Morning Briefing
Summaries of health policy coverage from major news organizations
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Federal Appeals Court Puts Chill On Maryland Law To Fight Drug Price-Gouging
The decision in Maryland鈥檚 case could slow momentum for other states that are attempting to take action to curb high drug costs.
Drug Test Spurs Frank Talk Between Hypertension Patients And Doctors
Roughly half of patients don't take their high blood pressure medicine as they should, even though heart disease is the leading cause of death in America. Now, a drug test can flag whether a patient is taking the prescribed medication and is meant to spark a more truthful conversation between patient and doctor.
Summaries Of The News:
Administration News
New CDC Director Divests Stock, Resigns From Four Groups To Comply With Ethics Standards
Centers for Disease Control and Prevention Director Robert Redfield has resigned聽his聽 positions at four groups, including a gene therapy biotechnology company and a conservative AIDS organization, to comply with government ethics rules, according to his financial disclosures. Redfield, a longtime HIV/AIDS researcher who started the job March 26, succeeded Brenda Fitzgerald, the former Georgia public health commissioner, who resigned Jan. 31 after serving only half a year because she was unable to divest from her financial holdings. She had also purchased tobacco stocks as CDC director. (Sun, 4/17)
In a Public Financial Disclosure Report, memorandum and letter reviewed by the Journal, Dr. Redfield, a veteran HIV/AIDS researcher, said he had resigned as a professor of medicine and from other posts at the University of Maryland. His compensation from the beginning of 2017 through March 2018 was $757,100 plus a $70,000 bonus.聽The CDC director鈥檚 compensation is $375,000. Dr. Redfield also resigned as consultant and chair of a clinical advisory committee for American Gene Technologies International Inc., a gene therapy biotech company; as a director of Children鈥檚 AIDS Fund International, an AIDS service organization with faith-based roots; and as a medical consultant for Guidepoint Global LLC, an advisory firm. He sold his stock in American Gene Technologies International and sold stock and forfeited options in Profectus Biosciences Inc., a vaccine development company. (McKay, 4/17)
In other administration news聽鈥
Health and Human Services Secretary Alex Azar is postponing a planned appearance before a Senate committee on Thursday as he recovers from an intestinal condition, an HHS official said Tuesday. The official said Azar, who was hospitalized overnight on Sunday before being released, has had his first bout of diverticulitis, an infection of pouches in the colon that can be painful. (Sullivan, 4/17)
Opioid Crisis
Bernie Sanders Wants To Impose Prison Sentences On Pharma Executives Who Play Role In Opioid Crisis
Sen. Bernie Sanders (I-Vt.) will introduce a bill Tuesday that would impose jail time for pharmaceutical executives whose companies engage in manipulative practices when marketing opioids. The legislation would impose a 10-year minimum prison sentence and fines equal to an executive鈥檚 compensation package if the individual鈥檚 company is found to have illegally contributed to the opioid crisis. It would also impose an additional fine on those companies of $7.8 billion 鈥 one-tenth the annual cost of the crisis, per a 2016 estimate. (Facher, 4/17)
The bill bans companies from marketing opioids to consumers as nonaddictive, and fines them 25 percent of profits from opioid products if they are found in violation. 鈥淭hey knew how dangerous these products were but refused to tell doctors and patients,鈥 he said. 鈥淵et, while some of these companies have made billions each year in profits, not one of them has been held fully accountable for its role in an epidemic that is killing tens of thousands of Americans every year.鈥 (Sullivan, 4/17)
In other news聽on the opioid crisis from Capitol Hill聽鈥
A House Energy and Commerce subcommittee will mark up legislation next Wednesday aimed at combatting the opioid epidemic. The April 25 markup in the panel鈥檚 health subcommittee comes as the panel's chairman pushes forward with his target of bringing a bill to the House floor by Memorial Day weekend. So far, lawmakers have reviewed more than 60 bills over three legislative hearings.聽(Roubein, 4/18)
U.S. Rep. Vern Buchanan announced an anti-drug plan Monday to address the growing opioid crisis. According to the Manatee County Republican, the bill will be introduced in the U.S. House later this week. The Opioid Emergency Response Act, is a seven-point plan built around ideas already introduced in Congress that adds incentives to use alternatives to addictive prescription opioids. (Martin, 4/17)
GOP New Hampshire Gov. Chris Sununu initially resisted a visit to his state from President Trump last month over the country's聽opioid addiction crisis, telling the White House that he didn't want his state used as a prop for the administration. CBS News reports 聽that Sununu battled White House aide聽Katy Talento, who sits on the White House聽Domestic Policy Council, over whether Trump could come to the state to promote his plan to battle the聽opioid聽epidemic聽while not providing additional funding for state initiatives. (Bowden, 4/17)
Proposed Rule Would Require DEA To Consider How A Drug Is Being Misused Before Setting Production Quotas
Drugmakers would be required to identify a legitimate need for controlled substances to justify their production under a proposed rule change intended to rein in the diversion of drugs for illicit purposes, the Drug Enforcement Administration announced Tuesday. According to the DEA, current regulations were issued in 1971 but need to be updated to reflect the nation鈥檚 opioid abuse crisis and changes in the manufacture of controlled substances. (Raby, 4/17)
