Tagged Pharmaceuticals

Viewpoints: Doctors Facing Racism In The Exam Room; Medication’s Role In Curbing Addiction

A selection of opinions on health care from around the country.

The Washington Post: Racist Patients Often Leave Doctors At A Loss
Patients refuse care based on health-care providers’ ethnicity and religion so often that this phenomenon has been dubbed “medicine’s open secret.” A new poll shows that a majority of health-care professionals say they have faced prejudice from patients. In 2013, a nurse in Flint, Mich., sued a pediatric intensive care unit after it granted a request from a father to enter “no African American nurses” on his infant’s care plan. Damon Tweedy, an African American psychiatrist, describes similar experiences in bruising detail throughout his memoir, “Black Man in a White Coat.” And when Esther Choo, an Asian American emergency department physician, tweeted last month that white nationalists refused her care, she set off a Twitter storm of health-care providers responding with similar stories. (Dorothy R. Novick, 10/19)

The Des Moines Register: To Prevent Full-Blown Opioid Crisis, Iowa Needs Overdose Of Vigilance
Drug overdoses are now the leading cause of death for Americans under age 50, killing roughly 64,000 people in the United States last year. An increase in fatalities is largely fueled by opioids, including fentanyl, a powerful synthetic substance considered up to 50 times more potent than heroin. Although Iowa has not been hit as hard as some other states by the opioid epidemic, we have not been spared. (10/19)

Stat: Long-Acting Medications For Addiction Help Patients Maintain Recovery
Many addicted people try to bind their future selves to a commitment to stop using drugs. Some move across the country to a place where they don’t know any dealers or fellow users. Others throw away all their drugs and injection equipment. … Such tactics are often thwarted by the future self of the addicted person who adopted them. Like other drugs to which people become addicted, opioids cause enduring adaptations in the brain that weaken self-control and increase the urge to use these drugs. In addition, many people with drug addictions inhabit social networks that provide repeated stimuli and opportunities to use drugs. (Keith Humphreys, 10/19)

The New York Times: The Trump Administration’s Power Over A Pregnant Girl
In early September, a 17-year-old girl from Central America was apprehended trying cross the border between the United States and Mexico. After being taken to a shelter for unaccompanied minors in South Texas to await immigration proceedings, she learned she was pregnant. The girl, referred to as Jane Doe in court filings, was adamant that she wanted an abortion. … For almost a month, some of these Trump appointees have been waging a crusade to force the young woman, whose future in this country is extremely uncertain, to carry her pregnancy to term. Their standoff shows us the real-world consequences of this administration’s radical disregard for women’s autonomy. (Michelle Goldberg, 10/20)

Los Angeles Times: The U.S. Government Can’t Hold Undocumented Pregnant Teens Hostage When They Want An Abortion
It is unconscionable that the federal government would so flagrantly undermine the rights of a person in its custody. The girl, known in court papers simply as Jane Doe, may not be here legally, but, while she is here, she has a constitutional right — like every other pregnant girl or woman in the United States — to a legal abortion. Even U.S. District Judge Tanya Chutkan, who ruled Wednesday that Doe could get the abortion, shook her head in disbelief when a U.S. Department of Justice lawyer at the hearing would not concede that Doe has constitutional rights. (10/20)

Los Angeles Times: A Judge Calls Foul On Allergan’s Attempt To Hide Its Drug Patents Behind An Indian Tribe’s Sovereignty
In the annals of cynical corporate subterfuges, it would be hard to top the effort by the drugmaker Allergan to fend off a patent challenge by selling its drug rights to a rural New York Indian tribe. … [Judge William] Bryson didn’t invalidate the tribal deal because that wasn’t at issue in the case before him, but he expressed “serious reservations” about whether the deal should be treated as valid. That could function as a guidepost for the U.S. Patent Office, which will have to rule on the transaction’s validity. Legal authorities say Bryson’s opinion should be taken as a red light by other companies thinking about using the same maneuver. (Michael Hiltzik, 10/19)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Prices For Cancer Drugs Creeping Up Much Higher Than Inflation Warrants

“Some [increases] exceeded inflation drastically and some increased at a slower rate,” said Dr. Daniel Goldstein, the author of the study. “But overall, we’re seeing a gradual creep each year.”

Stat: Cancer Drug Prices Have Been Rising Much, Much Faster Than Inflation
The prices for injectable cancer drugs — including older medicines that face competition — rose over a recent eight-year period at rates that far exceeded inflation, according to a new study. Specifically, the mean price increase for 24 branded cancer medicines that were approved in the U.S. between 1996 and 2012 was a whopping 25 percent. After adjusting for inflation, the increase was 18 percent. Moreover, gradual price increases over the years can result in substantial cumulative increases. In this instance, the mean cumulative price increase for all two dozen drugs was 36.5 percent. (Silverman, 10/19)

In other pharmaceutical news —

Stat: Allergan Faces A Cheaper, Compounded Version Of Its Restasis Eye Drops
Hoping to capitalize on consumer outrage, Imprimis Pharmaceuticals (IMMY) plans to sell a cheaper, compounded version of the Restasis dry-eye treatment that is sold by Allergan (AGN) and has been at the center of a widening controversy in recent weeks. The company plans to sell its version for a fraction of the roughly $500 monthly cost for Restasis, which generated nearly $1.5 billion in sales last year, although may now face generic competition next year after a federal court judge last week invalidated several patents for the medicine. (Silverman, 10/19)

Stat: Celgene Just Lost A Crucial Drug For Its Revenue Stream After A Clinical Trial Blowup
Celgene just lost one of the most important drugs in its research pipeline to a late-stage clinical trial blowup. The drug is mongersen, a key component in Celgene’s burgeoning immunology and inflammation franchise. On Thursday, a phase 3 study of mongersen in Crohn’s disease was halted prematurely following a finding of clinical futility by independent monitors, the company said. (Feuerstein, 10/19)

CNN: City Of Los Angeles Opens Investigation Into Drugmaker Following CNN Report
Los Angeles City Attorney Mike Feuer has launched an investigation into California-based drugmaker Avanir Pharmaceuticals, the subject of a CNN report into its aggressive targeting of nursing home residents with a drug called Nuedexta that may be unnecessary or unsafe for this population. Feuer confirmed the investigation to CNN, saying that his office is seeking information and tips from the public to help determine whether state or federal laws have been broken in the sale, marketing or prescribing of Nuedexta. (Ellis and Hicken, 10/19)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Viewpoints: Learning Cybersecurity Lessons From Medical Devices; Big Pharma Should Be Embarrassed — But Are They?

A selection of opinions on health care from around the country.

JAMA: Cybersecurity Concerns and Medical Devices: Lessons From a Pacemaker Advisory
Medical devices increasingly include capabilities for wireless communication and remote monitoring systems that relay clinical information from patients to clinicians. For example, many cardiac implantable electrical devices can transmit data regarding arrhythmia burden and heart failure metrics with minimal patient effort. This technology can improve patient care, but also introduces possible risks to data security and patient safety. (Daniel B. Kramer and Kevin Fu, 10/18)

The New York Times: ‘Drug Dealers In Lab Coats’
Big Pharma should be writhing in embarrassment this week after The Washington Post and “60 Minutes” reported that pharmaceutical lobbyists had manipulated Congress to hamstring the Drug Enforcement Administration. But the abuse goes far beyond that: The industry systematically manipulated the entire country for 25 years, and its executives are responsible for many of the 64,000 deaths of Americans last year from drugs — more than the number of Americans who died in the Vietnam and Iraq wars combined. The opioid crisis unfolded because greedy people — Latin drug lords and American pharma executives alike — lost their humanity when they saw the astounding profits that could be made. (Nicholas Kristof, 10/18)

The Washington Post: Democrats Are The Real Abortion Extremists
What would America’s abortion policy be if the number of months in the gestation of a human infant were a prime number — say, seven or eleven? This thought experiment is germane to why the abortion issue has been politically toxic, and points to a path toward a less bitter debate. The House has for a third time stepped onto this path. Senate Democrats will, for a third time, block this path when Majority Leader Mitch McConnell (R-Ky.) brings the House bill to the floor, allowing Democrats to demonstrate their extremism and aversion to bipartisan compromise. (George F. Will, 10/18)

JAMA: End-Of-Life Care Among Immigrants Disparities Or Differences In Preferences?
Although describing a “good death” is an existentially challenging exercise, most people, if asked to do so, would note the importance of the presence of friends and family, relief from distressing symptoms, time at home, completing life goals, and other values. Although these goals are likely shared quite widely, how they are prioritized, and how they relate to other goals, may vary among individuals and across cultures. (Michael O. Harhay and Scott D. Halpern, 10/17)

JAMA: Blood Transfusions From Previously Pregnant Women And Mortality: Interpreting The Evidence
The availability of large databases of blood donors and transfusion recipients has facilitated investigation of associations of donor characteristics with recipient outcomes. These databases are available in Sweden-Denmark, Canada, and the Netherlands, using government health data, and in the United States, using a donor-recipient database funded by the National Heart, Lung, and Blood Institute. (Ritchard G. Cable and Gustaf Edgren, 10/17)

JAMA: Better
I was in my first year of medicine residency, still losing my way to radiology, still forgetting the codes I needed to access one room or another, still desperately trying to learn how to keep track of my multiple patients and their multiple problems when I assumed his care. As the intern, it fell to me to examine Mr Jones and write admission orders. As the intern, I’d also been up all night. My new white coat was stained with coffee spilled while sprinting to accomplish one forgotten task or other. My pager was chirping regularly, a constant reminder of the calls I’d yet to return. Tired, anxious, and painfully aware of his nurse’s brisk competence as she quieted a beeping alarm and tugged the bed sheet, I introduced myself. (Jessica Gregg, 10/17)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Second Version Of Groundbreaking Immunotherapy Treatment Approved By FDA

The therapy is part of a hot new field that uses a patient’s own immune system to turn the cells into a “living drug” that attacks disease.

