DMARDs Get Some Support
There is “moderate” evidence that disease-modifying antirheumatic drugs are more effective than conventional treatments for juvenile idiopathic arthritis, according to a comparative-effectiveness review released by the federal Agency for Healthcare Research and Quality. The Duke Evidence-Based Practice Center in Durham, N.C., analyzed studies that compared DMARDs – biologics and nonbiologics – with conventional arthritis treatments and each other. While DMARDs generally performed better than therapies such as non-steroidal anti-inflammatory drugs, there was insufficient evidence about their long-term safety and effectiveness, the researchers found. The studies also failed to determine whether any type of DMARD is more effective than another against juvenile idiopathic arthritis.
Drugs, Biologics in Debt Plan
President Obama's latest plan to reduce the deficit, by about $4 trillion, includes two proposals to get generic drugs and follow-on biologics onto the market faster. One would give the Federal Trade Commission the authority to stop “pay for delay” agreements between brand name companies and generic manufacturers. The administration said that such a ban would save federal health programs about $2.7 billion over 10 years by increasing their access to lower-cost drugs. The second proposal would shorten the exclusivity period for brand-name biologics from 12 to 7 years. It would also eliminate some brand manufacturers' practice of “evergreening” market exclusivity by making minor changes to product formulations. The administration estimated savings of $3.5 billion over 10 years for federal health programs from the market exclusivity changes.
Stem Cell Challenge Goes On
The fate of federal funding for stem cell research continues to be in the hands of the courts. Plaintiffs challenging federal funding of human embryonic stem cell research have appealed the July U.S. District Court dismissal of their case. The plaintiffs say that the stem cell policy issued by the National Institutes of Health in 2009 is illegal because federal funding for research involving the destruction of human embryos is banned by the Dickey-Wicker amendment. But the Obama administration has countered that the policy does not fund destruction of embryos but rather supports the research done on stem cells from embryos. Federal funding for embryonic stem cell research will continue as the court reviews the case.
Lower Managed Care Cost
Seniors enrolling this fall in Medicare Advantage managed care plans for 2012 will likely see lower premiums for the same benefits, officials at the Centers for Medicare and Medicaid Services announced. They predicted an average premium that is 4% less than this year's, due in part to greater negotiating authority granted to the CMS under the Affordable Care Act. For example, the CMS can now deny what it sees as unreasonable premium and cost sharing increases, CMS Deputy Administrator Jonathan Blum said. Nevertheless, he and his colleagues predicted 10% more enrollment in the plans over 2011. The estimate conflicts with a Congressional Budget Office projection that enrollment will decline in response to health reform changes.
Information Rules Proposed
A proposed federal rule designed to expand patients' rights to their health records would allow people to receive test results directly from laboratories. Open for public comment through mid-November, the new rule would amend regulations governing clinical laboratories, which are currently barred from providing results directly to patients. That precludes people from being as active as possible in their own health care decision making, the U.S. Department of Health and Human Services said in its proposal. The notice added that “while individuals can obtain test results through the ordering provider, we believe that the advent of certain health reform concepts … would be best served” by lifting some disclosure limitations.
Patients Think Newer Is Better
Patients are more likely to choose newer drugs over older when they're not provided information about the products' safety and effectiveness, according to a study published in Archives of Internal Medicine. The researchers gave participants a choice between two fictitious drugs for heartburn and two for high cholesterol. More people chose a drug described as older if they were also told the newer drug many not be as safe and effective. But for the heartburn drug, most people who were not given that warning chose the newer drug. In their Internet survey, the researchers also found that 39% of respondents believed that the Food and Drug Administration approves only “extremely effective” drugs and 25% believed the FDA approves only drugs without serious side effects.