Attorney General Jeff Sessions announced the publishing of the proposed rule changes in a speech in North Carolina, saying the action would help address the nation鈥檚 opioid problem, which he called 鈥渢he deadliest drug crisis in American history.鈥 Under the proposal, the Drug Enforcement Administration must consider how much drugs, particularly powerful opioid painkillers, are being misused, abused or causing overdoses when setting production quotas. The DEA will be required to assess information provided by government health agencies such as the Federal Drug Administration, as well as the states. (Wilber, 4/17)
鈥淯nder this proposed new rule, if DEA believes that a company鈥檚 opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make,鈥 Attorney General Jeff Sessions said Tuesday during remarks he gave on the opioid crisis in North Carolina. (Roubein, 4/17)
Opioid-Addiction Advocate Patrick Kennedy Stands To Reap Profits From Congress' Newly Opened Wallet
Patrick Kennedy, the former Democratic representative and scion of the liberal political dynasty, has emerged as the unlikely go-to player for companies seeking to benefit from the Trump administration鈥檚 multibillion-dollar response to the opioid crisis, reaping well over $1 million in salaries and equity stakes in the firms. The 50-year-old son of the late Sen. Edward M. Kennedy, who stepped down from Congress in 2011 amid his own decades-long battles with addiction and mental illness, is a high-profile mental health advocate who sat on President Donald Trump鈥檚 opioid commission. (Cancryn, 4/17)
Dozens of people were arrested Tuesday in a major drug trafficking sweep in Huntington, West Virginia, a city hit hard by the opioid epidemic. U.S. Attorney Mike Stuart said more than 200 federal, state and local law enforcement officers targeted nearly 100 people for arrests aimed at dismantling a multi-state distribution network. He said 30 arrests were made as of midday Tuesday in the state鈥檚 second-largest city. (Raby, 4/17)
There鈥檚 a new push to replenish the state fund designed to cut the cost of the life-saving drug naloxone, months after its financial backing quietly dried up, increasing the price local first responders pay by nearly twofold. Attorney General Maura Healey鈥檚 office confirmed Tuesday that it deposited $250,000 last week into the Municipal Naloxone Bulk Purchase Trust Fund, providing the account with its first fresh infusion since it was depleted last fall. (Stout, 4/17)
A coalition of Colorado law enforcement and health care providers said Tuesday that it will punish the 鈥減oison pushers鈥 who spread heroin and fentanyl, and it will offer a helping hand to Colorado鈥檚 many addicts. Heroin distributors and dealers need to know cops are coming for them with the full backing of the federal government, said U.S. Attorney Bob Troyer. But聽the newly formed Heroin Impact Project goes beyond the typical law enforcement focus on drug dealers. This time, they will be offering support to those who are struggling with addiction, he said. (Phillips, 4/17)
In 2016, the city of Miami saw 641 opioid-related overdoses, a 20 percent increase from the year before. Now, attorneys for the city have filed a lawsuit in Miami-Dade County circuit court alleging that drug manufacturers violated Florida law by aggressively and deceptively marketing opioids as safe.聽The 134-page suit filed Monday alleges that the drug-manufacturing industry worked to cultivate a narrative 鈥渢hat pain was undertreated,鈥 which paved the way for increased prescribing of opioids for chronic pain. (4/17)
Emergency room physicians and hospital officials in Maryland say they have become overwhelmed with such patients in need of treatment for mental health or substance-use problems. Emergency room visits in Maryland fell 8 percent from 2013 to 2016, but the number of patients with behavioral health problems jumped 18.5 percent. Such cases now make up roughly a quarter of all emergency visits in Maryland. (Cohn and McDaniels, 4/18)
As the U.S. continues to grapple with a deadly opioid epidemic, a top health official in the Trump administration says all options should be on the table for addiction treatment 鈥 including medication. 鈥淚t takes a culture change,鈥 said Elinore McCance-Katz, a physician and assistant secretary of mental health and substance abuse for the U.S. Department of Health and Human Services. (Luthern, 4/17)
Veterans' Health Care
VA Nominee Commits To Stance Against Privatization, A Top Democratic Senator Says
President Donald Trump's pick to be Veterans Affairs secretary is promising not to privatize the agency, a key Democratic senator said Tuesday, taking a stance on a politically charged issue that his predecessor says led to his firing. The confirmation hearing of Ronny Jackson, Trump's White House doctor and a Navy rear admiral chosen to speed up improvements to the VA, is scheduled for next week. On Tuesday, he met privately with Sen. Jon Tester of Montana, the top Democrat on the Senate Veterans Affairs Committee, as a part of visits this week to assure lawmakers he could effectively lead the government's second-largest department. (Yen, 4/17)
Sen. Jon Tester (Mont.), the ranking Democrat on the Senate Veterans鈥 Affairs Committee, said Jackson pledged during a one-on-one meeting that he is against privatization. 鈥淗e said all the right things, seems to have the same position on privatization that Shulkin had,鈥 Tester told reporters. 鈥淗e answered the questions right on privatization.鈥 Political tensions about privatization could complicate the confirmation process. (Weixel, 4/17)
In other news聽鈥
It was a cold, sunny day last spring when retired U.S. Army Specialist Michael McCoy visited the war memorial in Cumberland, Md., to look for the name of Pfc. Albert M. Nelson. Mr. McCoy, who grew up in West Baltimore, and Mr. Nelson, who was from West Philadelphia, became close friends in 2006 just before Mr. McCoy鈥檚 second of two yearlong deployments to Iraq. Mr. Nelson was a bit of a joker and, at 31, a few years older than the other soldiers. He was a big brother figure, well liked, especially by Mr. McCoy. (O'Reilly, 4/18)
Marketplace