The New York Times: F.D.A. Approves Second Gene-Altering Treatment For Cancer
The Food and Drug Administration on Wednesday approved the second in a radically new class of treatments that genetically reboot a patient’s own immune cells to kill cancer. The new therapy, Yescarta, made by Kite Pharma, was approved for adults with aggressive forms of a blood cancer, non-Hodgkin’s lymphoma, who have undergone two regimens of chemotherapy that failed. (Grady, 10/18)

The Washington Post: Cutting-Edge Immunotherapy Treatment Approved For Another Deadly Cancer
The treatment is for adults with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment, such as chemotherapy and bone-marrow transplants. The group numbers about 7,500 patients a year in the United States.The one-time infusion, known as CAR T-cell therapy, is made by Kite Pharma, which is based in Santa Monica, Calif., and recently was bought by Gilead Sciences for $11.9 billion. Kite announced Wednesday that the treatment’s brand name will be Yescarta and its price will be $373,000. (McGinley, 10/18)

Stat: FDA Approves A Game-Changing Treatment For Blood Cancer
In a six-month trial on 101 patients, 36 percent saw their cancer completely disappear thanks to a single dose of Gilead’s therapy, and 82 percent had their tumors shrink by at least half. But the treatment is not without risks. More than 40 percent of patients suffered anemia during the trial, and common side effects include a dangerous lowering of white blood cell counts and toxicity in the brain. Two patients in the study died of treatment-related complications. (Garde, 10/18)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Anthem, Spurning Express Scripts, Will Join With CVS To Start A Drug Plan Business

The new business, which will start in 2020, will be a new pharmacy benefit manager (PBM) company. PBMs serve as intermediaries between drug companies and the prescription plans, but they have come under increasing pressure for not being transparent about how much money they save and how much is passed along to consumers.

Bloomberg: Anthem Breaks With Express Scripts, Will Start Own Drug Plan 
Health insurer Anthem Inc. plans to set up its own pharmacy benefits management unit, signaling a final break with Express Scripts Holding Co. after accusing it of overcharging by billions of dollars. The move means Express Scripts will not only lose its biggest client but also face a new rival. Anthem’s new unit, called IngenioRx, will grow its own business with a “full suite” of services, the insurer said in a statement on Wednesday. (Flanagan and Rausch, 10/18)

Modern Healthcare: Anthem’s New PBM To Spark Change Throughout The Industry 
There has been heightened scrutiny on the role PBMs play in the pricing of drugs in recent years. PBMs, which oversee prescription drug benefits for employers and insurers, negotiate drug discounts with pharmaceutical companies, build pharmacy networks and create their own drug benefit plans, are involved in a blame game across the secretive pharmaceutical supply chain. PBMs, drug manufacturers, insurers and wholesale distributors have pointed fingers at each other to try to explain why savings via negotiated rebates aren’t ultimately passed to the consumer. (Kacik, 10/18)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial

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.
[embedded content]

“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.

Categories: Health Industry, Pharmaceuticals, Public Health

Tags: , ,

Viewpoints: In Defense Of Sanctuary Hospitals; Medicare, Medicaid Funding Fairness For Puerto Rico

A selection of opinions on health care from around the country.

JAMA: Making A Case For Sanctuary Hospitals
In July 2017, Jose de Jesus Martinez, an undocumented immigrant, wept at the bedside of his 16-year-old son Brandon, who was comatose in the intensive care unit of a San Antonio, Texas, hospital after being found in a parked unventilated trailer. Several agents from US Immigration and Customs Enforcement (ICE) entered Brandon’s hospital room and aggressively began questioning Jose. The incident was just one in a recent trend of disturbing actions by ICE agents at or near hospitals and other health care facilities. … everyone deserves to feel secure when in need of medical care, particularly the most vulnerable members of communities. Under previous government administrations, even ICE recognized that hospitals, like schools and places of worship, were sensitive locations where enforcement actions should not take place unless “exigent circumstances” existed. (Altaf Saadi, Sameer Ahmed and Mitchell H. Katz, 10/16)

Modern Healthcare: Puerto​ Rico​ Deserves​ Fair​ Medicaid​ And​ Medicare​ Funding
The Puerto Rican healthcare system, which serves the 3.4 million people devastated by Hurricane Maria, operates under patently unfair Medicaid and Medicare funding rules. As Americans gear up to help their fellow citizens, it’s critical that Congress and the Trump administration correct this injustice. Not only should they offer immediate aid, they should revise the inequitable formulas that systematically shortchange the 69 hospitals and approximately 20 federally qualified health centers with nearly 90 facilities that dot the Caribbean island. (Merrill Goozner, 10/14)

The Washington Post: Congress Wants To Make Americans With Disabilities Second-Class Citizens Again
Led by the hospitality and retail industries, special interests want to shift the burden of [the Americans With Disabilities Act] compliance away from business owners and onto individuals with disabilities. They’re backing a bill that has already passed the House Judiciary Committee, the so-called ADA Education and Reform Act, which would reward businesses that fail to comply with the law. The bill would allow businesses to wait until they are notified of their failure to meet legal obligations before they even have to start removing barriers that prevent Americans with disabilities from leading independent lives. (Sen. Tammy Duckworth, 10/17)

The Des Moines Register: Not Even Death Spares You From Iowa’s Budget Cuts
[G]overnment may now be too small for many Iowans, including those with complaints about a nursing home, those seeking a court date or those trying to get someone on the phone to ask questions about their now privatized Medicaid health insurance. And not even death can deliver people from the negative consequences of failing to adequately fund state government. A shortage of forensic pathologists at the Iowa Medical Examiner’s Office is delaying autopsies, which can leave families waiting weeks for their loved one’s remains. This means not only waiting for answers about a death, but also waiting to schedule funerals and burials. (10/17)

Detroit Free Press: Parents Need Honest Answers To Questions About Childhood Vaccines
My heart aches for Rebecca Bredow, the young Metro Detroit mom jailed for violating an Oakland County Circuit Court judge’s order to immunize her son against vaccine-preventable diseases. As I watched Michigan and national media coverage of Rebecca’s case, I saw a young woman who, from all indications, loves her son and is trying to do what is best for him. When Rebecca shared her story with the public, memories came flooding back of my family’s experiences with childhood immunizations. (Veronica McNally, 10/16)

Cleveland Plain Dealer: GOP’s Drastic Medicaid Cuts Would Be Devastating For HIV-Positive Ohioans Like Me
I have been living with HIV for 20 years. HIV is a very smart and dangerous virus – it can become out of control in your body quickly, and it can make the common cold a deadly illness. To manage my HIV, I take a daily medication that has the dual benefits of keeping the virus from spreading and boosting my immune system. Missing even one dose of my medication is not an option. … Medicaid expansion meant that, for the first time since I was diagnosed HIV-positive, I was able to afford all of the treatment I needed in the same month. I no longer had to choose what I would treat from month to month. (Olga Irwin, 10/18)

Stat: Canada Needs A National Registry Of Drug Company Payments To Doctors
The province of Ontario recently took a historic step for Canada by introducing legislation that would shine a light on interactions between drug companies and prescribers. The use of the term “historic” here is not hyperbole, since the extent of payments towards physicians in Canada has never been known. Other countries, such as the United States and France, have been making such information public for a few years now. But Ontario’s bill would provide a wider scope of transparency by including all sorts of prescribers — not just doctors — into the mix, and even bringing in medical device companies. (Nav Persaud, Joel Lexchin and Andrew S. Boozary, 10/17)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Thoughts On The Drug Industry And The Opioid Epidemic: Look No Further Than The Swamp; Examining Enforcement Tools

Opinion writers continue to examine the government’s role in the opioid crisis and strategies to curb it.

Chicago Tribune: Drug Industry Swims In Washington’s Swamp
But not so fast. More than most of the controversies that have tested this president, the opioid crisis tragically plagues some of the most desperate communities in Trump’s political base. To voters who turned in good faith to Trump’s promises to “drain the swamp” in Washington, Trump’s drain appeared to be clogged. hat makes this opiate-gate scoop into a scandal is how dramatically it illustrates the corruption and insider deal-making that gives Trump’s swamp-draining talk traction with his rally crowds. (Clarence Page, 10/17)

USA Today: Drug Law Hasn’t Hurt Enforcement
The Ensuring Patient Access and Effective Drug Enforcement Act was a bipartisan, commonsense step forward to improve enforcement efforts and combat the opioid epidemic. At its core, the law supported greater coordination between the Drug Enforcement Administration and drug manufacturers and distributors, pharmacies and doctors. In no way does it diminish DEA’s enforcement tools. (John M. Gray, 10/17)

The Charlotte Observer: Here’s How To Address The Opioid Epidemic
In 2004, my closest friend died of an opioid overdose. Since then I’ve met hundreds of mothers, brothers and daughters who have lost loved ones, too. I’ve spent my entire career treating addiction, and it’s clear that efforts to explain the current crisis and its solutions are missing some vital points. Recently, President Trump commissioned a group to examine how to solve this crisis, and its first suggestion was to declare an emergency. It’s been over 70 days since that report was released, and more than 6,500 people have died since. What will it take for us to act? (Omar Manejwala, 10/17)

Stat: Online Sellers Of Designer Drugs Are A Dark Partner In The Opioid Epidemic
DRC and companies like it sideline the doctor, the pharmaceutical industry, and its regulators from the patient-physician relationship. Over the last few years, the use of new psychoactive substances has increased dramatically. They may represent the future of medicine: the patient-chemical relationship. (Abraham Nussbaum, 10/17)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Viewpoints: It’s Time To Stop Drug Companies From ‘Gaming The System And Gaming The Rules’

Read recent commentaries about drug-cost issues.

