policies have not been overhauled in more than 40 years, researchers say.

Only one federal government contractor grows marijuana for federally funded research. Researchers complain the pot grown by the contractor at the is inadequate for high-quality studies.

, which comes in a micronized form, is less potent than the pot offered at dispensaries, researchers say. It also differs from other products offered at dispensaries, such as so-called edibles that are eaten like snacks. The difference makes it difficult to compare the real-life effects of the marijuana compounds.

Researchers also face time-consuming and costly hurdles in completing the complicated federal application process for using marijuana in long-term clinical trials.

“It’s public policy before science,” said Dr. Chinazo Cunningham, a primary care doctor who is the lead investigator on one of the few federally funded studies exploring marijuana as a treatment for pain. “The federal government’s policies really make it much more difficult.”

Cunningham, who received a five-year, $3.8 million federal grant, will not be administering marijuana directly to participants. Instead, she will follow 250 HIV-positive and HIV-negative adults with chronic pain who use opioids and have been certified to get medical marijuana from a dispensary.

“It’s a catch-22,” said Cunningham, who is with the Albert Einstein College of Medicine. “We’re going to be looking at all of these issues — age, disease, level of pain — but when we’re done, there’s the danger that people are going to say ‘Oh, it’s anecdotal’ or that it’s inherently flawed because it’s not a randomized trial.’’

Without clear answers, hospitals, doctors and patients are left to their own devices, which can result in poor treatment and needless suffering.

Hospitals and other medical facilities have to decide what to do with newly hospitalized patients who normally take medical marijuana at home.

Some have a “don’t ask, don’t tell” approach, said Devinsky, who sometimes advises his patients to use it. Others ban its use and substitute opioids or other prescriptions.

Young adults, for instance, have had to stop taking cannabidiol compounds for their epilepsy because they’re in federally funded group homes, said Devinsky, the director of NYU Langone’s Comprehensive Epilepsy Center.

“These kids end up getting seizures again,” he said. “This whole situation has created a hodgepodge of insanity.”

The Trump administration, however, has resisted policy changes.

Last year, the had been gearing up to allow facilities other than the University of Mississippi to grow pot for research. But after the DEA received 26 applications from other growers, Attorney General Jeff Sessions halted the initiative.

The Department of Veterans Affairs also recently announced it would not fund studies of using marijuana compounds to treat ailments such as pain.

The DEA and HHS have cited concerns about medical supervision, addiction and a lack of “well-controlled studies proving efficacy.”

Patients, meanwhile, forge ahead.

While experts say they don’t know exactly how many older Americans rely on marijuana for medicinal purposes, the number of Americans 65 and older who say they are using the drug from 2006 to 2013.

Some patients turn to friends, patient advocacy groups or online support groups for information.

Owen, for one, kept searching for a doctor and eventually found a neurologist willing to certify her to use marijuana and advise her on what to take.

“It’s saved my life,” said the retired university administrative assistant who credited marijuana for weaning her off opioids. “It not only helps my pain, but I can think, walk and talk again.”

Mary Jo, a Minnesotan, was afraid of being identified as a medical marijuana user, even though she now helps friends navigate the process and it’s legal in her home state.

“There’s still a stigma,” said Mary Jo, who found it effective for treating her pain from a nerve condition. “Nobody helps you figure it out, so you kind of play around with it on your own.”

Still, doctors and scientists worry about the implications of such experimentation.

In a sweeping report last year, the National Academies of Sciences, Engineering and Medicine called on the federal government to support better research, decrying the “lack of definitive evidence on using medical marijuana.”

The national academies’ committee reviewed more than 10,000 scientific abstracts related to the topic. It made 100 conclusions based on its review,Ìý finding evidence that marijuana relieves pain and chemotherapy-induced nausea. But it found “inadequate information” to support or refute effects on Parkinson’s disease.

Yet those who find that medical marijuana helps them can become fierce advocates no matter what their doctors say.

Caryl Barrett, a 54-year-old who lives in Georgia, said she decided to travel out of state to Colorado to treat her pain from her transverse myelitis and the autoimmune disease neurosarcoidosis.

“I realized it worked and I decided to bring it back with me,” she said. “I broke federal law.”

Georgia, meanwhile, permitted limited medicinal use of marijuana but did not set up dispensaries. As a result, patients resort to ordering it online or driving to another state to get it.

The conflict in the law makes her uneasy. But Barrett, who had been on opioids for a decade, said she feels so strongly about it working that “if someone wants to arrest me, bring it on.”

Others experience mixed results.

Melodie Beckham, who had metastatic lung cancer, tried medical marijuana for 13 days in a clinical trial at Connecticut Hospice before deciding to quit.

“She was hopeful that it would help her relax and just kind of enjoy those days,” said her daughter, Laura Beckham.

Instead, it seemed to make her mother, who died in July at age 69, “a little more agitated or more paranoid.”

The marijuana “didn’t seem effective,” nor did it keep her mother from hitting her pain pump to get extra doses of an opioid, her daughter said.

The researchers running the trial at Connecticut Hospice spent two years getting necessary approvals from the Food and Drug Administration, the National Institute on Drug Abuse (NIDA) and the DEA.

Started in May, the trial has enrolled only seven of the 66 patients it plans to sign up because many patients were too sick, too close to death or simply couldn’t swallow the pills. So far, the trial has shown “mixed results,” said James Prota, director of pharmacy for the hospice.

Researchers point out they are still exploring the basics when it comes to marijuana’s effects on older adults or the terminally ill.

“We just have no data on how many older adults are using medical marijuana, what they are using it for and most importantly what are the outcomes,” said Brian Kaskie, a professor at the University of Iowa’s College of Public Health. “It’s all anecdotal.”

Kaskie, who specializes in public policy and the aging, received grants from the state of Colorado and the Chicago-based to survey the use of medical marijuana by older Americans.

In many quarters, there’s a growing appetite for solid information, he said.

“When I first started this, my colleagues joked we were going to find all the aging hippies who listen to the Grateful Dead,” said Kaskie, who has been studying medicinal marijuana for years. “Now, they’re starting to realize this is a legitimate area of research.”

Twenty researchers received marijuana from the federal program last year, which was more than any previous year since 2010, according to NIDA statistics.

In a recent funding announcement, the National Institutes of Health requested grant applications to study the effects of on older adults and .

NIH, however, continues to funnel much of its funding into studying the adverse effects of marijuana, researchers said.

Although NIH acknowledged in one of the announcements that some research supports “possible benefits” of marijuana, it emphasized “there have not been adequate large controlled trials to support these claims.”

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The Trump administration announced that HIV expert Dr. Robert Redfield will lead the Centers for Disease Control and Prevention, ignoring complaints that his work on a high-profile vaccine research more than 20 years ago was flawed.

The Army in 1994 acknowledged accuracy issues with HIV vaccine clinical trials led by , but concluded at the time that the data errors did not constitute misconduct.

In an announcement Wednesday afternoon, Health and Human Services Secretary Alex Azar emphasized Redfield’s care of HIV/AIDS patients and his work as a researcher, which included the controversial research.

Yet one of the whistleblowers who first raised the matter to the Army told Kaiser Health News this week that he remains so troubled about Redfield’s handling of the vaccine research that he has decided to speak out publicly.

Redfield was principal investigator over clinical trials of a treatment vaccine at the Walter Reed Army Institute of Research. The research was conducted at a time when there was intense pressure to come up with a treatment for HIV/AIDS, which often killed patients within a matter of months.

“Either he was egregiously sloppy with data or it was fabricated,” said former Air Force Lt. Col. Craig Hendrix, a doctor who is now director of the division of clinical pharmacology at Johns Hopkins University School of Medicine. “It was somewhere on that spectrum, both of which were serious and raised questions about his trustworthiness.”

In a letter to Trump this week, Washington Sen. Patty Murray, the ranking Democrat on the health committee, cited the research controversy as an example of a “pattern of ethically and morally questionable behavior” by Redfield that should prompt the president to reconsider the appointment.

Redfield’s appointment, which does not require Senate confirmation, was leaked to the news media over the weekend. Redfield did not respond to questions.

Redfield, who denied any scientific misconduct at the time, is now an HIV/AIDS expert at the University of Maryland School of Medicine. He has been praised by his supporters for his care of patients. He oversees a clinical program that treats 6,000 patients in the Baltimore-Washington area, according to an online bio.

But Redfield’s critics said the appointment demonstrates that the Trump administration is not vetting appointees thoroughly. The first CDC head, Brenda Fitzgerald, stepped down in January after a controversy over her purchase of tobacco stocks, and former HHS Secretary Tom Price resigned late last year amid criticism over his use of government and private planes for official travel.

“The White House claimed they would do better background checks,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “But that statement is dangerously laughable. If they had done a proper background check, they wouldn’t have chosen Dr. Redfield.”

Public Citizen, a Washington watchdog group, was a leading critic of the Army’s handling of Redfield’s data at the time and obtained and published documents that detailed the controversy.

Hendrix, who was the director of an Air Force HIV clinical unit when he raised the concerns, said: “Two members of his [Redfield’s] team told me they had tried to replicate the analysis, but they couldn’t. When they tried to go to the Army, they said they were ignored.”

After Hendrix couldn’t replicate the results, he drafted a letter to his superiors reporting the data problems.

Hendrix said Redfield’s superiors initially told him not to send a letter detailing the concerns. Instead, the military scheduled a meeting with Redfield and other researchers so Hendrix could discuss the concerns. In the meeting, Hendrix recalled, Redfield acknowledged he had overstated how promising the results were.

“I thought it was resolved,” said Hendrix, who said he later called Redfield to say he was proud to work in an organization that could openly discuss such concerns.

