Tagged Pharmaceuticals

Viewpoints: Effectiveness Should Guide Doctors’ Prescribing; Climate Change And Medicine

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

Stat: Drug Effectiveness Should Influence What Doctors Prescribe
Physicians and payers have called for more outcomes-based drug pricing arrangements. These tie reimbursements to innovation and the value the drug provides, such as how well a drug reduces hemoglobin A1c (a measure of blood sugar) among people with diabetes, or alleviates skin plaques among people with psoriasis, or reduces fracture rates among those with osteoporosis, to name a few examples. Yet the execution of such programs is limited to a handful of agreements between payers and drug makers, each one unique to the parties involved. (Larry Blandford, 4/27)

The Des Moines Register: Saving Medicines, Saving Money, Saving Lives
After the rough, recently-concluded legislative session, you might need a reason to feel good about our state’s priorities. Fortunately, if you were tuned in to NPR’s Morning Edition on Thursday, you would have gotten a strong dose of Iowa pride. Iowa, it turns out, is the envy of the nation for a unique lifesaving, cost-saving and environmentally friendly approach to providing no-cost medicines to people in need. It’s based on reclaiming and redistributing unused prescription drugs through a drug donor repository. (Rekha Basu, 4/27)

The New England Journal Of Medicine: Preventive Medicine For The Planet And Its Peoples
For many Americans, the effects of climate change seem distant: island nations will sink beneath rising seas, areas of the Middle East will become uninhabitable because of extreme heat. But though the worst effects will be felt by poorer people in poorer countries that are less resilient to droughts, floods, and heat, climate change already affects the health of vulnerable U.S. populations, and U.S. health professionals see these effects. (David J. Hunter, Howard Frumkin and Ashish Jha, 4/27)

Cincinnati Enquirer: How The Trump Administration Is Fighting The Opioid Epidemic
One of the most exciting lines of work we get to support at the U.S. Department of Health and Human Services is the development of new drugs to combat deadly diseases. America’s scientists are constantly pushing the boundaries of what is possible, solving or ameliorating conditions we once thought incurable. So it is both heartening and heartbreaking that one of our top priorities in that work is now fighting a disease that is largely of our own making: opioid addiction. (Secretary of Health and Human Services Tom Price, 4/27)

The Washington Post: If Abortions Become Illegal, Here’s How The Government Will Prosecute Women Who Have Them
You’ve heard the stories of the coat hanger and the back alley, those bloody days before Roe v. Wade. Sen. Patrick Leahy told one recently at the Supreme Court confirmation hearings for Judge Neil Gorsuch. As a state prosecutor in 1968, three years before the court struck down state abortion bans, cops woke him up in the middle of the night, because “a young co-ed nearly died from bleeding from a botched abortion.” The senator from Vermont’s drift was clear: If confirmed, Gorsuch could cast a vote, or several, to bring back those horrors (if not the archaic phrase “co-ed”). (Irin Carmon, 4/28)

The New England Journal Of Medicine: Bridging The Data-Sharing Divide — Seeing The Devil In The Details, Not The Other Camp
The movement toward sharing data from clinical trials has divided the scientific community, and the battle lines were evident at a recent summit sponsored by the Journal. On one side stand many clinical trialists, whose lifeblood — randomized, controlled trials (RCTs) — may be threatened by data sharing. On the other side stand data scientists — many of them hailing from the genetics community, whose sharing of data markedly accelerated progress in that field. (Lisa Rosenbaum, 4/26)

The New England Journal Of Medicine: Learning What We Didn’t Know — The SPRINT Data Analysis Challenge
On January 28, 2016, the International Committee of Medical Journal Editors (ICMJE) posted for public comment a proposed plan on sharing clinical trial data. The response was starkly divided: data analysts called for immediate and open access to all clinical trial data; clinical trialists were convinced that investigators should hold data closely. Trialists argued that they would have no incentive to conduct trials if they weren’t given the opportunity to publish all their findings, while data analysts countered that data obtained under federally funded programs belonged to the public and should be available for examination. Ideally, at the center of the debate are patients who participate in clinical trials, often at great risk to themselves, who expect researchers and analysts to use the data in a responsible way to advance medicine. Although much subjective input was obtained, few respondents offered concrete examples on which to base directive action. (Nancy S. Burns and Pamela W. Miller, 4/26)

Tampa Bay Times: Adverse Childhood Experiences Can Have Long-Term Health Consequences 
Lungs expand, and every muscle sits on the verge of action. This describes the stress response, a normal reaction to a normal emotion. But when a child experiences strong, frequent or prolonged adversity, without adequate adult support, it’s referred to as toxic stress, and there can be long-term health consequences. (Zach Spoehr-Labutta, 4/27)

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

State Highlights: Texas Lawmakers Take Aim At Insurers And Drug Coverage Practices; Fla. House Poised To Approve Trauma Center Deregulation Bill

Media outlets report on news from Texas, Florida, Minnesota, California, Georgia, Massachusetts and Maryland.

Houston Chronicle: Lawmakers Take Aim At Insurance Plan Changes To Patients’ Medications
Health insurers are under pressure from Texas legislators to halt a practice that allows them to change the terms of coverage for prescription drugs with a pair of bills in the House and Senate that would extend earlier protections. Patient advocacy groups and doctor and nurse associations long have been opposed to the practice known as “non-medical switching,” which allows insurers to drop medications from their plans, raise co-pays, or add other restrictions and requirements, typically for financial, as opposed to medical, reasons. (Canaves, 4/27)

Tampa Bay Times: Watered-Down Deregulation Of Trauma Care On Tap In Florida House 
The Florida House is expected to pass watered-down legislation meant to increase the number of trauma centers in the state on Friday. Trauma centers, which handle the worst, most time-sensitive injuries like gunshot wounds and violent car crashes, are limited under state law based on the need in each part of the state. State Rep. Jay Trumbull, R-Panama City, had proposed to get rid of limits statewide. (Auslen, 4/28)

Pioneer Press: Minnesota Measles Outbreak Grows To 29 Cases, Spreads To Stearns County
A measles outbreak that began last month in Hennepin County has grown to 29 confirmed cases and has spread to Stearns County, according to the Minnesota Department of Health. The outbreak’s victims have all been children age 5 and younger, and only one is known to have been vaccinated against measles, the MDH said. Twenty-five have been unvaccinated Somali-Minnesotan children, while the vaccination status and ethnicity of the others is not yet known. Twenty-eight of the cases are located in Hennepin County, while one is in Stearns County. (Woltman, 4/27)

The Star Tribune: 5 More Cases Of Measles Include First Outside Hennepin County 
State health officials reported five more cases of measles Thursday, including one in Stearns County that marked the first time the current outbreak has spread beyond Hennepin County. A total of 29 children have now been sickened since the end of March, making it the largest measles outbreak in Minnesota since 1990. (Howatt, 4/27)

Sacramento Bee: Doctor Shortage At CA State Prison Sacramento Hurts Care 
A summary of the unidentified inmate’s death is included in the latest report by a state inspector general calling attention to “inadequate” health services at a prison with a difficult population of 2,400 inmates that sits next door to Folsom State Prison. The new report, released in late March by the state Office of Inspector General, faulted a “critical shortage” of doctors at the prison and a “seemingly unprecedented ability to recruit and retain” primary care providers. (Ashton, 4/27)

Boston Globe: UMass Boston Nursing Program Faces Uncertain Future 
The nursing school at the University of Massachusetts Boston, one of the campus’s most successful programs, faces an uncertain future because of a logistical snafu caused by the myriad construction projects underway at the same time. The program is housed in a building set to be demolished in the next few years, but the Baker administration has nixed a plan to fund a replacement building, leaving the nursing program looking for a new home. (Krantz, 4/28)

California Healthline: California Proposes Stringent Cap On Toxic Chemical In Drinking Water
California regulators are proposing a strict limit on a toxic man-made chemical that has contaminated water supplies throughout the state, particularly in its vast agricultural heartland. California would be the second state, after Hawaii, to establish a threshold for the former pesticide ingredient and industrial solvent known as TCP (1,2,3-trichloropropane) in drinking water. The chemical compound, identified in California as a human carcinogen, is no longer in wide use but has leached over the years into many wells and reservoirs in California and other states. (O’Neill, 4/27)

Miami Herald: Partners Of Florida Medical Marijuana Grower Fight In Court Over Pending Sale 
A lucrative deal that would place a private Fort Lauderdale equity firm at the center of Florida’s fast-growing medical marijuana market is at risk of collapsing amid allegations of “ransom demands” and a corporate coup inside a state-licensed pot dispensary. According to the details of a lawsuit brought by politically connected Panhandle developer Jay Odom against his partners, the shareholders of the Chestnut Hill Tree Farm cannabis nursery in Alachua have splintered over the pending sale of the company’s assets to a new operator. (Smiley, 4/27)

The Baltimore Sun: Keswick Campus To Get Center For Healthy Living 
Keswick, which provides long-term care and other services to seniors, plans to open a Center for Health Living housed on its campus in Baltimore’s Roland Park-Hampden area.The center will connect older adults in the community to health and wellness services that can help them stay fit and in their own homes. Keswick residents and community members will have access to programs focused on socialization, education, arts, lifelong learning and exercise. There will also be information on chronic disease and care management. The center, spanning more than 10,000 square feet, is currently being designed and will be located inside Keswick’s Bauernschmidt Building. (Cohn, 4/27)

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

Longer Looks: Black Market Insulin; Opioid Deaths; And Birth Control Access

Each week, KHN’s Shefali Luthra finds interesting reads from around the Web.

The Atlantic: How To Make Primary Care Transgender-Friendly
The medical knowledge needed to provide transgender-affirming care is not particularly complex — “it’s about as difficult as managing menopause,” says Madeline Deutsch, the clinical leader of the University of California, San Francisco (UCSF) Center of Excellence for Transgender Health and and the author of the center’s transgender-care guidelines.Yet physicians often perceive transgender care as hopelessly enigmatic. (Keren Landman, 4/21)

Vox: The Opioid Epidemic May Be Even Deadlier Than We Think
he opioid epidemic has led to the deadliest drug crisis in US history — deadlier than the crack epidemic of the 1980s and 1990s. Drug overdoses now cause more deaths than gun violence and car crashes. They even caused more deaths in 2015 than HIV/AIDS did at the height of the epidemic in 1995.A new study, however, suggests that we may be in fact underestimating the death toll of the opioid epidemic and current drug crisis. And we don’t even know by how much. (German Lopez, 4/26)

FiveThirtyEight: Some States Are Making It Easier To Get Birth Control
Two months into the Trump presidency, the fate of the Affordable Care Act’s contraceptive mandate is still undecided. But although the Trump administration hasn’t yet changed or removed the controversial regulation that requires insurance companies to cover birth control without making patients share the cost, many states are introducing or revising legislation to shore up or expand access to birth control. And if the federal mandate changes, that could mean that access to contraception could vary more and more widely between states. (Amelia Thomson-Deveaux, 4/24)

Vox: America’s Health Care Cost Problem Might Shut Down Hollywood
If you miss out on the last few episodes of Saturday Night Live this summer, blame America’s decades-long struggle to bring its health care costs under control. The Writers Guild of America, the union that represents television and film writers, could go on strike as early as May 2 — and a big reason why is the cost of health care. (Dylan Scott, 4/24)

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

Negotiating Drug Prices: Should State Agencies Band Together?

Citing budget-busting drug costs, a California lawmaker wants state health programs to band together to negotiate better prices with drug companies.

Assemblymember David Chiu (D-San Francisco) has introduced a bill that would strengthen intra-agency collaboration on drug cost-saving strategies. Lawmakers will consider the bill at an Assembly Health Committee hearing on Tuesday.

“Californians and Americans are frustrated with the lack of progress around drug prices,” Chiu said, citing the uproar over EpiPen and hepatitis C medications.

He said state agencies should pool their efforts “so that we can leverage that consumer power and get the best deal for our money.”

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While the proposed California Drug Costs Reduction Act does not mandate that various California health programs such as Medi-Cal or Covered California purchase drugs together, it would require administrators of those programs and 17 other state agencies to convene twice a year to strategize about ways to keep costs down.

Through the California Pharmaceutical Collaborative (CPC), state officials would consider a uniform state drug formulary and look at paying for drugs based on the value they bring to the health system.

A pharmaceutical collaborative by that name already exists within the California Department of General Services and purchases drugs for state prisons, hospitals and universities. This bill would expand on those efforts.

Chiu says it’s unclear what the current program is doing, and if it has been successful in bringing down drug costs. The 2002 legislation that created the collaborative required only a few agencies to participate, and only one report back to the legislature in 2005.