USA Today: Stop Big Pharma From ‘Getting Away With Murder’
Few things are more infuriating to consumers than the constant, surging increases in drug prices. Americans under 65 are projected to pay an additional 11.6% this year, while seniors are expected to see increases of 9.9%. These increases follow similar ones in recent years. Price hikes like these, which run well above inflation and wage growth year after year, are a keen indication of how the drug industry lacks market fundamentals. Or, as President Trump put it Monday, prescription drug prices “are out of control” and the big pharmaceutical companies “are getting away with murder.” (10/16)

Bloomberg: Here’s How Drug Companies Game The Patent System
The Senate Health Committee held a hearing Tuesday morning about why prescription drugs cost so much and what might done to make them more affordable. According to the committee’s website, the witnesses include a lobbyist for the pharmaceutical industry, a lobbyist for the pharmacy industry and a lobbyist for the pharmacy benefits-management industry. (Joe Nocera, 10/17)

USA Today: PhRMA: We’re Working To Protect Patients
Ensuring patient access to medicines that are revolutionizing how we fight disease is critically important. Equally so is understanding when additional safeguards are required to ensure a medicine’s benefits outweigh its risks. In such cases, the Food and Drug Administration may require the biopharmaceutical company that manufactures the medicine to implement additional procedures, called Risk Evaluation and Mitigation Strategies (REMS), to facilitate safe use of the medicine. (James C. Stansel, 10/16)

Forbes: The Cost Of Developing Drugs Is Insane. That Paper That Says Otherwise Is Insanely Bad
You probably know this poem, or at least the story it tells. One man likens the elephant to a wall, another to a spear, a third to a snake, a fourth to a tree. The point is that each sees only part of the animal, and is thereby deceived. Well, here’s how the same thing happened when it came to a new estimate of the cost of developing a new medicine. For years, the pharmaceutical industry has relied on estimates from the Tufts Center for the Study of Drug Development, the most recent of which that puts the cost of bringing a medicine from invention to pharmacy shelves at $2.7 billion. Last month, two cancer researchers grabbed headlines by asserting that estimate is way off. Their number, published in JAMA Internal Medicine: $648 million. In an editorial that ran alongside the new study, journalist Merrill Goozner wrote: “Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation.” There are reasons to think that (more on that later), but this paper does not add to them. (Matthew Harper, 10/16)

The Hill: The Future Of Drug Pricing: Value Over Volume
Doctors and hospitals are increasingly being paid not for the quantity of care they provide, but for the outcome or quality of care patients receive. The emerging trend in health care is about rewarding value, rather than volume. This is the future, where there is less focus on the number of tests or treatments a patient receives and more focus on whether a patient’s health is improving. (Jim Greenwood, 10/11)

Stat: Canada Needs A National Registry Of Drug Company Payments To Doctors
The province of Ontario recently took a historic step for Canada by introducing legislation that would shine a light on interactions between drug companies and prescribers. The use of the term “historic” here is not hyperbole, since the extent of payments towards physicians in Canada has never been known. Other countries, such as the United States and France, have been making such information public for a few years now. But Ontario’s bill would provide a wider scope of transparency by including all sorts of prescribers — not just doctors — into the mix, and even bringing in medical device companies. (Nav Persaud, Joel Lexchin and Andrew S. Boozary, 10/17)

The Columbus Dispatch: Ohioans Should Vote No On Issue 2
Tens of millions of dollars are being spent on advertising for and against Issue 2, the “Drug Price Relief Act.” After all this, Ohioans remain confused about this proposed voter-initiated law on the Nov. 7 ballot — a wishful scheme that aims to force the state to buy drugs at unattainable discounts. The muddle is understandable. Ohioans are being told to vote for one thing, but are being sold a bill of goods on another. Its merits shaky, Issue 2 campaigns against a straw man: Big Pharma. (10/18)

Columbus Dispatch: Should Ohioans Support The Drug Price Relief Act? Yes
As a Vietnam veteran and former head of the United States Veterans Administration, I have spent most of my life advocating for veterans. And I’m not stopping now. One of the biggest challenges now facing Ohio families and veterans is posed by the out-of-control pharmaceutical drug industry. This industry has been and continues ripping off Ohio veterans and taxpayers daily by selling our government agencies — including Medicaid — drugs at outrageous prices. (Max Cleland, 10/16)

The Courier: No On Issue 2
High drug costs are a national issue, not just an Ohio one. But voters statewide will get to weigh in on the Ohio Drug Relief Act, Issue 2, on Nov. 7. The run-up to the election, and the outcome, will be closely watched throughout the country.Issue 2, if approved, would create a new law requiring state agencies in Ohio to not pay more for prescription drugs than the federal Department of Veterans Affairs. It also would require state payment of attorney fees and expenses to specific individuals for defense of the law.The issue, which was brought about through an initiative petition signed by nearly 200,000 Ohioans, pits a California health care CEO against Big Pharma in a state which would become the first to directly take on the drug price problem if the issue is approved. (10/18)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

‘I’m Not Interested In Their Money,’ Trump Says Of Pharma. But He Took It Anyway.

News outlets report on stories related to pharmaceutical pricing.

Stat: When It Comes To Pharma Money, Trump Was With The Elephant In The Room
President Trump on Monday addressed a well-established tenet of life in Washington: The pharmaceutical industry has loads of money and doesn’t hesitate to spend it on Congress. “They contribute massive amounts of money to political people,” Trump said during an impromptu news conference, turning to Senate Majority Leader Mitch McConnell, who was standing to his side. “I don’t know, Mitch, maybe even to you.” …Trump was not wrong. In his last race in 2014, McConnell raked in $550,923 from the pharmaceutical and health products industries — more than any other individual lawmaker received that year, according to the Center for Responsive Politics, which analyzes political spending data from the Federal Election Commission. (Swetlitz and Mershon, 10/16)

Stat: What Risks? Consumers Are Tuning Out Side Effect Info In TV Drug Ads
The litany of side effects recited in TV drug ads are designed to alert you to all of the potential risks, big and small. But it turns out these well-intended laundry lists, which are required by regulators, actually have the opposite effect — consumers pay less attention to the most serious side effects and, consequently, focus on the benefits of the drug, according to a new study. In short, regulators may have created a paradox if the marketability of the drugs has increased. (Silverman, 10/12)

ProPublica: Oversized Eyedrops Waste Medicine And Money
If you’ve ever put in eyedrops, some of them have almost certainly spilled onto your eyelid or cheek. The good news is the mess doesn’t necessarily mean you missed. The bad news is that medicine you wiped off your face is wasted by design — and it’s well-known to the drug companies that make the drops. (Allen, 10/18)

USA Today: Families Allege Big Pharma Helped Finance Iraq’s Mahdi Army Through Bribes
he families of dozens of U.S. troops killed or injured during the war in Iraq filed a federal lawsuit Tuesday against several U.S. and European pharmaceutical and medical supply companies, alleging that the corporations knowingly financed the anti-American militia Mahdi Army through bribes and kickbacks to officials at a government ministry controlled by the group. (Madhani, 10/17)

Stat: Why Do We Need Drug Rebates, Anyway? A Top Lawmaker Wants To Know
Sen. Lamar Alexander has a question: why do we have drug rebates, anyway? “Why do we need rebates?” the Tennessee Republican asked a panel of pharmaceutical industry representatives at a Senate committee hearing. The Health, Education, Labor, and Pensions committee met Tuesday morning for the second of three hearings on drug pricing, and heard testimony from five interest groups representing companies that play different roles in getting medicines to patients. (Swetlitz, 10/17)

Bloomberg: Drug Supply Players Point A Finger Everywhere But Themselves
A day after President Donald Trump renewed his attack on high drug prices, officials from the drug industry’s top lobbying groups sat down at a black cloth-draped table in a Senate hearing room and told lawmakers who’s to blame: the person a few seats over. Drugmakers said in prepared remarks that insurers, pharmacy-benefit managers and hospitals, among others, keep a large chunk of the money Americans spend on medicine and don’t pass on savings to patients. (Edney, 10/17)

USA Today: Cost Of Cold And Flu Season Can Make You Sick
Cold and flu season isn’t just physically painful — it can hurt your wallet too. The average consumer shops for over-the-counter medicine 26 times each year. That’s $338 per household, according to data collected by the Consumer Healthcare Products Association, a trade organization, in 2015, the most recent available. That same year, Americans spent $328 billion on prescription retail drugs, or prescription drugs purchased in pharmacies, according to estimates from the Department of Health and Human Services. (Ell, 10/17)

The Wall Street Journal: Johnson & Johnson Outlook Buoyed By Drug Unit
Johnson & Johnson increased its 2017 sales and adjusted profit guidance for the third quarter in a row, though net income in the quarter fell due to one-time items and amortization related to the company’s Actelion acquisition.J&J, one of the largest health-products companies by revenue based in the U.S., urged lawmakers in Washington to “unite behind” a plan to overhaul the corporate tax system but said its 2017 guidance doesn’t assume there will be tax reform this year. (Rockoff and Lombardo, 10/17)

Stat: Q&A: Will We See More Drug Makers File Antitrust Lawsuits Against Rivals?
Three times in recent weeks, a big drug maker sued another for allegedly using illegal tactics to win valuable contracts with payers. In one lawsuit, Pfizer claimed that Johnson & Johnson violated antitrust law when convincing insurers not to cover its biosimilar version of the Remicade rheumatoid arthritis treatment. Then, Shire alleged Medicare Part D plans refused to cover its Xiidra dry-eye treatment, because Allergan used “bundled discounts” and “exclusive” deals to lock down the market. And Sanofi accused Mylan of thwarting its move to sell an EpiPen rival. Drug makers regularly offer discounts to payers, but the lawsuits are drawing new attention to behind-the-scenes dealings. We spoke with Michael Carrier, a Rutgers University School of Law professor who specializes in antitrust matters in the pharmaceutical industry, about the implications. (Silverman, 10/16)

Stat: Who Will Pay For A $1 Million Drug? Gene Therapies Raise Tough Questions
Gene therapy has the potential to be a one-shot treatment that could reverse blindness, restore blood clotting function to hemophiliacs, or even cure rare diseases outright. But what kind of price tag comes with that promise — and who will pay for it?  The question is no longer academic: On Thursday, Spark Therapeutics won unanimous support from a Food and Drug Administration advisory panel for its gene therapy drug, Luxturna. It seems likely to win FDA approval in the coming months. But the cost will be hefty: Analysts estimate that Luxturna, which has been shown to restore vision in children with an inherited form of blindness, could cost $1 million per patient. (Keshavan, 10/13)

Kaiser Health News: Cascade Of Costs Could Push New Gene Therapy Above $1 Million Per Patient
Outrage over the high cost of cancer care has focused on skyrocketing drug prices, including the $475,000 price tag for the country’s first gene therapy, Novartis’ Kymriah, a leukemia treatment approved in August. But the total costs of Kymriah and the 21 similar drugs in development — known as CAR T-cell therapies — will be far higher than many have imagined, reaching $1 million or more per patient, according to leading cancer experts. The next CAR T-cell drug could be approved as soon as November. (Szabo, 10/17)