However, Hendrix soon heard Redfield make the same inaccurate representations of the data at a conference and decided to file an official complaint requesting an investigation into scientific misconduct.

An Air Force institutional review board also recommended that the Army launch an inquiry stating: “The committee agreed the information presented by Dr. Redfield seriously threatens his credibility as a researcher and has the potential to negatively impact AIDS research funding for military institutions as a whole.”

But the Army did not appear to launch a full investigation, said Hendrix, who was interviewed at the time by the military official who conducted the inquiry. The military official declined Hendrix’s attempts to provide documented evidence, telling him the investigation was “informal.”

Hendrix later asked the commander of his hospital about the outcome of the investigation. He recalled that the commander called another officer to ask.

“I just remember him saying “Yes, sir,” he said. “When he hung up, he told me, ‘We will not be discussing this again.’”

Redfield was transferred from the laboratory he headed and assigned to treat patients, although the Army said he was not being punished. The Army also said the data would be corrected, and the military scrapped the program.

The project had earlier drawn criticism because Congress had set aside $20 million for the vaccine after lobbying by a former senator on behalf of the manufacturer.

Hendrix said he occasionally interacted over the years with Redfield and holds no grudges.

“Before this happened, he made important contributions to HIV-prevention efforts,” he said. “I respected him.”

However, he said, he remains disturbed by the military’s handling of the matter. He teaches a class on medical ethics and uses his own experience without naming Redfield to describe to his students the ethical quandaries faced in research.

Faulty data can lead other scientists to repeat the same mistakes and prompt participants to seek out trials for drugs and vaccines that don’t work.

“It’s a huge waste of funds,” he said. “But just as importantly, it diminishes trust, which is essential in science. If truth is eroded, then the whole enterprise falls apart.”

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SIU professor William Halford, who died in June, had injected Americans 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 Food and Drug Administration or an institutional review board.

Two of the participants who filed the lawsuit, Elizabeth Erkelens and Ed Biel, received the vaccine in the Caribbean trial, according to the lawsuit. The third participant, Terry Graham, was injected in two Illinois hotel rooms, it states.

The lawsuit, which was filed Friday in an Illinois circuit court, demands compensation from Halford’s company, Rational Vaccines, alleging his research violated U.S. and international laws aimed at protecting the rights of participants in experiments.

Alan Milstein, a New Jersey lawyer representing the three participants, said his clients believe they should receive compensation not only for their medical costs, but also “pain and suffering” and loss of “dignity.” Milstein said he is still exploring legal options against the university, which shared in the vaccine’s patent, set up a business account to collect donations for Halford’s research and promoted his work.

“My clients are anxious to ensure such unethical experimentation on human subjects are not repeated,” said Milstein, who specializes in such cases.

A spokesman for Rational Vaccines did not respond to a request for comment. Earlier, the company had said that it plans to continue testing the vaccine and hopes to eventually secure approval from the FDA, although it’s unclear how it could without oversight from the federal government.

Halford co-founded Rational Vaccines with Hollywood filmmaker Agustín Fernández III in 2015. The company has since received millions of dollars in private investment from billionaire Peter Thiel, who contributed to President Donald Trump’s campaign. Thiel has declined to comment on his investment.

Rational Vaccines has said it considers the 2016 trial a success — though it is unclear what data it used to support that claim.

Another participant, Richard Mancuso, has publicly asserted the vaccine cured him of herpes.

The lawsuit comes as the university is still investigating what it now describes as Halford’s misconduct.

SIU, a state university with a medical school in Springfield, Ill., initially said it bore no responsibility for the experiments because Halford conducted the research independently. 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 has since acknowledged that Halford’s conduct violated university rules and U.S. laws but said that Halford hid his misconduct from the university. The investigation probing his research and the help he might have received by other SIU employees is ongoing.

The dean of SIU’s medical school, Jerry Kruse, has refused multiple requests by Kaiser Health News for an interview, but in a statement he said he and other university officials knew nothing about improper research methods. Sen.Chuck Grassley, an Iowa Republican who is known for pushing for accountability on such matters, demanded a response from HHS and the university about their handling of the controversy. HHS’ Office for Human Research Protections, which is supposed to monitor such violations, may not investigate the matter, HHS told Grassley.

“OHRP expects that SIU’s forthcoming report will provide sufficient information … to determine whether the office has jurisdiction,” Matthew Bassett, the HHS assistant secretary for legislation, wrote Grassley in a letter obtained by KHN.

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SIU’s ethics panel launched a “full” investigation Dec. 5 of the herpes vaccine experiments by university professor William Halford, according to a memo obtained by Kaiser Health News.

Halford, who died in June, had injected Americans with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without routine safety oversight from the Food and Drug Administration or an institutional review board, according to ongoing reporting by KHN. Some of the participants say they are experiencing side effects.

The panel, known as the Misconduct in Science Committee, told SIU’s medical school dean that the inquiry should not only investigate the extent of Halford’s alleged wrongdoing, but also scrutinize “members of his research team,” according to the Dec. 5 memo obtained through a Freedom of Information Act request.

“The Misconduct in Science Committee is now in its investigative stage and the School anticipates this investigation will take approximately 120 days,” SIU spokeswoman Karen Carlson told KHN in an emailed response. “However, the investigation could take longer.”

The panel’s inquiry marks the second one to be launched by SIU since Halford’s methods were detailed in a KHN report in 2017.

The Department of Health and Human Services asked the university to determine whether Halford’s activities violated the institution’s pledge to HHS. SIU, a state university, had pledged to follow human-subject safety protocols for all research, even if privately funded.

In October, SIU medical school’s institutional review board determined Halford’s activities were in “serious noncompliance” with university rules and U.S. regulations and recommended that the misconduct committee investigate, according to records obtained by KHN under open-records laws.

Now, the committee has taken up the case, putting more pressure on SIU’s medical school, which initially said it bore no responsibility for the experiments.

The committee, which is made up of five faculty members, holds hearings about such misconduct and can call witnesses before reaching a conclusion.

The university is required to have such a committee to assure the federal government that it will examine allegations of research misconduct, said , a professor of health law at SIU’s medical school in Springfield,Ill. The medical school receives about $ 9 million a year in federal research dollars.

“Part of the reason this committee exists is to keep the federal funding clean and flowing,” said Spielman, who specializes in bioethics. “Any university that does research, especially with human subjects, wants to be trusted by the federal government and the public.”

In SIU’s response to KHN’s open-records request, the university excised the names of the committee members.

Carlson said that after the committee’s investigation is complete “in conjunction with recommendations from the appropriate federal agencies, we will address our policies and procedures and anything else that arises from the investigation.”

“Currently, no herpes research is being conducted at SIU,” she said.

SIU had said Halford conducted his research on human subjects independently in the Caribbean in 2016 with a company he co-founded with a Hollywood filmmaker. Yet, SIU’s medical school shared in a patent on a prospective vaccine with Halford’s company, Rational Vaccines, and promoted Halford’s vaccine research on its website.

The university has not responded to questions about its role in earlier experiments on human experiments by Halford. According to emails obtained by KHN and an account by one of the participants in the herpes vaccine experiment, Halford injected patients with the vaccine in 2013 in Illinois hotel rooms.

Many of the email exchanges with the participants in 2013 — asking them to send photographs of rashes, blisters and other reactions — were sent from Halford’s university email account. He used the university phone for communication and he referred to a graduate student as assisting in the experiment and to using the lab, which ethics experts said could constitute an improper use of state funds.

It is unclear whether the committee will have access to Halford’s or his former colleagues’ emails for its inquiry. An SIU colleague who had worked with him on his research took a job with Rational Vaccines, according to his online profile. Edward Gershburg, a former SIU professor, describes himself as the company’s chief technology officer, . Gershburg, who is no longer with the university, could not be reached for comment, and the company did not respond to questions about him.

In the Dec. 5 memo obtained by KHN, the misconduct committee pointed out that Halford received federal funding for his research on animals from the National Institutes of Health. In such cases, universities are supposed to ensure that researchers don’t use federal funding for unauthorized research, ethics experts told KHN. SIU’s Carlson said Halford’s NIH funds stopped in 2012.

“It is unclear at this time whether that grant is affected by the alleged misconduct,” stated the memo, which was sent to the medical school dean, Jerry Kruse, who assumed that role on Jan. 1, 2016.

In a reference to Halford’s nasal cancer, which was diagnosed before the human-subject experiments, the committee added: “We can only speculate as to [Halford’s] motivation, which may have been related to his terminal illness.”

NIH declined comment and HHS did not respond to questions.

The pressure on the university has intensified with attention from Capitol Hill and a high-profile lawyer.

In letters sent out earlier this month, Iowa Sen. Chuck Grassley, the Republican chair of the Judiciary Committee, told the Trump administration and Southern Illinois University that he wanted to be reassured that “corrective action” was being taken to prevent similar research abuses.

In a separate development, three participants injected with an unauthorized herpes vaccine by Halford are demanding compensation from SIU for alleged side effects from the vaccine.

The participants recently hired , a New Jersey lawyer who specializes in litigating research abuses. In late December, Milstein notified SIU that the participants hired him to pursue litigation. Milstein asked for a meeting to discuss the participants’ fears about the vaccine and possible side effects.

“They realize now they were used as guinea pigs in outrageously unethical experiments that defied and flouted the most basic requirements of human-subject research in this country,” Milstein said in an interview.

The participants, who have herpes, have requested anonymity to protect the privacy of their health.

Milstein sent a similar letter to Halford’s company, Rational Vaccines.

Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III and has since received millions of dollars in private investment from billionaire Peter Thiel, who contributed to President Donald Trump’s campaign.

SIU declined to comment, and the company did not respond to questions about Milstein’s letter.

