From Health Care

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! We have officially made it through the dog days of summer. (Fun fact: Apparently those are set dates and not just … a vague concept of “sometime in August when it’s hot.” I was today-years-old when I learned that.) But that doesn’t mean we’ve had even close to a dearth of health care news. So buckle up, here’s what you may have missed this week.

Planned Parenthood officially rejected Title X funding rather than comply with what it deemed a “gag rule” on its providers. The price tag on that decision? About $60 million annually. Clinics across the country are bracing for the financial hit, and the organization is leaning heavily on donors to try to stanch the wound.

The New York Times: Planned Parenthood Refuses Federal Funds Over Abortion Restrictions

The Associated Press: Planned Parenthood Sees Swift Fallout From Quitting Program

Meanwhile, it was a bit of a roller-coaster week in terms of whether President Donald Trump would be pushing for background checks in his proposal to stem gun violence. After the dual mass shootings in El Paso, Texas, and Dayton, Ohio, Trump seemed open to the strategy, despite it being less than popular with his party. Then The Atlantic reported that following a phone call with NRA chief Wayne LaPierre, Trump softened that stance. Then Trump claimed the media reports were inaccurate and that some kinds of background checks were still on the table.

Pretty much nothing seems set in stone yet (at least publicly), and we should all just wait to see what comes in the official proposal likely to coincide with Congress’ return in September.

The Atlantic: Trump’s Phone Calls With Wayne LaPierre Reveal NRA’s Influence

Politico: Trump to Release Gun Control Proposals, Including Background Check Updates

We did find out this week exactly what was in the Parkland students’ plan, though. And let me tell you, they swung for the fences with it. Included in the roadmap: a national licensing and gun registry; a mandatory gun buyback program for assault-style weapons; a limit of one firearm purchase a month per person; the establishment of a national director of gun violence prevention; and a new multistep gun licensing system that would include in-person interviews and a 10-day waiting period before gun purchases are approved.

USA Today: Parkland Students Announce Gun Control Plan, Aim to Halve Gun Violence Rate in 10 Years

The Trump administration (and the Obama administration, as well) has long chafed at the restrictions that come with the Flores Settlement Agreement, which offers protection to detained immigrant children in U.S. custody. So, this week it released a new set of rules that effectively replace those regulations. Among other things, the new standards allow the government to detain children indefinitely instead of for 20 days, as laid out in the Flores agreement.

Reuters: Trump Imposes Rule Allowing U.S. to Detain Migrant Families Indefinitely

What’s definitely worth a read: the history behind the agreement and the story of the lawyers who have been defending it for decades. (“If someone had told me in 1985 that our work to protect children would continue into 2019, there is no way I would have believed it,” says Carlos Holguin, one of those original lawyers.)

The New York Times: The Flores Agreement Protected Migrant Children for Decades. It’s Under Threat.

Thirteen years ago, then-U.S. Surgeon General Richard Carmona was warned about some “disturbing” data that top federal scientists had discovered. It turned out that opioids were addictive and dangerous. The scientists recommended urgent action be taken to address the startling statistics, which hinted at a brewing crisis. Carmona agreed.

Yet the public was never told, and the momentum to do so fizzled. So what happened?

Politico: Federal Scientists Warned of Coming Opioid Crisis in 2006

Seemingly to further emphasize that the opioid epidemic’s early days were marked by (in retrospect) devastating missed opportunities and deep regret, another story looks at a little town in Appalachia in the late 1990s. There, a nun, a doctor and a lawyer were among the nation’s first activists to sound the alarm. Their efforts were ultimately crushed by Purdue Pharma.

The New York Times: A Nun, a Doctor and a Lawyer — and Deep Regret Over the Nation’s Handling of Opioids

Meanwhile, a study links states’ expansion of Medicaid and the uptick of opioid treatment prescription rates.

The New York Times: Opioid Treatment Is Used Vastly More in States That Expanded Medicaid

And HHS is going to relax privacy regulations around how patients’ history with addiction is noted in their charts. The rules were put in place so that patients felt comfortable seeking medical help without law enforcement being alerted, but HHS Secretary Alex Azar said they’ve become a barrier to proper care.

The Associated Press: Feds to Revamp Confidentiality Rules for Addiction Treatment

The FDA is stepping in to join the CDC’s investigation into cases of lung disease across the country that seem linked to vaping.

The New York Times: Vaping Sicknesses Rising: 153 Cases Reported in 16 States

And don’t miss the story from KHN’s own Victoria Knight about a West Virginia physician who all the way back in 2015 filed a paper on a patient with a lung disease he suspected was tied to vaping.