Stat: Judge Invalidates Allergan Patents And Criticizes Deal With The Mohawks
In a blow to Allergan (AGN), a federal judge invalidated the patents on its Restasis eye treatment, the latest twist in a captivating controversy over the fate of the best-selling medicine. The ruling brings some of the largest generic drug makers — Mylan and Teva Pharmaceuticals (TEVA) — a big step closer to selling lower-cost versions of a product that generated nearly $1.5 billion in sales last year. For now, though, the companies must first win regulatory approval and, meanwhile, battle in court still more since Allergan plans to appeal. And this will take months to resolve, stretching well into next year. (Silverman, 10/16)

Wisconsin Public Radio: Democrat Seeks Price Transparency On Prescription Drugs
Frustration over prescription drug prices is prompting some states to force pharmaceutical makers to justify the cost of medications. California’s governor recently signed a bill doing just that. And Democratic lawmakers in Wisconsin are pushing a similar measure. A bill introduced by Debra Kolste, D-Janesville, would require advance notification to the state Office of the Commissioner of Insurance and state Department of Health Services anytime the cost of a drug increases more than 25 percent. She said consumers, insurers, the government and the public would like to better understand pharmaceutical pricing. (Mills, 10/16)

The Hill: Battle Over Drug Prices Shifts Back To The States
President Trump has derided pharmaceutical companies as “getting away with murder,” but there’s been little action in Washington to rein in the costs of prescription drugs. Some states are taking matters into their own hands. California passed a new law that requires pharmaceutical companies to explain a drug’s price tag, and other states are considering similar measures. (Roubein, 10/11)

Politifact: Ohio Issue 2 Ballot Initiative Proponents Overstate Impact On EpiPen Prices
Ohio Taxpayers for Lower Drug Prices claims its ballot initiative could lower the price tag for the EpiPen, a popular auto-injector for serious allergic reactions. “We’ve gone from paying about $100 for EpiPens to over $600. And they only hold about one dollar’s worth of medicine,” the Aug. 29, 2017, video says. “We don’t have a choice but to pay it and the drug companies know it. Vote yes on Issue 2, the Drug Price Relief Act.” (Tobias, 10/13)

Cleveland Plain Dealer: State Report: Issue 2 Savings Impossible To Predict
An analysis by the Ohio Office of Budget and Management finds the state could save some money if Issue 2 passes, but it is impossible to say with certainty or how much. Issue 2 is the ballot initiative that would require the state to pay no more for pharmaceuticals than what the U.S. Department of Veterans Administration does. (Richardson, 10/11)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Following Investigation, Congress On Edge Over Old Bill That Undermined DEA’s Power During Opioid Crisis

The report caused Rep. Tom Marino (R-Pa.) to withdraw his name for the White House drug czar position and has prompted Sen. Claire McCaskill to introduce legislation to repeal the law.

The Hill: Newly Controversial Opioid Enforcement Law Under Fire 
Several lawmakers are pushing to repeal or revisit a law critics say enables the flow of deadly and addictive opioids, hours after President Trump’s drug czar nominee withdrew his name amid the controversy. The little-noticed legislation is reportedly undermining the Drug Enforcement Administration’s (DEA) ability to police drug distributors and was heavily influenced by industry lobbying, according to a joint Washington Post and “60 Minutes” investigation published Sunday.  The report was based in part on a high-ranking whistleblower within the DEA. (Roubein, 10/17)

The Washington Post: Congresswoman Requests Hearings On Whether DEA Chief Misled Her About Bill
A Los Angeles congresswoman who co-sponsored a controversial law that has hobbled the Drug Enforcement Administration said Tuesday that the head of the agency personally assured her that the measure would not hamstring law enforcement efforts. Rep. Judy Chu (D-Calif.), an original co-sponsor of the bill, called Tuesday for an investigation into whether the law is harming enforcement against “bad actors” and requested hearings to examine whether she was misled. (Higham and Bernstein, 10/17)

The Washington Post: McCaskill’s False Claim That She ‘Wasn’t Here’ When The DEA Bill Was Passed
In the wake of The Washington Post/“60 minutes” investigation detailing how 2016 legislation passed by Congress weakened the Drug Enforcement Administration’s ability to go after drug distributors, even as opioid-related deaths continue to rise, Sen. McCaskill has led the charge for repealing the law. Already, President Trump’s choice for drug czar, Rep. Tom Marino (R-Pa.), withdrew his nomination after the report exposed his role in spearheading the bill’s passage through Congress. (Kessler, 10/17)

In other news on the epidemic —

The Washington Post: Another Outbreak Related To The Nation’s Opioid Crisis: Hepatitis C
The nation’s opioid epidemic has unleashed a secondary outbreak: the rampant spread of hepatitis C. New cases of the liver disease have nearly tripled nationwide in just a few years, driven largely by the use of needles among drug users in their 20s and 30s, spawning a new generation of hepatitis C patients. Because a treatment that cures the disease costs tens of thousands of dollars, is limited by insurance and Medicaid, and is mostly unavailable to people who are still using illicit drugs, there probably will be financial and public health ramifications for decades to come. (Zezima, 10/17)

Modern Healthcare: Hospitals Move Forward Fighting In Opioid Abuse Despite Lack Of Federal Assistance
President Donald Trump plans to officially declare the opioid epidemic a national emergency by next week, two months after first announcing a pledge to do so. “We are going to have a major announcement, probably next week, on the drug crisis and on the opioid massive problem and I want to get that absolutely right,” Trump said during a news conference Monday. Some have criticized the delay in declaring the opioid crisis a national emergency, saying a declaration would immediately release resources to help municipalities and states in their efforts. More than 500,000 people have died from drug overdoses from 2000 to 2015. The deaths are occurring at an average of 91 deaths a day, according to the Centers for Disease Control and Prevention. (Johnson, 10/17)

Iowa Public Radio: Needle Exchanges Urged As More Iowans Inject Heroin
A legislative committee studying Iowa’s opioid epidemic heard testimony today on a serious side effect of increased heroin use in the state. Addicts share needles to shoot heroin, and public health experts say that has contributed to a large increase in hepatitis C cases in Iowa. (Russell, 10/17)

Orlando Sentinel: Amidst Opioid Epidemic, New Medical Codes May Have Muddled Data
The number of babies who were exposed to opioids in the womb jumped by 200 percent in Florida between 2015 and 2016 — to more than 2,500 cases — the biggest spike in the past decade, according to state data. But the number of newborns statewide who were diagnosed with opioid-withdrawal symptoms known as neonatal abstinence syndrome dropped by 68 cases to 1,468, bucking the past decades’ trend of steady increase. (Miller, 10/17)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Pharma Is Still ‘Getting Away With Murder,’ Trump Says Hinting At Intent To Bring Down Costs

President Donald Trump railed against high drug prices, reiterating a talking point from the campaign, but though he promised to get prices “way down,” he offered little detail on how to accomplish that.

The Hill: Trump Promises Action On Drug Prices
President Trump on Monday attacked prescription drug companies and hinted at taking action to bring down rising drug prices. “We are going to get prescription drug prices way down because the world is taking advantage of us,” Trump said during a wide-ranging press conference. (Weixel, 10/16)

In other pharmaceutical news —

The New York Times: Patents For Restasis Are Invalidated, Opening Door To Generics
A federal judge in Texas invalidated four key patents for the dry-eye treatment Restasis on Monday, dealing a blow to its manufacturer, Allergan, which had sought to protect its patents by transferring them to a Native American tribe. The ruling, by United States Circuit Judge William C. Bryson of the Eastern District of Texas, does not mean that generic versions of the drug will be available soon, however. Allergan said that it would appeal the decision, and the Food and Drug Administration has not yet approved copycat versions of the drug. (Thomas, 10/16)

Bloomberg: Drugmakers Are Planning To Start A Phase 2 Trial To Cure Peanut Allergy
Aimmune Therapeutics Inc. is teaming with Regeneron Pharmaceuticals Inc. in hopes of developing a cure for peanut allergies. Aimmune, based in Brisbane, California, specializes in food allergy treatments and has been developing a desensitizing therapy, AR101, to protect peanut allergy sufferers against reactions from accidental exposures. By combining AR101 with Regeneron’s inflammation-inhibiting drug Dupixent, the companies are seeking to increase protection enough so patients stop reacting to peanuts even after treatment ends. (Chen, 10/16)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Cascade of Costs Could Push New Gene Therapy Above $1 Million Per Patient

Outrage over the high cost of cancer care has focused on skyrocketing drug prices, including the $475,000 price tag for the country’s first gene therapy, Novartis’ Kymriah, a leukemia treatment approved in August.

But the total costs of Kymriah and the 21 similar drugs in development — known as CAR T-cell therapies — will be far higher than many have imagined, reaching $1 million or more per patient, according to leading cancer experts. The next CAR T-cell drug could be approved as soon as November.

Although Kymriah’s price tag has “shattered oncology drug pricing norms,” said Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center in New York, “the sticker price is just the starting point.”

These therapies lead to a cascade of costs, propelled by serious side effects that require sophisticated management, Saltz said. For this class of drugs, Saltz advised consumers to “think of the $475,000 as parts, not labor.”

Dr. Hagop Kantarjian, a leukemia specialist and professor at the University of Texas MD Anderson Cancer Center, estimates Kymriah’s total cost could reach $1.5 million.

CAR T-cell therapy is expensive because of the unique way that it works. Doctors harvest patients’ immune cells, genetically alter them to rev up their ability to fight cancer, then reinfuse them into patients.

Taking the brakes off the immune system, Kantarjian said, can lead to life-threatening complications that require lengthy hospitalizations and expensive medications, which are prescribed in addition to conventional cancer therapy, rather than in place of it.

Dr. Keith Eaton, like nearly half of patients who receive CAR T-cell therapy, developed a life-threatening complication in which his immune system overreacted. He says he feels fortunate to be healthy today. (Courtesy of Dr. Keith Eaton)

Dr. Keith Eaton, a Seattle oncologist, said he ran up medical bills of $500,000 when he participated in a clinical trial of CAR T cells in 2013, even though all patients in the study received the medication for free. Eaton, who suffered from leukemia, spent nearly two months in the hospital.

Like Eaton, nearly half of patients who receive CAR T cells develop a severe or life-threatening complication called “cytokine storm,” in which the immune system overreacts, causing dangerously high fevers and sudden drops in blood pressure. These patients are typically treated in the intensive care unit. Other serious side effects include stroke-like symptoms and coma.

The cytokine storm felt like “the worst flu of your life,” said Eaton, now 51. His fever spiked so high that a hospital nurse assumed the thermometer was broken. Eaton replied, “It’s not broken. My temperature is too high to register on the thermometer.”