UnitedHealth's Evolution From Traditional Insurer Into Multifaceted Business Pays Off
UnitedHealth Group Inc. posted a 31% increase in profit for its latest quarter and raised its earnings outlook for the year. UnitedHealth, the parent of the biggest U.S. health insurer, on Tuesday reported a first-quarter profit of $2.84 billion, or $2.87 a share, up from $2.17 billion, or $2.23 a share, a year earlier. The company earned $3.04 a share on an adjusted basis, compared with $2.37 a share. (Prang, 4/17)
As health insurance companies continue to evolve from their traditional role as claims processors to care facilitators and blur the lines between payer and provider, UnitedHealth leads the pack. Other insurers are playing catch-up. The insurer has been adding doctor practices and lower-cost outpatient facilities to its portfolio of businesses in a bid to better control where patients access care. Most recently, its Optum subsidiary in December said it would buy DaVita's medical group, which boasts 300 medical clinics, along with 35 urgent-care centers and six outpatient surgery centers. The insurer also picked up Surgical Care Affiliates, an operator of ambulatory surgery centers, and MedExpress, an operator of urgent-care clinics, in recent years. (Livingston, 4/17)
During a conference call Tuesday to discuss first-quarter results, Renfro said the venture fund will invest in a variety of emerging health care technologies including digital care, consumer care and health analytics with artificial intelligence, big data and machine learning. "A tremendous effort will go into ventures," Renfro said. "We hope to accelerate early-stage, open-market innovations across the breadth of the health care services marketplace, with up to $600 million in newly committed funds." (Snowbeck, 4/17)
The Only Way To Fix Health Care Is To Break The Current Business Model, Advocates Say
It鈥檚 the stuff disruptors dream of. A group of Seattle doctors and investors had a plan to revolutionize primary care by freeing themselves, and their patients, from the dictates of insurance. They would charge a monthly membership fee for delivering on-demand medical services. No insurance bureaucracy. No reimbursement delays. No incomprehensible bills. In 2010, Amazon founder Jeff Bezos became one of the project鈥檚 biggest investors, providing an infusion of capital and the instant credibility his name conveys. The company, called Qliance (pronounced Key-liance), scored early successes in Seattle but faltered amid a series of financial setbacks. It closed its doors last summer. (Ross, 4/18)
In other health industry news聽鈥
Ford Motor Co said on Wednesday that it was expanding a medical transport service called GoRide in Southeast Michigan, one of several efforts by the U.S. automaker to build new ride service businesses around its Transit commercial van. Under a multi-year agreement with Michigan healthcare system Beaumont Health, Ford will use Transit vans to transport patients to medical appointments, or from hospitals to home or rehabilitation centers. (White, 4/18)
Public Health
Mice In New York City Found To Be Carrying Dangerous Drug-Resistant Bacteria
Potentially聽harmful germs dwell inside聽the guts of urban mice, according to a team of scientists who trapped more than 400 of the rodents around聽New York City. The researchers, conducting the largest survey of microorganisms living in city mice, also identified several genes that give germs resistance to antibiotic聽drugs. 鈥淭his doesn't tell us that these mice are directly responsible for infecting humans,鈥 said W. Ian Lipkin, director of Columbia University's聽Center for Infection and Immunity.聽鈥淏ut they have the potential to do so.鈥 (Guarino, 4/17)
In addition, the mice carried 36 types of viruses, most of which had never before been seen in mice. Mice found in the Manhattan neighborhood of Chelsea, which were fatter than other mice, harbored the greatest number of viruses. The results were published in the journal mBio. The precise level of dangerousness of New York City mice feces was, until now, not fully researched. The findings, in part, confirm common sense: Mouse droppings really are stomach-churning. For the immunosuppressed, ill or very old, mice with pathogenic microbes can be especially dangerous. (West, 4/17)
"You not only have mice carrying bacteria that have the potential to cause human disease, but also carrying bacteria that have components that actually would thwart our ability to treat these infections with antibiotics," (Dr. Ian) Lipkin says. Lipkin stresses that the researchers haven't actually linked mice to any large outbreaks of human disease. So people shouldn't overreact whenever they see a mouse in the house. But they should take steps to protect themselves. (Stein, 4/17)
Just because certain bacteria are present does not suggest they are going to be pathogenic 鈥 meaning they can first infiltrate our systems and then cause disease, said Timothy Walsh, an expert on antimicrobial resistance at Cardiff University, who was not involved with the study. Past research has found similar bacterial warning signs in mice in other parts of the world, but they haven鈥檛 led to outbreaks of human disease. (Joseph, 4/17)
Technology That Can Turn Ordinary Skin Cells Into Eggs Or Sperm Is A Lot Closer To Reality Than Science Fiction
So you want to have a baby. Would you like a dark-haired girl with a high risk of someday getting colon cancer, but a good chance of above-average music ability? Or would you prefer a girl with a good prospect for high SAT scores and a good shot at being athletic, but who also is likely to run an above-average risk of bipolar disorder and lupus as an adult? (Ritter, 4/18)
In findings with potentially broad implications for the public's health, new research has found that some women who treat their high blood pressure with a class of drugs that relaxes the blood vessels were more likely to develop pancreatic cancer than those who use other hypertension medications. In a large and intensively-studied group of middle-aged and older women, the risk of developing pancreatic cancer was more than twice as high for those who took a short-acting calcium channel blocker for more than three years. (Healy, 4/17)