A 2005 report from the California State Auditor suggested the Department of General Services could do more to bring down pharmaceutical costs for California.

A more recent analysis from the nonpartisan Legislative Analyst’s Office showed spending by the Department of General Services has increased at a relatively high rate — about 20 percent annually between 2012 and 2016, although that trend may have been skewed by the release of high-cost hepatitis C drugs during that time.

“I haven’t had transparency about the work that’s happened,” Chiu said. During a February 2017 California legislative hearing about drug prices, the lawmaker expressed frustration about not being able to get information about the workings of the CPC.

Chiu’s bill would require annual reports from the pharmaceutical collaborative, which the lawmaker says would ensure more accountability.

A spokesman with the Department of General Services, Brian Ferguson, wrote in a statement that it has been meeting “regularly” to create a “roadmap” to cut drug costs.

The proposal so far has no registered opposition. Priscilla VanderVeer, a spokeswoman with the drug company trade association Pharmaceutical Research and Manufacturers of America (PhRMA) had no comment on the proposal.

Other states such as Massachusetts have bulk purchasing programs for drugs, according to the National Academy for State Health Policy. And Oregon and Washington have joined together to create a bulk purchasing program. It is one of five multi-state pharmaceutical programs in the country, according to the National Conference of State Legislatures.

About a third of Californians have health care coverage through Medi-Cal alone. Together with Covered California, and the California Public Employees’ Retirement System (CalPERS), these agencies insure more than 16 million people.

Experts say the diverse ways state programs pay for drugs would make it hard to implement an across-the-board prescription drug purchasing system in California.

Ben Johnson, fiscal and policy analyst with the Legislative Analyst’s Office said that the Medi-Cal program has different rules for payment and coverage than the state’s prison system. Medi-Cal is also entitled to deep drug discounts that other state agencies don’t receive.

“A lot of work would have to be done to be able to actually harmonize and create a uniform system of drug procurement in the state,” Johnson said. His agency does not take positions on legislation.

Advocates for AIDS patients and retired people support the bill. The California Public Interest Research Group (CALPIRG), which sponsored the initial legislation to create the collaborative in 2002, supports the current proposal as well. In a letter to the bill’s author, the group said the measure would provide “additional tools and direction” and increase accountability on the state government’s actions to reduce drug prices.

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

Categories: California Healthline, Pharmaceuticals

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Widespread Hype Gives False Hope To Many Cancer Patients

After Michael Uvanni’s older brother, James, was diagnosed with a deadly form of skin cancer, it seemed as if everyone told the family what they wanted to hear: Have hope. You can beat this, and we are here to help.

The brothers met with doctors at a half-dozen of the country’s best hospitals, all with impressive credentials that inspired confidence.

Michael Uvanni was in awe when he visited the University of Texas MD Anderson Cancer Center in Houston, one of world’s most respected cancer hospitals. It was like seeing the Grand Canyon, said Uvanni, 66, of Rome, N.Y. “You never get used to the size and scope.”

Even the MD Anderson logo on buses and buildings — with “Cancer” crossed out in red, above the words “Making cancer history” — made the family’s battle seem winnable.

“I thought they were going to save him,” said Uvanni, an interior designer.

Patients and families are bombarded with the news that the country is winning the war against cancer. The news media hypes research results to attract readers. Drug companies promise “a chance to live longer” to boost sales. Hospitals woo paying customers with ads that appeal to patients’ fears and hopes.

“I’m starting to hear more and more that we are better than I think we really are,” said Dr. Otis Brawley, chief medical officer at the American Cancer Society. “We’re starting to believe our own bullshit.”

The consequences are real — and they can be deadly. Patients and their families have bought into treatments that either don’t work, cost a fortune or cause life-threatening side effects.

“We have a lot of patients who spend their families into bankruptcy getting a hyped therapy that [many] know is worthless,” Brawley said. Some choose a medicine that “has a lot of hype around it and unfortunately lose their chance for a cure.”

Although scientists have made important strides in recent years, and many early-stage cancers can now be cured, most of those with advanced cancer eventually die of their disease.

For Uvanni, hope gave way to crushing disappointment when his brother’s health declined and he died from metastatic melanoma in 2014.

“You get your hopes up, and then you are dropped off the edge of a cliff,” said Uvanni. “That’s the worst thing in the world.”

Caregivers like Uvanni can suffer prolonged grief and guilt if their loved ones are riddled with side effects and don’t survive as long as the family expected, noted Holly Prigerson, co-director of the Center for Research on End-of-Life Care at Weill Cornell Medical College.

For decades, researchers have rolled out new cancer therapies with great fanfare, announcing that science has at last found a key to ending one of the world’s great plagues, said Dr. Vinay Prasad, an assistant professor of medicine at Oregon Health & Science University. When such efforts fail to live up to expectations, the cancer world simply moves on to the next big idea.

Hyping early scientific results — based on lab tests or animal studies — can attract investors that allow researchers to continue their work. Positive results can lead biotech firms to be bought out by larger drug companies.

“It’s in the interest of almost every stakeholder in the health system to be optimistic about these therapies,” said Dr. Walid Gellad, co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

Uvanni says his brother may have gotten more time from the many drugs he tried during his illness but that his quality of life was mostly terrible. (Mike Roy for KHN)

Of course, there is plenty of money to be made.

The U.S. spent nearly $88 billion treating cancer in 2014, with patients paying nearly $4 billion out-of-pocket, according to the American Cancer Society Cancer Action Network. Spending on cancer, a disease that most afflicts the aging, is predicted to soar as people live longer.

“While many people are trying to make patients’ lives healthier and longer and better, there are others that are exploiting their vulnerability,” said Dr. Leonard Saltz, chief of the gastrointestinal oncology service at New York’s Memorial Sloan Kettering Cancer Center.

Others argue that the excitement about cancer research is justified. A spokeswoman for the Pharmaceutical Research and Manufacturers of America, an industry group, said cancer patients have good reason for optimism.

“We continue to see great strides in identifying the genetic mutations and related factors that can drive the seemingly random formation of abnormal cells in cancer,” spokeswoman Holly Campbell said in a statement. “In the last decade, we’ve seen a number of scientific advances transform the landscape of many cancers.”

Promises To Cure Abound

Even the country’s top scientists sometimes get carried away.

In 1998, Nobel laureate James Watson — who co-discovered the structure of DNA — told The New York Times that scientists would “cure cancer in two years” using drugs that block tumor blood supplies. At that time, the drugs had succeeded only in mice.

In 2003, the director of the National Cancer Institute, Dr. Andrew von Eschenbach, announced a goal of “eliminating suffering and death due to cancer by 2015” by better understanding tumor genetics.

Last year, when President Barack Obama announced the Cancer Moonshot, which aims to accelerate and better coordinate research, he said, “Let’s make America the country that cures cancer once and for all.”

In a recent interview, von Eschenbach acknowledged he didn’t communicate his goal well.

“We all fall into that trap,” said von Eschenbach, now a senior fellow at the Milken Institute, a health and public policy think tank. “We’re offering what we have, but making it appear that it’s more than what it is.”

It’s easy to see how patients’ hopes are raised, said Timothy Turnham, former executive director at the Melanoma Research Foundation, an advocacy group. Researchers are frequently overly enthusiastic about early discoveries that have little chance of leading to a new drug.

“There is a disconnect between what researchers think is statistically significant and what is really significant for patients,” Turnham said. “Patients hear ‘progress,’ and they think that means they’re going to be cured.”

A Marketing Blitz

Uvanni said his brother’s experience was nothing like the sunny images in TV commercials, in which smiling cancer patients hug their grandchildren, hike in the mountains and lead dance classes.

A TV commercial for the Bristol-Myers Squibb drug Opdivo projects the words “a chance to live longer” on the side of skyscrapers, as a captivated crowd looks on. In much smaller type, a footnote reveals that lung cancer patients taking Opdivo lived just 3.2 months longer than others.

(Screenshot of Opdivo TV Commercial)

(Screenshot of Opdivo TV Commercial)

A TV ad for Merck’s Keytruda features reassuring images of a smiling, healthy patient hugging her family — not fighting for breath or struggling to walk. Although the commercial notes that the people in the ad are portrayed by actors, the commercial claims the drug provides “a chance for a longer life. It’s Tru.”

“Your heart sinks when you see those ads,” Uvanni said. Seeing the family depicted in the ad, he said “makes you wonder if they’re going down the same path that we did.”

The Keytruda ad notes that 71 percent of patients given the drug were alive “at the time of patient follow-up,” compared with 58 percent of those who received chemotherapy. The ad doesn’t mention that the “time of follow-up” was 11 months.

(Screenshot of Keytruda TV Commercial)

“It’s not false; it’s just incomplete,” said pharmacist Harold DeMonaco, a visiting scientist at the Massachusetts Institute of Technology in Boston. “They don’t give patients or the patients’ family enough information to make a reasonable decision.”

In an interview, Merck senior vice president Jill DeSimone said that the company aims to be responsible with its advertising, noting that the Keytruda ad reminds patients to talk to their doctors. “The physician is the ultimate decider on treatment,” DeSimone said.

In a statement, Bristol-Myers’ senior vice president Teresa Bitetti said that Opdivo ads play “an important role in educating patients about new treatment options and fostering informed conversations between patients and their doctors.”

Hospitals also have drawn criticism for overstating their success in treating cancer. In 1996, Cancer Treatment Centers of America, a for-profit chain, settled allegations from the Federal Trade Commission that “they made false and unsubstantiated claims in advertising and promoting their cancer treatments.”

The company’s current commercials — dozens of which are featured on their website — boast of offering “genomic testing” and “precision cancer treatment.”

The commercials don’t tell patients that these tests — which aim to pair cancer patients with drugs that target the specific mutations in their tumors — are rarely successful, Prasad said. In clinical trials, these tests have matched only 6.4 percent of patients with a drug, according to Prasad’s 2016 article in Nature. Because these drugs only manage to shrink a fraction of tumors, Prasad estimates that just 1.5 percent of patients actually benefit from precision oncology.

In a statement, Cancer Treatment Centers of America said, “We use national media to help educate cancer patients and their families about the latest diagnostic tools and treatment options. … All of our advertising undergoes meticulous review for clinical accuracy as well as legal approval to ensure we tell our story in an informative and responsible manner, and in compliance with federal guidelines.”

Spending on ads for hospitals that treat cancer soared 220 percent from $54 million in 2005 to $173 million in 2014, according to a 2016 article in JAMA Internal Medicine. Ads for Cancer Treatment Centers of America accounted for nearly 60 percent of all total cancer center advertising.

Targeting Melanoma

For more than a decade, the Food and Drug Administration approved no new treatments for metastatic melanoma. Patients typically died within a year of diagnosis.

Since 2011, however, the FDA has approved 11 new treatments, including several immunotherapies, which aim to harness the immune system to fight cancer. Last year, doctors leading a clinical trial announced that the median survival of patients taking the drug Keytruda had grown to two years. Forty percent of patients were alive three years later, according to the clinical trial, presented at the American Society of Clinical Oncology.

Researchers have tested immunotherapies against a variety of tumors, leading to approvals in lung cancer, kidney cancer, bladder cancer and others.

Such success has led doctors to label cancer immunotherapy as a “game changer.” N­­ewspapers and magazines call it a “breakthrough.” And hospitals laud them as “a miracle in the making.”

Yet these treatments — which were initially assumed to be gentler than chemotherapy — can provoke fatal immune system attacks on the lungs, kidneys, heart and other organs.

And there are no approved immunotherapies for tumors of the breast, colon, prostate and pancreas.

Only about 10 percent of all cancer patients can expect to benefit from immunotherapy, Prasad said.

Uvanni’s brother — who tried immunotherapy, as well as a number of other approved and experimental treatments — survived 3½ years after his diagnosis. That might lead many oncologists to describe his story as a success.

Uvanni sees no reason to celebrate. He wanted more than short-term survival for his brother.

“I thought we were going to have a treatment where we’d at least have a good block of quality time,” Uvanni said.

But treatments meant to control the cancer only made him sick. Some caused flu-like symptoms, with fever, chills and shakes. Others left him nauseated, unable to eat or move his bowels. Others caused dangerous infections that sent him to the emergency room.

“I hope that if something like that happens to me,” Uvanni said, “I would be strong enough to say no to treatment.”

Categories: Cost and Quality, Health Industry, Mental Health, Pharmaceuticals

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Perspectives: Importing Drugs Isn’t The ‘Nuclear Option’ The Industry Paints It To Be

Read recent commentaries about drug-cost issues.

