Edwards, 73, began showing symptoms of the disease in early April, according to the accounts of three inmates who lived with him in a dormitory. He was short of breath, had chest pain and could barely talk. He was also dizzy, sweaty and throwing up.

Edwards was serving a 40-year sentence for attempting to kill someone in 2001. He would have been released to home detention on May 1 but died on April 13. The next day, the Indiana Department of Correction sent out a statement that indicated Edwards’ symptoms came on suddenly: “The offender, a male over the age of 70, who did not have indications of illness, reported experiencing chest pains and trouble breathing on Monday.”

Edwards’ fellow inmates dispute the statement and say he had been seeking medical attention at the prison for days before he died.

Since the start of the pandemic, prisoners and their families have contradicted state officials about the conditions inside Indiana prisons. Many inmates report they’ve had no way to protect themselves from close contact with other inmates and staff members. They believe contracting the disease is inevitable. Indeed, 85% of the prisoners tested at Westville have been positive for the virus. Many of them were housed in the same dorm as Edwards.

As of May 22, at least  had died from confirmed or presumed coronavirus infections, and 650 inmates had tested positive for the virus. And while the state has maintained it isolates men and women with symptoms, inmates say even severely ill prisoners have been left in their dorms until it is too late. Their accounts call into question efforts to contain the virus, along with the care inmates receive once they have it.

“[Edwards] had been sick for approximately about a week and a half,” said one inmate named Josh. Josh allowed a family member to record a call about Edwards, and he asked to be identified only by his first name because he fears retaliation from prison staff.

His fellow prisoners say Edwards couldn’t even make it to see medical staff on his own — they pushed him in a wheelchair. Each time, he was sent back to his quarters.

“Those bastards said I’m fine, I just need to drink water and rest,” Josh recounted Edwards saying. “I’m clearly not fine — I can’t breathe.” Another prisoner wrote in an electronic message to a reporter that Edwards’ room “smelled like sickness and death.”

On the day he died, Josh said Edwards looked pale before he stumbled on his way to the bathroom. A pair of fellow inmates caught him and helped him sit down. “He sounded like he was winded, like he had just ran a marathon,” Josh wrote via the prison system’s electronic communications software. “He was just saying ‘I can’t breathe, I can’t breathe.'” He said an officer called the prison medical staff, who tended to Edwards in the bathroom for about 45 minutes.

“They finally took him out on oxygen,” Josh said. “Next thing we know, five hours later, he died.”

The Westville inmates emphasize that Edwards didn’t wait until that Monday to report his symptoms — he had complained to staff for days. “There is a major problem here with this place and it’s outta control,” wrote Josh.

, chief medical officer for the Indiana Department of Correction, declined to explain the different accounts of his death. “We do not talk about specific cases and patient clinical status,” she said.

Across the nation, at least 415 prisoners had died of the infection as of the week of May 20, and more than 29,000 had tested positive,Ìý.

The American Civil Liberties Union and other advocacy groups have called for the early release of some prisoners, especially the old and sick. Protesters have demonstrated outside Westville and other Indiana prisons to call attention to the conditions inside. Governors in the nearby states of Ìý²¹²Ô»åÌý have ordered some prisoners released, but  has refused. He said it’s up to local judges to decide, on a case-by-case basis.

In the meantime, Dauss said Indiana prisons are taking steps to control the spread of the coronavirus. “We move quickly and, in fact, immediately to separate those who are sick from those who are not sick,” said Dauss.

But according to accounts from numerous inmates, that kind of quick isolation of sick prisoners hasn’t always happened, at least through much of April.

Three different prisoners described another COVID-19 death in a different Indiana prison, the Plainfield Correctional Facility, on April 19. Lonnell Chaney, they said, had been asking for medical help for days.

“He didn’t even know where he was,” one inmate wrote to a reporter. Medical staff had checked on Chaney, who mumbled in response, but left him in the quarters. A prisoner tried to convince officers that the man’s condition was serious — Chaney couldn’t catch his breath — but the officers brushed it off.

The prisoners say Chaney, who was 61, died in his bed in the crowded dorm. “You must be almost dead to get outside help,” wrote the Plainfield inmate.

Six Plainfield prisoners have died during the coronavirus pandemic. The Department of Correction has not released a statement about any of those men. Of 145 Plainfield prisoners tested for the virus, 119 were positive. Forty-five staffers tested positive, as well. Indiana has reported two deaths of prison staffers, as of May 22.

At the Westville prison, Josh said another man in his dorm complained about similar symptoms, and correctional officers wrote the man up for being disruptive.

“Everybody here is terrified,” Josh said.

As the virus spreads, prisoners’ families are . They say prisons refuse to disclose basic information that would put them at ease, including whether an inmate is alive. In Scottie Edwards’ case and others, families didn’t know their loved ones were sick until after they had died — even though a department policy calls for notification when “death may be imminent.”

Crystal Gillispie talked to her father, Lonnell Chaney, for the last time on April 13. Their call lasted five minutes but felt shorter. He told her to send pictures of his grandchildren. And even though the coronavirus had started to spread in his dorm at the Plainfield Correctional Facility, he was more concerned about his family.

“He was like, ‘Just make sure you’re wearing your gloves and masks,'” Gillispie remembered. “I was like, ‘OK, Daddy. You do the same.’ He was so worried about us, and he ended up catching it.”

The next time she heard news of her father, it was from her aunt, his sister: The prison had called her to say Chaney was dead.

Edwards’ sister, Gloria Sam, said her brother was new to Westville prison, because he’d recently requested a transfer to a facility with a law library. He ended up at Westville just before the pandemic started.

“He said, ‘I am afraid of this virus because we’re here close together, and if it comes out, it’ll spread like wildfire,'” she said. Sam hadn’t heard from Edwards in more than a week when her phone rang on April 14. She remembers that even though her caller ID said it was from the State of Indiana, it didn’t occur to her that it was about her brother.

“They said, ‘Well, we have some bad news.’ I thought they were gonna say he was sick,” she said. They told her he had died.

If possible, Sam said, she would have wanted to say goodbye.

“It’s one of the most hurtful things I’ve experienced in my life,” she said.

This story is part of a partnership that includes , , and Kaiser Health News.

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On April 6, an inmate named Dennis stayed up late at Indiana’s Plainfield Correctional Facility. He wrote to his wife, Lisa, and told her he was scared.

“I can tell you right now, with nearly 100% certainty, that I am going to get this virus,” he wrote. Lisa said Dennis suffers from , which could cause complications if he contracts COVID-19. (KHN agreed to omit their last names because they fear retaliation from prison staff.)

“I just need you to know how sorry I am for not being there … during these scary uncertain times,” Dennis wrote to his wife. He was sent to prison a year ago for theft, driving on a suspended license and resisting arrest. His earliest possible release date is in June 2021.

“If I don’t getta come home, please always know that you are and always will be the love of my life,” he wrote.

Two days later, he told Lisa that for the first time, prison staff took the inmates’ temperatures. Some, including an inmate next to him, had fevers but were still kept in the dorm with dozens of other men.

“He is about 3 ft. from me right now,” Dennis wrote of the man with a fever. He wrote again that night after midnight to tell her the prisoners with fevers had finally been removed.

The Indiana Department of Correction said it is taking measures to prevent the spread of the coronavirus among the nearly housed in the state’s 18 adult and three juvenile facilities — including supplying hand sanitizer to inmates and isolating anyone who exhibits COVID symptoms.

But accounts from inmates and their relatives contradict the agency’s claims. Kaiser Health News and NPR have heard from dozens of people concerned about their family members in prison. We’ve read messages from inmates and heard recorded phone calls with their loved ones. They said prison staff members haven’t taken adequate precautions to prevent the spread of the virus.

Many inmates who exhibit COVID-19 symptoms have been left in crowded quarters, according to these complaints. Inmates don’t have hand sanitizer and were only recently issued face masks.

“That’s illustrative of what’s happening across the country in county jails and departments of corrections,” said of the Brennan Center for Justice in New York.

Thousands of incarcerated people have been infected — in one Ohio prison, 73% of inmates tested positive for the coronavirus — and many have died.

After about 1,300 inmates and guards at a Tennessee prison for the virus, officials in Tennessee said they will test inmates at correctional facilities across the state. Of those who tested positive in the privately run Trousdale Turner Correctional Center, about two dozen were guards. And 98% of the COVID-19-positive inmates and employees had no symptoms at the time of their test, according to the Tennessee Department of Health.

“These are communal spaces, and they really are petri dishes for transmission of diseases such as COVID-19,” said Eisen.

As of April 30, Indiana had reported in correctional facilities. Indiana officials declined to be interviewed for this story and, so far, have not said how many prisoners have been tested. The Department of Correction now its COVID-19 statistics each business day.

Symptoms And Fears Mount

In an April phone call, Dennis told Lisa he was sick. “I’m doing bad. I’m not doing good at all,” he said, according to a recording she made of the call. “My head is splitting.”

Dennis estimated that 15 prisoners had been removed from his dorm, which normally houses more than 80 people. He guessed about half of the remaining prisoners showed some sort of symptoms.

“It scares me so bad,” Lisa said to Dennis.

“It scares me, too,” Dennis replied. “Most of the guys in here are saying, “Well, we all got it. Just some of us have symptoms, some of us don’t.'”

“They brought us another bar of soap today,” Dennis said. “Everybody in here thinks, ‘Well, somebody must have died today.'”

The state announced the next day that a prisoner from the Westville Correctional Facility had died. He tested positive for COVID-19.

Prisoners Say They Can’t Protect Themselves

Other inmates and their family members tell similar stories about the conditions in Indiana prisons. Prisoners in their quarters exhibit symptoms, they said, but the staff isn’t checking on them unless they complain — in some cases, multiple times.

While the disease spreads, prisoners said, they aren’t able to take measures to protect themselves.

A second prisoner at the Plainfield facility told his wife in a recorded call that social distancing is impossible. “At this very moment, I can reach out and touch somebody,” he said. “We’ve got a reason to be scared for our lives,” said the man who was sentenced for a robbery. His earliest possible release date is in 2022.

His wife told KHN her husband tried to make a tent with blankets to protect himself, but a guard told him to take it down.

She said she told her husband: “Absolutely not. This is the only way that you have to even protect yourself.”

Two inmates, one at the Pendleton Correctional Facility and another at the Indiana State Prison, described incidents in which guards jokingly coughed in their direction.

“That’s nothing to play with. It’s my life,” the Pendleton inmate said in a recorded call. He has asthma, he said. Many guards only recently began wearing masks.

put out by the Centers for Disease Control and Prevention, which the state said it follows, stresses the importance of hand sanitizer, social distancing and masks. The Indiana Department of Correction recently released a indicating the agency regularly cleans its facilities, provides hand sanitizer to inmates and encourages social distancing.

Family members who saw the video said it made them angry.

Advocates Push For Limited Prisoner Release

“[Inmates] should not have less opportunity to keep themselves healthy than the general public,” said , the former head of the New York City Department of Correction and the Pennsylvania Department of Corrections.

The U.S. Supreme Court ruled, in a 1976 decision in the case , that to serious medical needs” is unconstitutional.

“They should be making every effort to spread the inmates apart as much as possible to provide for social distancing,” said Horn, who now lectures at the John Jay College of Criminal Justice in New York City.

The ACLU of Indiana, the and other advocates have pushed the state to release certain inmates, such as the oldest or nonviolent offenders.

“It’s necessary to curb the spread of coronavirus behind bars in this country,” said Eisen of the Brennan Center. She pointed out that states such as ,  and New York already have taken such steps in response to the pandemic.

So far, Indiana officials have resisted calls to do so.

“I do not believe in releasing those low-level offenders,” Gov. Eric Holcomb said at a news conference on April 13. “We have got our offenders in a safe place — we believe maybe even safer than just letting them out.”

A week later, three prisoners had died from COVID-19, and the confirmed case count had jumped from 27 to more than 200. Some family members of inmates said that if something happens to their loved ones, they’ll blame Holcomb.

Lisa laughed when she heard the quote from the governor.

“Wow. That’s a big lie,” she said. “They have them herded like cattle, all crammed together, where the virus can just jump from one to the other. There’s no protection.”

“Yes, they committed a crime and they were sentenced,” Lisa said. “But they weren’t sentenced to death.”

This story is part of a partnership that includes Side Effects Public Media,  and Kaiser Health News.

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“I immediately called my mom and said, ‘Mom, is it possible that I have random siblings out there somewhere?'” said Woock, of Indianapolis. She recalled her mom responded, “No, why? That’s ridiculous.”

But the messages continued, and some of them mentioned an Indianapolis fertility practice that she knew her mom had consulted when she had trouble conceiving.

Woock researched and finally learned the truth. Dr. Donald Cline, the fertility doctor her mother saw in 1985, is her biological father.

“I went through an identity crisis,” she said. “I couldn’t look in the mirror and think about, ‘Where did my eyes come from? Where did my hair color come from?’ I didn’t even want to think about any of that.”

Woock hadn’t known that her mom had used artificial insemination to conceive her, and neither of them knew the doctor had used his own sperm.

“We now know Cline used his own sample and squirted it into my mom,” Woock said.

In the 1970s and ’80s, Cline deceived dozens of patients and used his sperm to impregnate them. He has more than 60 biological children — and counting.

For Woock, as the story of her parentage sunk in, it was distressing for another reason: She wanted to start her own family and was having trouble conceiving. And now she needed to turn to the fertility industry that had so badly betrayed her mom.

“We were doing all of the calendaring … everything that is out there to help you get pregnant, we were doing that,” Woock recalled.

But after six months, when she still wasn’t pregnant at 32, she went to a fertility clinic for some tests.

“I had to fill out all this paperwork, and there’s a slot that says kind of like, ‘Is there anything else you’d like to share?’ ” Woock said.

Yes, there most certainly was.

The Odds Of ‘Fertility Fraud’ These Days

New allegations of doctors using their own sperm keep coming to light — because of genetic-testing services like Ancestry revealing networks of half siblings — in states like , Ohio, Colorado and Arkansas.

But those doctors performed artificial inseminations decades ago. Could what happened to Woock’s mom happen in a modern fertility clinic?

Dr. Bob Colver, a fertility specialist in Carmel, Indiana, said it’s a question many of his patients have asked. But it’s unlikely, he said. These days, there are more people involved in the process, and in vitro fertilization happens in a lab, not an exam room.

“Unless you’re in a small clinic where there’s absolutely no checks and balances, I can’t even imagine that today,” Colver said.

It’s now illegal in  for a doctor to use his sperm to impregnate his patients. But there’s no national law criminalizing what’s called “fertility fraud.”

Fertility medicine has advanced a lot since the 1980s, but women trying to get pregnant today with the help of medicine face a baffling array of treatment options that can be hard to navigate and can be hugely expensive. And some critics say the growing, multibillion-dollar fertility industry needs more regulation.

For example, sperm banks may not get accurate medical histories from their donors, who could pass along genetic diseases. And there’s no limit on how many times a donor’s sperm can be used, which some donor children worry could increase the chance of inbreeding. Sperm donation guidelines from organizations like the American Society for Reproductive Medicine are voluntary. There was a contestant on  last year who said his sperm had helped father more than 100 kids.

Unrealistic Expectations

When Woock decided to get her first fertility treatment, she set preconditions with the clinic. She insisted on having a female doctor and insisted that a doctor be in the room for all appointments and oversee everything that happened.

Her experience with her clinic was very different from her mother’s with Cline, but nonetheless there were surprises along the way.

The clinic told her that her problems conceiving could be because of husband Rob’s low sperm count and motility (meaning his sperm weren’t great swimmers). They advised a form of in vitro fertilization that involved injecting one sperm directly into one of her eggs in a petri dish.

When doctors told Woock she needed IVF, she felt pretty optimistic.

“I’m thinking going into this that our chances of success are 70, 75%,” Woock said.

Fertility treatment can be really expensive, and patients may start treatment with unrealistic expectations. That’s because success rates are complicated, and some clinics use only the best numbers in their .

For example, clinics can advertise high fertilization rates. But a 70% fertilization rate doesn’t mean 70% of eggs turn into babies — plenty can go wrong after the lab combines egg and sperm.

