Guest guest Posted August 19, 2010 Report Share Posted August 19, 2010 Off Labeling Of Drugs. Understand this every-time you see your doctor. There are doctors that are pharmedout and need support education and help from the general public. http://www.pharmedout.org/aboutus.htm PharmedOut is a town University Medical Center project run by physicians for physicians and other prescribers. Our goals are to: Document and disseminate information about how pharmaceutical companies influence prescribing Provide access to unbiased information about drugs Encourage physicians to choose pharma-free CME --- In , " healinghope " <mfrreman@...> wrote: > > Another example of a good doctors challenges. > http://www.kevinmd.com/blog/2010/08/physicians-fda-ad-enforcement.html > The Food and Drug Administration (FDA) wants physicians to turn in Big Pharma marketing and promotional materials that are misleading, that are poisoning us with information that reaches beyond FDA's approved indications and regulations. This new government initiative is called the `Bad Ad' program, a name so absurd, that it must have taken months of committee meetings to create. Physicians who encounter a rogue drug rep, or promotional materials that promise more than the FDA permits, can anonymously report the offender via an email address and phone number, which I will not provide here. > > There is a Stalinesque aura to all of this. If I ask a drug rep about off label use of a drug, am I doing so to acquire medical information for a patient, or am I serving as a government agent, a G-Man, who is setting a trap? > > Is this a good idea? Will this foster collaboration and trust between the medical profession and the pharmaceutical industry? Is it physicians' role to serve as an enforcement arm of the government? > > Personally, I believe that the FDA regulations on marketing to physicians is overly restrictive. For example, every physicians prescribes off label medicines, but we can't discuss these uses with Pharma reps who are often excellent resources on unapproved medication uses. These sales folks may call on leaders in the field and may be able to relate to us nuances and new uses of medicines that can benefit our patients. > > I know that these guys and gals are not physicians, but are trying to sell products, like everyone else in the marketplace. Sometimes, marketers go over the line. For example, Kellogg, the cereal company, had to take back two health claims: > > • Frosted Mini-Wheats can improve kids' attention spans. > • Rice Krispies can enhance kids' immunity. > > In these cases, the Federal Trade Commission was right to intervene. Drug promotion can also go over the line and need to be reined in and sanctioned. I am not sure, however, that the line is in the right place presently. What is your view? > > I don't like the `bad ad' program, and I don't intend to have the FDA on my speed dial. I don't like the precedent of folks being encouraged to turn in colleagues. Imagine where this idea could take us. > > This post has riled me up and I need to calm down. I need an `off label' anxiolytic. It's time for a Vodka i, shaken not stirred. > > Kirsch is a gastroenterologist who blogs at MD Whistleblower. > > S > > --- In , " healinghope " <mfrreman@> wrote: > > > > Doctors are blindsided by lies and corruption just like the people they care for, not all doctors but some still work on ethics. To put all care providers in a corrupt greed oriented care system for me is just wrong. Many doctors truly believe in healing and helping the sick. > > http://www.pcrm.org/news/avandia_pcrm_lawsuit_1007.html > > > > News Release Archive 2010 > > > > NEWS RELEASE > > > > July 19, 2010 > > > > > > Doctors Sue FDA Over Diabetes Drugs' Fatal Side Effects > > > > Warning Labels Should Alert Patients to Safe Alternatives to Avandia, Says Lawsuit Filed in U.S. District Court > > > > WASHINGTON—In a lawsuit filed this month against the Food and Drug Administration, a doctors group seeks to compel the agency to alert patients to safe dietary alternatives to Avandia and other diabetes drugs that may increase the risk of stroke, heart failure, and death. The nonprofit Physicians Committee for Responsible Medicine (PCRM) is filing the suit in the U.S. District Court for the District of Columbia. > > > > The lawsuit targets FDA commissioner Margaret Hamburg, M.D., for failing to act on a PCRM administrative petition urging the FDA to require that diabetes drugs carry warning labels telling patients that low-fat plant-based diets can effectively treat type 2 diabetes without dangerous side effects associated with oral medications. > > > > A 2006 study funded by the National Institutes of Health found that a low-fat plant-based diet was as effective as oral medications at reducing blood glucose and cholesterol in people with diabetes.This month, other researchers unveiled data linking Avandia to life-threatening side effects that may have killed or injured tens of thousands of people. The FDA took expert and public testimony on Avandia at a special joint meeting of two advisory panels on July 13 and 14. > > > > " A plant-based diet is as effective as drugs for lowering blood sugar, and much more effective for trimming body weight, " says PCRM president Neal Barnard, M.D. " Doctors and patients need the facts. " > > > > As the doctors point out in their lawsuit, " PCRM's petition requested that FDA require a disclosure in the labeling of drugs, such as Avandia, used to manage blood glucose in diabetes treatment. The disclosure would state that a low-fat plant-based diet has an efficacy and safety profile that can be as favorable as, or more favorable than, oral diabetes medications. FDA has failed to provide a substantive response to PCRM's petition in a reasonable time, in violation of the Administrative Procedure Act. " > > > > Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit health organization that promotes preventive medicine, conducts clinical research, and encourages higher standards for ethics and effectiveness in research. > > > > MEDIA CONTACT: > > Jeanne S. McVey > > 202-527-7316 > > jeannem@ > > > > > > Neal Barnard, M.D. > > > > Quote Link to comment Share on other sites More sharing options...
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