Years Ago, This Doctor Linked a Mysterious Lung Disease to Vaping

In this week’s miscellaneous file:

  • Emergency care in financially depressed areas has become a standoff between insolvent rural hospitals and patients who don’t have the money to pay their ER bills. That fight is ending up in court so often that locals in a small Missouri town call it the “follow-up appointment.”

The Washington Post: The ‘Follow-Up Appointment’

  • One of the side effects of the growing popularity of at-home DNA tests? More and more, people who were born using artificial insemination are finding out that their fathers aren’t the sperm donors their mothers chose but rather the doctor who performed the procedure.

The New York Times: Their Mothers Chose Donor Sperm. The Doctors Used Their Own.

Also, be sure to check out the Dallas Morning News’ original reporting from April on one of the women featured in the story.

Dallas Morning News: ABC’s ’20/20′ Features Dallas Woman Who Found Out Her Mother’s Fertility Doctor Is Her Father

  • The patient suffers from tremors, difficulty walking and loss of balance. If the patient is a man, his symptoms would be enough to have doctors start wondering if it’s Parkinson’s. But if it’s a woman, it’s chalked up to the modern-day version of what Victorians called female “hysteria.”

ProPublica: In Men, It’s Parkinson’s. In Women, It’s Hysteria.

  • For years, residents of a Newark neighborhood have been saying their water tastes funny because of the dangerous levels of lead. And yet little has been done to fix it.

The New York Times: ‘Tasting Funny for Years’: Lead in the Water and a City in Crisis

That’s it for me, and have a great weekend!

Skilled Nursing Homes Set To Lose Medicaid Money Brace For Battle With Connecticut Over Slashed Funds

The Connecticut legislature passed a law this year that allows the state to reduce Medicaid money to nursing homes that don’t maintain at least a 70 percent occupancy level. The facilities that will be hit the hardest are hoping to challenge the cuts. Medicaid news comes out of Georgia and Colorado, as well.

The Opioid Reckoning: It’s Rare To Hold Directors Liable For Corporate Conduct, But Sacklers May Prove To Be Exception

As court cases against Purdue Pharma progress, details continue to be revealed about the extent the Sackler family was involved in making decisions about the company’s strategy. In other news on the crisis: lawyers fight to give newborns suffering from opioid epidemic a voice in the upcoming legal battles; Ohio’s attorney general warns Endo and Allergan that their settlements don’t resolve all the claims against them; a look at how journalists dug into DEA records on the root of the crisis; and more.

There’s Little Incentive To Develop Antibiotics, But Does TB Drug’s Recent Success Story Herald New Model For Future?

In recent decades, pharmaceutical funding has been directed primarily toward drug research and development that will yield higher revenue, such as cancer drugs. But TB Alliance relied on donors from across the world to fund the development of its new tuberculosis antibiotic, and experts wonder if this is a path forward for new drugs. In other pharmaceutical news: the Norvartis data manipulation case continues, the FDA flexes its muscles, and a new treatment might help blood cancer patients.

Addiction Clinics Market Pricey, Unproven Treatments To Desperate Patients

Jason was hallucinating. He was withdrawing from drugs at an addiction treatment center near Indianapolis, and he had hardly slept for several days.

“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 90% of patients. The treatment has gained attention on addiction recovery blogs 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 Basia Andraka-Christou, 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 “Double Chloride of Gold Cure” 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 kratom and other types of supplements. The FDA and the FTC cracked down on a few of these 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 vial containing the mix of supplements that Emerald uses in its infusion treatments.(Jake Harper/Side Effects Public Media)

A Hard Sell

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

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

Another center 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 testimonials 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 “restore[s] the brain to its pre-addiction neurologic state,” 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 Emily Zarse, 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.”

Brain scans from Emerald show what it claims to be before (top) and after (bottom) images of a woman’s brain following NAD treatment. The images appear in an Emerald brochure, including text that says, “The brain is more calm after 12 days of NAD+ Amino Acids Therapy.”(Emerald/Screenshot by Side Effects Public Media)

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 brochure 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 Leslie Hulvershorn, 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 its role in aging. 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 seizures — 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 Chris D’Adamo, 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 uncritically repeats 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.

Dr. John Humiston and Star Voigt, former CEO of Emerald, in January at the Emerald clinic.(Jake Harper/Side Effects Public Media)

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. (Indiana law 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 Side Effects Public Media, NPR and Kaiser Health News.

