It is not clever to make rules which are smarter than we are.
Burton Report, 2007
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.