Morning Briefing
Summaries of health policy coverage from major news organizations
From Ńîąóĺú´«Ă˝Ň•îl Health News - Latest Stories:
Ńîąóĺú´«Ă˝Ň•îl Health News Original Stories
Would You Like Some Insurance With Your Insurance?
Gap insurance plans, used to cover out-of-pocket health expenses like high deductibles, are becoming increasingly popular among consumers and businesses.
Veterans Courted In California's Ballot Fight Over Curbing Drug Prices
The initiative would prohibit California state agencies from paying more for a prescription drug than what the Department of Veterans Affairs pays. Both sides are deploying veterans’ sympathetic and trusted image to win over voters.
Summaries Of The News:
Capitol Watch
Congress Still Battling Over Funding Bill That Includes Zika Money, But Optimism Grows
Top congressional leaders said Tuesday that negotiators are making slow but steady progress on a must-do spending bill to prevent a government shutdown next week and fund the battle against the Zika virus. Some tricky issues remain, but optimism was building that an agreement might be unveiled in the next day or two. Congressional aides said that progress included an offer from Republicans to drop especially controversial provisions that would have eased pesticide regulations under the Clean Water Act and blocked tighter regulations on the length of workweeks for truckers. (Taylor, 9/20)
With Florida's public laboratories taking as long as five weeks to deliver Zika test results to doctors and patients, federal and state health officials said this week that they are buying more supplies and equipment and hiring more workers to speed up the often lengthy process for diagnosing the virus. The Centers for Disease Control and Prevention announced on Tuesday that it had purchased about $2.5 million in laboratory resources to expand access to Zika testing and reduce wait times for results in several states, including Florida, where Gov. Rick Scott has repeatedly accused the federal government of failing to meet the state's needs. (Chang, 9/20)
In other news from Capitol Hill —
Legislation to speed the approval of new medical cures will not move in Congress before lawmakers leave town for the election despite a last-minute push, lobbyists and aides said. House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) is not planning to introduce a new version of his 21st Century Cures Act before the recess after all, the sources said. However, he is still hoping to get the legislation passed in the lame duck session after the election. (Sullivan, 9/20)
Health Law
Molina Healthcare Expands Its Medicaid Business To Become Key Player On Marketplaces
A California-based insurer that once sold mostly Medicaid plans has become a top competitor in ObamaCare’s marketplaces. In likely the toughest year yet for the reform law, Molina Healthcare is thriving in a market that’s seen high-profile departures from some of the nation’s largest health insurers. Dr. Mario Molina, the company’s CEO, attributes much of the company’s success to its long history of selling Medicaid plans, which forced it to rein in costs. (Ferris, 9/20)
Colorado residents who buy their health insurance themselves will pay 20 percent more on average next year, and, for the first time, residents in 14 counties will have the choice of only one carrier offering plans in their area via the state health insurance exchange. The increases are the largest in Colorado since the 2014 launch of the Affordable Care Act, also known as Obamacare. In some parts of rural Colorado, premium increases will top 40 percent, according to figures approved Tuesday by the Colorado Division of Insurance. However, tax credits for low-income residents will help blunt the impact of some of those increases, with consumers who currently receive the credits in line to see an average decrease of 11 percent in their premiums. (Ingold, 9/20)
Marketplace
Dispute Over Contract Reportedly Threatens Anthem, Yale Medicine Alliance
Yale Medicine, the medical practice that includes more than 1,400 Yale School of Medicine clinical faculty physicians, could leave Anthem Blue Cross and Blue Shield’s network next month if the two organizations don’t reach a contract agreement. The dispute pits Connecticut’s largest insurer against a major group of clinicians, and could affect thousands of patients. Anthem says Yale Medicine told the insurer it plans to terminate its contracts if they don’t reach an agreement by Oct. 7. (Levin Becker, 9/21)
For the first time in her life, 26-year-old freelance designer Susannah Lohr had to shop for health insurance this year. She called up a major insurer in the St. Louis area where she lives, and it offered her a plan with a hefty $6,000 deductible — that’s the amount she would have to cover herself before the insurance kicks in. When she balked, the salesman on the phone suggested that she could buy a “gap plan,” a separate policy for $50 a month to cover her deductible. (Sable-Smith, 9/21)
Administration News
