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The Pharm-bots Are Coming!
Panasonic is venturing into robotics with a new machine that sorts and delivers drugs. “This robot is the first in our robotics project,” said a spokesman for the Japanese electronics giant in the Associated Press. “It sorts out injection drugs for patients, saving time for pharmacists.” The expensive device—each costing several hundred thousand dollars—will be sold to Japanese hospitals starting in March and later in the U.S. and Europe. The robot, which resembles a cabinet with lots of small drawers, uses electronic medical records to sort each prescription into a drawer labeled with the patient’s name. This task would take a pharmacist at a 400-bed facility up to four hours, but this electronic assistant can get the job done in half the time—and also could prevent some human error. Panasonic hopes its drug-dispensing robot will lead the charge in this new field, as the company is currently developing other medical robots to assist the elderly and ailing move about. The consumer electronics company is eyeing the healthcare field for an annual revenue of $315 million by March 2016 for its medical robots. —Andrew Matthius

Anti-Flutter
Sanofi-aventis is hoping its new anti-arrhythmic, Multaq (dronedarone), is the summer blockbuster after FDA approval last month. Multaq is the first drug approved in the United States with clinical evidence of reduced cardiovascular hospitalization in patients with atrial fibrillation (AF) or atrial flutter (AFL). Atrial fibrillation is a potentially life-threatening condition that affects about 2.5 million people in the United States and 4.5 million people in the European Union. “Sanofi-aventis is proud to contribute to reducing the public health burden of atrial fibrillation,” said CEO Christopher A. Viehbacher.
Three years ago the FDA denied approval for the drug because a trial showed it increased overall mortality in patients suffering from severe heart failure. Researchers then focused on a different set of patients and conducted a new study, the Athena trial, which gave 400 mg tablets of Multaq to patients with AF/AFL or a recent history of those conditions. The study showed a 24% reduction in cardiovascular hospitalization or death from any cause when compared to the placebo. The side effects associated with taking Multaq during the trial included diarrhea, nausea, bradycardia, QT-interval prolongation, and rashes. To ensure this drug is used properly, Sanofi-aventis also introduced mPACT, Multaq Partnership for Appropriate Care and Treatment, the Risk Evaluation and Mitigation Strategy (REMS) developed to help healthcare professionals identify the appropriate patients for Multaq. —A.M.

Effient Debuts
For a decade, Plavix has been the gold standard in the anti-clotting drug market, but the newly FDA-approved Effient (prasugrel) is the upstart challenger. The drug’s developers, Daiichi Sankyo and Eli Lilly, are pricing their new pill at a premium, about $5.45 per tablet or 18% more than Plavix. The new drug reduced the risk of heart attacks and strokes in a large clinical trial, but Effient carries a boxed warning on its prescribing label alerting doctors that it can cause sometimes-fatal bleeding. The study showed that for every 1,000 patients treated with Effient as compared to Plavix, 23 fewer patients had heart attacks but 6 more had major bleeding events. High-risk patients for bleeding include anyone who weighs less than 132 pounds, is 75 years or older, or has had a prior history of transient ischemic attack or stroke.
While Plavix is approved for use in a wide range of patients, Effient is approved only for patients with acute coronary symptoms (ACS) who are managed with percutaneous coronary intervention (PCI), usually when a stent is used to keep an artery open. ACS affects almost 1.5 million people in the U.S. annually. Bristol-Myers Squibb and Sanofi-aventis will lose their U.S. patent protection for Plavix in just a few years. Effient will then have to compete with generic versions. —A.M.

Clean Eggs and Ham
The Obama Administration revealed its plan last month to overhaul the food safety system by focusing on preventing food-borne disease. The bottom line is the government is sick of people getting sick from a long list of contaminated foods, including ground beef, peanuts, spinach, tomatoes, pistachios, peppers, and cookie dough. “There are few responsibilities more basic or important for the government than making sure the food our families eat is safe,” said Vice President Joe Biden at a White House news conference. The Vice President, Health and Human Services Secretary Kathleen Sebelius, and Agriculture Secretary Tom Vilsack oversee the Food Safety Working Group, which was formed in March to examine the food safety system and propose improvements. Their recommendations include targeting Salmonella contamination by developing tougher standards; preventing the threat of E. coli with stronger enforcement in beef facilities and new guidelines for leafy greens, melons, and tomatoes; developing a national trace-back and response system for contaminated food; and creating new positions at key food safety agencies.
The first recommendation to get implemented is the new FDA regulation that requires egg producers to buy chicks from suppliers that monitor for Salmonella, refrigerate eggs on the farm and during shipment, and regularly test their poultry houses. The FDA believes these restrictions will help reduce food-borne illnesses by 60% and save the nation $1.4 billion in medical expenses, while costing egg producers $81 million. The changes proposed by the working group will help plug some of the holes in the food safety system, but more drastic measures must come from Congress. Currently, legislators are debating whether to give the FDA the authority to recall tainted food, while another bill calls for the creation of an agency established specifically for food safety. —A.M.