Last week, Novartis agreed to settle criminal allegations involving Trileptal, an anti-epilepsy drug, as it deals with similar investigations involving five other Novartis drugs: Diovan, Exforge, Zelnorm, Keturna and Sandostatin. Novartis has agreed to plead guilty to violations of the U.S. Food, Drug, & Cosmetic Act and pay a fine of $185 million. The settlement is pending court approval.
Perhaps the most troubling part of a recent study published yesterday in the Archives of Internal Medicine, which estimates that 48,000 people died in 2006 after developing deadly infections while in the hospital, was that many of the deaths involved healthy people who had minor procedures. Sepsis and pneumonia were the two most prevalent infections, accounting for one-third of the 1.7 million that American patients pick up every year while in the hospital, but the figure may be even higher according to the Study. And while certainly many hospital-acquired infections are unavoidable, many of the infections occur because of a lack of proper infection control. This is a serious and growing problem that some hospitals have addressed but many have not.
In an attempt to drive down health care costs, insurance companies are utilizing what is commonly called "Step Therapy". Step Therapy, also called Step Protocol, forces patients to try the least expensive drug for a particular condition first to see if it is effective. If that drug is not effective, then the insurer will approve payment for the next least expensive drug and so on. From allergy and heartburn medications, to blood pressure medications, to medications for pain, New Jersey doctors and patients continue to be denied and denied again when it comes to Step Therapy.
The drug Fentora is Cephalon’s next generation narcotic painkiller which is only approved for cancer patients who are in severe pain and already taking morphine or other painkillers. In other words, this drug should only be used for those cancer patients whose normal pain medications are not providing pain relief. This highly addictive drug is considered a “Class II” opiate, 80 times more powerful than morphine. So why are thousands of patients taking this drug for migraines, back pain and other injuries?
Dr. Joseph Carrese, director of the ethics and clinical practice program at John Hopkins Berman Institute of Bio-Ethics, recently stated that he believes surgeons need to inform all of their patients about the risks associated with the use of a pain pump catheter during shoulder surgery. Presently, many arthroscopic shoulder surgeries utilize this tiny catheter, placed directly into the shoulder joint, which infuses pain medication continuously for several days following the procedure. The concern that Dr. Joseph Carrese and many others have, is what happens to patients in the long run, as the result of this device.