Tag Archives: Kaiser Health News

Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial

A screenshot of U.S. researcher William Halford’s blog, where he posted updates about the St. Kitts offshore clinical trial. Pictured here with Halford, right, is his business partner, Agustín Fernández III.

Controversial drug trial which broke all the rules on patient safety has among its investors Trump supporter — and FDA critic — Peter Thiel.

As 20 Americans and Brits flew to a Caribbean island for a controversial herpes vaccine trial, many of them knew there were risks.

The lead U.S. researcher, William Halford, openly acknowledged he was flouting Food and Drug Administration regulations in the consent forms they signed. He would be injecting them with a live, though weakened, herpes virus without U.S. safety oversight.

Still, many of them felt upbeat when they arrived on St. Kitts and Nevis in the spring of 2016. They had struggled for years with debilitating, painful herpes. Halford, the creator of the vaccine, sounded confident.

Maybe they could be cured.

“It felt like paradise,” one of the participants recalled. “Or therapy combined with vacation.”

A year later, their optimism has turned to uncertainty. Memories of kicking back in a Caribbean hotel during the trial have been overshadowed by the dread of side effects and renewed outbreaks.

But they can’t turn to Halford, a Southern Illinois University professor. He died of cancer in June.

They also can’t rely on his university, which shares in the vaccine’s patent but says it was unaware of the trial until after it was over. Because the FDA didn’t monitor the research, it can’t provide guidance. Indeed, there is little independent information about what was in the vaccine or even where it was manufactured, since Halford created it himself.

At a time when the Trump administration is pushing to speed drug development, the saga of the St. Kitts trial underscores the troubling risks of ambitious researchers making their own rules without conventional oversight.

“This is exactly the problem with the way the trial was conducted,” said Jonathan Zenilman, an expert on sexually transmitted diseases at Johns Hopkins Bayview Medical Center in Baltimore. “These people are supposed to have rights as human subjects, but now there’s nowhere for them to go. We may never know if this vaccine worked, didn’t work or, even worse, harmed anyone.”

Rational Vaccines, the U.S. company co-founded by Halford, still hopes to market the vaccine. It touted success online and to other researchers, prompting millions of dollars of recent investment, including from a company run by Peter Thiel, a backer of President Donald Trump.

Thiel, a PayPal co-founder who has excoriated the FDA as too bureaucratic, declined to answer questions about his investment, which occurred after the trial had ended.

Kaiser Health News interviewed five of the 20 participants in the clinical trial and several associates of Halford.

The participants agreed to speak on condition of anonymity because they don’t want to be known as having herpes. Most also said they feared retaliation from Halford’s company but hoped by speaking out some of their concerns might be addressed.

Their accounts, along with documents, a video and emails obtained by KHN from the offshore trial, pointed to what experts said were serious irregularities:

Halford did not rely on an institutional review board, or an “IRB,” which monitors the safety of research trials. The company has said it doesn’t know where Halford manufactured the vaccine, so it isn’t known whether he followed U.S. government guidelines when transporting it. Halford offered booster shots of the unapproved vaccine inside the United States. FDA regulations prohibit such injections.

“The FDA goes after these types of violations,” said Holly Fernandez Lynch, a lawyer and assistant professor who specializes in medical ethics at the University of Pennsylvania’s Perelman School of Medicine. “[Researchers] can be prosecuted.”

SIU, however, did little to discourage Halford. The university, which has a financial interest in the patent, said it learned of “the concerns” only after his death. In August, after KHN asked about the trial, the medical school’s IRB launched an investigation into whether Halford violated U.S. regulations or university rules.

In a statement to KHN, Rational Vaccines acknowledged that Halford “discussed a myriad of concerns … including the potential need for booster shots.”

“Unfortunately, Dr. Halford is no longer with us to address all the ways in which he may have investigated his concerns …,” stated the company. It added, “We nevertheless wholeheartedly intend to continue his line of investigation in a clinical setting to international good clinical practice standards.”

Racing Against Time

Halford first broke with scientific protocols in 2011, shortly after he was diagnosed with nasal cancer and treated with chemotherapy and radiation, according to an account he later posted on his blog.

By then, Halford was in his 40s and had worked almost a decade at SIU’s School of Medicine.

