June 25, 2014

FDA approved medicines, Off-label uses

When you have the American College of Cardiology (ACC) for cardiovascular diseases and the American Association of Clinical Endocrinologists (AACE) for endocrine related disorders holding classes for pharmaceutical sales people, is it any surprise that these drug reps are heavily promoting 'off-label' prescriptions. I quite imagine that some of these sales reps have then started classes for the companies they are employed by for more sales reps.

The blog here is written for medical professionals, but patients should learn from this and how their medical professionals may be promoting drugs 'off-label' for other than good medical reasons. The term 'off-label' means that the FDA has not approved the medicine for these uses.

The problem confronting us as patients is two-fold. Many physicians are receiving money to promote drugs and pharmaceutical drugs reps are promoting 'off-label' uses and dosages of many drugs. Then add to this that fact that many medical care providers do not stay current with the drugs entering the market or even many already on the market, and you have real problems because the doctors do not know what is approved or not approved for use by the FDA.

For 160 drugs tracked that are prescribed to U.S. adults and children, 21 percent were for off-label prescriptions totaling 150 million prescriptions. It is not surprising that 73 percent had little to no scientific backing. Psychoactive drugs had the highest level of off-label use. We should not be surprised that sales representatives are misrepresenting their companies' products. They systematically overemphasize the positive aspects and downplay or completely omit the negative features of their drugs.

This information is worth quoting. “The most recent study examined the quantity and quality of safety information that a random sample of primary care doctors in Montreal and Vancouver, Canada, Toulouse, France, and Sacramento, U.S. received from sales representatives. Serious adverse events were mentioned in just 5-6 percent of promotions, although 45 percent of promotions were for drugs with FDA “black box” warnings.”

To have a better understanding of the scope, pharmaceutical companies in Canada and the United States spend about $16.7 billion in 2009 on sales representatives (no wonder our medicines are so expensive!). These representatives come into doctors' offices with detailed information about their individual prescribing practices as well as free samples of their medicines. They use their personal relationships to promote the medicines of the company they represent, promote 'off-label' use of medications, and promote different dosages for the medications their company manufacturers.

Restricting access needs to be accompanied by a multipronged education effort. Mansfield and colleagues have outlined an educational campaign based on studies of psychology students’ responses to persuasion, and medical students’ and physicians’ responses to pharmaceutical promotion that should be pursued throughout all levels of training and continued once doctors are in practice.

The fourfold objectives of this campaign are: explicitly educating doctors about decision making and how to evaluate evidence and promotion; helping doctors to understand that there is no proven method to enable them to have an overall positive benefit from promotion; helping doctors to understand their responsibility to avoid pharmaceutical and device promotion; and explicitly educating doctors about the most reliable sources of information.”

Hopefully, some of the last two paragraphs will come to fruition, doctors can get back to being doctors, and use FDA approved medications of the correct dosage and less 'off-label' use. There are some 'off-label' uses that are appropriate, but even then, the FDA should approve the use.

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