Success depends on your age, your clinic and the type of procedure you need. But most of the time, assisted reproduction procedures such as IVF don’t work. The Centers for Disease Control and Prevention, which  in the U.S., reports only about 24% of attempts result in a baby.

‘Add-On’ Technology — And Prices

When Woock started her first IVF cycle, she gave herself shots, a couple a day, to stimulate her ovaries to get multiple eggs ready at once. Multiple eggs means more chances for fertilization.

But the drugs have side effects. They gave her headaches and made her moody and less patient.

“I was actually allergic to one of the medications, which just means that you keep taking it and deal with the itching and rash,” Woock said.

But she hung on until it was time for a doctor to surgically retrieve her eggs, at which point patients can face even more choices. Because the couple’s fertility problem appeared to be with Rob’s sperm, the clinic offered to use a special device to help pick the best sperm for IVF.

“We were kind of like, ‘Yeah, why wouldn’t you?'” Woock said. “If it’s gonna give us a better chance, do it.”

A device like that is called an add-on. Add-ons are often new technology, described as cutting-edge, which can appeal to patients. Examples of add-ons include — which some specialists argue improves the odds of a live birth — and Ìý²¹²Ô»åÌý, both methods claiming to facilitate implantation.

Jack Wilkinson, a biostatistician at the University of Manchester in England, , which he has found can increase costs — and, he said, they may not work.

“We quite often see there’s no benefit at all,” Wilkinson said. “Or, possibly even worse, that there’s a disadvantage of using that treatment.”

Wilkinson said the device Woock’s clinic offered could work, but the evidence supporting it is thin.

Failed Fertilizations

The clinic called Woock the morning after her egg retrieval. None of Woock’s eggs fertilized. The procedure revealed that her husband’s sperm quality wasn’t the only fertility issue the couple faced.

“They immediately saw that there was something wrong with my eggs,” Woock said. “My eggs are just total crap.”

She underwent a second round of IVF with the same result — no fertilization.

“Getting that news the second time … felt even more set in stone that this was going to be a very long, challenging road,” Woock said.

Challenging and expensive. Most states, including Indiana, don’t require insurers to cover fertility treatment. Without insurance, a round of IVF can cost more than $10,000 — even more than $20,000 — with no guarantee the patient will get pregnant.

Woock was lucky that her employer-provided insurance covered a lot. But it still wasn’t cheap. She had to pay for some medications, “plus, you have to pay lab and facility fees that insurance doesn’t pay,” Woock said.

Donor sperm and eggs aren’t generally covered, either. Those can be tens of thousands of dollars.

Woock faced a hard choice: After two failed attempts, did she want a kid enough to go through IVF again? She and her husband decided they did. So Woock did a third round of IVF. And then a fourth. When that didn’t work, she gave up on using her own eggs.

“What I expected as I was growing up and picturing my children is not what I will see,” Woock said.

Woock and her husband decided to try donor eggs. If all goes according to plan, she could still carry a child. She wants to keep trying.

“I realize that pregnancy is incredibly challenging on your body and your mental state,” she said. “If I can make it through a year of IVF, I can make it through morning sickness.”

This story is part of a partnership that includes , and Kaiser Health News. The story was adapted from Episode 6 of the podcast . You can hear more about the fallout from Dr. Donald Cline’s deception on Sick’s first season, at .

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“He was reaching for things, and he was talking to Bill Gates and he was talking to somebody else I’m just certain he hasn’t met,” his mother, Cheryl, says. She remembers finding Jason lying on the floor of the treatment center in late 2016. “I would just bring him blankets because they didn’t have beds or anything.”

Cheryl had taken Jason to the clinic out of desperation. Jason, now in his late 30s, has struggled with addiction since he was a teenager. Cheryl saw his drug use escalate after he was prescribed a benzodiazepine for his anxiety, and he eventually began using heroin and meth. Over the years, Jason would try to get into recovery, but treatment programs didn’t help him for very long.

“I thought he was going to die,” Cheryl says. (KHN and NPR are using only first names because Jason worried he would lose his job if his employer found out about his addiction history.)

In late 2016, she saw a local TV news segment about a clinic called Emerald Neuro-Recover. The staff there treats addiction with something called NAD therapy, an IV infusion that can contain amino acids and other nutritional supplements, including nicotinamide adenine dinucleotide, a compound found in living cells.

The infusion, which is delivered over 10 to 15 days, cost $15,000, and it wasn’t covered by insurance. But the TV report said Emerald’s treatment was “proven to wipe drug cravings away.” Cheryl was intrigued.

Emerald and dozens of other companies across the U.S. say NAD therapy can address conditions from anxiety to depression to chronic fatigue and even Alzheimer’s.

And clinicians offering the treatment say that it reduces or stops cravings for alcohol or illicit drugs in up to  of patients. The treatment has gained attention on  and in the mainstream media.

But such claims about NAD therapy and addiction are not supported by scientific evidence, and they may conflict with federal and state regulations against deceptive marketing of medical treatments. Emerald and other addiction treatment clinics use these claims on websites, social media and in the news to attract clients looking for help. Emerald even used patients’ stories to promote the therapy — in some cases, more than a year after the patients returned to using illicit drugs.

In an interview with Side Effects Public Media, Emerald leadership defended its use of the therapy. “It’s not really controversial; it’s just novel or new,” says John Humiston, a family medicine physician and the company’s medical director. “The cravings we expect to be gone within days.”

Earlier this year, Emerald leadership discussed NAD therapy with Side Effects but cut the interview short amid questions about the treatment’s efficacy. Company officials declined another interview and did not respond to follow-up questions via email. For that reason, Side Effects was unable to ask them about Jason’s case.

Treatment centers touting high success rates can sound appealing to vulnerable people suffering from addiction or to their families, even if there’s no solid evidence to support their methods. “[Clinics] know this is a really desperate population,” says , a health policy researcher focused on substance use disorders at the University of Central Florida.

Unsubstantiated claims have long been a part of addiction treatment. For instance, in the late 19th century, a doctor dubbed his formula the “” and sold it via mail order for addiction, claiming a 95% cure rate. “In a week the desire to drink will be gone,” read one advertisement.

More recently, NAD therapy is among a wide range of unproven treatments currently marketed to people with addiction, including the herbal extract  and other types of supplements. The FDA and the FTC  last year but have limited resources to police the market for unproven treatments. And that leaves consumers on their own to sort out fact from fiction.

While patients spend time and money on ineffective treatments, they miss out on proven therapies that can reduce their risk of relapsing, including behavioral counseling and medications approved by the FDA for treating addiction, says Andraka-Christou. “We do actually now have evidence-based treatments available,” she says. “But you still do have these quack treatments popping up.”

A Hard Sell

Numerous companies make bold claims about NAD therapy. A Las Vegas says, “IV NAD+ therapy has a 90% success rate at reducing cravings and a 7% relapse rate.”

´¡Ìý in Pooler, Ga., says NAD therapy can provide “rapid reduction or even elimination of cravings, restoring clarity of mind and enthusiasm to be alive.”

´¡²Ô´Ç³Ù³ó±ð°ùÌý in Greenville, S.C., says, “Withdrawal signs of addiction go down approximately 70-80% on the first day and continue to decline as the therapy progresses.”

Similar glowing  from Emerald led Cheryl and Jason to meet with Emerald leadership in late 2016, including founder Joe Pappas and patient liaison Amora Scott. Cheryl recalls, “They said, ‘This is going to fix it. … It has never not worked for us. It works for everyone.'”

Jason insisted his mother shouldn’t pay thousands of dollars for his treatment. She had already spent too much money on him. They decided not to come back.

“Well, then Amora started calling me and calling me and calling me,” Cheryl says. Unknown to Jason at the time, Cheryl says Scott persuaded her to pay for the treatment upfront.

Cheryl took out an advance on her credit card and met Scott at a gas station to hand over the money. “When I gave her that check, I looked at her and said, ‘This is to save my son’s life,’ ” Cheryl recalls.

Fifteen thousand dollars could seem like a bargain for such a quick fix — one that “,” according to a press release from Emerald.

But there has been little research on the effects of the formulas used by Emerald and similar clinics.

“I don’t know where those claims could come from, but it doesn’t seem realistic to me,” says , an addiction psychiatrist in Indianapolis. She says there’s insufficient evidence to support using NAD therapy over other standard treatments: “There’s no actual data on any of these things.”

For an additional $400 fee, Emerald patients can have their brain scanned at a nearby clinic to document their progress with NAD therapy. An Emerald  shows a series of scans from a woman whose “brain is suffering from alcoholism.” Areas that glow red, orange and yellow — “HYPERACTIVE and OVERACTIVE” — totally disappear from the scans after 12 days of NAD therapy, according to the company.

“This is totally bogus,” says , an addiction psychiatrist at the Indiana University School of Medicine with expertise in brain imaging who reviewed the images via email. “We do not have research in our field that allows us to use EEG or any other brain imaging technique to document treatment response.”

NAD, which is an important coenzyme in several cellular processes, including energy metabolism, is being researched at Harvard for . Supplements claiming to boost NAD levels have recently gained popularity for purported anti-aging benefits. But NAD’s benefits in addiction treatment are unproven, and providers cite unpublished research to make sweeping claims.

One pilot study cited among some NAD therapy providers shows close to 90% of patients have reduced cravings after 10 days of treatment. The study falls short of the standard used by the scientific community to weigh evidence: It did not compare NAD therapy to a placebo or other treatment. It also did not undergo rigorous peer review, and the results have not been published in a scientific journal.

A doctor involved with that study, Richard Mestayer, says he is used to skepticism. Mestayer runs a clinic in Springfield, La., that offers NAD therapy. He says it is unclear how NAD therapy helps with addiction but that his personal experience convinced him it works.

“I think there’s a lot of stuff we don’t know yet,” he says. “I was a skeptic, but when a two-by-four hits you in the head every time, you say, ‘Oh, I better pay attention.'”

Dangerous Withdrawals

The hallucinations started several days into Jason’s treatment at Emerald. Cheryl wanted to take him to the emergency room.

Rapidly withdrawing patients from benzodiazepines can cause dangerous side effects, such as  — it can even be fatal, says Zarse. “There are two types of withdrawal symptoms that can kill you: alcohol and benzodiazepines,” she says. “It can cause enough misfiring in the brain that it can lead to brain death.”

The standard treatment is to slowly wean someone off benzodiazepines. “They even give benzos for benzodiazepine withdrawal in jail — that shows you how serious this is,” Zarse says.

Still, Cheryl says, Emerald staff told her to take Jason home rather than to the hospital. She decided to go to the ER anyway after Jason tried to throw himself through a wall.

Jason was still hallucinating when he arrived at the ER, and then the seizures started. “He was just totally out of it for about three days,” Cheryl says. “Not even alert.”

One of the doctors who treated Jason noted in his medical records: “Unclear exactly what this NAD substance/medication is.”

When Jason left the hospital, he returned to Emerald to finish the treatment. “I didn’t know what else to do,” he says.

Jason says the therapy didn’t work. He white-knuckled his way through abstinence for three months before he relapsed. “One day out of the blue, I called somebody up and just was going to do it one time,” he says. “You know how that goes.”

Marketing Unapproved Substances

The federal Food and Drug Administration has not approved NAD therapy, according to a spokesperson for the agency.

Substances marketed as treatments for specific conditions are considered medications and must be approved by the FDA for that purpose, says Andraka-Christou. For medications, FDA approval requires three phases of human clinical trials. Without that approval, it would violate FDA regulations to market a treatment for that condition.

More broadly, making unsupported claims about a medical treatment or supplement violates federal rules. Both the FDA and the Federal Trade Commission regulate how companies advertise treatments and supplements.

But no publicly available information could be found to show that either agency has taken enforcement action against any clinic offering NAD treatments.

Spokespeople for the FDA and the FTC said via emails that their agencies could not comment on specific cases. “All advertising under our jurisdiction must be true, not deceptive, and supported by competent and reliable scientific evidence,” wrote the FTC spokesperson.

“The FDA takes action against companies that engage in ‘health fraud,'” said the email from the FDA.

Lack of FDA action doesn’t mean it is acceptable for clinics to market the therapy, says , an assistant professor at the University of Maryland who researches dietary supplements.

“The FDA can be slow, and it’s understandable because there are so many [potential enforcement issues] out there,” he says. “There could still be cause for concern.”

Patient Stories

Since its inception, Emerald has featured patients’ stories on social media and in news coverage, much of which  the company’s claims about ending addiction. But several of these same patients went to jail for drug and alcohol offenses soon after being treated at Emerald.

In a 2017 TV news story about Emerald, a man says that Emerald helped him get his alcohol and pill addiction under control. Reached by phone, he told Side Effects that he reluctantly said those things to get the TV interview over with. “[NAD therapy] was a complete waste of my time and my family’s money,” he said. “It did absolutely nothing for me.” (He asked to remain anonymous because many of his family and friends don’t know about his addiction, and he worries about his future job prospects.)

He added that he also experienced a seizure when the doctor quickly cut him off from alcohol without antiseizure medication. He says he started drinking again about a week after he finished NAD therapy, and he was arrested for drunken driving a few months later.

In another video Emerald posted on YouTube in 2017, an Indianapolis man is seen leaving Emerald on a sunny day. “I feel wonderful,” he says. “Using heroin, I had a lot of racing thoughts, anxieties, cravings. All that’s gone.” He tells other people who use heroin to go to Emerald.

Six months later, he was in jail for possession of a syringe. Reached by phone, he said that the treatment didn’t work for him, and that he received it free of charge.

Emerald still promoted patients’ stories like these on social media until December 2018. The company began removing content from its website, YouTube and Facebook shortly after Side Effects began reporting this story.

Emerald executives declined to provide Side Effects with a patient to interview.

Asked about cases of relapse among Emerald patients, Humiston replied: “What I’ve seen is that [the treatment is] very effective.” Humiston started work at Emerald in January 2019, but he was a medical adviser for the company before then, and emails between Cheryl and Emerald staff indicate that he was consulted about Jason’s treatment there.

Origins Of Treatment

Humiston says he believes in the treatment he offers: “It’s got quite a reputation of success. Nothing’s 100%, although for most people, it is 100%. That’s been my experience.”

But Humiston acknowledges that he does not regularly track patients’ long-term outcomes: “That’s the reason to get a study organized,” he says. Last year, Humiston told a local TV station that a clinical trial was forthcoming, but it has not materialized.

Humiston first learned about NAD therapy from a man named William Hitt. Hitt is often credited with originating the treatment, but he was not a doctor or a researcher. According to a lawsuit brought by the state of Texas in the mid-’80s, he falsely claimed to be a doctor when he treated AIDS patients with “injections of the patient’s own filtered urine.” Forced to shut down in Texas, he moved to Tijuana, Mexico, where Humiston worked with him from 2003 until his death in 2010.

Humiston himself has had trouble with his medical license. The Medical Board of California reprimanded him, according to investigation documents, for committing “gross negligence in his care and treatment” of his teenage son, who almost died in 2016 when Humiston failed to seek proper treatment for the boy’s heart infection. Documents say Humiston began performing IV treatments on the boy before he was 3 years old, which may have caused the boy’s heart issues.

Asked about the investigation, Humiston said there was “inaccurate information put in there” but that he accepted a public reprimand from the medical board “just to end it.” He did not respond to emailed follow-up questions about the disciplinary case.

Humiston applied for an Indiana medical license in November 2018, and the state granted it. He became Emerald’s medical director in January. He is at least the sixth doctor to work with the company in its three years of operation.

‘I Owe Her The Money’

When asked in January about Emerald’s claims and the origins of NAD therapy, Star Voigt, the CEO at the time, declined to answer further questions. “We’re trying to help people,” she said. “So if you’re going to go into that, then I’m going to ask you kindly to leave.”

Side Effects sent further questions via email, but the company did not answer them. Instead, Voigt sent a statement from Humiston expressing concern that Side Effects’ reporting wouldn’t be balanced or objective. Voigt left the company soon after.

Cheryl, the patient Jason’s mother, wrote to Emerald founder Pappas a few months after her son left Emerald. She told him that Jason was facing an $11,000 medical bill from his hospital stay and that he still struggled to stay away from illicit drugs. She reminded Pappas that stopping benzodiazepines cold turkey — what Jason went through at Emerald — is dangerous and goes against standard medical practice.