Halford, who did not have herpes, realized his cancer might not give him much time. If he submitted to the FDA’s oversight, it would take years, he reasoned in his account.

He decided to become his own research subject, injecting himself more than two dozen times with the vaccine.

“There is an ongoing herpes pandemic that demands the scientific community’s attention today, not tomorrow,” he wrote in his blog, which by his count received thousands of hits.

The experiments on himself, Halford believed, demonstrated the vaccine was safe.

In 2015, Halford set his sights on launching an offshore clinical trial.

However, his unorthodox approach made some of his peers recoil.

“He sat in my kitchen and tried to convince me to join him,” said Terri Warren, a nurse practitioner in Oregon who was approached by Halford in 2016 to help with the trial. “He believed so firmly in his vaccine. He said, ‘Think of all of the herpes patients who are suffering.’”

Warren had previously worked with Halford on a different, IRB-approved trial studying a new blood test to diagnose herpes. This time, she said, she became concerned about his methods, including how he was selecting his participants.

“I told him absolutely not,” she recalled. “I didn’t want anything to do with it. I felt bad for him because he was dying, but I thought he had lost perspective.”

But Halford did find backers, including Hollywood filmmaker Agustín Fernández III, whose credits include action films and an award-winning documentary.

Fernández recently declined to respond to questions. But in an earlier interview this year with KHN, he said he initially contacted Halford to try to help someone he knew who was battling the disease. He said he didn’t have herpes, or a background in science.

Fernández, however, became such a believer in Halford, he said, he allowed Halford to inject him with the vaccine. In 2015, he co-founded Rational Vaccines with Halford and invested his own money into the company. That same year, the company licensed two patents related to the vaccine from SIU.

“I felt like Bill had the answer, and we had to make sure he got a chance to prove it,” Fernández said.

‘Finally … Someone Who Cared’

As soon as news began spreading in the tight-knit herpes online community that Halford may have a cure, he began hearing from the most desperate who asked to be included in any future research.

For many, herpes is a mild disease that can be controlled by antiviral medicines. However, for some, it becomes a life-altering disease that destroys any hope of intimate relationships.

To several of the participants, Halford was an empathetic scientist who refused to give up on finding a cure.

“After dealing with doctors who had no answers, it felt like you were finally talking to someone who cared and could help,” said a participant in his 30s from the South who had described the trial as “paradise.”

There were other perks as well.

Rational Vaccines told some participants they would be reimbursed for their flight and hotel expenses. If they got through the entire trial, they would be given an extra $500.

As Halford organized two groups of 10 participants, he instructed them on drawing their own blood for the trial, according to a video filmed in a medical lab.

He proceeded with the trial from April to August 2016, giving participants three shots over three months.

Once in St. Kitts, many of them quickly bonded with one another and Halford. Even though they ranged in age from their 20s to 40s and came from different regions, they had the disease in common. They commiserated about how herpes had wreaked havoc on their lives.

“It was a relief to meet people who understood what we were talking about,” the Southerner said.

But other participants now say they noticed some troubling signs.

They received the injection in a house in St. Kitts, not a medical clinic.

Halford, whose gaunt frame made his cancer apparent by then, at times appeared disoriented.

Fernández, a constant presence, was introduced to them by name and made some of them uncomfortable when they socialized over drinks and dinner.

Some patients became anxious about their participation soon after receiving the vaccine.

One, a web developer in his 20s, felt ill after receiving just one dose.

“I experienced tiredness and ringing in my ears,” said the web developer, who reported the feelings along with “disequilibrium and slurred speech” continue to this day.

He said he decided not to return to St. Kitts for follow-up shots after Halford dismissed his symptoms as arising from a common cold.

Another participant, a Colorado woman in her 40s, said she told Halford she experienced flu-like aches and pains and tingling and numbness soon after the second shot. The symptoms were followed by an “excruciating” 30-day outbreak of herpes.

“I have new symptoms every day,” that woman later wrote Halford in an email exchange provided to KHN. “This is terrifying.”

Halford initially dismissed her symptoms, speculating they were caused by a mosquito-borne virus, she said.

She returned for the third shot but had her doubts. Halford and Fernández met her at a café to talk about her concerns, she recalled.

“[Fernández] kept saying, ‘You signed the consent form. You knew the risks,’” said the Colorado woman, who said Halford then removed her from the trial.

