Clinical trials for new drugs receive scant FDA attention according to a recent report. In fact, the FDA only inspected one out of 100 trial sites. These issues affect the safety and efficacy of new drugs coming to the market. Part of the issue concerns lack of resources the FDA can utilize to properly perform inspections and monitoring of new pharmaceuticals.
Cardinal Adam Maida, a conservative canon lawyer and Archbishop of Detroit has announced plans to make the Archdiocese’s 288 parishes individual entities. The Archdiocese of Detroit, like all other archdioceses and dioceses in the United States, has been structured as a corporation sole, an arcane legal structure that vests all finances, church property, and parishes in the Corporate Sole who is the bishop. The move is viewed as a way to avoid priest abuse litigation and protect millions of archdiocesan assets. If the move is executed, it will make it more difficult for survivors of sexual abuse to hold the church and the perpetrators of the abuse accountable for their actions. Maida also holds a civil law degree and would be in a position to understand the civil benefits for such a move.
The FDA relies heavily upon advisory panels of scientists to make determinations concerning a drug’s safety, its potential side effects and make prescription recommendations. However, these advisory panels have come under scrutiny and at times, criticism, for financial ties some of the scientists have with the pharmaceutical companies. These conflict of interest issues are the main reason that the FDA is planning to revamp these advisory panels.
When Congress approved a bill that gives more oversight power to the FDA, one area of the debate escaped largely unscathed. Regulation of drug ads and the marketing tactics used by the pharmaceutical companies will not be tightened as a result of the legislation. In earlier drafts of the legislation, closer scrutiny of drug ads and the manner in which drugs are marketed was part of the bills. However, the drug companies got a powerful assist in the lobbying efforts from Madison Avenue. The country’s large marketing firms lobbied Congress and were successful in convincing legislators to drop strict controls on pharmaceutical advertising and marketing.
The Grocery Manufacturers Association, the food industry’s largest trade group, has called on the federal government to provide more regulation, supervision and control over imported food products. The unusual move comes as a result of the recent spate of food contamination cases involving e coli contaminated spinach and lettuce and the ConAgra peanut butter contamination problem. In addition to calling on more federal oversight on imported food stuffs, the trade group also wants Congress to spend more money on the FDA so that the agency can regulate farms and food packing plants around the country. Part of the problem with the increase in food contamination cases is the lack of consistency in which our food supply is monitored. The sheer quantity of food stuffs and the myriad manufacturing and processing plants make it difficult for and agency like the FDA to properly monitor and regulate the industry, especially foods that are coming from places like China.
Boston Scientific, a leading manufacturer of cardiac stents, has received a warning letter from the FDA regarding its failure to promptly disclose five deaths in clinical trials involving its device used to treat ruptured blood vessels in the abdomen. The device, called a stent-graft, was developed by TriVascular Inc., a company Boston Scientific acquired in 2005. According to the FDA letter, Boston Scientific letter not only failed to disclose the five deaths it also failed to determine the cause of two of those deaths. At least 25 patients have been determined to have cracks in the implanted stents and these cracks were not reported in a timely fashion, according to the FDA.
A new study by Hill-Rom Company estimates that half of all acute-care hospital patients are at risk of developing pressure ulcers. The study finds fault with hospitals in that they are not doing enough to prevent the sores in the first place. The survey comes in the wake of U.S. Centers for Medicare and Medicaid Services’ (CMS) announcement that as of October 2008 it will no longer reimburse hospitals for such care. CMS stated that pressure ulcers were preventable if hospitals followed a consistent prevention program as part of their standard of care. According to CMS, pressure ulcers were a “secondary diagnosis” in 323,000 Medicare patients last year.
In the wake of increased public scrutiny over the safety of medical devices and drugs, the US Senate is trying to make public any and all gifts made to doctors. The news is not popular with big pharma or the manufacturers of medical devices. Senator Charles Grassley, co-author of the legislation, stated “Right now, the public has no way to know whether a doctor’s been given money that might affect prescribing habits.” The bill stems from the alarming relationship between gifts to doctors and their prescription/medical device dispensing habits.