Cheryl wanted a refund so she could pay off Jason’s medical bill. “Can we compromise?” she wrote.

Scott, the patient liaison, wrote back that Humiston believed Jason should be tested “for mold … infections, and/or inflammation in the blood and body.” Instead of a refund, Emerald offered further NAD treatments and another therapy — for $3,000.

Cheryl and Jason declined the offer. “First, do no harm,” Cheryl wrote back. She filed complaints with the FTC and the state attorney general, but nothing came of it. ( allows the state attorney general to prosecute companies for deceptive advertising. The office would not confirm or deny whether it is investigating Emerald’s practices.)

The hospital eventually did waive the $11,000 bill. But Cheryl still has not received a refund from Emerald.

“I feel like I owe her the money,” Jason says. “At some point, I’ll pay it back.” He says he finally got help with his addiction through a local 12-step program that he has been part of for two years. Looking back at his treatment at Emerald, he says he felt duped into trying NAD therapy. “I think it’s taking advantage of people.”

“I can’t believe that no one stops them,” Cheryl says. “You’ve got these people selling snake oil, and they’re getting away with it.”

This story is part of a partnership that includes , and Kaiser Health News.

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Months in prison didn’t rid Daryl of his addiction to opioids. “Before I left the parking lot of the prison, I was shooting up, getting high,” he said.

Daryl had used heroin and prescription painkillers for more than a decade. Almost four years ago, he became one of more than 200 people who tested positive for HIV in a historic outbreak in Scott County, Ind. After that diagnosis, he said, he went on a bender.

But about a year ago, Daryl had an experience that made him realize he might be able to stay away from heroin and opioids. For several days, he said, he couldn’t find drugs. He spent that time feeling terrible because of withdrawal sickness.

His friend offered him part of a strip of Suboxone Film, a brand-name version of the addiction medication buprenorphine that is combined with naloxone.

“At first it felt like I was high,” Daryl said. “But I think that’s what normal feels like now. I have not been normal in a long time.”

is a long-acting opioid that is generally used to treat opioid addiction. It reduces cravings for the stronger opioids he had been taking, prevents physical withdrawal from those drugs and comes with a significantly lower risk of fatal overdose.

Daryl injected the buprenorphine, and his opioid withdrawal symptoms disappeared. (Daryl is his middle name, which NPR and Kaiser Health News are using to protect his identity because it is illegal to use buprenorphine without a prescription.)

Weeks later, the grind of chasing heroin had worn on him. Buprenorphine controlled his withdrawal symptoms longer, and Daryl decided to use it to stay away from other drugs.

“I didn’t crave nothing. I wasn’t sick. My belly didn’t hurt. I wasn’t hurting in my joints,” he said.

Buprenorphine is one of just three federally approved medications to treat opioid addiction. It’s an opioid itself, so some people misuse it — they snort or inject the medication. And patients who have prescriptions for buprenorphine sometimes sell or give it away, which is known as diversion. Some policymakers and officials point to diversion as a reason to further increase regulations. Providers already need to be certified to prescribe it, and there’s a cap on the number of patients they can treat with the drug.

But addiction treatment professionals argue the problem of buprenorphine diversion is often misunderstood. A black market exists in part, they point out, because addiction treatment can be . President Donald Trump is expected to sign a bill that would increase access to the medication, but it’s unclear how quickly that access will grow.

In the meantime, many people dealing with addiction will turn to the black market for buprenorphine — sometimes using it to get high, sometimes using it to prevent withdrawal until they can get something stronger and sometimes using it exactly as it is intended to be used: to treat addiction.

It’s A Weaker Opioid

, president of the American Society of Addiction Medicine, which supports the measure that would increase access to buprenorphine, contends that making the drug more widely available outweighs the risk. For one thing, buprenorphine is not as dangerous as other opioids. “The risks of overdose with buprenorphine are minimal,” she said.

±õ³ÙÌýis possible to fatally overdose on buprenorphine — especially if users don’t have a tolerance to opioids or they mix it with other substances. But .

Buprenorphine’s effects are less potent than those of heroin and fentanyl, and the medication can block other opioids’ effects. Because of these attributes, few people use buprenorphine to get high. Instead, more people use it to  and to stay away from other illegal drugs such as heroin and illicit fentanyl.

Some leading addiction experts argue that self-treatment with buprenorphine can save lives because it is used in place of more dangerous substances that are blamed for the .

“It was not diverted buprenorphine that’s responsible for our current situation,” ²õ²¹¾±»åÌý,Ìýan addiction specialist and instructor at Harvard Medical School. “The majority of people are using it in a way that reduces their risk of overdose.”

“It’s definitely illegal,” Daryl said. “But would they rather me be driving to Louisville and picking up two 8-balls of heroin?”

Limited Access

People often try to treat themselves when they ²õ²¹¾±»åÌý, an addiction specialist and researcher at the University of Kentucky.

“These people want help, and they tried and they didn’t succeed. So now they’re going to go get it if it’s available,” she said.

Professional treatment with buprenorphine can be difficult for patients to get. Prescribers need a special waiver to prescribe the medication, and federal rules limit the number of people they can treat, a cap that is specific to buprenorphine.

Federal guidelines changed under the Obama administration to increase the number of prescribers and the number of patients they can treat. Nurse practitioners and physician assistants can now apply for a waiver to prescribe buprenorphine, and doctors who meet certain requirements can now treat up to 275 patients — that’s up from the previous limit of 100.

The new bill on its way to Trump’s desk would let more nurses prescribe buprenorphine and allow some doctors who recently got waivers to treat more patients.

Amid these efforts, some law enforcement officials and policymakers have said that  actions are needed to stop diversion.

But Basia Andraka-Christou, an assistant professor and addiction policy researcher at the University of Central Florida, said increasing regulations or shutting down prescribers would limit treatment options for people addicted to opioids.

“I guarantee you,” she said, “they’re either going to go and buy heroin and get high — which surely is not a great policy solution here — or they’re going to go buy Suboxone on the street.”

A Step Toward Safer Treatment

Getting Suboxone on the black market is obviously not ideal. Addiction is a complex, chronic disorder and patients need comprehensive care. That means a treatment professional to help them figure out the proper dose and counseling to address other mental health needs that are common among people with addiction. But Lofwall said people addicted to heroin or painkillers often realize they want professional help in quitting after trying buprenorphine illegally.

“They’ve had it and they know it works for them and they want to get it legally,” Lofwall said. “They want to get their life back.”

Daryl had that sort of experience. Several weeks after he began using buprenorphine regularly, Daryl tried to sign up for insurance so he could get help — medication and counseling — in staying away from other opioids.

“I think if I had never started [Suboxone] on the street, I wouldn’t have no interest in doing nothing but getting high,” he said.

Daryl still hasn’t made it into treatment. He had trouble starting his insurance, and the market for illicit buprenorphine can be fragile. Daryl struggled to stay away from heroin when the person from whom he bought buprenorphine lost the prescription. Addiction can take years to conquer, and many attempts, but Daryl said his time on buprenorphine allowed him to see a way back to a normal life.

“I’m at a point of my life now where I know I’ve got to change something, or I’m going to go back to prison,” he said. “I’m definitely ready to do something different.”

This story was produced in partnership with ,Ìý, and Kaiser Health News. A longer version of the story appears in Side Effects’ podcast 

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A few months ago, Kourtnaye Sturgeon helped save someone’s life. She was driving in downtown Indianapolis when she saw people gathered around a car on the side of the road. Sturgeon pulled over, and a man told her there was nothing she could do: Two men had overdosed on opioids and appeared to be dead.

“I kind of recall saying, ‘No man, I’ve got Narcan,'” she said, referring to a brand-name version of the opioid overdose antidote, naloxone. “Which sounds so silly, but I’m pretty sure that’s what came out.”

Sturgeon sprayed a dose of the drug up the driver’s nose and waited for it to take effect. About a minute later, she said, the paramedics showed up.

“As they were walking towards us, the driver started slowly moving,” she said. Both people survived.

Sturgeon had the drug with her because she works for Overdose Lifeline, a nonprofit devoted to distributing naloxone. But many bystanders in that situation would be unprepared to help.

Last month, U.S. Surgeon General Jerome Adams urging more Americans to learn to use naloxone and to carry it with them in case they encounter someone who has overdosed.

With the increase in overdoses nationwide, the advisory suggests that lay responders — people who may witness an overdose before police or emergency medical services arrive — can play a critical role in saving lives.

But if you’re not a medical professional, getting a dose of naloxone can be difficult. It is a prescription drug, and normally a doctor or nurse would have to directly prescribe it for the person at risk of overdosing. , an attorney for the National Health Law Program, said that creates a barrier for people with addiction.

“A lot of people at risk of an overdose don’t have contact with a medical provider or they’re afraid because of stigma,” he said.

To broaden access, every state and Washington, D.C., have making it easier for friends, family members or bystanders to get and use naloxone. Just how easy it is depends on your state, or even the pharmacy you use.

Davis said most states allow something called third-party prescribing, which lets doctors prescribe naloxone to someone who knows the person at risk of an overdose. And most states have passed providing legal immunity for people who administer the drug or call 911.

Davis said another type of law allows a kind of prescription called a standing order.

“But instead of having a person’s name on it, it has a group of people,” said Davis.

A standing order could apply, for example, to anyone who takes opioid painkillers or suffers from addiction. Or, Davis said, “anybody who might be in a position to assist someone, which, unfortunately, today means essentially everybody.”

In his home state of Indiana, Surgeon General Adams signed a statewide standing order in 2016, while serving as the state’s health commissioner. It allows pharmacies, local health departments or nonprofits that register with the state and follow certain requirements to dispense the drug to anyone who requests it.

But two years later, only about half of Indiana pharmacies are registered, and local advocates say many people, even some pharmacists, are still unaware of the law.

Even if you understand the laws regulating naloxone in your state — and you feel comfortable asking for it at the pharmacy counter — there’s still the cost, which has  in recent years. Two pharmacies near WFYI in Indianapolis stock naloxone. One charged $80 for two doses of the generic form of the drug. The other charged $95 for two doses of Narcan, a brand-name version.

“It’s expensive,” says Brad Ray, a researcher at Indiana University’s School of Public and Environmental Affairs. “People who are users are scraping money together to buy drugs. They’re not prepared to buy naloxone with that money.”

More than a dozen U.S. senators have signed a urging Health and Human Services Secretary Alex Azar to negotiate with drug companies to lower the price of naloxone.

For people who can’t afford the drug, Ray said, health departments and nonprofits can help. Laws in many states allow these organizations to dispense naloxone to lay responders.

Indiana’s health department used federal and state funds to purchase nearly 14,000 naloxone kits since 2016, the state reported. The state distributes those free doses through county health departments. But nearly half of Indiana counties didn’t request kits. And the majority of the kits went to first responders.

Local health departments, Ray said, need to work harder to get naloxone to people who might use it. People who use drugs, after all, may not feel comfortable going to the government for naloxone.

“Getting it in the hands of users — that’s the trick we need to figure out,” Ray said.

Davis said there is one change that could really help. The Food and Drug Administration or Congress could make naloxone an over-the-counter medication to make it easier to access, and maybe cheaper. FDA Commissioner Scott Gottlieb has the authority to do so, Davis said, but so far he has not.

This story is part of a reporting partnership with NPR, WFYI,ÌýÌý²¹²Ô»åÌý.

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The Bridge looks something like a hearing aid or a futuristic earring, and its makers claim that the device mitigates the misery of withdrawal sickness from opioids. With a small electrical pulse, it creates a “bridge” that may get people with addiction through flu-like withdrawal symptoms and on to medicines that can control cravings once opioids are cleared from a patient’s system.

But there’s a problem. Scientific evidence doesn’t yet show the Bridge works.

Side Effects Public Media reporter Jake Harper spoke to NPR’s Rachel Martin about his and how it has been marketed to politicians and treatment centers in Indiana and elsewhere without sufficient proof.

This <a target="_blank" href="/mental-health/listen-device-is-said-to-ease-opioid-withdrawal-but-does-the-evidence-support-it/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

In overdose cases, the fluids may contain clues for investigators.

“We send that off to a toxicology lab to be tested for what we call drugs of abuse,” said Alfie Ballew, chief deputy coroner. The results often include drugs such as cocaine, heroin, fentanyl or prescription pharmaceuticals.

After testing, coroners typically make note of the drugs involved in an overdose on the death certificate — but not always.

Standards for how to investigate and report on overdoses vary widely across states and counties. As a result, opioid overdose deaths aren’t always captured in the data reported to the federal government. The country undercounts opioid-related overdoses by 20 to 35 percent, according to a  published in February in the journal Addiction.

“We have a real crisis, and one of the things we need to invest in, if we’re going to make progress, is getting better information,” ²õ²¹¾±»åÌý, the author of the paper and a health economist at the University of Virginia.

Data from death certificates move from coroners and medical examiners to states and eventually the Centers for Disease Control and Prevention, which publishes reports on overdose counts across the U.S. According , more than 42,000 people died from opioid-related overdoses in 2016, a 30 percent increase from the year before.

But that number is only as good as the data states submit to the CDC. Ruhm said the real number of opioid overdose deaths is closer to 50,000. He came to the higher estimate through an analysis of overdoses that weren’t linked to specific drugs.

On a death certificate, coroners and medical examiners often leave out exactly which drug or drugs contributed to a death. “In some cases, they’re classifying it as a drug death, but they don’t list the kind of drug that was involved,” said Ruhm. In the years he reviewed in his paper, 1999 to 2015, investigators didn’t specify a drug in one-sixth to one-quarter of overdose deaths.

Some states do worse than others. In 14 states, between 20 and 48 percent of all overdose deaths weren’t attributed to specific drugs in 2016, according to a breakdown from .

Many overdoses not linked to a specific drug were likely opioid-related, Ruhm said, so the lack of specificity leads to undercounting. According to Ruhm’s , Indiana’s opioid overdose fatality rate is especially far off. He estimated the state’s rate in 2014 was 14.3 overdose deaths per 100,000 people, twice as high as the rate reported that year.

In some states such as Indiana, independent county coroners investigate deaths. Coroners are usually elected, and they aren’t necessarily medical professionals. Other states, though, have medical examiners, who are doctors. Some even have a chief medical examiner who oversees death investigations for the whole state.

“States that have centralized oversight with medical examiners tend to do better than those with coroners,” said Ruhm.

In some places, death investigators don’t list substances on a death certificate because they haven’t tested for them. Brad Ray, a policy researcher at Indiana University’s School of Public and Environmental Affairs, said toxicology reports cost hundreds of dollars each, which could strain county budgets.

Additionally, toxicology reports are currently optional for Indiana coroners. “So if you’re not required to pay for it, and you’re not required to report it, why would you?” said Ray.

Indiana’s legislature recently passed a bill to standardize how coroners handle suspected overdoses, and Republican Gov. Eric Holcomb is expected to sign it. Starting in July, coroners will have to run toxicology screens and report the results to the state health department. The state will also help cover the added costs.

Data that is more accurate would likely make the opioid problem look worse as the numbers go up. But Ray said realistic data could help the state access federal funds to tackle the opioid epidemic and keep better track of drug problems.

“So we can see when trends are happening. We can see when there tend to be increases in cocaine and meth and decreases in opioids, if that happens,” Ray said.

Marion County’s Ballew learned at a conference last year that she could help improve the state’s data. Her office was already getting toxicology reports for all suspected overdoses, and now her team will list the drugs involved in an overdose on the death certificate.

“We’ll say ‘drug overdose’ or ‘drug intoxication,’ and then we identify the drugs,” she said. “So if it’s five drugs that have caused or contributed to the death, then we put those five drugs down.”

Ballew said she plans to travel the state and train other coroners to do it the same way.

This story is part of a partnership that includes , and Kaiser Health News.

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Philip Kirby said he first used heroin during a stint in a halfway house a few years ago, when he was 21 years old. He quickly formed a habit.

“You can’t really dabble in it,” he said.

Late last year, Kirby was driving with drugs and a syringe in his car when he got pulled over. He went to jail for a few months on a separate charge before entering a drug court program in Hamilton County, Ind., north of Indianapolis. But before Kirby started, he says the court pressured him to get a shot of a drug called Vivitrol.