The New York Times: How To Stop Drug Price Gouging
If Mr. Trump wishes to show he’s serious about his populist promise, the place to start is by declaring war on the price gougers. The key power is found in the “import relief” law — an important yet unused provision of the Medicare Modernization Act of 2003 that empowers the Food and Drug Administration to allow drug imports whenever they are deemed safe and capable of saving Americans money. The savings in the price-gouging cases would be significant. Daraprim, the antiparasitic drug whose price was raised by Mr. Shkreli to nearly $750 per pill, sells for a little more than $2 overseas. The cancer drug Cosmegen is priced at $1,400 or more per injection here, as opposed to about $20 to $30 overseas. The remedy is simple: The government can create a means for pharmacies to get supplies from trusted nations overseas at much lower prices. Doing this would not only save Americans a lot of money but also deflate the incentive to engage in abusive pricing in the first place. (Tim Wu, 4/20)

RealClear Health: Does Crime Pay When It Comes To Fake Drugs?
The purpose of penalties such as fines and jail time is to address and correct perpetrators’ bad behaviors, whilst signaling to others that illicit behavior will not be tolerated – “crime will not pay.” However, when it comes to the business of counterfeit prescription medications, law enforcement falls far short as an effective deterrent. (Steve Pociask, 4/26)

Bloomberg: Express Scripts’ Anthem Loss Goes Deeper Than Numbers
In losing Anthem Inc. as a client, Express Scripts Holding Co. is surrendering more than just its biggest customer and 18 percent of its revenue. Its very identity is now at risk. The PBM on Monday night said it expected to lose Anthem’s business at the end of 2019 after a long, bitter pricing dispute. Through Monday’s trading, Express Scripts shares had fallen more than 20 percent since the Anthem squabble began in December 2015 — so this news was somewhat priced into the stock.  (Max Nisen, 4/25)

CNN: How To Cut The Price Of Prescription Drugs
Reducing the cost of medical care, rather than health insurance, is so often underemphasized or even absent from discussions of reforming the health care system. And yet lowering costs of medical care is essential for broadening access to care, reducing insurance premiums and ultimately ensuring better health. (Atlas, 4/20)

Bloomberg: Generic Drug Woes Aren’t Going Away 
Cardinal Health Inc. on Tuesday announced a $6.1 billion deal for a Medtronic PLC medical supplies unit. But this deal was overshadowed by the gruesome earnings forecast Cardinal released at the same time. The company warned 2017 earnings will be at the low end of its already lowered guidance and said 2018 would miss Wall Street expectations. Cardinal shares fell 12 percent on Tuesday.That’s bad news for the drug distributor and its peers McKesson Corp. and AmerisourceBergen Corp. as they enter earnings season. It also confirms a multi-year price crunch in generic and specialty drugs may not be going anywhere soon — just as the market for such assets appears to be getting hot. Buyer beware.  (Max Nisen, 4/19)

East Bay Times: Pass Bill To Sunshine Prescription Drugs Prices
Pharmaceutical companies need an intervention to address their addiction to prescription drug price gouging. Californians should demand that Big Pharma be more transparent about drug-pricing habits and put an end to pharmaceutical industry practices that state Sen. Ed Hernandez says “literally rape the American people at the expense of the taxpayer.” (4/24)

The Oregonian: Oregon Must Address Drug Costs And Transparency
The rising cost of prescription drugs in Oregon should worry us all. I often hear from neighbors and constituents about the real challenges of out-of-pocket costs for prescription medicines. Given that the clock usually resets for a patient’s insurance deductible responsibility in January, this time of year can be especially difficult for Oregon families who depend on expensive prescription drug treatments. (Bill Kennemer, 4/21)

Bloomberg: An Alcon Sale Will Take A Bargain Price
Novartis AG’s consideration of a spinoff or sale of its Alcon eye-care business just got serious; Bloomberg News reported Thursday the company has hired Bank of America to review its options. It’s eminently reasonable for the company to consider it, as my colleague Chris Hughes and I wrote when the company aired the notion in January. The declining business has become more trouble than it’s worth. And Novartis could use the money to supplement its growing generics business, or to bolster its all-important pharma division as its best-selling medicine Gleevec faces generic competition. (Max Nisen, 4/20)

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

This Lawyer Is Tired Of Pharma Getting Richer And Americans Paying The Price — So He’s Suing

News outlets report on stories related to pharmaceutical pricing.

Stat: Meet The Lawyer Trying To Pry Drug Pricing Secrets Out Of Big Pharma
Class action attorney Steve Berman is coming after a drug industry he says is “gouging” the American consumer. And his suits have the potential to crack the lid on the black box of drug pricing, shedding light on a secretive process that has sparked an escalating blame game between drug makers and the many middlemen in the US health care system. Berman sees the drug pricing system as a Rube Goldberg machine for extracting money from patients: Pharma sets a high price for a given medication, and then promises a big, undisclosed rebate to the pharmacy benefits managers who control which drugs get covered by insurers. (Garde, 4/20)

The Wall Street Journal: Corporate Feud Exposes Big Profits On Drug Sales
The rising pressure on drug pricing has shifted to the companies that were supposed to guard against rampant increases.A dispute between two of the most important companies in the health-care industry, Express Scripts Holding Co., the largest pharmacy benefit manager, and health insurance giant Anthem Inc., has shown in stark terms how profitable some relationships have become. That will give more ammunition to critics of the system. (Grant, 4/25)

CNBC: In The Debate Over Rising Drug Prices, Both Drugmakers And PBMs Claim Innocence
The battle over rising drug prices has become a full-blown he-said-she-said. Drug companies have pointed the finger at middlemen in the health-care system, saying they not only benefit from rising drug prices but contribute to their increases. Those middlemen — namely, pharmacy benefits managers (or PBMs) — have said the only parties responsible for drugs’ list prices are the manufacturers. So who’s right? (Tirrell, 4/19)

Stat: Supreme Court To Review Biosimilar Battle Between Amgen And Sandoz
A hotly anticipated hearing takes place at the US Supreme Court on Wednesday about biosimilars and the eventual decision is expected to have widespread implications for health care costs. At issue are some of the complex procedures found in the Biologics Price Competition and Innovation Act that are supposed to determine when lower-cost biosimilar medicines, which are highly identical versions of expensive biologics, can be launched. And one brand-name drug maker, Amgen, is squabbling with Sandoz, a generic company, over competing interpretations of two provisions. (Silverman, 4/25)

Bloomberg: Biotech M&A Falls Off As Trump Dashes Hopes Of A New Pharma Boom
Pharmaceutical and biotech acquisitions totaled $44 billion last quarter, down 13 percent from a year earlier, and 35 percent below the first quarter of 2015, according to data compiled by Bloomberg. And exchange-traded funds, a good indicator of investors’ appetite in a sector because they typically track an index, are seeing about half as much trading volume in health care as three years ago, data show.Part of the reason is that President Donald Trump dashed hopes for a new biotech boom. Once thought friendlier to the industry than his Democratic campaign opponent, he’s since attacked drugmakers and vowed to force down their prices. (Hopkins, 4/21)

FierceHealthcare: Drug Prices Still A Major Concern For Healthcare Leaders
Rising drug prices remain a top concern for health system leaders, according to a new survey.Premier, Inc.’s spring Economic Outlook Survey polled 91 people representing a variety of roles in U.S. health systems, including physicians, C-suite members and supply chain management professionals.Almost every respondent agreed that increasing pharmaceutical prices pose a significant challenge to their operations. In addition, more than 90% said they would likely experience continued drug shortages over the next three years. (Minemayer, 4/25)

Stat: Gene Therapy 1.0 Is A Flop, But Biotech Isn’t Worried
The Western world’s first gene therapy is soon to become but a footnote in biotech history, doomed by minuscule demand and a colossal price. But its failure has hardly dampened the enthusiasm of the scientists and biotech companies betting that gene therapy’s best days are ahead. The therapy, made by the Dutch biotech UniQure, treats a one-in-a-million rare disease called familial lipoprotein lipase deficiency and has been used exactly once since winning European approval in 2012, the company said. That’s in part because it costs about $1 million for a one-time dose, a price that made it nearly impossible to get insurance coverage, as MIT Technology Review reported last year. (Garde, 4/21)

Bloomberg: Top White House Officials To Meet With Biotech Executives And Researchers 
Almost a dozen top administration officials, including the vice president and two Trump family members, are scheduled to meet next month with drug companies and government scientific researchers at the White House, according to an agenda obtained by Bloomberg. Vice President Mike Pence, President Donald Trump’s daughter Ivanka Trump and his son-in-law Jared Kushner will attend the May 8 summit, along with the head of the U.S. National Institutes of Health, executives from Celgene Corp. and Regeneron Pharmaceuticals Inc., and leaders of top research universities and hospitals. (Hopkins, 4/21)

Stat: Roche Faces Investigation Into Charges It Wrongly Thwarted Rivals
The Competition Commission of India has ordered an investigation into charges that Roche tried to block a more affordable biosimilar version of its Herceptin breast cancer drug. Although the agency did not issue a final opinion, its order suggested that Roche moved to eliminate competition after reviewing communications the drug maker sent to the Drugs Controller General of India and the National Pharmaceutical Pricing Authority, as well as doctors and hospitals. (Silverman, 4/25)

Kaiser Health News: A Spoonful Of Kids’ Medicine Makes The Profits Go Up
When prescribing medications, caring for children poses a particular challenge. They’re not just little adults. Their still-developing brains and bodies metabolize drugs differently, and what works for grown-ups can yield radically different — and sometimes dangerous — results in kids. (Luthra, 4/24)

Stat: Bristol-Myers Shuffles Management And Its Chief Strategy Officer Is Leaving
Following setbacks with an important cancer drug, Bristol-Myers Squibb reorganized some key managerial slots last week and, as part of the shuffling, chief strategy officer Emmanuel Blin will leave in June, according to a memo written by chief executive officer Giovanni Caforio. The drug maker is integrating all commercial functions into one organization and Murdo Gordon, who is the chief commercial officer, will expand his responsibilities to include both worldwide oncology commercial activities and specialty drugs. (Silverman, 4/24)

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Widespread And Growing Trend Of Physician Burnout Putting Patients’ Safety At Risk

The consequences of the burnout can range from medical errors and high mortality rates of hospitalized patients to lower medical knowledge and impaired professionalism. In other public health news: cholesterol-lowering drugs, knee replacements, an ad campaign for condoms, the bird flu and more.

Atlanta Journal-Constitution: Patients At Risk As “Burnout” Among Physicians Increases 
Doctors across the country are facing high rates of stress and burnout — a dangerous trend for doctors and patients that is now a hot topic in the medical profession… “Four hundred U.S. physicians take their own lives every year,” Dr. Humayun Chaudhry, president and CEO of the Federation of State Medical Boards, told an audience Thursday at the federation’s annual meeting. (Teegardin, 4/22)

The Washington Post: Many People Stop Taking Life-Saving Drugs After Heart Attacks
Within two years of having a heart attack, nearly 1 in 5 people stop taking lifesaving cholesterol-lowering drugs known as statins, according to a new study. And nearly 2 in 5 end up taking the drugs in lower doses or less often than they should, researchers report in JAMA Cardiology. “From a societal perspective, we need to make sure the highest-risk individuals are being treated with guideline-directed therapy,” said senior author Robert Rosenson, a professor of cardiology at the Icahn School of Medicine at Mount Sinai in New York. (Seaman, 4/23)

Stat: As Orthopedic Procedures Rise, Surgeons Debate ‘Necessity’
Dr. Bart Ferket’s study of knee replacements begins with a few eye-popping facts. Since 2000, the annual rate of that surgery has more than doubled in the United States. More than 640,000 are now performed each year, at a cost of more than $10 billion. But in some cases, Ferket found, the patients receiving them had relatively mild symptoms, and derived limited physical benefits. Published in BMJ, his study concluded that surgeries on such patients were “economically unjustifiable.” (Ross, 4/24)

The New York Times: XOXO Campaign: Will It Spell Profit Or Trouble For Condom Maker?
It seemed like a sensible advertising strategy. When a company discovered that women accounted for less than one-third of the purchases of its products, it shifted direction to appeal more directly to them. But when the company is the largest condom seller in America, at a time of heightened divisiveness regarding reproductive rights and women’s health, the situation can get a little more complicated. (Schonburn, 4/23)

KCUR: As Bird Flu Strengthens In China, Midwest Farmers Prepare For The Next Outbreak 
Midwest farmers are warily watching as one strain of a highly contagious bird flu virus infects and kills humans in China and another less-worrying but still highly contagious strain infects a Tennessee poultry farm. Two years after a devastating bird flu outbreak in the Midwest, many farmers here say they now have a better idea of how to keep bird flu at bay. In January 2015, avian influenza, or bird flu, appeared in backyard flocks in Washington state. Within six months, the virus reached 15 states, including Iowa, Nebraska, Minnesota, and Missouri. About 50 million birds died. (Gerlock, 4/24)

The Associated Press: Doctor’s Arrest Brings Attention To US Female Circumcisions
Zehra Patwa learned only a few years ago that during a family trip to India at age 7, she was circumcised, which is common for girls in parts of Asia, Africa and the Middle East. Patwa, 46, doesn’t remember undergoing the procedure, which is also called female genital mutilation or cutting and which has been condemned by the United Nations and outlawed in the U.S. But she doesn’t want to. (4/23)

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A Spoonful Of Kids’ Medicine Makes The Profits Go Up

When prescribing medications, caring for children poses a particular challenge. They’re not just little adults. Their still-developing brains and bodies metabolize drugs differently, and what works for grown-ups can yield radically different — and sometimes dangerous — results in kids.