Another participant, a Californian in his 30s, said he went through with all three shots despite feeling a “terrible pain in my stomach.”

Halford then told him he had noticed in his research of mice that another version of the virus entered the gut of the mice and killed them, the participant said.

“I then thought maybe this is dangerous,” said the Californian, whose pain went away but his outbreaks did not.

Warren, the nurse practitioner in Oregon, said two participants tracked her down as a herpes expert. She said that they described possible side effects from the vaccine.

Halford had told participants he would follow up on their reactions to the vaccine for a year, according to the consent form. But he stopped sending questionnaires to the two participants who said they had been dropped from the trial.

Warren said that even when researchers stop administering a vaccine because of possible side effects, known as adverse events, they have a duty to track the subjects’ reactions.

“There is no doubt that these were adverse events that should have been reported,” Warren said.

Rational Vaccines did not respond to questions about the complaints. In previous public statements, it acknowledged that one of the 20 participants was concerned about possible side effects.

Some participants also wonder where Halford made the vaccine and how he transported it to St. Kitts.

Halford told his business partner he had made it outside of the United States, without disclosing where.

After the trial ended, some participants began complaining that the vaccine hadn’t worked. Halford and Fernández offered booster shots, according to four participants.

One participant, a man in his 40s who was also from California, declined to get the booster. He said he decided to go back to antiviral drugs when his outbreaks returned.

The Southerner said he agreed to allow Halford to give him booster shots at an office in Springfield, Ill., where Halford worked.

“It was between me and him,” said the participant. “He was doing me a favor.”

“I don’t know if it was a different strain or what, but he gave me a set of double boosters at the same time, one in each leg,” recalled the Southerner, who said he didn’t have records of the injections. He said he received them as Halford continued to collect data for the trial.

Months later, he said, he returned a second time for another set of boosters.

Courting Support Without Results

Halford, meanwhile, tried to persuade a U.S. scientific journal to publish a lengthy manuscript detailing the results of both his experiments on himself and his offshore trial. Halford put the cover letter on SIU letterhead.

In December 2016, only months after the trial had ended, Halford’s paper was rejected by the journal.

“This manuscript is partly a vision, partly science, and partly wishful thinking …,” said one reviewer for the journal. “Neither safety nor efficacy has been demonstrated by the data presented.”

Halford asked his former doctoral adviser, Daniel Carr, to attend a Rational Vaccines advisory board meeting. Carr, a University of Oklahoma Health Services Center professor, said he and other invitees heard glowing reports about the trial.

Carr agreed in May to present the trial data at a conference of herpes experts in Colorado.

A published summary of the event listed Carr as a lead author, though he said he wasn’t involved in the research.

“I just did it to help him out,” said Carr, who asked for his university’s permission to be on Rational Vaccines’ advisory board and is waiting for word on federal funding to study another version of Halford’s vaccine. “I also presented it because I thought that the scientific community would find it interesting.”

Despite its patent agreement reached in 2015, SIU said it was in the dark about Halford’s offshore activities until October 2016 — months after the trial had ended.

Halford, meanwhile, promoted his work at events attended by university officials.

In October 2016, Halford was a keynote speaker at an SIU-sponsored technology and innovation event to discuss his vaccine work.

Then, in April 2017, Halford and Rational Vaccines held a press conference to trumpet an investment pledge by Thiel’s company, according to materials handed out at the event. University officials, including SIU’s medical school dean, were invited speakers.

The university’s IRB is continuing its investigation, which includes scrutinizing whether Halford used university resources.

“If there are areas of concern, SIU will report those findings promptly to Department of Health and Human Services,” said SIU spokeswoman Karen Carlson. “We will also communicate our findings with the scientific community and the public.”

FDA spokeswoman Lauren Smith Dyer declined to comment on the trial except to say the FDA does not have jurisdiction over offshore trials that don’t seek agency approval.

Dyer, however, added that the export from the United States of an unapproved vaccine for research use and the injection of it on U.S. soil would be within the agency’s jurisdiction.

Even so, some participants don’t regret taking part in the trial.

“When you feel like a disease has ruined your life, you become desperate,” said the Southerner, who believes the boosters have lessened his outbreaks. “Some people contemplate suicide. You’re willing to do almost anything.”