Falls are a leading cause of injury and death among older adults. In 2014, about 1 in 3 adults aged 65 and older reported falling, and falls were linked to 33,000 deaths. If you want to reduce the risk of falling, regular exercise may be your best bet, according to the latest recommendations from the U.S. Preventive Services Task Force. The influential group came to that conclusion after reviewing evidence from about 20 studies that included adults 65 and older. (Aubrey, 4/17)
There is considerable research showing that nuts, with their high levels of unsaturated fatty acids, fiber and minerals, may help reduce the risk for cardiovascular disease. But a large Swedish analysis published in Heart has found that the benefits are limited and depend largely on other healthy behaviors. Researchers followed 61,364 adults for up to 17 years. They had all completed questionnaires on diet, lifestyle and other risk factors for chronic disease. (Bakalar, 4/17)
J茅r么me聽Hamon is the first person in the world to receive two face transplants. And a few months after receiving his second transplant in January,聽he聽spoke to reporters and told them that he was feeling well. 鈥淚 still have moments when I鈥檓 exhausted, but overall I feel well,鈥 he said. (Rosenberg, 4/17)
Kaiser Health News: Drug Test Spurs Frank Talk Between Hypertension Patients And Doctors
There鈥檚 an irony at the heart of the treatment of high blood pressure. The malady itself often has no symptoms, yet the medicines to treat it 鈥 and to prevent a stroke or heart attack later 鈥 can make people feel crummy. 鈥淚t鈥檚 not that you don鈥檛 want to take it, because you know it鈥檚 going to help you. But it鈥檚 the getting used to it,鈥 said Sharon Fulson, a customer service representative from Nashville, Tenn., who is trying to monitor and control her hypertension. (Farmer, 4/18)
There鈥檚 a lot on the line this week for Sanofi Pasteur鈥檚 troubled dengue vaccine, Dengvaxia. On Wednesday, an expert panel that advises the World Health Organization will vote to update its recommendations outlining how and when the vaccine should be used 鈥 and more importantly, how and when it should not be administered. A decision is expected Thursday. (Branswell, 4/17)
State Watch
State Highlights: Calif. Medical Students Call For Health Care Equity After Stephon Clark's Shooting; State Lawmakers Back Off On Curtailing LGBT Rights
Lying on the cement in front of the University of California, Davis School of Medicine in Sacramento, roughly 100 medical students participated in a "die-in" protest Tuesday, urging healthcare providers to do more to help people experiencing trauma after police incidents. Tuesday's event was hosted by the school's chapter of White Coats 4 Black Lives, a national group founded in 2015 in the aftermath of the police shooting of Michael Brown and the in-custody death of Eric Garner. (Chavez, 4/17)
In a striking shift from recent years, major legislation curtailing LGBT rights has been completely stymied in state capitols around the country this year amid anxiety by Republican leaders over igniting economic backlash if they are depicted as discriminatory. In the thick of this year's legislative sessions, LGBT activists were tracking about 120 proposed bills that they viewed as threats to their civil rights. Not one of them has been enacted as many sessions now wind down; only two remain under serious consideration. (4/17)
Ohio lawmakers blocked cities and villages from enacting their own gun laws 12 years ago, but now they want to remove any wiggle room that could allow new restrictions and penalties in local communities. Language inserted months ago into a "stand your ground" bill is getting new attention from city leaders who want to pass gun laws in the wake of shootings in Parkland, Florida, and Las Vegas. (Borchardt, 4/17)
The owner and operator of 15 Kansas nursing homes has consented to be placed in receivership after defaulting on payments to vendors and failing to meet payroll. Kansas Department for Aging and Disability Services Secretary Tim Keck has been appointed receiver and will oversee operations of the homes, which are scattered across the state. The owner, Skyline Health Care LLC of Wood-Ridge, New Jersey, previously acknowledged that it had insufficient funds to pay basic utilities and food service vendors. (Margolies, 4/17)
In the campaign video, the little girl wearing ponytails and Mary Janes looks bewildered. There鈥檚 a man beside her at the sink in a public restroom. He鈥檚 putting on lip gloss. 鈥淎 little girl shouldn鈥檛 have to wonder why there鈥檚 a man using the women鈥檚 bathroom,鈥 says the child narrator. Expect many similar images this year as Massachusetts becomes ground zero in the latest round of the nation鈥檚 culture wars. A November ballot question asking voters whether to keep or repeal the state鈥檚 2016 antidiscrimination law is expected to be the first statewide referendum on transgender rights, taking the national temperature on a fiery hot social issue. (Ebbert, 4/17)
The pressure from Gov. Nathan Deal evidently worked. Deal announced聽Tuesday聽afternoon that Blue Cross and Blue Shield of Georgia and Piedmont Healthcare had reached a 鈥渉andshake鈥 agreement on a new contract. The accord thus met his deadline of close of business聽Tuesday, after which the state would have been forced, in his words, 鈥渢o initiate executive action.鈥 (Miller, 4/17)
Women's reproductive health advocates are calling on New York officials to take steps to reduce the state's maternal mortality rate among black women. Planned Parenthood of New York leaders, state Assembly members and maternity health services providers held a news conference in Albany Monday to call for action to reduce the state's national ranking of 30 out of 50 states when it comes to maternal deaths. (4/17)
