Drugmakers’ Influence On Treatment Guideline Authors Worries Experts

ProPublica: Pharma Money Reaches Guideline Writers, Patient Groups, Even Doctors On Twitter
The long arm of the pharmaceutical industry continues to pervade practically every area of medicine, reaching those who write guidelines that shape doctors' practices, patient advocacy organizations, letter writers to the Centers for Disease Control and Prevention and even oncologists on Twitter, according to a series of papers on money and influence published Tuesday in JAMA Internal Medicine. (Ornstein, 1/17)

Stat: Are Treatment Guidelines Swayed By Conflicts Of Interest With Pharma?
As physicians increasingly rely on treatment guidelines issued by medical societies and government agencies, researchers raise concerns that drug makers may subtly influence the proceedings through various financial relationships and they recommend stronger actions for disclosing potential conflicts of interest. The industry influence can take different forms, however, according to the research, which was published in a pair of papers on Tuesday in JAMA Internal Medicine. (Silverman, 1/17)

Stat: Few Americans Believe Pharma Places Patients Over Profits: Poll
Just 9 percent of Americans believe drug makers place more value on patients than profits, and only insurers have an overall worse reputation among consumers than the pharmaceutical industry among different entities in the health care system, according to a new Harris Poll. (Silverman, 1/17)

Stat: Pfizer Chief: Hatred Of Pharma Is ‘A Problem Of Perception’
The pharma business may be “getting away with murder” in the eyes of President-elect Donald Trump, but the leader of the US’s biggest drug maker remains defiant and unapologetic in the face of mounting criticism for his industry. Speaking at the annual World Economic Forum in Davos, Switzerland, Pfizer CEO Ian Read said pharma has hardly earned its bad reputation, blaming instead a handful of bad actors, widespread misunderstanding, and what he sees as a woefully flawed healthcare system. (Garde, 1/17)

Bloomberg: New FDA Chief Should Have Medical Experience, Drugmakers Say 
President-elect Donald Trump’s pick to lead the U.S. Food and Drug Administration should have a medical background, and the agency should continue evaluating new medications’ effectiveness, drugmaker executives said in comments indicating opposition to two candidates for the regulator’s top post. Trump’s FDA chief should be a doctor or physician-scientist with experience in clinical care and medical research, said Roger Perlmutter, head of research and development for Merck & Co. The president-elect is considering appointing former biotechnology industry executive Balaji Srinivasan and Jim O’Neill, a Silicon Valley investor, according to people with knowledge of the matter. Neither has a medical background, and O’Neill has suggested that the FDA should focus solely on new drugs’ safety, leaving the market to decide whether they work. (Hopkins, 1/17)

Stat: With Faster Drug Approvals, Taxpayers May Be Left To Foot The Bill
Between a new law aimed at springboarding treatments and a new administration promising to steamroll regulations, the federal government seems primed to approve more prescription drugs — and to do so faster. But one unintended consequence could be a waste of taxpayer dollars. Whether the Food and Drug Administration should hasten drug approvals is a matter of vigorous debate from a scientific and safety standpoint. But many critics of that approach also make another argument that has been largely overlooked: More drug approvals could mean more unnecessary public spending. (Joseph, 1/13)

Boston Globe: Mass. Biotechs Won’t Commit To Drug Price Cap
Under growing pressure to control prices, three big drug companies have separately pledged to hold increases on their prescription medicines to below 10 percent in 2017. So far, however, biopharma companies that are based in Massachusetts or have large operations here have declined to make a similar pledge, even though some say their recent price increases have been below the 10 percent cap embraced by AbbVie Inc., Allergan PLC, and Novo Nordisk. (Weisman, 1/13)

The New York Times: Trump’s Plan To Cut Drug Imports Could Raise Prices, Not Lower Them
First it was cars, then air-conditioners. This week, President-elect Donald J. Trump targeted another industry that has shifted manufacturing abroad: pharmaceuticals. American drug imports have grown significantly in recent years, figures show. At the same time, however, drug costs continue to rise, an issue Mr. Trump suggested his government could address. But any move to curtail pharmaceutical imports could raise, rather than lower, drug prices, experts warn. That is because many of the cheaper drugs in the United States come from abroad. (Bradsher, 1/12)

Bloomberg: Why Trump Faces Stiff Fight To Slash Drug Prices
Pharmaceutical executives briefly celebrated Donald Trump’s election to the U.S. presidency, expecting the businessman to be friendlier to their industry than his opponent Hillary Clinton, a tough critic. But foreboding about Trump’s unpredictable ire soon set in, and the fears proved justified nine days before the inauguration, when Trump said the industry was “getting away with murder.” He vowed to bring prices down by making pharmaceutical companies bid for the government’s business. (Bloomfield, 1/13)