Other participants still hope for some sort of accountability.

“I feel like without a doubt that my symptoms were vaccine-related,” said the Colorado woman. “I feel like it triggered something that I’ll have for the rest of my life.”

No matter what, experts said, the university has a responsibility to conduct an in-depth investigation. So far, the university has not reached out to participants who spoke to KHN.

“This researcher went rogue,” said Fernandez Lynch, the lawyer who specializes in medical ethics. “It’s true that universities can’t stand behind their researchers watching their every move. But when one of their own goes rogue, a university should launch an aggressive investigation, interview the participants and make sure it never happens again.”

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation and its coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation.

Congress Revamps Housing Program To Benefit Areas Where HIV Is Spreading

In a bipartisan push, Congress has restructured a federal program that provides housing assistance for people living with HIV to funnel more money into areas struggling to control the outbreak.

While legislators and housing advocates say the adjustments will better target regions with high rates of the virus, these changes are likely to mean less money for some of the large cities that confronted the early effects of the epidemic.

To help with the transition, Congress increased funding for the Housing Opportunities for Persons With AIDS (HOPWA) program about 6 percent this year. In the past, this money was distributed across the country based on a jurisdiction’s cumulative number of cases (including people who had died).

Now under the 2017 funding, finalized by Congress in May, HOPWA has awarded $320.4 million to qualifying states and local jurisdictions to be apportioned primarily based on their share of the total number of people living with the virus. The number of cases required to qualify for funding also changed from 1,500 cumulative AIDS cases to 2,000 living cases of HIV/AIDS.

No jurisdiction will receive less HOPWA money than in 2016, but about 25 cities and counties are getting a smaller piece of the pie than before. The top five seeing their percentage of funding drop are, in order, New York City, Atlanta, Miami, Washington, D.C., and Houston.

“As the formula is fully implemented, without additional funds those jurisdictions will lose out,” said Opal Jones, vice president of the National AIDS Housing Coalition, a housing advocacy group in favor of the formula change. “It’s a great start. It’s just not enough.”

The program, which began in 1992, provides financial assistance to help participants pay for rent, mortgage and utility costs. HOPWA also offers competitive grants to jurisdictions and organizations, but that allotment accounts for only about 10 percent of its budget and is not included in the $320.4 million.

Shelter represents one of the most important factors in determining an individual’s success in HIV treatment. According to the Department of Housing and Urban Development, which administers the HOPWA program, housing instability is linked to delayed testing and gaps in care. The department estimates roughly half of the individuals living with HIV in the U.S. will experience a housing crisis in their lifetime.

“I think we can’t underestimate the power that home has in improving the health in somebody with a chronic condition,” said Russell Bennett, executive director of the National AIDS Housing Coalition.

Shyronn Jones, 39, has struggled financially since she was diagnosed with HIV. She was once a homeowner in New York, but when she moved to Atlanta several years ago, the only housing she could afford was an apartment in a crime-ridden pocket of the city. She was having trouble getting medical care, her white blood cell count dipped to dangerously low levels, and her mental health deteriorated.

But then, a housing assistance organization connected Jones to HOPWA, which helped her to move into a better neighborhood with a nearby grocery store, post office and park, where her daughter can play.

“I had a lot riding on HOPWA,” she said. “HOPWA just saved me.”

Seeking to soften the impact of the formula change, the law increased appropriations this year so that each jurisdiction would see at least a small rise in funding. Over time, areas with higher rates of HIV transmission, such as the South, will continue seeing increases. The Centers for Disease Control and Prevention estimated 44 percent of all individuals living with HIV in the country reside in the South, even though only 37 percent of the U.S. population live in the region.

The extra $20 million allocation nationwide this year translated to double-digit percentage increases for more than 100 out of the 140 participating jurisdictions. Smaller cities such as Greenville, S.C., and Syracuse, N.Y., saw their funding jump by nearly 14 percent. Notably, some larger metropolitan hubs such as Portland, Ore., and Chicago also saw similar growth in their grants.

But efforts to funnel money into current HIV epicenters without additional funding could mean cuts for large metropolitan areas such as Atlanta and New York. To mitigate potential losses, the program’s statute stipulates that over the next five years, a grantee cannot lose more than 5 percent or gain more than 10 percent of its share of the previous year’s total HOPWA formula funds.