Intense Personnel Clash Threatens To Hobble Office Monitoring Research Misconduct
A small government office that monitors misconduct in biomedical research is in turmoil, jeopardizing oversight of billions of dollars in grants to universities and other institutions around the country. Six of the eight investigators in the federal Office of Research Integrity have signed a letter hinting that they may leave, a move that could hobble federal efforts to detect data maÂnipuÂlaÂtion and other misconduct by laboratory researchers. The office’s new head has filed personnel actions against the two division directors she inherited and installed a new deputy to supervise the entire staff. (Bernstein, 9/20)
Public Health
How One Photo Captured The Toll Of The Opioid Epidemic
The photo that drove home the depth of America’s opioid crisis — two overdosed adults sprawled in the front of a car, while a little boy in a dinosaur T-shirt looked on from the back — did not shock authorities in this faded Rust Belt city. They see something like it nearly every day. Unconscious addicts are so frequently dumped in the hospital parking lot that administrators developed a special alert system to treat them. Paramedics have plucked overdose victims from roadside ditches, from the Walmart parking lot, and from living rooms across town. It has become routine for children to see a passed-out parent jolted to life with a dose of Narcan. (Ross, 9/21)
Many people struggling with opioid addiction can't find a doctor to provide medication-assisted treatment, even though it's highly effective. One reason could be that doctors who are qualified to prescribe the medication typically treat just a handful of patients. (Shute, 9/20)
Media outlets also offer coverage of the crisis out of the state —
American Indian tribal leaders from northern New Mexico — an area of the country devastated by heroin and opioid addiction — met with the U.S. Justice Department over ways to combat opioid abuse amid high overdose deaths among Native Americans. And both sides say much more needs to be done. (9/21)
Seattle officials are moving forward with a controversial plan for what would be the nation’s first supervised heroin-injection clinics — government-financed shooting galleries that supporters say can save lives but that critics say will only enable drug users. A new 99-page task force study envisions at least two safe-use facilities — one in Seattle, another in the suburbs — where heroin addicts can legally take narcotics while being monitored by medical personnel who can administer aid or call 911 if needed. (Anderson, 9/21)
Nobody called 911 when James Chavez overdosed on heroin in August 2011. Drug users knew that Marion police regularly charged people who overdosed — along with their friends — so Chavez's companions left the man facedown in a backyard. Two days later, Lt. B.J. Gruber stood over the man's corpse in that weed-choked yard and realized police in the city of 35,000 could not arrest their way out of a huge heroin problem. (Perry, 9/21)
There is no corner of the region not affected by the heroin crisis, said the leaders of Northern Kentucky's largest counties said at the Northern Kentucky Chamber of Commerce's State of Northern Kentucky event Tuesday. They agreed the epidemic is turning into a greater burden on the region's economy. The region, like many other parts of the country, is facing a major skilled-worker shortage. The reason? Many people cannot pass drug tests, say government officials and addiction specialists. (Hussein, 9/21)
With treatment for opioid addiction in distressingly short supply even as need increases year after year, Philadelphia’s behavioral health agency invited physicians and other medical providers to a half-day teach-in Tuesday titled the Buprenorphine Summit. The topic turned out to be enticing enough – and the problem big enough – that more than 200 health professionals showed up. (Sapatkin, 9/20)
More Older Americans Are Dying From 'Epidemic' Of Falling
Elderly people seldom want to talk about it. It’s scary, and if it’s happened to them and they’ve survived, they’re often embarrassed. And worried. One time too many and — whoosh — it’s off to a nursing home. But it’s happening more and more: People 65 and older are falling and an increasing number are dying as a result. Nationally, the rate of death after a fall jumped more than 35% between 2005 and 2014. (Rutledge, 9/20)
Health care is being swamped by the so-called silver tsunami: 10,000 seniors are turning 65 and becoming Medicare-eligible every day. But rather than ride the wave, investors in Silicon Valley and elsewhere are too focused on the shallower pool of younger, healthier Americans. (Diamond, 9/21)
Public Health Roundup: Chronic Fatigue Syndrome Treatment Often Wrong; Potential Cancer-Anxiety Link In Men