An Overland Park hospital that specializes in weight-loss surgery is suing government health officials after they cut off its participation in Medicare. Blue Valley Hospital (BVH), an acute care facility at 129th Street and Metcalf Avenue, claims to perform 35 percent of all Missouri Medicaid bariatric surgeries, the umbrella term for weight-loss operations. If it loses its Medicare funding and has to shut down, 鈥渢he residents of Kansas and Missouri will lose access to crucial bariatric procedures, which are necessary to prevent a multitude of life-threatening and life-altering conditions,鈥 the suit alleges. (Margolies, 4/17)
Tampa General Hospital is throwing its support behind a bipartisan proposal that, if passed by Congress, would allow it and other large health-care systems to challenge how the government estimates additional Medicare payments. U.S. Sen. Marco Rubio, R-Fla., and U.S. Sen. Bill Nelson, D-Fla., are filing legislation Tuesday that would strike a provision in current law that precludes hospitals from challenging such payment decisions or the data used in reaching the decisions. (4/17)
A federal whistleblower complaint alleges that a major California insurer failed to pay an estimated $89 million in taxes on premium revenue as required under the Affordable Care Act. The complaint against Blue Shield of California focuses on the taxation of certain health plans that are funded by both an employer and insurer. It could spark more scrutiny by federal officials into whether all insurers are paying their fair share of taxes on premiums. (Terhune, 4/17)
Nearly 8,300 Washingtonians die from tobacco-related illness each year: more than car crashes, suicide, opioid overdoses and alcohol combined. And smoking costs Washington an estimated $2.8 billion per year in direct medical costs, including almost $790 million in Medicaid spending. Yet, with nearly 900,000 smokers in the state and $622 million in tobacco-related tax collections, Washington spends almost no money on programs to help people quit. (Alexander, 4/17)
New Hampshire's new child advocate is pressing for changes to the law to strengthen her office's ability to protect the state's most vulnerable residents. Lawmakers created the office last year as part of larger effort to reform New Hampshire's Division of Children, Youth and Families, which has been under scrutiny since two toddlers under its supervision were killed in 2014 and 2015. (4/17)
A Florida man has been sentenced to more than a year in prison for his role in a $23 million auto insurance fraud involving chiropractors' clinics. The SunSentinel reports 55-year-old Jason Dalley wept in court Monday as a judge sentenced him to spend a year and nine months in prison and pay more than $1.8 million in restitution. (4/17)
A 66-year-old woman who was sickened by E. coli is suing Panera Bread after apparently eating contaminated romaine lettuce at a restaurant in New Jersey. Louise Fraser first experienced abdominal pain within days of eating at聽a restaurant in Somerset County, according to a federal complaint. Then came bloody diarrhea and vomiting that sent her to the emergency room March 25. Doctors diagnosed hemolytic uremic syndrome, a life-threatening illness that聽happens to聽a small number of people infected with聽Escherichia coli聽and can lead to kidney failure. (Phillips, 4/17)
Water at one of Sacramento鈥檚 most popular public beaches regularly records E. coli levels far higher than what federal regulators recommend as safe for recreational use. Tiscornia Beach, at the confluence of the American and Sacramento rivers near Discovery Park, recorded E. coli levels in February that were seven times the threshold set by the Environmental Protection Agency, according to new weekly testing by the Central Valley Regional Water Quality Control Board. (Fletcher, 4/17)
Los Angeles Mayor Eric Garcetti has a new plan to try to solve the city's homeless crisis. Garcetti would like to spread temporary shelters across the city, placing one in each of L.A.'s 15 council districts. There's also a promise of more enforcement to keep the areas near those shelters clear of homeless encampments. It's an ambitious plan with a $20 million price tag. Andy Bales is CEO of the Union Rescue Mission. The mayor's proposal is a good first step, Bales said, but more needs to be done.聽(Henderson, 4/16)
Prescription Drug Watch
Tying Drug Costs To Performance Is A Favored Strategy To Tackle Prices, But Past Failures May Damper Enthusiasm
The Trump administration is pushing drug plans that tie costs to performance as a way to lower health-care spending in the U.S. In Italy鈥攚here they鈥檝e used the strategy for years鈥攕uch plans haven鈥檛 brought down costs. A number of global drug companies, in response to criticism of high prices in the U.S., have recently committed to tying the cost of some of their most-expensive treatments to how well they work. So called 鈥渙utcomes-based鈥 contracts鈥攚hich reimburse insurance companies for treatments that turn out to be ineffective鈥攈as been trumpeted by the industry as a way to lower health-care costs, while also avoiding broad price cuts. (Bisserbe, 4/17)
President Trump is scheduled to give a speech on drug prices next week, but few expect the policy proposals that will accompany it to pack a real punch to the pharmaceutical industry 鈥 unless the president goes off-script. What they're saying: 鈥淲e are hopeful the administration will embrace market-oriented policies that address patient affordability ... We would obviously be concerned if the administration pursued Medicare negotiation or importation which we think would take the system in the wrong direction," said Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America. (Owens, 4/16)
The cost of new anti-cancer drugs increased more than five-fold from 2006 to 2015, but a new analysis suggests that cancer patients and insurers may be getting less for their money. Anticancer medications account for the lion鈥檚 share of global drug spending, and the average price per month of these drugs is known to have more than doubled in recent years, Dr. Kelvin Chan of Sunnybrook Health Sciences Centre in Toronto and colleagues note in the Journal of Oncology Practice. (4/12)