While critics have accused Milstein of relying on overly aggressive tactics that obstruct legitimate research, he is widely known to pursue research misconduct cases, even those involving some of the nation’s most prominent research institutions.

Over the past decade, Milstein has represented plaintiffs alleging research abuses committed by drug companies and prestigious universities, including Stanford University and the University of Pennsylvania. The complaints often have led to confidential settlements.

Regardless of whether SIU can be found negligent in court, Spielman of SIU said she believed the university owed the participants an “institutional apology” for how the research was conducted.

“The university should acknowledge that there must have been some kind of breakdown in the system,” she said.

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Over the past two years, more than 200 patients have flocked to see after learning that two drugs he prescribes could possibly stave off aging. One 95-year-old was so intent on keeping her appointment that she asked her son to drive her from Maryland after a snowstorm had closed the schools.

Green is among a small but growing number of doctors who prescribe drugs “off-label” for their possible anti-aging effects. Metformin is typically prescribed for diabetes, and rapamycin prevents organ rejection after a transplant, but doctors can prescribe drugs off-label for other purposes — in this case, for “aging.”

Rapamycin’s anti-aging effects on animals and metformin’s on people with diabetes have encouraged Green and his patients to experiment with them as anti-aging remedies, even though there’s little evidence healthy people could benefit.

“Many of [my patients] have Ph.D.s,” said Green, who is 76 and has taken the drugs for three years. “They have read the research and think it’s worth a try.”

In fact, it’s easier for patients to experiment with the drugs — either legally off-label or illegally from a foreign supplier — than it is for researchers to launch clinical trials that would demonstrate they work in humans.

No rigorous large-scale clinical trials have been conducted aimed at aging. The FDA so far has not agreed that a treatment could be approved for delaying the onset of aging or age-related diseases, citing questions about whether research can demonstrate an overall effect on aging rather than just on a specific disease.

Given such reservations, pharmaceutical companies have little incentive to fund costly, large-scale trials. Also, both metformin and rapamycin are generic and relatively cheap.

“There’s no profit,” said , a professor of pathology at the University of Washington medical school whose team received a $15 million grant from the National Institutes of Health to study the effects of rapamycin in dogs, but has noted the lack of funds for studies in people. “Without profit, there’s no incentive.”

Supplements with purported anti-aging effects routinely enter the market with little scrutiny and less evidence.

Yet, late last year, the NIH rejected a $77 million grant by a prominent group of researchers to determine whether metformin could target multiple age-related diseases at once. It was the second rejection of the ambitious but unorthodox bid.

“We’re going to keep trying,” said a lead author of the metformin proposal, Stephen Kritchevsky, a co-director of the Sticht Center for Healthy Aging and Alzheimer’s Prevention. “These things take time.”

Less is known about rapamycin’s anti-aging effects and its possible side effects in the general population, including the possibility it could lead to insulin resistance. Yet a litany of studies show that rapamycin extends animal life spans. It also has been shown in such studies to stave off age-related diseases, from cancer to cardiovascular diseases to cognitive diseases.

“There should have been a clinical trial for rapamycin and Alzheimer’s disease years ago,” said Kaeberlein, who has publicly urged NIH to use a historic boost in Alzheimer’s funding to . “But the fact is, the clinical trials are really hard and expensive.”

Alexander Fleming, a former FDA official and advocate for the metformin proposal, said he believed it was difficult for regulators and funders to grasp that aging can be tackled as a whole — not just one disease at a time.

In fact, NIH reviewers who rejected the metformin proposal cited problems with the project’s aim of testing multiple age-related diseases at once. The researchers considered appealing the decision, asserting those reviewers were biased against studying aging as a whole. NIH, which declined to comment, discouraged the attempt.

, director of the National Institute on Aging’s division of geriatrics and clinical gerontology, told Kaiser Health News that NIH is not ruling out funding projects that target aging, saying such proposals are still “of interest.”

The FDA also is open to considering such efforts “based on the scientific evidence presented to us,” said FDA spokeswoman Amanda Turney.

Fleming, who oversaw the controversial FDA approval of metformin for Type 2 diabetes, said an argument could be made that it could approve a drug like metformin for preventing age-related diseases instead of just treating them. He points to now widely used statins, which were approved to prevent heart disease.

“There is some kind of belief that the FDA can’t approve a therapy to reduce the progress of aging or age-related conditions,” said Fleming, an endocrinologist. “It’s just not true.”

Given the lack of consensus, other researchers have moved ahead with clinical trials focused on specific age-related conditions.

Researchers have shown that a “cousin” of rapamycin boosts the effectiveness of flu shots and lowers the incidence of upper respiratory infections in seniors by up to 30 percent. This group, led by Dr. Joan Mannick, has licensed it from Novartis and is now working on getting approval to target Parkinson’s disease.

“We’re trying to be pragmatic,” Mannick said of .

Some doctors and patients have decided not to wait. At a recent scientific forum on aging, one of the researchers on the NIH proposal asked the 300 or so people in attendance to raise their hands if they were already taking metformin for aging.

“Half the audience raised their hands,” recalled the researcher, director of the Institute for Aging Research at the Albert Einstein College of Medicine, who said a pharmaceutical rep recently estimated that metformin sales are up 20 percent.

Barzilai is concerned about the off-label trend, although he sees metformin as promising. He contends that researchers in the longevity field first need to set up a framework for testing in clinical trials. Even if metformin doesn’t pan out as the most effective drug, he asserts a model like the metformin proposal is needed for any major clinical trial to proceed. His group is now trying to secure about half the amount of funding it requested from NIH from a mix of nonprofit and private investment.

“Much of the aging field is charlatans,” Barzilai said. “They tell you take this or that and you’ll live forever. But you have to do a clinical trial that is placebo-controlled and only then can you say what it really is and whether it’s safe.”

Green nonetheless said he plans to continue prescribing. He estimates about 5 percent of his patients are doctors themselves. Others have backgrounds in science or are in the upper-income bracket. According to his website, he charges $350 for an initial visit and does not accept insurance.

“They fly to see me on their own planes,” he said.

But other doctors who are open to prescribing metformin are holding off on rapamycin, given side effects in higher doses in sick patients.

“I need to see more evidence,” said Dr. Garth Denyer, a doctor in The Woodlands, a wealthy Houston suburb, who said he prescribed metformin to a small number of patients but is waiting on rapamycin. “I’m hoping to see more data on safety.”

Michael Slattery, who has been HIV-positive since 1983, said he is taking both drugs because the virus is likely to shorten his life expectancy.

So far, he has not noticed any side effects or benefits. His partner, however, who is also HIV-positive, stopped taking rapamycin after getting kidney infections.

“I feel I have nothing left to lose,” said Slattery, a retired biotech consultant.

Other patients remain hopeful, even though the evidence is unlikely to be definitive anytime soon.

Linda Mac Dougall, 70, of Port Hueneme, Calif., said she participated in a small study that did not have a placebo control. She’s uncertain whether it had any effect on her.

“I really haven’t noticed anything, but that doesn’t mean it didn’t work,” said Mac Dougall, a massage therapist for seniors. She has slightly more confidence in the wide array of supplements she takes, she said: “If I live until I’m 110, we’ll know.”

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What’s the 49-year-old’s secret? He says his daily regimen includes ingesting a molecule his own research found improved the health and lengthened the life span of mice. Sinclair now boasts that he has the lung capacity, cholesterol and blood pressure of a “young adult” and the “heart rate of an athlete.”

Despite his enthusiasm, published scientific research has not yet demonstrated the molecule works in humans as it does in mice. Sinclair, however, has a considerable financial stake in his claims being proven correct, and has lent his scientific prowess to commercializing possible life extension products such as molecules known as “NAD boosters.”

His financial interests include being listed as an inventor on a patent licensed to Elysium Health, a supplement company that sells a NAD booster in pills for $60 a bottle. He’s also an investor in the company that he says measured his age.

Discerning hype from reality in the longevity field has become tougher than ever as reputable scientists such as Sinclair and pre-eminent institutions like Harvard align themselves with promising but unproven interventions — and at times promote and profit from them.

Fueling the excitement, investors pour billions of dollars into the field even as many of the products already on the market face fewer regulations and therefore a lower threshold of proof.Ìý

“If you say you’re a terrific scientist and you have a treatment for aging, it gets a lot of attention,” said Jeffrey Flier, a former Harvard Medical School dean who has been critical of the hype. “There is financial incentive and inducement to overpromise before all the research is in.”

Elysium, co-founded in 2014 by a prominent MIT scientist to commercialize the molecule nicotinamide riboside, a type of NAD booster, highlights its “exclusive” licensing agreement with Harvard and the Mayo Clinic and Sinclair’s role as an inventor. According to the company’s , the agreement is aimed at supplements that slow “aging and age-related diseases.”

Further adding scientific gravitas to its brand, the website lists and 19 other prominent scientists who sit on its scientific advisory board. The company also advertises with Harvard and U.K. universities Cambridge and Oxford.

Some scientists and institutions have grown uneasy with such ties. announced in 2017 it would receive funding from Elysium, cementing a research “partnership.” But after hearing complaints from faculty that the institute was associating itself with an unproven supplement, it quietly decided not to renew the funding or the company’s membership to its “innovation” board.

“The sale of nutritional supplements of unproven clinical benefit is commonplace,” said Stephen O’Rahilly, the director of Cambridge’s Metabolic Research Laboratories who applauded his university for reassessing the arrangement. “What is unusual in this case is the extent to which institutions and individuals from the highest levels of the academy have been co-opted to provide scientific credibility for a product whose benefits to human health are unproven.”

The bottom line is I don’t try any of these things. Why don’t I? Because I’m not a mouse.