If your doctor diagnoses you with chronic fatigue syndrome, you’ll probably get two pieces of advice: Go to a psychotherapist and get some exercise. Your doctor might tell you that either of those treatments will give you a 60 percent chance of getting better and a 20 percent chance of recovering outright. After all, that’s what researchers concluded in a 2011 study published in the prestigious medical journal the Lancet, along with later analyses. Problem is, the study was bad science. And we’re now finding out exactly how bad. (Rehmeyer, 9/21)
Men over 40 who are plagued with the omnipresent of generalized anxiety disorder are more than twice as likely to die of cancer than are men who do not have the mental affliction, new research finds. But for women who suffer from severe anxiety, the research found no increased risk of cancer death. That finding, presented Tuesday at the European College of Neuropsychopharmacology’s Congress in Vienna, emerges from the largest study ever to explore a link between anxiety and cancer. It tracked 15,938 Britons over 40 for 15 years. (Healy, 9/20)
[Keith] Berkle, a surgeon with Virginia Women’s Center, started offering hysterectomies at the surgery center — which operates on an outpatient basis, without beds where patients can spend the night — earlier this year. But since 2008, he has been performing laparoscopic hysterectomies, which involve using incisions of about a centimeter in length or less in a patient’s abdomen — VanRensselaer’s had three — to remove the uterus. Traditionally, hysterectomies have been performed as abdominal procedures in which physicians use large incisions to remove the uterus. That type of surgery is associated with greater risk, experts said. (Demeria, 9/20)
According to his influential 2007 report for the American Journal of Public Health, when you look at all wisdom teeth, the likelihood of developing a problem is closer to 20 percent. Friedman said there may be a financial incentive because wisdom teeth extractions make up a large part of dental practice income. (Benavides, 9/20)
Health IT
Wearing A Fitness Tracker Might Be Counterproductive To Weight Loss, Study Finds
Fitness trackers remain wildly popular, but do they make us fit? Maybe not, according to a study that asked overweight or obese young adults to use the tiny tracking tools to lose weight. The 470 people in the study were put on a low-calorie diet and asked to exercise more. They all started losing weight. Six months in, half the group members started self-reporting their diet and exercise. The other half were given fitness trackers to monitor their activity. After two years, both groups were equally active. But the people with the fitness trackers lost less weight. (Ross, 9/20)
This year alone, 19 million people are scheduled to buy fitness wearables with a simple mission in mind: Get fit. But these purchases may have zero effect when it comes to weight loss, based on new research from the University of Pittsburgh. This two-year study — the longest of its kind on electronic fitness trackers — shows the average person on a weight loss program can cut more pounds without a workout wearable. (Akpan, 9/20)
Quality
In Own Versions Of Hippocratic Oath, Students Reaffirm Importance Of The Patient
As they don their white coats for the first time, a new crop of medical students nationwide is taking an oath — but it may not be the one you think. The Hippocratic oath has been out of fashion for a while. It doesn’t actually say, “do no harm,” but it does pledge allegiance to mythical goddesses, among other things. In its place are modernized oaths, which combine the idea of “do no harm” with vows to remember both the human beings on the other end of the stethoscope and their social and financial well-being when treating them. (Bailey, 9/21)
In other news —
On Wednesday, Tufts is expected to announce a $15 million gift from the Jaharis Family Foundation that will relocate the anatomy laboratory to the third floor, double its size, and equip it with advanced digital imaging equipment. A portion of the donation will also provide scholarships for students starting careers in family practice. The plans, officials said, reinforce Tufts’ commitment to dissection as a bedrock aspect of medical education, even as digital technology can provide detailed images of every nook and cranny of human anatomy. (Freyer, 9/21)
State Watch
Hospital Readmission Rates Falling Across Country
Hospitals across the nation, including in Ohio, are doing a better job of slowing the revolving door of hospital readmissions, new federal data show. Ohio is one of 49 states reporting declines of patient readmissions, and among 11 where percentages fell by more than 10 percent between 2010 and 2015, according to the Centers for Medicare and Medicaid Services. (Pyle, 9/21)
Kindred Healthcare will pay a $3 million penalty and close several sites after failing to implement corrections to its billing system under a corporate integrity agreement with the federal government. It's the largest such penalty issued to date. HHS' Office of Inspector General said Tuesday that the massive post-acute care provider failed to correct improper billing practices during the fourth year of its five-year corporate integrity agreement, stemming from a prior $25 million False Claims Act settlement with Gentiva Healthcare. Kindred acquired Gentiva in February 2015 in a $1.8 billion deal. (Teichert, 9/20)
