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Boniva Gets Dubious Distinction
The osteoporosis therapy ibandronate (Boniva) ranked in the top 10 drugs most cited as possibly contributing to patient deaths in 2009, according to a report from the Institute for Safe Medication Practices. But those figures don't indicate a safety problem with the drug, the same report said. The large volume of patient deaths was actually attributable to marketing by the manufacturer, Roche. The company used postcards to remind patients, most of whom were elderly, to take their medication each month. If the postcard was returned to the manufacturer with the note “addressee decreased,” Roche reported an adverse event associated with ibandronate. Nearly 90% of the 250 ibandronate-associated deaths in the United States last year were reported through this program, according to Roche.
Gout Patients Report Pain, Stress
More than a third of gout patients polled in a recent survey said they would give up winning the lottery if it meant they would never have to have another gout flare. The telephone survey of 1,000 people found that they experienced significant pain and stress from the condition, even though 91% said they feel that their condition is under control. The survey revealed that 22% feared their next gout attack, and 28% have had to take time off from work because of flares. The survey was conducted by Braun Research Inc. and supported by Takeda Pharmaceuticals North America Inc., which markets the gout drug febuxostat (Uloric).
PsA Coverage Is Limited
About a third of patients with psoriatic arthritis (PsA) and psoriasis go without treatment because of insurance barriers, according to a survey by the National Psoriasis Foundation. About 12% of those surveyed reported having no insurance. However, even people with insurance had limited access to treatment. About 11% of patients said that the treatment they needed was not covered so they went without it. Another 11% said that high copayments prevented them from obtaining treatment. Access to care appeared to be worst among people with the most severe psoriatic conditions. For example, 10% of all survey respondents said that they had no prescription drug coverage vs. 21% of those with a severe psoriatic condition. The results are based on phone and online interviews with 422 individuals. About 54% of respondents had psoriasis alone, 2% had PsA alone, and 44% had both.
FDA Drafts Transparency Rules
The Food and Drug Administration's Transparency Task Force has issued 21 draft proposals concerning public disclosure of FDA operations without compromising patents or companies' trade secrets. Part of the FDA's transparency initiative that was launched last summer, the proposals are aimed at helping consumers, stakeholders, and others understand how the agency makes and enforces decisions. The FDA said that one of the draft proposals would support research into rare diseases by freeing the agency to discuss that a company has abandoned its application for an orphan drug. Once made public, this information could enable another drug manufacturer to pick up where the first one left off toward a potentially new therapy for a rare disease, the agency said.
House Probes OTC Genetic Testing
Three key House lawmakers have launched an investigation into over-the-counter (OTC) genetic-testing kits. The investigation, spearheaded by House Energy and Commerce Committee Chairman Henry A. Waxman (D-Calif.) and supported by Rep. Joe Barton (R-Tex.), Rep. Bart Stupak (D-Mich.), and Rep. Michael C. Burgess (R-Tex.), has targeted the companies 23andMe Inc., Navigenics Inc., and Pathway Genomics Corp. The companies already offer their tests to consumers by phone or online, and San Diego–based Pathway announced in May that it is seeking to sell testing kits in retail locations, despite concerns from the scientific community about the accuracy of test results. In letters to the companies, the lawmakers said they want information on how the companies analyze test results and identify potential genetic risks. The three lawmakers also want to know how the companies collect, store, and process individual genetic samples collected from consumers.
Survey: Telehealth Improves Care
Eight of 10 health care and information technology professionals believe that telehealth technology will improve quality of care, especially for the aging population, according to a survey conducted for the technology company Intel Corp. It surveyed top medical and IT executives at hospitals, clinics, home health organizations, disease management companies, and private payers. Challenges to the adoption of telehealth technology reside mainly in financial issues, such as reimbursement for services provided via telehealth, the survey respondents said. More than two-thirds said that health care providers probably will implement telehealth technology if financial issues are resolved. Intel is a developer of telehealth devices.