Felipe Sierra, the director of the division of aging biology at the National Institute on Aging at NIH

The Promise

A generation ago, scientists often ignored or debunked claims of a “fountain of youth” pill.

“Until about the early 1990s, it was kind of laughable that you could develop a pill that would slow aging,” said Richard Miller, a biogerontologist at the University of Michigan who heads one of three labs funded by the National Institutes of Health to test such promising substances on mice. “It was sort of a science fiction trope. Recent research has shown that pessimism is wrong.”

Mice given molecules such as rapamycin live as much as 20 percent longer. Other substances such as 17 alpha estradiol and the diabetes drug Acarbose have been shown to be just as effective — in mouse studies. Not only do mice live longer, but, depending on the substance, they avoid cancers, heart ailments and cognitive problems.

But human metabolism is different from that of rodents. And our existence is unlike a mouse’s life in a cage. What is theoretically possible in the future remains unproven in humans and not ready for sale, experts say.

History is replete with examples of cures that worked on mice but not in people. Multiple drugs, for instance, have been effective at targeting an Alzheimer’s-like disease in mice yet have failed in humans.

“None of this is ready for prime time. The bottom line is I don’t try any of these things,” said Felipe Sierra, the director of the division of aging biology at the National Institute on Aging at NIH. “Why don’t I? Because I’m not a mouse.”

The Hype

Concerns about whether animal research could translate into human therapy have not stopped scientists from racing into the market, launching startups or lining up investors. Some true believers, including researchers and investors, are taking the substances themselves while promoting them as the next big thing in aging.

“While the buzz encourages investment in worthwhile research, scientists should avoid hyping specific [substances],” said S. Jay Olshansky, a professor who specializes in aging at the School of Public Health at the University of Illinois at Chicago.

Yet some scientific findings are exaggerated to help commercialize them before clinical trials in humans demonstrate both safety and efficacy, he said.

“It’s a great gig if you can convince people to send money and use it to pay exorbitant salaries and do it for 20 years and make claims for 10,” Olshansky said. “You’ve lived the high life and get investors by whipping up excitement and saying the benefits will come sooner than they really are.”

Promising findings in animal studies have stirred much of this enthusiasm.

Research by Sinclair and others helped spark interest in resveratrol, an ingredient in red wine, for its potential anti-aging properties. In 2004, Sinclair co-founded a company, Sirtris, to test resveratrol’s potential benefits and declared in an interview with the journal Science it was “as close to a miraculous molecule as you can find.” GlaxoSmithKline bought the company in 2008 for $720 million. By the time Glaxo halted the research in 2010 because of underwhelming results with possible side effects, Sinclair had already received $8 million from the sale, according to Securities and Exchange Commission documents. He also had earned $297,000 a year in consulting fees from the company, according to The Wall Street Journal.

At the height of the buzz, Sinclair accepted a paid position with Shaklee, which sold a product made out of resveratrol. But he resigned after The Wall Street Journal highlighted positive comments he made about the product that the company had posted online. He said he never gave Shaklee permission to use his statements for marketing.

Sinclair practices what he preaches — or promotes. On his LinkedIn bio and in media interviews, he describes how he now regularly takes resveratrol; the diabetes drug metformin, which holds promise in slowing aging; and nicotinamide mononucleotide, a substance known as NMN that his own research showed rejuvenated mice.

Of that study, he said in a video produced by Harvard that it “sets the stage for new medicines that will be able to restore blood flow in organs that have lost it, either through a heart attack, a stroke or even in patients with dementia.”

In an interview with KHN, Sinclair said he’s not recommending that others take those substances.

“I’m not claiming I’m actually younger. I’m just giving people the facts,” he said, adding that he’s sharing the test results from InsideTracker’s blood tests, which calculate biological age based on biomarkers in the blood. “They said I was 58, and then one or two blood tests later they said I was 31.4.”

InsideTracker sells an online age-tracking package to consumers for up to about . The company’s Sinclair’s support for the company as a member of its scientific advisory board. It also touts a study that describes the benefits of such tracking, which Sinclair co-authored.

Sinclair is involved either as a founder, an investor, an equity holder, a consultant or a board member with 28 companies, according to a of his financial interests. At least 18 are involved in anti-aging in some way, including studying or commercializing NAD boosters. The interests range from longevity research startups aimed at humans and even pets to developing a product for a to advising a longevity investment fund. He’s also an inventor named in the patent licensed by Harvard and the Mayo Clinic to Elysium, and one of his companies, MetroBiotech, has filed a related to nicotinamide mononucleotide, which he says he takes himself.

Sinclair and Harvard declined to release details on how much money he — or the university — is generating from these disclosed outside financial interests. Sinclair estimated in a 2017 interview with Australia’s Financial Review that he raises $3 million a year to fund his Harvard lab.

Liberty Biosecurity, a company he co-founded, estimated in Sinclair’s online bio that he has been involved in ventures that “have attracted more than a billion dollars in investment.” When KHN asked him to detail the characterization, he said it was inaccurate, without elaborating, and the comments later disappeared from the website.

Sinclair cited confidentiality agreements for not disclosing his earnings, but he added that “most of this income has been reinvested into companies developing breakthrough medicines, used to help my lab, or donated to nonprofits.” He said he did not know how much he stood to make off the Elysium patent, saying Harvard negotiated the agreement.

Harvard declined to release Sinclair’s conflict-of-interest statements, which university policy requires faculty at the medical school to file in order to “protect against any faculty bias that could heighten the risk of harm to human research participants or recipients of products resulting from such research.”

“We can only be proud of our collaborations if we can represent confidently that such relationships enhance, and do not detract from, the appropriateness and reliability of our work,” the policy states.

Elysium advertises both Harvard’s and Sinclair’s ties to its company. It was co-founded by Massachusetts Institute of Technology professor , Sinclair’s former research adviser and an investor in Sinclair’s .

Echoing his earlier statements on resveratrol, Sinclair is quoted on Elysium’s website as describing NAD boosters as .”

Supplement Loophole?

The Food and Drug Administration doesn’t categorize aging as a disease, which means potential medicines aimed at longevity generally can’t undergo traditional clinical trials aimed at testing their effects on human aging. In addition, the FDA does not require supplements to undergo the same safety or efficacy testing as pharmaceuticals.

The banner headline on Elysium’s website said that “clinical trial results prove safety and efficacy” of its supplement, Basis, which contains the molecule nicotinamide riboside and pterostilbene. But the did not demonstrate the supplement was effective at anti-aging in humans, as it may be in mice. It simply showed the pill increased the levels of the substance in blood cells.

“Elysium is selling pills to people online with the assertion that the pills are ‘clinically proven’” said O’Rahilly. “Thus far, however the benefits and risks of this change in chemistry in humans is unknown.”

“Many interventions that seem sensible on the basis of research in animals turn out to have unexpected effects in man,” he added, citing a large clinical trial of beta carotene that showed it increased rather than decreased the risk of lung cancer in smokers.

Elysium’s own research documented a “small but significant increase in ,” but added more studies were needed to determine whether the changes were “real or due to chance.” One independent has suggested that a component of NAD may influence the growth of some cancers, but researchers involved in the study warned it was too early to know.

Guarente, Elysium’s co-founder and chief scientist, told KHN he isn’t worried about any side effects from Basis, and he emphasized that his company is dedicated to conducting solid research. He said his company monitors customers’ safety reports and advises customers with health issues to consult with their doctors before using it.

If a substance meets the FDA’s definition of a supplement and is advertised that way, then the agency can’t take action unless it proves a danger, said Alta Charo, a former bioethics policy adviser to the Obama administration. Pharmaceuticals must demonstrate safety and efficacy before being marketed.

“A lot of what goes on here is really, really careful phrasing for what you say the thing is for,” said Charo, a law professor at the University of Wisconsin. “If they’re marketing it as a cure for a disease, then they get in trouble with the FDA. If they’re marketing it as a rejuvenator, then the FDA is hamstrung until a danger to the public is proven.”

“This is a recipe for some really unfortunate problems down the road,” Charo added. “We may be lucky and it may turn out that a lot of this stuff turns out to be benignly useless. But for all we know, it’ll be dangerous.”

The debate about the risks and benefits of substances that have yet to be proven to work in humans has triggered a debate over whether research institutions are scrutinizing the financial interests and involvement of their faculty — or the institution itself — closely enough. It remains to be seen whether Cambridge’s decision not to renew its partnership will prompt others to rethink such ties.

Flier, the former dean of Harvard Medical School, had earlier heard complaints and looked into the relationships between scientists and Elysium after he stepped down as dean. He said he that many of the board members who allowed their names and pictures to be posted on the company website knew little about the scientific basis for use of the company’s supplement.

Flier recalls that one scientist had no real role in advising the company and never attended a company meeting. Even so, Elysium was paying him for his role on the board, Flier said.

Caroline Perry, director of communications for Harvard’s Office of Technology Development, said agreements such as of research funds from Elysium comply with university policies and “protect the traditional academic independence of the researchers.”

Harvard “enters into research agreements with corporate partners who express a commitment to advancing science by supporting research led by Harvard faculty,” Perry added.

Like Harvard, the Mayo Clinic refused to release details on how much money it would make off the Elysium licensing agreement. Mayo and Harvard engaged in “substantial diligence and extended negotiations” before entering into the agreement, said a Mayo spokeswoman.

“The company provided convincing proof that they are committed to developing products supported by scientific evidence,” said the spokeswoman, Duska Anastasijevic.

Guarente of Elysium refused to say how much he or Elysium was earning off the sale of the supplement Basis. MIT would not release his conflict-of-interest statements.

Private investment funds, meanwhile, continue to pour into longevity research despite questions about whether the substances work in people.