Ascension is launching its largest ever advertising and marketing campaign to rebrand all of its hospitals. The national Catholic hospital giant is starting the rebranding at its hospitals and facilities in Michigan and Wisconsin, then gradually rolling it out to the rest of the country, said Ascension CEO Anthony Tersigni. The effort, Tersigni said, is aimed at getting patients and employees thinking about Ascension as a system that offers care locally but with the clinical and financial backing of the nation's largest not-for-profit hospital company. (Barkholz, 9/20)
Ascension Wisconsin will soon begin taking steps to make clear its status as the state’s second-largest health system. The health system will adopt the Ascension name for the hospitals, clinics and other operations of its four health systems in the state. With the name change, which will take place over the next 12 to 18 months, Wheaton Franciscan’s St. Joseph Hospital will become Ascension St. Joseph Hospital, for example, and Columbia St. Mary’s will become Ascension Columbia St. Mary’s Hospital. (Boulton, 9/20)
Reflecting a growing trend in health care, John Muir Health and UC San Francisco Health are teaming up to open a new outpatient center in Berkeley as soon as 2018. The 100,000-square-foot facility will be located in West Berkeley and offer urgent care and primary care practices staffed by John Muir physicians. There will also be specialty physicians from both John Muir and UCSF, imaging and lab services. (Ioffee, 9/20)
Children’s Mercy Hospital is partnering with Olathe Medical Center to provide pediatric urgent care and specialty clinics at an as-yet unbuilt facility on OMC’s 250-acre campus at 151st Street and Interstate 35. The partnership is the first between the two hospitals. It will allow Olathe Medical Center to take advantage of the wide range of expertise that Children’s Mercy has in treating children, especially those with complex medical conditions. “It ties in with our vision of providing a full continuum of care on the Olathe Medical Center campus,” Olathe Medical Center CEO Frank H. Devocelle said in an email. “We will be able to offer an enhanced level of services for children. (Margolies, 9/20)
Ark. Officials Report That Backlog Of Medicaid Application Reviews Will Be Clear By January
The state Department of Human Services is on schedule to eliminate its backlog of Medicaid applications overdue for review by year's end, officials reported to a legislative committee Tuesday. Department officials also reported for the first time that no recipients were overdue for an annual review of their eligibility. (Moritz, 9/21)
A legislative committee Tuesday approved putting a limit on a mental health benefit for Medicaid recipients, despite objections from providers who said it would disrupt patient care and force treatment facilities to close. Under the change approved by the Legislative Council's Administrative Rules and Regulations Subcommittee, Medicaid reimbursement for group psychotherapy would be limited to one hour a day, instead of an hour and a half a day. (Davis, 9/21)
It could be as long as a year before a new state law allowing doctors to charge Medicaid patients late fees for missing an appointment goes into effect. And, even then, the future of the controversial law backed by Missouri’s Republican-led Legislature remains in limbo. Lawmakers last week overrode Democratic Gov. Jay Nixon’s veto of the measure allowing for the late fees and giving doctors the ability to refuse to schedule new appointments until the missed appointment fee is paid. (Erickson, 9/20)
State Highlights: Southern Calif. Is Hot Spot For Stem-Cell Treatment Industry; Troubled Ohio Nursing Home Faces Permanent Closure
The stem cell treatment industry is flourishing in the U.S. without much oversight. Southern California is a hotspot for clinics advertising stem cell treatments for everything from stroke to autism. And experts say San Diego is an attractive location for any company hoping to usher patients across the border for expensive treatments that have not been proven to be safe or effective in humans. (Wagner, 9/20)
The state health department could soon revoke a South Side nursing home’s license, forcing a permanent shutdown of the troubled facility. The Regency Manor Rehabiliation and Subacute Center is accused of more than a dozen recurring health and safety violations, according to state and federal public records obtained this month. Among them: sanitary concerns, errors distributing medication, abuse, neglect, privacy concerns, poor living conditions and failure to follow emergency protocols. (Widman Neese, 9/21)
