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This past Monday, January 23rd 2006, a joint advisory
committee of the FDA voted 11-3 to change the status of Orlistat from a
prescription weight loss drug to an over-the-counter (OTC) medication. If
approved by the FDA (which is highly likely and generally the case when
recommended to by their advisory panels) it will send a terrible message to the
public in general and to the adults of the future - our kids.
With the change GlaxoSmithKleine and the FDA are supporting the use of
a pill (in this case a fat blocking drug) rather than recommending taking
personal responsibility for one's health by making wise dietary choices and
increasing one's activity level.
The advisory boards' primary arguments for its reclassification to
OTC status are greater weight loss on Orlistat compared to
placebo groups and that over a ten-year period of release as a prescription
drug no cases of severe medical side effects have been reported.
An important reason to stop its re-classification to OTC status and
keep it a prescription medication is that in the studies on Orlistat's
effectiveness, virtually all those who used the drug and lost weight
regained the weight once the drug was discontinued. Without regulation
and physician supervised release it is unknown whether future
over-the-counter users will modify their diet and exercise along with taking the
drug.
There is also the question as to whether side effects take a longer time to
develop. Although eating saturated fat has been linked to a host of diseases
including heart disease, cancer and diabetes it takes much longer than ten years
of a high saturated fat intake for any of these diseases to
progress to a life-threatening level.
Also unknown is if the new drug, which will be released under the name
Alli (pronounced "Ally") and at half the dose of the prescription medication, is
as effective. No long-term studies have been completed. As with all
over-the-counter medications - there are questions of compliance to the
manufacturer's warnings and recommendations. The possibility for abuse is
obviously much greater.
It is unfortunate that the pharmaceutical, medical, and governmental agencies
that profess to be watching over the health and well being of the American
population don't take a stronger lead. While these groups get up on their "soap
box" and preach for healthy eating, lifestyle modification, and restraint
in drug use (both recreational and unnecessary drug use), they undermine that
message with support of drug use and re-classifications like this which take the
focus away from most American's diet and activity choices and places it on a
quick fix approach. With this announcement they are basically sending a message
which says "take this drug to lose weight ... don't change your eating
habits, don't exercise, It's not what you eat. Its what you take to block what
you eat."
Is that the correct message our physicians and regulators should be
sending? | 
