Off label use of anemia drugs..was it supported?

May/09/2007 06:19 Filed in: HCP Marketing
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The tale of anemia drug use in the US is taking more turns and twists than "curve ahead" road in San Francisco. According to an article in this mornings New York Times, doctors are gaining a financial benefit for prescribing the drug and the more they prescribe the more they make. The drug companies simply say "what we are doing is legal" but frankly that is not enough and it's time for the FDA to come down hard on Amgen and J&J if they find that they supported this practice


The anemia drugs when used according to the label maybe safe and effective but the problem seems to be that physicians in this country are using it off label and as such have been getting millions of dollars in payments from the pharmaceutical industry. How does the pharma industry respond? "What we are doing is perfectly legal". What a bunch of duckers and a load of crap.
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The FDA needs to determine if Amgen and J&J knew about the off label dosing and if they did what did they do to inform physicians that the drug had not been tested at these higher doses. My guess is that they knew of the higher dosing but chose to turn away because after all it provides millions of dollars in sales to the bottom line. However what is lost in this whole myriad if misinformation and turning a blind eye is patients health. According to the article;

Dr. Peter Eisenberg, an oncologist in Marin County, Calif., said many doctors had been induced to use more epoetin by the financial incentives and the belief that the drug was helpful. “The deal was so good,” he said. “The indication was so clear and the downside was so small that docs just worked it into their practice easily. “Now it’s much scarier than that,” he said. “We could really be doing harm.”



And of course the drug companies involved did not conduct clinical trials at the higher doses..why should they there was no financial incentive and could only harm a potential blockbuster?

This is why the pharmaceutical industry continues to reap the scorn of the media. This is what is wrong with the pharmaceutical industry and frankly it is this authors opinion that the FDA should come down really hard on Amgen and J&J if there is ANY information that showed these companies promoted off label use. The FDA is supposed to protect us from dangerous drugs and it seems that in this case they failed to intervene when the drug companies conducted business as usual. the problem is that business as usual should not endanger patients....

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