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gdpawel · 03-25-2010, 09:48 AM

This is an article about how drug companies accept huge fines as a cost of doing business for the lucrative off-label market. One of the examples in the piece is off-label claims for Neurontin. Doctors are legally free to prescribe it, but at their own peril (do no harm).

http://www.washingtonpost.com/wp-dyn...905578_pf.html

It has been very routine and well-accepted practice to prescribe drugs in cancer types and disease stages outside of those in which the drugs originally received FDA approval. Generally, however, insurance companies have paid for drugs used outside of FDA-approved settings because the treating physician finds their use in those instances to be "medically necessary." An estimated 60 percent of anti-cancer drugs are used off-label.

However, Medicare has radically expanded its authorization for use of cancer drugs by putting off-label decision making in the hands of compendia writers in the private sector, many of whom are on the payrolls of the companies that make the drugs. The public knows nothing about the financial relationships between drug companies and the physicians, biostatisticians and other scientists who comprise the fourty-four panels that write clinical practice guidelines and determine which drugs, indications and weight of evidence that are included in its compendium.

Compendia claims to use evidence-based methods in their evaluation of therapeutic agents, however, cited literature is often neither the most recent nor the most valid in terms of study design. To give cancer patients confidence that the treatments they receive are worth the cost, the compendia used to justify payment for the off-label use of anti-cancer drugs should adhere to the highest standards of clinical evidence and arrive at their conclusions in a fully transparent manner that includes full disclosure of "conflicts of interest."

All drug reps have to do is bring into the doctor a Compendia report and then it is off to the races! How goes Medicare, goes the private insurance companies.

I'm all for cancer patients, particularly at end-stages, receiving these needed drugs. My personal belief in having additional support of drug patient-specific activity, as determined by extensive laboratory pre-tests to improve patient outcomes, could very well bolster an argument for off-label use of specific cancer drugs, with no economic ties to outside healthcare organizations; recommendations made without financial or scientific prejudice.

03-25-2010, 09:48 AM	#8
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	When drug makers' profits outweigh penalties This is an article about how drug companies accept huge fines as a cost of doing business for the lucrative off-label market. One of the examples in the piece is off-label claims for Neurontin. Doctors are legally free to prescribe it, but at their own peril (do no harm). http://www.washingtonpost.com/wp-dyn...905578_pf.html It has been very routine and well-accepted practice to prescribe drugs in cancer types and disease stages outside of those in which the drugs originally received FDA approval. Generally, however, insurance companies have paid for drugs used outside of FDA-approved settings because the treating physician finds their use in those instances to be "medically necessary." An estimated 60 percent of anti-cancer drugs are used off-label. However, Medicare has radically expanded its authorization for use of cancer drugs by putting off-label decision making in the hands of compendia writers in the private sector, many of whom are on the payrolls of the companies that make the drugs. The public knows nothing about the financial relationships between drug companies and the physicians, biostatisticians and other scientists who comprise the fourty-four panels that write clinical practice guidelines and determine which drugs, indications and weight of evidence that are included in its compendium. Compendia claims to use evidence-based methods in their evaluation of therapeutic agents, however, cited literature is often neither the most recent nor the most valid in terms of study design. To give cancer patients confidence that the treatments they receive are worth the cost, the compendia used to justify payment for the off-label use of anti-cancer drugs should adhere to the highest standards of clinical evidence and arrive at their conclusions in a fully transparent manner that includes full disclosure of "conflicts of interest." All drug reps have to do is bring into the doctor a Compendia report and then it is off to the races! How goes Medicare, goes the private insurance companies. I'm all for cancer patients, particularly at end-stages, receiving these needed drugs. My personal belief in having additional support of drug patient-specific activity, as determined by extensive laboratory pre-tests to improve patient outcomes, could very well bolster an argument for off-label use of specific cancer drugs, with no economic ties to outside healthcare organizations; recommendations made without financial or scientific prejudice.