One key Elysium is the Morningside Group, a private equity firm run by Harvard’s top donor, Gerald Chan, who also gave

Billionaire and WeWork co-founder Adam Neumann has invested in Sinclair’s Life Biosciences.

An investment firm led by engineer and physician Peter Diamandis gave a group of Harvard researchers $5.5 million for their startup company after their research was publicly challenged by several other scientists.

In its announcement of the seed money, the company, Elevian, said its goal was to develop “new medicines” that increase the activity levels of the hormone GDF11

It described research by its founders, which include Harvard’s , as demonstrating that “replenishing a single circulating factor, GDF11, in old animals mirrors the effects of young blood, repairing the heart, brain, muscle and other tissues.”

Other in the field have either failed to replicate or contradict key elements of their observations.

Elevian’s CEO, Mark Allen, said the early scientific data on GDF11 is encouraging, but “drug discovery and development is a time-intensive, risky, regulated process requiring many years of research, preclinical [animal] studies, and human clinical trials to successfully bring new drugs to market.”

Flier worries research in the longevity field could be compromised, although he recognizes the importance and promise of the science. He said he’s concerned that alliances between billionaires and scientists could lead to less skepticism.

“A susceptible billionaire meets a very good salesman scientist who looks him deeply in the eyes and says, ‘There’s no reason why we can’t have a therapy that will let you live 400 or 600 years,’” Flier said. “The billionaire will look back and see someone who is at MIT or Harvard and say, ‘Show me what you can do.’”

Despite concerns about the hype, scientists are hopeful of finding a way forward by relying on hard evidence. The consensus: A pill is on the horizon. It’s just a matter of time — and solid research.

“If you want to make money, hiring a sales rep to push something that hasn’t been tested is a really great strategy,” said Miller, who is testing substances on mice. “If instead you want to find drugs that work in people, you take a very different approach. It doesn’t involve sales pitches. It involves the long, laborious, slogging process of actually doing research.”

KHN senior correspondent Jay Hancock contributed to this report.

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Among the most prominent: Dr. Robert Redfield, director of the Centers for Disease Control and Prevention. Smith said he enthusiastically urged administration officials to pick his longtime friend and associate, who now oversees one of the agencies that fund the multibillion-dollar international prevention and treatment program known as the President’s Emergency Plan for AIDS Relief (PEPFAR).

And within the White House itself are certain aides the activist has known for years, as he acknowledged during a series of interviews with Kaiser Health News. They include Katy Talento, a leading conservative voice on health care policy, and staffers in Vice President Mike Pence’s office who court religious conservatives on a variety of issues.

Even Smith’s wife, who has had her own high-profile activism over the years, is working on abstinence efforts within the administration. Anita Smith was hired recently as a part-time PEPFAR consultant by one of the couple’s longtime allies.

“This is the new in crowd,” said Paul Zeitz, an expert on global AIDS epidemic control who worked for the State Department from mid-2014 until last August. “These are the people who are likely to be influencing how we spend taxpayer money on AIDS efforts for the rest of the administration.”

Such connections signal a resurgence of religious conservatives’ influence over health care issues well beyond abstinence education. Last year, President Donald Trump announced that PEPFAR must now follow the , which bans foreign, non-governmental organizations from using their funds for abortion-related services such as counseling.

The origins of Shepherd Smith’s high-profile contacts are detailed in memos, letters and military documents in an archive of KHN examined hundreds of pages there to help assess the Trump administration’s approach to health policy and AIDS treatment and prevention.

While PEPFAR is credited with saving millions of lives in Africa and elsewhere, several of its programs, especially those encouraging abstinence, have been criticized by scientists and relief experts as ineffective and impractical.

In the late 1980s, Smith developed relationships with government scientists even as other religious leaders balked at the idea of getting involved in AIDS prevention efforts. That included recruiting Redfield, at what was then Walter Reed Army Medical Center, to join the advisory board of the Smiths’ fledgling Americans for a Sound AIDS/HIV Policy. The now-defunct organization strongly supported abstinence education.

“We sought [the scientists] out because we thought they were doing the right thing,” the 73-year-old Smith told KHN. “It’s not rocket science. We figured out a plan for our message to become important.”

Redfield also served as chairman and an advisory board member of another organization that Smith and his wife later founded. He stepped down from Children’s AIDS Fund International, which also backs abstinence education, only to comply with government ethics rules after he joined the CDC in March.

In recent media interviews, the physician-researcher said he has rethought his opposition to promoting condom use in the fight against AIDS. He elaborated on that in a statement in July to KHN, saying he supports programs that encourage people who are not sexually active to delay sex and have fewer partners — an approach hailed by conservative activists.

“We know that abstinence is the only 100 percent effective way to prevent HIV and other transmitted diseases,” he noted in the statement.

Anita Smith is now a consultant within PEPFAR to Deborah Birx, a physician and ambassador-at-large who oversees the program’s estimated $5 billion annual budget. Birx is also a former board member of Children’s AIDS Fund International and served until she was hired by the CDC in 2005, a PEPFAR spokesman said. (The organization received PEPFAR grants between 2004 and 2008 despite an early evaluation from experts who deemed it “not suitable for funding,” at the time.)

Smith’s hiring earlier this year was part of a strategy to improve prevention programs aimed at preteen girls, including support for “decision-making around whether to delay, abstain or protect,” according to a statement from Birx’s office.

“The administration is trying to put sweeteners in there for religious conservatives,” said Heather Boonstra, director of public policy at the Guttmacher Institute, a nonprofit focused on reproductive health. “It’s not as if these concepts are a problem if they are included as part of a whole array of programs. The concern is that these changes are opening the door for a greater number of programs that focus solely on abstinence.”

Through her husband, Anita Smith declined to answer any questions. “My wife is an expert on these types of programs,” he said, “so it’s not surprising she would be asked to weigh in.” She remains president of the children’s AIDS organization, which is based in Sterling, Va. Shepherd Smith no longer has an official position there.

Birx’s statement explained her connection to the couple, noting that she became involved in the children’s organization through an annual Christmas event of gift-wrapping presents for families affected by HIV. “When they asked me to join their board, I did so to show my support for the concept of services to others in need,” she said.

Shepherd Smith’s alliances can be traced through the University of Michigan archive. It was set up by science writer Jon Cohen, whose 2001 book, “” examined what went wrong in the epidemic’s early years. According to a government transcript there, Smith sized up Redfield swiftly when they first met. “He was as happy to see us, as we were him,” Smith said in an interview with military investigators. Their relationship deepened as the activist and scientist rose in prominence, Smith’s letters to Walter Reed officials suggest.

Smith, who secured CDC dollars for Americans for a Sound AIDS/HIV Policy (ASAP) in the 1980s, regularly stopped by Walter Reed to see Redfield and others who joined the organization’s board, according to military records in the archive. Under Smith’s direction, ASAP touted Redfield’s vaccine research as being “the most important scientific advancement in the epidemic to date.” In turn, as ASAP chairman, Redfield called the group “the most effective AIDS/HIV organization I know” in its 1991 annual report.

The archive reveals that some Walter Reed scientists complained to Army officials about the organization’s possible influence with Redfield. The complaints triggered an inquiry into allegations that Smith was pressuring researchers to skew Redfield’s vaccine data to help secure congressional funding.

Though Redfield insisted he did not give Smith preferential treatment, a military investigator found that the researcher violated military rules and recommended the “close relationship” between Walter Reed and ASAP be “severed so there is not an appearance of endorsement or favoritism.” A separate inquiry concluded that Redfield had publicly overstated his data but cleared him of scientific misconduct charges.

In 1996, Redfield left the military and helped to establish the University of Maryland’s Institute of Human Virology.

To this day, Smith remains a fierce supporter. After controversy stirred over Redfield’s $375,000 salary — significantly more than previous CDC leaders earned — Smith told KHN the amount was well deserved. It ultimately was reduced to $209,700.

Smith describes himself as still pushing others hard for both information and action to stop the AIDS epidemic, but he demurred when asked how regularly he contacts administration officials, including the CDC director.

“I have no control over the guy,” Smith said when asked whether he expected Redfield to implement policy changes he supports. “I can only hope we’ll have a little more balance than we’ve seen in the last few years.”

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Previously, the administration’s “zero-tolerance” immigration stance meant splitting children from parents.Ìý Immigration authorities acknowledged that during that policy 2,322 children 12 and under Ìýwere detained and placed in facilities run by the Department of Health and Human Service.

The policy of detaining families “during the pendency of their immigration cases” was announced Friday night in a . But experts and former government officials warn the new approach — which places parents and children in the custody of the Department of Homeland Security for months or even longer — won’t improve the situation.

The DOJ declined to comment. DHS did not immediately respond to requests for comment.

“We’re seeing a repeat pattern of this administration,” said Sarah Pierce, a policy analyst with the Migration Policy Institute and former immigration attorney. “The president makes laws and policies and the administration then struggles to implement what he does.”

For longer detentions, DHS will need resources for young children that the agency doesn’t generally set up, such as educational facilities.

“They even need diapers, formula and bottles,” Pierce said. “We’re talking about the basics for caring for children.”

Making matters more complicated, DHS’ family facilities under the indefinite detention policy. The White House has also asked the Department of Defense to make detention facilities available.

“DHS’ primary focus — [its facilities] were designed to hold these people, and not let them out,” said Peter Boogaard, a former DHS spokesman under the Obama administration. “It is not in any way designed to protect the health and well-being of families and young children.”

While the Obama administration grappled with a sudden influx of families in 2014, the detention of families triggered litigation under the agreement, which required that families be detained together at DHS facilities and the children be released within 20 days. The Obama administration then began releasing the families under the agreement.

“Most of these families were released before the 20 days were up,” Pierce said.