And now, even as high drug prices make headlines, the challenge of getting sick children the kind of medication they can take and tolerate — often by creating liquid formulations of drugs that are already on the market — is seen by some companies as a lucrative opportunity.

It is part of a pattern in which patent laws and government incentives — meant to encourage development of less-profitable drugs — enable some companies to get a leg up in the market and set high prices. The Best Pharmaceuticals for Children Act, for instance, allows for delaying the approval of competing generics if companies test their drugs in children. And the Pediatric Research Equity Act requires more companies to have pediatric-focused drugs clinically assessed in kids. These laws have spurred companies to do more in terms of testing and developing pediatric medicines. The companies can market the drugs without facing competition for a longer period of time. And as a result, the treatments cost exponentially more.

Critics say the higher price tags are out of line with the cost of developing kid-friendly remedies.

“The only R&D, if you will, that went into making these liquid is finding a solution to dissolve them in, and making sure it was stable and well-absorbed,” said Thomas Welch, who leads the pediatrics department at Upstate Medical University in Syracuse, N.Y. He co-authored a letter in the New England Journal of Medicine assessing the price increase for two of these drugs, which treat hypertension and heart conditions in children.

For Carissa Baker-Smith, a pediatric cardiologist at the University of Maryland, those drugs — Qbrelis, approved last July, and Epaned, approved in 2013 — could have been a godsend. They presented an alternative to their long-available generic adult versions, which, because of their strength, meant she usually referred her young patients to compounding pharmacies for liquid formulations, a step, she said, that requires “a bit of blind trust.”

At these pharmacies, licensed specialists use approved medications to create formulations for people whose needs are not met commercially.

On the plus side, these two drugs not only meet medical needs of Baker-Smith’s patients, but they went through the Food and Drug Administration’s rigorous approval process and are produced under the agency’s manufacturing-practice regulations, which do not apply to compounding pharmacies.

But their cost yields a different kind of angst.

Liquids pose “a financial burden to families,” Baker-Smith said. She added that parents frequently ask when their child is finally ready for the less pricey tablet.

“My patients need heart transplants, or have other issues,” she said. “That’s a huge cost.”

Seizing An Opportunity

How so? Qbrelis costs 775 times as much as the generic tablet, while Epaned is 21 times costlier than the off-brand, according to Welch’s letter.

Here’s another real-world comparison. If a compound pharmacy filled a prescription for a liquid formulation using the generic liquid Lisinopril — the active ingredient in Qbrelis — it would cost up to $20 a month. The patented liquid, though, could yield a monthly bill of $500 to $1,000, depending on how large a dose the child needs, estimated Erin Fox, an adjunct associate professor of pharmacotherapy at the University of Utah. For Epaned, a monthly regimen could cost $500 to $2,000; a compound pharmacy’s formulation of a comparable generic liquid would cost $20 to $80, she said.

The two drugs are both manufactured by Colorado-based Silvergate Pharmaceuticals. By creating liquid solutions of these drugs that can be dispensed in smaller doses, Silvergate was able to obtain patents for each. It controls the market on them until at least 2030, according to the FDA’s Orange Book, a comprehensive roster of drug approvals.

The company filed legal complaints when a rival — Bionpharma — sought to introduce a generic competitor to Epaned, saying it would infringe upon its patent. Representatives from Silvergate did not respond to multiple requests for comment.

In other circumstances, drugmakers could pursue even more market protections from the FDA. For instance, if the process of reformulating the drug involved clinical trials with children, manufacturers can win an additional six months of market exclusivity.

Additionally, two FDA guides are in the works recommending that doctors default to agency-approved drugs over similar compounded medicines, unless there is a particular chemical difference that makes the compound more effective. Cost isn’t a factor.

Together, experts say, those regulations can make it easier for companies looking to profit from limited investment or innovation.

“There’s . . . an increasing list of companies where it was only about gaming the rules, and not about anything that can be recognized as real pharmaceutical research,” said Jerry Avorn, a professor of medicine at Harvard Medical School who studies prescription drug policy. Silvergate, he added, appears to fit that mold.

A Safer Drug, But At A Price

Getting a compound drug can be logistically difficult for patients — not all pharmacies are certified to make them — and it assumes some trust, because the pharmacists involved aren’t held to the same manufacturing standards as for commercially available drugs. A 2012 fungal meningitis outbreak linked to the New England Compounding Center left 64 patients dead and raised consumer and regulatory concerns. Ultimately, the outbreak triggered heightened federal oversight of compounding.

Fox suggested that the value added by the new drugs — while meaningful — is counteracted when the price climbs.

“It’s better for patients if we’re using FDA-approved drugs,” Fox said. “But if no one can afford them, or if they raise prices so much other things are being impacted, then all the FDA approval in the world won’t improve access.”

These liquids do serve an important purpose, though — they’re lower-risk than compounds, and reformulating these drugs certainly requires work. But critics say the creativity involved in developing the drugs doesn’t justify its expense. And the generic enzyme inhibitors they use cost pennies.
At stake for Baker-Smith’s patients is getting needed medical care, or going without.

“There are plenty of kids who can’t take a pill. For them,” she said, getting liquid drugs “is lifesaving.”

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

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Drugmakers Dramatically Boosted Lobbying Spending In Trump’s First Quarter

Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.

Congressional records show those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115 percent from a year ago as several companies embroiled in controversies raised their outlays significantly.

“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”

Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sens. Bernie Sanders (I-Vt.) and John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.

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Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” LaPira said.

Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.

PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter —more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.

In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.

When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.

“It’s quite literally hitting their bottom line,” LaPira said.

Drugmakers under fire more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.

Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.

Teva and Shire also more than doubled their spending. Teva was accused as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.

Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.

Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultra-conservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.

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

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Marathon Pharmaceutical Drops Out Of PhRMA Following Drug Price Controversy

With the sale of its controversial rare-disease drug finalized, Marathon Pharmaceuticals has taken the unusual step of resigning from the powerful industry lobbying group PhRMA.

Marathon had been a member of the Pharmaceutical Research and Manufacturers of America, and Marathon’s CEO, Jeffrey Aronin, had held a position on the board.

The news of Marathon’s resignation comes after the company was widely criticized this year for the $89,000 price tag for Emflaza, a drug for Duchenne muscular dystrophy. Last month, it sold the drug to PTC Therapeutics.

The resignation also falls as PhRMA works on a review of its membership criteria.

“My view is that we want to represent companies that are really swinging for the fences … [companies] that are taking enormous risks in bringing breakthrough treatments to market,” PhRMA President Stephen Ubl said in a recent interview with Kaiser Health News. “So we’ll be looking at our membership criteria to really focus on those attributes.”

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An announcement about PhRMA’s membership criteria is expected in the coming weeks.

Mallinckrodt Pharmaceuticals is also no longer a member of PhRMA. A company spokesperson confirmed Mallinckrodt’s resignation in an email, saying “the significant financial and time commitment required” for PhRMA membership outweighed the policy value.

Mallinckrodt, like Marathon, has been in the spotlight for a high-priced drug. The company had bought the decades-old drug H.P. Acthar Gel, which is used to treat a variety of conditions, including lupus and multiple sclerosis. The drug cost $1,235 in 2005, but in 2015, it was priced at about $35,000.

PhRMA said it had no comment about the two drugmakers leaving the association. Neither company is listed as a member on the association’s website.

Marathon declined to comment for this story. The company has no drugs on the market.

According to a company memo obtained by Kaiser Health News, Marathon has discontinued membership in “all relevant associations” after the sale of Emflaza.

Emflaza was approved as an orphan drug by the Food and Drug Administration in February. But the drug has been available outside the U.S. for decades under the generic name deflazacort.

It is a steroid used to lessen the symptoms of Duchenne, a fatal muscle-wasting disease that affects mostly boys. For years, many American patients have imported the generic version at a cost averaging from $1,000 to $1,600 annually.

Facing public outcry over the price of Emflaza, Marathon first said it would “pause” the launch of the drug. In March, it announced that PTC Therapeutics would buy rights to the drug for $140 million in cash and stock. The drug’s new price has not been announced.

Ken Kaitin, a professor at Tufts University School of Medicine said the pharmaceutical industry has justified high prices by saying it needs to pay for research and development.

But when members like Marathon and Mallinckrodt take older drugs and charge high prices, “the rest of the pharma industry has trouble explaining that to the public.”

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

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Drug Companies Turned ‘Blind Eye’ To Opioids Flooding Community, Cherokee Nation’s Suit Claims

“Today, we are facing another challenge, a plague that has been set upon the Cherokee people by these corporations,” said Todd Hembree, attorney general for the Cherokees. “Their main goal is profit, and this scourge has cost lives and the Cherokee Nation millions.”

The Washington Post: Cherokee Nation Sues Drug Firms, Retailers For Flooding Communities With Opioids
Lawyers for the Cherokee Nation opened a new line of attack against the pharmaceutical industry Thursday, filing a lawsuit in tribal court that accuses the nation’s six top drug distributors and pharmacies of flooding communities in Oklahoma with hundreds of millions of highly addictive pain pills. The suit alleges that the companies violated sovereign Cherokee laws by failing to prevent the diversion of pain pills to the black market, profiting from the growing opioid epidemic and decimating communities across the nation’s 14 counties in the state. (Higham and Bernstein, 4/20)

Stat: Cherokee Nation Sues Pharmacies Over Tribal Opioid Crisis
“These drug wholesalers and retailers have profited greatly by allowing the Cherokee Nation to become flooded with prescription opioids,” the lawsuit alleges. “They have habitually turned a blind eye to known or knowable problems in their own supply chains.” (Thielking, 4/20)

The Hill: Cherokee Nation Sues Drug Firms Over Opioid Epidemic: Report
The suit lists AmerisourceBergen, Cardinal Health and McKesson Corp., which are reportedly three of the nation’s largest drug distributors, controlling almost 85 percent of the country’s prescription pill distribution. The suit also names major corporations who sell drugs including CVS, Walgreens and Wal-Mart. (Beavers, 4/20)

In other news on the opioid crisis —

The Washington Post: The DEA Warned NFL Doctors About Drug Laws In 2011. It Didn’t Go Well.
On a cold day in February 2011, doctors and athletic trainers from the NFL’s 32 teams gathered at a hotel ballroom in downtown Indianapolis. Under scrutiny for its handling of prescription drugs, the league had invited the Drug Enforcement Administration , and an official named Joseph T. Rannazzisi made the trip from Washington armed with more than 80 slides of charts, photographs and bullet points about federal laws that govern how the doctors can medicate professional football players suffering from pain and injuries. (Maese, 4/20)

Kaiser Health News: What Doesn’t Kill You Can Maim: Unexpected Injuries From Opioids
The trouble started for Lisa when she took a blood pressure pill and one to control seizures, along with methadone, a drug used to help wean patients off heroin. “I inadvertently did the methadone cocktail and I went to sleep for like 48 hours,” Lisa said, rolling her eyes and coughing out a laugh. “It kicked my butt. It really kicked my butt.” (Bebinger, 4/21)

Courier-Journal: Drug Increases In Austin As Families Struggle To Survive 
The Courier-Journal spent six months examining how [Johnathon] Cooke, the rest of the community and the larger world has responded to this singular outbreak, interviewing dozens of health workers and experts, patients, community members, state officials and others; examining state, federal and community records; and witnessing the start of the city’s recovery. What happened here provides lessons for the entire country about preventing a deadly epidemic and stopping its spread. (Ungar, 4/21)

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Longer Looks: Overcoming Opioids; Single Payer; And American Anxiety

Each week, KHN’s Shefali Luthra finds interesting reads from around the Web.

