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Opioid Panel Member Slams Inaction Over Epidemic: Government Is Just ‘Reshuffling Chairs On The Titanic’

University Under Fire For Off-The-Grid Herpes Vaccine Experiments

WASHINGTON — Southern Illinois University’s medical school has halted all herpes research, one of its most high-profile projects, amid growing controversy over a researcher’s unauthorized methods offshore and in the U.S.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

NIH declined comment and HHS did not respond to questions.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Banding Together To Stop Opioid Addiction Where It Often Starts — In Hospitals

Doctors at some of the largest U.S. hospital chains admit they went overboard with opioids to make people as pain-free as possible, and now they shoulder part of the blame for the nation’s opioid crisis. In an effort to be part of the cure, they’ve begun to issue an uncomfortable warning to patients: You’re going to feel some pain.

Even for people who’ve never struggled with drug abuse, studies are finding that patients are at risk of addiction anytime they go under the knife.

“I had the C-section, had the kiddo,” said Michelle Leavy of Las Vegas. “And then they tell me, ‘It’s OK, you can keep taking the pain medications, it’s fine.’”

Leavy is a mother of three and a paramedic who has dealt with many patients coping with addiction. She welcomed the high-dose intravenous narcotics while in the hospital and, upon her release, gladly followed doctors’ orders to keep ahead of the pain with Percocet pills.

But then she needed stronger doses. Soon, she realized, she was no longer treating pain.

“Before I went to work, I took them, and to get the kids after school, I had to take them,” she said. “Then I was taking them just to go to bed. I didn’t really realize I had a problem until the problem was something more than I could have taken care of myself.”

She said she was becoming like the patients with addiction problems that she transported by ambulance, lying to emergency room doctors to con a few extra doses.

Soon she lost her job and her fiancé, before going to rehab through American Addiction Centers and stitching her life back together.

A 180 On Opioids

Opioid addiction is a reality that has been completely disconnected from where it often starts — in a hospital. Anesthesiologist David Alfery said he was rarely stingy with the pain medicine.

“If I could awaken them without any pain whatsoever, I was the slickest guy on the block, and it was a matter of enormous pride,” he said.

Alfery is part of a working group at the Nashville-based consulting firm Health Trust behind hospital efforts to set aside rivalry and swap ideas about a top priority: reducing opioid use.

“It starts with patient expectations, and I think, over the years, patients have come to expect more and more in terms of, ‘I don’t want any pain after surgery,’ and it’s an unrealistic expectation,” Alfery said.

Michelle Leavy had emergency gallbladder surgery in June. She refused opioids before, during and after the procedure. “It hurt,” she says, “but I lived.” (Courtesy of Michelle Leavy)

That expectation exists in part because pain treatment was institutionalized. Hospitals are graded on how well they keep someone’s pain at bay. And doctors can feel institutional pressure, and on a personal level.

“I just wanted my patient not to be in pain, thinking I was doing the right thing for them and certainly not an outlier among my colleagues,” said Mike Schlosser, chief medical officer for a division of HCA, the nation’s largest private hospital chain.

Schlosser spent a decade as a spinal surgeon putting his patients at HCA’s flagship facility in Nashville through some of the most painful procedures in medicine, like correcting back curvature. He said he genuinely wanted to soothe the hurt he caused.

“But now looking back on it, I was putting them at significant risk for developing an addiction to those medications,” he said.

Using HCA’s vast trove of data, he found that for orthopedic and back surgeries, the greatest risk isn’t infection or some other complication — it’s addiction.

So the nation’s largest private hospital chain is rolling out a new protocol prior to surgery. It includes a conversation Schlosser basically never had when he was practicing medicine.

“We will treat the pain, but you should expect that you’re going to have some pain. And you should also understand that taking a narcotic [dose so high] that you have no pain, really puts you at risk of becoming addicted to that narcotic,” Schlosser said, recounting the new recommended script for surgeons speaking to their patients.

Besides issuing the uncomfortable warning, sparing use of opioids also takes more work on the hospital’s part — trying nerve blocks and finding the most effective blend of non-narcotic medicine. Then after surgery, the nursing staff has to stick to it. If someone can get up and walk and cough without doubling over, maybe they don’t need potentially addictive drugs, or at least not in high dosage, he said.

There are potential benefits aside from avoiding addiction.

“I’ve had people tell me that the constipation [resulting from opioid use] was way worse than the kidney stone,” said Valerie Norton, head of the pharmacy and therapeutics council for Scripps Health System in San Diego, which is participating in the Health Trust working group.