Vivitrol is a monthly injection of naltrexone, which blocks opioid receptors in the brain. It’s one of three medications approved by the Food and Drug Administration for treating opioid addiction. While it’s effective in some people, it’s not for everyone. Patients have to be ready to be opioid-free, and some patients won’t do well on it. It can also have , which Kirby says he experienced.

“I had sinus problems, chest problems for the whole month I was on it,” Kirby said. “I couldn’t shake it.”

He says he also got a rash — another possible reaction to Vivitrol, according to the product’s warnings. Months after he had the shot, he still had white splotches on his arms, which he attributed to the drug. But even with those symptoms, Kirby said the court urged him to stick with the medication for a couple more months. “They were way too pushy about it,” he said.

More than 130,000 Americans will go through drug courts this year, according to the National Association of Drug Court Professionals. Drug courts are designed to allow some people whose crimes stem from addiction to get treatment instead of jail time. But the treatment that is offered varies from court to court and is entirely at the judge’s discretion.

Some courts offer participants a full range of evidence-based treatment, including medication-assisted treatment. Others don’t allow addiction medications at all. And some permit just one: Vivitrol.

Prime targets for marketing

One reason for this preference is that Alkermes, Vivitrol’s manufacturer, is doing something nearly unheard of for a pharmaceutical company: It is marketing directly to drug court judges and other officials.

The strategy capitalizes on a market primed to prefer their product. Judges, prosecutors and other criminal justice officials can be suspicious of the other FDA-approved addiction medications, buprenorphine and methadone, because they are themselves opioids. Alkermes promotes its product as “nonaddictive.”

The argument worked for Judge Lewis Gregory, who heads the city court in Greenwood, Ind. About a year and a half ago, Gregory didn’t allow participants to start on addiction medications while in the program. “We were failing miserably with the heroin population,” he said.

At the time, Gregory was only familiar with buprenorphine and methadone. Both are opioid medications that can prevent withdrawals, reduce cravings and ultimately help people maintain a stable recovery. When they are properly prescribed and administered, patients don’t get a euphoric feeling or a “high.”

Buprenorphine and methadone have been the standard of care for opioid addiction for years, but because they’re opioids, it is possible to misuse them. They’re also sold illegally on the street.

“I was certainly not going to do a medication-assisted treatment program with drugs which people use to get high,” Gregory said, adding that he would not order someone to stop buprenorphine treatment if it were legally prescribed by a physician, a situation he rarely sees.

Then he received some Vivitrol literature in the mail and a phone call from an Alkermes sales representative. “So we ended up meeting in the early part of 2016, and she began educating me a bit,” he said.

Six months later, his court began a Vivitrol program, permitting some participants to use the drug. A sales representative sometimes sits in on the court’s treatment team meetings, Gregory said.

Many treatment specialists say allowing judges and other criminal justice officials with no medical training to exert influence over medical decisions is problematic. The power makes them prime targets for Vivitrol marketing, they say.

“You would think it would be more appropriate to go after physicians,” said, who researches drug courts at the  at Indiana University.

“What this is implying is that the judges in these cases are actually making a lot of the medical decisions, and that should be very concerning to everyone,” she said.

, who researches pharmaceutical marketing at Georgetown University, said she has not heard of another drug company going after judges. She says it’s not just unique — it’s inappropriate and could ultimately be damaging to patients. “They’re not health care providers. They don’t know data. They don’t know research,” she says.

A company strategy

The drug court Kirby went through doesn’t allow medications other than Vivitrol for treating addiction. In fact, NPR and Side Effects Public Media have identified at least eight courts out of the several dozen in Indiana that say they only allow Vivitrol treatment.

NPR and Side Effects Public Media have learned that Alkermes sales reps have also marketed the drug to court officials in Missouri and Ohio. A report from  that extensive marketing is leading judges to favor Vivitrol around the country.

The company is open about this part of its sales strategy. At an investor event last year, policy director Jeff Harris said that drug courts are a huge market for Vivitrol.

“We’re making progress but still just barely scratching the surface on the need that exists across the country,” Harris said in a presentation. “There are over 3,000 counties in the United States, and there are over 3,000 drug courts.”

A shot of Vivitrol costs around $1,000, making it pricier than the other addiction treatments. In many cases, the drug is paid for through Medicaid or other public funds. And marketing to criminal justice settings seems to have paid off for the company, whose earnings have grown significantly since its introduction. Vivitrol sales reached $209 million in 2016 — up from just $30 million in 2011. Sales have continued to climb this year.

Alkermes goes beyond marketing to judges. It also  to write laws that favor Vivitrol — and in some cases, hamper access to other addiction medications. The company has said it supports the use of all medications for addiction, but in practice, it doesn’t.

The company supported one law in Indiana that encourages the use of Vivitrol in drug courts. Signed in 2015, the bill allows judges to require medication as a condition of participating in a drug court, and the language specifically highlights Vivitrol treatment.

Alkermes declined repeated interview requests. In a written statement, the company defended the practice of marketing in criminal justice settings by noting that judges don’t actually prescribe their product.

No one-size-fits-all solution

Drug court judges interviewed for this story say they don’t mandate Vivitrol treatment, and that people can say no.

“We encourage it, but we never force anybody,” said Judge Gail Bardach of the Hamilton County, Ind., drug court, where Philip Kirby was a participant.

But facing potential jail time and court officials who really believe in Vivitrol, participants say getting the shot doesn’t always feel like a choice.

“They made it seem like they were forcing it upon me, like I couldn’t come into the program until I got it,” Kirby said.

For some patients, Vivitrol does help. Jeremy Templin went through the Hamilton County drug court program a few years ago after he was arrested for theft. He said the decision to go on Vivitrol seemed like it was made without him, but he credits his recovery, in large part, to the drug.

“I don’t know what it would have been like without it, but I know that I did have it, and here I am today,” he said. “I’m still alive.”

But Vivitrol is far from a one-size-fits-all solution. It’s not ideal for patients who are dealing with chronic pain on top of their addiction, or for pregnant women. It’s expensive. Furthermore,Ìý for all kinds of opioid addiction treatment are high, and after a period of not using, tolerance for opioids is low. Treatment with Vivitrol, which contains no opioid ingredients, could make someone more likely to overdose if they relapse, addiction specialists warn.

Dan Mistak, an attorney with , said courts should allow all medication options and let doctors make treatment decisions — including whether or not someone should use medication in their recovery.

“We rely on outside experts all the time in the judicial system. We don’t ask a judge to come in and be an expert in arson,” for example, he said. “This is a responsibility that a judge doesn’t want.”

°Õ³ó±ðÌý and the agree that courts should allow all three FDA-approved opioid addiction medication options.

“Especially with this exploding opioid use epidemic, we have to make available, as much as we can, whatever interventions are out there that are likely to be effective,” said Dr. Terrence Walton, chief operating officer for the NADCP, which lists Alkermes as one of its biggest donors.

For some judges, limited access to buprenorphine and methadone shapes their decisions about what to allow in drug court programs. The medications are heavily regulated, and many communities lack providers who can prescribe and dispense the drugs. Judge Bardach says she would consider allowing participants to use methadone if there were a provider closer to the court.

A need for regulation?

Currently, there is no regulatory agency that can ensure that judges follow best practices.

“There are not that many ways to leverage accountability over these courts,” ²õ²¹¾±»åÌý, a researcher at Physicians for Human Rights. Mehta recently authored a  on drug courts, focusing on three states. “Really the key is attaching restrictions and requirements to funding,” she said.

The federal government has put some  for courts receiving grants from the Bureau of Justice Assistance. They have to show that they “will not deny any eligible client access to the program because of their use of FDA-approved medications for the treatment of substance use disorders.” But only about 200 of the more than 3,000 drug courts nationwide operate with help from a BJA grant.

The Substance Abuse and Mental Health Services Administration has  grant-making guidelines in place, but it currently funds only 172 courts.

Mehta says states and counties need to implement similar requirements and work to educate drug court officials about all addiction medication options. She argues that until drug courts allow all of the medications, they’re not fulfilling their promise.

“If drug courts say that they provide access to treatment instead of prison, they are inherently violating that by saying, ‘Well, we only provide Vivitrol,’ ” she said.

Mehta says Alkermes’ marketing would be less effective if judges were compelled to follow best practices.

Georgetown researcher Fugh-Berman thinks that pharmaceutical companies like Alkermes should be barred from marketing to court officials and lawmakers.

“It would be great if the [FDA] went after this,” she said. “I think it does fall under their jurisdiction, but I wouldn’t rely on that being enough.” She says Congress could pass a law preventing such marketing, as well.

Philip Kirby says his probation officer finally relented when he lifted his shirt and showed that his rash was covering his whole body.

That rash has since cleared up, but it has left a pattern of white spots on his arms.

“I don’t know if they’ll go away,” he said. “I hope they go away eventually.”

He says he wishes he’d never taken Vivitrol in the first place.

This story is part of a partnership that includes WFYI,Ìý,Ìý and Kaiser Health News. Esther Honig of WOSU in Columbus, Ohio, and Bram Sable-Smith of KBIA in Columbia, Mo., contributed reporting.

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But a close reading of the shows that misleading and inaccurate information is being used to justify extending HIP 2.0.

This is important because the initial application and expansion happened on the watch of then-governor and now Vice President . And , who is President Donald Trump’s pick to lead the Centers for Medicare & Medicaid Services, helped design it. (Among other functions, CMS oversees all Medicaid programs.) So, states are watching to see if the approval of Indiana’s application is a bellwether for Medicaid’s future.

To get the program extended again, the Indiana Family and Social Services Administration has to prove to CMS that the experiment is and that low-income people in the state are indeed getting access to care and using health care efficiently.

The key part of Indiana’s experiment requires low-income participants to make monthly payments. Advocates say this promotes recipients’ taking personal responsibility for their health care. But some health policy experts say the information provided by the state shows that the provision isn’t working as well as it should. Some examples:

The Claim: Most members are making regular payments to maintain coverage.

The Fact: A lot of people are missing the first payment.

The state’s application says that “over 92 percent of members continue to contribute [to their POWER accounts] throughout their enrollment.”

This claim is missing context. Here’s a primer on how HIP 2.0 works: Members can get HIP 2.0’s more complete coverage, the plan, by making monthly payments into a “Personal Wellness and Responsibility Account,” or POWER account.

If they don’t make the payments, there are penalties. If a recipient makes less than the federal poverty level — about $12,000 a year — they’re bumped to HIP Basic, a lower-value plan that requires copays and doesn’t include vision or dental insurance.

If a recipient is above the poverty line and misses a payment, they become locked out of coverage completely for six months.

The state’s claim that 92 percent of members make consistent payments is based on data in a , a health policy research firm in Virginia that evaluated HIP 2.0’s first year.

But the Lewin report also says that when people sign up for HIP 2.0 they can be declared “conditionally enrolled,” which means they’re eligible but have not yet made their first payment.

According to the Lewin report, in HIP 2.0’s first year, about a third of people who were conditionally enrolled never fully joined.

“I don’t see those numbers being captured,” ²õ²¹¾±»åÌý, senior policy analyst with the National Health Law Program, which advocates for low-income individuals. Machledt said the state should recalculate the figure to include those people, because it’s potentially an indicator that people are confused about how the program works or that they can’t afford the payments.

He added that the figure cited is based on the first year of HIP 2.0, and that the rate of losing coverage for missing payments has increased substantially since then.

The Claim: HIP 2.0 users check their POWER account.

The Fact: More than half of people don’t even know they have one.

The state says the POWER account is promoting personal responsibility in health care; meaning, if someone is aware of how much they are spending, they’ll choose their medical care wisely. As evidence, the state writes in its application that 40 percent of HIP Plus members “check their [POWER Account] balance at least once a month.”

Again, the state leaves out important context. According to the Lewin report, most people in HIP Plus didn’t know they had a POWER account. Of those who did, 40 percent checked their account once a month, but that’s much smaller than 40 percent of all HIP Plus members. In fact, an analysis of the numbers shows only about 19 percent of HIP Plus members reported checking the balance of their POWER account monthly.

Rather than evidence of personal responsibility, , vice president for Health Policy at Center on Budget and Policy Priorities, sees evidence of confusion.

“I think that’s another really significant finding [in the Lewin report] that so far I have never seen the state come to terms with,” said Solomon.

A spokesperson for the state wrote in an e-mail that the phrase “of the members surveyed” was unintentionally omitted from the application.

The message did not address the overall concern that the statement was misleading.

The Claim: People on HIP Plus are more responsible.

The Fact: Experts say HIP Plus is just better insurance.

The application also says “HIP members who contribute [to their POWER accounts] are twice as likely to obtain primary care (31 percent to 16 percent), have better prescription drug adherence (84 percent to 67 percent), and rely less on the emergency room for routine treatment.”

Machledt said simply showing that HIP Plus members use the emergency room less frequently than HIP Basic members doesn’t tell the whole story.

“They don’t talk about the risk profile of those different groups,” Machledt said. He said people who are above the poverty line are generally to frequent the ER in the first place. “There’s no evidence to me that they’ve risk-adjusted … to show that they’re comparing apples to apples,” he said.

Indiana argues that the higher levels of primary care use and drug adherence for those making POWER account payments “confirms the principle of personal responsibility.”

But Solomon said the differences in behaviors simply confirm something else: Those who pay their POWER account have better insurance. HIP Plus makes it easier for people to access primary care and to adhere to their prescription drug regimens, Solomon said.

“The policy for people in HIP Plus is that they get a three-month supply of drugs, and can even use mail order, without any copays,” she said. Meanwhile, people in HIP Basic have to pay copays and are limited to a one-month supply of drugs.

Solomon said getting less primary care and relying on the ER for health crises is worse for patients and could also mean higher costs. “You have large numbers of people that are not getting care in the right place at the right time, and not maintaining adherence to prescription drug regimens.”

The Claim: HIP 2.0 is meeting its enrollment projections.

The Fact: No,Ìýit isn’t.

The state’s application reads “HIP has continued to meet its enrollment goals with over 394,000 individuals fully enrolled in HIP as of December 1, 2016.”

But the state isn’t meeting its enrollment goals. According to a chart published in 2014 in Indiana’s original proposal for HIP 2.0, its enrollment goal for December of 2016 was higher: 424,339. (The chart is off by a month, because the state started HIP 2.0 a month later than planned, so the actual projection for December 2016 appears on the line for November 2016.)

The most recent shows 403,142 HIP members in January 2017, short of the state’s projection of 427,702.

The Claim: The survey shows people like HIP 2.0

The Fact: The survey’s data and methodology are unreliable.

There’s reason to doubt the survey results that underlie much of the Lewin report, according to , director of the Center for Health Policy Research at the Milken Institute School of Public Health at George Washington University.

“They were not using what would generally be considered best practices in their survey methodology,” Ku said.

Ku ²õ²¹¾±»åÌýthe methodology available to the public is vague. From the information provided, he said, there are multiple ways that bias could have been introduced into the survey results used in the Lewin report. For one thing, the sample sizes of the survey were too small to draw accurate conclusions, Ku said, and the data was analyzed using “not an optimal method.”

Ku said that the results are not displayed in a scientific manner and that it appears the survey and analysis were done in a hurry. “You would not, as a survey researcher, have great confidence in the results that they show,” he said.

Conclusion

As Indiana looks to extend HIP 2.0, health policy experts say it’s important to get an accurate picture of how well the program is working. Requiring POWER account payments was key to making the program a reality in Indiana, but they say a more traditional Medicaid expansion — one that does not require monthly payments and six-month lockouts — is a better option.

heads the Indiana Family and Social Services Administration, the government agency that runs HIP 2.0. She said that in order to comment on discrepancies between the state’s extension application and the Lewin report, “I would have to go back and look at the way that these data were reported.” She continued, “I’m happy to look into that and get that for you.”

In a separate prepared statement, the agency noted that the state “has made significant achievements” on HIP 2.0’s stated goals and that it looks forward “to continuing to build on these successes with future versions of HIP. … The analysis of this program is constant and ongoing and includes continuous conversation with our federal partners to discuss all aspects of the proposed waiver as well as program outcomes.”

If the application does not go forward, the state could choose to expand Medicaid under the Affordable Care Act without any special provisions, or not accept the expansion at all. The federal government on Indiana’s application until March 17.

This story is part of a partnership that includes WFYI, , and Kaiser Health News.

