More on drug safety and money
Dr. Steven Nissen, a cardiologist from the Cleveland Clinic and University of Michigan Medical School graduate, has been a leading critic of the country's pharmaceutical industry. It was his close examination of previously unavailable data on the diabetes drug Avandia that lead to a federal safety alert in May and the upcoming re-examination of the safety of the drug by a federal panel.
Dr. Nissen was also the critic who sounded the alarm on Vioxx and prompted its removal from the market, after his detailed investigation of the manufactuer's safety data identified cardiac risks that the manufacturer had not disclosed to the public. Dr. Nissen and others have made effective use of manufacturer's clinical trial data that was previously unavailable to the public and which was obviously not thoroughly examined by the FDA in the past.
Nissen's work also points out the enormous sums of money that are involved in the sale and marketing of pharmaceuticals in the United States. Avandia sales had earned 3.2 billion dollars for GlaxoSmithKline in the prior year, and the federal alert issued in response to Nissen's work led to a 30 percent decline in sales: that is, about a billion dollar loss of income. That makes for substantial resources to fight regulation or investigation. Some critics of Nissen point out that he is actively involved in industry-financed drug research and approval, himself, and that his Cleveland Clinic has been paid hundreds of thousands of dollars for drug research, including research into drugs that are the direct competitors of Avandia. Nissen's response is to direct investigators to the charities to whom he has directed all income that he personally would have received from this research. Those charities include medically-related institutions and the Cleveland Museum of Art.
The influence of the enormous sums of money involved in the American pharmaceutical industry is pervasive. Last night, while I was waiting to meet with a physician to discuss a client, a drug salesman visited the doctor's office to schedule a lunch for the ten-person staff. They picked a date that fitted the salesman's schedule between other physician staff lunches, and chose a very expensive nearby restaurant. They laughed over whether or not the salesman would have five minutes to explain how to confirm prescription coverage for "his drug": Procrit. This salesman represents only that drug, and only for some uses. His co-worker markets the drug with local doctors who would use it to treat cancer and certain other maladies. With his business concluded, the salesman went back to his car and retrieved what appeared to be a very nice pastry for the office staff to enjoy the following day. All-in-all a successful marketing visit for his employer if it will mean more prescriptions written for Procrit.
The next day, the NYT carried an article that examined the implications of the Bush administration's tax policy on pharmaceuticals. Despite a "one time" holiday on offshore taxes that allowed the industry to avoid billions in income taxes a few years ago, the major drug manufacturers continue to play games with American drug income that in some cases maintains their tax liability below six percent of income, rather than the scheduled liability of one-third that would normally apply to 3 or 4 billion dollars of income. It is news to no one that U.S. citizens pay more than other people for medications, and that the leading problem in health care costs today is the cost of medication. Unfortunately, these costs are not driven by research, but rather by marketing campaigns, including ubiquitous TV ads for so-called "lifestyle" drugs, and extensive payments to physicians [refer to previous weblogs for details and amounts]. Until American taxpayers gain control over this industry, it will continue to drive manufacturing overseas, to control access to the courts for victims [in places like Michigan, for example, where FDA approval by an industry-laden panel immunizes drugs from liability], and to evade its share of taxes through overseas corporate gimmickry.