Years Ago, This Doctor Linked A Mysterious Lung Disease To Vaping

Dr. John E. Parker was working at a West Virginia hospital in 2015 when a 31-year-old female patient was admitted with acute respiratory problems. A team of doctors ultimately suspected that her mysterious case of lipoid pneumonia might be related to vaping and weren’t sure they had seen anything like it before. They were intrigued enough to publish a case report — a type of medical paper on unusual or provocative patient findings. Such reports can serve as a call to the medical community to be on the lookout, though they sometimes raise more questions than they provide answers.

This summer, almost four years later, federal officials began investigating a national outbreak of severe lung illnesses linked to vaping that has struck more than 150 patients in 16 states. In an interview, Parker, a professor of pulmonary critical care and sleep medicine at West Virginia University, described what happened.

Q: Can you describe what the patient’s symptoms were when she arrived?

We would view them as classic for what is getting to be called vaping-associated lung disease. She was very, very short of breath and had a cough, and we were, of course, very worried that she might have pneumonia or some other acute respiratory illness. And then she was so sick she needed to be intubated.

Q: What happens next in cases like this?  

We look for things like a [hemorrhage] or an active infection. And then for lipid-containing macrophages. And then we usually start some antibiotics [and a] low-dose steroid and then support the patient with a ventilator and oxygen and nutrition. And then just kind of wait and see if any other cultures come back to prove anything different than what you might be thinking.

Early on, we just felt like it was an unusual case and may not be a common viral or bacterial infection.

Q: How did you figure out the cause of her lipoid pneumonia was e-cigarettes?

It’s a diagnosis of exclusion. We excluded other [options], and it became the most likely cause.

We were convinced enough that the case was submitted for publication [in the medical journal Chest] and was accepted.

Q: Once you figured out the cause could be e-cigarettes, did you contact the Centers for Disease Control and Prevention or the Food and Drug Administration or any other regulatory agency to tell them about this?

We did not. We felt at the time that putting it in the medical literature was appropriate. And if other case reports from other parts of the country came forward, then we’d have more of a clustering of findings that might then warrant research agencies [getting a] better understanding [about] the cause of the disease.

Q:Which federal agency would you report it to, if you did?

Dr. John E. Parker(Courtesy of the West Virginia University Health Sciences Center)

In 2015, the FDA, of course, was still regulating cigarettes, but I don’t think the government had yet decided who would regulate vaping products. So I’m sure it was unclear who we should call.

Q: So did you or your team think this was a one-off event when you witnessed it?

We really felt that it wasn’t going to be a one-off event and that it was what we usually called in public health a “sentinel” health event … that it was an example of a respiratory illness that can be caused by this exposure and that it probably wasn’t the first case ever seen nor would it be the last.

Q: Was it the first case that you had seen at your institution?

To our knowledge it was our first case, but we are humble enough clinicians to realize we may have missed some other cases that we interpreted [as] viral pneumonia or bacterial pneumonia.

Q: Have you seen more cases since then?

I know we’ve seen a case [of alveolar hemorrhage syndrome] that we published, and in polling some colleagues we think we’ve probably also seen [cases of] cryptogenic organizing pneumonia as well as lipoid pneumonia and acute eosinophilic pneumonia. Yeah, we’ve certainly seen at least probably four forms of lung disease from vaping.

Q: If your team was seeing this back in 2015, is it possible that it’s been happening in the four years since then and people just don’t know about it?

I really have every reason to think we were not the first ones to see it, by any means.

And I don’t think we were even the first ones to report it. I think that there were some clusters in Wisconsin and some other places in the U.S. I also know that the Japanese have been very interested. They’ve probably got four or five papers at least in the medical literature about vaping related lung injury.

Q: Do you have a theory of what might be causing the lipoid pneumonia cases? Do you think there may be certain chemicals that are irritants?

We need a strong multidisciplinary team to understand the real etiology and cause of lung injury from inhalation. I think it could be any number of components in the mixtures. Lungs don’t like oil, in general, and probably the most specific agent that’s been studied recently is diacetyl, which was studied in popcorn-flavoring lung disease.

Q: Have these kinds of cases changed the way you approach patients?

Yeah, we search very carefully for a history of vaping. … I think it’s quite important to understand if they might be using inhaled agents or vaping that might present new toxicities to the lung.

Q: Will these illnesses have long-term health effects?

An inhalational injury may cause an acute lung injury that’s life-threatening and that someone may survive from and have no long-term sequelae [condition]. But there also is the possibility that long-term [e-cigarette] use may cause more insidious or chronic diseases from which there may not be a full recovery.