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Edwards, 73, began showing symptoms of the disease in early April, according to the accounts of three inmates who lived with him in a dormitory. He was short of breath, had chest pain and could barely talk. He was also dizzy, sweaty and throwing up.

Edwards was serving a 40-year sentence for attempting to kill someone in 2001. He would have been released to home detention on May 1 but died on April 13. The next day, the Indiana Department of Correction sent out a statement that indicated Edwards’ symptoms came on suddenly: “The offender, a male over the age of 70, who did not have indications of illness, reported experiencing chest pains and trouble breathing on Monday.”

Edwards’ fellow inmates dispute the statement and say he had been seeking medical attention at the prison for days before he died.

Since the start of the pandemic, prisoners and their families have contradicted state officials about the conditions inside Indiana prisons. Many inmates report they’ve had no way to protect themselves from close contact with other inmates and staff members. They believe contracting the disease is inevitable. Indeed, 85% of the prisoners tested at Westville have been positive for the virus. Many of them were housed in the same dorm as Edwards.

As of May 22, at least  had died from confirmed or presumed coronavirus infections, and 650 inmates had tested positive for the virus. And while the state has maintained it isolates men and women with symptoms, inmates say even severely ill prisoners have been left in their dorms until it is too late. Their accounts call into question efforts to contain the virus, along with the care inmates receive once they have it.

“[Edwards] had been sick for approximately about a week and a half,” said one inmate named Josh. Josh allowed a family member to record a call about Edwards, and he asked to be identified only by his first name because he fears retaliation from prison staff.

His fellow prisoners say Edwards couldn’t even make it to see medical staff on his own — they pushed him in a wheelchair. Each time, he was sent back to his quarters.

“Those bastards said I’m fine, I just need to drink water and rest,” Josh recounted Edwards saying. “I’m clearly not fine — I can’t breathe.” Another prisoner wrote in an electronic message to a reporter that Edwards’ room “smelled like sickness and death.”

On the day he died, Josh said Edwards looked pale before he stumbled on his way to the bathroom. A pair of fellow inmates caught him and helped him sit down. “He sounded like he was winded, like he had just ran a marathon,” Josh wrote via the prison system’s electronic communications software. “He was just saying ‘I can’t breathe, I can’t breathe.'” He said an officer called the prison medical staff, who tended to Edwards in the bathroom for about 45 minutes.

“They finally took him out on oxygen,” Josh said. “Next thing we know, five hours later, he died.”

The Westville inmates emphasize that Edwards didn’t wait until that Monday to report his symptoms — he had complained to staff for days. “There is a major problem here with this place and it’s outta control,” wrote Josh.

, chief medical officer for the Indiana Department of Correction, declined to explain the different accounts of his death. “We do not talk about specific cases and patient clinical status,” she said.

Across the nation, at least 415 prisoners had died of the infection as of the week of May 20, and more than 29,000 had tested positive,Ìý.

The American Civil Liberties Union and other advocacy groups have called for the early release of some prisoners, especially the old and sick. Protesters have demonstrated outside Westville and other Indiana prisons to call attention to the conditions inside. Governors in the nearby states of Ìý²¹²Ô»åÌý have ordered some prisoners released, but  has refused. He said it’s up to local judges to decide, on a case-by-case basis.

In the meantime, Dauss said Indiana prisons are taking steps to control the spread of the coronavirus. “We move quickly and, in fact, immediately to separate those who are sick from those who are not sick,” said Dauss.

But according to accounts from numerous inmates, that kind of quick isolation of sick prisoners hasn’t always happened, at least through much of April.

Three different prisoners described another COVID-19 death in a different Indiana prison, the Plainfield Correctional Facility, on April 19. Lonnell Chaney, they said, had been asking for medical help for days.

“He didn’t even know where he was,” one inmate wrote to a reporter. Medical staff had checked on Chaney, who mumbled in response, but left him in the quarters. A prisoner tried to convince officers that the man’s condition was serious — Chaney couldn’t catch his breath — but the officers brushed it off.

The prisoners say Chaney, who was 61, died in his bed in the crowded dorm. “You must be almost dead to get outside help,” wrote the Plainfield inmate.

Six Plainfield prisoners have died during the coronavirus pandemic. The Department of Correction has not released a statement about any of those men. Of 145 Plainfield prisoners tested for the virus, 119 were positive. Forty-five staffers tested positive, as well. Indiana has reported two deaths of prison staffers, as of May 22.

At the Westville prison, Josh said another man in his dorm complained about similar symptoms, and correctional officers wrote the man up for being disruptive.

“Everybody here is terrified,” Josh said.

As the virus spreads, prisoners’ families are . They say prisons refuse to disclose basic information that would put them at ease, including whether an inmate is alive. In Scottie Edwards’ case and others, families didn’t know their loved ones were sick until after they had died — even though a department policy calls for notification when “death may be imminent.”

Crystal Gillispie talked to her father, Lonnell Chaney, for the last time on April 13. Their call lasted five minutes but felt shorter. He told her to send pictures of his grandchildren. And even though the coronavirus had started to spread in his dorm at the Plainfield Correctional Facility, he was more concerned about his family.

“He was like, ‘Just make sure you’re wearing your gloves and masks,'” Gillispie remembered. “I was like, ‘OK, Daddy. You do the same.’ He was so worried about us, and he ended up catching it.”

The next time she heard news of her father, it was from her aunt, his sister: The prison had called her to say Chaney was dead.

Edwards’ sister, Gloria Sam, said her brother was new to Westville prison, because he’d recently requested a transfer to a facility with a law library. He ended up at Westville just before the pandemic started.

“He said, ‘I am afraid of this virus because we’re here close together, and if it comes out, it’ll spread like wildfire,'” she said. Sam hadn’t heard from Edwards in more than a week when her phone rang on April 14. She remembers that even though her caller ID said it was from the State of Indiana, it didn’t occur to her that it was about her brother.

“They said, ‘Well, we have some bad news.’ I thought they were gonna say he was sick,” she said. They told her he had died.

If possible, Sam said, she would have wanted to say goodbye.

“It’s one of the most hurtful things I’ve experienced in my life,” she said.

This story is part of a partnership that includes , , and Kaiser Health News.

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On April 6, an inmate named Dennis stayed up late at Indiana’s Plainfield Correctional Facility. He wrote to his wife, Lisa, and told her he was scared.

“I can tell you right now, with nearly 100% certainty, that I am going to get this virus,” he wrote. Lisa said Dennis suffers from , which could cause complications if he contracts COVID-19. (KHN agreed to omit their last names because they fear retaliation from prison staff.)

“I just need you to know how sorry I am for not being there … during these scary uncertain times,” Dennis wrote to his wife. He was sent to prison a year ago for theft, driving on a suspended license and resisting arrest. His earliest possible release date is in June 2021.

“If I don’t getta come home, please always know that you are and always will be the love of my life,” he wrote.

Two days later, he told Lisa that for the first time, prison staff took the inmates’ temperatures. Some, including an inmate next to him, had fevers but were still kept in the dorm with dozens of other men.

“He is about 3 ft. from me right now,” Dennis wrote of the man with a fever. He wrote again that night after midnight to tell her the prisoners with fevers had finally been removed.

The Indiana Department of Correction said it is taking measures to prevent the spread of the coronavirus among the nearly housed in the state’s 18 adult and three juvenile facilities — including supplying hand sanitizer to inmates and isolating anyone who exhibits COVID symptoms.

But accounts from inmates and their relatives contradict the agency’s claims. Kaiser Health News and NPR have heard from dozens of people concerned about their family members in prison. We’ve read messages from inmates and heard recorded phone calls with their loved ones. They said prison staff members haven’t taken adequate precautions to prevent the spread of the virus.

Many inmates who exhibit COVID-19 symptoms have been left in crowded quarters, according to these complaints. Inmates don’t have hand sanitizer and were only recently issued face masks.

“That’s illustrative of what’s happening across the country in county jails and departments of corrections,” said of the Brennan Center for Justice in New York.

Thousands of incarcerated people have been infected — in one Ohio prison, 73% of inmates tested positive for the coronavirus — and many have died.

After about 1,300 inmates and guards at a Tennessee prison for the virus, officials in Tennessee said they will test inmates at correctional facilities across the state. Of those who tested positive in the privately run Trousdale Turner Correctional Center, about two dozen were guards. And 98% of the COVID-19-positive inmates and employees had no symptoms at the time of their test, according to the Tennessee Department of Health.

“These are communal spaces, and they really are petri dishes for transmission of diseases such as COVID-19,” said Eisen.

As of April 30, Indiana had reported in correctional facilities. Indiana officials declined to be interviewed for this story and, so far, have not said how many prisoners have been tested. The Department of Correction now its COVID-19 statistics each business day.

Symptoms And Fears Mount

In an April phone call, Dennis told Lisa he was sick. “I’m doing bad. I’m not doing good at all,” he said, according to a recording she made of the call. “My head is splitting.”

Dennis estimated that 15 prisoners had been removed from his dorm, which normally houses more than 80 people. He guessed about half of the remaining prisoners showed some sort of symptoms.

“It scares me so bad,” Lisa said to Dennis.

“It scares me, too,” Dennis replied. “Most of the guys in here are saying, “Well, we all got it. Just some of us have symptoms, some of us don’t.'”

“They brought us another bar of soap today,” Dennis said. “Everybody in here thinks, ‘Well, somebody must have died today.'”

The state announced the next day that a prisoner from the Westville Correctional Facility had died. He tested positive for COVID-19.

Prisoners Say They Can’t Protect Themselves

Other inmates and their family members tell similar stories about the conditions in Indiana prisons. Prisoners in their quarters exhibit symptoms, they said, but the staff isn’t checking on them unless they complain — in some cases, multiple times.

While the disease spreads, prisoners said, they aren’t able to take measures to protect themselves.

A second prisoner at the Plainfield facility told his wife in a recorded call that social distancing is impossible. “At this very moment, I can reach out and touch somebody,” he said. “We’ve got a reason to be scared for our lives,” said the man who was sentenced for a robbery. His earliest possible release date is in 2022.

His wife told KHN her husband tried to make a tent with blankets to protect himself, but a guard told him to take it down.

She said she told her husband: “Absolutely not. This is the only way that you have to even protect yourself.”

Two inmates, one at the Pendleton Correctional Facility and another at the Indiana State Prison, described incidents in which guards jokingly coughed in their direction.

“That’s nothing to play with. It’s my life,” the Pendleton inmate said in a recorded call. He has asthma, he said. Many guards only recently began wearing masks.

put out by the Centers for Disease Control and Prevention, which the state said it follows, stresses the importance of hand sanitizer, social distancing and masks. The Indiana Department of Correction recently released a indicating the agency regularly cleans its facilities, provides hand sanitizer to inmates and encourages social distancing.

Family members who saw the video said it made them angry.

Advocates Push For Limited Prisoner Release

“[Inmates] should not have less opportunity to keep themselves healthy than the general public,” said , the former head of the New York City Department of Correction and the Pennsylvania Department of Corrections.

The U.S. Supreme Court ruled, in a 1976 decision in the case , that to serious medical needs” is unconstitutional.

“They should be making every effort to spread the inmates apart as much as possible to provide for social distancing,” said Horn, who now lectures at the John Jay College of Criminal Justice in New York City.

The ACLU of Indiana, the and other advocates have pushed the state to release certain inmates, such as the oldest or nonviolent offenders.

“It’s necessary to curb the spread of coronavirus behind bars in this country,” said Eisen of the Brennan Center. She pointed out that states such as ,  and New York already have taken such steps in response to the pandemic.

So far, Indiana officials have resisted calls to do so.

“I do not believe in releasing those low-level offenders,” Gov. Eric Holcomb said at a news conference on April 13. “We have got our offenders in a safe place — we believe maybe even safer than just letting them out.”

A week later, three prisoners had died from COVID-19, and the confirmed case count had jumped from 27 to more than 200. Some family members of inmates said that if something happens to their loved ones, they’ll blame Holcomb.

Lisa laughed when she heard the quote from the governor.

“Wow. That’s a big lie,” she said. “They have them herded like cattle, all crammed together, where the virus can just jump from one to the other. There’s no protection.”

“Yes, they committed a crime and they were sentenced,” Lisa said. “But they weren’t sentenced to death.”

This story is part of a partnership that includes Side Effects Public Media,  and Kaiser Health News.

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“I immediately called my mom and said, ‘Mom, is it possible that I have random siblings out there somewhere?'” said Woock, of Indianapolis. She recalled her mom responded, “No, why? That’s ridiculous.”

But the messages continued, and some of them mentioned an Indianapolis fertility practice that she knew her mom had consulted when she had trouble conceiving.

Woock researched and finally learned the truth. Dr. Donald Cline, the fertility doctor her mother saw in 1985, is her biological father.

“I went through an identity crisis,” she said. “I couldn’t look in the mirror and think about, ‘Where did my eyes come from? Where did my hair color come from?’ I didn’t even want to think about any of that.”

Woock hadn’t known that her mom had used artificial insemination to conceive her, and neither of them knew the doctor had used his own sperm.

“We now know Cline used his own sample and squirted it into my mom,” Woock said.

In the 1970s and ’80s, Cline deceived dozens of patients and used his sperm to impregnate them. He has more than 60 biological children — and counting.

For Woock, as the story of her parentage sunk in, it was distressing for another reason: She wanted to start her own family and was having trouble conceiving. And now she needed to turn to the fertility industry that had so badly betrayed her mom.

“We were doing all of the calendaring … everything that is out there to help you get pregnant, we were doing that,” Woock recalled.

But after six months, when she still wasn’t pregnant at 32, she went to a fertility clinic for some tests.

“I had to fill out all this paperwork, and there’s a slot that says kind of like, ‘Is there anything else you’d like to share?’ ” Woock said.

Yes, there most certainly was.

The Odds Of ‘Fertility Fraud’ These Days

New allegations of doctors using their own sperm keep coming to light — because of genetic-testing services like Ancestry revealing networks of half siblings — in states like , Ohio, Colorado and Arkansas.

But those doctors performed artificial inseminations decades ago. Could what happened to Woock’s mom happen in a modern fertility clinic?

Dr. Bob Colver, a fertility specialist in Carmel, Indiana, said it’s a question many of his patients have asked. But it’s unlikely, he said. These days, there are more people involved in the process, and in vitro fertilization happens in a lab, not an exam room.

“Unless you’re in a small clinic where there’s absolutely no checks and balances, I can’t even imagine that today,” Colver said.

It’s now illegal in  for a doctor to use his sperm to impregnate his patients. But there’s no national law criminalizing what’s called “fertility fraud.”

Fertility medicine has advanced a lot since the 1980s, but women trying to get pregnant today with the help of medicine face a baffling array of treatment options that can be hard to navigate and can be hugely expensive. And some critics say the growing, multibillion-dollar fertility industry needs more regulation.

For example, sperm banks may not get accurate medical histories from their donors, who could pass along genetic diseases. And there’s no limit on how many times a donor’s sperm can be used, which some donor children worry could increase the chance of inbreeding. Sperm donation guidelines from organizations like the American Society for Reproductive Medicine are voluntary. There was a contestant on  last year who said his sperm had helped father more than 100 kids.

Unrealistic Expectations

When Woock decided to get her first fertility treatment, she set preconditions with the clinic. She insisted on having a female doctor and insisted that a doctor be in the room for all appointments and oversee everything that happened.

Her experience with her clinic was very different from her mother’s with Cline, but nonetheless there were surprises along the way.

The clinic told her that her problems conceiving could be because of husband Rob’s low sperm count and motility (meaning his sperm weren’t great swimmers). They advised a form of in vitro fertilization that involved injecting one sperm directly into one of her eggs in a petri dish.

When doctors told Woock she needed IVF, she felt pretty optimistic.

“I’m thinking going into this that our chances of success are 70, 75%,” Woock said.

Fertility treatment can be really expensive, and patients may start treatment with unrealistic expectations. That’s because success rates are complicated, and some clinics use only the best numbers in their .

For example, clinics can advertise high fertilization rates. But a 70% fertilization rate doesn’t mean 70% of eggs turn into babies — plenty can go wrong after the lab combines egg and sperm.