Two U.S. senators are calling for an investigation into wait times at Veterans Affairs facilities in Colorado after the suicide of a 26-year-old U.S. Army Ranger who did not receive counseling for post-traumatic stress disorder in time. The request, by Republican U.S. Sens. Cory Gardner of Colorado and Ron Johnson of Wisconsin, also asks that an internal watchdog at the U.S. Department of Veterans Affairs examine allegations that VA officials forged documents after the service member’s death and then threatened a whistle-blower who raised these issues with authorities, according to a letter dated Monday. (Matthews, 9/20)
Orlando is trying to show itself as a place far different than a land of fantasy. An important part of Orlando’s emerging presence as a mature and innovative city is the 14-square-mile Lake Nona project, which is being built on land that only a decade ago was mostly pasture. Once finished, the development, being built by Tavistock Development Company, will resemble a city in everything but name, with hospitals, hotels, office buildings, schools and colleges, recreational and sports training facilities, retail centers, entertainment spots and, ultimately, about 11,000 homes and more than 25,000 residents. (Madigan, 9/20)
Drinking water tainted with a cancer-causing toxin made famous by the environmental activist Erin Brockovich was found in all but one of the 30 water systems in Northeast Ohio, according to a report released today. The Environmental Working Group, a health research and advocacy organization, said its report marked the first time widespread contamination by Chromium 6 had been documented in the drinking water of more than 200 million Americans in every state in the U.S. None of the levels of Chromium 6 found in the water tested exceeded California's legal limit of 10 parts per billion. (McCarty, 9/21)
Two community mental health centers in Kansas hope a new program will help young people recently diagnosed with schizophrenia avoid its possible complications — a higher risk of unemployment, homelessness and incarceration and lower life expectancy — and achieve goals for school, work and their personal lives. This year, Valeo Behavioral Health Care in Topeka received a $193,000 grant from the Kansas Department for Aging and Disability Services to start a program in Shawnee County for young patients in the early stages of psychosis. Wyandot Center in Kansas City launched its program last year with help from a $174,000 KDADS grant. (Hart, 9/20)
Three patients who underwent heart surgery at Penn Presbyterian Medical Center contracted unusual infections linked to a medical device called a heater-cooler, bringing the total of such cases in Pennsylvania to at least 20. A fourth patient at Penn Presbyterian tested positive for the type of bacteria in question but did not show signs of infection, said Patrick J. Brennan, chief medical officer of the University of Pennsylvania health system. (Avril, 9/20)
Moving quickly after a judge tossed out challenges to controversial new state water-quality standards, the city of Miami has signaled it will continue battling in an appeals court... The water standards, which were developed by the Department of Environmental Protection and approved July 26 by the state Environmental Regulation Commission, have been highly controversial. They involve new and revised limits on chemicals in waterways, with the department saying the plan would allow it to regulate more chemicals while updating standards for others. (Saunders, 9/20)
Kellogg’s has announced a voluntarily recall of roughly 10,000 cases of its Eggo Nutri-Grain Whole Wheat waffles. Officials with the company say the product might be contaminated with listeria. This is the only Eggo product that is linked to this recall. No related illnesses have been reported thus far. (Lorinc, 9/20)
Andy Miller and his brother Tracy Miller operate Healthmark Investment Trust. Andy Miller said they are minority owners in a Florida company called QMedRx Inc. The Millers and QMedRx are accused of participating in submitting fraudulent claims for reimbursement from TRICARE, a federal health care program for military members and their families, according to a Sept. 13 settlement agreement from the office of the U.S. Attorney for the Middle District of Florida. (Boucher and Ebert, 9/20)
Prescription Drug Watch
Red Tape, Lawsuits Tangle Biosimilar Approval Process, Keeping Biologic Prices Sky High
Drugs made from living cells, instead of by mixing chemicals, have brought major advances since the late 1990s to the treatment of various cancers, immune system disorders, growth hormone deficiency and eye diseases. But the drugs, called biologics, often have enormous price tags — up to hundreds of thousands of dollars a year, with crushing out-of-pocket costs for many patients. Part of the problem is that until recently there was no system in place for U.S. regulators to approve cheaper “generic” competition for these treatments because exact copies can’t be made. (9/18)
