First Edition: September 22, 2016
Today's early morning highlights from the major news organizations.
Kaiser Health News:
It’s Not Just For Kids: Medicare EpiPen Spending Up 1,100 Percent
Even as the cost of EpiPens dramatically rose, so too did the number of prescriptions written for patients in Medicare, sending spending by the program skyrocketing nearly 1,100 percent from 2007 to 2014, a new report shows. During the same period, the total number of Medicare beneficiaries using EpiPens climbed 164 percent, from nearly 80,000 users in 2007 to more than 211,000 in 2014, according to the analysis by the Kaiser Family Foundation. While the report does not delve into what’s behind the increase, factors could include increased awareness among people with allergies, marketing efforts and access to insurance coverage. (Appleby and Carey, 9/21)
The New York Times:
Mylan’s Chief Is Chastised By Lawmakers Questioning EpiPen Pricing
Members of Congress on Wednesday pelted the chief executive of Mylan, the company behind the EpiPen, the treatment for severe allergy attacks, with questions about steep price increases on the product and accused her of turning her back on families that could no longer afford the lifesaving treatment. The chief executive, Heather Bresch, was the latest in a string of drug company leaders to be interrogated by the House Committee on Oversight and Government Reform as public outrage has grown over the rising cost of drugs. (Thomas, 9/21)
Reuters:
U.S. Lawmakers Blast Mylan CEO Over 'Sickening' EpiPen Price Hikes
The House Committee on Oversight and Government Reform called Bresch to testify in the wake of public outrage over EpiPen, whose list price has risen to $600 for a pair of the devices compared with $100 in 2007. Lawmakers in turn described the actions as "sickening," "disgusting" and showing "blatant disrespect" for American families who can no longer afford the life-saving device for children susceptible to severe allergic reactions. (Humer, 9/21)
The Associated Press:
Mylan CEO Infuriates Lawmakers At Hearing On EpiPen Costs
Mylan CEO Heather Bresch infuriated lawmakers as she tried — and mostly failed — to explain steep cost increases of her company's life-saving EpiPens. ... In almost four hours of questioning, the soft-spoken CEO at times seemed unsure, or declined to answer directly, when asked questions about the company's finances and profits, angering lawmakers. (Jalonick, 9/22)
The Washington Post:
Lawmakers Grill Mylan CEO Over EpiPen Price Hikes
Proposed solutions included finding ways for the Food and Drug Administration to ease the drug-approval process so competition can help bring down prices and calls for greater transparency in pharmaceutical pricing. But Heather Bresch, Mylan's chief executive, stayed firm in her message that the list price of EpiPen had increased because of the inherent complexity of the pharmaceutical marketplace and that few patients were paying the list price. She has attempted to shift blame away from her company to a network of middlemen that sits between drug companies and patients and take a cut of the price. Bresch said that Mylan's efforts to cut down the price patients pay - including its plan to release a half-price generic version of EpiPen - would solve the problem. (Johnson, 9/21)
The Wall Street Journal:
Mylan CEO Faces Tough Questioning In Congressional EpiPen Hearing
“We believe it was a fair price, and we now just lowered it by half,” Ms. Bresch said. Her remarks triggered criticism from Oversight and Government Reform Committee members from both parties. Several accused Mylan during the first hours of the hearing of profiting excessively from a relatively inexpensive drug that patients’ lives depend on. “I am a very conservative and pro-business Republican, but I am sickened by what I’ve heard,” Rep. John Duncan (R., Tenn.) said. (Rockoff, Radnofsky and Hernandez, 9/22)
Los Angeles Times:
Mylan CEO Blames Rising Cost Of The EpiPen On 'Opaque' Industry Pricing
She said most patients at risk of an allergic reaction now have access to the drug, and that 85% of patients pay less than $100 for a two-unit package. “Looking back, I wish we had better anticipated the magnitude and acceleration of the rising financial issues for a growing minority of patients who may have ended up paying the full … price or more,” she said. “We never intended this.” Bresch said the company was making far less on the drug than the public believed. She said after rebates and fees Mylan received just $274 of the device’s $608 wholesale price. (Petersen, 9/21)