Success depends on your age, your clinic and the type of procedure you need. But most of the time, assisted reproduction procedures such as IVF don’t work. The Centers for Disease Control and Prevention, which  in the U.S., reports only about 24% of attempts result in a baby.

‘Add-On’ Technology — And Prices

When Woock started her first IVF cycle, she gave herself shots, a couple a day, to stimulate her ovaries to get multiple eggs ready at once. Multiple eggs means more chances for fertilization.

But the drugs have side effects. They gave her headaches and made her moody and less patient.

“I was actually allergic to one of the medications, which just means that you keep taking it and deal with the itching and rash,” Woock said.

But she hung on until it was time for a doctor to surgically retrieve her eggs, at which point patients can face even more choices. Because the couple’s fertility problem appeared to be with Rob’s sperm, the clinic offered to use a special device to help pick the best sperm for IVF.

“We were kind of like, ‘Yeah, why wouldn’t you?'” Woock said. “If it’s gonna give us a better chance, do it.”

A device like that is called an add-on. Add-ons are often new technology, described as cutting-edge, which can appeal to patients. Examples of add-ons include — which some specialists argue improves the odds of a live birth — and Ìý²¹²Ô»åÌý, both methods claiming to facilitate implantation.

Jack Wilkinson, a biostatistician at the University of Manchester in England, , which he has found can increase costs — and, he said, they may not work.

“We quite often see there’s no benefit at all,” Wilkinson said. “Or, possibly even worse, that there’s a disadvantage of using that treatment.”

Wilkinson said the device Woock’s clinic offered could work, but the evidence supporting it is thin.

Failed Fertilizations

The clinic called Woock the morning after her egg retrieval. None of Woock’s eggs fertilized. The procedure revealed that her husband’s sperm quality wasn’t the only fertility issue the couple faced.

“They immediately saw that there was something wrong with my eggs,” Woock said. “My eggs are just total crap.”

She underwent a second round of IVF with the same result — no fertilization.

“Getting that news the second time … felt even more set in stone that this was going to be a very long, challenging road,” Woock said.

Challenging and expensive. Most states, including Indiana, don’t require insurers to cover fertility treatment. Without insurance, a round of IVF can cost more than $10,000 — even more than $20,000 — with no guarantee the patient will get pregnant.

Woock was lucky that her employer-provided insurance covered a lot. But it still wasn’t cheap. She had to pay for some medications, “plus, you have to pay lab and facility fees that insurance doesn’t pay,” Woock said.

Donor sperm and eggs aren’t generally covered, either. Those can be tens of thousands of dollars.

Woock faced a hard choice: After two failed attempts, did she want a kid enough to go through IVF again? She and her husband decided they did. So Woock did a third round of IVF. And then a fourth. When that didn’t work, she gave up on using her own eggs.

“What I expected as I was growing up and picturing my children is not what I will see,” Woock said.

Woock and her husband decided to try donor eggs. If all goes according to plan, she could still carry a child. She wants to keep trying.

“I realize that pregnancy is incredibly challenging on your body and your mental state,” she said. “If I can make it through a year of IVF, I can make it through morning sickness.”

This story is part of a partnership that includes , and Kaiser Health News. The story was adapted from Episode 6 of the podcast . You can hear more about the fallout from Dr. Donald Cline’s deception on Sick’s first season, at .

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“He was reaching for things, and he was talking to Bill Gates and he was talking to somebody else I’m just certain he hasn’t met,” his mother, Cheryl, says. She remembers finding Jason lying on the floor of the treatment center in late 2016. “I would just bring him blankets because they didn’t have beds or anything.”

Cheryl had taken Jason to the clinic out of desperation. Jason, now in his late 30s, has struggled with addiction since he was a teenager. Cheryl saw his drug use escalate after he was prescribed a benzodiazepine for his anxiety, and he eventually began using heroin and meth. Over the years, Jason would try to get into recovery, but treatment programs didn’t help him for very long.

“I thought he was going to die,” Cheryl says. (KHN and NPR are using only first names because Jason worried he would lose his job if his employer found out about his addiction history.)

In late 2016, she saw a local TV news segment about a clinic called Emerald Neuro-Recover. The staff there treats addiction with something called NAD therapy, an IV infusion that can contain amino acids and other nutritional supplements, including nicotinamide adenine dinucleotide, a compound found in living cells.

The infusion, which is delivered over 10 to 15 days, cost $15,000, and it wasn’t covered by insurance. But the TV report said Emerald’s treatment was “proven to wipe drug cravings away.” Cheryl was intrigued.

Emerald and dozens of other companies across the U.S. say NAD therapy can address conditions from anxiety to depression to chronic fatigue and even Alzheimer’s.

And clinicians offering the treatment say that it reduces or stops cravings for alcohol or illicit drugs in up to  of patients. The treatment has gained attention on  and in the mainstream media.

But such claims about NAD therapy and addiction are not supported by scientific evidence, and they may conflict with federal and state regulations against deceptive marketing of medical treatments. Emerald and other addiction treatment clinics use these claims on websites, social media and in the news to attract clients looking for help. Emerald even used patients’ stories to promote the therapy — in some cases, more than a year after the patients returned to using illicit drugs.

In an interview with Side Effects Public Media, Emerald leadership defended its use of the therapy. “It’s not really controversial; it’s just novel or new,” says John Humiston, a family medicine physician and the company’s medical director. “The cravings we expect to be gone within days.”

Earlier this year, Emerald leadership discussed NAD therapy with Side Effects but cut the interview short amid questions about the treatment’s efficacy. Company officials declined another interview and did not respond to follow-up questions via email. For that reason, Side Effects was unable to ask them about Jason’s case.

Treatment centers touting high success rates can sound appealing to vulnerable people suffering from addiction or to their families, even if there’s no solid evidence to support their methods. “[Clinics] know this is a really desperate population,” says , a health policy researcher focused on substance use disorders at the University of Central Florida.

Unsubstantiated claims have long been a part of addiction treatment. For instance, in the late 19th century, a doctor dubbed his formula the “” and sold it via mail order for addiction, claiming a 95% cure rate. “In a week the desire to drink will be gone,” read one advertisement.

More recently, NAD therapy is among a wide range of unproven treatments currently marketed to people with addiction, including the herbal extract  and other types of supplements. The FDA and the FTC  last year but have limited resources to police the market for unproven treatments. And that leaves consumers on their own to sort out fact from fiction.

While patients spend time and money on ineffective treatments, they miss out on proven therapies that can reduce their risk of relapsing, including behavioral counseling and medications approved by the FDA for treating addiction, says Andraka-Christou. “We do actually now have evidence-based treatments available,” she says. “But you still do have these quack treatments popping up.”

A Hard Sell

Numerous companies make bold claims about NAD therapy. A Las Vegas says, “IV NAD+ therapy has a 90% success rate at reducing cravings and a 7% relapse rate.”

´¡Ìý in Pooler, Ga., says NAD therapy can provide “rapid reduction or even elimination of cravings, restoring clarity of mind and enthusiasm to be alive.”

´¡²Ô´Ç³Ù³ó±ð°ùÌý in Greenville, S.C., says, “Withdrawal signs of addiction go down approximately 70-80% on the first day and continue to decline as the therapy progresses.”

Similar glowing  from Emerald led Cheryl and Jason to meet with Emerald leadership in late 2016, including founder Joe Pappas and patient liaison Amora Scott. Cheryl recalls, “They said, ‘This is going to fix it. … It has never not worked for us. It works for everyone.'”

Jason insisted his mother shouldn’t pay thousands of dollars for his treatment. She had already spent too much money on him. They decided not to come back.

“Well, then Amora started calling me and calling me and calling me,” Cheryl says. Unknown to Jason at the time, Cheryl says Scott persuaded her to pay for the treatment upfront.

Cheryl took out an advance on her credit card and met Scott at a gas station to hand over the money. “When I gave her that check, I looked at her and said, ‘This is to save my son’s life,’ ” Cheryl recalls.

Fifteen thousand dollars could seem like a bargain for such a quick fix — one that “,” according to a press release from Emerald.

But there has been little research on the effects of the formulas used by Emerald and similar clinics.

“I don’t know where those claims could come from, but it doesn’t seem realistic to me,” says , an addiction psychiatrist in Indianapolis. She says there’s insufficient evidence to support using NAD therapy over other standard treatments: “There’s no actual data on any of these things.”

For an additional $400 fee, Emerald patients can have their brain scanned at a nearby clinic to document their progress with NAD therapy. An Emerald  shows a series of scans from a woman whose “brain is suffering from alcoholism.” Areas that glow red, orange and yellow — “HYPERACTIVE and OVERACTIVE” — totally disappear from the scans after 12 days of NAD therapy, according to the company.

“This is totally bogus,” says , an addiction psychiatrist at the Indiana University School of Medicine with expertise in brain imaging who reviewed the images via email. “We do not have research in our field that allows us to use EEG or any other brain imaging technique to document treatment response.”

NAD, which is an important coenzyme in several cellular processes, including energy metabolism, is being researched at Harvard for . Supplements claiming to boost NAD levels have recently gained popularity for purported anti-aging benefits. But NAD’s benefits in addiction treatment are unproven, and providers cite unpublished research to make sweeping claims.

One pilot study cited among some NAD therapy providers shows close to 90% of patients have reduced cravings after 10 days of treatment. The study falls short of the standard used by the scientific community to weigh evidence: It did not compare NAD therapy to a placebo or other treatment. It also did not undergo rigorous peer review, and the results have not been published in a scientific journal.

A doctor involved with that study, Richard Mestayer, says he is used to skepticism. Mestayer runs a clinic in Springfield, La., that offers NAD therapy. He says it is unclear how NAD therapy helps with addiction but that his personal experience convinced him it works.

“I think there’s a lot of stuff we don’t know yet,” he says. “I was a skeptic, but when a two-by-four hits you in the head every time, you say, ‘Oh, I better pay attention.'”

Dangerous Withdrawals

The hallucinations started several days into Jason’s treatment at Emerald. Cheryl wanted to take him to the emergency room.

Rapidly withdrawing patients from benzodiazepines can cause dangerous side effects, such as  — it can even be fatal, says Zarse. “There are two types of withdrawal symptoms that can kill you: alcohol and benzodiazepines,” she says. “It can cause enough misfiring in the brain that it can lead to brain death.”

The standard treatment is to slowly wean someone off benzodiazepines. “They even give benzos for benzodiazepine withdrawal in jail — that shows you how serious this is,” Zarse says.

Still, Cheryl says, Emerald staff told her to take Jason home rather than to the hospital. She decided to go to the ER anyway after Jason tried to throw himself through a wall.

Jason was still hallucinating when he arrived at the ER, and then the seizures started. “He was just totally out of it for about three days,” Cheryl says. “Not even alert.”

One of the doctors who treated Jason noted in his medical records: “Unclear exactly what this NAD substance/medication is.”

When Jason left the hospital, he returned to Emerald to finish the treatment. “I didn’t know what else to do,” he says.

Jason says the therapy didn’t work. He white-knuckled his way through abstinence for three months before he relapsed. “One day out of the blue, I called somebody up and just was going to do it one time,” he says. “You know how that goes.”

Marketing Unapproved Substances

The federal Food and Drug Administration has not approved NAD therapy, according to a spokesperson for the agency.

Substances marketed as treatments for specific conditions are considered medications and must be approved by the FDA for that purpose, says Andraka-Christou. For medications, FDA approval requires three phases of human clinical trials. Without that approval, it would violate FDA regulations to market a treatment for that condition.

More broadly, making unsupported claims about a medical treatment or supplement violates federal rules. Both the FDA and the Federal Trade Commission regulate how companies advertise treatments and supplements.

But no publicly available information could be found to show that either agency has taken enforcement action against any clinic offering NAD treatments.

Spokespeople for the FDA and the FTC said via emails that their agencies could not comment on specific cases. “All advertising under our jurisdiction must be true, not deceptive, and supported by competent and reliable scientific evidence,” wrote the FTC spokesperson.

“The FDA takes action against companies that engage in ‘health fraud,'” said the email from the FDA.

Lack of FDA action doesn’t mean it is acceptable for clinics to market the therapy, says , an assistant professor at the University of Maryland who researches dietary supplements.

“The FDA can be slow, and it’s understandable because there are so many [potential enforcement issues] out there,” he says. “There could still be cause for concern.”

Patient Stories

Since its inception, Emerald has featured patients’ stories on social media and in news coverage, much of which  the company’s claims about ending addiction. But several of these same patients went to jail for drug and alcohol offenses soon after being treated at Emerald.

In a 2017 TV news story about Emerald, a man says that Emerald helped him get his alcohol and pill addiction under control. Reached by phone, he told Side Effects that he reluctantly said those things to get the TV interview over with. “[NAD therapy] was a complete waste of my time and my family’s money,” he said. “It did absolutely nothing for me.” (He asked to remain anonymous because many of his family and friends don’t know about his addiction, and he worries about his future job prospects.)

He added that he also experienced a seizure when the doctor quickly cut him off from alcohol without antiseizure medication. He says he started drinking again about a week after he finished NAD therapy, and he was arrested for drunken driving a few months later.

In another video Emerald posted on YouTube in 2017, an Indianapolis man is seen leaving Emerald on a sunny day. “I feel wonderful,” he says. “Using heroin, I had a lot of racing thoughts, anxieties, cravings. All that’s gone.” He tells other people who use heroin to go to Emerald.

Six months later, he was in jail for possession of a syringe. Reached by phone, he said that the treatment didn’t work for him, and that he received it free of charge.

Emerald still promoted patients’ stories like these on social media until December 2018. The company began removing content from its website, YouTube and Facebook shortly after Side Effects began reporting this story.

Emerald executives declined to provide Side Effects with a patient to interview.

Asked about cases of relapse among Emerald patients, Humiston replied: “What I’ve seen is that [the treatment is] very effective.” Humiston started work at Emerald in January 2019, but he was a medical adviser for the company before then, and emails between Cheryl and Emerald staff indicate that he was consulted about Jason’s treatment there.

Origins Of Treatment

Humiston says he believes in the treatment he offers: “It’s got quite a reputation of success. Nothing’s 100%, although for most people, it is 100%. That’s been my experience.”

But Humiston acknowledges that he does not regularly track patients’ long-term outcomes: “That’s the reason to get a study organized,” he says. Last year, Humiston told a local TV station that a clinical trial was forthcoming, but it has not materialized.

Humiston first learned about NAD therapy from a man named William Hitt. Hitt is often credited with originating the treatment, but he was not a doctor or a researcher. According to a lawsuit brought by the state of Texas in the mid-’80s, he falsely claimed to be a doctor when he treated AIDS patients with “injections of the patient’s own filtered urine.” Forced to shut down in Texas, he moved to Tijuana, Mexico, where Humiston worked with him from 2003 until his death in 2010.

Humiston himself has had trouble with his medical license. The Medical Board of California reprimanded him, according to investigation documents, for committing “gross negligence in his care and treatment” of his teenage son, who almost died in 2016 when Humiston failed to seek proper treatment for the boy’s heart infection. Documents say Humiston began performing IV treatments on the boy before he was 3 years old, which may have caused the boy’s heart issues.

Asked about the investigation, Humiston said there was “inaccurate information put in there” but that he accepted a public reprimand from the medical board “just to end it.” He did not respond to emailed follow-up questions about the disciplinary case.

Humiston applied for an Indiana medical license in November 2018, and the state granted it. He became Emerald’s medical director in January. He is at least the sixth doctor to work with the company in its three years of operation.

‘I Owe Her The Money’

When asked in January about Emerald’s claims and the origins of NAD therapy, Star Voigt, the CEO at the time, declined to answer further questions. “We’re trying to help people,” she said. “So if you’re going to go into that, then I’m going to ask you kindly to leave.”

Side Effects sent further questions via email, but the company did not answer them. Instead, Voigt sent a statement from Humiston expressing concern that Side Effects’ reporting wouldn’t be balanced or objective. Voigt left the company soon after.

Cheryl, the patient Jason’s mother, wrote to Emerald founder Pappas a few months after her son left Emerald. She told him that Jason was facing an $11,000 medical bill from his hospital stay and that he still struggled to stay away from illicit drugs. She reminded Pappas that stopping benzodiazepines cold turkey — what Jason went through at Emerald — is dangerous and goes against standard medical practice.