The has also requested the Flores settlement be modified to permit longer detention of families being prosecuted, including children.

People who are stopped by the U.S. Border Patrol receive some baseline health screenings. And the Office of Refugee Resettlement, the HHS program in charge of “unaccompanied alien children,” typically provides some medical care for children detained at the border, including consultations with child psychologists and social workers.

In recent weeks, ORR — which took responsibility for children who had been separated from their parents — has come for providing reportedly substandard care, including reports that children’s psychiatric records and case files were being used in immigration court. Many experts have also suggested ORR couldn’t handle the number of kids being detained, and lacked expertise in caring for the many 12-and-under children detained who were separated from their families.

Still, unlike DHS, many noted, ORR has some expertise in providing children’s health services. Boogaard said he was unfamiliar with any protocols to ensure kids receive adequate vaccinations, or consultations with child psychologists and social workers.

“They are not resourced and not staffed to be able to deal with the unique challenges of dealing with children,” he said.

U.S. Immigration and Customs Enforcement, the DHS agency that operates detention centers, redirected questions to on standards for family centers. It says residents will have access to “health care education and maintenance services that are determined by the health care authority to be necessary and appropriate,” including “prevention, diagnosis, and treatment of medical, dental, and mental health conditions.”

Advocates and watchdog organizations, though, suggest that hasn’t been the case.

A argued “dangerously substandard medical care” had contributed to eight out of the 15 deaths documented in records released by ICE from December 2015 to April 2017. Medical reviewers also noted instances of poor medical care in six of the other deaths.

“ICE’s record of providing inadequate care to adults does not bode well if the agency is put in charge of providing care to increasing numbers of children,” said Alison Parker, who directs HRW’s U.S. program.

Meanwhile, children currently crossing the border have particularly intense health needs — in no small part because many are fleeing violent circumstances. Lengthy detention can add to that trauma, experts said.

“Historically thinking about what family detention has looked like in this country, we have reason to be concerned,” said Shadi Houshyar, who directs early childhood and child welfare initiatives at Families USA, an advocacy group. “Detention is no place for children.”

Prior to the 2015 ruling, she added, children in detention facilities were found “dehydrated, and not eating, and having intestinal problems.” Many new mothers, she added, experienced depression and trouble nursing.

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The Trump administration has detained 2,322 children 12 years old or younger amid its border crackdown, a Department of Health and Human Services official told Kaiser Health News on Wednesday. They represent almost 20 percent of the immigrant children currently held by the U.S. government in the wake of its latest immigrant prosecution policy.

Their welfare is being overseen by a small division of the Department of Health and Human Services — the Office of Refugee Resettlement (ORR) — which has little experience or expertise in handling very young children.

The number of children has exploded in the past six weeks since the Trump administration moved to stop parents and their children at the U.S. border and separate and detain them in different facilities. A total of 11,786 children under age 18 are currently detained, the official said.

President Donald Trump signed an Wednesday that seeks to detain parents and children together. The order also changes oversight of detention from HHS to the Department of Homeland Security. But it’s unclear whether the children currently detained by HHS will be transferred and whether the order will comply with a court standard for the treatment of children in custody, known as the Flores agreement.

Since 2003, ORR has been charged with sheltering and finding suitable homes for “unaccompanied alien children” — generally teenaged immigrants who reach the United States without a parent or guardian.

But its responsibilities have morphed and multiplied since April because the immigration crackdown means that the ORR is now responsible for detaining not only more children, but minors who are far younger than those who had arrived in the past, experts said.

Beyond specialized medical care, younger children have different food and housing needs, and require more personal attention.

“The children are younger and will be there for a longer time and are deeply traumatized by being forcibly separated from their parents,” said Mark Greenberg, a former administration official at HHS’ Administration for Children and Families, which oversees the ORR. “All of that makes it much more difficult to operate the program.”

The complex crisis is magnified by the inexperience of some of the political appointees leading the response, said critics who include former officials from both Republican and Democratic administrations of the past decade.

ORR Director Scott Lloyd is a lawyer whose career has been focused on anti-abortion efforts. He led the Trump administration’s legal efforts to prevent abortions for detained teen immigrants. Lloyd’s main immigration experience before leading ORR was research for a report on refugees for the Knights of Columbus, a Catholic service organization with an anti-abortion stance,

Kenneth Wolfe, the HHS spokesman who provided the figures, declined to address how many people are currently working at ORR or whether ORR had secured additional staff or expertise to cope with the influx of young children. He also would not say how many of the 2,322 children 12 and younger have been separated from their families.

The administration had previously refused to provide the ages of the children separated from their families — saying only that about 2,300 children have been separated and detained since the policy took effect.

The detention conditions, which include children being held in chain-link holding pens and “tent cities,” have ignited a political firestorm over possible abuse in the treatment of children as young as 4. Some of these younger children — including toddlers — are being sent to “tender age” shelters, according to media reports. The care is also costly: Tents alone cost HHS $775 per person per day, according to media reports.

Republicans, including former , have called on the administration to stop the policy. Trump has blamed Congress for the detentions, but top White House advisers were actively promoting family separations as a policy shift.

have described children as young as 5 being scolded for playing, one teenager teaching others how to change a small child’s diaper, and caretakers not being permitted to touch children. ProPublica reported that detained are younger than 4.

ORR, experts add, is already at a disadvantage.

“It’s significantly challenging to create that capacity, and quite expensive,” noted Robert Carey, a former ORR director from the Obama administration. “All the aspects of care are dramatically different based on age. … You need people who are trained in early childhood development or care.”

That’s a heavy lift for an office that, experts stress, was never built to serve as a long-term housing system.

It’s not clear, Carey and others said, that the administration has had sufficient time or support to adapt.

Many ORR employees, Carey added, are career staffers with deep knowledge about immigration and child welfare, with whom he frequently worked while in office.

“The kids are going into the custody of ORR without adequate resources,” said Shadi Houshyar, who directs early childhood and child welfare initiatives at Families USA, an advocacy group. “It’s definitely going to result in some potentially damaging decisions being made. The capacity, training and fundamental orientation — while understanding the needs of children — is not the orientation that ORR has.”

While ORR has a history of placing teenagers who arrive on their own with relatives of families in the U.S., that challenge is heightened by the policy of separating children, who are young and may understand little of the experience or be able to identify relatives who could take them in.

Making matters more complicated, when families are separated, parents and children are tracked by different federal agencies — the parents by the U.S. Department of Homeland Security, and the children by ORR. Children are also tracked and treated the same as minors who arrived on their own. Together, that makes reunification more difficult. And that’s a problem experts worry will persist, even if family separations cease.

“It does not look like they’ve figured out this process,” said a former HHS official, who requested anonymity because she could face professional ramifications for speaking publicly. As a result, she added, “the time the child stays in ORR could be significantly longer” — which in turn adds to trauma and causes other long-term problems.

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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.”

Sen. Chuck Grassley (D-Iowa), the chair of the Judiciary Committee, applauded the FDA’s action after he had called on the agency to look into the matter, citing Kaiser Health News’ investigation.

“We ought to find out if the research was done with the knowledge of those who should’ve acted to stop it instead of turning a blind eye …” he said in a statement. “This research broke just about every rule in the book and put human subjects at extreme health risk.”

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,Ìý, 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 , a corporate official may be prosecuted for a criminal misdemeanor offense under the 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, Ill., 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 U.S. 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 , for instance, pleaded guilty in 2010 to charges related to her fabrication of data in a study of children taking the antidepressant Paxil. later agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability in the case.

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For four years, her doctor prescribed the 61-year-old a wide range of opioids for her transverse myelitis, a debilitating disease that caused pain, muscle weakness and paralysis.

The drugs not only failed to ease her symptoms, they hooked her.

When her home state of New York legalized marijuana for the treatment of select medical ailments, Owens decided it was time to swap pills for pot. But her doctors refused to help.

“Even though medical marijuana is legal, none of my doctors were willing to talk to me about it,” she said. “They just kept telling me to take opioids.”

While 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Owen who use marijuana and the doctors who treat them are caught in the middle of a conflict in federal and state laws — a predicament that is only worsened by thin scientific data.

Because the federal government classifies marijuana a Schedule 1 drugÌý— by definition a substance with no currently accepted medical use and a high potential for abuse — research on marijuana or its active ingredients is highly restricted and even discouraged in some cases.

Underscoring the federal government’s position, Health and Human Services Secretary Alex Azar recently pronounced that there was “no such thing as medical marijuana.”

Scientists say that stance prevents them from conducting the high-quality research required for FDA approval, even as some early research indicates marijuana might be a promising alterative to opioids or other medicines.

Patients and physicians, meanwhile, lack guidance when making decisions about medical treatment for an array of serious conditions.

“We have the federal government and the state governments driving a hundred miles an hour in the opposite direction when they should be coming together to obtain more scientific data,” said Dr. Orrin Devinsky, who is researching the effects of cannabidiol, an active ingredient of marijuana, on epilepsy. “It’s like saying in 1960, ‘We’re not going to the moon because no one agrees how to get there.’”

The problem stems partly from the fact that the federal government’s restrictive marijuana research policies have not been overhauled in more than 40 years, researchers say.

Only one federal government contractor grows marijuana for federally funded research. Researchers complain the pot grown by the contractor at the is inadequate for high-quality studies.

, which comes in a micronized form, is less potent than the pot offered at dispensaries, researchers say. It also differs from other products offered at dispensaries, such as so-called edibles that are eaten like snacks. The difference makes it difficult to compare the real-life effects of the marijuana compounds.

Researchers also face time-consuming and costly hurdles in completing the complicated federal application process for using marijuana in long-term clinical trials.