“There are lots of other complications from opioids — severe constipation, nausea, itching, hallucinations, sleepiness. We really need to treat these drugs with respect and give people informed consent. And let people know these are not benign drugs.”

Managing The Optics

Of course, business-wise, no one wants to be known as the hospital where treatment hurts more.

“You don’t want to portray the fact that you’re not going to treat people appropriately,” said John Young, national medical director of cardiovascular services for LifePoint Health, another player at the table with Health Trust. The Nashville-based hospital chain is putting special emphasis on how it handles people coming into the ER looking for pain medicine.

Young said tightening up on opioids becomes a delicate matter but it’s the right thing to do.

“We really do have a lot of responsibility and culpability and this burden, and so we have to make sure we do whatever we can to stem this tide and turn the ship in the other direction,” he said.

While hospitals get their ship in order, some patients are taking personal responsibility.

Now that she’s in recovery, Michelle Leavy won’t touch opioids. That meant she had emergency gallbladder surgery in 2017 without any narcotics. Leavy said she was nervous about telling her doctors about her addiction, but they were happy to find opioid alternatives.

“I mean, it hurt,” she said. “But I lived.”

This story is part of a partnership that includes Nashville Public Radio, NPR and Kaiser Health News.

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Must-Attend Health Conference All About The Deals Amid Uncertainty For Millions

SAN FRANCISCO — There’s so much money floating around here this week, you can almost see it wafting through the air.

About 10,000 attendees, mostly confident men in well-cut suits and even nicer watches, are packing the elegant Westin St. Francis Hotel for the invite-only J.P. Morgan Healthcare Conference, which ends Thursday.

For many of these investors, health providers, insurers and entrepreneurs at the nation’s largest and most prestigious health investment conference, it’s all about the deal — and the after-hours parties.

In the first few days of what’s become known as J.P. Morgan Week, New Jersey-based Celgene announced it would spend up to $7 billion to acquire Impact Biomedicines. And Novo Nordisk, the world’s biggest insulin maker, bid $3.1 billion for a Belgian biotech firm.

For those who didn’t land a coveted invite, satellite conferences on digital health and biotechnology dot the city, offering lesser mortals an opportunity to network and make their own deals. Former Vice President Joe Biden even popped into town to keynote the StartUp Health Festival satellite conference, speaking about cancer treatment costs and electronic health records.

The J.P. Morgan gathering comes at a jarring time when you consider that the other world of health care is flooded with uncertainty for the millions of ordinary Americans who inhabit it. They face a precarious political landscape in which the future of the Affordable Care Act remains uncertain and Republican leaders in Congress mull dramatic cuts to Medicaid and Medicare.

John Baackes, CEO of the nation’s largest public health plan, L.A. Care, which insures 2.1 million low-income patients, said if his enrollees wandered into the conference, “they’d think they were in a foreign land and that this has nothing to do with them.”

Much of U.S. health care is underwritten by public dollars, but people here didn’t come to talk about that or rising costs, particularly for prescription drugs. Only a few presentations at this year’s conference have touched on prices, including a J.P. Morgan study released Monday that found many Americans put off medical care until they get their tax refund — a clear sign that that they don’t have enough saved up to pay for care when they need it.

“It’s just so striking how much maneuvering and desire there is at this meeting for a piece of the 18 percent of GDP spent on health care,” mused Dr. Vivian Lee, the former leader of the University of Utah Health Care system, who generated controversy with her efforts to track costs with pinpoint precision. “Is anyone here trying to decrease their share?”

Baackes, who comes to the conference to network and monitor the latest developments in health care, said he’s always skeptical of the well-heeled company officials who attend promising better health outcomes and cost savings. “In a way, there’s too much money walking around here,” he said. “Investors are thinking, ‘Health care is a $3 trillion sector of the economy; surely it will benefit from my genius.’”

Many attendees view the conference with a less critical eye.

“It’s a useful place for us to be,” said Amanda Cowley, strategy director of the quasi-governmental organization that produces the U.S. Pharmacopeia, a compendium of information and standards for producing medicines and food ingredients. Cowley said she and her colleagues need to learn about emerging health technologies so they can anticipate their future work products.

Cowley stood in a line of hundreds of attendees waiting to dine on tri-tip, vegetables and macarons while listening to Microsoft founder Bill Gates talk about how his foundation is helping improve the health of subsistence farmers and children in the developing world.

But there was little talk of America’s subsistence patients, who often cannot afford the expensive drugs and medical devices that are bought and sold in deals brokered at conferences like these, in private rooms guarded by phalanxes of staffers at tony hotels.

