ACCME DEVELOPS REVISED CME STANDARDS
Neurologists taking continuing medical education (CME) courses may notice less of an industry presence in future classes. The Accreditation Council for Continuing Medical Education (ACCME) took a close look at the role pharmaceutical and medical device companies play in physician CME, and decided it was time to update its standards for commercial support in CME. The updated standards set specific limits on how commercial interests can influence the development of physician education classes.
The standards address a variety of situations where industry interacts financially with CME. For example, they dictate how and when conflicts of interest should be disclosed, where advertising messages can and cannot appear at CME activities, and what subjects and therapies are appropriate for CME.
Murray Kopelow, MD, Executive Director of the ACCME, explained in an e-mail message that the updated standards “provide additional guidance for providers as they strive to maintain independence from industry and to ensure the absence of commercial bias.” This, in turn, will lead to better-quality CME. “Everyone involved in the education process must disclose their relationships to industry,” he said. “And the provider must take action to resolve all conflicts of interest that result from that relationship in the context of the person's teaching role.” Dr. Kopelow said.
The updated standards must be approved by all seven member organizations of ACCME before taking effect. The organizations have until September 28th to consider the standards. The standards are available online here: www.accme.org/whatsnew/sec_new_nw1_251.asp.
FDA PLANS CRACKDOWN ON SUPPLEMENTS
The FDA has outlined a plan to crack down on dietary supplements that are unsafe or that make misleading claims. The highly publicized ban on the diet supplement ephedra has focused attention on the safety of supplements, and the FDA plans to duplicate its approach in evaluating ephedra's safety to review other supplements.
Commenting by e-mail, Allen Bow-ling, MD, PhD, Clinical Associate Professor of Neurology at the University of Colorado Health Sciences Center in Denver, CO, called the FDA plan a “good first step,” but stressed that improvements necessitate a staff and budget to enforce regulations. Dietary supplements are a $20 billion-per-year industry, but the FDA has only about 60 people and a $10 million-per-year budget to enforce the regulations.” Dr. Bowling conducts research on complementary and alternative medicine therapies for multiple sclerosis.
This science-based approach consists of looking at pharmacology, published literature, evidence-based reviews, and adverse event information on individual supplements, and using this information to decide whether a product is safe. Additionally, the FDA aims to clamp down on supplements that claim to treat or cure diseases – which is not allowed – or that make untrue or misleading claims about their effect on the body. The FDA is also developing “good manufacturing practices,” guidelines for the manufacture and handling of supplements that should protect against the inclusion of impurities and contaminants.
While Dr. Bowling agrees that more regulation is needed to ensure safety and quality, and to counter false claims, he does not think that regulations should restrict patient access to supplements unnecessarily. “I think there is a reasonable ‘middle ground’ in which these products are more regulated but are still available,” he said.
But how can neurology patients who use supplements decide which are helpful and which are harmful? “Neurologists who become knowledgeable and have information resources in this area can improve the quality of care for their patients by guiding patients away from supplements that may be harmful, and, if appropriate, towards supplements that may be helpful,” Dr. Bowling suggested.
The FDA will release further details of its science-based plan to regulate dietary supplements in the coming months.
MEDICARE TO TRY DISEASE MANAGEMENT
A new Medicare initiative seeks to save money by coordinating management of chronic conditions like congestive heart failure and diabetes. Called the Voluntary Chronic Care Improvement Program, it challenges disease management organizations and health care providers to save at least 5 percent of Medicare costs by coordinating the care of patients with chronic conditions and providing patients with information and advice on managing their own health. In fact, the program requires that participating disease management programs meet the 5-percent threshold to be paid for their coordinated care efforts. Participating disease management organizations will be paid a monthly fee for each patient they manage.
The disease management program aims to enable physicians to get the total picture of a patient's health, not a snapshot of a specific problem excluding co-morbidities. The program will also focus on individual patients by helping them follow their physicians' advice and take advantage of all of the benefits that Medicare offers.
Unlike many new Medicare initiatives, the Chronic Care Improvement Program will start out as a small-scale pilot, with about 10 individual programs serving 150,000 to 300,000 patients. Initially, it will enroll only fee-for-service Medicare patients with congestive heart failure, complex diabetes, or chronic obstructive pulmonary disease, but all of their co-morbidities – including cognitive impairment – will be addressed by their coordinated care program. If successful at the end if its three-year trial period, the program could become a standard part of Medicare nationwide and be expanded to manage other chronic conditions.
The Centers for Medicare and Medicaid Services is currently accepting proposals from organizations with chronic care management experience. For more information about the Chronic Care Improvement Program, visit www.cms.hhs.gov/medicarereform/ccip.
HHS BLUEPRINT TARGETS CHRONIC ILLNESS
In another prong of the attack on chronic disease, HHS released a new report, Prevention: A Blueprint for Action. The Blueprint offers advice for individuals, health care providers, schools and community groups, the media, and other groups on strategies to improve health and prevent chronic disease.
Chronic diseases account for at least 70 percent of US deaths and 60 percent of medical costs, according to an HHS press release. Neurology practices, too, are touched by the effects of chronic conditions like diabetes and obesity, many of which have neurological components.
The plan recommends that physicians get training on how to effectively communicate with all types of patients; follow evidence-based recommendations on when to use preventative services; and keep up to date on medical best practices on reducing risk behaviors. It also encourages health researchers to continue their focus on the pathogenesis, etiology, epidemiology, prevention, and treatment of chronic conditions.
The Blueprint suggests that the HHS create new patient education materials on obesity and diabetes, many of which will target specific at-risk populations, and develop evidence-based approaches to train health care professionals to effectively communicate with all patients, including those with low literacy levels.
To learn more about the Blueprint for Action, visit: http://aspe.hhs.gov/health/blueprint.
FOR NIH, PANEL RECOMMENDS FINANCIAL DISCLOSURE
The NIH's Blue Ribbon Panel on Conflict of Interest Policies has released a draft of recommendations for NIH employees, and the news is mixed. On one hand, the panel wants more conflict-of-interest disclosure for high-level employees, and greater limits on compensation from industry. On the other hand, the panel recommended fewer restrictions on NIH employees' participation in the scientific community – which could mean more compensation for teaching, writing, and speaking.
The panel was appointed to review existing NIH policy and rules on conflict-of-interest concerns for its high-level employees, and to make recommendations for improving these rules. NIH Director Elias A. Zerhouni, MD, created the panel in response to media allegations that NIH scientists were receiving millions of dollars from pharmaceutical companies, creating potential conflicts of interest. Chairing the panel were Bruce Alberts, PhD, a biochemist and President of the National Academy of Sciences, and Norman R. Augustine, Chairman of the Executive Committee of Lockheed Martin.
The panel suggests that employees responsible for outside grants, contracts, and other funding decisions be barred from industry consulting. All other employees should be limited to consulting incomes of less than 50 percent of their salaries – not to be paid in stock or stock options – and that they should not spend more than 400 hours on outside professional activities, except writing.
The panel suggested, however, that NIH employees could be paid for teaching, speaking, or writing for professional societies or academic and research institutions, and that they could receive bona fide cash awards for their work. They also advised that more employees be required to file financial disclosure forms. Finally, the panel recommends that the NIH provide more education and information to its employees on how to interpret ethics rules and handle conflicts of interest. The draft of the Blue Ribbon Panel's report is available online here: www.nih.gov/about/ethics_COI_panelreport.pdf.