Although Eaton recovered, he wasn’t done with treatment. His doctors recommended a bone-marrow transplant, another harrowing procedure, at a cost of hundreds of thousands of dollars.

Eaton said he feels fortunate to be healthy today, with tests showing no evidence of leukemia. His insurer paid for almost everything.

Kymriah’s sticker price is especially “outrageous” given its relatively low manufacturing costs, said Dr. Walid Gellad, co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

The gene therapy process used to create Kymriah costs about $15,000, according to a 2012 presentation by Dr. Carl June, who pioneered CAR T-cell research at the University of Pennsylvania. June could not be reached for comment.

To quell unrest about price, Novartis has offered patients and insurers a new twist on the money-back guarantee.

Novartis will charge for the drug only if patients go into remission within one month of treatment. In a key clinical trial, 83 percent of the children and young adults treated with Kymriah went into remission within three months. Novartis calls the plan “outcomes-based pricing.”

Novartis is “working through the specific details” of how the pricing plan will affect the Centers for Medicare & Medicaid Services, which pays for care for many cancer patients, company spokeswoman Julie Masow said. “There are many hurdles” to this type of pricing plan but, Masow said, “Novartis is committed to making this happen.”

Masow said that Kymriah’s manufacturing costs are much higher than $15,000, although she didn’t cite a specific dollar amount. She noted that Novartis has invested heavily in the technology, designing “an innovative manufacturing facility and process specifically for cellular therapies.”

As for Kymriah-related hospital and medication charges, “costs will vary from patient to patient and treatment center to treatment center, based on the level of care each patient requires,” Masow said. “Kymriah is a one-time treatment that has shown remarkable early, deep and durable responses in these children who are very sick and often out of options.”

Some doctors said Kymriah, which could be used by about 600 patients a year, offers an incalculable benefit for desperately ill young people. Kymriah is approved for children and young adults with a type of acute lymphoblastic leukemia and already have been treated with at least two other cancer therapies.

“A kid’s life is priceless,” said Dr. Michelle Hermiston, director of pediatric immunotherapy at UCSF Benioff Children’s Hospital San Francisco. “Any given kid has the potential to make financial impacts over a lifetime that far outweigh the cost of their cure. From this perspective, every child in my mind deserves the best curative therapy we can offer.”

Other cancer doctors say the Novartis plan is no bargain.

About 36 percent of patients who go into remission with Kymriah relapse within one year, said Dr. Vinay Prasad, an assistant professor of medicine at Oregon Health & Science University. Many of these patients will need additional treatment, said Prasad, who wrote an editorial about Kymriah’s price Oct. 4 in Nature.

“If you’ve paid half a million dollars for drugs and half a million dollars for care, and a year later your cancer is back, is that a good deal?” asked Saltz, who co-wrote a recent editorial on Kymriah’s price in JAMA.

Dr. Steve Miller, chief medical officer for Express Scripts, a pharmacy benefit manager, said it would be more fair to judge Kymriah’s success after six months of treatment, rather than one month. Prasad goes even further. He said Novartis should issue refunds for any patient whose leukemia relapses within three years.

A consumer advocate group called Patients for Affordable Drugs also has said that Kymriah costs too much, given that the federal government spent more than $200 million over two decades to support the basic research into CAR T-cell therapy, long before Novartis bought the rights.

Rep. Lloyd Doggett, D-Texas, wrote a letter to the Medicare program’s director last month asking for details on how the Novartis payment deal will work.

“As Big Pharma continues to put price gouging before patient access, companies will point more and more proudly at their pricing agreements,” Doggett wrote. “But taxpayers deserve to know more about how these agreements will work — whether they will actually save the government money, defray these massive costs, and ensure that they can access life-saving medications.”

KHN’s coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation.

Categories: Cost and Quality, Pharmaceuticals

Tags: , ,

Viewpoints: The Toll Of Gun Violence On Public Health; Gene Mapping Moves Closer To Reality

A selection of opinions on health care from around the country.

The New York Times: Gun Carnage Is A Public Health Crisis
“We’ll be talking about gun laws as time goes by,” President Trump promised all too casually after the Las Vegas gunman took 58 lives in a rapid-fire slaughter. Time is indeed going by, and the silence is alarming as the Republican Congress and Mr. Trump, the devoted candidate of the National Rifle Association, duck their responsibility to confront the public health crisis of gun deaths. (10/13)

The Wall Street Journal: Gene Editing Is Here, And Desperate Patients Want It
Should Americans be allowed to edit their DNA to prevent genetic diseases in their children? That question, which once might have sounded like science fiction, is stirring debate as breakthroughs bring the idea closer to reality. Bioethicists and activists, worried about falling down the slippery slope to genetically modified Olympic athletes, are calling for more regulation. (Henry I. Miller, 10/12)

Stat: With Little Help From Doctors, I Mapped My Recovery From Brain Surgery
There was no map for this recovery, no compass to point the way. I had no advocate, no guide to ensure that I received necessary treatments. How was I supposed to find my way? How was I supposed to heal? Would I ever be able to return to my work as a college math professor? Could I be a good mom again? Or would I be lost, a perpetual victim to my symptoms, forever struggling with dizziness, balance, short-term memory, sensory overload, emotional meltdowns — and even with thinking itself? (Deb Brandon, 10/12)

The Columbus Dispatch: Shady Clinics Add To Hell Of Opioids
As Ohio struggles under the crushing burden of an opioid-abuse crisis, flaws in state policy have the potential to make the problem dramatically worse. A mushrooming new business — standalone clinics where addicts can get prescriptions for Suboxone, another highly addictive opioid meant to help them get off of heroin — threatens to spawn a new generation of “pill mills.” (10/13)

Bloomberg: The FDA Needs This Nudge To Speed Along New Drugs
[B]elow those high-volatility positions work layers of appointees who are far enough from the president to be somewhat insulated from the chaos, but sufficiently high up to make a major difference in how the government works. The FDA commissioner is one of those appointees, and Gottlieb represents a much-needed countervailing force against the agency’s tendency to prize caution over speed. He has forcefully and persuasively articulated a vision of an FDA that better weighs the costs of risk aversion against the costs of bad side effects. (Megan McArdle, 10/12)

Chicago Tribune: How Illinois Failed Kenan And Other Babies
Well-run organizations keep track of their work. If a project runs late by weeks or months, managers ask questions, problem-solve and demand results. Suppose that assignment involves a new state law with potentially life-or-death consequences for babies. How long before officials get impatient with delays and sound the alarm? Six days? Six weeks? Six long months? (11/12)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Viewpoints: The Toll Of Gun Violence On Public Health; Gene Mapping Moves Closer To Reality

A selection of opinions on health care from around the country.

The New York Times: Gun Carnage Is A Public Health Crisis
“We’ll be talking about gun laws as time goes by,” President Trump promised all too casually after the Las Vegas gunman took 58 lives in a rapid-fire slaughter. Time is indeed going by, and the silence is alarming as the Republican Congress and Mr. Trump, the devoted candidate of the National Rifle Association, duck their responsibility to confront the public health crisis of gun deaths. (10/13)

The Wall Street Journal: Gene Editing Is Here, And Desperate Patients Want It
Should Americans be allowed to edit their DNA to prevent genetic diseases in their children? That question, which once might have sounded like science fiction, is stirring debate as breakthroughs bring the idea closer to reality. Bioethicists and activists, worried about falling down the slippery slope to genetically modified Olympic athletes, are calling for more regulation. (Henry I. Miller, 10/12)

Stat: With Little Help From Doctors, I Mapped My Recovery From Brain Surgery
There was no map for this recovery, no compass to point the way. I had no advocate, no guide to ensure that I received necessary treatments. How was I supposed to find my way? How was I supposed to heal? Would I ever be able to return to my work as a college math professor? Could I be a good mom again? Or would I be lost, a perpetual victim to my symptoms, forever struggling with dizziness, balance, short-term memory, sensory overload, emotional meltdowns — and even with thinking itself? (Deb Brandon, 10/12)

The Columbus Dispatch: Shady Clinics Add To Hell Of Opioids
As Ohio struggles under the crushing burden of an opioid-abuse crisis, flaws in state policy have the potential to make the problem dramatically worse. A mushrooming new business — standalone clinics where addicts can get prescriptions for Suboxone, another highly addictive opioid meant to help them get off of heroin — threatens to spawn a new generation of “pill mills.” (10/13)

Bloomberg: The FDA Needs This Nudge To Speed Along New Drugs
[B]elow those high-volatility positions work layers of appointees who are far enough from the president to be somewhat insulated from the chaos, but sufficiently high up to make a major difference in how the government works. The FDA commissioner is one of those appointees, and Gottlieb represents a much-needed countervailing force against the agency’s tendency to prize caution over speed. He has forcefully and persuasively articulated a vision of an FDA that better weighs the costs of risk aversion against the costs of bad side effects. (Megan McArdle, 10/12)

Chicago Tribune: How Illinois Failed Kenan And Other Babies
Well-run organizations keep track of their work. If a project runs late by weeks or months, managers ask questions, problem-solve and demand results. Suppose that assignment involves a new state law with potentially life-or-death consequences for babies. How long before officials get impatient with delays and sound the alarm? Six days? Six weeks? Six long months? (11/12)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Research Roundup: Medicaid Reduces Payday Loans; Diabetes Management; Chronic ER Use

Each week, KHN compiles a selection of recently released health policy studies and briefs.

