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.  Immigration authorities acknowledged that during that policy 2,322 children 12 and under  were 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, , 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 drug — 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,  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.”

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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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In sent out Thursday, Iowa Sen. Chuck Grassley also told the administration and Southern Illinois University that he wanted to be reassured that “corrective action” was being taken to prevent similar research abuses.

Southern Illinois University professor William Halford tested his experimental herpes vaccine on participants in the Caribbean and in U.S. hotel rooms without Food and Drug Administration or institutional review board oversight. After Halford died in June and Kaiser Health News raised questions about the research, the university concluded he was in “serious noncompliance with regulatory requirements and institutional policies and procedures.”

“[T]his entire episode illustrates a failure in necessary governmental oversight of vaccine research as well as a failure by SIU to properly oversee its research staff,” Grassley wrote in the letters that cited KHN’s ongoing reporting.

Grassley, the chair of the Judiciary Committee, is well-known for pushing U.S. agencies to account for what he describes as breakdowns or lapses in the federal bureaucracy — even when the GOP is in charge.

In this case, his letters to the Department of Health and Human Services and the Food and Drug Administration could put pressure on the Trump administration to take a more aggressive role in any investigation of Halford’s research. Grassley’s letter to SIU could also lead to the university implementing tougher reforms in the wake of the unauthorized research, which participants say occurred as early as 2013 and continued into 2017.

“The type of research conducted, apparently all under-the-radar to the Obama administration and the very university that employed [Halford], has put individuals at extreme health risk,” Grassley wrote.

Grassley also sent his letter to the federal Office for Human Research Protections (OHRP), which monitors how human subjects are treated in trials.

OHRP could have jurisdiction in launching an independent investigation because the university had pledged to follow human-subject safety protocols for all research, even if it was funded privately.

But experts say that the federal government has become less aggressive about pursuing human-subject research violations over the years.

The agency’s public assessments of research misconduct peaked in 2002, when it issued more than 100 “determination letters.” That number has steadily declined. In 2017, it issued one.

Further politicizing the matter, Halford’s company, Rational Vaccines, received millions of dollars for future research on the experimental vaccine from billionaire Peter Thiel, a President Donald Trump supporter and high-profile critic of the FDA.

Thiel has not commented on the matter, despite investing in Rational Vaccines after Halford’s offshore trial.

SIU, meanwhile, has previously said it had no role or responsibility for Halford’s work, which it said it didn’t know about until after it was completed.

Following a KHN report that Halford completed the 2016 trial in St. Kitts and Nevis with no independent safety oversight, HHS demanded the university account for the research. The FDA and OHRP, however, have not commented on their roles in the matter.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

However, the rule does not address privately funded trials.

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

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

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

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

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

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

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