The Associated Press: Overcoming Opioids: The Quest For Less Addictive Drugs
This growing dependence on opioids has mushroomed into a national health crisis, ripping apart communities and straining police and health departments. Every day, an overdose of prescription opioids or heroin kills 91 people, and legions more are brought back from the brink of death. With some 2 million Americans hooked on these pills, evidence is growing that they’re not as good a choice for treating chronic pain as once thought. (Marilynn Marchione, 4/17)

The Atlantic: Why America Has Fewer Types Of IUDs Than Other Countries
My uterus needs more options. In 2013, a gynecologist told me that it was too short to fit any FDA-approved IUD. So I traipsed from Colorado to Canada to get a smaller IUD called the GyneFix. This IUD isn’t shaped like a “T”—as all American IUDs are—but, rather, a rod. (Caroline Beaton, 4/18)

The New York Times: America’s New ‘Anxiety’ Disorder
In 1947, W.H. Auden published a very long poem that, despite winning a Pulitzer Prize, is now remembered less for its contents than for its title: “The Age of Anxiety.” Something about the idea that an age can be anxious must resonate deep in America’s cultural bones, because the phrase has been used to describe countless moments since, from the vogue for tranquilizers like Miltown and Valium in the ’50s and ’60s to the coronation of today’s young adults as, in The New York Post’s recent estimation, “The Anxious Generation.” At this point, it’s difficult to imagine a slice of time whose resident humans would not agree with the notion that their lives were more hectically modern — more anxiety-inducing, more in need of the occasional benzo — than any before. (Nitsuh Abebe, 4/18)

The Atlantic: Did Obamacare Increase Voter Turnout? 
The ACA expansion established Medicaid as the bedrock of public insurance and public assistance in America. Now, there’s evidence that it not only expanded health insurance coverage, but the electorate itself. (Vann Newkirk, 4/18)

The New York Times: Why The Menace Of Mosquitoes Will Only Get Worse
The outbreak began so slowly that no one in Dallas perceived it at first. In June 2012, a trickle of people began showing up in emergency rooms broiling with fever, complaining that their necks were stiff and that bright lights hurt their eyes. The numbers were initially small; but by the middle of July, there were more than 50 victims each week, slumping in doctors’ offices or carried into hospitals comatose or paralyzed from inflammation in their brains. In early August, after nine people died, Dallas County declared a state of emergency: It was caught in an epidemic of what turned out to be West Nile virus, the worst ever experienced by a city in the United States. By the end of the year, 1,162 people had tested positive for the mosquito-borne virus; 216 had become sick enough to be hospitalized; and 19 were dead. (Maryn McKenna, 4/20)

New York Magazine: The Pharmacist Who Tries Not To Judge You
We don’t get any training in how to spot a drug user; it’s just through experience. A definite red flag is when they bring in a prescription for a narcotic — say, Percocet — and tell me, “I want to pay full price in cash.” (Alexa Tsoulis-Reay, 4/14)

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‘I Need Medicine For This Pain’: The Landmines Of Treating Someone Addicted To Opioids

There’s no definitive guidance for doctors on what to do when their patient is someone who is in recovery from an opioid addiction, but also in need of pain relief. In other public health news: antidepressants, mysterious diseases, antibiotic-resistant infections, stress in kids and sexual enhancement pills.

NPR: Opioid Addiction Complicates Pain Relief After Surgery
Nearly one and a half million Americans were treated for addiction to prescription opioids or heroin in 2015, according to federal estimates, and when those people get seriously hurt or need surgery, it’s often not clear, even to many doctors, how to safely manage their pain. For some former addicts, what begins as pain relief ends in tragedy. (Lemoult, 4/20)

The Washington Post: Antidepressants Not As Harmful During Pregnancy As Previously Thought, A New Study Shows
Women who take antidepressants early in pregnancy are not at a higher risk of having children who develop autism or attention deficit hyperactivity disorder (ADHD), contrary to earlier reports, a study published Tuesday found. The new study, published in the Journal of the American Medical Association, found only a slight increase in the risk of premature birth for infants of mothers who used antidepressants during the first trimester of their pregnancy. But the researchers found no increase in the risk of autism, ADHD or reduced fetal growth among children exposed to antidepressants during fetal development. (Naqvi, 4/19)

Kaiser Health News: Stalking The ‘Unknown Enemy’: Doctors Turn Scope On Rare Diseases
Lynn Whittaker stood in the hallway of her home looking at the framed photos on the wall. In one, her son, Andrew, is playing high school water polo. In another, he’s holding a trombone. The images show no hint of his life today: the seizures that leave him temporarily paralyzed, the weakness that makes him fall over, his labored speech, his scrambled thoughts. Andrew, 28, can no longer feed himself or walk on his own. The past nine years have been a blur of doctor appointments, hospital visits and medical tests that have failed to produce answers. (Gorman, 4/20)

St. Louis Public Radio: What You Should Know About The Rising Problem Of Antibiotic Resistance
Antibiotic-resistant infection is a rising issue in American society and thousands of people die each year when they develop infections that no antibiotic can control… A person is most vulnerable to antibiotic-resistant infection in the hospital, because that is a place that is more likely to harbor bacteria that has become resistant … and people in the hospital are more vulnerable and unable to fight the infection off. (Moffitt, 4/19)

Miami Herald: These Sexual Enhancement Pills Recalled Due To Problem Ingredients
From A to Zrect, Organic Herbal Supply has recalled its sexual assistance pills for men and women. The men’s pills — Uproar, Monkey Business, Zrect, Rectalis, Cummor, Tornado, ZDaily, Enhancerol, BigNHard — all contain tadalafil, the active ingredient in Cialis. While tadalafil is FDA-approved for dealing with male erectile dysfunction, the recall notice says, “the presence of tadalafil in these male enhancement products renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.” (Neal, 4/19)

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With Drug Costs In Crosshairs, Health Firms Gave Generously To Trump’s Inauguration

Facing acute risks to their businesses from Washington policymakers, health companies spent more than $2 million to buy access to the incoming Trump administration via candlelight dinners, black-tie balls and other inauguration events, new filings show.

Drugmaker Pfizer gave $1 million to help finance the inauguration, according to documents filed with the Federal Election Commission. Amgen, another pharmaceutical company, donated $500,000. Health insurers Anthem, Centene and Aetna all gave six-figure contributions.

They joined a surge of corporate donors from multiple industries to break inauguration-finance records even as then-President-elect Donald Trump promised to “drain the swamp” of Washington influence-peddling.

But the stakes for the health industry were especially high as the new administration prepared to take power.

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Two weeks before Pfizer’s donation, Trump told Time magazine: “I’m going to bring down drug prices.” At the same time, one of his top goals was repealing Obamacare — the Affordable Care Act — and its billions in subsidies for insurance companies and hospitals.

Also writing checks for the inauguration were drugmaker Abbott Laboratories, drug wholesaler Caremark, insurer MetLife and Managed Care of North America, a dental benefits manager.

Trump’s inaugural committee raised $107 million, more than twice as much as for any previous presidential investiture. President Barack Obama’s 2009 inauguration held the previous record of $53 million.

Obama banned corporate donations that year and limited individual donations to $50,000 but accepted corporate grants for his 2013 inauguration.

No health company gave more to Trump’s event than Pfizer, whose profits for Lyrica, Prevnar 13 and other high-priced medicines could come under pressure if the Medicare program for seniors is allowed to negotiate on cost, as Trump has suggested.

Lyrica alleviates nerve and muscle pain. Prevnar 13 is a vaccine against pneumococcal pneumonia.

Along with several other pharma companies, Pfizer is the subject of a Justice Department investigation over donations to charities that help Medicare patients avoid copayments for expensive drugs.

Pfizer CEO Ian Read is also a vocal advocate of cutting corporate income taxes, which Trump has pledged to do. The Obama administration thwarted Pfizer’s $160 billion deal to move its legal residency to low-tax Ireland to merge with Botox maker Allergen.

Pfizer’s $1 million donation entitled it to four tickets to a “leadership luncheon” with “select Cabinet appointees and House and Senate leadership,” according to a solicitation brochure obtained and posted online by the Center for Public Integrity.

“As it has been the case with previous presidential inaugurations, we made a financial contribution to the 58th Presidential Inaugural Committee and a group of our senior leaders participated in various official events,” said Pfizer spokesperson Sharon Castillo. She declined to identify the executives.

Amgen’s inauguration gift of $500,000 was the second-biggest from a health care donor. The company makes Enbrel for arthritis and Epogen for anemia, among other drugs.

Amgen’s contribution bought it two tickets to “an intimate dinner” with then-Vice President-elect Mike Pence and his wife, Karen Pence. Amgen CEO Robert Bradway was among seven pharma executives who met with Trump in the White House on Jan. 31, although that wasn’t part of the inauguration package.

Amgen spokesperson Kelley Davenport declined to comment beyond describing the company as joining “numerous other donors from a diverse group of industries and individuals” supporting the event.

Pfizer also got entrée to the Pence inaugural dinner. Both companies had access to balls, receptions, luncheons, concerts and other events available to lesser donors.

Neither Pfizer, Amgen nor other large, health care donors to Trump’s inauguration made contributions to Obama’s 2013 inauguration, which did accept corporate money. Pfizer gave $250,000 to President George W. Bush’s 2005 inauguration.

The biggest health care corporate donor to Obama’s 2013 investiture was drugmaker Genentech, which gave $750,000, records show. The company did not contribute to Trump’s inauguration. “Prior to the 2016 election, we made a decision not to sponsor any inaugural activities for the foreseeable future,” said Genentech spokesperson Susan Willson.

Contributors for this year’s event also included insurer Anthem, one of the largest participants in the Affordable Care Act’s online marketplaces, and Centene, which also sells insurance plans through the online exchanges. Anthem gave $100,000 while Centene gave $250,000.

Both companies’ marketplace businesses depend on generous federal subsidies that would be jeopardized by an ACA repeal or other actions by the administration. Anthem has pressed the administration to preserve the subsidies and tighten rules for marketplace enrollment.

Anthem CEO Joseph Swedish was one of a group of insurance executives who met with Trump in February. Swedish met again with Trump in the White House last month, Modern Healthcare reported.

Centene, which manages state and federal Medicaid programs for low-income people in many states, also benefited from the ACA’s Medicaid expansion. Analysts see the company as especially vulnerable to a potential repeal of Obama’s health law.

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

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Readers: Training Patients To Advocate For Their Illnesses Is ‘A Virtue Not A Sin’

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

The recent story Drugmakers Help Turn Patients With Rare Diseases Into D.C. Lobbyists (Tribble, 4/10) drew a strong reader response. Here’s a sampling:


Encouraging patient advocacy is a virtue not a sin. Your article fails to put the gap in treating rare diseases in context. There are tens of millions of patients with rare diseases but about 95 percent of them have no effective treatment. Pushing for more research and cures is not venal or symbiotic with the pharmaceutical industry policy agenda. Rather, patient advocates — often parents of very sick children — need the resources necessary to push the government toward helping those patients.

— David Beier, San Francisco


I was extremely distraught by your recent story. … You have grossly misrepresented the outstanding work advocates Shira Strongin and Emily Muller do. … You have painted them, the advocacy groups they work with and the legislation they have worked on as corrupt and solely fueled by the pharmaceutical industry. [But] they selectively choose advocacy groups to work with, such as EveryLife Foundation, and give all of themselves to bettering the world, creating a reality where people with diseases … can live to see another day and can build happy and fruitful futures. I have seen the efforts of their labor firsthand, and they were born not out of the influence of the pharma industry but out of grass-roots labor.

— Shannon Linford, Leesburg, Va.


I have a rare disease and am the president of a patient foundation. I have also participated in Rare Disease Week on Capitol Hill two times. I could not disagree more strongly with this article. I have never received any message that I am supposed to push when meeting with my representatives. Nor am I asked to share a sob story. What I am given [is] information on how our government works. … We might have a better functioning process if all individuals were given the opportunity to learn hands-on. … If anyone is using patients to their gain, it was the author. Disgusting.

— Andra Stratton, Los Lunas, N.M.


When you or a loved one gets sick, you assume there will be a treatment. However, if you are one of the 30 million Americans diagnosed with a rare disease, there is only a 5 percent chance that your disease will have an FDA-approved treatment.  What’s worse is that treatments that have already been developed for more common diseases could help millions of rare disease patients, but our health system does not provide sufficient incentives to bring these treatments to those who need them the most.