NPR:
EpiPen Profits: $50 Per Injector, Company Says
While the company apparently is looking to use the analysis to downplay its profits, analysts say the margin is still quite high. Ronny Gal, a pharmaceutical industry analyst at the investment firm Sanford Bernstein, says Bresch's numbers mean Mylan makes a 40 percent profit margin on the device. (Kodjak, 9/21)
Politico:
Anne Filipic Warns That Obamacare Doom-And-Gloom Can Be Self-Fulfilling
With insurers dropping out and premium rates going up, Obamacare has hit its roughest patch in years. Even some Democrats are acknowledging the law needs fixes. But according to Anne Filipic, the doom-and-gloom predictions aren't just misplaced — they're making her job harder. "We have real challenges in reaching the remaining uninsured and helping them understand that there are affordable options," the president of Enroll America told POLITICO's "Pulse Check" podcast. "This broader narrative isn’t helpful to them." (Diamond, 22)
Politico:
Democratic Liberals, Moderates Feud Over Public Option
A liberal attempt to revive the so-called public option — a government-run insurance plan to shore up gaps in the Affordable Care Act — is opening old wounds between the Democratic Party’s liberal and moderate wings. Thirty-three mostly liberal Democrats, including all the Senate leadership, have signed onto a nonbinding Senate resolution introduced last Friday to add the public option to Obamacare, arguing that it is needed to fix problems with the president’s signature health care law. (Haberkorn, 9/22)
The New York Times:
Mark Zuckerberg And Priscilla Chan Pledge $3 Billion To Fighting Disease
Mark Zuckerberg, Facebook’s chief executive, and his wife, Dr. Priscilla Chan, last year said they would give 99 percent of their Facebook shares to charitable causes. Now they are putting a large chunk of that money to work. The Chan Zuckerberg Initiative, the limited liability company into which Mr. Zuckerberg and Dr. Chan put their Facebook shares, on Wednesday said it would invest at least $3 billion over the next decade toward preventing, curing or managing all diseases by the end of the century. (Benner, 9/21)
The Washington Post:
Mark Zuckerberg And Priscilla Chan’s $3 Billion Effort Aims To Rid World Of Major Diseases By End Of Century
The many components of the initiative include creating universal technology "tools" based on both traditional science and engineering on which all researchers can build, including a map of all cell types, a way to continuously monitor blood for early signs of illness, and a chip that can diagnose all diseases (or at least many of them). The money will also help fund what they referred to as 10 to 15 “virtual institutes” that will bring together investigators from around the world to focus on individual diseases or other goals — an idea that has the potential to upend biomedical science. (Cha, 9/21)
Los Angeles Times:
Priscilla Chan And Mark Zuckerberg Pledge $3 Billion To Fight Diseases
Neuroscientist and geneticist Cori Bargmann was named the Chan Zuckerberg Initiative’s president of science and will be in charge of bringing together scientists and engineers to develop medical breakthroughs. Chan also announced that the initiative will spend an additional $600 million to establish a “bio hub” in San Francisco to support researchers from Stanford University, UC Berkeley and UC San Francisco as they develop new tools to understand and treat diseases. (Lien, 9/21)
The New York Times:
World Leaders Agree At U.N. On Steps To Curb Rising Drug Resistance
World leaders agreed Wednesday on steps to curb the rapid rise of drug resistance, the first global effort to stop the spread of dangerous superbugs that are fast becoming immune to many of the most critical medicines. Infectious disease doctors have long warned that overuse of antibiotics in people and in animals puts human health at risk by reducing the power of the drugs, some of modern medicine’s most prized jewels. The problem is global, because the bugs are mobile. (Tavernise, 9/21)
The Associated Press:
UN Adopts Declaration On Anti-Microbial Resistance
World leaders approved a wide-ranging declaration Wednesday aimed at addressing the rising number of drug-resistant infections — something the World Health Organization says has the potential to kill millions and undermine the global economy, likening it to "a slow-motion tsunami." The declaration recognizes the size of the problem and encourages countries to develop plans to cut back on antibiotic use, make better use of vaccines and fund development of new drugs to combat antimicrobial resistance (AMR), which currently claims the lives of an estimated 700,000 people each year and is expected to rise sharply. (9/21)
Los Angeles Times:
United Nations Takes On Antimicrobial Resistance
Meeting under the umbrella of the United Nations General Assembly, international leaders on Wednesday launched new efforts to stem the rising tide of antimicrobial resistance, which has blunted the effectiveness of existing medications in treating infectious diseases.Heads of state and country delegates gathered at a U.N. meeting on the subject vowed to increase international coordination and funding aimed at monitoring the emergence of antimicrobial resistance and reducing the misuse of antimicrobial agents in human and veterinary health and agriculture. (Healy, 9/21)
The Washington Post:
Gonorrhea Is More Dangerous Than Ever As Resistance To Antibiotics Grows
U.S. health officials have identified a cluster of gonorrhea infections that show sharply increased resistance to the last effective treatment available for the country's second most commonly reported infectious disease. The findings from a cluster of Hawaii cases, presented Wednesday at a conference on prevention of sexually transmitted diseases, represent the first cluster of cases in the United States that have shown such decreased susceptibility to the double-antibiotic combination used when other drugs have failed. (Sun, 9/21)
The Wall Street Journal:
Anthem, Cigna Have Accused Each Other Of Merger Breach
Anthem Inc. and Cigna Corp. have accused one another of violating the terms of their merger agreement, according to a legal filing by the Justice Department, which is suing to block the health-insurance deal on antitrust grounds. In the filing, Justice attorneys say that in a telephone conference on Aug. 16, Cigna’s lawyers disclosed “further deterioration” in the relationship between the two companies, which have for months been engaged in behind-the-scenes sniping amid efforts to pull together their $48 billion deal. (Wilde Mathews and Kendall, 9/21)
The Wall Street Journal:
Sarepta To Sell Up To $225 Million Of Stock
Sarepta Therapeutics Inc. intends to sell up to $225 million of stock and use the proceeds for clinical trials, drug commercialization, manufacturing and other purposes. The company’s shares surged 74% to $48.94 on Monday as the U.S. Food and Drug Administration gave accelerated approval to eteplirsen, its drug for Duchenne muscular dystrophy, following sharp disagreements within the agency. Sarepta stock rose 14% on Tuesday, when it received favorable patent decisions in a dispute with BioMarin Pharmaceutical Inc. (Beckerman, 9/21)
The Wall Street Journal:
Big Pharma’s Big Checkbooks Drive Biotech Resurgence
Drug companies are starting to open their wallets again. That means big things for small biotechs. Merger-and-acquisition activity has returned with a fury. Allergan announced Tuesday it had acquired Tobira Therapeutics in a deal worth up to $1.7 billion if Tobira’s products hit certain milestones. That amounts to more than 19 times Monday’s closing price. (Grant, 9/21)
The Associated Press:
Lawmakers Want Perjury Investigation Over Costly VA Hospital
Federal prosecutors should investigate whether a former Veterans Affairs Department executive committed perjury when he testified about the cost of a new Denver-area VA hospital, which is more than $1 billion over budget, members of Congress said. Florida Rep. Jeff Miller, chairman of the House Veterans Affairs Committee, and Rep. Mike Coffman, R-Colo., said Wednesday the Justice Department should investigate Glenn Haggstrom’s statements to Congress in 2013 and 2014. (Elliott, 9/22)
The Associated Press:
House Panel Holds Fetal Tissue Firm In Contempt, Dems Walk
