Medtronic (NYSE: MDT) announced its commitment to voluntarily disclose payments to U.S. physicians. The company will begin capturing payment data for all of its businesses on January 1, 2010 and will publicly report this information annually. The first disclosure will occur in March of 2011 and will address payments made to physicians during calendar year 2010. The company will commission an annual third party audit to demonstrate its commitment to the accuracy of these postings, and will make a summary of the audit results public.
Medtronic will report the amount paid in consulting fees, royalties or honoraria for physicians who receive payments of $5,000 or more per year from Medtronic. Consulting agreements include counsel for areas such as education and training, clinical trial design and administration, and product design and safety. The company currently plans to report these data on its company website.
"Relationships between industry and doctors are essential to innovation, education and training in our industry." said Bill Hawkins, chairman and CEO. "Through greater transparency about the nature of these relationships, we will help people better understand how important they are to developing life-saving and enhancing products for patients who need them."
Medtronic initiated a first step toward greater transparency when it launched its online Donations Registry in August 2008 (available at medtronic). The donations registry makes public donations given by Medtronic to U.S. customers or organizations affiliated with customers, including patient groups and medical societies. In addition, the company has supported Senator Charles Grassley and Senator Herb Kohl's proposed legislation, the Physician Payments Sunshine Act, which proposed that all medical device manufacturers publicly disclose payments made to physicians for their inventions and assistance in product development, research and training. The company continues to support appropriate legislation in this area. Finally, Medtronic, with the Advanced Medical Technology Association, led the creation of an industry code of ethics designed to guide industry day-to-day relationships with healthcare professionals.
"We will work hard with the bill sponsors to get this legislation passed," said Hawkins. "These efforts will ensure a level playing field and consistency in reporting."
About Medtronic
Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Medtronic
Mammogram readings by both radiologists and non-physician technologists improve breast cancer detection rates, according to a study in the July 24 Journal of the National Cancer Institute.
Studies have shown that breast cancer detection may increase when mammograms are reviewed by both a radiologist and a mammographic technologist. In The Netherlands, a breast cancer screening program was implemented in the 1990s that required all mammograms be read by two radiologists. Mammographic technologists were also trained to look for abnormalities.
Lucien Duijm, M.D., Ph.D., of Catharina Hospital in Eindhoven, The Netherlands, and colleagues examined whether adding readings by two technologists to the standard examination by two radiologists would improve cancer detection rates and the accuracy of the readings.
The breast cancer detection rate increased 6.8% (from 5.27 to 5.63 cancers per 1,000 women screened) when the mammograms were read by two technologists and two radiologists. And adding two technologists only slightly increased the number of false positives, compared with readings by a pair of radiologists alone.
"Our results indicate that all technologist-positive readings should be considered for [further] examination because this subset of screening mammograms shows a high prevalence of breast cancer," the authors write.
In an accompanying editorial, Joann Elmore, M.D., of Harborview Medical Center in Seattle and James Brenner, M.D., J.D., of the University of California, San Francisco discuss the challenges of generalizing the results of the study because of differences in screening programs around the world.
"Ultimately, deciding on the number of readers needed to interpret a screening mammogram will depend on how many readers are available and which outcomes we seek," the authors write.
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* Article: Brigitte Rijshouwer, Cathartina Hospital
* Editorial: Joann Elmore washington.edu
Citations:
* Article: Duijm LEM, Groenewoud JH, Fracheboud J, De Koning HJ. Additional Double Reading of Screening Mammograms by Radiologic Technologists: Impact on Screening Performance Parameters. J Natl Cancer Inst 2007; 1162-1170
* Editorial: Elmore JG, Brenner RJ. The More Eyes, the Better to See" From Double to Quadruple Reading of Screening Mammograms. J Natl Cancer Inst 2007; 99: 1141-1143
The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage.
Visit the Journal online at jnci.oxfordjournals/.