Rare-disease patients are underserved by virtually every aspect of the health system from diagnosis to availability of treatments to reimbursement because they have not been heard by policymakers and regulators. Our community deserves better, which is why the EveryLife Foundation for Rare Diseases works to ensure rare-disease patients and their families have the opportunity to impact these life-and-death policy decisions. There is real hope in bipartisan legislation such as the OPEN ACT (HR 1223), which would bring lifesaving treatments to rare-disease patients quickly, safely and affordably.

Kaiser Health News’ recent article undermines the value of the patient voice in the legislative process, demeans patients and damages the democratic process. We believe that participation in our democracy should not be available only to people who have the financial means to travel to D.C. We submit grant applications to both foundations and industry to cover our program costs so we can make our events free and provide some assistance to patients and caregivers to offset travel costs. We received 397 applications for travel assistance, but due to limits on funding we were able to provide assistance only to 95 patients. Without support from our industry partners, patients would continue to be denied a voice.

As an organization that seeks to enhance innovation so that all rare-disease patients can access FDA-approved treatments, we value our collaborations with patients, advocacy organizations, researchers, public officials and industry — which all play a critical role in the discovery, development and delivery of lifesaving medicines to patients.

— Julia Jenkins, executive director and board member, EveryLife Foundation for Rare Diseases; Max Bronstein, EveryLife chief advocacy and science policy officer; and Mark Dant, EveryLife board member and president and CEO of the National MPS Society

Categories: Cost and Quality, Health Industry, Pharmaceuticals

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Perspectives: Pharma Desperately Needs Some Sunshine In Its Life

Read recent commentaries about drug-cost issues.

Bloomberg: Take The Mystery Out Of Drug Pricing
Americans have clear reason to think they’re paying too much for prescription drugs. The cost of medicines is rising faster than any other category of health-care spending, standing at almost 17 percent of total health costs. What’s harder to discern is what to do about it, in part because so little is known about how drug prices are set, what discounts and rebates drugmakers negotiate with wholesale buyers, and to what extent savings are passed along to customers at the pharmacy counter. Addressing this lack of transparency would be a good first step. (4/18)

Roll Call: Stifling Competition Reduces Access To Affordable Prescriptions
Americans are rightfully concerned with rising medical costs, but some of the ways by which costs rise can be tedious and difficult to understand for those not already familiar with broader regulatory issues. What’s going on, though, is actually pretty straightforward: Brand-name producers regularly take advantage of systems designed to protect consumers to instead protect their bottom lines and crush out competition from their generic competitors. One common way by which anti-competitive behavior occurs is by preventing access to the materials needed to test generic or biosimilar alternatives. In other words, pharmaceutical companies refuse to let competitors prove their safety, and then enjoy the monopoly that results when theirs are the only drugs proven to be safe. (Jonathan Bydlak, 4/18)

RealClear Health: Canada Cannot Be America’s Drugstore
The drug importation debate, sparked by Sen. Bernie Sanders’ introduction of legislation that would allow Americans and pharmacies to import medicines not approved by the FDA from foreign countries through and including Canada, is largely focused on one key question: A­re medications imported from outside the FDA’s jurisdiction safe for consumers? (Marvin D. Sheperd, 4/19)

Morning Consult: America Needs An Rx For Its Prescription Drug Prices
When President Donald Trump and Sen. Bernie Sanders, (I-Vt.) see eye to eye on an issue, you know that it is politically volatile. That is the state of the current debate around prescription drug pricing, which has become a cause célèbre for lawmakers across the political spectrum. The frustration is justified. For too long, patients have endured repeated price hikes for the medicines they need to go about their daily lives. An opaque pricing system and supply chain that effectively operates as a “black box” of rebates, clawbacks and middlemen only serves to exacerbate patient anger. (Larry Smith and Larry Ellingson, 4/18)

RealClear Health: Is Drug Pricing At An Inflection Point?
In recent months, we have seen encouraging signs of a new commitment to the social contract drug makers have with patients. Novo Nordisk and Allergan have made pledges to hold the line on drug prices. Mylan has taken responsibility for the price increases for EpiPen, and is promising to do more to advance affordability. More recently, Regeneron engaged early on in a meaningful and responsible way to discuss pricing of a new therapy. (Steve Miller, 4/14)

Bloomberg: How Drug-Company ‘Benevolence’ Silences The Sick
Among the drugs that helped bring Valeant Pharmaceuticals International low, none did more damage to its reputation and stock price than Syprine. Syprine is a drug that treats a rare illness called Wilson disease, which prevents the body from metabolizing copper and can lead to liver failure and death if left untreated. For decades, the price of Syprine was $1 per 250-milligram tablet, according to a recent article in the medical journal Hepatology. For most people, a maintenance dose requires four pills a day, bringing the price during that era to $1,460 a year. (Joe Nocera, 4/18)

Sacramento Bee: Transparency Needed On Companies That Manage Prescription Drugs
If you’re like most Californians who have health insurance, you know two things about how prescription drugs fit into your health plan. You know that you receive some level of coverage for medications, and you know that soaring prices for prescription drugs are a major cost-driver that have caused insurance premiums to soar. What you don’t know is how your coverage for prescription drugs works, who determines which drugs are covered, or who gets how much from the money you pay for your prescription drugs. The fact is, almost no one knows those things. (Jim Wood, 4/17)

San Francisco Chronicle: Require Drugmakers To Report When They Raise Prices 
Big Pharma wants us to believe that such costs reflect the expensive nature of research and development. But what the pharmaceutical companies spend on research, clinical trials and their 24/7 advertising campaigns is kept hush-hush. One study found that for every $1 drug companies spend on R&D, they spend $19 on advertising. (Ed Hernandez and Tom Steyer, 4/18)

Medscape: Destroy Them: One Way To Up Price Of Generic Cancer Drugs
In a now-leaked email, a senior executive at a large  pharmaceutical company discussed destroying supplies of generic cancer drugs as part of a pricing battle with health authorities in Spain, according to a report in the British newspaper The Times. The idea was floated in 2014 in an exchange with another staff member at Aspen Pharmacare, which has a market valuation of $10 billion and sells products globally, including in the United States, according to the company website. (Nick Mulcahy, 4/17)

Bloomberg: Lilly’s New-Drug Promise Is Fading
It’s much easier to tell a story of unlimited promise and sales growth than to deliver on it. Eli Lilly & Co. has been aggressively talking up its revamped drug pipeline. Investors who bought into this got a rude awakening Friday, when the company disclosed that the FDA had declined to approve baricitinib, an expected blockbuster arthritis treatment. Many investors assumed baricitinib would hit the market this year. But the FDA has asked for data on the drug’s safety and optimal dose, meaning it may not be approved for years. (Max Nisen, 4/17)

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

While Drugmakers Lick Wounds From Public Outrage Over Prices, One Company Remains Defiant

News outlets report on stories related to pharmaceutical pricing.

The New York Times: Defiant, Generic Drug Maker Continues To Raise Prices
Congressional hearings. Federal investigations. Consumer outrage. In the wake of developments like these, many drug company executives are laying low. Their favored business models, based on raising drug prices indiscriminately, are now seen as a liability; many pharmaceutical companies are curbing increases on their products and accepting that this once-lucrative jig may be up. (Morgenson, 4/14)

Stat: Want To Avoid A Drug Price Backlash? Keep The Cost To Yourself
All the recent rancor over drug pricing has led biotech to change its ways. Not by making new drugs cheaper, of course, but by holding off on naming a price — and thus inviting controversy — until the last possible minute. Nowadays, as soon as a drug wins Food and Drug Administration approval, so begins a debate about whether it’s worth the thousands of dollars a year new therapies generally cost. And so companies, perhaps mindful of how a few scolding tweets can snowball into a market-moving event, are starting to keep that information under wraps for as long as possible. (Garde, 4/12)

The Wall Street Journal: Cardinal Health Feels Pain Of Falling Drug Prices
Making money when drug prices were rising was easy. Now comes the hard part.The latest signal: Distribution giant Cardinal Health lowered earnings expectations Tuesday morning and told investors that business wouldn’t pick up until the middle of 2018. The company is being hit by falling prices of generic drugs, which are expected to decline by a percentage in the low double digits for the fiscal year ending in June. (Grant, 4/18)

Stat: Bill Would Make It Easier For Pharma To Talk Off-Label Drug Uses
In a bid to loosen off-label communications, a congressman quietly introduced a bill late last month that would expand the ability of drug makers to discuss unapproved uses of their medicines with doctors. The legislation, which was proposed by Representative Morgan Griffith (R-Va.), addresses a controversial, if technical term called “intended use.” The Food and Drug Administration maintains that discussion of an unapproved, or off-label use, creates a new intended use for which a drug maker must have regulatory approval. (Silverman, 4/18)

The Washington Post: 1st Drug OK’d For Movement Disorder Caused By Certain Meds
U.S. regulators have approved the first drug for treating a neurological syndrome that causes uncontrollable body movements that can also interfere with speech, swallowing and breathing. The sometimes-disabling disorder, tardive dyskinesia, is caused by some widely used prescription medicines for psychiatric and gastrointestinal disorders. It can surface while patients are on those medicines or years after they stop. It affects about 500,000 U.S. patients. (Johnson, 4/11)

Kaiser Health News: Non-Profit Linked To PhRMA Rolls Out Campaign To Block Drug Imports
A nonprofit organization that has orchestrated a wide-reaching campaign against foreign drug imports has deep ties to the Pharmaceutical Research and Manufacturers of America, or PhRMA, the powerhouse lobbying group that includes Eli Lilly, Pfizer and Bayer. A PhRMA senior vice president, Scott LaGanga, for 10 years led the Partnership for Safe Medicines, a nonprofit that has recently emerged as a leading voice against Senate bills that would allow drug importation from Canada. (Kopp and Bluth, 4/19)

Stat: Patient Groups, Backed By Pharma, Fight Nevada Drug Pricing Bill
Abill that was recently introduced in Nevada to fight the cost of diabetes medicines is quickly generating vociferous opposition from several patient organizations, some of which receive financial support from the pharmaceutical industry. The groups include the National Organization for Rare Disorders, Caregiver Voices United, the Myositis Association, the International Pain Foundation, RetireSafe, and the Epilepsy Foundation. And most of their letters, which were sent to Nevada state senators, use nearly identical language in citing concerns. (Silverman, 4/17)

Boston Globe: Alere Agrees To Be Bought By Abbott For Reduced Price
The long and contentious purchase of Alere Inc. of Waltham by Abbott Laboratories appears at hand, after the two health care companies said Friday they have a new deal that lowers the takeover price by $500 million. The amended takeover, under which Abbott will pay $51 for each share of Alere, is valued at $5.3 billion, down from the $5.8 billion the parties had initially agreed to in February 2016. (Weisman, 4/14)

Stat: A Surprise FDA Rejection Puts Lilly’s Turnaround In Jeopardy
Eli Lilly’s path to what looked like a surefire blockbuster got derailed by an unforeseen FDA rejection, clouding the future of a drug the company viewed as a pipeline in a pill. The Food and Drug Administration declined to approve Lilly’s baricitinib, an oral treatment for rheumatoid arthritis. According to Lilly, the agency wants to see more clinical data to determine the safety and ideal doses for the drug. Lilly didn’t disclose whether that means it will have to recruit and run new studies of the treatment, but if so, a resubmission could be delayed by months. (Garde, 4/14)

Forbes: The Billionaire And The Drug Price-Fixing Scandal
In September 2015, Satish Mehta, the billionaire chief executive of the Indian drug company Emcure Pharmaceuticals, wrote an effusive email congratulating Jeffrey Glazer, the CEO of his U.S. crown jewel, Heritage Pharmaceuticals, on a job well done. “In a short span of 4.5 years, you have taken Heritage to another level,” Mehta wrote, adding that he considered Glazer to be “an integral part of our family.” (Vardi and Karmali, 4/18)

Nashville Tennessean: Senate OKs Prescription Drug Redistribution Program, But Not For Opioids
The Senate unanimously approved a measure Monday to create a prescription drug-share program that would allow donations of packaged cancer drugs, but not opioids. The bill would allow nonprofit organizations to donate and redistribute prescription drugs still in their manufacturer packaging to people who don’t have health insurance and meet other criteria. Multiple senators said the medication will largely come from long-term care facilities, which throw away a large amount of unused medication. (Lowary, 4/17)

Stat: Drug Research Firms Push For Tax Break Amid Foreign Competition
The legislation, which was introduced by Pennsylvania Representative Patrick Meehan, a Republican, was co-sponsored by two North Carolina congressmen, Republican George Holding and Democrat G.K. Butterfield. In their home state, CROs employ some 24,000 people. Today, North Carolina is home to 152 CROs, which include powerhouses like PPD, PRA Health Sciences, and INC Research, as well as smaller outfits like Rho and Cato Services. CROs — which are also often referred to as contract research organizations — are a boon to North Carolina’s life science industry, which raked in nearly $2.2 billion in state and local government tax revenues in 2016, according to an economic impact report from the North Carolina Biotechnology Center. (Broadfoot, 4/18)

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

Device Promises Relief From ‘Suicide Headaches,’ But Is It All Hype?