The generic drug industry, responding to public anger over big price hikes for some generic products, is calling for action on a bipartisan Senate bill it says would increase the number of cheaper generic drugs and reduce U.S. drug spending. Meanwhile, broader congressional efforts are building to hold both generic and brand-name drug manufacturers accountable for price spikes. Drugmakers would have to justify price hikes of 10% or more and disclose the information behind those pricing decisions under a separate bipartisan Senate bill called the Fair Drug Pricing Act. (Meyer, 9/18)
Months after Valeant Pharmaceuticals International Inc. said it would make discounts available to U.S. hospitals for two high-priced heart drugs, some medical centers say they have yet to see a cent of savings. Valeant became the face of high American drug prices when it acquired Isuprel and Nitropress last year and immediately raised their prices by 525 percent and 212 percent. Facing a backlash, representatives from the company stood before Congress in April and said they would work to cut prices for the drugs. (Koons and Hopkins, 9/16)
Allergan PLC on Tuesday said it agreed to acquire Tobira Therapeutics Inc., a biopharmaceutical company that develops therapies for liver diseases, in a deal worth as much as $1.7 billion, or 19 times Tobira’s previous market value. Tobira focuses on products that treat nonalcoholic steatohepatitis, or NASH, a common liver disease associated with obesity and type-2 diabetes. NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage, and it can lead to scarring of the liver and progress to cirrhosis, liver cancer and eventual liver failure. (Stynes, 9/20)
Nothing about a Washington state lawsuit called B.E. v. Teeter is as simple as it seems. It was filed this year by two hepatitis C patients against the state's Medicaid program to help the poor gain access to drugs such as Gilead Sciences Inc.'s $1,000-a-pill cure. But behind the team bringing the case is Gilead itself. While the drug giant isn't involved in the lawsuit, the company and its foundation have donated hundreds of thousands of dollars to the researchers, lawyers, patient advocates and medical expert who have helped build the case. (Martin and Glovin, 9/19)
With drug prices dominating attention in Congress and agitating the public, GPhA CEO Chip Davis wants to be sure low-cost generics are top of mind as a way to save money--and he has some ideas to amp up their strength in the marketplace. Answering some recent news about "extraordinary" generic price increases, Davis emphasized in a presentation on Monday that those hikes were few and far between in the copycat-drug universe. If you're looking for drug-cost drivers, look no further than specialty drugs, which in 2014 accounted for 31.8% of spending on 1% of the population, said Davis, who heads up the Generic Pharmaceutical Association. (Sagonowsky, 9/20)
After weeks of deliberations, the Colombia health minister is proceeding with plans to unilaterally lower the price of a Novartis cancer drug that has become the latest symbol of the battle between access to medicines and intellectual property rights. The amount of the reduction has not been announced, but Colombia media reported Health Minister Alejandro Gaviria may drop the price for Gleevec by up to 45 percent. Patient advocacy groups note that the annual cost of the drug is roughly $15,000, compared with per capita gross national income of about $8,000. This would amount to “significant savings for the whole health system,” the patient groups said. (Silverman, 9/16)
In this year’s presidential campaign, health care has taken a back seat. But one issue appears to be breaking through: the rising cost of prescription drugs. The blockbuster drugs to treat hepatitis C as well as dramatic price increases on older drugs, most recently the EpiPen allergy treatment, have combined to put the issue back on the front burner. (Rovner, 9/16)
The good news: U.S. consumers still get more bang for their buck from generic drugs as prices of the cheaper versions of the originals are generally falling. The bad news: Recent years have seen an increasing count of sharp cost spikes for generics -- the drugs produced after the patents on their branded versions expire. “The broader picture of generic costs is the decline over time, and the lower prices traditionally seen,” said John Dicken, director of health care issues at the Government Accountability Office (GAO), the agency Congress has tasked with investigating how taxpayer money is spent. (Gibson, 9/16)
Once a month at the Veterans of Foreign Wars building in Sacramento, a couple dozen former soldiers, many with white hair tucked under their service caps, stand and salute as they take up matters close to their communities. For discussion at a recent meeting: proper burial services for homeless veterans and a Harley Davidson motorcycle BBQ fundraiser. Also on the agenda: California’s Proposition 61 — a controversial measure on the November ballot that aims to rein in prescription drug prices. (Bartolone, 9/21)
