May 21, 2010
By Allison Cohen and Leah Voigt*
NIH Proposed Rule on Financial Conflicts Would Broaden Disclosure Requirements
National Institutes of Health (NIH) Director Francis Collins announced this week that NIH is considering substantial changes to its rules for monitoring and reporting financial conflicts of interest of the scientists it funds, including proposals to increase reporting requirements, lower and in some cases eliminate the monetary thresholds for disclosure, and require institutions to post all the disclosures on a publicly accessible website.
Financial conflicts of interest, particularly the relationship between publicly funded scientists and drug and device companies—has been an important topic in and around NIH, piquing the interest of lawmakers such as Senator Charles Grassley (R-IA), who has conducted a number of investigations over the past several years on the disclosure practices of researchers at universities.
Under the new rule, NIH would shift how the focus of disclosing significant financial interests on a project-specific basis—interests that would appear to affect the particular NIH-funded research—to focus instead on how a significant financial interest may affect an investigator's institutional responsibilities. NIH also stated that it expects this new approach to increase the number of disclosures generated by investigators.
The rule will be open for public comment for sixty days. Collins said the rule will not be finalized until later this year. Access the Notice of Proposed Rulemaking.
Jeannie Baumann, NIH Proposed Rule on Financial Conflicts Would Broaden Disclosure Requirements, BNA's Health Care Daily Report (May 21, 2010) (note: registration is required to view this content).
Young Doctors Getting Defensive Medicine Lessons Early On
According to a recent survey, defensive medicine practices creep into physicians' activities as early as medical school. Eighty-seven percent of doctors who described themselves in a new survey as current residents or fellows reported being taught to practice defensive medicine while in medical school or residency.
Of survey respondents in the twenty-five to thirty-four-year-old age bracket, 83% learned to practice defensively by ordering additional tests or referrals, or by avoiding high-risk procedures to safeguard against potential liability. Attending physicians and mentors are teaching these tactics, respondents said. The results were based on online questionnaires of more than 1,400 physicians across the country and released in April by Jackson Healthcare, an Atlanta area-based healthcare management and technology company. The survey was part of a series of recent polls by Jackson Healthcare aimed at quantifying the impact of liability fears on medical care.
The latest survey findings suggest that defensive medicine practices have become more common in recent years. Only 19% of physicians age sixty-five and older and nearly one-third of doctors age fifty-five to sixty-four reported learning such behaviors during their medical training. Seventy-two percent of physicians viewed defensive medicine as having a negative impact on patient care, while 67% said such practices come between doctors and patients. High-risk specialties appeared to be particularly vulnerable to medical liability lawsuits, according to the study. Eighty-three percent of obstetrician-gynecologists polled, reported having been named in a lawsuit, as had 79% of surgeons and 68% of emergency physicians.
Amy Lynn Sorrel, Young Doctors Getting Defensive Medicine Lessons Early On, Am. Med. News (May 19, 2010).
Dual Tests Might Permit Ovarian Cancer Screening
A test that considers levels of the tumor biomarker CA-125 and, if suspicious, follow-up with transvaginal ultrasound may help doctors determine if a woman should undergo surgery for suspected ovarian cancer, researchers suggest.
In a study in which 3,252 postmenopausal women were screened using the one-two test approach, eight women eventually went on to surgery and doctors identified five cancers, including three early-stage invasive malignancies, according to a lead researcher at the University of Texas MD Anderson Cancer Center in Houston. "Currently we will perform about 10 operations to detect one ovarian cancer. In this study we needed to perform three surgeries to detect one invasive cancer. This was very reassuring to us," she said at a recent press conference.
Researchers used a risk of ovarian cancer algorithm as a screening tool in postmenopausal women. "There are no effective screening methods for ovarian cancer," the lead researcher said, noting that if the disease is detected early and excised, 60% to 90% of women can expect to be cured.
In this study, 2,666 women were determined by CA-125 testing to have low risk of ovarian cancer and continued to be screened on a yearly basis. There were 501 women who exhibited an intermediate risk and were screened every three months. There were eighty-five women who were at high risk, and these patients underwent transvaginal ultrasound and a gynecologic oncology workup. Of that group, eight underwent surgery; three of the masses removed were high-grade invasive cancers and two were borderline invasive cancers. Two of the masses were benign ovarian tumors and in one patient no ovarian abnormality was found, although that woman was later determined to have endometrial cancer.
In commenting on the study, the president and professor of medicine at the University of Michigan in Ann Arbor told MedPage Today that if the confirmatory trial shows that screening improves outcomes "this could become part of the regular physical examination for postmenopausal women." But, he said, "the test is not yet ready for prime time."
Ed Susman, ASCO: Dual Tests Might Permit Ovarian Cancer Screening, MedPage Today (May 20, 2010).
