Newsroom RX

• Congress hears from FDA on drug safety two years after heparin scare 03/05/2010

  The House Energy and Commerce subcommittee on Health will hear from FDA deputy commissioner Joshua Sharfstein and other agency officials Wednesday March 10 at the first drug safety hearing since the new administration took office. You can watch the hearing live here at 2 PM EST.

  Two years ago, contaminated batches of heparin, a commonly-used blood thinner, made their way from uninspected factories in China to the U.S. Over a 17-month period, the FDA received reports of 149 Americans who died after receiving heparin and suffering one or more symptoms associated with a known contaminant. The incident spurred calls for better oversight and more transparency of the origin and contents of pharmaceuticals that enter the U.S. drug supply.

  To learn more about safety problems in the drug supply chain, visit the Pew Prescription Project's supply chain initiatives page.

• "Marketplace" follows academic detailers in Pennsylvania 02/24/2010

  Marketplace (American Public Media) takes a look at what some states are doing to combat pharmaceutical sales reps influence on prescribing, and help get doctors the best evidence--without the sales pitch.

  Marketplace followed "academic detailers" employed by the state of Pennsylvania as they visit with physicians. The director of the program, which employs 11 academic detailers--often nurses or pharmacists--said the program was small but effective.

  "Since the program began in 2005, the doctors who have met with academic detailers have prescribed fewer brand name drugs and fewer drugs overall."

  Because of the success of such programs at the state level, development of a federal prescriber education program is underway.

  Listen to the full story here. Learn more about prescriber education at the Pew Prescription Project.

• Sunshine rules in White House health care bill 02/22/2010

  In his health care reform proposal revealed today to Congress and the nation, President Obama has included requirements for pharmaceutical and medical device companies to disclose payments to health care providers and hospitals. These ‘Sunshine provisions,’ modeled after a bill introduced in the Senate in 2007 by Senators Herb Kohl and Charles Grassley, have bipartisan, bicameral support, and were included in the health care reform bills passed by both the House and Senate this winter.

  Here’s the language:

  To prevent conflicts of interests and insure full transparency and information for patients, the Act requires all drug companies, device, and medical supply manufacturers to fully disclose and report any gifts they make or financial arrangements they have with doctors, a physician practice or group.

  The proposal, released ahead of a much-awaited bipartisan health care reform summit at Blair House this week, reflects a growing national consensus about the need for robust transparency of the financial relationships between providers and the pharmaceutical and device industries, including recommendations by the Institute of Medicine and the Medicare Payment Advisory Commission.

  For more about the prescription drug proposals in the President's health reform bill, read PostScript and visit Community Catalyst's National Health Reform page.

   

• JAMA: RxP and consumers, industry weigh online ads at FDA hearing 01/26/2010

  This week, JAMA highlights the risks the Pew Prescription Project and other consumer safety advocates raised at a recent FDA hearing on the use and conduct of pharmaceutical companies online.

  Among the problems posed by direct-to-consumer ads and other consumer intereactions with pharma on the web that were discussed at the hearing, consumers believe there are more safeguards on what can be advertised and how than there are. For instance, RxP Director Allan Coukell cited studies that showed most consumers think only highly safe and effective drugs can be advertised on TV, and that the commercials are screened and approved by regulators beforehand (they're not.)

  Consumer advocates like Coukell and Steve Findlay, senior health policy analyst for Consumers Union, argued that the loosening of advertising restrictions that opened the floodgates for drug companies to do consumer advertising on television in the 1990s should serve as a cautionary tale, since there is no evidence such advertising yields any public health benefits, and strong evidence that consumers don't have enough information through online and tv interactions to weigh the risks and benefits of a therapy.

  At the hearing, Findlay "argued that drug and device manufacturers should not be able to interact with patients through direct e-mail, text messages, blast e-mail, or chat rooms at all, except on a company's own Web site. Coukell said that such interactions should at least meet the same requirements as advertisements.
  
  'You can call it a social interaction, but when it takes place on the Internet, it lasts for years and it can be viewed by millions of people . . . that kind of social media still functions like a mass-market advertisement,' Coukell said.

  Read the full JAMA article here (subscription required).

   

   

• Miami Herald: RxP says voluntary disclosures inconsistent, don't capture CME 01/25/2010

  In a look at company disclosures of payments to doctors, the Miami Herald reports that University of Miami is planning to post a searchable database of professors and payments they receive from companies March 1. The University would join several other academic medical centers that publicly disclose faculty payments, including the Cleveland Clinic and Stanford University, though the details of what would be publicly reported are still under consideration.

  "Our thinking is let's get this stuff out on the table," Executive Research Dean Richard Bookman told the Herald.

  Beyond those academic medical centers and several states, another group has begun do disclose payments to doctors: the pharmaceutical industry itself. Allan Coukell, director of the Pew Prescription Project, told the Herald that voluntary company disclosures are of limited value because they represent a small fraction of payments, do not disclose uniform categories, and do not include a big source of physician payments -- Continuing Medical Education.

  "I don't think anyone is disclosing CME, because they're not directly funded by the drug companies,'' Coukell told the Herald, and added that "[a] lot of people are expressing concerns that CME is really drug promotion in disguise."

  Read the full Herald story here, or find out more about disclosure and CME policies at academic medical centers here.