The Wall Street Journal: Pharma Investors Find Themselves In The Spotlight
If drug makers thought they would escape the political spotlight in 2017, the first few weeks of the new year have certainly dissuaded them of that notion. In magazine and newspaper interviews, on Twitter and during his press conference, President-elect Donald Trump has homed in on the industry’s pricing of drugs. That’s not something investors in those companies expected. The iShares Nasdaq Biotechnology exchange-traded fund had surged 8.9% the trading session after Election Day, apparently on the belief that a Republican-controlled White House and Congress was unlikely to prioritize drug pricing reform. That clearly is not the case. (Eisen, 1/17)

Stat: Supreme Court Agrees To Review Biosimilar Launch Rules
The US Supreme Court has agreed to delve into a contentious patent dispute between Sandoz and Amgen over how quickly lower-cost biosimilar drugs can make it to market. This has huge implications for how all biosimilars are marketed and priced, because these drugs represent some $44 billion in health care cost savings through 2024. Biosimilars are expected to be priced at 10 to 30 percent less than their branded counterparts. (Keshavan, 1/13)

Kaiser Health News: Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies
More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored. By the drugmakers’ calculations, the markets for such diseases weren’t big enough to bother with. But lucrative financial incentives created by the Orphan Drug Act signed into law by President Ronald Reagan in 1983 succeeded far beyond anyone’s expectations. More than 200 companies have brought almost 450 “orphan drugs” to market since the law took effect. (Tribble and Lupkin, 1/17)

Kaiser Health News: Sky-High Prices For Orphan Drugs Slam American Families And Insurers
Sarah Jane Tribble and Sydney Lupkin report: "Before Luke Whitbeck began taking a $300,000-a-year drug, the 2-year-old’s health was inexplicably failing. A pale boy with enormous eyes, Luke frequently ran high fevers, tired easily and was skinny all over, except his belly stuck out like a bowling ball. “What does your medicine do for you?” Luke’s mother, Meg, asked after his weekly drug treatment recently. “Be so strong!” Luke said, wrapping his chubby fist around an afternoon cheese stick." (Tribble and Lupkin, 1/17)

Stat: Sound Advice: Making Drug Packaging Easy — And Helpful
Patients tired of tiny print guidelines and difficult-to-understand drug use instructions could see their medical packaging get an innovative upgrade. Design and development company Cambridge Consultants has created a new type of medical packaging that could make it easier for patients to learn how to properly take their medication. It could be particularly useful for self-injected drugs such as insulin, which can run the risk of user error. The AudioPack aims to cut down on that risk by breaking down instructions in an easy-to-read package with oral, step-by-step instructions from a helpful guide named Anna. (Thielking, 1/17)

Stat: FDA Is Making Progress Inspecting Foreign Drug Plants, But Could Do Better
In the wake of concerns over the safety of foreign-made medicines, the US Food and Drug Administration significantly increased the number of inspections of overseas facilities. Yet the agency has failed to assess the extent to which its efforts are actually improving the quality of drugs entering the country, according to a new report by the US Government Accountability Office. The GAO noted that nearly 40 percent of finished drugs and about 80 percent of active pharmaceutical ingredients are made in facilities that are registered in more than 150 countries. And by some measures, the FDA has made progress – the agency has reduced the number of facilities that have gone without an inspection history to 33 percent of foreign establishments, compared to 64 percent in 2010. (Silverman, 1/17)

Stat: FDA Guidelines For Biosimilars May Give Edge To Big Pharma
After years of anticipation, the US Food and Drug Administration released a final guideline for naming both pricey biologic medicines and identical, but lower-cost versions that are known as biosimilars. However, the agency appears to have adopted a position that may give an edge to brand-name drug makers, a significant move given the huge sales that are at stake. (Silverman, 1/12)

Bloomberg: Where The U.S. Actually Gets Its Drug Supply: QuickTake Q&A
After calling out makers of cars and air conditioners, U.S. President-elect Donald Trump has set his sights on a new industry to pressure for manufacturing jobs: drug companies. In his first press conference since his election, Trump lumped pharmaceutical firms in with the car companies that so far have borne the brunt of his Twitter feed for moving operations abroad. “We’ve got to get our drug industry back,” he said. “They supply our drugs but they don’t make them here, to a large extent.” Afterward, pharmaceutical stocks around the world plunged, partly on Trump’s promise to cut drug prices but also on concerns that companies could face the same choice he’s proposed for carmakers: make it in the U.S. or face punitive tariffs. (Altstedter, 1/17)