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Saturday, September 23, 2006
F.D.A. Under Fire For Drug Safety... The New York Times reports that "the nation’s system for ensuring the safety of medicines needs major changes, advertising of new drugs should be restricted, and consumers should be wary of drugs that have only recently been approved, according to a long-anticipated study of drug safety. The report by the Institute of Medicine, part of the National Academy of Sciences, is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the government’s oversight. The debate heated up in September 2004 when Merck withdrew its popular arthritis drug Vioxx after studies showed that it doubled the risks of heart attacks." "Newly approved drugs in the U.S. should carry a warning that their safety isn't guaranteed, the medications should be reviewed in five years, and they shouldn't be advertised for two years," said a story in the Chicago Tribune, drawing from the recently published study. Rather predictably, "consumer groups and advocates of overhauling the FDA hailed the report, while the drug industry was cautious. "Though there is always room for improvements; it would be a mistake to accept the notion that the FDA drug-safety system is seriously flawed," said Caroline Loew, vice president of the Pharmaceutical Research and Manufacturers of America, as quoted in a Seattle Times report. While the study and the news reports about it do broach significant problems with the FDA and drug matters, one of the primary problems just isn't seeming to get a great deal of attention. I suppose that is because it is a rather complex problem -- Big Pharm and even bigger money. These "ask your doctor for" ads are all about profit. The expensive gifts, etc. and so on to doctors, by drug companies, that's all about profit, too, keeping the name of the new med fresh in the doctor's mind. Do you see all those prescription medication name emblazoned note pads, pens, calendars, and other items in your doctor's office? Think about that for a few minutes. The problem is definately a complex one. After all, the drug companies do have to be able to make a healthy profit in order to be inspired to create new and helpful drugs. However, there is a line and I do believe that it is all too frequently crossed, such as when money is used to rush through approval of drugs and when pressure is applied to use certain drugs above others, not because they are medically better, but because they make more money for the industry, which has been noted particularly in the prescribing of certain new medications when the old standards serve just as well. Too often, the primary problem with the old standard seems to be that it is available generically, and is more affordable to the consumer. One of the most egregious crossings of that line, in my opinion, is when the government guarantees profits by making certain drugs mandatory and the consumer is unable to refuse the drug, or takes great risks in doing so, and also has little or no recourse if harm results. This is the case with mandatory vaccinations and often with ADD, ADHD, and other medications pressed upon children. If a parent refuses vaccinations or ADD or other medications, such as anti-depressants (often not tested upon or meant for use in children), they run the risk of facing a court battle against the State for custody of their children. And, in the case of children in foster care or other State care, well... there is no choice. (This is a topic I have researched indepth and written about, with work published, among other places, in Under The Influence: The Disinformation Guide To Drugs.) Blogger News Network is advertiser-supported, and your visits to our advertisers help BNN to meet its expenses. Help keep us afloat! posted by Sharon Secor at 11:20 AM |
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