“We’ll see some losses in funding [for some areas] over the years,” said Rita Flegel, director of the Office of HIV/AIDS Housing. “And then money will be distributed more evenly among people living with HIV.”

Rep. David Price (D-N.C.), who was one of the co-sponsors of the bill that reformulated the funding, said the phase-in coupled with the boost in funding helped assuage fears of cutbacks among lawmakers from areas with a legacy of large numbers of HIV cases.

“People of all sorts of political persuasions supported this because this was a question of fairness,” he said. Yet, “it was very clear that we needed to increase the size of the pie to make this proposition less difficult.”

One of the cities that could lose out is the nation’s capital. Nearly 13,000 residents, or nearly 2 percent of the population, live with HIV in Washington, D.C., according to the city’s health department.

HOPWA has not been able to keep up with demand of the area’s residents and the city discontinued its waiting list last year with more than 1,200 individuals, according to Michael Kharfen, the senior deputy director of the city’s HIV/AIDS, Hepatitis, STD, and TB Administration. The area is expected to receive $11.2 million, a 1 percent increase from last year’s funding.

But the nation’s capital is not unique in its struggle to keep up with the demand. According to the latest data from HUD, 138,427 HIV-affected households across the country were in need of housing assistance.

Jones, of Atlanta, now resides in a three-bedroom, two-bathroom apartment in a neighborhood she dreamed of while growing up in New York City.

Her white blood cell count has doubled since her move, she said, and her mental state has improved. Jones, who is a policy fellow for the HIV advocacy organization Positive Women’s Network USA and runs a business that advises HIV patients on resources, is grateful to HOPWA for the assistance. But she said she hopes to become self-sufficient and help others dealing with situations similar to those she once faced.

“That’s what I’m striving for,” she said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Taxpayers also pay when drug companies price gouge

epipen

Even as the cost of EpiPens dramatically rose, so too did the number of prescriptions written for patients in Medicare, sending spending by the program skyrocketing nearly 1,100 percent from 2007 to 2014, a new report shows.

During the same period, the total number of Medicare beneficiaries using EpiPens climbed 164 percent, from nearly 80,000 users in 2007 to more than 211,000 in 2014, according to the analysis by the Kaiser Family Foundation. While the report does not delve into what’s behind the increase, factors could include increased awareness among people with allergies, marketing efforts and access to insurance coverage.

The abrupt rise is notable because many people think that life-threatening allergies are less common among the elderly. In addition, epinephrine — the active ingredient in EpiPens — can pose greater risks to older adults. Food and Drug Administration labeling urges caution when prescribing to this age group.

“That level of increase gives me pause,” said Martha Twaddle, senior medical officer for Illinois at Aspire Health, which provides home-based supportive care for people with serious illness.  She did not work on the study. Epinephrine — the active ingredient in EpiPens — can cause side effects including chest pain, rapid increase in blood pressure or irregular heart rhythms, which could be fatal, for people with certain medical conditions, including heart disease.

The foundation study comes amid ongoing scrutiny — including congressional testimony Wednesday by Mylan CEO Heather Bresch — over EpiPen price increases. (Kaiser Health News is an editorially independent program of the Foundation.)

EpiPens are used in cases of severe allergic reactions. Costs for a two-pack of the pens has gone from about $94 in January 2007 to $609 in May of this year. In response to criticism of its price increase, Mylan announced in late August that it would make a generic version and price it at half of its current brand name price.

The new numbers from Medicare could add fuel to the debate over these price increases and voters’ demands that Congress take action to roll back the cost of the popular medication.

The health insurance program for senior citizens and disabled people spent about $6.4 million on the devices in 2007, but spent $75.3 million in 2014, with sharp price hikes by the manufacturer driving much of the increase. Those figures reduce the amount spent based on estimates of how much Medicare saved in rebates from manufacturers, although the agency would not disclose the exact amounts.

Still, when patients show up in emergency rooms with life-threatening allergic reactions, epinephrine is a first line of defense, said Robert Glatter, emergency room physician at Lenox Hill Hospital in Manhattan. Those whose allergic reaction isn’t immediately life threatening would more likely get a mix of steroids and antihistamines, he said.

