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The
division of Drug Marketing, Advertising and Communications
of the FDA sent a letter to Purdue Pharma stating that they
were in clear violation of FDA regulations. Their violation:
making unsubstantiated claims of effectiveness and grossly
overstating the safety profile of OxyContin while promoting
it for obtaining a "Life with Relief." Despite
Purdue Pharma's non- compliance with the law, the FDA did
not press charges. As a result, their false marketing continues.
Putting
wealth before health, Purdue Pharma L.P. distributed 15,000
copies of an OxyContin video to physicians without submitting
it to the FDA for review. Entitled `I Got My Life Back:
Patients in Pain Tell Their Story,' the video presented
pain relief experiences of various patients and the pain
medications, including OxyContin, they had been prescribed.
FDA regulations require pharmaceutical
manufacturers to submit all promotional materials for approved
prescription drug products to the FDA at the time of their
initial use. Purdue Pharma L.P. did not comply with this
regulation. Thus, the FDA did not have an opportunity to
review the video to ensure that the information it contained
was truthful, balanced, and
accurately communicated. Purdue and the FDA acknowledged
the oversight of not submitting the video to FDA for approval.
No action was taken.
Releasing
a second version of the video, Purdue Pharma L.P. followed
legal procedure by submitting it to the FDA for review.
Though, in its report to Congress, the U.S. General Accounting
Office (GAO) stated that the FDA failed to review the video.
Later, it was discovered that it, like the first video,
made unsubstantiated claims and minimized the risks associated
with taking OxyContin. Most astounding, Purdue Pharma L.P.
claimed that OxyContin had been shown to cause addiction
in less than 1 percent of patients - a damned lie.
Pushing
for approval by the FDA in 1995, Purdue Pharma L.P. insisted
that OxyContin be used only for cancer pain. Purdue Pharma
sold $1 billion worth of OxyContin in less than five years
from the time of its approval thanks to false DTC advertising.
In addition to profits, false marketing has led to devastating
effects on those people who were prescribed Oxycontin under
the wrong conditions. Consider that the number of people
who used OxyContin for illicit purposes at least once increased
from 399,000 to 957,000 in a single year.
Recognizing
the dangers of OxyContin, the Drug Enforcement Agency (DEA)
has listed OxyContin as a Schedule II controlled substance
in the USA. According to the DEA, since its release on the
market, the annual number of prescriptions for the "synthetic
morphine" has risen from around 300,000 to nearly 6
million. During that same period, the number of oxycodone-related
deaths has skyrocketed by 400%. Currently, OxyContin is
the number one prescribed Schedule II narcotic in the United
States.
Exactly
how OxyContin works in the body is not understood. But its
dangers are well documented. OxyContin is an opioid agonist
(narcotic), which possesses powerful addictive properties.
These addictive properties are akin to heroin and morphine
and know no boundaries of destruction. Its addictive nature
can smother even the strongest of wills. OxyContin produces
respiratory depression. Additionally, Oxycodone causes a
reduction in motility associated with an increase in smooth
muscle tone in the antrum of the stomach and duodenum. As
a result, digestion of food in the small intestine is delayed
or nonexistent, and propulsive contractions are decreased,
culminating in constipation and the back up of fecal matter.
False
advertising is the number one tool used by drug companies
to turn perfectly healthy people into patients. While the
FDA has acknowledged Purdue Pharma's indiscretions by acting
as a paper tiger, it has done nothing to ameliorate it.
They have failed as the self-proclaimed custodians of national
health.
About
the Author
Shane holds a Master's degree in organic chemistry and
has first- hand industry experience with drug research,
design and synthesis. He understands that Americans want
and deserve education rather than prescriptions. His shocking
eBook surrounding cholesterol-lowering drugs can be downloaded
for FREE as a pdf file at www.health-fx.net/eBook.pdf.
His award-winning book Health Myths Exposed is available
at Amazon or www.healthmyths.net. |