Those patients, however, were the focus of a Medicaid panel held Tuesday at Glide Memorial Church in San Francisco’s troubled Tenderloin district, a few blocks and a world away from the Westin St. Francis. That event, which drew about 70 people, was sponsored by ConsejoSano, a Southern California-based startup that has raised $7.2 million to help Spanish speakers better navigate the health system.

Rallying the troops at Glide was former Medicare and Medicaid chief Andy Slavitt, a fierce critic of Republican efforts to repeal and replace the ACA. Slavitt recently invested in Cityblock Health, a public health startup focusing on Medicaid and other low-income patients.

The good thing about J.P. Morgan Week, Slavitt told Kaiser Health News, is that it draws innovative people who want to invest. “The question is, should health care capital be focused on solving big problems and getting rewarded for them, or just focused on the status quo?”

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

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Fallout From ‘Nuclear Button’ Tweets: Sales Of Anti-Radiation Drug Skyrocket

A Twitter battle over the size of each “nuclear button” possessed by President Donald Trump and North Korea’s Kim Jong-un has spiked sales of a drug that protects against radiation poisoning.

Troy Jones, who runs the website www.nukepills.com, said demand for potassium iodide soared last week, after Trump tweeted that he had a “much bigger & more powerful” button than Kim — a statement that raised new fears about an escalating threat of nuclear war.

“On Jan. 2, I basically got in a month’s supply of potassium iodide and I sold out in 48 hours,” said Jones, 53, who is a top distributor of the drug in the United States. His Mooresville, N.C., firm sells all three types of the product approved by the Food and Drug Administration. No prescription is required.

In that two-day period, Jones said, he shipped about 140,000 doses of potassium iodide, also known as KI, which blocks the thyroid from absorbing radioactive iodine and protects against the risk of cancer. Without the tweet, he typically would have sent out about 8,400 doses to private individuals, he said.

Jones also sells to government agencies, hospitals and universities, which aren’t included in that count.

Alan Morris, president of the Williamsburg, Va.-based pharmaceutical firm Anbex Inc., which distributes potassium iodide, said he’s seen a bump in demand, too.

“We are a wonderful barometer of the level of anxiety in the country,” said Morris.

A spokeswoman for a third firm, Recipharm AB, which sells low-dose KI tablets, declined to comment on recent sales.

Jones said this is not the first time in recent months that jitters over growing nuclear tensions have boosted sales of potassium iodide, which comes in tablet and liquid form and should be taken within hours of exposure to radiation.

It’s the same substance often added to table salt to provide trace amounts of iodine that ensure proper thyroid function. Jones sells his tablets for about 65 cents each, though they’re cheaper in bulk. Morris said he sells the pills to the federal government for about 1 penny apiece.

Yet, neither the FDA nor the Centers for Disease Control and Prevention recommends that families stockpile potassium iodide as an antidote against nuclear emergency.

“KI (potassium iodide) cannot protect the body from radioactive elements other than radioactive iodine — if radioactive iodine is not present, taking KI is not protective and could cause harm,” the CDC’s website states.

The drug, which has a shelf life of up to seven years, protects against absorption of radioactive iodine into the thyroid. But that means that it protects only the thyroid, not other organs or body systems, said Dr. Anupam Kotwal, an endocrinologist speaking for the Endocrine Society.

“This is kind of mostly to protect children, people ages less than 18 and pregnant women,” Kotwal said.

States with nuclear reactors and populations within a 10-mile radius of the reactors stockpile potassium iodide to distribute in case of an emergency, according to the Nuclear Regulatory Commission. An accident involving one of those reactors is far more likely than any nuclear threat from Kim Jong-un, Anbex’s Morris said.

Still, the escalating war of words between the U.S. and North Korea has unsettled many people, Jones said. Although some of his buyers may hold what could be regarded as fringe views, many others do not.

“It’s moms and dads,” he said. “They’re worried and they find that these products exist.”

Such concern was underscored last week, when the CDC announced a briefing on the “Public Health Response to a Nuclear Detonation.” One of the planned sessions is titled “Preparing for the Unthinkable.”

Hundreds of people shared the announcement on social media, with varying degrees of alarm that it could have been inspired by the presidential tweet.

A CDC spokeswoman, however, said the briefing had been “in the works” since last spring. The agency held a similar session on nuclear disaster preparedness in 2010.

“CDC has been active in this area for several years, including back in 2011, when the Fukushima nuclear power plant was damaged during a major earthquake,” the agency’s Kathy Harben said in an email.

Indeed, Jones saw big spikes in potassium iodide sales after the Fukushima Daichii disaster, after North Korea started launching missiles — and after Trump was elected.