All patients with suspected severe allergic reactions — even the elderly — are given either a prescription or an actual epinephrine auto injector upon discharge, he said.

“We tell them to have it and use it if they have a lip or tongue swelling, shortness of breath, a skin rash [or other symptoms] of a problem,” said Glatter, adding that adults tend to become more susceptible to food allergies as they age.

Increased awareness among doctors and patients about the importance of epinephrine could account for some of the increase seen in the study, said Richard Lockey, a past president of both the World Allergy Organization and the American Academy of Allergy, Asthma & Immunology.

“Most people survive an allergic reaction … the people who don’t survive are those who don’t get epinephrine or don’t get it soon enough,” said Lockey, who says it is necessary to balance this idea with the possible risks epinephrine poses for older patients. “It’s a matter of clinical judgment.”

Although Medicare is generally thought of as the government health program for older people, about 16 percent — or 9.1 million beneficiaries — are younger than 65. They are generally disabled or have kidney problems requiring dialysis. According to foundation researchers, although the majority of users were older than 65, a disproportionate share – 35 percent — of the EpiPen users were younger than 65. Additionally, 26 percent were between 65 and 69. Use fell off with age, with only 15 percent of the users being between ages 75-85.

“You can come up with a ton of reasons why the under-65 population might see an increase in EpiPen use,” said James Goodwin, an expert in geriatric medicine at the University of Texas Medical Branch in Galveston. He did not work on the study.

As for the overall increase, Goodwin said there are likely many factors and it isn’t necessarily evidence of overutilization. Still, Goodwin says he specializes in patients older than age 80 and has never prescribed an EpiPen, nor had three of his colleagues, who work with slightly younger elderly patients.

One geriatrician said he has patients who are on it with prescriptions from their allergists, who weigh the pros and cons of having the drug. Those physicians “are the ones to say your allergy is serious enough to potentially become life threatening.”

At the American Geriatrics Society, epinephrine is not included on the organization’s list of potentially inappropriate medicines, said Nicole Brandt, a professor at the School of Pharmacy at the University of Maryland.

“When you look at in context of someone having a severe anaphylactic reaction, which is life threatening, you want access to treatment,” said Brandt. She said doctors should caution patients about the appropriate use of the devices and encourage them to seek additional medical attention if they experience side effects.

She suggested the increase in Medicare prescriptions seen in the study reflects access to insurance more than overuse.

Since Medicare drug plans cover part of enrollees’ total drug costs, beneficiaries in prescription drug plans pay less that the full retail price. But beneficiaries still paid significantly more of their own money for EpiPens during the seven-year period studied in the report. Average out-of-pocket spending for beneficiaries with Medicare drug coverage nearly doubled for each EpiPen, from $30 to $56. The report does not include price increases beyond 2014.

Still, those costs are far less than what some people with private insurance might pay, particularly those with high deductibles. As a result, at least one doctor — geriatrician David Barile from Princeton, New Jersey — who did not work on the study, speculated that the rise in Medicare use of EpiPens might simply be older people getting them for their grandchildren.

Mylan's embattled CEO Heather Bresch is shown here (right) speaking at Fortune Magazine's at a meeting for Wall's Street's most powerful women.
Mylan’s embattled CEO Heather Bresch is shown here (right) speaking at a Fortune Magazine meeting for Wall’s Street’s most powerful women.

Liz Szabo contributed to this report.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Could Calif. become the first stage for the public option?

Public Option

With major insurers retreating from the federal health law’s marketplaces, California’s insurance commissioner said he supports a public option at the state level that could bolster competition and potentially serve as a test for the idea nationwide.

“I think we should strongly consider a public option in California,” Insurance Commissioner Dave Jones said in a recent interview with California Healthline. “It will require a lot of careful thought and work, but I think it’s something that ought to be on the table because we continue to see this consolidation in an already consolidated health insurance market.”

Nationally, President Barack Obama and other prominent Democrats have revived the idea of the public option in response to insurers such as Aetna Inc. and UnitedHealth Group Inc. pulling back from the individual insurance market and many consumers facing double-digit rate hikes.

The notion of a publicly run health plan competing against private insurers in government exchanges was hotly debated but ultimately dropped from the Affordable Care Act when it passed in 2010.

Health insurers have long opposed the idea, and other critics fear it would lead to a full government-run system.

