The FDA overeacts to anemia drugs and issues black box warnings

Mar/10/2007 08:14 Filed in: Pharma Business
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According to an article in August of 2006, the Annals of Internal Medicine "Off-label use is the common practice of prescribing a drug for an indication other than those approved by the FDA. The physician rationale for prescribing off-label is often based on the lack of FDA-approved effective treatments, reports of clinical effectiveness for the off-label use, or both. A recent study confirms that off-label prescribing continues in earnest, with 21% of drugs listed in a data set being prescribed for off-label uses, most with little scientific evidence of efficacy. One then has to wonder why the FDA issued a sweeping safety warning about heart and cancer risks that arise from overuse of a family of anemia treatments that is the biotech industry's biggest drug class with $7.3 billion in U.S. sales in 2006.



The move comes as the FDA is under pressure from Congress to show that it is focusing on drug safety, in the wake of a series of incidents including the market withdrawal of the painkiller Vioxx. FDA officials said the black box was sparked by recent studies that have pointed to risks tied to the drugs, particularly when doctors used them for very aggressive treatments. Karen Weiss, deputy director of the agency's office of oncology drug products, said the "bulk of the data that has raised concerns" came when patients were given higher-than-recommended doses, whether they were suffering from anemia tied to kidney problems or cancer treatment. The evidence is that "this type of strategy is not beneficial and in fact has some evidence of harm," she said.

Pushing hemoglobin to levels as high as 13, 14, or 15 -- done by physicians acting on their own against label recommendations or by researchers testing benefits of more intense treatment -- carries a heightened increased risk of death, or serious cardiovascular events. It also may lead to faster tumor progression of head and neck cancer in patients on radiation, as well as shorter survival and increased deaths of advanced breast cancer patients receiving chemotherapy.

So what we have here is is:

1: The FDA trying to please Congress by showing it is proactive in a potential issue.

2: The FDA overreacting because the majority of this off label use is done by physicians acting on their own against label recommendations.

Have the pharmaceutical companies benefitted from this off-label use? The answer to that of course is yes but unless there is undeniable evidence that Amgen & J&J promoted off-label use why are they being held accountable for the actions of physicians? This is what is happening to the pharmaceutical industry and is in the end is going to lead to higher drug development costs as well as higher costs for prescription drugs. The original study that started this whole debate was a study in which Amgen's drug was given at higher doses than recommended and for indications for which the drug label did not support.

If this is the new leadership of the FDA than God help us all. This is not what a leader does this is what a politician does. This action is shortsighted and politically motivated and one has to wonder if this is going to be the new direction for the FDA.



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