Health Affairs: Early Medicaid Expansion Associated With Reduced Payday Borrowing In California
We examined the impact of California’s early Medicaid expansion under the Affordable Care Act on the use of payday loans, a form of high-interest borrowing used by low- and middle-income Americans. …The early Medicaid expansion was associated with an 11 percent reduction in the number of loans taken out each month. It also reduced the number of unique borrowers each month and the amount of payday loan debt. (Allen, Swanson, Wang et. al., 10/1)

JAMA: Insulin Pump Vs Insulin Injection And Type 1 Diabetes Complications
Are the rates of severe hypoglycemia and diabetic ketoacidosis lower with insulin pump therapy than with insulin injection therapy in young patients with type 1 diabetes? …Insulin pump therapy was associated with reduced risks of short-term diabetes complications and with better glycemic control compared with injection therapy. (Karges, Schwandt, Heidtmann et. al., 10/10)

Health Affairs: Persistent Frequent Emergency Department Use: Core Group Exhibits Extreme Levels Of Use For More Than A Decade
Many frequent emergency department (ED) users do not sustain high use over time, which makes it difficult to create targeted interventions to address their health needs. …A small but nontrivial population (16.5 percent, 5.7 percent, and 1.9 percent) exhibited persistent frequent use for three, six, and eleven consecutive years, respectively. The strongest predictor of persistent frequent ED use was the intensity of ED use in the baseline study year. (Kanzaria, Niedzwiecki, Montoy et. al., 10/1)

JAMA Internal Medicine: Patients’ Experiences With Institutional Responses To Medical Injury 
Do patients’ and families’ experiences with communication-and-resolution programs suggest aspects of institutional responses to injury that could better promote reconciliation after medical injuries? This interview study of 40 patients, family members, and hospital staff found that patients have a strong need to be heard after medical injury that is often unmet. …Opportunities are available to provide institutional responses to medical injuries that are more patient centered. (Moore, Bismark, Mello, et. al., 10/9)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Research Roundup: Medicaid Reduces Payday Loans; Diabetes Management; Chronic ER Use

Each week, KHN compiles a selection of recently released health policy studies and briefs.

Health Affairs: Early Medicaid Expansion Associated With Reduced Payday Borrowing In California
We examined the impact of California’s early Medicaid expansion under the Affordable Care Act on the use of payday loans, a form of high-interest borrowing used by low- and middle-income Americans. …The early Medicaid expansion was associated with an 11 percent reduction in the number of loans taken out each month. It also reduced the number of unique borrowers each month and the amount of payday loan debt. (Allen, Swanson, Wang et. al., 10/1)

JAMA: Insulin Pump Vs Insulin Injection And Type 1 Diabetes Complications
Are the rates of severe hypoglycemia and diabetic ketoacidosis lower with insulin pump therapy than with insulin injection therapy in young patients with type 1 diabetes? …Insulin pump therapy was associated with reduced risks of short-term diabetes complications and with better glycemic control compared with injection therapy. (Karges, Schwandt, Heidtmann et. al., 10/10)

Health Affairs: Persistent Frequent Emergency Department Use: Core Group Exhibits Extreme Levels Of Use For More Than A Decade
Many frequent emergency department (ED) users do not sustain high use over time, which makes it difficult to create targeted interventions to address their health needs. …A small but nontrivial population (16.5 percent, 5.7 percent, and 1.9 percent) exhibited persistent frequent use for three, six, and eleven consecutive years, respectively. The strongest predictor of persistent frequent ED use was the intensity of ED use in the baseline study year. (Kanzaria, Niedzwiecki, Montoy et. al., 10/1)

JAMA Internal Medicine: Patients’ Experiences With Institutional Responses To Medical Injury 
Do patients’ and families’ experiences with communication-and-resolution programs suggest aspects of institutional responses to injury that could better promote reconciliation after medical injuries? This interview study of 40 patients, family members, and hospital staff found that patients have a strong need to be heard after medical injury that is often unmet. …Opportunities are available to provide institutional responses to medical injuries that are more patient centered. (Moore, Bismark, Mello, et. al., 10/9)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

‘There’s No Simple Solution’ To Ending Opioid Crisis, But Here Are Steps Experts Recommend

Two experts on the opioid epidemic weigh in on moves the government could make to help alleviate the crisis, including a ban on ultra-high dosage painkillers. Meanwhile, lawmakers wonder why there’s been a delay in officially declaring the epidemic a national emergency.

The Hill: Warren, Murkowski: Where’s The Emergency Declaration On Opioids? 
A Democratic and Republican senator are questioning why President Trump hasn’t officially declared the opioid epidemic a national emergency, despite saying his administration was drafting the paperwork to do so two months ago. “We applaud your stated commitment to addressing opioid addiction and agree with you that the crisis is a ‘serious problem’ deserving of increased federal resources,” Sens. Elizabeth Warren (D-Mass.) and Lisa Murkowski (R-Alaska) wrote in a letter to Trump, referring to comments he made on Aug. 10. (Roubein, 10/12)

And in other news —

Detroit Free Press: Wayne, Oakland Sue Drugmakers Over Opioid Epidemic
Wayne and Oakland county executives announced a joint lawsuit today against several drug manufacturers and distributors, alleging the “deceptive marketing and sale of opioids” including OxyContin and Fentanyl. Wayne County Executive Warren Evans called the opioid-related addictions and deaths—which have claimed 817 lives in his county in 2016, up from 506 in 2015 — a “full-blown health crisis from which the drug companies have made billions,” in a joint news release. (Dudar, 10/12)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

‘There’s No Simple Solution’ To Ending Opioid Crisis, But Here Are Steps Experts Recommend

Two experts on the opioid epidemic weigh in on moves the government could make to help alleviate the crisis, including a ban on ultra-high dosage painkillers. Meanwhile, lawmakers wonder why there’s been a delay in officially declaring the epidemic a national emergency.

The Hill: Warren, Murkowski: Where’s The Emergency Declaration On Opioids? 
A Democratic and Republican senator are questioning why President Trump hasn’t officially declared the opioid epidemic a national emergency, despite saying his administration was drafting the paperwork to do so two months ago. “We applaud your stated commitment to addressing opioid addiction and agree with you that the crisis is a ‘serious problem’ deserving of increased federal resources,” Sens. Elizabeth Warren (D-Mass.) and Lisa Murkowski (R-Alaska) wrote in a letter to Trump, referring to comments he made on Aug. 10. (Roubein, 10/12)

And in other news —

Detroit Free Press: Wayne, Oakland Sue Drugmakers Over Opioid Epidemic
Wayne and Oakland county executives announced a joint lawsuit today against several drug manufacturers and distributors, alleging the “deceptive marketing and sale of opioids” including OxyContin and Fentanyl. Wayne County Executive Warren Evans called the opioid-related addictions and deaths—which have claimed 817 lives in his county in 2016, up from 506 in 2015 — a “full-blown health crisis from which the drug companies have made billions,” in a joint news release. (Dudar, 10/12)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Hot New Cancer Treatment Comes With Sometimes Toxic Side Effects, And Scientists Want To Know Why

The therapy uses patients’ own immune system to help fight the disease, but it can lead to dangerous complications. In other public health news: cervical cancer, the evolution of cells, stroke risks, high blood pressure, vaccines and more.

The Washington Post: Cancer Researchers Learn More About Toxic Side Effects Of New Treatments
One of the most promising new cancer treatments involves altering patients’ own immune cells to attack blood cancers. But it comes with a big downside: It can cause serious side effects, including high fevers and sharp drops in blood pressure as well as potentially fatal brain swelling. Now researchers at two major cancer centers — Fred Hutchinson Cancer Research Center in Seattle and MD Anderson Cancer Center in Houston — are homing in on these toxic complications to better understand why they occur, which patients are most vulnerable to the side effects and how to prevent them. (McGinley, 10/12)

NPR: Do Women Still Need 2 Tests For Cervical Cancer?
A proposal to simplify cervical cancer screening could end up missing some cancers, researchers and patient advocates say. And that could be especially true for minority women. Latina and black women already have the highest rates of cervical cancer in the U.S., and more than half of women with the disease were not screened in the five years before their diagnosis, according to the Centers for Disease Control and Prevention. (Haelle, 10/11)

Boston Globe: Scientists Aim To Address Racial And Ethnic Disparities In Cancer Research
It is a medical puzzle: Why are death rates for black men with prostate cancer almost 2.5 times the rate of white men in the United States? … Understanding those biological differences is difficult, however, because many ethnic and racial groups are underrepresented in genomic studies and in the cell lines and clinical trials used to test new drugs, said Franklin Huang, an oncologist at Dana-Farber Cancer Institute. (Levenson, 10/11)

Stat: Meet The MacArthur ‘Genius’ Tracking The Evolution Of Our Cells
This year’s crop of MacArthur “geniuses” included artists, writers, computer scientists — and one biomedical researcher: Gabriel Victora, an immunologist who’s studying how our bodies respond to foreign invaders. Victora — who runs an immunology research lab at Rockefeller University in New York City — didn’t pick up the phone the first time the folks at MacArthur tried to call to notify him he’d won the award. Nor did he pick up the second time his phone rang, or the third. He was sitting in on a seminar. (Thielking, 10/12)

NPR: Modifiable Stroke Risks Still Rising Across All Ages, Races
For years, doctors have been warning us that high cholesterol, cigarette smoking, illegal drug use and diabetes increase our chances of having a potentially fatal stroke. And yet, most of the stroke patients showing up at hospitals from 2004 to 2014 had one or more of these risk factors. And the numbers of people at risk in this way tended to grow among all age groups and ethnicities in that time period. (Fulton, 10/11)

The New York Times: High Blood Pressure In Midlife Tied To Later Dementia
Women with high blood pressure in their 40s are at increased risk for dementia in later years, researchers report. But the finding does not hold for men. Beginning in 1964, investigators collected health and lifestyle information on 5,646 men and women when they were 30 to 35 years old, and again when they were in their 40s. From 1996 to 2015, 532 of them were found to have Alzheimer’s or other forms of dementia. The study is in Neurology. (Bakalar, 10/11)

NPR: Why Does Sex Exist? This 18-Million-Year-Old Worm Left It All Behind
Abstinence may have found its most impressive poster child yet: Diploscapter pachys. The tiny worm is transparent, smaller than a poppy seed and hasn’t had sex in 18 million years. It’s basically just been cloning itself this whole time. Usually, that’s a solid strategy for going extinct, fast. What’s its secret? (Bichell, 10/12)

Stat: Century-Old Vial Sheds Light On One Of Medicine’s Enduring Mysteries
A115-year-old vaccine vial has provided an important clue in the search for an answer to one of medicine’s enduring mysteries: What went into the world’s first vaccine?  Medical legend has it that Edward Jenner — the father of vaccination — used cowpox virus to protect against the dreaded smallpox. But a new report, published Wednesday, shows a virus closely related to the horsepox virus was used in a 1902 smallpox vaccine, providing fresh ammunition to those who believe the history books have it wrong. (Branswell, 10/11)