Most of the discussion surrounding a public option, however, has focused on a nationwide plan, not one emanating from a state. In July, Democratic presidential nominee Hillary Clinton said she would “pursue efforts to give Americans in every state in the country the choice of a public-option insurance plan.”

Jones offered few specifics on what a public option might look like in the Golden State.

“I don’t want to begin to prejudge it,” said Jones, an elected Democrat serving his second term as head of the state Department of Insurance, one of two insurance regulators in California. “I don’t know whether you would start in certain areas of the state and expand from there. I think there would be significant reservations about the state running it. There would be a wide variety of governance models you could come up with.”

Politically, the proposal may gain more traction in Sacramento than Washington with Democrats firmly in control of the state Legislature and many lawmakers eager to go beyond the boundaries of the federal health law. Depending on what form it took, a public option would require state legislation, some type of federal approval and some source of funding.

The idea of a California-style public option drew mixed reaction. Some consumer groups say they welcome another run at the public option after a disappointing outcome in 2010.

“We’re certainly very interested,” said Anthony Wright, executive director of Health Access California. “This is something we advocated for in its most ambitious form during the debate over health reform and there are elements of the proposal that could be adapted for California.”

Some health-policy experts questioned whether the proposal would backfire, ultimately reducing competition.

“I don’t know what would compel other insurers to stay in the market, so the public option could quickly become the only option,” said Katherine Hempstead, who directs the Robert Wood Johnson Foundation’s work on health insurance coverage. “I think that is only a clear win when the alternative is nothing.”

State Sen. Ed Hernandez (D-West Covina), chairman of the Senate Health Committee, said a public option could make sense in some underserved areas. But he said it may not address the problem of large health systems dictating high prices, and it could interfere with the progress made by the Covered California insurance exchange.

Covered California said 7.4 percent of its 1.4 million enrollees will only have two health plans to choose from for 2017. The state’s biggest markets of Los Angeles, San Francisco and Orange County all feature six to seven insurers.

“I don’t know if a public option will create a lower price [for] the consumer,” Hernandez said. “Covered California has done a good job of keeping rates fairly stable and it has enough plans.”

Health insurers agreed. “Covered California has arguably one of the strongest and most stable exchanges in the country. There is robust consumer choice so we don’t think we need to mess with something that isn’t broken,” said Nicole Evans, a spokeswoman for the California Association of Health Plans, a trade group.

 

For years, Jones has criticized the lack of competition in Covered California, and more recently he has opposed the mergers proposed by industry giants Anthem Inc. and Aetna Inc., saying they’re anticompetitive.

Anthem wants to acquire Cigna, while Aetna is trying to merge with Humana, but the U.S. Justice Department has sued to block both deals.

Covered California has fared better than many states in terms of insurer competition. Eleven health plans are participating in the state-run exchange for 2017, but UnitedHealth is dropping out after just one year in California’s individual market.

Consumer advocates had hoped UnitedHealth would become a strong rival to the state’s four largest insurers. Anthem, Blue Shield of California, Kaiser Permanente and Health Net (now a unit of Centene) account for 90 percent of the state’s exchange enrollment.

After modest 4 percent rate increases in 2015 and 2016, Covered California premiums are set to climb by 13.2 percent on average next year.

Jones said he anticipates that critics will cite the failure of numerous co-ops across the country as evidence a public option won’t work. But he said that criticism is unjustified because the Republican-led Congress eliminated crucial funding that many of the co-ops were depending on.

The co-ops are nonprofit insurers backed with federal loans and designed as an alternative to commercial health plans.

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Kratom Defenders Fight Plan To Ban Herb Used By People In Recovery

caprain_vietnam_kratom

(This article originally appeared on NPR and is used with permission.)

Since 2014, Karisa Rowland has gotten up every morning, removed a bag of kratom powder from her fridge, stirred about a teaspoonful into a mug of water and drank it.

In the past, Rowland, who lives a half hour south of Fort Worth, Texas, struggled with a serious prescription opioid dependence. After several back surgeries, she was using pills — hydrocodone, fentanyl and oxycodone — to deal with her chronic pain. Her morning ritual with kratom has helped her handle her pain without taking opioid drugs, she said.