“It’s public policy before science,” said Dr. Chinazo Cunningham, a primary care doctor who is the lead investigator on one of the few federally funded studies exploring marijuana as a treatment for pain. “The federal government’s policies really make it much more difficult.”

Cunningham, who received a five-year, $3.8 million federal grant, will not be administering marijuana directly to participants. Instead, she will follow 250 HIV-positive and HIV-negative adults with chronic pain who use opioids and have been certified to get medical marijuana from a dispensary.

“It’s a catch-22,” said Cunningham, who is with the Albert Einstein College of Medicine. “We’re going to be looking at all of these issues — age, disease, level of pain — but when we’re done, there’s the danger that people are going to say ‘Oh, it’s anecdotal’ or that it’s inherently flawed because it’s not a randomized trial.’’

Without clear answers, hospitals, doctors and patients are left to their own devices, which can result in poor treatment and needless suffering.

Hospitals and other medical facilities have to decide what to do with newly hospitalized patients who normally take medical marijuana at home.

Some have a “don’t ask, don’t tell” approach, said Devinsky, who sometimes advises his patients to use it. Others ban its use and substitute opioids or other prescriptions.

Young adults, for instance, have had to stop taking cannabidiol compounds for their epilepsy because they’re in federally funded group homes, said Devinsky, the director of NYU Langone’s Comprehensive Epilepsy Center.

“These kids end up getting seizures again,” he said. “This whole situation has created a hodgepodge of insanity.”

The Trump administration, however, has resisted policy changes.

Last year, the had been gearing up to allow facilities other than the University of Mississippi to grow pot for research. But after the DEA received 26 applications from other growers, Attorney General Jeff Sessions halted the initiative.

The Department of Veterans Affairs also recently announced it would not fund studies of using marijuana compounds to treat ailments such as pain.

The DEA and HHS have cited concerns about medical supervision, addiction and a lack of “well-controlled studies proving efficacy.”

Patients, meanwhile, forge ahead.

While experts say they don’t know exactly how many older Americans rely on marijuana for medicinal purposes, the number of Americans 65 and older who say they are using the drug from 2006 to 2013.

Some patients turn to friends, patient advocacy groups or online support groups for information.

Owen, for one, kept searching for a doctor and eventually found a neurologist willing to certify her to use marijuana and advise her on what to take.

“It’s saved my life,” said the retired university administrative assistant who credited marijuana for weaning her off opioids. “It not only helps my pain, but I can think, walk and talk again.”

Mary Jo, a Minnesotan, was afraid of being identified as a medical marijuana user, even though she now helps friends navigate the process and it’s legal in her home state.

“There’s still a stigma,” said Mary Jo, who found it effective for treating her pain from a nerve condition. “Nobody helps you figure it out, so you kind of play around with it on your own.”

Still, doctors and scientists worry about the implications of such experimentation.

In a sweeping report last year, the National Academies of Sciences, Engineering and Medicine called on the federal government to support better research, decrying the “lack of definitive evidence on using medical marijuana.”

The national academies’ committee reviewed more than 10,000 scientific abstracts related to the topic. It made 100 conclusions based on its review,Ìý finding evidence that marijuana relieves pain and chemotherapy-induced nausea. But it found “inadequate information” to support or refute effects on Parkinson’s disease.

Yet those who find that medical marijuana helps them can become fierce advocates no matter what their doctors say.

Caryl Barrett, a 54-year-old who lives in Georgia, said she decided to travel out of state to Colorado to treat her pain from her transverse myelitis and the autoimmune disease neurosarcoidosis.

“I realized it worked and I decided to bring it back with me,” she said. “I broke federal law.”

Georgia, meanwhile, permitted limited medicinal use of marijuana but did not set up dispensaries. As a result, patients resort to ordering it online or driving to another state to get it.

The conflict in the law makes her uneasy. But Barrett, who had been on opioids for a decade, said she feels so strongly about it working that “if someone wants to arrest me, bring it on.”

Others experience mixed results.

Melodie Beckham, who had metastatic lung cancer, tried medical marijuana for 13 days in a clinical trial at Connecticut Hospice before deciding to quit.

“She was hopeful that it would help her relax and just kind of enjoy those days,” said her daughter, Laura Beckham.

Instead, it seemed to make her mother, who died in July at age 69, “a little more agitated or more paranoid.”

The marijuana “didn’t seem effective,” nor did it keep her mother from hitting her pain pump to get extra doses of an opioid, her daughter said.

The researchers running the trial at Connecticut Hospice spent two years getting necessary approvals from the Food and Drug Administration, the National Institute on Drug Abuse (NIDA) and the DEA.

Started in May, the trial has enrolled only seven of the 66 patients it plans to sign up because many patients were too sick, too close to death or simply couldn’t swallow the pills. So far, the trial has shown “mixed results,” said James Prota, director of pharmacy for the hospice.

Researchers point out they are still exploring the basics when it comes to marijuana’s effects on older adults or the terminally ill.

“We just have no data on how many older adults are using medical marijuana, what they are using it for and most importantly what are the outcomes,” said Brian Kaskie, a professor at the University of Iowa’s College of Public Health. “It’s all anecdotal.”

Kaskie, who specializes in public policy and the aging, received grants from the state of Colorado and the Chicago-based to survey the use of medical marijuana by older Americans.

In many quarters, there’s a growing appetite for solid information, he said.

“When I first started this, my colleagues joked we were going to find all the aging hippies who listen to the Grateful Dead,” said Kaskie, who has been studying medicinal marijuana for years. “Now, they’re starting to realize this is a legitimate area of research.”

Twenty researchers received marijuana from the federal program last year, which was more than any previous year since 2010, according to NIDA statistics.

In a recent funding announcement, the National Institutes of Health requested grant applications to study the effects of on older adults and .

NIH, however, continues to funnel much of its funding into studying the adverse effects of marijuana, researchers said.

Although NIH acknowledged in one of the announcements that some research supports “possible benefits” of marijuana, it emphasized “there have not been adequate large controlled trials to support these claims.”

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The Trump administration announced that HIV expert Dr. Robert Redfield will lead the Centers for Disease Control and Prevention, ignoring complaints that his work on a high-profile vaccine research more than 20 years ago was flawed.

The Army in 1994 acknowledged accuracy issues with HIV vaccine clinical trials led by , but concluded at the time that the data errors did not constitute misconduct.

In an announcement Wednesday afternoon, Health and Human Services Secretary Alex Azar emphasized Redfield’s care of HIV/AIDS patients and his work as a researcher, which included the controversial research.

Yet one of the whistleblowers who first raised the matter to the Army told Kaiser Health News this week that he remains so troubled about Redfield’s handling of the vaccine research that he has decided to speak out publicly.

Redfield was principal investigator over clinical trials of a treatment vaccine at the Walter Reed Army Institute of Research. The research was conducted at a time when there was intense pressure to come up with a treatment for HIV/AIDS, which often killed patients within a matter of months.

“Either he was egregiously sloppy with data or it was fabricated,” said former Air Force Lt. Col. Craig Hendrix, a doctor who is now director of the division of clinical pharmacology at Johns Hopkins University School of Medicine. “It was somewhere on that spectrum, both of which were serious and raised questions about his trustworthiness.”

In a letter to Trump this week, Washington Sen. Patty Murray, the ranking Democrat on the health committee, cited the research controversy as an example of a “pattern of ethically and morally questionable behavior” by Redfield that should prompt the president to reconsider the appointment.

Redfield’s appointment, which does not require Senate confirmation, was leaked to the news media over the weekend. Redfield did not respond to questions.

Redfield, who denied any scientific misconduct at the time, is now an HIV/AIDS expert at the University of Maryland School of Medicine. He has been praised by his supporters for his care of patients. He oversees a clinical program that treats 6,000 patients in the Baltimore-Washington area, according to an online bio.

But Redfield’s critics said the appointment demonstrates that the Trump administration is not vetting appointees thoroughly. The first CDC head, Brenda Fitzgerald, stepped down in January after a controversy over her purchase of tobacco stocks, and former HHS Secretary Tom Price resigned late last year amid criticism over his use of government and private planes for official travel.

“The White House claimed they would do better background checks,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “But that statement is dangerously laughable. If they had done a proper background check, they wouldn’t have chosen Dr. Redfield.”

Public Citizen, a Washington watchdog group, was a leading critic of the Army’s handling of Redfield’s data at the time and obtained and published documents that detailed the controversy.

Hendrix, who was the director of an Air Force HIV clinical unit when he raised the concerns, said: “Two members of his [Redfield’s] team told me they had tried to replicate the analysis, but they couldn’t. When they tried to go to the Army, they said they were ignored.”

After Hendrix couldn’t replicate the results, he drafted a letter to his superiors reporting the data problems.

Hendrix said Redfield’s superiors initially told him not to send a letter detailing the concerns. Instead, the military scheduled a meeting with Redfield and other researchers so Hendrix could discuss the concerns. In the meeting, Hendrix recalled, Redfield acknowledged he had overstated how promising the results were.

“I thought it was resolved,” said Hendrix, who said he later called Redfield to say he was proud to work in an organization that could openly discuss such concerns.

However, Hendrix soon heard Redfield make the same inaccurate representations of the data at a conference and decided to file an official complaint requesting an investigation into scientific misconduct.

An Air Force institutional review board also recommended that the Army launch an inquiry stating: “The committee agreed the information presented by Dr. Redfield seriously threatens his credibility as a researcher and has the potential to negatively impact AIDS research funding for military institutions as a whole.”

But the Army did not appear to launch a full investigation, said Hendrix, who was interviewed at the time by the military official who conducted the inquiry. The military official declined Hendrix’s attempts to provide documented evidence, telling him the investigation was “informal.”

