Morning Briefing
Summaries of health policy coverage from major news organizations
Two Novartis Researchers Ousted Who Were At Center Of Scandal Involving Falsified Data For $2M Drug
Stat: Novartis Ousted Top Scientists Over Manipulation Of Data For Gene Therapy
Novartis dismissed the top two scientists at its gene therapy division shortly after CEO Vas Narasimhan learned of internal data falsification that has since snowballed into a damaging scandal, a person familiar with the situation said Wednesday. The company previously said it was “in the process of exiting” scientists who were responsible for the scandal but did not identify them. In a statement on Wednesday, Novartis (NVS) said that it had appointed a new chief scientific officer for AveXis and that other scientists, Brian and Allan Kaspar, “have not been not been involved in any operations at AveXis since early May 2019,” without elaborating. (Garde and Herper, 8/14)
The Wall Street Journal: Novartis Replaces Two Researchers Amid Data Scandal
Zolgensma, which costs $2.1 million for a one-time infusion, treats babies with a devastating inherited disease known as spinal muscular atrophy. ... Last week, the U.S. Food and Drug Administration said data manipulation had taken place during company studies of Zolgensma, but that the drug should stay on the market as the manipulation involved a small portion of early-stage data on animals, rather than human clinical trials. Dr. Narasimhan has said the issue came to light internally in mid-March and that Novartis decided to hold off alerting the regulator until the company had completed its own investigation. (Roland, 8/14)
Reuters: Novartis Replaces Top Scientists At Avexis After Drug Data Manipulated
Novartis AG said on Wednesday it replaced the two top research and development executives at its Avexis unit after some data was manipulated from early testing of a gene therapy for infants that costs more than $2 million. Avexis’ Chief Scientific Officer Brian Kaspar and Senior Vice President of Research and Development Allan Kaspar have not been involved in any operations at Avexis since early May 2019, Novartis said in a statement. ... Page Bouchard has taken on both those roles at Avexis as of Aug. 5, Novartis said. (8/14)
Stat: Regeneron Drug Proves Effective In Genetic Form Of High Cholesterol
Regeneron Pharmaceuticals presented new data Wednesday showing a drug it developed can treat patients with a genetic disease that causes very high cholesterol levels. In homozygous familial hypercholesterolemia, or HoFH, patients can have levels of low-density lipoprotein of 500 milligrams per deciliter or more, five times normal levels, and can have heart attacks or other cardiovascular problems in their 20s. The disorder, which results from having two non-functioning copies of the LDL receptor gene that is involved in removing cholesterol from the blood, afflicts about 1,300 patients in the United States. (Herper and Garde, 8/14)
FierceHealthcare: GAO: PBMs Passed On Nearly All Part D Rebates To Plans In 2016
A federal watchdog found that pharmacy benefit managers (PBMs) passed nearly all Medicare Part D rebates on to plan sponsors in 2016 as the amount of rebates skyrocket. The Government Accountability Office (GAO) explored the sources of revenue and service agreements between PBMs and Medicare Part D plans in a report released Tuesday (PDF). The report comes as the Department of Health and Human Services (HHS) has ramped up scrutiny over the administration of rebates, which the agency believes are a major driver of drug prices. (King, 8/13)
Bloomberg: DNA Test For Antidepressants Raises FDA Doubts; Myriad Drops
A company that helped pioneer genetic tests used to diagnose and treat disease lost more than 40% of its value on Wednesday, after U.S. regulators raised questions about whether a DNA test that’s key to the firm’s growth can help personalize the prescribing of antidepressant drugs. Myriad Genetics Inc. fell as much as 43% to $25.45 Wednesday, the stock’s worst intraday drop since 2000. In a securities filing, it said the Food and Drug Administration had asked for changes to its GeneSight test, which is used to determine how well popular antidepressants will work for patients. Several other companies sell similar tests. (Brown, 8/14)
FierceHealthcare: Trump Administration Announces Departure Of Drug Pricing Adviser John O'Brien
John O'Brien, a top drug policy adviser to the Trump administration and one of the "key architects" of the president's blueprint plan to reduce prescription drug prices, plans to leave the role. Department of Health and Human Services (HHS) Secretary Alex Azar said in a statement Monday that John Brooks, principal deputy director of the Center for Medicare, will expand his role to help spearhead the Trump administration's efforts to lower drug prices upon O'Brien's departure. (Reed, 8/12)
Concord Monitor: New Group Hopes That Reverse Auctions On Drug Middlemen Can Help Cut Costs
A wide-ranging group of organizations, businesses and office-holders say New Hampshire could cut millions of dollars off prescription drug costs by tackling a portion of the industry that few people even know about: pharmacy benefit managers, or PBMs. ...The loose group of officials says state and local governments, as well as private businesses in New Hampshire, could save perhaps 15% off their prescription drug costs – which would save the state about $30 million under its s current 3-year contract with Express Scripts – if they followed a “reverse-auction” model for PBMs as pioneered by New Jersey. (Brooks, 8/8)
Stat: A Battle Over Verifying Online Canadian Pharmacies Goes To Court
As more Americans look to Canada for cheaper medicines, a company whose website devoted to verifying prescription drugs sold by online pharmacies is suing five organizations, including two with ties to the pharmaceutical industry, for allegedly running a campaign to manipulate and suppress information available to consumers. In its lawsuit, PharmacyChecker.com claims the groups, including the National Association of Boards of Pharmacy, have essentially created a type of shadow regulation through private agreements with “key internet gatekeepers,” such as Google, to “choke off” information about importing medicines from online pharmacies in Canada and other countries. (Silverman, 8/14)