The gammaCore device did show benefits in a small group of people, but experts are skeptical. In other public health news: Parkinson’s drugs, the March for Science, measles in Minnesota and marijuana for epilepsy.

Stat: Patients With ‘Suicide Headaches’ Just Got A New Therapy Option
Cluster headaches, as the rare condition is known, are characterized by bursts of severe pain in cyclical patterns. They’re often misdiagnosed and undertreated. But on Tuesday, the Food and Drug Administration cleared a new, first-of-its kind option for such patients: a handheld device, designed to be used by patients to zap their own necks with a mild electrical signal to relieve symptoms. The hitch: It’s not clear how much difference the “gammaCore” device will make for the several hundred thousand people in the United States with the condition. (Robbins, 4/18)

Chicago Tribune: New Drug Provides Long-Awaited Breakthrough For Parkinson’s Psychosis
Most people recognize Parkinson’s patients through tremors, slow body movements and other motor problems. Yet up to half of patients develop psychosis at some time during the disease’s course, often in the later stages and sometimes as a side effect from drugs prescribed to help motor skills. Tackling the psychosis has proved difficult, in part because doctors struggled for decades to address the motor problems, [Dr. Rajesh] Pahwa said. As gains happened there, the nonmotor problems became a bigger and bigger challenge to manage, he said. (McGuire, 4/18)

Stat: Who’s Going To The March For Science?
Routes are planned. Speakers are announced. But there’s still one question about this weekend’s March for Science that is begging to be answered: Who exactly is going to show up? The march has carved a wide mandate for itself as a non-partisan “celebration of science,” leaving the door open for many different groups to gather under its umbrella. Now, in recent weeks, the organizers of the Washington march and the hundreds of satellite marches across the US and overseas have been trying to anticipate who is going to turn up on April 22, including surveying social media and asking marchers to RSVP. (Sheridan, 4/19)

Minnesota Public Radio: Think Your Child Has The Measles? Call Before You Seek Care 
Dr. Jon Hallberg is having fewer conversations with vaccine skeptics at his Minneapolis practice now. He credits that to the spread of information that vaccines are safe and the debunking of any false claims otherwise. Still, as of Tuesday, there have been nine recent cases of measles in Minnesota kids — all of them unvaccinated. (Crann and Nelson, 4/18)

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

Non-Profit Linked To PhRMA Rolls Out Campaign To Block Drug Imports

A nonprofit organization that has orchestrated a wide-reaching campaign against foreign drug imports has deep ties to the Pharmaceutical Research and Manufacturers of America, or PhRMA, the powerhouse lobbying group that includes Eli Lilly, Pfizer and Bayer.

A PhRMA senior vice president, Scott LaGanga, for 10 years led the Partnership for Safe Medicines, a nonprofit that has recently emerged as a leading voice against Senate bills that would allow drug importation from Canada. LaGanga was responsible for PhRMA alliances with patient advocacy groups and served until recently as the nonprofit’s principal officer, according to the partnership’s tax forms.

In February, LaGanga moved to a senior role at PhRMA and stepped down as executive director of the Partnership for Safe Medicines — just as the group’s campaign to stop import legislation was revving up.

Both PhRMA and the partnership have gone to great lengths to show that drugmakers are not driving what they describe as a “grass-roots” effort to fight imports — including an expensive advertising blitz and an event last week that featured high-profile former FBI officers and a former Food and Drug Administration commissioner.

The partnership’s new executive director, Shabbir Safdar, said LaGanga resigned from the group to avoid the appearance of a conflict of interest.

“That’s why Scott’s not executive director anymore,” he said. PhRMA declined to make LaGanga available for an interview.

A Kaiser Health News analysis of groups involved in the partnership shows more than one-third have received PhRMA funding or are local chapters of groups that have received PhRMA funding, according to PhRMA tax disclosures from 2013 to 2015. Forty-seven of the organizations listed in the ads appear to be advocacy organizations that received no money from PhRMA in those years.

The Senate push to allow Americans to buy pharmaceuticals from Canada comes as more patients balk at filling prescriptions because of soaring drug prices. Prescription medicines purchased in the U.S. can run three times what they cost in Canada, data from the company PharmacyChecker.com show. In 2016, about 19 million Americans purchased pharmaceuticals illegally from foreign sources through online pharmacies or while traveling, according to a Kaiser Family Foundation poll; many survey respondents cited pricing disparities as the reason.

The U.S. drug industry has strongly opposed efforts to open the borders to drug imports, but PhRMA is not mentioned in the partnership’s recent advertising blitz. The nonprofit said its grass-roots effort is supported by 170 members, including professional organizations and trade groups.

The nonprofit describes PhRMA as a dues-paying member with no larger role in shaping the group’s activities. Partnership spokeswoman Clare Krusing would not say how much each member contributes. PhRMA spokeswoman Allyson Funk declined to say whether PhRMA funds the partnership.

“PhRMA engages with stakeholders across the health care system to hear their perspectives and priorities,” Funk said. “We work with many organizations with which we have both agreements and disagreements on public policy issues, and believe engagement and dialogue are critical.”

LaGanga is listed as the nonprofit’s executive director on each of the partnership’s annual tax filings since 2007, the earliest year for which they are available from ProPublica’s Nonprofit Explorer.

LaGanga wrote a 2011 article about the partnership’s origins. Published in the Journal of Commercial Biotechnology, it described “public-private partnerships in addressing counterfeit medicines.” His PhRMA job was not disclosed.

From 2010 to 2014, the organization hosted a conference called the Partnership for Safe Medicines Interchange. At a 2013 event posted to YouTube, LaGanga thanks pharmaceutical companies for sponsoring the event, most of them PhRMA members.

The partnership recently launched its ambitious ad campaign — including television commercials, promoted search results on Google and a full-page print ad in The Washington Post and The Hill. The group’s YouTube page shows recent commercials targeted to viewers in 13 states.

“We don’t disclose specific ad figures, but the campaign is in the high six figures,” Safdar said.

The campaign warns against the alleged dangers of legalizing Canadian drug imports. The commercials ask voters to urge their senators to “oppose dangerous drug importation legislation.”

The newspaper ad reads, “Keep the nation’s prescription drug supply safe. Urge the Senate to reject drug importation measures.” Its splash headline declares that “170 healthcare advocacy groups oppose drug importation,” touting a letter to Congress signed by its many members. It lists 160, and PhRMA’s name is not included.

“Having a big membership allows the coalition to present what looks like a unified show of grass-roots support … but it does raise questions about which members of the coalition are really driving and funding the group’s policymaking,” said Matthew McCoy, a postdoctoral fellow at the University of Pennsylvania who studies patient advocacy groups.

The list of “grass-roots groups” includes at least 64 trade organizations representing the biomedical industry, professional associations representing pharmacists, a private research company and two insurance companies.

One group that signed the letter, the “Citrus Council, National Kidney Foundation of Florida Inc,” represents a single volunteer, according to an email from the group. A spokesman for the National Kidney of Foundation of Florida said the volunteer’s views contradict the position of the umbrella group, and said the foundation supports “any sort of drug importation that allows our patients to have access to drugs at the best price.”

Two of the hepatitis advocacy groups listed — the National Association of Hepatitis Task Forces and the California Hepatitis C Task Force — are run by the same person: Bill Remak. Remak said the groups receive small amounts of PhRMA funding.

“I don’t enjoy having to take this extreme position of saying we shouldn’t import at all, but until we have some oversight regime, some way of protecting consumers, it’s a really tough call,” he said in an interview.

“Current drug importation proposals do not appear to have equal safety and chain-of-custody accountability laid out adequately for patient safety concerns,” said William Arnold, president of the Community Access National Network, an advocacy and support group for people living with HIV/AIDS or hepatitis in Washington, D.C. His group did not accept money from PhRMA from 2013 to 2015.

Last week, the partnership hosted a panel at the National Press Club featuring former FBI director Louis Freeh and former FDA commissioner Dr. Andrew von Eschenbach. The discussion focused on the health and legal dangers of online pharmacies.

“You can talk about lowering prices, but if a drug comes with a high probability of toxicity and death, that comes at a high cost to the patient,” von Eschenbach said. “That’s what’s at issue with drug importation.”

Each speaker argued that the bill co-sponsored by Sen. Bernie Sanders (I-Vt.) would be harmful to patients. That legislation would provide a mechanism for Canadian drug manufacturers to sell to U.S. consumers and pharmacies. Sanders introduced the bill in February. Around the same time, the partnership sent emails to member organizations seeking help to stop such a measure.

In the House, Rep. Elijah Cummings (D-Md.) introduced a similar bill to Sanders’, along with 23 other Democrats. In January, Sens. John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.) also introduced a bill to allow drug imports from Canada.

Speakers at the partnership event claimed importation would lead to a flood of counterfeit medicines laced with arsenic, fentanyl and lead paint.

“These drugs are manufactured in jungles, in tin drums, in basements … those are the sort of sanitary conditions we’re talking about here,” said George Karavetsos, a former director of the FDA’s Office of Criminal Investigations.

Josh Miller-Lewis, Sanders’ deputy director of communications, refuted those arguments in an interview. He said Canadian drugmakers can apply for licenses, and all drugs would have to come from FDA-inspected plants.

Both von Eschenbach and Karavetsos have ties to the pharmaceutical industry: Von Eschenbach left the FDA in 2009 to join Greenleaf Health, which counsels pharmaceutical clients, before starting his own consulting company; and Karavetsos counsels pharmaceutical clients at DLA Piper, a Washington, D.C., law firm.

This isn’t Sanders’ first attempt to legalize importation. But Politico reported in October that PhRMA is bolstering its war chest by another $100 million a year, suggesting to many industry watchers that drugmakers are gearing up for a ferocious fight.

“I think it’s safe to say pharmaceutical corporations are prepared to spend some fraction of their multibillion-dollar profits to fight drug importation and any other policy that might end the plague of overpriced medicine,” said Rick Claypool, research director for Public Citizen, a watchdog group critical of the drug industry.

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Viewpoints: Exploring Today’s Health Policy Buzz Words… Single-Payer, Transparency, Market Stabilization

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

The Washington Post: Sorry, Republicans, But Most People Support Single-Payer Health Care
Despite the rise of the tea party and unified Republican control of government, one decidedly anti-free-market idea appears ascendant: single-payer health care. And it’s no wonder, given that a record-high share of the population receives government-provided health insurance. As a country, we’ve long since acquiesced to the idea that Uncle Sam should give insurance to the elderly, veterans, people with disabilities, poor adults, poor kids, pregnant women and the lower middle class. (Catherine Rampell, 4/17)

Vox: The GOP’s Problem On Health Reform Is They’ve Spent Years Hiding Their Real Position
The most interesting policy argument in America right now is the debate between conservatives’ real position on health care and their fake position. The fake, but popular, position goes something like this: Conservatives think everyone deserves affordable health insurance, but they disagree with Democrats about how to get everyone covered at the best price. This was the language that surrounded Paul Ryan and Donald Trump’s Obamacare alternative …. Their real position is that universal coverage is a philosophically unsound goal, and that blocking Democrats from creating a universal health care system is of overriding importance. To many conservatives, it is not the government’s role to make sure everyone who wants health insurance can get it, and it would be a massive step toward socialism if that changed. (Ezra Klein, 4/17)

Milwaukee Journal Sentinel:  Obamacare Is Failing Wisconsin
Earlier this month, The New York Times reported that Obamacare is not in the death spiral that Republicans are claiming, and health insurers might soon see profitable years ahead. … However, when you read further you learn why insurers may start profiting from the Obamacare exchanges. … Simply stated, insurers are charging individuals more while offering fewer choices and services. This isn’t a positive development for our health system or the American people. (Rep. Jim Sensenbrenner, (R-Wis.) 4/17)

Real Clear Health: Don’t Meddle With Medicare’s Prescription Drug Benefit
Seema Verma, the new administrator of the Centers for Medicare and Medicaid Services, recently praised Medicare’s prescription drug benefit for giving seniors access to affordable medicines, saying she was “thankful” for the program. There’s a lot to be thankful for. Medicare Part D, as the drug benefit is known, provides seniors with huge discounts on medicines, enabling them to live healthier, longer lives. A recent University of Illinois study found that Part D has reduced elderly mortality by 2.2 percent annually since 2006. That’s good news for the more than 41 million Americans who currently rely on the program for prescription drug coverage. (Joel White, 4/18)

