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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