Readers And Tweeters Take Dialysis Providers To Task: Nowhere But In The USA

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

The Undue Strain Of Dialysis

This is criminal, and the dialysis companies are not the only ones plundering the public (“Bill Of The Month: First Kidney Failure, Then A $540,842 Bill For Dialysis,” July 25). If you have no medical insurance and go to a doctor or hospital for medical care, you get charged tenfold what they accept from insurance companies. No properly run health care facility or doctor is losing money by accepting the agreed fees that the insurance companies pay. It’s absolutely outrageous to charge people who can least afford to pay up to 10 times the insurance charges. This scam has existed for decades and Congress has done nothing to protect consumers. My understanding is that no other country allows this discrimination against the poor. It’s time this outrageous exploitation of consumers be terminated.

— Jorg Meister, Middlegrove, N.Y.

— David W.S. Lieberman, Somerville, Mass.

This is in response to the bill of Sovereign and Jessica Valentine. It is ridiculous that Fresenius can charge them $14,000 per session when dialysis in Mexico using the same dialysis machines and procedures runs $400 USD per session. I take my mother there frequently for vacation, and we pay cash for her dialysis sessions.

—Martina Patella, Oakland, Calif.

— Andrea Hilderman, Manitoba, Canada

I was appalled to read your article on dialysis. I have a dear friend who built, opened and now operates a dialysis center in Thessaloniki, Greece. His father is a kidney specialist of 30+ years. He wrote the string below about dialysis in Greece when I forwarded the story to him:

“If you have insurance dialysis is free
The average price that dialysis facilities in Greece charge the Greek NHS is around 136 euros.

If a patient who does not have insurance goes to a dialysis facility, he will be charged around 200 euros [about $223 in the United States]. That will be a great day for the facility.”

— Jerry Efremides, New York City

PBMs Put Patients In A Pickle

Besides the delay of generic drugs to market (“California Bill Would Fight Deals That Delay Generic Drugs,” Aug. 1), the pharmacy benefit managers (PBMs) have deals with the manufacturers, and pharmacies are not allowed to dispense a new generic because the PBM will not allow it to happen. Currently, there are Medicare plans that will not pay for generic Ventolin or Advair and demand that we dispense the brand name. It costs patients more, the plan more, and pharmacies lose by dispensing the brand-name drugs.

— David Smith, A & O Clinic Pharmacy, Salinas, Calif.

Winning The Match Game

This is not news (“American Medical Students Less Likely To Choose To Become Primary Care Doctors,” July 3). Medical students have been choosing the higher-end specialties over primary care for decades. I have been in the health care industry for over 40 years and have worked with literally thousands of physicians as an executive at Cedars-Sinai Medical Center and at my two companies, Practice Management Information Corp. and Flash Code Solutions LLC. My daughter and her husband are both radiation oncologists. Board certification in a higher specialty results in higher income and better career choices. Why settle for family practice if you can be an orthopedic surgeon?

— James B. Davis, president and CEO of Practice Management Information Corp., Beverly Hills, Calif.

— Dr. Jacqueline Ivey-Brown, Chicago

Meds And Momentary Mental Lapses

I read your Navigating Aging column about how many medications affect older adults (“Common Medications Can Masquerade As Dementia In Seniors,” July 18). I am 85 and had two knee replacement surgeries. Every time I have to go to the dentist, I must take four amoxicillin antibiotic tablets one hour before the dentist appointment. I noticed that after I took these antibiotics, my memory became very bad. After a few days, I felt like myself again.

— Janet Gileno, Bomoseen, Vt.

— Dr. James P. Richardson, Baltimore

Weighing Costs And Benefits Of Intravenous Iron

I feel your article about iron infusions (“Infusion Treatments — Needed or Not — Can Deplete Patients’ Wallets” Aug. 2) was biased. The article did not discuss the reasons a physician might choose to use IV iron to treat a patient versus oral iron – oral iron is not well tolerated and in the presence of inflammation in the body is not well absorbed. There are blood management programs in the United States that regularly use IV iron to treat anemia to decrease the patient’s risk for a blood transfusion. Although the cost of IV iron differs from one drug to another (the less expensive drugs, such as Ferrlecit, require multiple infusions), when you add up the cost, it includes not only the administration of the drug, but the nursing time and pharmacy preparation time for the medication.

One also must consider the risk for reaction when choosing a particular form of IV iron. Anaphylactic reactions can occur in patients receiving IV iron. Injectafer is one of the drugs we use on a regular basis because other forms of IV iron have a greater risk for reaction. One must consider the added cost of treating an anaphylactic reaction in a patient. Injectafer is a longer-acting form of IV iron; slow-release preparations such as ferric carboxymaltose (Injectafer) are first taken up by macrophages, the shell is digested, and the iron is released slowly over few days as opposed to near-immediate iron release found in other preparations that lead to more adverse reactions.

