Rheumatic Diseases Research Plan
New approaches to the treatment for rheumatoid arthritis are needed, according to a draft of the long-range plan for the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The draft outlines research needs for fiscal years 2006–2009 and calls for exploring immunosuppressive agents in inflammatory rheumatic disorders and gaining a better understanding of the epidemiology and disease manifestations of diseases such as juvenile arthritis and juvenile dermatomyositis. The draft report also notes the importance of developing new imaging technologies.
Rare Disease Studies
Officials at the National Institutes of Health have launched the first clinical studies that are part of its Rare Diseases Clinical Research Network. The network has received a total of $71 million in 5-year funding awards to study rare diseases. In the next few months, more than 20 studies are expected to open in sites around the world. For example, an investigator at the Johns Hopkins Vasculitis Center in Baltimore will conduct a study of giant cell arteritis. Other studies will focus on conditions including Angelman's syndrome, episodic ataxia, and urea cycle disorders. “By studying the genetic component of these rare diseases, we hope to be able to better predict the course of the illnesses and provide more effective, personalized treatments for those afflicted,” NIH Director Dr. Elias A. Zerhouni said in a statement. “Ultimately, this individualized approach, completely different from how we treat patients today, will allow us to prevent or to promptly treat the complications arising from these genetic disorders.”
Medicare Formulary Guidance
If officials at a Medicare Part D drug plan change the preferred or nonpreferred formulary drugs, remove dosage forms, or exchange therapeutic alternatives, they must allow beneficiaries currently taking the drug to be exempt from the changes for the rest of the year, according to guidance from the Centers for Medicare and Medicaid Services. Abby L. Block, director of the CMS Center for Beneficiary Choices issued a memo to Part D sponsors in April outlining policies for formulary changes made after a beneficiary has signed onto a plan at the beginning of the plan year. In addition, Part D plans can only change therapeutic categories and classes in a formulary at the beginning of each plan year, except to account for new therapeutic uses or newly approved drugs. CMS also noted that after March 1, Part D drug plans are only allowed to make “maintenance changes” to their formulary, such as replacing a brand name drugs with a new generic drug. All proposed formulary changes, except for expansions, must be submitted to CMS for review and approval, according to the memo. “Prescription drug therapies are constantly evolving, and new drug availability, new medical knowledge, and new opportunities for improving safety and quality in prescription drug use at a low cost will inevitably occur over the course of the year,” Ms. Block said in the memo to Part D sponsors.
Stem Cell Committee Named
The Institute of Medicine and the National Research Council, two divisions of the National Academies, have appointed a committee to “monitor and revise” voluntary guidelines on the conduct of human embryonic stem cell research. The committee will provide updates to the voluntary guidelines issued last year by the National Academies; it is currently seeking comments on the guidelines. It also will have workshops to keep informed about developments in the field. The 14-member committee will be cochaired by R. Alta Charo, professor of law and bioethics at the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., investigator at the Howard Hughes Medical Institute and professor of cancer research at the Massachusetts Institute of Technology, Cambridge. The Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute will provide funding for the committee.
Maryland OKs Stem Cell Research
The Maryland legislature passed a bill establishing a $15 million fund to promote stem cell research in the state. The measure, which passed by a vote of 90–48 and signed by Republican Gov. Robert Ehrlich last month, will establish procedures for reviewing research projects involving either adult or embryonic stem cells. An independent commission—including representatives from the patient advocate, biotechnology, and ethics communities—will administer grants to universities and private sector researchers. “This new law will solidify Maryland's reputation as a national leader in medical research, attract and retain biotech companies and researchers to Maryland, and offer hope to millions of American suffering from debilitating conditions,” the governor said in a statement.