Hours after markets closed on Bristol-Myers Squibb Co.鈥檚 worst day in more than a year, executives used a sugary analogy to explain to Wall Street why the drugmaker鈥檚 new cancer treatment would do just fine against its main competitor. 鈥淧oint blank, these are Coke and Pepsi in lung cancer, OK?鈥 Bristol-Myers Chief Scientific Officer Thomas Lynch told a hotel ballroom packed with analysts and investors at a major medical conference in Chicago. Merck & Co.鈥檚 drug, Keytruda, had shown impressive results at the conference -- but Bristol-Myers was right there with it, Lynch said. (Hopkins and Lipschultz, 4/17)
Merck & Co. is making one of the biggest bets on a single drug in the pharmaceutical industry, a move that is risky but that could, if successful, pay off for the company and a broad array of cancer patients. Merck鈥檚 Keytruda, a new type of cancer drug that harnesses patients鈥 immune systems to fight tumors, is already marketed to treat lung, skin, bladder and other cancers. Global sales soared to more than $3.8 billion in 2017鈥攁bout 9% of Merck鈥檚 total revenue鈥攆ueled by a monthly U.S. price tag of $13,500 and studies showing it prolongs patient survival in some cancers. (Loftus, 4/15)
With an eye toward making a low-cost hepatitis C treatment available in numerous countries, a nonprofit says that a mid-stage study showed an experimental combination of two pills appeared safe and effective, while offering high cure rates for hard-to-treat patients. The results were greeted with enthusiasm by patient advocacy groups, because once testing is completed, the nonprofit hopes to register the combination treatment in middle-income countries, starting with Malaysia, where it could be sold for $300, or about half the price of existing treatment in that country. (Silverman, 4/12)
Kaiser Health News: Federal Appeals Court Puts Chill On Maryland Law To Fight Drug Price-Gouging
States continue to battle budget-busting prices of prescription drugs. But a federal court decision could limit the weapons available to them 鈥 underscoring the challenge states face as they, in the absence of federal action, go one-on-one against the powerful drug industry. The 2-to-1 ruling Friday by the U.S. 4th Circuit Court of Appeals invalidated a Maryland law meant to limit 鈥減rice-gouging鈥 by makers of generic drugs. The measure was inspired by cases such as that of former Turing Pharmaceutical CEO Martin Shkreli, who raised one generic鈥檚 price 5,000 percent after buying the company. (Luthra, 4/17)
Highmark Health, a Pittsburgh-based Blues plan, has entered into a value-based drug-pricing contract with pharmaceutical company AstraZeneca for Symbicort, which is used to treat asthma and other chronic lung diseases. Under the contract, Highmark said it will track whether the symptoms of its plan members using Symbicort are in line with the results of AstraZeneca's clinical trials. If the drug doesn't live up to its promise, AstraZeneca will provide Highmark with some savings. Highmark didn't release specifics on the agreement's financial terms, but said the contract applies to commercial members in Pennsylvania, West Virginia and Delaware. (Livingston, 4/17)
Using data from聽MyLogIQ, which collects data from filings from the Securities and Exchange Commission,聽we charted the median salaries for 32 biopharma companies, ranging from the tiny Geron to the multinational Johnson & Johnson. The result: The drug business pays better than any other industry, according to聽MyLogIQ. (Garde, 4/16)
A new drug-pricing advocacy group on Tuesday announced its first endorsement of the 2018 campaign, backing Rep. David McKinley (R-W.Va.) for聽standing up to pharmaceutical companies. The group, Patients for Affordable Drugs NOW, which was founded this year, says it will spend six figures on the race and is seeking to help counterbalance pharmaceutical companies鈥 spending in November's midterm elections. (Sullivan, 4/17)
Douglas Fambrough III had good news about his fledgling biotech company when he met with a roomful of investment analysts in a swanky midtown Manhattan hotel on a November morning in 2014. During a half-hour presentation at the Lotte New York Palace, the chief executive of Dicerna Pharmaceuticals Inc. showed 19 slides that gave an overview of his Watertown, Mass., firm. The 11th one featured a diagram with circles and squiggly lines. It represented a new delivery system for gene-silencing drugs that Dicerna hoped to develop to treat rare disorders. (Saltzman, 4/17)
In biopharma, patents are everything. In tech? Not so much. Which is why it was unusual to see a company that鈥檚 trying to turn software into medicine announce this week that it鈥檚 bagged several patents. Boston-based Akili Interactive Labs鈥檚 new patents, issued聽in the U.S. and Japan, are meant to deter competitors from copying the algorithms underlying the video games it鈥檚 developing to try to treat conditions like ADHD, depression, and聽multiple sclerosis. (Robbins, 4/13)
The Food and Drug Administration lags behind its European counterpart when it comes to approving biosimilars 鈥 but a top agency official insisted Tuesday that the agency is not as far behind as some critics suggest. Leah Christl, the associate director for therapeutic biologics at the FDA鈥檚 Center for Drug Evaluation and Research, pushed back on an oft-cited statistic that shows the European Medicines Agency has so far approved more than 40 biosimilars, drugs that are almost identical to biologics, compared to just nine approved in the U.S. by the FDA. (Mershon, 4/17)
Johnson & Johnson reported higher-than-expected sales in its latest quarter and boosted its sales outlook for the year despite ongoing pricing pressures for its prescription drugs and medical devices. J&J said it planned to cut costs in its supply chain by $600 million to $800 million a year by 2022. To carry out the changes, J&J expects it will take $1.9 billion to $2.3 billion in charges over the next several years. (Rockoff, 4/17)