The Wall Street Journal: Ebola Vaccines Show Promise In New Study
The first placebo-controlled study of two vaccines against the Ebola virus found they both successfully created a powerful antibody response for a year, suggesting they both could be tools to save lives in a future epidemic of the deadly disease. The research, by doctors from the U.S. and Liberian governments and elsewhere, was published Wednesday in the New England Journal of Medicine. The study looked at 1,500 patients in Liberia, and took place amid and after the outbreak of Ebola in Liberia from 2014 into 2015. (Burton, 10/11)

WBUR: Obesity In Children And Teens Rose Sharply Worldwide Over Past 4 Decades
In just over four decades, obesity levels in children and teenagers have risen dramatically worldwide, though that rise has been far from uniform. In a new study published online Tuesday, British researchers and the World Health Organization say those levels have plateaued lately in high-income countries, “albeit at high levels,” while the rise in obesity rates has only accelerated in regions such as East Asia and Latin America. (Dwyer, 10/11)

Denver Post: Aurora Mental Health Agencies And Kaiser Permanente Expand Access, End Stigma
Kaiser Permanente timed the kickoff of some efforts to broaden its reach to coincide with National Suicide Prevention Awareness Month in September. Its new campaign, “Find Your Words,” encourages people to discuss their mental illness and treatment and help remove the stigma. One of Kaiser’s public service announcements features a young black teenager walking alone around his neighborhood. He doesn’t speak, but the lyrics to rapper and songwriter Kendrick Lamar’s confessional “i” are recited. It is vastly different from the typical pharmaceutical industry commercial related to mental health. (Scoville, 10/11)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

To Bring Down Big Pharma, This BioHacker Wants To Teach Patients To Make Own Medications

Michael Laufer’s latest plan involves developing a desktop lab and a recipe book meant to equip patients to cook up a range of medicines, including a homemade version of the expensive hepatitis C drug Sovaldi, on their kitchen counters. In other news: an old FDA program is responsible for higher drug prices and lawmakers want more oversight over the 340B program, which allows hospitals to purchase drugs at a discounted rate.

Stat: An Anarchist Takes On Big Pharma — By Promoting DIY Prescription Drugs
Swaggering, charismatic, and complex, Michael Laufer has become a fixture in the growing biohacker movement ever since he published plans last year for a do-it-yourself EpiPencil — a $35 alternative to the pricey EpiPen. It’s not clear whether anyone has actually ever used a homemade EpiPencil to prevent anaphylactic shock. But that seems almost an afterthought to Laufer’s bigger goal — trying to build a DIY movement to attack high pharma pricing and empower patients. (Piller, 10/12)

Stat: An FDA Program To Approve Old Drugs Causes Higher Prices And Shortages
In 2006, the Food and Drug Administration launched a program to require drug makers to win approval of medicines that — believe it or not — were being sold without the agency’s imprimatur or remove them from the market. At the time, hundreds of treatments were readily available because some companies failed to comply with a 1962 law mandating companies prove drugs were effective. …More medicines may have received needed regulatory approval, but often enough, shortages ensued, prices rose, and there was no new clinical evidence to support the vast majority of the medicines that were approved, according to a new study published in the Journal of Managed Care & Specialty Pharmacy. (Silverman, 10/11)

Stat: D.C. Pharmacist Has Something To Say About That Alzheimer’s Remark
The pharmacist who prepares prescription drugs for Congress would like you to know that he does not know of any members with Alzheimer’s. And if he did, he wouldn’t tell you. “I am not aware of any member that actually has Alzheimer’s and would certainly not disclose any such information if I did know,” Mike Kim said, adding that “patient privacy is a very serious matter that I am committed to upholding.” (Mershon, 10/11)

Modern Healthcare: Lawmakers Worry Providers Are Abusing The 340B Program
Federal lawmakers said Wednesday that the 340B program that allows hospitals to purchase drugs at discounted rates does not have enough oversight, leaving it susceptible to misuse. Approximately 45% of all acute-care hospitals participate in the 340B program, which has grown significantly. The Medicare Payment Advisory Commission estimates that 2,140 hospitals participated in the program in 2014, up from 583 in 2005. Program spending during that period jumped from $2.4 billion to $14 billion, according to federal data. (Dickson, 11/11)

Morning Consult: House Republicans Ramp Up Scrutiny Of Providers In Drug Discount Program
House Republicans are intensifying scrutiny of a federal program that gives thousands of safety-net providers hefty discounts on prescription drugs but that they say doesn’t have effective tools to track where the savings are going. The 340B Drug Pricing Program makes some providers, such as children’s hospitals, federal health centers and specialty clinics, eligible for discounts of between 25 to 50 percent on outpatient drugs. Providers are supposed to use the generated savings to ensure low-income patients have access to essential health services and treatments. … At a hearing on Wednesday, the [Energy and Commerce] committee’s chairman, Greg Walden, (R-Ore.) said some providers recently interviewed by the committee don’t have policies in place to ensure all their eligible patients directly benefit from the program or track their 340B savings on a regular basis. (Reid, 10/11)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Perspectives: Expensive Cancer Drugs May Finally Be In For A Little Competition

Read recent commentaries about drug-cost issues.

Bloomberg: Cancer-Drug Prices Are At A Tipping Point
Cancer drugs generate a great deal of outrage with their six-figure price tags for vulnerable patients. Until now, they’ve faced little in the way of price competition. That finally might be set to change with a recent wave of FDA approvals. (Max Nisen, 10/10)

Bloomberg: The Hepatitis Drug Market Is Worse Than Wall Street Realizes
And then there were three.Johnson & Johnson and Merck & Co. Inc. have both recently halted development of drugs to treat hepatitis C (HCV), with no plans to work on any others. This capitulation leaves the market largely split between Gilead Sciences Inc., AbbVie Inc., and a drug Merck already has on the market. (Max Nisen, 10/4)

Forbes: Reforming The 340B Program Will Lower The Price Of Prescription Drugs
The U.S. health care system needs systemic reforms that comprehensively address the problems of declining quality and rising costs. Alas, beneficial systemic reforms will not be implemented any time soon. There are still opportunities for Congress to implement tailored reforms that can help address these problems in the near term. One such opportunity is reforming the out-of-control 340B drug pricing program (the federal drug discount program created under the Veterans Health Care Act of 1992). (Wayne Winegarden, 10/10)

Detroit News: Drug Prices Need State Review
Back-to-school season can be an exciting and hectic time of year for many of us. As a former teacher, I know our educators are busy making final preparations to ensure our classrooms are safe and productive learning spaces. Parents are working to check off every last item on the school supply list to set their student up for success. But for many Michigan families, this back-to-school list can have some expensive additions. In particular, many families across the state stare wide-eyed at their checking accounts as they prepare to purchase another critical item for their student: the year’s supply of EpiPens. (Darrin Camilleri, 10/10)

The Baltimore Sun: Pharma Balked When Maryland Tried To Regulate Prescription Drug Costs; Now They Have To Contend With California
Generic drug manufacturers suffered a setback in court late last month when a federal judge dismissed one half of their argument against a new Maryland law regulating price gouging and cast doubt on the other. They suffered an even bigger one Monday when California Gov. Jerry Brown signed a prescription drug price law that is in some ways even more sweeping than Maryland’s. (10/10)

Bloomberg: Express Scripts’ Deal Helps Answer Amazon Threat
Amazon.com Inc. is seemingly on the brink of entering the prescription-drugs market. Express Scripts Holding Co. shareholders should be pleased that the pharmacy-benefits manager isn’t taking this development lying down. On Tuesday, Express Scripts said it’s buying medical-benefits manager EviCore Healthcare for $3.6 billion, its biggest deal since the nearly $30 billion acquisition of Medco Health Solutions in 2012. While few details have been released, the purchase is expected to be accretive to Express Scripts’ adjusted diluted earnings per share in its first full year. (Gillian Tan, 10/10)

Los Angeles Times: Shining A Narrow But Necessary Beam Of Light On Drug Price Hikes
Pharmaceutical companies have so much power over their customers, it’s practically an abusive relationship. Maybe that’s why consumer advocates are heralding what might otherwise seem like a minor legislative win over Big Pharma. SB 17, which Gov. Jerry Brown signed Monday morning, would not stop drug companies from making a brand new drug costlier than a college education, or from driving the price of an existing drug up faster than a hot tech stock. It wouldn’t place anything that even vaguely resembles a price control on pharmaceutical companies. Instead, it tries to discourage big price hikes by shining a light on which drug companies are imposing big price hikes and why. In short, it’s naming and shaming. (Jon Healey, 10/9)

The Wall Street Journal: A Flawed Study Depicts Drug Companies As Profiteers
Are drug companies ripping off cancer patients? Of course they are, suggests a much-hyped study published last month in the journal JAMA Internal Medicine. The truth is more complicated. Drug companies receive a staggering return on investment “not seen in other sectors of the economy,” write Vinay Prasad of Oregon Health and Science University and Sham Mailankody of Memorial Sloan Kettering Cancer Center. They estimate that pharmaceutical firms spend $720 million on average to develop a single cancer drug, while the average cancer therapy generates sales of $6.7 billion. The editors at JAMA are brilliant physicians, but they could use a refresher on the economics of drug development. (Peter J. Pitts, 10/9)

US News: Switch And Save On Medicare Part D
In just less than a week, 41 million seniors will have the opportunity to make a choice that might save them hundreds, perhaps thousands, of dollars in health care costs. Too many of them, however, will fail to take advantage, leaving billions on the table, all to the benefit of insurance and pharmaceutical companies. (Daniel McFadden and Joachim Winter, 10/10)

The Wall Street Journal: Reverse Patent Trolls Are Harming Drug Innovation—and Patients
Allergan ’s agreement with the Saint Regis Mohawk Tribe has inspired a lot of commentary. Under the deal, my company transferred the patents for Restasis, a prescription eyedrop, to the Native American tribe as a way of protecting the intellectual property from unfair challenges. The agreement was intended to address the disadvantage that “inter partes review” creates for biopharma innovators and the patients they serve. (Brent Saunders, 10/8)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Author Of New Drug Transparency Law Hopes Rest Of Country Will Follow In California’s Footsteps

News outlets report on stories related to pharmaceutical pricing.