Although your story provided the experience of a single patient, it did not report the “whole” story about why physicians use IV iron. I receive no incentive for using one drug over another and must consider the patient’s clinical condition and the risks associated with giving IV iron. IV iron will correct iron levels more rapidly in patients because you can give a higher concentration of the drug, versus oral iron, which can take upward of a couple months to improve iron levels. Without really knowing the physician’s rationale for using IV iron in the case of the patient in the article, the author drew conclusions without having all the facts. I agree that we really need to look at health care costs, but the author of the article also failed to mention Big Pharma’s role in driving up the cost of health care.

— David J. Sterken, Grand Rapids, Mich.

— Jim McMullen, Kansas City. Mo.

As a Board Certified Oncology Pharmacist (BCOP), hematology/oncology is my field. Our institution used the cheaper iron (Venofer, which, at a low dose of 100 mg, needs to be given more often) for years. Medicare stopped paying for it because the charge was less than $100 — for some reason, the federal insurance program will not bother to pay for lower-cost IV drugs. Seriously. We switched our formulary iron to Injectafer, 750 mg per vial (cost to us ~$100-$750/vial, and the charge to patients per vial is about $1,000 and up), because we were reimbursed by Medicare for the Injectafer (because it is more than $100).

You are spot-on: The USA does not give our healthy iron-deficient patients enough time to benefit from oral iron. We inject IV iron for iron-deficiency anemia even when the patient does not suffer from anything other than bad lab tests.

Most hospitals and ambulatory care centers base their formulary decisions in large part on reimbursement. Medicare cannot bid for drug pricing and does not have a national formulary. This is a serious error on the part of the legislature and costs billions of dollars or more in taxpayer money that goes directly into the pocket of the pharmaceutical industry. Not paying for lower-cost IV drugs is just one very small example. It is terrible for the patients who must bear the cost of this discrepancy.

Reimbursement is a complex issue these days in no small part to the waste of the government.

— Mary Davis, Bellingham, Wash.

— Dr. Nicolas Argy, Boston

Shefali Luthra’s article on intravenous iron is rife with error. The pricing is not close, relative costs are wrong, and the implication of inappropriate use may be correct only based on utterly usurious prices listed.

More than 70% of those prescribed oral iron (PO) report significant gastrointestinal (GI) perturbation, intolerance and non-adherence. PO iron causes diarrhea and constipation, gastric cramping, metallic taste and thick, green tenacious stool. A year of therapy is required to replace stores and correct hemoglobin concentrations, all of which can be done with IV iron in 30 minutes. For people with hereditary bleeding disorders, there is zero credible expectation oral iron can keep up with losses since 10% (maximum) of PO is absorbed and PO raises a protein, hepcidin, which blocks iron absorption for 24 to 48 hours, making adequate repletion unrealistic.

InjectaFer is the most expensive iron. It costs $843 for 750 milligrams. Based on the preponderance of published evidence, a gram of iron in a single dose is about all we can utilize. The recommended dose of InjectaFer is 1,500 mg, $1,686 for a course (not vial) of iron. I think that wastes 500 mg, and there is double-blind, prospective evidence supporting that conclusion. It costs $100 for an office visit, chair time nursing and IVs, which takes 15 minutes. If you visit twice, that’s an additional $100.The charges you mentioned suggest that an institution in New York is fleecing its clients or insurance companies. This is usury and should be investigated and stopped.

The health economist Richard Pollock is mistaken. IV iron is widely used in Great Britain and it is extremely likely, not unlikely, a patient with chronic blood loss would get IV iron, irrespective of symptoms. That being said, Ferinject, the European name for InjectaFer, costs $140 per gram and health providers don’t have to deal with the ridiculous 750 mg vial we do. Feraheme costs $466 for 510 mg and requires two vials for a gram (1,020 mg). Four insurers allow me to give 1,020 mg in a single 30-minute infusion: the Blues, MedStar, Priority Partners and Cigna. The rest, including Medicare and Medicaid, require two visits. The only benefit is to our practice, which gets $100 for the completely unnecessary second visit. Despite making it clear the single 1,020 mg infusion is just as safe and effective, you halve the number of IVs and chances for minor reactions. It’s not covered, I have no choice. A third get it once; two-thirds, twice. We charge $932 plus a 6% markup to cover nursing costs and paraphernalia.

INFeD, or low molecular weight iron dextran, costs $243 per gram, comes as 100 mg vials and requires 10 vials for 1 gram. It takes an hour and is just as safe and efficacious.