Source: Liz Savage
Journal of the National Cancer Institute
Senate Finance Committee Chair Chuck Grassley (R-Iowa) and Senate Health, Education, Labor and Pensions Committee Chair Michael Enzi (R-Wyo.) on Tuesday called on President Bush to appoint a new FDA commissioner after Lester Crawford resigned Friday, CQ HealthBeat reports (CQ HealthBeat, 9/27). Crawford resigned two months after his confirmation as FDA commissioner in July. In an e-mail to FDA employees, Crawford wrote that "after three and a half years as deputy commissioner, acting commissioner and, finally, as commissioner, it is time, at the age of 67, to step aside." In a letter to Bush on Friday, Crawford said that his resignation was "effective immediately." Crawford, a veterinarian and a food safety expert, became FDA deputy commissioner in 2002 and later became acting agency commissioner. Bush named Andrew von Eschenbach, director of the National Cancer Institute, as acting FDA commissioner (Kaiser Daily Health Policy Report, 9/27). HHS Secretary Mike Leavitt on Monday said that "there is no timetable" for the nomination of a permanent FDA commissioner and that von Eschenbach will provide "strong leadership" at the agency. Von Eschenbach also has said that he will retain his position as NCI director. However, Grassley said, "I expect that whoever is named commissioner -- either acting or confirmed -- will know that it's not possible to give the FDA the kind of strong new leadership that is needed to reinvigorate the agency on a part-time basis." Grassley added, "I look forward to a new commissioner, who can be totally dedicated to the job, being named as soon as possible. The FDA has struggled with temporary leadership for too many years." In a letter to Leavitt on Tuesday, Sen. Edward Kennedy (D-Mass.) also raised concerns about "the current unsatisfactory situation" at FDA, adding that "there are also intrinsic conflicts of interest between the role of NCI director, who manages a research program that includes drug development, and the role of FDA commissioner, whose responsibility is to review the safety and effectiveness of those drugs" (CQ HealthBeat, 9/27). An HHS spokesperson said she is looking into the issue but had no immediate comment (Lumpkin, AP/Arizona Republic, 9/28). Leavitt spokesperson Christina Pearson on Tuesday said that Bush will not revise the plan for von Eschenbach to retain his position as director of NCI (Saul/Pear, New York Times, 9/28).
Additional Criticism
Sen. Christopher Dodd (D-Conn.) said that the plan for von Eschenbach to lead both FDA and NCI "ain't going to work." Dodd added, "I don't care who the guy is -- he could be Jonas Salkl he's not going to do both jobs." Sen. Ron Wyden (D-Ore.) said that the appointment of von Eschenbach as acting FDA commissioner "looks like a conflict," adding, "Given the problems at the agency, that's not a prescription in my view for turning things around" (Rovner, Reuters News, 9/27). Wyden said his staff has begun an investigation into whether precedent exists for one individual to hold two high-level positions in the federal government (CQ HealthBeat, 9/28). Marc Scheineson, a former FDA associate commissioner, said, "It's a foot in both camps. He's going to quickly have to decide where to put his foot. You have to be on one side or the other." Abbey Meyers, president of the National Organization for Rare Disorders, said, "I don't know how he's going to" lead both FDA and NCI. "Maybe he doesn't realize how big a job it is," Meyers said (AP/Arizona Republic, 9/28).
Crawford Resignation
In related news, "questions linger" about the reasons why Crawford resigned as FDA commissioner, CQ HealthBeat reports (CQ HealthBeat, 9/27). On Tuesday, William Walker, his brother-in-law, said that an unintentional failure to disclose financial holdings led Crawford to resign. Walker did not name specific holdings but said, "They had a money manager, and they thought they had divested." Crawford in February disclosed a six-figure portfolio that in large part consisted of blue-chip stocks in companies such as Dell, Home Depot, Staples and Bank of America -- none of which appeared to conflict with his position at FDA. However, Crawford might have "more complex" finances because his wife, Catherine Walker Crawford, shared proceeds of a $140 million sale of Walker Drug, which was owned by her family, to prescription drug wholesaler AmeriSource Health in 1997, the Times reports. In addition, his wife in 2002 became heir to the proceeds of the sale that her mother received (New York Times, 9/28).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
The Royal Australian College of General Practitioners (RACGP) today congratulated the Australian Government for beginning a conversation about men's health and for their proposal to develop Australia's first ever National Men's Health Policy.