After months of controversy, the Food and Drug Administration on Monday approved a Sarepta Therapeutics drug for Duchenne muscular dystrophy, a rare disease that confines boys to wheelchairs and sends them to an early death. But debate continues over whether the FDA lowered standards to approve a drug for an unmet medical need. And the price is a concern, too. The drug will cost about $300,000 per patient per year, depending upon weight, which means the price can run much higher. We spoke briefly with Dr. Ed Kaye, the interim Sarepta chief executive, about the approval. This is an edited version of the conversation. (Silverman, 9/20)
Family physicians are frustrated with the rising cost of prescription drugs and they took that frustration to the the American Academy of Family Physicians Congress of Delegates today demanding action from the AAFP board. The delegates made their case with a trio of resolutions debated before the AAFP's advocacy reference committee. (Basen, 9/19)
Perspectives: Big Pharma Needs Dose Of Own Medicine, But Prop 61 Isn't The Way To Do It
It would serve Big Pharma right if Californians passed Proposition 61, capping drug prices by prohibiting state agencies from paying any more for prescription medication than the rock-bottom prices paid by the U.S. Department of Veterans Affairs. The industry certainly has given voters every reason to do it – from jacking up the cost for lifesaving EpiPens by a whopping 500 percent to making the most effective treatments for hepatitis C so expensive that they’re out reach for millions of Americans. (9/19)
Proposition 61, or the California Drug Price Relief Act, is a ballot initiative promoted as a tool for reducing state spending on prescription drugs. If approved by voters in November, it would prohibit state government agencies (excluding managed-care plans in Medi-Cal) from paying more for drugs than the lowest price negotiated for the same drug by the U.S. Department of Veterans Affairs. Advocates believe it would safeguard California taxpayers, whom they argue are ruthlessly victimized by drug industry "price-gouging." Alas, prescription-drug pricing is much more complicated. (Paul Howard, 9/19)
One of the longest and most contentious biotech sagas in recent memory is finally over(ish). The FDA on Monday granted accelerated approval to Sarepta's drug Exondys, which treats the rare muscle-wasting disease Duchenne Muscular Dystrophy (DMD). The drug could be available to patients before the end of the year. The approval is conditional and can be reversed if a more-rigorous new trial shows the drug doesn't work. (Max Nisen, 9/19)
The pharma giant announced Tuesday that it struck a deal to buy the California biotech for an upfront payment of $28.35 per share in cash. And Allergan said it would pay as much as $49.84 per share in contingent value rights if Tobira, which doesn’t have any approved treatments on the market, meets certain developmental milestones. That means the total deal could be valued as high as $1.7 billion. ... That’s not a particularly exorbitant nominal sum in health care and biotech acquisitions. But it’s a staggering amount when it comes to the premium paid relative to a company’s current value. (Sy Mukherjee, 9/20)
You might think that after enduring months of government scrutiny and becoming the subject of multiple state and federal investigations, Valeant Pharmaceuticals would not immediately return to the same behavior that sent its stock price careening down 90% since last October. In that case, you are wrong. (Linette Lopez, 9/19)
It's a recipe for ending biopharma's slow year for deals that almost looks designed in a lab. Cancer drugs known as PARP inhibitors have major upside sales potential. There are two potentially acquirable makers of such drugs in Tesaro and Clovis, which recently saw shares jump due to potential interest from Gilead. Both their medicines are rushing toward approval just as a number of companies are getting hungry to buy a cancer-drugmaker. (Max Nisen, 9/15)
Editorials And Opinions
Viewpoints: The Politics Of Zika Funding; Statins Through The Lens Of Evidence-Based Medicine
“Hold up. Wait, wait, wait a minute.” That was my response when Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told me that the ongoing congressional battle over Zika funding forced the federal government to take money from other diseases to finance the hunt for a vaccine. “First, we took money from other infections. We borrowed money from ourselves from malaria and TB,” Fauci told me in the sixth episode of “Cape Up.” (Jonathan Capehart, 9/20)
The United States is in the middle of a public health crisis brought on by the spread of the Zika virus. Yet Sen. Roy Blunt, R-Mo., continues to look out for his own political interests instead of standing up for Missouri families. Now that Congress is in session, it is time to put aside partisan games and get things done for the American people. (Alison Dreith, 9/21)