The author is mistaken about Venofer, iron sucrose and Ferrlecit, ferric gluconate. You can’t give more than 200-250 mg because the sugar that carries iron does so much less tightly than the carbohydrate cores of InjectaFer, Feraheme and INFeD. To give a gram takes four to five visits. I never use these drugs for that reason, but I have no criticism of nephrologists who use them in dialysis with thrice-weekly visits. Venofer is $600 per gram (definitely more than INFeD) and Ferrlecit $1,000 per gram.

The medical system you wrote is screwing the community. IV iron is an unmet need. Oral iron cannot keep up with losses in abnormal uterine bleeding, be absorbed after bariatric surgery, makes inflammatory bowel disease worse because it is directly toxic to the intestinal epithelium and makes the wrong bacteria grow, and most of all doesn’t get to babies in the third trimester when the fetal brain needs iron for normal development. IV iron is a godsend for millions.

— Dr. Michael Auerbach, Baltimore

Correct By Degrees

The article “‘Climate Grief’: Fears About The Planet’s Future Weigh On Americans’ Mental Health” (July 18) said a recent report by the Intergovernmental Panel on Climate Change predicts that “by 2040 the Earth will warm by 2.7 degrees Fahrenheit (1.5 degrees Celsius).” As the report’s opening page (to which you link) says, by 2040 the Earth will have warmed by 2.7F above preindustrial levels. That’s total warming over 200 years, not future warming in the next 22 years.

The report also provides little support for the extreme claims that have terrified so many people — and, even less excusably, terrified so many children. This is also true of many reports by the major climate agencies.

The IPCC is the largest and best-run project of its kind, ever — an assessment of current science, which is then summarized for non-scientists. The tragedy is that its work has been largely abandoned for propaganda that exaggerates or even ignores the findings. I believe this has caused the gridlock in U.S. climate policy, so that we are not only unprepared for future extreme weather, but for the inevitable repeat of past extreme weather.

— Larry Kummer, editor of the Fabius Maximus website, Davenport, Iowa

Editor’s note: Warm thanks for pointing out the error. Our article has been updated.

— Michelle Mills, Chicago

— James C. Coyne, Philadelphia

Incrementally Exploited By Politicians

My copay requirement of $7,500 plus a monthly payment must be paid before my insurance pays any expenses. This is not health care. On paper I have health care; but the reality is I can’t afford to use it. It simply would stop me from bankruptcy in case of an emergency. However, these politicians and attorneys are making millions and getting a lot of publicity with every petition they file (“Biden’s ‘Incremental’ Health Plan Still Would Be A Heavy Lift,” July 22).

I feel the politicians should have the same health care choices as the American people. This would help them make better choices. Democrats and Republicans know health care in the U.S. is unaffordable. They should all be fired for not doing their job.

I also believe they should be able to serve only two terms, just like the presidential office. Politicians treat their position as a lifestyle instead of a job.

— Catherine Mossner, Gladwin, Mich.

The Battle For Uniform Excellence In Tribal Care

I’m part Inupiaq Eskimo from northwestern Arctic Alaska. The article “How The Eastern Cherokee Took Control Of Their Health Care”(July 22) states that the Cherokee benchmarked a program developed by Southcentral Foundation, a Tribal Health Organization originally created by an ANCSA (Alaska Native Claims Settlement Act) corporation but allowed to operate as a Public Law 93-638 entity. Awarded largely no-bid contracts through the Indian Health Service, Southcentral Foundation legally represents only shareholders of Cook Inlet Region Inc. — not all Alaska Native peoples.

To say SCF and other Alaska Natives run the program may be partly accurate, but it does not give credit to valuable contributors who served for decades ensuring we understood and implemented programs designed for all cultures — even families related to non-Indian Health Service beneficiaries.

Augusta Reimer is one of those deserving credit for this program. She was the first female Alaska Native/American Indian chief of an Indian Health Service department and was largely responsible for creating an atmosphere of wellness and creativity. Reimer, from IHS, and Mike McKeown from the University of Alaska-Anchorage designed my degree in human services; she spent hours working with interns and volunteers educating them on laws impacting us. Everyone who contributed deserves to be cited accurately and not just in a side note as other “Alaska Natives.”

The government has been pretty decent about encouraging native peoples’ self-determination, but it does not come without responsibility to follow the standards of care and communication and the law to ensure the quality and longevity of our programs.

The Indian Health Service was not approved to provide care to non-Indian health service beneficiaries. So the Nuka system of care — originally called Nutuqsiivik, which means “new beginnings” — was created to help identify gaps in data that were barriers to providing care to families with multiple health care providers and health and socioeconomic issues.

