#script care

Previously effective as an injection in mice exposed to fatal doses of salmonella, the University of Texas Medical Branch (UTMB) in Galveston has now modified the vaccine so that it can be administered orally, along the same path that the bacteria uses to enter the body. Though, currently, effectiveness has only been tested in mice, the vaccine is a promising advancement as concerns of antibiotic resistance and potential use as a bioweapon grow.

Foodsafety.gov is hoping to remind everyone responsible for food preparation of the key components to food safety. In addition to washing all fruits and vegetables, wash your hands, surfaces and utensils prior to, and intermittently during, food prep; avoid washing raw meat and eggs prior to cooking. Further, they highlight the importance of avoiding cross contamination between raw meat, poultry and eggs with other food items. Finally, make sure that all food is cooked to a safe temperature and leftovers are refrigerated promptly.

Andy Slavitt, the acting administrator for the Centers for Medicare and Medicaid Services (CMS), made a dramatic appeal to the industry, reiterating the need to curtail costs. Quoting statistics regarding the substantial current and projected growth trends, Slavitt voiced concerns that the Medicare program will not be able to keep up with the looming cost increases. Arguments that innovation will stop if funding is decreased or that critics are not accounting for the value of medicine were rejected; Slavitt pointed to the fact that for a cost increase to be feasible, another cost burden must decrease – and that has yet to be seen in most instances.

In response to recommendations from a UN commissioned panel aimed at reducing the costs of drugs, world-wide, the US government called the information presented ‘flawed’ and accused the panel of suggesting measures that would severely restrict future drug innovation. Experts, however, point out that the current system is largely ineffective – treatments for many of the currently underserved conditions would not be profitable for the drug companies and, therefore, receive little attention during development. The panel suggests that incentives must be provided for research and development, separate from manufacturers in order to spur innovation without giving more power to the drug makers.

Article Summary: There are currently three approved biosimilars meant to treat rheumatoid arthritis and, while its commonly accepted that biosimilars will be an important piece in helping to control the cost of specialty drugs, the actual impact these drugs will have remains unclear. Acceptance will be highly dependent on the FDA classifying the drugs as “interchangeable.” Further, actual cost impacts will likely not be realized immediately upon release, as most prescribers are unlikely to change therapy for a patient if it has already proven successful. Lastly, it is still unknown to what extent insurers will cover drugs coming from an unproven distribution chain.

Heather Bresch, the CEO of the company responsible for the recent EpiPen price hike, was called before the House Oversight and Government Reform Committee late last month. Although Bresch acknowledged that their decision to raise prices caused hardships on consumers, any accusation of the profitability of the price hike was denied. She was also unable to provide specific details around Mylan’s patient assistance programs, revenues and supposed medical cost savings. Doug Throckmorton, a deputy director of the FDA, was also present as the recipient to criticisms over the onerous and complicated approval policies of the Administration.

As the debate over drug pricing shows no sign of stalling, and without any Federal action, the responsibility of reigning in consumer costs is being taken up by the States. And while many legislatures have seen bills with cost containment goals (Vermont was the first to pass one of these bills into law) many attempts have fallen to the wayside. Further, critics suggest that bills requiring drug manufacturers to open their books are simply political posturing; lawmakers appearing to be “doing something” for the voters, while fully understanding that increased transparency will have little effect on actual costs. Drug manufacturers, however, are working diligently to strike these bills down – indicating, at least some, concern of the potential consequences new reporting requirements might have on their operations.