"Australian GPs welcome this commitment which recognises men's health as a policy priority. This move adds to efforts to enhance awareness of the many important health issues men face across all age groups," said Dr Chris Mitchell, RACGP President and GP in northern New South Wales.
"We also want to see this campaign getting men on the front foot, going to see their GP, and taking steps to improve their lifestyle to ensure better health; it's sometimes just as important to see your GP when you are healthy as it is to do so when you are sick.
Men face a higher death rate than women when it comes to cancer, heart disease, strokes, diabetes, respiratory disease and mental health problems, including suicide and accidents. Men tend to present later with health problems, visit their GP less frequently and when they do, they have shorter consultations and are less likely to come in for preventative health checks.
"The college is in the process of developing a national men's preventative health campaign with seed funding from The Australian Government Department of Health and Ageing. The campaign will be launched in March 2009," said Dr Mitchell.
"We are very keen on working with the Government to improve the health of men around Australia," Dr Mitchell said.
The Royal Australian College of General Practitioners (RACGP) is responsible for maintaining standards for quality clinical practice, education and training, and research in Australian general practice. The RACGP has the largest general practitioner membership of any medical organisation in Australia and represents the majority of Australia's general practitioners.
Royal Australian College of General Practitioners
The American Medical Student Association (AMSA), the nation's largest independent medical student organization, approves the updated conflict-of-interest policy that Harvard Medical School released early yesterday morning, which completely prohibits all personal gifts, travel or meals from industry.
"As a world leader in medical education, Harvard is showing its commitment to evidence-based medicine with these recommendations," says John Brockman, AMSA national president. "Two years ago, AMSA called for the elimination of conflicts of interest surrounding the interactions of the pharmaceutical companies and the Harvard medical community. As the organization leading the PharmFree movement, AMSA is pleased to see Harvard using scientific evidence over marketing and doing what is ultimately the best for patients. We hope to see other medical centers follow this example."
In October 2008, just two months before Harvard convened its Harvard University Faculty of Medicine Committee on Conflicts of Interest and Commitment, AMSA members from Harvard Medical School and across New England gathered and asked for involvement in the policy drafting process, increased transparency, mandatory lecturer disclosure and a reasonable timeline for drafting and implementation.
Harvard's new policy also states:
- Restricting industry advertising and exhibitions at CME events, ensuring that industry programs and exhibits are marketed separately from Harvard programs.
- Reviewing and assessing any faculty member's proposed participation on the fiduciary board of a for-profit biomedical business.
- Prohibiting faculty participation in industry speakers bureaus. Further, faculty will not be able to accept compensation for a speaking engagement that limits the faculty member's intellectual independence in presenting content.
"Notably, Harvard's recommendations include a ban on industry gifts, meals and travel. This positive step is all the more significant as the Massachusetts legislature, bowing to pharmaceutical and restaurant industry pressure, moves toward repealing the ban on industry gifts and meals to physicians it instituted just last year," says Chris Manz, AMSA PharmFree director.
Harvard received a 'B' on the most recent AMSA PharmFree Scorecard . A majority of medical schools in Massachusetts were given strong grades on the Scorecard. Harvard, the University of Massachusetts Medical School, and Boston University received 'B's. Tufts University School of Medicine received a 'D.' The 2010 AMSA PharmFree Scorecard is scheduled to be released later this year. The call for policies was recently announced. The deadline for medical schools to submit is August 20.
Launched in 2002, AMSA's PharmFree Campaign guides medical students in organizing to advocate for evidence-based rather than marketing-based prescribing practices, the removal of conflicts of interest and global access to essential medicines.
Source:
American Medical Student Association