Indian Health Service programs have come a long way, but consistency and uniformity among tribal areas is highly concerning. In the age of a one-payer review, transparency is critically important. So is accuracy. Data and the lack thereof can cause a myriad of health and economic issues the patient or customer may have to deal with while their tribal organization isn’t monitored or corrected when needed. Without competition, I fear, these programs do not adequately respect patient needs, desires and have no real incentive to improve the quality of their care in order to keep their customers.

The Alaska legislature has created a committee specifically designed to educate lawmakers and the public on issues affecting the public and the tribes because there are so many of us. These programs do not live in a vacuum, but rather impact local economic development and regulatory control over your community. I encourage accountability among all parties and the mirroring of the U.S. Constitution and laws, so we have a legal template to follow.

— Cheryl Bowie, Anchorage, Alaska

Dialysis Industry Spends Big To Protect Profits

The dialysis industry spent about $2.5 million in California on lobbying and campaign contributions in the first half of this year in its ongoing battle to thwart regulation, according to a California Healthline analysis of campaign finance reports filed with the state.

Last year, dialysis companies poured a record-breaking $111 million into a campaign to defeat a ballot initiative that would have capped their profits.

This year’s political spending, which includes an online and broadcast advertising blitz, is aimed at killing a bill in the state legislature that would disrupt the industry’s business model — and likely reduce its profits. The dialysis industry counters that the bill would threaten some low-income patients’ access to the lifesaving treatment.

“Nobody is spending $2.5 million out of the goodness of their hearts,” said David Vance, a spokesman for Common Cause, a nonprofit group that advocates for campaign finance reform. “That kind of money is spent to get the attention of legislators and to get results.”

And the spending doesn’t appear to be slowing. Since the most recent campaign finance reporting deadline, which showed a total of $2.5 million spent through June, a campaign committee backed by the industry has spent at least $470,000 more since then.

Dialysis filters the blood of people whose kidneys are no longer doing the job. People on dialysis, who typically need three treatments a week, usually qualify for Medicare, the federal health insurance program for people 65 and older, and those with kidney failure and certain disabilities.

But dialysis companies can get higher reimbursements from private insurers than from Medicare. One way dialysis patients remain on private insurance is by getting financial assistance from the American Kidney Fund, which helps nearly 75,000 low-income dialysis patients, including about 3,700 in California.

The American Kidney Fund receives most of its donations from DaVita Inc. and Fresenius Medical Care, the two largest dialysis companies. The fund does not disclose its donors, but an audit of its finances reveals that 82% of its annual funding in 2018 — nearly $250 million — came from two companies.

Critics of this system, including some California lawmakers, insurance companies and a powerful nurses union, say it’s a way for the dialysis industry to inflate profits by steering patients away from Medicare and other public insurance coverage to private insurance, which pays higher rates.

The measure under consideration in the legislature, AB-290 by state Assemblyman Jim Wood (D-Santa Rosa), would limit the private-insurance reimbursement rate that dialysis companies receive for patients who get assistance from groups such as the American Kidney Fund. The bill would also address a similar dynamic in drug treatment programs.

“The minute you try to close one of those loopholes, the folks involved spend millions and millions to fight you,” Wood said.

The state Assembly approved the bill in May, and the state Senate is now considering it. The legislature passed a similar measure last year that former Gov. Jerry Brown vetoed, saying the language was too broad and the move would have allowed providers to refuse care to some patients.

DaVita and Fresenius declined to comment and directed questions to Kathy Fairbanks, spokeswoman for the “Dialysis is Life Support” coalition, which includes dialysis providers, industry groups, patients and caregivers. She said the dialysis industry isn’t the only stakeholder trying to influence the political process.

Groups supporting the measure, including large insurance companies and labor unions, also are spending big, she said. For instance, a committee formed and funded by the Service Employees International Union-United Healthcare Workers West to support last year’s initiative — and challenge the dialysis industry and its profits — spent $580,000 in the first half of this year.

The $2.5 million in political spending by the dialysis industry between January and June falls into two categories: lobbying the legislature, and campaign contributions to support candidates and influence public opinion. Campaign spending made up about $1.3 million of the total.

DaVita accounted for the biggest chunk of the campaign spending: $580,000. Fresenius spent $270,000.

These contributions went to 48 of the state’s 80 Assembly members and 21 of the state’s 40 senators, primarily to their prospective 2020 or 2022 campaigns.

