Bill Would Track Neuro Diseases
Researchers need better data on neurologic diseases, according to Sen. Mark Udall (D-Colo.), so he has introduced a bill to create national registries for Parkinson's disease and multiple sclerosis. The National Neurological Diseases Surveillance System Act (S. 425) “would give the research community a one-stop shop for data being collected on these diseases from around the country,” Sen. Udall said in remarks accompanying the bill. Currently, “the frustrating truth is that we actually don't know how many people are living with Parkinson's disease in America,” Parkinson's Action Network CEO Amy Comstock Rick said in a statement. The registries would include data on the prevalence, common patient characteristics, geographic similarities, and other information about neurological diseases.
Group Asks FDA to Reject Drug
Public Citizen Health Research Group has urged the Food and Drug Administration to reject florbetapir F18 (Amyvid) injections for diagnosing Alzheimer's disease. “Given the significant inter-reader variability that was seen in the single-phase III clinical trial evaluating the performance of florbetapir positron-emission tomographic (PET) imaging, such PET scans would have little clinical utility in the evaluation of patients presenting with cognitive deficits or early dementia and suspected of having Alzheimer's disease,” the group wrote. The letter followed the January vote of an FDA advisory panel to endorse florbetapir if Avid Radiopharmaceuticals Inc. and Eli Lilly and Co., the companies developing the compound, train readers in a consistent technique and then reevaluate trials of the imaging agent. In its letter, the advocacy group wrote, “It is unlikely that better training and a new study in the more appropriate patient population are realistic hurdles to overcome.”
FDA Denies MS Drug
The FDA has denied approval of cladribine, an investigational oral drug for the long-term treatment of relapsing forms of multiple sclerosis. “The announcement was disappointing to members of the MS community, who were hoping to see another option added to the list of available disease-modifying therapies for the long-term treatment of MS,” according to the Multiple Sclerosis Association of America. In its own statement, cladribine maker EMD Serono acknowledged the FDA letter but said the agency found the drug effective while asking for additional information on safety. The tablets have been approved in Russia and Australia.
Drug Risk High for Older Adults
Drugs such as pain relievers and anxiety and insomnia medications were the cause of about one-fourth of emergency department visits by adults aged 50 or older for adverse drug reactions in 2008, according the Drug Abuse Warning Network. Among medications acting on the central nervous system, narcotic pain relievers accounted for 9% of the year's 1,112,000 drug-related emergencies in this population and nonnarcotic pain relievers made up nearly 8%. In a separate category, psychotherapeutic drugs accounted for 5% of the emergencies. The study appeared in The Dawn Report, published by the Substance Abuse and Mental Health Services Administration. Nearly one-third of 50-and-older adults going to emergency departments for drug reactions in 2008 were admitted to the hospital.
Bill to Prevent Drug Shortages
New federal legislation aims to prevent shortages of critical prescription drugs by giving more information to the Food and Drug Administration. The bill would require drug manufacturers to notify the FDA early of any problems that could lead to a shortage of medications. Those factors might include changes to raw material supplies, adjustments to manufacturing capabilities, and business changes such as mergers. “Physicians, pharmacists, and patients are currently among the last to know when an essential drug will no long be available – that's not right,” Sen. Amy Klobuchar (D-Minn.), one of the sponsors of the bill, said in a statement. The Preserving Access to Life-Saving Medications Act (S. 296) also directs the FDA to notify the public of shortages and what the agency is doing to address them.