Stat: Q&A: Can California’s New Drug Price Transparency Law Make A Difference?
On Monday, California adopted a law that requires drug makers to explain and justify price hikes, making it only the third state in the country to demand some transparency in response to rising medicine prices. Although the law does not actually allow the state to control pricing, the pharmaceutical industry fought the effort over concerns other states will now pursue similar legislation, since California is often seen as a bellwether. We spoke with state Sen. Ed Hernandez, the Democratic legislator who shepherded the bill — and who believes it can force a change in the national conversation about drug pricing. (Silverman, 10/10)

Stat: Biotech Execs Are Fretting A Bit Less These Days About Lowering Drug Prices
Biotech executives appear slightly less concerned about drug pricing than in the recent past, according to a new analysis, but the continued pressure from payers and lawmakers to bring down costs does still weigh on them. A review of risk factors cited by the 100 largest companies listed in the Nasdaq Biotechnology Index found 84 percent cited worries over pricing pressures, according to the BDO advisory and consulting firm, which examined the most recent crop of annual filings with the US Securities and Exchange Commission. (Silverman, 10/5)

Bloomberg: Trump’s Fastest Moving Agency Is Approving Drugs And Pleasing Wall Street 
Gridlock under the Trump administration, particularly the repeated failures to repeal and replace Obamacare, is riveting the nation’s attention. Yet at least one government agency is running smoothly — and even accelerating its operations. The U.S Food and Drug Administration, under Commissioner Scott Gottlieb, is taking advantage of policy groundwork laid in past years to speed drug approvals. Thirty-four new drugs — treating everything from cancer to rare genetic diseases — have been approved so far this year. That’s on pace to nearly double last year’s approvals. So far, at least nine decisions came more then 20 days ahead of the FDA’s scheduled action date. (Chen and Paton, 10/6)

Stat: California Bans Drug Coupons When Cheaper Alternatives Are Available
Call it a one-two punch. At the same time California Governor Jerry Brown signed a law requiring drug makers explain and justify price hikes, he also signed another law prohibiting the use of prescription drug coupons when a lower-priced medicine is available. The law reflects controversy over the role that coupons play in the debate over rising health care costs, and also arrives as state and federal authorities examine other forms of financial assistance that the pharmaceutical industry provides patients. (Silverman, 10/10)

Healthline: Drug Price Gouging Laws May Become A New Trend
Maryland has permission to go after prescription drug price gouging.A federal judge gave the go-ahead last week. Drug makers had attempted to block the state’s first-in-the-nation law targeting extreme increases in generic drug prices. The ruling adds Maryland to a growing number of states taking action against high drug prices, as Congress lags behind with similar proposed legislation. (Radcliffe, 10/10)

The New York Times: Price Matters, In Patients’ Minds
When people believe a medicine is expensive, they may show a greater response to it. Researchers told 49 volunteers that they were testing two anti-itch creams — one that was costly, and one cheap — that contained the same ingredient known to reduce itch, but that the ingredient sometimes increased sensitivity to heat. (Bakalar, 10/5)

Bloomberg: Amazon Is Headed For The Prescription-Drug Market, Analysts Say
Amazon.com Inc. is almost certain to enter the business of selling prescription drugs by 2019, said two analysts at Leerink Partners, posing a direct threat to the U.S.’s biggest brick-and-mortar drugstore chains. “It’s a matter of when, not if,” Leerink Partners analyst David Larsen said in a report to clients late Thursday. “We expect an announcement within the next 1-2 years.” (Langreth and Soper, 10/6)

Forbes: One Of Biotech’s Hottest Names Embraces Pharma’s Bygone Era
Susan Waite, 48, still remembers hearing her disease’s name, myelofibrosis, for the first time five years ago. “You Google,” she says. “I know you’re not supposed to, but everybody does. And at the time the average life expectancy was two and a half years.” This rare cancer was turning her bone marrow, which produces blood cells, into scar tissue, leaving her anemic. She had one child in high school and two more in college, and was so tired she’d gone from being a social butterfly to a person who goes to bed right after dinner. Her spleen was so enlarged with blood cells that it hurt and prevented her from eating. (Herper, 10/10)

Stat: Spark’s Gene Therapy For Blindness Is Racing To A Historic Date With The FDA
The $1 million medicine is coming. On Thursday, a committee of experts invited by the FDA will meet outside Washington D.C. to review an experimental gene therapy from Spark Therapeutics (ONCE). Barring unexpected surprises, the experts will advise the FDA to approve the one-time shot, which will be used to treat a rare, inherited form of childhood blindness. (Feuerstein, 10/9)

CBS News: Time To Review Your Medicare Rx Coverage
With Medicare’s open-enrollment period approaching — Oct. 15 to Dec. 7 — you should be getting ready to review your Medicare prescription drug coverage. Your goal is to minimize your total out-of-pocket spending for prescription drugs, including your premiums, co-payments and deductibles. Let’s first look at some basic information about prescription drug coverage under Medicare. (Vernon, 10/10)

Bloomberg: Big Pharma Gets Boost As China Speeds Up New Drug Approvals
For decades, Chinese patients have struggled to gain access to cutting-edge medicines thanks to bureaucratic delays that have hamstrung drug development. Now a sweeping government overhaul of drug approvals is poised to change that.  Beijing on Sunday announced new rules that will speed up approvals of medicines and medical devices, easing bottlenecks in introducing new treatments. The move is also a growth opportunity for international and local drugmakers in the world’s second biggest pharmaceutical market. It also parallels the acceleration of approvals by the U.S. Food and Drug Administration. (10/8)

Stat: A Drug With The Power To Mute Defective Genes Raises Hopes — Cautiously
The experimental drug has startling powers: It can turn down a mutant gene in a patient’s body, stopping the production of proteins that cause a terribly painful rare disease. A crucial, late-stage clinical trial showed that the drug works — and that it’s safe. And now the biotech company behind it, Alnylam, is poised to bring this first-of-its-kind therapy to market. (Keshavan, 10/5)

Nashville Tennessean: How United Way Helped Families Save Millions On Rx
Pricey prescriptions can easily sink family budgets but United Way of Metropolitan Nashville has helped connect more than 52,000 people to a discount program that’s saved them millions of dollars in prescription costs. Families around Nashville have saved about $7 million at the pharmacy through United Way’s decade-long partnership with FamilyWize, a for-profit company that offers prescription discount cards. People using the program in Rutherford and Cannon counties have saved an additional $836,146, according to an estimate from United Way officials. (Fletcher, 10/4)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

What Do Lawmakers Do When They Need Prescriptions Filled? They Don’t Walk Into The Nearest CVS

It’s a little-known perk, but lawmakers have their pills delivered directly to the Capitol, so they can just walk down and pick them up. That also means the pharmacist in charge of filling the prescriptions knows a lot more about the leaders of the country than most pharmacists know about their customers.

Stat: Pharmacy Hand-Delivers Drugs To Congress, A Perk For The Powerful
If House Speaker Paul Ryan comes down with the flu this winter, he and his security detail won’t be screeching off toward the closest CVS for his Tamiflu. Instead, he can just walk downstairs and pick up the pills, part of a little-known perk open to every member of Congress, from Ryan and Majority Leader Mitch McConnell down to the newest freshman Democrat. Nearly every day for at least two decades pharmaceutical drugs have been brought by the carload to the Capitol — an arrangement so under the radar that even pharmacy lobbyists who regularly pitch Congress on their industry aren’t aware of it. (Mershon, 10/11)

In other pharmaceutical news —

Stat: FDA Permits Importation Of Saline Bags To Address Shortages
To address a shortage of intravenous solution bags exacerbated by Hurricane Maria, the Food and Drug Administration has granted permission for a health supply company to import certain products to the United States from Australia and Ireland. In letters dated Monday, the company, Baxter International, informed its customers that they could now order bags of saline solution that are manufactured abroad even though they are not FDA-approved because they are not marketed in the United States. Saline solution, given intravenously, is used for hydration and to dilute drugs. (Swetlitz, 10/10)

Arizona Republic: Goldwater Institute Seeks Ebola Drug Records FDA Refuses To Provide
The federal agency that oversees drug safety made a quick decision in 2014 to allow two health-care workers to take a yet-to-be-tested drug after they contracted the Ebola virus while volunteering in Liberia. The two health workers, Dr. Kent Brantly and Nancy Writebol, became the first humans to ever get the experimental drug, called ZMapp, and both recovered from their illness. (Alltucker, 10/10)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

10 Years Ago This Lawyer Went Up Against Pharma Over Opioids And Won. Now He’s Ready For Round Two.

Back in 2007, Purdue settled with individual patients who alleged that it had underplayed the addiction risk of its medications. It was a huge case for lawyer Paul Hanly and a rare win against makers of painkillers. Now, in an entirely different landscape — one where these companies are becoming the targets of states who want to try to curb the national crisis — Hanly is gearing up to go again. Meanwhile, PBS looks at how the brain gets addicted to opioids in the first place.

Stat: A Veteran NY Litigator Is Taking On Opioid Makers. They Have A History
It is one of the few instances — maybe the only one, experts say — in which a drug maker agreed to pay individual patients who alleged that it had underplayed the addiction risk of its medications. A decade later, the smooth, stylish [Paul] Hanly has again set his sights on opioid manufacturers, this time on behalf of cities and counties in five states. The drug companies, those plaintiffs allege, sought to create a false perception around opioids, seeding a public health and safety crisis that has cost Hanly’s clients hundreds of millions of dollars. (Joseph, 10/10)

PBS NewsHour: How A Brain Gets Hooked On Opioids
Pain and pleasure rank among nature’s strongest motivators, but when mixed, the two can become irresistible. This is how opioids brew a potent and deadly addiction in the brain. (Akpan and Griffin, 10/9)

PBS NewsHour: How One Group Of Doctors Drastically Decreased Opioid Prescriptions
With addictions and overdoses surging over the past two decades, recent CDC guidelines urge doctors to avoid or dramatically limit the use of legal painkillers. In Southern California, a group of Kaiser Permanente doctors has been helping chronic pain patients “step down” from high-dose opioids with the help of alternative therapies that work well for many. (Wise, 10/9)

And in other news on the epidemic —

Los Angeles Times: Gov. Jerry Brown Vetoes Measure To Create New State Task Force On Opioid Prescriptions
Gov. Jerry Brown vetoed a measure on Monday that sought to curb escalating opioid addiction rates by creating a new state working group tasked with determining best practices in prescribing addictive drugs. The measure, Assembly Bill 715 by Assemblyman Jim Wood (D-Healdsburg), would have directed the state Department of Public Health to convene doctors, opioid addiction specialists and other experts to examine how painkillers are being prescribed to treat acute, short-term pain. (Mason, 10/9)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.