Cheryl wanted a refund so she could pay off Jason’s medical bill. “Can we compromise?” she wrote.

Scott, the patient liaison, wrote back that Humiston believed Jason should be tested “for mold … infections, and/or inflammation in the blood and body.” Instead of a refund, Emerald offered further NAD treatments and another therapy — for $3,000.

Cheryl and Jason declined the offer. “First, do no harm,” Cheryl wrote back. She filed complaints with the FTC and the state attorney general, but nothing came of it. ( allows the state attorney general to prosecute companies for deceptive advertising. The office would not confirm or deny whether it is investigating Emerald’s practices.)

The hospital eventually did waive the $11,000 bill. But Cheryl still has not received a refund from Emerald.

“I feel like I owe her the money,” Jason says. “At some point, I’ll pay it back.” He says he finally got help with his addiction through a local 12-step program that he has been part of for two years. Looking back at his treatment at Emerald, he says he felt duped into trying NAD therapy. “I think it’s taking advantage of people.”

“I can’t believe that no one stops them,” Cheryl says. “You’ve got these people selling snake oil, and they’re getting away with it.”

This story is part of a partnership that includes , and Kaiser Health News.

This <a target="_blank" href="/health-industry/addiction-clinics-expensive-unproven-infusion-treatments-desperate-patients/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

Months in prison didn’t rid Daryl of his addiction to opioids. “Before I left the parking lot of the prison, I was shooting up, getting high,” he said.

Daryl had used heroin and prescription painkillers for more than a decade. Almost four years ago, he became one of more than 200 people who tested positive for HIV in a historic outbreak in Scott County, Ind. After that diagnosis, he said, he went on a bender.

But about a year ago, Daryl had an experience that made him realize he might be able to stay away from heroin and opioids. For several days, he said, he couldn’t find drugs. He spent that time feeling terrible because of withdrawal sickness.

His friend offered him part of a strip of Suboxone Film, a brand-name version of the addiction medication buprenorphine that is combined with naloxone.

“At first it felt like I was high,” Daryl said. “But I think that’s what normal feels like now. I have not been normal in a long time.”

is a long-acting opioid that is generally used to treat opioid addiction. It reduces cravings for the stronger opioids he had been taking, prevents physical withdrawal from those drugs and comes with a significantly lower risk of fatal overdose.

Daryl injected the buprenorphine, and his opioid withdrawal symptoms disappeared. (Daryl is his middle name, which NPR and Kaiser Health News are using to protect his identity because it is illegal to use buprenorphine without a prescription.)

Weeks later, the grind of chasing heroin had worn on him. Buprenorphine controlled his withdrawal symptoms longer, and Daryl decided to use it to stay away from other drugs.

“I didn’t crave nothing. I wasn’t sick. My belly didn’t hurt. I wasn’t hurting in my joints,” he said.

Buprenorphine is one of just three federally approved medications to treat opioid addiction. It’s an opioid itself, so some people misuse it — they snort or inject the medication. And patients who have prescriptions for buprenorphine sometimes sell or give it away, which is known as diversion. Some policymakers and officials point to diversion as a reason to further increase regulations. Providers already need to be certified to prescribe it, and there’s a cap on the number of patients they can treat with the drug.

But addiction treatment professionals argue the problem of buprenorphine diversion is often misunderstood. A black market exists in part, they point out, because addiction treatment can be . President Donald Trump is expected to sign a bill that would increase access to the medication, but it’s unclear how quickly that access will grow.

In the meantime, many people dealing with addiction will turn to the black market for buprenorphine — sometimes using it to get high, sometimes using it to prevent withdrawal until they can get something stronger and sometimes using it exactly as it is intended to be used: to treat addiction.

It’s A Weaker Opioid

, president of the American Society of Addiction Medicine, which supports the measure that would increase access to buprenorphine, contends that making the drug more widely available outweighs the risk. For one thing, buprenorphine is not as dangerous as other opioids. “The risks of overdose with buprenorphine are minimal,” she said.

±õ³ÙÌýis possible to fatally overdose on buprenorphine — especially if users don’t have a tolerance to opioids or they mix it with other substances. But .

Buprenorphine’s effects are less potent than those of heroin and fentanyl, and the medication can block other opioids’ effects. Because of these attributes, few people use buprenorphine to get high. Instead, more people use it to  and to stay away from other illegal drugs such as heroin and illicit fentanyl.

Some leading addiction experts argue that self-treatment with buprenorphine can save lives because it is used in place of more dangerous substances that are blamed for the .

“It was not diverted buprenorphine that’s responsible for our current situation,” ²õ²¹¾±»åÌý,Ìýan addiction specialist and instructor at Harvard Medical School. “The majority of people are using it in a way that reduces their risk of overdose.”

“It’s definitely illegal,” Daryl said. “But would they rather me be driving to Louisville and picking up two 8-balls of heroin?”

Limited Access

People often try to treat themselves when they ²õ²¹¾±»åÌý, an addiction specialist and researcher at the University of Kentucky.

“These people want help, and they tried and they didn’t succeed. So now they’re going to go get it if it’s available,” she said.

Professional treatment with buprenorphine can be difficult for patients to get. Prescribers need a special waiver to prescribe the medication, and federal rules limit the number of people they can treat, a cap that is specific to buprenorphine.

Federal guidelines changed under the Obama administration to increase the number of prescribers and the number of patients they can treat. Nurse practitioners and physician assistants can now apply for a waiver to prescribe buprenorphine, and doctors who meet certain requirements can now treat up to 275 patients — that’s up from the previous limit of 100.

The new bill on its way to Trump’s desk would let more nurses prescribe buprenorphine and allow some doctors who recently got waivers to treat more patients.

Amid these efforts, some law enforcement officials and policymakers have said that  actions are needed to stop diversion.

But Basia Andraka-Christou, an assistant professor and addiction policy researcher at the University of Central Florida, said increasing regulations or shutting down prescribers would limit treatment options for people addicted to opioids.

“I guarantee you,” she said, “they’re either going to go and buy heroin and get high — which surely is not a great policy solution here — or they’re going to go buy Suboxone on the street.”

A Step Toward Safer Treatment

Getting Suboxone on the black market is obviously not ideal. Addiction is a complex, chronic disorder and patients need comprehensive care. That means a treatment professional to help them figure out the proper dose and counseling to address other mental health needs that are common among people with addiction. But Lofwall said people addicted to heroin or painkillers often realize they want professional help in quitting after trying buprenorphine illegally.

“They’ve had it and they know it works for them and they want to get it legally,” Lofwall said. “They want to get their life back.”

Daryl had that sort of experience. Several weeks after he began using buprenorphine regularly, Daryl tried to sign up for insurance so he could get help — medication and counseling — in staying away from other opioids.

“I think if I had never started [Suboxone] on the street, I wouldn’t have no interest in doing nothing but getting high,” he said.

Daryl still hasn’t made it into treatment. He had trouble starting his insurance, and the market for illicit buprenorphine can be fragile. Daryl struggled to stay away from heroin when the person from whom he bought buprenorphine lost the prescription. Addiction can take years to conquer, and many attempts, but Daryl said his time on buprenorphine allowed him to see a way back to a normal life.

“I’m at a point of my life now where I know I’ve got to change something, or I’m going to go back to prison,” he said. “I’m definitely ready to do something different.”

This story was produced in partnership with ,Ìý, and Kaiser Health News. A longer version of the story appears in Side Effects’ podcast 

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A few months ago, Kourtnaye Sturgeon helped save someone’s life. She was driving in downtown Indianapolis when she saw people gathered around a car on the side of the road. Sturgeon pulled over, and a man told her there was nothing she could do: Two men had overdosed on opioids and appeared to be dead.

“I kind of recall saying, ‘No man, I’ve got Narcan,'” she said, referring to a brand-name version of the opioid overdose antidote, naloxone. “Which sounds so silly, but I’m pretty sure that’s what came out.”

Sturgeon sprayed a dose of the drug up the driver’s nose and waited for it to take effect. About a minute later, she said, the paramedics showed up.

“As they were walking towards us, the driver started slowly moving,” she said. Both people survived.

Sturgeon had the drug with her because she works for Overdose Lifeline, a nonprofit devoted to distributing naloxone. But many bystanders in that situation would be unprepared to help.

Last month, U.S. Surgeon General Jerome Adams urging more Americans to learn to use naloxone and to carry it with them in case they encounter someone who has overdosed.

With the increase in overdoses nationwide, the advisory suggests that lay responders — people who may witness an overdose before police or emergency medical services arrive — can play a critical role in saving lives.

But if you’re not a medical professional, getting a dose of naloxone can be difficult. It is a prescription drug, and normally a doctor or nurse would have to directly prescribe it for the person at risk of overdosing. , an attorney for the National Health Law Program, said that creates a barrier for people with addiction.

“A lot of people at risk of an overdose don’t have contact with a medical provider or they’re afraid because of stigma,” he said.

To broaden access, every state and Washington, D.C., have making it easier for friends, family members or bystanders to get and use naloxone. Just how easy it is depends on your state, or even the pharmacy you use.

Davis said most states allow something called third-party prescribing, which lets doctors prescribe naloxone to someone who knows the person at risk of an overdose. And most states have passed providing legal immunity for people who administer the drug or call 911.

Davis said another type of law allows a kind of prescription called a standing order.

“But instead of having a person’s name on it, it has a group of people,” said Davis.

A standing order could apply, for example, to anyone who takes opioid painkillers or suffers from addiction. Or, Davis said, “anybody who might be in a position to assist someone, which, unfortunately, today means essentially everybody.”

In his home state of Indiana, Surgeon General Adams signed a statewide standing order in 2016, while serving as the state’s health commissioner. It allows pharmacies, local health departments or nonprofits that register with the state and follow certain requirements to dispense the drug to anyone who requests it.

But two years later, only about half of Indiana pharmacies are registered, and local advocates say many people, even some pharmacists, are still unaware of the law.

Even if you understand the laws regulating naloxone in your state — and you feel comfortable asking for it at the pharmacy counter — there’s still the cost, which has  in recent years. Two pharmacies near WFYI in Indianapolis stock naloxone. One charged $80 for two doses of the generic form of the drug. The other charged $95 for two doses of Narcan, a brand-name version.

“It’s expensive,” says Brad Ray, a researcher at Indiana University’s School of Public and Environmental Affairs. “People who are users are scraping money together to buy drugs. They’re not prepared to buy naloxone with that money.”

More than a dozen U.S. senators have signed a urging Health and Human Services Secretary Alex Azar to negotiate with drug companies to lower the price of naloxone.

For people who can’t afford the drug, Ray said, health departments and nonprofits can help. Laws in many states allow these organizations to dispense naloxone to lay responders.

Indiana’s health department used federal and state funds to purchase nearly 14,000 naloxone kits since 2016, the state reported. The state distributes those free doses through county health departments. But nearly half of Indiana counties didn’t request kits. And the majority of the kits went to first responders.

Local health departments, Ray said, need to work harder to get naloxone to people who might use it. People who use drugs, after all, may not feel comfortable going to the government for naloxone.

“Getting it in the hands of users — that’s the trick we need to figure out,” Ray said.

Davis said there is one change that could really help. The Food and Drug Administration or Congress could make naloxone an over-the-counter medication to make it easier to access, and maybe cheaper. FDA Commissioner Scott Gottlieb has the authority to do so, Davis said, but so far he has not.

This story is part of a reporting partnership with NPR, WFYI,ÌýÌý²¹²Ô»åÌý.

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The Bridge looks something like a hearing aid or a futuristic earring, and its makers claim that the device mitigates the misery of withdrawal sickness from opioids. With a small electrical pulse, it creates a “bridge” that may get people with addiction through flu-like withdrawal symptoms and on to medicines that can control cravings once opioids are cleared from a patient’s system.

But there’s a problem. Scientific evidence doesn’t yet show the Bridge works.

Side Effects Public Media reporter Jake Harper spoke to NPR’s Rachel Martin about his and how it has been marketed to politicians and treatment centers in Indiana and elsewhere without sufficient proof.

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In overdose cases, the fluids may contain clues for investigators.

“We send that off to a toxicology lab to be tested for what we call drugs of abuse,” said Alfie Ballew, chief deputy coroner. The results often include drugs such as cocaine, heroin, fentanyl or prescription pharmaceuticals.

After testing, coroners typically make note of the drugs involved in an overdose on the death certificate — but not always.

Standards for how to investigate and report on overdoses vary widely across states and counties. As a result, opioid overdose deaths aren’t always captured in the data reported to the federal government. The country undercounts opioid-related overdoses by 20 to 35 percent, according to a  published in February in the journal Addiction.

“We have a real crisis, and one of the things we need to invest in, if we’re going to make progress, is getting better information,” ²õ²¹¾±»åÌý, the author of the paper and a health economist at the University of Virginia.

Data from death certificates move from coroners and medical examiners to states and eventually the Centers for Disease Control and Prevention, which publishes reports on overdose counts across the U.S. According , more than 42,000 people died from opioid-related overdoses in 2016, a 30 percent increase from the year before.

But that number is only as good as the data states submit to the CDC. Ruhm said the real number of opioid overdose deaths is closer to 50,000. He came to the higher estimate through an analysis of overdoses that weren’t linked to specific drugs.

On a death certificate, coroners and medical examiners often leave out exactly which drug or drugs contributed to a death. “In some cases, they’re classifying it as a drug death, but they don’t list the kind of drug that was involved,” said Ruhm. In the years he reviewed in his paper, 1999 to 2015, investigators didn’t specify a drug in one-sixth to one-quarter of overdose deaths.

Some states do worse than others. In 14 states, between 20 and 48 percent of all overdose deaths weren’t attributed to specific drugs in 2016, according to a breakdown from .

Many overdoses not linked to a specific drug were likely opioid-related, Ruhm said, so the lack of specificity leads to undercounting. According to Ruhm’s , Indiana’s opioid overdose fatality rate is especially far off. He estimated the state’s rate in 2014 was 14.3 overdose deaths per 100,000 people, twice as high as the rate reported that year.

In some states such as Indiana, independent county coroners investigate deaths. Coroners are usually elected, and they aren’t necessarily medical professionals. Other states, though, have medical examiners, who are doctors. Some even have a chief medical examiner who oversees death investigations for the whole state.

“States that have centralized oversight with medical examiners tend to do better than those with coroners,” said Ruhm.

In some places, death investigators don’t list substances on a death certificate because they haven’t tested for them. Brad Ray, a policy researcher at Indiana University’s School of Public and Environmental Affairs, said toxicology reports cost hundreds of dollars each, which could strain county budgets.

Additionally, toxicology reports are currently optional for Indiana coroners. “So if you’re not required to pay for it, and you’re not required to report it, why would you?” said Ray.

Indiana’s legislature recently passed a bill to standardize how coroners handle suspected overdoses, and Republican Gov. Eric Holcomb is expected to sign it. Starting in July, coroners will have to run toxicology screens and report the results to the state health department. The state will also help cover the added costs.

Data that is more accurate would likely make the opioid problem look worse as the numbers go up. But Ray said realistic data could help the state access federal funds to tackle the opioid epidemic and keep better track of drug problems.

“So we can see when trends are happening. We can see when there tend to be increases in cocaine and meth and decreases in opioids, if that happens,” Ray said.

Marion County’s Ballew learned at a conference last year that she could help improve the state’s data. Her office was already getting toxicology reports for all suspected overdoses, and now her team will list the drugs involved in an overdose on the death certificate.

“We’ll say ‘drug overdose’ or ‘drug intoxication,’ and then we identify the drugs,” she said. “So if it’s five drugs that have caused or contributed to the death, then we put those five drugs down.”

Ballew said she plans to travel the state and train other coroners to do it the same way.

This story is part of a partnership that includes , and Kaiser Health News.

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Philip Kirby said he first used heroin during a stint in a halfway house a few years ago, when he was 21 years old. He quickly formed a habit.

“You can’t really dabble in it,” he said.

Late last year, Kirby was driving with drugs and a syringe in his car when he got pulled over. He went to jail for a few months on a separate charge before entering a drug court program in Hamilton County, Ind., north of Indianapolis. But before Kirby started, he says the court pressured him to get a shot of a drug called Vivitrol.