Idaho Statesman: Health Care Failed My Son — And I’m A Doctor 
Jack had access to care. Despite this, the correct diagnosis was not made early on in his disease course; early diagnosis and appropriate intervention may have made a difference. We need a better understanding into the science behind mental health illnesses, including substance abuse disorder, to develop better methods of detection, prevention and treatment. (Kathryn Beattie, 4/17)

St. Louis Post-Dispatch: Mallinckrodt Helps Address Opioid Misuse, Diversion
As a publicly traded company, Mallinckrodt routinely discloses information affecting the company, such as the agreement in principle reached with the U.S. Drug Enforcement Agency and U.S. Attorneys’ Offices to settle the previously disclosed investigations of the company’s monitoring programs for controlled substances. The disclosure of the $35 million settlement was in no way meant to downplay the seriousness of the opioid epidemic. Mallinckrodt recognizes that prescription drug abuse is one of the St. Louis region’s — and the nation’s — greatest health and safety concerns, with devastating societal and emotional effects as well as an economic burden on the healthcare system. (Mark Trudeau, 4/18)

The Washington Post: Long-Term Care Insurance Facing Major Pricing Shift
One of the biggest fears people have about retirement is getting sick and running out of money to cover their health issues. So in comes long-term care insurance, which can cover the cost of nursing homes, assisted-living facilities and in-home care. Medicare — except in very limited situations — does not cover long-term care. Medicaid covers long-term care, but to qualify for the benefit, you have to be pretty poor. (Michelle Singletary, 4/17)

Detroit Free Press: Bills To Weaken Vaccine Rules Put Kids At Risk
As pediatricians in training, here are some patients we have encountered recently: a previously healthy toddler who did not receive his yearly influenza vaccine and was placed on full life support due to multi-organ failure from the flu. An infant too young to receive vaccines who caught whooping cough at her older sister’s school and required admission to intensive care. A preschooler who was receiving chemotherapy for leukemia, now in remission, who cannot safely attend school because of the number of unvaccinated children. A child who has undergone multiple complex heart surgeries requiring intensive and risky anesthesia, medications and interventions, but whose parents will not vaccinate him against illnesses that routinely killed even healthy children before the age of vaccines. (Dr. Phoebe Danziger and Dr. Rebekah Diamond, 4/15)

Stat: NIH Program Strives To Turn More Lab Discoveries Into Real-World Treatments
Translating fundamental scientific knowledge into actual treatments for diseases is exceedingly challenging. Research often reveals the molecular and systemic changes that cause or contribute to a disease. Although that can lead to new ideas about how to prevent or treat that condition, only a tiny fraction of these ideas ever make it to being tested in humans. Of the few that do, the necessary clinical trials can take hundreds of millions of dollars and many years to complete, and in that process most will fail to show sufficient safety and effectiveness. It’s also next to impossible to predict which avenues of research will ultimately lead to medical breakthroughs. (Paula J. Bates, Diane Fabel, Clinton T. Rubin, Vadim J. Gurvich and Charles C. Muscoplat, 4/17)

San Jose Mercury News: Fact-Based Sex Ed Helps Keep Teens Safe, Healthy
Cupertino Union School District is in the midst of a furious debate about sexual education that is reverberating through the Peninsula and making national news. As the school board considers adopting new curricula, I would like to remind them of their responsibility to the health and futures of our students. (Stacy Tong, 4/17)

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Kids With Hepatitis C Get New Drugs And Coverage May Prove Easier Than For Adults

With the approval this month of two drugs to treat hepatitis C in children, these often overlooked victims of the opioid epidemic have a better chance at a cure. Kids may have an easier time than adults getting treatment approved, some experts say.

Medicaid programs and private insurers have often balked at paying for the pricey drugs for adults, but stricter Medicaid guidelines for kids may make coverage more routine.

The two drugs approved for pediatric use by the Food and Drug Administration, Harvoni and Sovaldi, both have been highly effective in treating adults with the disease. In two clinical trials of children ages 12 to 17, the drugs eliminated all traces of the virus in 97 to 100 percent of patients, generally in 12 weeks. Trials that test the effectiveness of the drugs in younger children are ongoing.

Michelle AndrewsInsuring Your Health

“It’s great news for our kids,” said Dr. Jessica Wen, medical director for the viral hepatitis clinical care program Children’s Hospital of Philadelphia, which had more than a dozen kids participating in the trials. “Historically every new medication that’s approved for adults, there’s always a lag for pediatrics,” she said, noting that the wait can be as long as a decade.

The FDA approved Sovaldi in 2013 and Harvoni in 2014 for adults, and the drugs were widely hailed because they cured nearly everyone with minimal side effects, typically in 12 weeks. Earlier treatment regimens that required interferon injections and antiviral pills for six months or more were less effective and frequently caused severe side effects.

But until the FDA approved the drugs for pediatric use, many doctors were delaying treatment. Because the FDA approval applies to children 12 and older who weigh at least 77 pounds, this group would require an adult dose.

Researchers estimate that 23,000 to 46,000 children in the United States are infected with hepatitis C, a blood-borne infection that causes inflammation of the liver and can lead to liver failure, cancer and death. Most of the estimated 2.7 million to 3.9 million people overall that have chronic hepatitis C in the U.S. got it from transfusions of contaminated blood or sharing needles and other equipment while injecting illicit drugs. But only about 20 percent of children get it from drug use. The majority of kids become infected by their mom during pregnancy. A baby has about a 6 percent chance of contracting hepatitis C if their mother has it.

Since neither adults nor children are routinely screened for hepatitis C and many don’t develop any symptoms after becoming infected, people may have the disease for years before learning they’re sick.

Children often come to clinicians’ attention when their regular pediatrician learns the mother is infected, said Dr. Karen Murray, a professor of pediatrics at University of Washington medical school who works at Seattle Children’s Hospital, which had several children in the trials.  

Children who contract hepatitis C may suffer less liver damage over time than those who contract it as adults, Murray said.

Still, “there are all these social and biological events that may happen like marriage and childbirth, and it would be nice if they were cleared of the virus before then,” she said.

When the new drugs were introduced a few years ago, insurers often balked at the price tag, which typically approached $100,000 for a course of treatment. Medicaid programs, in particular, restricted access to the drugs for adults, often requiring that people have significant liver damage and/or prove that they’d been drug- and alcohol-free for several months before they would approve treatment. (Because the drugs weren’t approved for children, many pediatricians said they didn’t attempt to prescribe them.)

Increased competition from the introduction of new drugs has helped reduce the price somewhat in recent years, and insurers aren’t creating quite as many obstacles to treatment now, said Ryan Clary, executive director of the National Viral Hepatitis Roundtable, an advocacy group.

However, “coverage is still a very significant problem,” Clary said.

Insurance coverage may be less problematic for children, experts say. Under federal law, state Medicaid programs must cover “early and periodic screening, diagnostic, and treatment services” for children under age 21 that are necessary to correct or ameliorate physical and mental illnesses.

“The short answer is that [Medicaid] will likely require coverage for all kids regardless of whatever the coverage policies for adults may be,” said Matt Salo, executive director of the National Association of Medicaid Directors.

State Medicaid programs have leeway with adults to decide that a treatment isn’t medically necessary unless the person’s liver is damaged, said Kelly Whitener, an associate professor at Georgetown’s Center for Children and Families.

“But for kids, the federal standard … is broader, so medical necessity could not be linked to severity of illness/liver disease,” she said.

It’s unclear what private insurers will do regarding coverage for kids.

“Given these are recently approved drugs, we expect plans will follow their normal practices,” said Kristine Grow, a spokeswoman for America’s Health Insurance Plans, a trade group. “This includes evaluating the evidence, systematic review of the medication’s effectiveness, considering any federal or state mandates, and updating their policies as new evidence is available.”

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Getting To Delivery Room A Harrowing Journey For Some Amid Rural Hospital Crisis

Because of financial strain, many rural hospitals are shutting down their labor and delivery services. Women in those areas are then faced with long drives to get to a safe place to deliver their babies. In other public health news: infectious diseases, strokes, young blood, genetic testing, fertility treatments, trauma care and more.

Stat: A Crisis In Rural Health Care Puts Mothers-To-Be On A Risky Road
Financial pressures, insurance problems, and doctor shortages forced more than 200 hospitals to close their birthing units between 2004 and 2014, according to the University of Minnesota’s Rural Health Research Center. That’s left millions women of reproductive age facing longer drives to deliver babies — who sometimes arrive en route. The long drives, understandably, increase anxiety. They also make mothers and babies less safe; studies show these distances bring with them increased rates of complications and infant deaths, as well as longer stays in neonatal intensive care units. (Ross, 4/17)

Stat: Former CDC Head: Outbreaks ‘Tremendous Threats To Business’
The world has faced a string of infectious disease threats in the past dozen or so years, with SARS, bird flu, swine flu, MERS, and Ebola wreaking havoc. Yet despite the abundance of evidence that microbes pose major threats, both to human health and economies, global preparedness is not where it needs to be, Dr. Julie Gerberding warned this week. Gerberding was a former director of the Centers for Disease Control and Prevention — a post she held during the 2003 SARS outbreak. She is now Merck’s executive vice-president for strategic communications, global health policy and population health. (Branswell, 4/14)

The Washington Post: Giving Young Blood To Older Animals Raises Tantalizing Possibilities For People
Dracula may have been onto something. It wasn’t just blood, but the blood of youth that was the secret to staying alive for centuries. The rejuvenating effect of young blood has been demonstrated in strange, draculoid experiments first done 150 years ago. Two genetically compatible animals, one young and one old, are sewn together. With their circulatory systems connected, the old animal gains access not only to the younger animal’s blood but also to the detoxifying and metabolizing function of its organs. The state is known as heterochronic parabiosis. (Brown, 4/14)

Los Angeles Times: What The New, FDA-Approved 23andMe Genetic Health Risk Reports Can, And Can’t, Tell You
Genetic testing firm 23andMe got approval from the Food and Drug Administration last week to sell reports that show customers whether they have an increased genetic risk of developing certain diseases and conditions. The go-ahead is the first time the federal agency has approved such direct-to-consumer genetic tests and comes about three years after the FDA warned Mountain View, Calif.-based 23andMe to stop marketing its health reports because they lacked agency authorization. (Masunaga, 4/14)

Tampa Bay Times: Here’s Why Two Doctors Who Treated Pulse Victims Oppose A Plan For More Trauma Centers
But many trauma doctors, including some who treated the Pulse shooting victims, say that’s a bad idea. They say caps on the number of trauma centers ensure each is filled with highly trained specialists, in densely populated areas where they get plenty of practice treating everything from bullet wounds to car crash injuries. Critical lawmakers say Republicans are trying to fix something that already works. (Auslen, 4/17)

Dallas Morning News: Are Heartburn Medicines Linked To A Serious Gut Infection?
The pills you take to control heartburn and suppress stomach acid may be linked to increased risk of a serious gut infection. A study published late last month in JAMA Internal Medicine reports that people who take commonly used prescription and over-the-counter indigestion medicines such as Prilosec and Zantac are at risk of repeat infection with the bacteria Clostridium difficile. (Yasmin, 4/15)

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Lawmakers Strike Deal To Reauthorize FDA User Fee Agreements

The agreement extends the agency’s authority to collect fees from drug and medical device manufacturers. Without the fees, 5,000 Food and Drug Administration employees could be laid off and drug reviews would be prolonged.

Modern Healthcare: Lawmakers Reach Bipartisan Deal To Extend FDA User Fees 
Legislators reached a tentative deal Friday to reauthorize the FDA’s authority to collect user fees, extending funding to maintain and streamline the agency’s product approval process. The bipartisan leaders of the Senate’s and U.S. House of Representatives’ health committees released a draft of the bipartisan Food and Drug Administration Reauthorization Act Friday. The act would reauthorize the FDA’s four user fee agreements that renew the FDA’s authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, and several crucial programs at the FDA. The fees would incrementally increase year over year. (Kacik, 4/14)

Morning Consult: Senior Republicans, Democrats Reach Deal On FDA User Fee Reauthorization
Top Republicans and Democrats in Congress have reached a preliminary deal to extend funding for several programs that are crucial to the approval of new drugs and medical devices in the United States. The deal announced Friday would reauthorize four user fee agreements that drug and medical device makers and the Food and Drug Administration depend upon to get products approved. (Reid, 4/14)

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