Changes to Human Research Regulations

The US Department of Health and Human Services (DHHS) is considering changing the regulations governing research involving human study participants, according to a July 22, 2011, press release from DHHS. The federal government is considering “various ways of enhancing” the current regulations, known as the Common Rule, in place since 1991. DHHS is asking for input from the public on issues relating to the ethics, safety, and oversight of human research. The changes being considered are available in an Advance Notice of Proposed Rulemaking, Human Subjects Research Protection: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register (https://www.hhs.gov/ohrp). One section of the proposed changes includes a requirement that researchers receive permission from participants to have biospecimens such as blood used in studies other than the one in which they are enrolled. In addition, the changes include a requirement that all institutions receiving any federal funding must follow federal guidelines for human research. The majority of other revisions would aim to streamline the research trial process. Updates to Varenicline Label The label for varenicline (Chantix) has been updated by the US Food and Drug Administration (FDA) to include information about the smoking cessation drug’s safety and efficacy in patients with cardiovascular disease or chronic obstructive pulmonary disease (COPD). According to an article in Medpage Today, the update to the label follows a June statement from the FDA saying it was reviewing reports that use of varenicline was associated with an increase in recurrent myocardial infarction or new-onset peripheral arterial disease. The agency said that in a trial with 700 smokers, those who used varenicline were twice as likely to quit smoking as those receiving placebo, but the same study found a small, increased risk of certain cardiovascular events in participants with stable cardiovascular disease, adding that the absolute risk of cardiovascular events with the drug was small in relation to its efficacy. The new label also indicates that varenicline was “more effective in helping COPD patients quit smoking and remain abstinent from smoking for as long as 1 year compared with placebo.” Express Lane Strategies for States Under the Patient Protection and Affordable Care Act, millions of uninsured adults and children will gain eligibility for Medicaid or health coverage through new health insurance Exchanges beginning in 2014. The law requires states to develop simple and streamlined processes for establishing, verifying, and updating eligibility for Medicaid, the Children’s Health Insurance Program (CHIP), and federal subsidies for Exchange coverage. The Henry J. Kaiser Family Foundation has issued a brief illustrating how states can use “express lane” principles in designing systems that use existing data held by other government agencies to help identify individuals who may be eligible for Medicaid, CHIP, or subsidies for other coverage and enroll them or renew their coverage, as appropriate under the health reform law. The brief is available on the Kaiser Foundation Web site, www.kff.org. Bariatric Surgery Cost-Effective A recent study has found that bariatric surgery is cost-effective regardless of the degree of obesity or presence of comorbidities. According to an article in Medpage Today, researchers found that for patients whose body mass index was between 35 and 40, and who had obesity-related diseases such as diabetes and hypertension, the incremental cost-effectiveness ratio of surgery was only $2413 per quality-adjusted life-year gained. The study, reported online in Maturitas, was a meta-analysis of weight-loss surgery outcomes and a multifaceted cost-effectiveness analysis that included a total of 280,315 patients. New Regulations for Bioequivalents The FDA is considering imposing stricter standards for bioequivalency on medications known as critical dose drugs or narrow therapeutic index (NTI) drugs. According to an article in Medpage Today, small changes in the dose of NTIs could cause serious or even life-threatening adverse effects. In 2010, the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted that the current requirements for bioequivalence are not sufficient for NTIs. The new proposals include requiring generic drugmakers seeking approval for an NTI to conduct a replicate design study to quantify the variability of the generic and the reference product to determine bioequivalence.