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Off Label Prescrition Concerns

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Is your doctor prescribing off-label?

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It would have never dawned on me that any of my mom's many, many heart drugs could be prescribed in any way that was not medically indicated ... However, a doctor has authority that may impact your health. When your doctor prescribes a prescription drug, did you know they have the authority to prescribe it for something other than what is is made to treat? Or that a doctor may, at their own discretion, prescribe more of the drug than is generally prescribed? This is called off-label prescribing and it is happening a lot.

So, why should it matter if your doctor prescribes more of something that is normal or prescribes a medication that isn't exactly targeted specifically toward your situation. Well, if you don't know that, you also don't know that there could be added risks. It's vital to discuss this topic with your doctor and to have a say in any off-label prescribing that's being done. For more on this controversial subject, read unapproved prescription drug use, or off-label prescribing, and the implications.

Prescription Drug Controversy over Off-Labeling
Portions of this information, copyright and courtesy of Ira Marxe of Good Health Supplements. Home of ground-breaking nutrition for your heart supplements and much more.

Are Doctors and Drug Companies "Joined At the Hip"? I recently read a report on the drugs Aranesp, Epogen and Procrit, drugs approved by the FDA within a given dosage range to boost red blood cells and combat anemia.

Continued research has shown that these drugs, when used at higher-than-recommended doses, a practice that is becoming increasingly common with doctors writing prescriptions for higher dosages, leads to blood clots, strokes, heart attacks, and death in patients with chronic kidney failure. Studies also discovered that higher doses might produce more rapid tumor growth in patients with head and neck cancer. Anemia is a common side effect with certain forms of kidney disease, especially for patients undergoing dialysis and for cancer patients undergoing chemotherapy.

Both Dr. Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, and Dr. Ajay Singh, clinical chief of the renal division and director of dialysis at Brigham and Women's Hospital in Boston, noted that when used properly, the drugs are effective.

AranespT, EpogenT and ProcritT made up the majority of medications reimbursed by Medicare for treating cancer patients. Both Doctors Lichtenfeld and Singh want to see this off-label use curtailed. The New York Times reported that Amgen and Johnson & Johnson, the makers of these drugs, paid doctors millions of dollars in rebates to use these drugs. Such payments, to cancer doctors and the other big users of these drugs, like kidney dialysis centers, total hundreds of millions of dollars a year. Payoffs to doctors are nothing new, but I didn't realize how bad and wide spread this practice has become until I read AARP's recent newsletter with a three page article on just how wrapped up doctors were with drug reps.

It appears that doctors are writing prescriptions more for the money they get from drug companies than for the health of their patients. This is directly related to doctors writing millions of off-label prescriptions on the encouragement of over 101,000 drug company reps who call on doctors more than once a week. That's one drug company representative for every five office-based physicians.

How Effective is the Drug Representative in Marketing Your Drugs? Adriane Fugh-Berman, M.D., a Georgetown University associate professor who has studied drug industry tactics cites an industry study that showed when a drug rep got one minute with a doctor, the prescription rate for that drug increased 16 percent. With three minutes ---- 52 percent.

Howard Brody, M.D., director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston, points to a national survey published last year in the New England Journal of Medicine, in which 94 percent of the doctors polled said they had "direct ties" to the drug industry.

The drug companies massive spending on marketing to doctors increased by 275 percent between 1996 to 2004, and despite a small dip in 2005, drug companies are still spending about 7 billion dollars a year to influence doctors decisions, and another 18 billion dollars a year on free drug samples for doctors, according to data compiled by the Prescription Project, an effort funded by the Pew Charitable Trust to curb the drug industry's influence. Compounding the problem are the carefully orchestrated TV ads that tout the miraculous benefits of the drugs with the side effects listed in small print and quickly glossed over.

Doesn't the FDA approve these marketing ads? If you are under the impression that these ads are approved by the FDA, you are quite mistaken. These ads are not approved nor are they regulated. continue...what the FDA said

Health Disclaimer: This off-label prescribing information is not designed to make you mistrust your doctor but to encourage proactive involvement in your own protocol. If there is increased risk with increased dosage, you need to know that. I believe you should have the choice of refusing off-label prescribing but if you don't even know it's happening, how can you know what your risks are or what other side effects might need to be monitored? Get involved with your doctor and your pharmacist. This is the information age. Utilize the internet. Learn the right questions to ask.