Informed Consent: Hospitals Explore Personalizing Risks
Some facilities are giving surgical patients individualized risk estimates. Informed consent has long been a bedrock principle of medical ethics, but the form intended to document a patient's understanding of a proposed intervention is too often written at a college reading level and is ambiguous about risks. Some doctors are out to change that, bringing a personalized medical approach to informed consent.
Nine medical centers around the country—including the Mayo Clinic in Rochester, MN, and the Henry Ford Hospital in Detroit—are testing an informed-consent process for patients undergoing nonemergent cardiac catheterization and potential angioplasty. The web-based program draws on a national cardiovascular database to predict individualized risks of death, bleeding, or restenosis. Proponents of the effort say that informed consent should include even more data, telling patients about cost, alternative treatments, and doctors' and hospitals' quality performance.
The new program tackles a serious problem. Some 60% to 70% of patients do not read or understand informed-consent forms, and nearly half cannot recall the exact nature of the planned operation, according to a 2005 National Quality Forum report. The program, known as Patient Refined Expectations for Deciding Invasive Cardiac Treatments (PREDICT), allows physicians to draw on information from the American College of Cardiology's massive National Cardiovascular Data Registry, which in May surpassed ten million cath-lab patient records.
PREDICT takes into account a patient's age, comorbidities, and other characteristics to estimate an individual's risk profile, given how similar patients have fared. The bleeding, death, and restenosis risks, and the pros and cons of bare-metal versus drug-eluting stents are presented in an easy-to-understand bar chart.
As part of PREDICT, additional information is provided separately to interventional cardiologists that can alert them to use different medical and procedural tactics to reduce risks during angioplasties.
Kevin B. O'Reilly, Informed Consent: Hospitals Explore Personalizing Risks, Am. Med. News (May 17, 2010).
House Energy and Commerce Committee to Investigate Personal Genetic Testing Kits
Leaders of the House Energy and Commerce Committee this week sent letters to manufacturers of personal genetic testing kits, asking for information about the tests in light of recent efforts by one company to sell the tests directly to consumers through a retail chain.
The letters noted that "at least one of the companies" was seeking to sell the testing kits in retail locations, "despite concern from the scientific community regarding the accuracy of test results." Pathway recently announced that it had made a deal with drug store chain Walgreen Co. to sell its testing kits directly to consumers starting in mid-May. However, the retail chain on May 12, 2010, announced it had backed out of plans to sell The Insight Saliva Collection Kit as a result of actions taken by the U.S. Food and Drug Administration (FDA). FDA sent a letter to Pathway telling the company that its kits may require agency authorization.
According to FDA, the Pathway test "appears to meet the definition" of a medical device under the law, which would make it subject to agency regulation. FDA had requested a response from Pathway by May 25, 2010. House lawmakers requested information on several aspects of the tests: how the companies analyzed test results to determine consumers' risk for any conditions, diseases, drug responses, and adverse reactions; the ability of the companies' genetic testing products to accurately identify any genetic risks; and the companies' policies for the collection, storage, and processing of individual genetic samples collected from consumers. Lawmakers said in the letters they wanted the companies to respond by June 4, 2010.Access the letters.
Nathaniel Weixel, House Energy and Commerce Committee to Investigate Personal Genetic Testing Kits, BNA's Health Care Daily Report (May 21, 2010) (note: registration is required to view this content).
Cancer Survivors Get Benefit from Yoga
Gentle stretching, breathing, and other exercises in a regular yoga program may ease sleep and fatigue problems common among cancer survivors, a randomized trial found.
Sleep quality rose 22% after just four weeks of yoga, compared with the 12% improvement from baseline on usual care, reported researchers at the University of Rochester Medical Center in Rochester, NY. Yoga had an even greater effect on fatigue, with a 42% reduction among yoga participants versus 12% among controls (P<0.05), the study's lead author reported at a recent American Society of Clinical Oncology meeting. Similar yoga classes done in the community would also likely fight these side effects, which affect the majority of cancer survivors, she noted.
Although there have not been any head-to-head studies to suggest which type of exercise is most effective, yoga may have some advantages beyond just getting patients moving, the researchers speculated. Small studies have suggested that the deep breathing training and mindfulness aspects of yoga may help regulate parasympathetic nervous system activity and the hypothalamic-pituitary-adrenal axis.
The researchers tested a program designed for cancer survivors (UR Yoga for Cancer Survivors, YOCAS®) that included only gentle yoga postures in standing, seated, transitional, and lying-down positions along with breathing exercises, meditation, and visualization. These components can be found in typical Hatha or restorative yoga classes in communities across the country, the study's lead author noted. However, she cautioned that the results may not generalize to more rigorous or heated forms of yoga in cancer survivors.
Crystal Phend, ASCO: Cancer Survivors Get Benefit from Yoga, MedPage Today (May 20, 2010).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.
*We would like to thank Allison Cohen, Esquire (Health Law and Policy LLM Candidate at American University Washington College of Law, Washington, DC), and Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.