“I now follow his Twitter feed just to gauge the day’s sales and determine how much to stock and how many radiation emergency kits to prep for the coming week,” Jones said, adding later:

“I don’t think he intended to have this kind of effect.”

KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Gordon and Betty Moore Foundation

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Facebook Live: It’s 2018, Can Big Pharma Hold The Line Against Pricing Controls?

What do we know about the drug industry’s agenda to quiet the drumbeat of cost control and transparency proposals? How will the industry target its efforts? Will the battles take place at the state level? Tune in to this Facebook Live as KHN senior correspondent Jay Hancock discusses these issues.

For more in-depth conversations with KHN reporters, check out our Facebook video archive.

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

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HHS Nominee Vows To Tackle High Drug Costs, Despite His Ties To Industry

Senate Democrats on Tuesday pressed President Donald Trump’s nominee for the top health post to explain how he would fight skyrocketing drug prices — demanding to know why they should trust him to lower costs since he did not do so while running a major pharmaceutical company.

Alex M. Azar II, the former president of the U.S. division of Eli Lilly and Trump’s pick to run the Department of Health and Human Services, presented himself as a “problem solver” eager to fix a poorly structured health care system during his confirmation hearing before the Senate Finance Committee. Azar said addressing drug costs would be among his top priorities.

But armed with charts showing how some of Eli Lilly’s drug prices had doubled on Azar’s watch, Democrats argued Azar was part of the problem. Sen. Ron Wyden of Oregon, the committee’s top Democrat, said Azar had never authorized a decrease in a drug price as a pharmaceutical executive.

“The system is broken,” Wyden said. “Mr. Azar was a part of that system.”

Azar countered that the nation’s pharmaceutical drug system is structured to encourage companies to raise prices, a problem he said he would work to fix as head of HHS.

“I don’t know that there is any drug price of a brand-new product that has ever gone down from any company on any drug in the United States, because every incentive in this system is towards higher prices, and that is where we can do things together, working as the government to get at this,” he said. “No one company is going to fix that system.”

Azar’s confirmation hearing Tuesday was his second appearance before senators as the nominee to lead HHS. In November, he faced similar questions from the Senate Health, Education, Labor and Pensions Committee during a courtesy hearing.

If confirmed, Azar would succeed Tom Price, Trump’s first health secretary, who resigned in September amid criticism over his frequent use of taxpayer-paid charter flights. A former Republican congressman who was a dedicated opponent of President Barack Obama’s signature health care law, Price had a frosty relationship with Democrats in Congress as he worked with Republicans to try to undo the law.

Price and the Trump administration often turned to regulations and executive orders to undermine the Affordable Care Act, since Republicans in Congress repeatedly failed to enact a repeal. “Repeal and replace” has been the president’s mantra.

But at the hearing, Azar was circumspect about his approach, noting that his job would be to work under existing law. “The Affordable Care Act is there,” he said, adding that it would fall to him to make it work “as best as it possibly can.”

Senate Republicans touted Azar’s nearly six years working for the department under President George W. Bush, including two years as a deputy secretary. Committee Chairman Orrin Hatch (R-Utah) praised Azar’s “extraordinary résumé,” adding that, among HHS nominees, he was “probably the most qualified I’ve seen in my whole term in the United States Senate.” Hatch, who is the longest-serving Republican senator in history, has been a senator for more than 40 years.

In addition to drug costs, Azar vowed to focus on the nation’s growing opioid crisis, calling for “aggressive prevention, education, regulatory and enforcement efforts to stop overprescribing and overuse,” as well as “compassionate treatment” for those suffering from addiction.

Pressed about Republican plans to cut entitlement spending to compensate for budget shortfalls, Azar said he was “not aware” of support within the Trump administration for such cuts.

“The president has stated his opposition to cuts to Medicaid, Medicare or Social Security,” Azar said. “He said that in the campaign, and I believe he has remained steadfast in his views on that.”

But Democrats pushed back, pointing out that Trump had proposed Medicaid cuts in his budget request last year. Sen. Sherrod Brown (D-Ohio) said such cuts would hurt those receiving treatment for opioid addiction.

“What happens to these people?” he said.

Despite such Democratic criticism, Azar is likely to be confirmed when the full Senate votes on his nomination. An HHS spokesman Tuesday pointed reporters to an editorial in STAT supporting Azar, written by former Senate majority leaders Bill Frist and Tom Daschle — a Republican and a Democrat. “We need a person of integrity and competence at the helm of the Department of Health and Human Services,” they wrote. “The good news is that President Trump has nominated just such a person, Alex Azar.”

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