What a great discussion group!!
I do not subscribe to the ADA journal. However, I do refer to their
web site occasionally and I do read allot of the HHS, FDA and other
published reports, journals and articles from Mayo and Joslin.
As a point of reference….. there are clinical trials for Byetta as
a stand alone (monotherapy) drug. However, the manufacturer elected
not to submit the data to support it because of the positive effects
data it already had on an adjunct to existing oral medications.
NCT00085969 was started in Sep 03 and completed the phase II in May
04. My Endo had some of his patients in the study here in
Jacksonville. In addition to approving Byetta for use as an adjunct
to existing oral medicines, the FDA also stated that Byetta is
approvable as a stand-alone therapy (monotherapy) for patients with
type II diabetes.
The phase III clinical study NCT00381342 is currently being conducted
to help support this position. It was started in Sep 06 and should
be completed sometime this year. Any additional data submitted to
support a monotherapy indication is expected to receive a six-month
review.
It is not uncommon for a physician to prescribe off-label uses of a
drug and the pactice is not regulated by the FDA. So it is not
illegal in any way. What is regulated is how the pharmaceutical
companies can market and disseminate information and claims on their
products. The "Food and Drug Administration Modernization Act of
1997 (FDAMA) allows manufacturers and sponsors to disseminate to
health care practitioners information — such as studies published in
scientific journals — about the safety, effectiveness or benefits of
off-label uses for marketed drugs, biologics and medical devices.
This information can only be disseminated for off-label uses which
have been, or will be, studied and submitted for FDA approval". The
Act is suppose to prevent a manufacturer making false claims that are
outside the purview of published and FDA approved studies.
It should be pointed out that if it were not for off-label
prescription of many drugs, we would not have the availability we
have today in medications. Medication that used to be used strictly
for depression would not be available to provide today’s cancer
patients pain relief.
As others have said, medications such as Byetta can be used as a
stand alone drug and it has been off-label prescribed to some. That
is, provided a person’s physician is in concert and prescribes it.
There is nothing more important than the dialogue between patient and
doctor. Many doctors are pushed by schedules, corporate heads and
insurance companies to spend even less time with a patient than ever
before. It has almost become an assembly line to visit a doctor’s
office. As a patient, we must be proactive and learn as much as we
can to be well informed and ask the tough questions of our doctors as
well as demand the time to get the answers.
Group sites such as this are a great forum to exchange ideas and
obtain information to formulate the questions about our own health,
experiences and well being. However, such sites should never be used
to change one’s own doctor’s prescribed treatment plan. While we can
all provide encouragement and support to get through some tough
times, the most important voices we should listen to is our own
bodies and the direction of our doctor.