Hendrix later asked the commander of his hospital about the outcome of the investigation. He recalled that the commander called another officer to ask.

“I just remember him saying “Yes, sir,” he said. “When he hung up, he told me, ‘We will not be discussing this again.’”

Redfield was transferred from the laboratory he headed and assigned to treat patients, although the Army said he was not being punished. The Army also said the data would be corrected, and the military scrapped the program.

The project had earlier drawn criticism because Congress had set aside $20 million for the vaccine after lobbying by a former senator on behalf of the manufacturer.

Hendrix said he occasionally interacted over the years with Redfield and holds no grudges.

“Before this happened, he made important contributions to HIV-prevention efforts,” he said. “I respected him.”

However, he said, he remains disturbed by the military’s handling of the matter. He teaches a class on medical ethics and uses his own experience without naming Redfield to describe to his students the ethical quandaries faced in research.

Faulty data can lead other scientists to repeat the same mistakes and prompt participants to seek out trials for drugs and vaccines that don’t work.

“It’s a huge waste of funds,” he said. “But just as importantly, it diminishes trust, which is essential in science. If truth is eroded, then the whole enterprise falls apart.”

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SIU professor William Halford, who died in June, had injected Americans 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 Food and Drug Administration or an institutional review board.

Two of the participants who filed the lawsuit, Elizabeth Erkelens and Ed Biel, received the vaccine in the Caribbean trial, according to the lawsuit. The third participant, Terry Graham, was injected in two Illinois hotel rooms, it states.

The lawsuit, which was filed Friday in an Illinois circuit court, demands compensation from Halford’s company, Rational Vaccines, alleging his research violated U.S. and international laws aimed at protecting the rights of participants in experiments.

Alan Milstein, a New Jersey lawyer representing the three participants, said his clients believe they should receive compensation not only for their medical costs, but also “pain and suffering” and loss of “dignity.” Milstein said he is still exploring legal options against the university, which shared in the vaccine’s patent, set up a business account to collect donations for Halford’s research and promoted his work.

“My clients are anxious to ensure such unethical experimentation on human subjects are not repeated,” said Milstein, who specializes in such cases.

A spokesman for Rational Vaccines did not respond to a request for comment. Earlier, the company had said that it plans to continue testing the vaccine and hopes to eventually secure approval from the FDA, although it’s unclear how it could without oversight from the federal government.

Halford co-founded Rational Vaccines with Hollywood filmmaker Agustín Fernández III in 2015. The company has since received millions of dollars in private investment from billionaire Peter Thiel, who contributed to President Donald Trump’s campaign. Thiel has declined to comment on his investment.

Rational Vaccines has said it considers the 2016 trial a success — though it is unclear what data it used to support that claim.

Another participant, Richard Mancuso, has publicly asserted the vaccine cured him of herpes.

The lawsuit comes as the university is still investigating what it now describes as Halford’s misconduct.

SIU, a state university with a medical school in Springfield, Ill., initially said it bore no responsibility for the experiments because Halford conducted the research independently. 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 has since acknowledged that Halford’s conduct violated university rules and U.S. laws but said that Halford hid his misconduct from the university. The investigation probing his research and the help he might have received by other SIU employees is ongoing.

The dean of SIU’s medical school, Jerry Kruse, has refused multiple requests by Kaiser Health News for an interview, but in a statement he said he and other university officials knew nothing about improper research methods. Sen.Chuck Grassley, an Iowa Republican who is known for pushing for accountability on such matters, demanded a response from HHS and the university about their handling of the controversy. HHS’ Office for Human Research Protections, which is supposed to monitor such violations, may not investigate the matter, HHS told Grassley.

“OHRP expects that SIU’s forthcoming report will provide sufficient information … to determine whether the office has jurisdiction,” Matthew Bassett, the HHS assistant secretary for legislation, wrote Grassley in a letter obtained by KHN.

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SIU’s ethics panel launched a “full” investigation Dec. 5 of the herpes vaccine experiments by university professor William Halford, according to a memo obtained by Kaiser Health News.

Halford, who died in June, had injected Americans with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without routine safety oversight from the Food and Drug Administration or an institutional review board, according to ongoing reporting by KHN. Some of the participants say they are experiencing side effects.

The panel, known as the Misconduct in Science Committee, told SIU’s medical school dean that the inquiry should not only investigate the extent of Halford’s alleged wrongdoing, but also scrutinize “members of his research team,” according to the Dec. 5 memo obtained through a Freedom of Information Act request.

“The Misconduct in Science Committee is now in its investigative stage and the School anticipates this investigation will take approximately 120 days,” SIU spokeswoman Karen Carlson told KHN in an emailed response. “However, the investigation could take longer.”

The panel’s inquiry marks the second one to be launched by SIU since Halford’s methods were detailed in a KHN report in 2017.

The Department of Health and Human Services asked the university to determine whether Halford’s activities violated the institution’s pledge to HHS. SIU, a state university, had pledged to follow human-subject safety protocols for all research, even if privately funded.

In October, SIU medical school’s institutional review board determined Halford’s activities were in “serious noncompliance” with university rules and U.S. regulations and recommended that the misconduct committee investigate, according to records obtained by KHN under open-records laws.

Now, the committee has taken up the case, putting more pressure on SIU’s medical school, which initially said it bore no responsibility for the experiments.

The committee, which is made up of five faculty members, holds hearings about such misconduct and can call witnesses before reaching a conclusion.

The university is required to have such a committee to assure the federal government that it will examine allegations of research misconduct, said , a professor of health law at SIU’s medical school in Springfield,Ill. The medical school receives about $ 9 million a year in federal research dollars.

“Part of the reason this committee exists is to keep the federal funding clean and flowing,” said Spielman, who specializes in bioethics. “Any university that does research, especially with human subjects, wants to be trusted by the federal government and the public.”

In SIU’s response to KHN’s open-records request, the university excised the names of the committee members.

Carlson said that after the committee’s investigation is complete “in conjunction with recommendations from the appropriate federal agencies, we will address our policies and procedures and anything else that arises from the investigation.”

“Currently, no herpes research is being conducted at SIU,” she said.

SIU had said Halford conducted his research on human subjects independently in the Caribbean in 2016 with a company he co-founded with a Hollywood filmmaker. Yet, SIU’s medical school shared in a patent on a prospective vaccine with Halford’s company, Rational Vaccines, and promoted Halford’s vaccine research on its website.

The university has not responded to questions about its role in earlier experiments on human experiments by Halford. According to emails obtained by KHN and an account by one of the participants in the herpes vaccine experiment, Halford injected patients with the vaccine in 2013 in Illinois hotel rooms.

Many of the email exchanges with the participants in 2013 — asking them to send photographs of rashes, blisters and other reactions — were sent from Halford’s university email account. He used the university phone for communication and he referred to a graduate student as assisting in the experiment and to using the lab, which ethics experts said could constitute an improper use of state funds.

It is unclear whether the committee will have access to Halford’s or his former colleagues’ emails for its inquiry. An SIU colleague who had worked with him on his research took a job with Rational Vaccines, according to his online profile. Edward Gershburg, a former SIU professor, describes himself as the company’s chief technology officer, . Gershburg, who is no longer with the university, could not be reached for comment, and the company did not respond to questions about him.

In the Dec. 5 memo obtained by KHN, the misconduct committee pointed out that Halford received federal funding for his research on animals from the National Institutes of Health. In such cases, universities are supposed to ensure that researchers don’t use federal funding for unauthorized research, ethics experts told KHN. SIU’s Carlson said Halford’s NIH funds stopped in 2012.

“It is unclear at this time whether that grant is affected by the alleged misconduct,” stated the memo, which was sent to the medical school dean, Jerry Kruse, who assumed that role on Jan. 1, 2016.

In a reference to Halford’s nasal cancer, which was diagnosed before the human-subject experiments, the committee added: “We can only speculate as to [Halford’s] motivation, which may have been related to his terminal illness.”

NIH declined comment and HHS did not respond to questions.

The pressure on the university has intensified with attention from Capitol Hill and a high-profile lawyer.

In letters sent out earlier this month, Iowa Sen. Chuck Grassley, the Republican chair of the Judiciary Committee, told the Trump administration and Southern Illinois University that he wanted to be reassured that “corrective action” was being taken to prevent similar research abuses.

In a separate development, three participants injected with an unauthorized herpes vaccine by Halford are demanding compensation from SIU for alleged side effects from the vaccine.

The participants recently hired , a New Jersey lawyer who specializes in litigating research abuses. In late December, Milstein notified SIU that the participants hired him to pursue litigation. Milstein asked for a meeting to discuss the participants’ fears about the vaccine and possible side effects.

“They realize now they were used as guinea pigs in outrageously unethical experiments that defied and flouted the most basic requirements of human-subject research in this country,” Milstein said in an interview.

The participants, who have herpes, have requested anonymity to protect the privacy of their health.

Milstein sent a similar letter to Halford’s company, Rational Vaccines.

Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III and has since received millions of dollars in private investment from billionaire Peter Thiel, who contributed to President Donald Trump’s campaign.

SIU declined to comment, and the company did not respond to questions about Milstein’s letter.

While critics have accused Milstein of relying on overly aggressive tactics that obstruct legitimate research, he is widely known to pursue research misconduct cases, even those involving some of the nation’s most prominent research institutions.

Over the past decade, Milstein has represented plaintiffs alleging research abuses committed by drug companies and prestigious universities, including Stanford University and the University of Pennsylvania. The complaints often have led to confidential settlements.

Regardless of whether SIU can be found negligent in court, Spielman of SIU said she believed the university owed the participants an “institutional apology” for how the research was conducted.

“The university should acknowledge that there must have been some kind of breakdown in the system,” she said.

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