Of the 69 legislators who received money from DaVita and Fresenius, Assemblyman James Ramos (D-Highland) got the most: $16,800 in the first half of the year. Ramos did not respond to requests for comment.

Nine other Assembly members and two senators each also received more than $10,000 in contributions from DaVita and Fresenius.

The rest of the $1.3 million in campaign spending was doled out by the campaign committee formed and funded by the industry to defeat Proposition 8 last year. The “Patients and Caregivers to protect dialysis patients” committee spent $440,000 in the first half of 2019, mostly on an advertising campaign to sway public opinion against Wood’s measure.

The media campaign began by promoting the message “Dialysis is Life Support” via social media accounts and a slick website, which emphasized the importance of dialysis to people with kidney failure. But the messaging has shifted and is now urging people to contact their legislators to oppose the bill. The committee spent $33,000 on advertising with Politico and $26,000 with The Sacramento Bee, among others, according to campaign finance reports.

The coalition and the patients featured in the ads argue the measure will threaten the health care and possibly survival of the California patients who get assistance from the American Kidney Fund, which has said it would cease operations in the state if the bill is adopted.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

KHN’s ‘What The Health?’: All About Medicare

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Before “Medicare for All,” there was just Medicare, the very popular program that serves 60 million Americans age 65 and older or younger people with certain disabilities.

But while Medicare is much loved by most of those it serves, it is anything but simple.

This week KHN’s “What the Health?” podcast takes a deep dive into Medicare. First, host Julie Rovner talks with Tricia Neuman, a senior vice president in charge of Medicare Policy at the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.)

Then, panelists Paige Winfield Cunningham of The Washington Post, Joanne Kenen of Politico and Kimberly Leonard of the Washington Examiner join Rovner for a discussion of some of the Medicare issues on the front burner in Washington in 2019.

Among the takeaways from this week’s podcast:

  • You can’t understand Medicare without getting a handle on its alphabet, from A to D.
  • Medicare also has a robust role for private insurance. About one-third of beneficiaries opt to join private insurance plans that contract with the federal government to provide an alternative to the traditional, fee-for-service government program. And that business is highly profitable for private insurance.
  • As Americans age, many fondly look forward to Medicare, imagining it will pay all their health bills. But the program has hefty cost-sharing requirements and doesn’t cover many expenses, including long-term nursing home care, dental care and most vision care.
  • Federal officials are eager to find ways to cut Medicare’s drug costs. But that raises many questions, such as whether Medicare should negotiate with drugmakers over prices or set up its own formulary of drugs it would cover.
  • An even harder question is how Medicare can work to control costs for the pricey drugs administered in doctors’ offices. Strong congressional lobbying from doctors and drugmakers has derailed efforts to do so in the past.
  • A vexing issue for some seniors is getting observation care at the hospital when they are not sick enough to be admitted but are too sick to go home. Patients receiving observation care likely face bigger cost sharing than if they were admitted and Medicare won’t pay for any nursing home care.

To hear all our podcasts, click here.

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Scores Of People Born Through Artificial Insemination Are Finding Out Their Fathers Are The Doctors Who Performed Procedure

With the growing use of consumer DNA tests, many have been left reeling by the news that the sperm donors that their mothers selected are not their fathers. “You build your whole life on your genetic identity, and that’s the foundation,” said one woman. “But when those bottom bricks have been removed or altered, it can be devastating.” In other public health news: Lyme disease, gene editing, a blood test for Alzheimer’s, employee wellness programs and more.

Maryland’s Pilot Program To Offer Dental Coverage To Some Medicaid Recipients Brings Smiles To Desperate Patients

The program is aiming to catch dangerous dental problems before they can result in costly emergency room visits for the Medicaid recipients. Experts were muted in their praise. “It’s a very primitive first step for people who don’t have dental care,” said Dr. Louis DePaola, the associate dean at the University of Maryland’s School of Dentistry. Medicaid news comes out of Minnesota as well.

Patient Privacy Continues To Be A Priority When Working On Increasing Access To Health Data, Federal Official Says

Dr. Donald Rucker, the chief of the Office of the National Coordinator for Health Information Technology, said balancing privacy and patients’ rights is a “delicate balancing act.” In other news at the intersection of health and technology: robotic nurses and artificial intelligence’s role in drug development.

Sky-High Diabetes Costs Are Forcing Patients To Ration Drugs, Ask For Lower-Cost Prescriptions

Stories of the fatal decision to skip or ration insulin have filled headlines in recent months, but new government data shows just how many people are taking those dangerous measures because of high costs. In other pharmaceutical news: Gilead’s stand-off with the government over Truvada, tips for shopping abroad for cheaper meds, and more.