Kratom, a relative of the coffee plant, is made from the leaves of a tree native to Southeast Asia. According to David Kroll, a pharmacologist and medical writer, farmers and indigenous people have used it for hundreds of years as both a stimulant to increase work output and also at the end of the day as a way to relax.

The leaves are brewed like a tea, crushed and mixed with water or pulverized and put into capsules. In the U.S., kratom has become popular among people like Rowland.

She recalls the night, in jail after being picked up for a DUI, when she hit a low. “I’m looking around and I’m watching raw [sewage] flow through a vent in the floor and I’m thinking, ‘Wow. This has to stop. I’m going to end up dead,’ ” she said. She stopped using opioids, went to a 12-step program and started taking kratom.   

Today, though, she is out of kratom.

In late August, the Drug Enforcement Administration (DEA) announced its intent to make kratom illegal by the end of September, classifying it as a Schedule I drug — in the same category as heroin and LSD. Since then, the place Rowland orders it from online has been sold out. Rowland says she’s in pain and she is angry. She has plenty of company.

In a YouTube video, a veteran shakes a bottle he says contains prescription opioids he has been given for pain. “This,” he says, “is not Schedule I.”

“Do I seem angry?” he continues, “Yes. Because you’re taking away a right that I fought for. When I did my tour in Iraq, I fought for my right to be in America and be able to help myself, to cure myself. I’m not talking about snorting cocaine, shooting up heroin, I’m not even talking about puffing a joint. I’m talking about brewing some tea leaves, having a sip and feeling better.”

In another video, comedian Trae Crowder says, “This would be like us banning pole vaulting because of concussions.” (Please note, the video contains prolific and inspired cursing.)

People have uploaded hundreds of videos talking about why they drink or swallow kratom pills — veterans coping with PTSD, recovering alcoholics, people with fibromyalgia. A petition on WhiteHouse.gov to keep it legal has more than 118,000 signatures.

Even the DEA has been hammered with calls, says spokesman Melvin Patterson. “The response has been unexpected,” he said. “People calling us in opposition of our plan to temporarily schedule kratom as a Schedule I, due to it not having a medicinal use.”

Patterson says the move to schedule kratom come out of a concern for public safety. Between January 2010 and December 2015, U.S. poison control centers received 660 calls related to kratom, he says.

In Texas, there have only been 17 kratom calls so far this year, but Kristina Domanski, with the North Texas Poison Center, says the numbers are creeping up.

“Most people obtain this online,” Domanski said. “Because this is not necessarily legal or regulated, you don’t know what you’re buying, there’s no quality control, it’s not a supplement [that’s] regulated. You don’t know what you’re buying, so there’s a risk that it’s not kratom; it could be mixed with something else.”

The DEA attributed 15 deaths to kratom between 2014 and 2016. Critics call it a legal heroin, ripe for abuse and addiction.

The science behind kratom is still evolving.

Pharmacologist Kroll said it is going overboard to classify this plant as a dangerous drug. “Kratom being lumped in with other opioids is both unfair and unscientific,” he said. “It glosses over the subtleties of how the main chemical in kratom actually works.”

That chemical is mitragynine. It binds to some of the same receptors in the brain as opioids, providing some pain relief and feelings of euphoria, but, Kroll said, not the same high. And the chemical doesn’t cause the same, sometimes deadly, side effects as opioids, such as respiratory depression.

“It turns out mitragynine has a very low risk of respiratory depression,” Kroll said. “It also appears that it’s very difficult to get mice addicted to ‘mitra’ — either with the herb or with the pure chemical.”

So what about the people who died? Fourteen of the 15 people also had other drugs or illegal substances in their systems. Advocates for keeping kratom legal also point out that opioid abuse kills tens of thousands of people every year.

Kroll worries an outright kratom ban could push people back to opioids or alcohol. And, he says, it would delay scientists’ researching the possible risks and benefits of the herb.

Kratom user Rowland is trying to get her friends and kratom users to speak out along with her. She has already sent letters to Texas Sens. John Cornyn and Ted Cruz seeking support.

“I’m the one in pain. The people making these laws, they’re not the ones going through this pain; they’re not the ones whose families have broken up,” she said. “I found life and I have no intention of letting it go.”

This story is part of a reporting partnership with NPR, local member stations and Kaiser Health News.