[H]undreds have protested Miami-Dade's aerial spraying of naled in an attempt to control spread of the Zika virus. Activists note the pesticide is blamed for the death of millions of honeybees in South Carolina last month. Miami-Dade officials claim aerial spraying is helping to eradicate Aedes aegypti, the mosquito that spreads the virus. But some residents are complaining that they weren't notified when naled was being sprayed near their homes; and the New York Times reported that activists are "collecting accounts from residents who say the pesticide has caused rashes, headaches and nausea." (Gil Smart, 9/20)
The latest fight between orthodoxy and free inquiry is about the benefits and harms of statins for primary prevention. A review, and an editorial, in the Lancet said the benefits of statins are real, the harms are exaggerated, and skepticism of benefits of statins should be censored because doubt can harm the public who may not take their statins and thus die prematurely. Stated differently, skepticism kills. The lead author of the review once asked the BMJ to retract a study which he felt overplayed the harms and denied the benefits of statins. ... The BMJ, at the crossfire of this inquisition, responded to Lancet’s accusation in kind. (Dr. Sarah Jha, 9/20)
It wasn't a good sign for Community Health Systems back in 2013 when analysts were telling the hospital operator's desperate acquisition target to "take the money and run." Community Health's $7.5 billion deal for Health Management Associates, completed early the following year, was effectively a take-under for some of HMA's shareholders and yet their best option at the time -- a "godsend" is how one analyst put it. For Community Health, it's been a case of "bad-dealitis". History is repeating itself: Now Community Health is the one left exploring a sale to become someone else's problem. (Tara Lachapelle, 9/19)
The Affordable Care Act has ushered in rapid change to our country’s health care system. Here are tangibles that come to mind: a plethora of new terminology (accountable care organizations, exchanges, population health, etc.), individuals dropped from their health plans, exchange plans that few providers accept, stratospheric premium increases, and insurance companies bailing from state exchanges, just to name a few. Sadly, what is missing is the creation of real value or increase in the quality of health care. (Michael Zucker, 9/20)
We all agree that medications are an important social good, and that a healthily functioning pharmaceutical market is good for everyone. Drug companies should get fair payment so they can continue to thrive and innovate. Everyone should be able to benefit from what they provide, at a cost they can afford. But none of this can happen if extortionate drug-price hikes continue unchecked. (Thomas Kottke and Charlie Fazio, 9/20)
Is your child susceptible to infections or suffering from pain? Does your child tire easily? Does he or she have learning problems? While it’s not likely, your child may have sickle cell disease (SCD). SCD is the most common genetic condition in the world and the most common condition identified by newborn screening in the United States. There are roughly 40 to 50 children born with SCD in Miami every year. (Ofelia Alvarez, 9/20)
While there is no cure yet for this devastating illness, the UK Sanders-Brown Center on Aging is working furiously to change that. And we have already achieved international recognition: the center was a pioneer in the discovery that a healthy lifestyle can help prevent dementia. (Linda Van Eldik, 9/20)
According to the U.S. Drug Enforcement Administration (DEA), in the Charlotte area alone there have been 148 heroin overdose-related deaths in 2016, an 80 percent increase compared to the same time period last year. In 10 of the overdose deaths, Fentanyl, a synthetic opioid pain killer which is 80 times more potent than morphine, was listed as a contributor. Mexican drug trafficking organizations, which supply the bulk of heroin to the United States, have used Fentanyl as an additive to expand the volume of heroin. Heroin addicts, unaware of this deadly additive, are overdosing at alarming rates. (Jill Westmoreland Rose, 9/20)
On Thursday, I will go before Miami-Dade County commissioners to ask them to fund case managers for the Adult Criminal Drug Court, where I have presided as the “Drug Court Judge” for the past four years. Drug courts save lives and save the community money. That’s why the federal government stepped up to the plate last year and allocated more than $100 million for drug courts nationwide. The county must do its part, as well. (Jeri Beth Cohen, 9/19)
"Cannabis Curious?” That’s the billboard my children and I see every day on our after-school drive on Ventura Boulevard. The questions from my kids, who are 11 and 13, have come spilling out: “What is cannabis? What's curious about it? Why does it have different names? What does it look like? Why do people use it?” (Elizabeth J. D'Amico, 9/21)