Vivitrol is a monthly injection of naltrexone, which blocks opioid receptors in the brain. It’s one of three medications approved by the Food and Drug Administration for treating opioid addiction. While it’s effective in some people, it’s not for everyone. Patients have to be ready to be opioid-free, and some patients won’t do well on it. It can also have , which Kirby says he experienced.

“I had sinus problems, chest problems for the whole month I was on it,” Kirby said. “I couldn’t shake it.”

He says he also got a rash — another possible reaction to Vivitrol, according to the product’s warnings. Months after he had the shot, he still had white splotches on his arms, which he attributed to the drug. But even with those symptoms, Kirby said the court urged him to stick with the medication for a couple more months. “They were way too pushy about it,” he said.

More than 130,000 Americans will go through drug courts this year, according to the National Association of Drug Court Professionals. Drug courts are designed to allow some people whose crimes stem from addiction to get treatment instead of jail time. But the treatment that is offered varies from court to court and is entirely at the judge’s discretion.

Some courts offer participants a full range of evidence-based treatment, including medication-assisted treatment. Others don’t allow addiction medications at all. And some permit just one: Vivitrol.

Prime targets for marketing

One reason for this preference is that Alkermes, Vivitrol’s manufacturer, is doing something nearly unheard of for a pharmaceutical company: It is marketing directly to drug court judges and other officials.

The strategy capitalizes on a market primed to prefer their product. Judges, prosecutors and other criminal justice officials can be suspicious of the other FDA-approved addiction medications, buprenorphine and methadone, because they are themselves opioids. Alkermes promotes its product as “nonaddictive.”

The argument worked for Judge Lewis Gregory, who heads the city court in Greenwood, Ind. About a year and a half ago, Gregory didn’t allow participants to start on addiction medications while in the program. “We were failing miserably with the heroin population,” he said.

At the time, Gregory was only familiar with buprenorphine and methadone. Both are opioid medications that can prevent withdrawals, reduce cravings and ultimately help people maintain a stable recovery. When they are properly prescribed and administered, patients don’t get a euphoric feeling or a “high.”

Buprenorphine and methadone have been the standard of care for opioid addiction for years, but because they’re opioids, it is possible to misuse them. They’re also sold illegally on the street.

“I was certainly not going to do a medication-assisted treatment program with drugs which people use to get high,” Gregory said, adding that he would not order someone to stop buprenorphine treatment if it were legally prescribed by a physician, a situation he rarely sees.

Then he received some Vivitrol literature in the mail and a phone call from an Alkermes sales representative. “So we ended up meeting in the early part of 2016, and she began educating me a bit,” he said.

Six months later, his court began a Vivitrol program, permitting some participants to use the drug. A sales representative sometimes sits in on the court’s treatment team meetings, Gregory said.

Many treatment specialists say allowing judges and other criminal justice officials with no medical training to exert influence over medical decisions is problematic. The power makes them prime targets for Vivitrol marketing, they say.

“You would think it would be more appropriate to go after physicians,” said, who researches drug courts at the  at Indiana University.

“What this is implying is that the judges in these cases are actually making a lot of the medical decisions, and that should be very concerning to everyone,” she said.

, who researches pharmaceutical marketing at Georgetown University, said she has not heard of another drug company going after judges. She says it’s not just unique — it’s inappropriate and could ultimately be damaging to patients. “They’re not health care providers. They don’t know data. They don’t know research,” she says.

A company strategy

The drug court Kirby went through doesn’t allow medications other than Vivitrol for treating addiction. In fact, NPR and Side Effects Public Media have identified at least eight courts out of the several dozen in Indiana that say they only allow Vivitrol treatment.

NPR and Side Effects Public Media have learned that Alkermes sales reps have also marketed the drug to court officials in Missouri and Ohio. A report from  that extensive marketing is leading judges to favor Vivitrol around the country.

The company is open about this part of its sales strategy. At an investor event last year, policy director Jeff Harris said that drug courts are a huge market for Vivitrol.

“We’re making progress but still just barely scratching the surface on the need that exists across the country,” Harris said in a presentation. “There are over 3,000 counties in the United States, and there are over 3,000 drug courts.”

A shot of Vivitrol costs around $1,000, making it pricier than the other addiction treatments. In many cases, the drug is paid for through Medicaid or other public funds. And marketing to criminal justice settings seems to have paid off for the company, whose earnings have grown significantly since its introduction. Vivitrol sales reached $209 million in 2016 — up from just $30 million in 2011. Sales have continued to climb this year.

Alkermes goes beyond marketing to judges. It also  to write laws that favor Vivitrol — and in some cases, hamper access to other addiction medications. The company has said it supports the use of all medications for addiction, but in practice, it doesn’t.

The company supported one law in Indiana that encourages the use of Vivitrol in drug courts. Signed in 2015, the bill allows judges to require medication as a condition of participating in a drug court, and the language specifically highlights Vivitrol treatment.

Alkermes declined repeated interview requests. In a written statement, the company defended the practice of marketing in criminal justice settings by noting that judges don’t actually prescribe their product.

No one-size-fits-all solution

Drug court judges interviewed for this story say they don’t mandate Vivitrol treatment, and that people can say no.

“We encourage it, but we never force anybody,” said Judge Gail Bardach of the Hamilton County, Ind., drug court, where Philip Kirby was a participant.

But facing potential jail time and court officials who really believe in Vivitrol, participants say getting the shot doesn’t always feel like a choice.

“They made it seem like they were forcing it upon me, like I couldn’t come into the program until I got it,” Kirby said.

For some patients, Vivitrol does help. Jeremy Templin went through the Hamilton County drug court program a few years ago after he was arrested for theft. He said the decision to go on Vivitrol seemed like it was made without him, but he credits his recovery, in large part, to the drug.

“I don’t know what it would have been like without it, but I know that I did have it, and here I am today,” he said. “I’m still alive.”

But Vivitrol is far from a one-size-fits-all solution. It’s not ideal for patients who are dealing with chronic pain on top of their addiction, or for pregnant women. It’s expensive. Furthermore,Ìý for all kinds of opioid addiction treatment are high, and after a period of not using, tolerance for opioids is low. Treatment with Vivitrol, which contains no opioid ingredients, could make someone more likely to overdose if they relapse, addiction specialists warn.

Dan Mistak, an attorney with , said courts should allow all medication options and let doctors make treatment decisions — including whether or not someone should use medication in their recovery.

“We rely on outside experts all the time in the judicial system. We don’t ask a judge to come in and be an expert in arson,” for example, he said. “This is a responsibility that a judge doesn’t want.”

°Õ³ó±ðÌý and the agree that courts should allow all three FDA-approved opioid addiction medication options.

“Especially with this exploding opioid use epidemic, we have to make available, as much as we can, whatever interventions are out there that are likely to be effective,” said Dr. Terrence Walton, chief operating officer for the NADCP, which lists Alkermes as one of its biggest donors.

For some judges, limited access to buprenorphine and methadone shapes their decisions about what to allow in drug court programs. The medications are heavily regulated, and many communities lack providers who can prescribe and dispense the drugs. Judge Bardach says she would consider allowing participants to use methadone if there were a provider closer to the court.

A need for regulation?

Currently, there is no regulatory agency that can ensure that judges follow best practices.

“There are not that many ways to leverage accountability over these courts,” ²õ²¹¾±»åÌý, a researcher at Physicians for Human Rights. Mehta recently authored a  on drug courts, focusing on three states. “Really the key is attaching restrictions and requirements to funding,” she said.

The federal government has put some  for courts receiving grants from the Bureau of Justice Assistance. They have to show that they “will not deny any eligible client access to the program because of their use of FDA-approved medications for the treatment of substance use disorders.” But only about 200 of the more than 3,000 drug courts nationwide operate with help from a BJA grant.

The Substance Abuse and Mental Health Services Administration has  grant-making guidelines in place, but it currently funds only 172 courts.

Mehta says states and counties need to implement similar requirements and work to educate drug court officials about all addiction medication options. She argues that until drug courts allow all of the medications, they’re not fulfilling their promise.

“If drug courts say that they provide access to treatment instead of prison, they are inherently violating that by saying, ‘Well, we only provide Vivitrol,’ ” she said.

Mehta says Alkermes’ marketing would be less effective if judges were compelled to follow best practices.

Georgetown researcher Fugh-Berman thinks that pharmaceutical companies like Alkermes should be barred from marketing to court officials and lawmakers.

“It would be great if the [FDA] went after this,” she said. “I think it does fall under their jurisdiction, but I wouldn’t rely on that being enough.” She says Congress could pass a law preventing such marketing, as well.

Philip Kirby says his probation officer finally relented when he lifted his shirt and showed that his rash was covering his whole body.

That rash has since cleared up, but it has left a pattern of white spots on his arms.

“I don’t know if they’ll go away,” he said. “I hope they go away eventually.”

He says he wishes he’d never taken Vivitrol in the first place.

This story is part of a partnership that includes WFYI,Ìý,Ìý and Kaiser Health News. Esther Honig of WOSU in Columbus, Ohio, and Bram Sable-Smith of KBIA in Columbia, Mo., contributed reporting.

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But a close reading of the shows that misleading and inaccurate information is being used to justify extending HIP 2.0.

This is important because the initial application and expansion happened on the watch of then-governor and now Vice President . And , who is President Donald Trump’s pick to lead the Centers for Medicare & Medicaid Services, helped design it. (Among other functions, CMS oversees all Medicaid programs.) So, states are watching to see if the approval of Indiana’s application is a bellwether for Medicaid’s future.

To get the program extended again, the Indiana Family and Social Services Administration has to prove to CMS that the experiment is and that low-income people in the state are indeed getting access to care and using health care efficiently.

The key part of Indiana’s experiment requires low-income participants to make monthly payments. Advocates say this promotes recipients’ taking personal responsibility for their health care. But some health policy experts say the information provided by the state shows that the provision isn’t working as well as it should. Some examples:

The Claim: Most members are making regular payments to maintain coverage.

The Fact: A lot of people are missing the first payment.

The state’s application says that “over 92 percent of members continue to contribute [to their POWER accounts] throughout their enrollment.”

This claim is missing context. Here’s a primer on how HIP 2.0 works: Members can get HIP 2.0’s more complete coverage, the plan, by making monthly payments into a “Personal Wellness and Responsibility Account,” or POWER account.

If they don’t make the payments, there are penalties. If a recipient makes less than the federal poverty level — about $12,000 a year — they’re bumped to HIP Basic, a lower-value plan that requires copays and doesn’t include vision or dental insurance.

If a recipient is above the poverty line and misses a payment, they become locked out of coverage completely for six months.

The state’s claim that 92 percent of members make consistent payments is based on data in a , a health policy research firm in Virginia that evaluated HIP 2.0’s first year.

But the Lewin report also says that when people sign up for HIP 2.0 they can be declared “conditionally enrolled,” which means they’re eligible but have not yet made their first payment.

According to the Lewin report, in HIP 2.0’s first year, about a third of people who were conditionally enrolled never fully joined.

“I don’t see those numbers being captured,” ²õ²¹¾±»åÌý, senior policy analyst with the National Health Law Program, which advocates for low-income individuals. Machledt said the state should recalculate the figure to include those people, because it’s potentially an indicator that people are confused about how the program works or that they can’t afford the payments.

He added that the figure cited is based on the first year of HIP 2.0, and that the rate of losing coverage for missing payments has increased substantially since then.

The Claim: HIP 2.0 users check their POWER account.

The Fact: More than half of people don’t even know they have one.

The state says the POWER account is promoting personal responsibility in health care; meaning, if someone is aware of how much they are spending, they’ll choose their medical care wisely. As evidence, the state writes in its application that 40 percent of HIP Plus members “check their [POWER Account] balance at least once a month.”

Again, the state leaves out important context. According to the Lewin report, most people in HIP Plus didn’t know they had a POWER account. Of those who did, 40 percent checked their account once a month, but that’s much smaller than 40 percent of all HIP Plus members. In fact, an analysis of the numbers shows only about 19 percent of HIP Plus members reported checking the balance of their POWER account monthly.

Rather than evidence of personal responsibility, , vice president for Health Policy at Center on Budget and Policy Priorities, sees evidence of confusion.

“I think that’s another really significant finding [in the Lewin report] that so far I have never seen the state come to terms with,” said Solomon.

A spokesperson for the state wrote in an e-mail that the phrase “of the members surveyed” was unintentionally omitted from the application.

The message did not address the overall concern that the statement was misleading.

The Claim: People on HIP Plus are more responsible.

The Fact: Experts say HIP Plus is just better insurance.

The application also says “HIP members who contribute [to their POWER accounts] are twice as likely to obtain primary care (31 percent to 16 percent), have better prescription drug adherence (84 percent to 67 percent), and rely less on the emergency room for routine treatment.”

Machledt said simply showing that HIP Plus members use the emergency room less frequently than HIP Basic members doesn’t tell the whole story.

“They don’t talk about the risk profile of those different groups,” Machledt said. He said people who are above the poverty line are generally to frequent the ER in the first place. “There’s no evidence to me that they’ve risk-adjusted … to show that they’re comparing apples to apples,” he said.

Indiana argues that the higher levels of primary care use and drug adherence for those making POWER account payments “confirms the principle of personal responsibility.”

But Solomon said the differences in behaviors simply confirm something else: Those who pay their POWER account have better insurance. HIP Plus makes it easier for people to access primary care and to adhere to their prescription drug regimens, Solomon said.

“The policy for people in HIP Plus is that they get a three-month supply of drugs, and can even use mail order, without any copays,” she said. Meanwhile, people in HIP Basic have to pay copays and are limited to a one-month supply of drugs.

Solomon said getting less primary care and relying on the ER for health crises is worse for patients and could also mean higher costs. “You have large numbers of people that are not getting care in the right place at the right time, and not maintaining adherence to prescription drug regimens.”

The Claim: HIP 2.0 is meeting its enrollment projections.

The Fact: No,Ìýit isn’t.

The state’s application reads “HIP has continued to meet its enrollment goals with over 394,000 individuals fully enrolled in HIP as of December 1, 2016.”

But the state isn’t meeting its enrollment goals. According to a chart published in 2014 in Indiana’s original proposal for HIP 2.0, its enrollment goal for December of 2016 was higher: 424,339. (The chart is off by a month, because the state started HIP 2.0 a month later than planned, so the actual projection for December 2016 appears on the line for November 2016.)

The most recent shows 403,142 HIP members in January 2017, short of the state’s projection of 427,702.

The Claim: The survey shows people like HIP 2.0

The Fact: The survey’s data and methodology are unreliable.

There’s reason to doubt the survey results that underlie much of the Lewin report, according to , director of the Center for Health Policy Research at the Milken Institute School of Public Health at George Washington University.

“They were not using what would generally be considered best practices in their survey methodology,” Ku said.

Ku ²õ²¹¾±»åÌýthe methodology available to the public is vague. From the information provided, he said, there are multiple ways that bias could have been introduced into the survey results used in the Lewin report. For one thing, the sample sizes of the survey were too small to draw accurate conclusions, Ku said, and the data was analyzed using “not an optimal method.”

Ku said that the results are not displayed in a scientific manner and that it appears the survey and analysis were done in a hurry. “You would not, as a survey researcher, have great confidence in the results that they show,” he said.

Conclusion

As Indiana looks to extend HIP 2.0, health policy experts say it’s important to get an accurate picture of how well the program is working. Requiring POWER account payments was key to making the program a reality in Indiana, but they say a more traditional Medicaid expansion — one that does not require monthly payments and six-month lockouts — is a better option.

heads the Indiana Family and Social Services Administration, the government agency that runs HIP 2.0. She said that in order to comment on discrepancies between the state’s extension application and the Lewin report, “I would have to go back and look at the way that these data were reported.” She continued, “I’m happy to look into that and get that for you.”

In a separate prepared statement, the agency noted that the state “has made significant achievements” on HIP 2.0’s stated goals and that it looks forward “to continuing to build on these successes with future versions of HIP. … The analysis of this program is constant and ongoing and includes continuous conversation with our federal partners to discuss all aspects of the proposed waiver as well as program outcomes.”

If the application does not go forward, the state could choose to expand Medicaid under the Affordable Care Act without any special provisions, or not accept the expansion at all. The federal government on Indiana’s application until March 17.

This story is part of a partnership that includes WFYI, , and Kaiser Health News.

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