For companies readying medicines for regulatory approval, the Food and Drug Administration can take up to half a year to issue follow-up warning letters over problematic manufacturing facilities. Last year, the median time it took the agency to issue a warning letter was 191 days, or slightly more than six months after closing an inspection and sending a so-called 483 form to a drug maker, according to a report released by the FDA. (Silverman, 4/17)
Sale adds to Brandicourt鈥檚 transactions to overhaul SanofiSanofi plans to sell its European generic-drug unit to buyout firm Advent International Corp. for 1.9 billion euros ($2.4 billion) as part of a broader move by Chief Executive Officer Olivier Brandicourt to focus resources on biotechnology and new medicines.聽Advent has made a binding and fully financed offer, and the companies are in exclusive negotiations, Paris-based Sanofi said in a statement Tuesday. The deal should close by the end of the year, it said. (Serafino and Baigorri, 4/17)
A Canadian online pharmacy company that figured prominently in a scandal several years ago over a counterfeit cancer medicine sold to U.S. doctors has been fined $34 million, a penalty that a nonprofit advocacy group with ties to the pharmaceutical industry called a 鈥渟lap on the wrist.鈥 Companies controlled by Canada Drugs had sold $78 million in聽mislabeled and unapproved medicines, including two counterfeit batches of the Avastin cancer treatment, that were made in several countries, according to federal prosecutors. The version of Avastin that was sold to U.S. doctors in 2011 did not contain any active ingredient. The brand-name medicine is marketed by Roche. (Silverman, 4/16)
Drug giant Bristol-Myers Squibb is partnering with Illumina, the leading maker of DNA sequencing gear, to develop diagnostic tests that will pair with Bristol's cancer drugs. One of the first tests will be for tumor mutation burden, a measure of how much a tumor's DNA has changed compared to the patient's healthy cells. Cancer drugs that target the immune system, like Bristol's Opdivo (2017 sales: $4.9 billion) and Yervoy (2017 sales: $1.2 billion), may work better in patients where the tumor mutation burden is higher, because this may make the cancer easier for the immune system to "see." (Herper, 4/13)
A new poll found that many Connecticut residents are concerned about rising drug prices, and state lawmakers are now trying to pass a bill to hold drug companies accountable. Berlin resident Greta Stifel was diagnosed with a rare cancer in 2015.鈥淗aving a chronic illness requires extensive work to find the right treatment and medical team,鈥 she said. 鈥淭he last thing I need is to figure out how to afford my medications.鈥 (Rayner, 4/12)
Perspectives: Technologies Like Artificial Intelligence Poised To Bring Skyrocketing Drug Prices Down To Earth
The cost of drug development has skyrocketed, but disruptive technologies can bring it back down to earth. Over the past several decades, drug-development costs have risen significantly, from $250 million per approved drug prior to the 1990s to $403 million in the 2000s and $873 million in 2010 ($1.778 billion if capitalization over the 14-year approval period is accounted for). Costs are distributed across the development cycle, with about one-third in discovery/preclinical development, two-thirds in clinical development and 5% in submission-to-launch. (Gunjan Bhardwag, 4/16)
Johnson & Johnson is in rarefied air. The world's largest health-care company (at $348 billion in market value, topping Pfizer by more than $130 billion) on Tuesday reported quarterly earnings and revenue that beat analyst estimates -- which has become a routine -- and raised its sales forecast for the year. But for all of its strengths, the company's hefty valuation leaves it little room for error.聽(Max Nisen, 4/17)
As President Trump seeks to lower drug prices, he should consider introducing an export price floor on foreign drug sales. That course of action would allow U.S. drug manufacturers to earn higher revenue on their foreign sales and thus offset the exorbitant prices they charge U.S. consumers. But an export price floor would also offer a moral market correction.After all, the current U.S. export market for drug sales is neither fair on U.S. consumers nor reflective of free market forces. (Tom Rogan, 4/17)
ver the last decade, the price of naloxone, a medication used to reverse the effects of opioids and prevent overdoses, has skyrocketed. One naloxone delivery system, Evizo, was priced at $690 in 2014 but is $4,500 today, a price increase of more than 500 percent, which makes it impossible for most Americans to access.In response, Connecticut lawmakers have聽proposed legislation that could help stabilize the price of this life-saving medication. (Nicholas John and Carrie Wade, 4/16)
Recently, FDA Commissioner Scott Gottlieb addressed those in attendance at America鈥檚 Health Insurance Plans鈥 (AHIP) National Health Policy Conference. His comments created a lot of visibility around several critical topics, including patient access to innovative treatments, cost-effectiveness, and the role that biosimilars 鈥 biologic products that are highly like already-approved and marketed medicines (called reference or originator products) 鈥 play in helping deliver access and cost-savings. A report from the Kaiser Family Foundation in 2015 found that 29 of the 50 most expensive drugs by Medicaid spending per prescription are biologics, many of which have faced no competition in the U.S. for more than a decade. (Vas Narasimhan, 4/12)
After losing out on one of the biggest leveraged buyouts in recent years, Advent International Corp. is getting its own back. The private equity firm is in exclusive talks to buy Sanofi's European generic drugs business -- almost a year after trying to land German peer Stada Arzneimittel AG and being outbid by聽Bain and Cinven. (Chris Hughes, 4/17)
