In June of 2007 the U.S. Food and Drug Administration (FDA)
began a crackdown on drugs generally recognized to be safe and
effective, prescribed by physicians for decades, but having not
gone through the present FDA regulatory process (The
FDA vs. Small Pharma, WSJ, September 21, 2007).
One of the many drugs being caught in this regulatory roundup is
quinine, which has been extensively used well before the FDA was
created in 1962. Even though the risk vs. benefit of this
medication is well known to the medical profession the FDA is
requiring it to go through expensive and extensive clinical
trials as well as its regulatory process in order for its use to
continue. In pharmacologic parlance drugs such as quinine
are referred to as "legacy" drugs. Legacy drugs are in
fact medical "orphans".
These are drugs and therapies with medically recognized high
value for patients but little visibility in the expensive M2H
blitz assailing our senses on a daily basis.On the
therapy side of the equation the procedure "percutaneous
radio-frequency facet blocks" (PRFFNB)
performed in the lumbar spine stands as an shining icon for
misguided therapeutic thinking. Other than psychiatric,
psychologic, and drug-related expenditures back problems account
for the single greatest expenditure in our health care system.
Lumbar facet blocks have been shown, by clinical experience,
over many decades, to be safe and clinically effective as well
as cost-effective. Even more important is that they have
served as an key means of effectively dealing with chronic back
pain and have served as an important alternative to
ill-advised back surgery particularly when multi-level
instrumented fusion is recommended as a primary therapy.
Even when prescribed by spine specialists some third party
payors have denied coverage for patients on the grounds that
these are "experimental" (code language meaning that there have
not been modern controlled scientific studies to document
efficacy). What researcher, in their right mind would
waste their valuable time to do this? What researcher
would waste their valuable time and resource to prove that
appendectomy for treatment of acute appendicitis is effective?
When spine specialist prescribed PRFFNBs are denied by an
insurer and the case is brought into a courtroom where the
court finds for he patient, insurers have even attempted to
block such decisions through the appeal process to avoid setting
a precedent (i.e. Minnesota Department of Labor
and Industry, Workers Compensation Division, File #475-56-6297,
Dec. 8, 2006).
Information and the appropriate use of
medical information is the real issue. So-called
"evidence based medicine" makes sense only when all meaningful
information is assessed and not just that meeting imposed
criteria.
The presence of underutilized orphan drugs and therapies
makes clear that better ways of doing things and more
intelligent use of good information are needed.
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