A Republican-run House committee voted along party lines Wednesday to hold a company that provides researchers with fetal tissue in contempt of Congress. Republicans say StemExpress has not produced all the documents they want. Democrats say the GOP is harassing the California-based company and trying to discourage fetal research. Democrats walked out of the meeting before the 8-0 vote. They say the committee lacks the authority to take such action. (9/21)
The Washington Post:
Democrats See Stopgap Spending Bill As Best Chance To Get Funding For Flint Water Crisis
Democrats believe they have finally found the leverage they need to force Republicans to approve funding to address the water crisis in Flint, Mich.: historic flooding in Louisiana. Democrats are pushing for a Senate-passed aid package for Flint to be linked to flood relief funds in a stop-gap spending bill that would prevent a government shutdown at the end of the month. Republicans say they want to give the House more time to consider passing funding for Flint, but Democrats have refused to sign off on the spending bill until the issue is resolved. (Snell, 9/21)
Reuters:
House Committee Launches Review Of FDA Criminal Office
A U.S. congressional committee has launched an examination of the Food and Drug Administration's criminal office, raising questions about the unit’s management and handling of cases involving food, drugs and devices. The House Energy and Commerce Committee told FDA Commissioner Robert Califf it is "examining management concerns" and "possible morale concerns with the field offices" of the Office of Criminal Investigations. (Greene, 9/21)
The Associated Press:
Planned Parenthood Pushes Challenge Of Mississippi Law
Planned Parenthood is asking a federal judge to quickly rule in its favor and overturn a Mississippi law that bans Medicaid spending with any health care provider that offers abortion. The women's health group points to a recent ruling by the 5th U.S. Circuit Court of Appeals that upheld an injunction against a similar law in Louisiana. (Wagster-Pettus, 9/21)
The New York Times:
Maternal Mortality Rate In U.S. Rises, Defying Global Trend, Study Finds
One of the biggest worldwide public health triumphs in recent years has been maternal mortality. Global death rates fell by more than a third from 2000 to 2015. The United States, however, is one of the few countries in the world that have gone against the grain, new data show. Its maternal mortality rate has risen despite improvements in health care and an overwhelming global trend in the other direction. (Tavernise, 9/21)
The Associated Press:
Colorado Medical Pot Law Poised To Add PTSD As Qualifier
Marijuana pioneer Colorado is poised to add post-traumatic stress disorder to its medical marijuana program, joining 18 other states that consider PTSD a condition treatable by pot. A panel of state lawmakers voted 5-0 Wednesday to endorse the addition of PTSD to Colorado’s 2000 medical pot law. The vote doesn’t have legal effect; it’s just a recommendation to the full Legislature, which resumes work in January. But the vote indicates a dramatic shift for a state that has allowed medical pot for more than a decade but hasn’t endorsed its use for PTSD. (Wyatt, 9/21)
The Associated Press:
Schneiderman Says Bills Would Create Opioid Abuse Loopholes
New York Attorney General Eric Schneiderman is urging Gov. Andrew Cuomo to veto two bills that he says would roll back efforts to fight prescription opioid abuse. Schneiderman, a Democrat, expressed his concerns in a letter to Cuomo's legal counsel Tuesday. One of the bills would exempt nursing home doctors from rules requiring electronic filing of prescriptions. The other would alter existing rules governing controlled substance prescriptions to allow doctors, in certain cases, to not report the prescriptions directly to state health officials. (9/21)
The Washington Post:
A Mysterious Polio-Like Illness That Paralyzes People May Be Surging This Year
Before dinner on July 29, 3-year-old Carter Roberts of Chesterfield, Va., seemed perfectly healthy. That evening, he vomited. When he woke up the next morning with a slight fever of 99 degrees, his mother, Robin Roberts, figured that he was coming down with a cold. The next morning, she found him collapsed on his bedroom floor. “Mommy,” she recalls him saying. “Help me, help me.” (Hurley, 9/21)