Editorials And Opinions
Viewpoints: Facebook Also Wants To Profit On Info About Your Health; Pull The Plug On Trump's Latest Bad Pick To Oversee The CDC
Let鈥檚 say you have had discussions on Facebook about your breast cancer diagnosis. It has been a useful forum for comparing treatment options with others who have dealt with similar health issues. There鈥檚 only one problem: Facebook has now categorized you as a patient, and you constantly receive precisely targeted ads about cancer services available near you. They are showing up on your computer screen at work, for all your co-workers to see, right when you鈥檙e up for a big promotion. Many users experience a version of this scenario when they receive creepily personalized ads while browsing on Facebook. When those ads follow users onto sites outside Facebook, it feels like an invasion of privacy. But how do you regulate data privacy in an age of big-data black boxes? (Kirsten Ostherr, 4/18)
The director of the Centers for Disease Control and Prevention is arguably the nation鈥檚 chief public health officer, someone who should be the trusted face of an agency that plays a critical role in everything from highway safety campaigns to Ebola and flu research. If only the Trump administration felt the same way. The White House raised eyebrows in public health circles last month when it named Dr. Robert Redfield as director of the CDC, in part because the administration seemed to overlook longstanding doubts about his research. ...Senator Patty Murray of Washington, the ranking Democrat on a key health committee, wrote a letter asking President Trump to reconsider the appointment, citing a 鈥減attern of ethically and morally questionable behavior.鈥 (4/18)
Five years ago, my 9-year old daughter and I were approaching the finish line of the Boston Marathon when bombs exploded in two different sites. I will never forget the feelings I had as a father shielding his daughter from the surrounding chaos, a husband looking for his wife who was running the marathon, and a surgeon trying to get to the hospital to help those who were injured. Although three people died that day, nearly 300 others who were injured were saved by a combination of heroic efforts from bystanders and nearby medical and emergency personnel. First responders, both civilian and professional, used belts, apron strings, and even new clothes to control bleeding from injured limbs. At the most basic level, these pre-hospital heroes employed improvised versions of an often-overlooked device: the tourniquet. (Jeffrey Kalish, 4/16)
When the Centers for Disease Control and Prevention makes maps examining the health of Americans, my state of Mississippi lights up red, as do other states in the rural South. Part of the problem is that people living here often lack the information they need to stay healthy or manage their conditions. Far too often, information that would be relevant to them just doesn鈥檛 exist. That鈥檚 because people from communities like mine in the Mississippi Delta 鈥 rural citizens, those with low incomes, and people of color 鈥 tend not to participate in health research. (Freddie White-Johnson, 4/18)
The food that people eat has become a major risk factor for disability and death worldwide. Yet countries and their philanthropic supporters seem not to be paying attention. They're investing far too little in improving diets and preventing nutrition-related disease. (Jessica Fanzo, 4/17)
Last month, I traveled to Puerto Rico to get a handle on what doctors are seeing on the island now, six months after the storm. Doctors there say that poor data collection and underreporting are hiding a health crisis whose true scale eclipses official accounts. ...The problems are particularly acute for chronically ill patients. Wendy Matos, a physician who supervises nearly 470 doctors as the executive director of the University of Puerto Rico鈥檚 faculty practice plan, said that her clinics are seeing increases in cardiac arrest and intracranial hemorrhage (bleeding inside the skull), more waterborne and infectious disease and swelling numbers of suicides since Maria. (Mekela Panditharatne, 4/18)
My patient and I were locked in a game of decision-making hot potato. 鈥淲hat would you do, Doc?鈥 he said. We鈥檇 been discussing whether he should get screened for prostate cancer. Such questions trouble most doctors. We often lob the choice back to patients, or 鈥渙n the one hand, on the other hand鈥 so much they start sympathizing with Harry Truman, who jokingly wished for one-handed advisers. (Dhruv Khullar, 4/17)
Doctors shouldn鈥檛 lie to their patients, even now when the parsing of words and the telling of white lies is common at the highest level of our government. But they do it all the time 鈥 sometimes for personal reasons but most of the time for what they believe is the good of their patients. ...But perhaps we sometimes lie for our own sake, and it is our feelings that need to be spared so we can get through the night without breaking down in the call room when all signs indicate the outcome will not be good. (Nana Matoba and Angira Patel, 4/17)
I recently paid my friend Megan Gogerty, a fellow East High School alum and playwriting instructor at the University of Iowa, a compliment on how measured and thoughtful she is 鈥 especially when she talks me through some crisis of depression or anxiety. I gushed that Megan always seemed so poised and that I admired and envied those qualities in her. Megan countered with more wisdom: "You get the greatest hits version of me. You don't see all the messy stuff behind the scenes." (Daniel P. Finney, 4/18)
For the politics of pot, the times they are a-changin鈥. But in which direction? For some politicians, that can depend on when you ask. For example, former House Speaker John Boehner, who was 鈥渦nalterably opposed鈥 to marijuana legalization as recently as 2015, announced on Twitter last week that he is joining the weed industry and the legalization cause. (Clarence Page, 4/17)