Page 1 - Antibiotic Therapy for Rheumatic Disease

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Antibiotic Therapy for Rheumatic Disease

You know where we have been; so where are we now?

David E. Trentham, M.D.
Beth Israel Deaconess Medical Center/Harvard Medical School
http://www.roadback.org/index.cfm/fuseaction/education.display/display_id/508.html

MYCOPLASMA THEORY The failure of the FDA to act reflects the fact that no
drug manufacturer has submitted an application for
From its emergence in the 1960s, the rationale for its approval for its use in RA. The reason? : There is
antibiotic therapy was predicated on the notion that an insufficient profit margin for an old generically
RA was a chronic inflammatory disease caused by available agent that has been supplanted by more
an infectious agent. The most plausible candidate effective antibiotic therapies.
at that time was a mycoplasma organism based on
early animal studies. Limited successful clinical This time lag and the widespread availability of
outcomes fostered its continued use and culminated newer FDA-approved drugs dampen physicians’
in two large scale placebo-controlled trials (the NIH use of minocycline. Prescribing minocycline for
sponsored MIRA and RA is still on a “compassionate use basis”. This
that of the RA Investigative Network, i.e., RAIN) tenet signifies that the prescription represents the
in the 1990s. The positive clinical results in both prescriber’s conclusion that it is the best approach
studies provide the scientific foundation for use of for that individual patient. Although a cardinal
minocycline today. Unfortunately, the continued rule throughout medicine, using this justification
espousal of the mycoplasma etiology, despite to prescribe inflicts a degree additional medicolegal
numerous negative searches for the organism, has risk for the prescriber if things go awry.
enshrouded the approach in controversy. Under-
appreciated is the frequency with which anti- Infrequent use also reflects practicing rheumatologists
rheumatic agents are used in the complete absence being bombarded by a plethora of new FDA-approved
of knowledge of how they work. And that situation RA drugs by the pharmaceutical industry. These
is pervasive in medicine. How ether puts one to new drugs being quite expensive are money-makers
sleep is unknown. In rheumatology, the case applies for their corporate sponsors. It’s not surprising that
to hydroxychloroquine(Plaquenil), methotrexate, specialists attend glamorous so-called continuing
leuflunomide(Arava), as well as minocycline. The education sessions featuring their products at
mechanism by which minocycline improves acne sessions at major meetings. At home physicians are
also remains elusive. frequented at their
doorsteps by drug representatives bearing information
LACK OF PHYSICIAN AWARENESS and even incentives or reminders. Thus, they are
overwhelmed by such a barrage of information and
Considerable time has now elapsed between the propaganda.
completion of those pivotal studies, now almost
two decades, and the present. A rule-of-thumb for Both printed and visual media advertisements
the Food and Drug Administration (FDA) approval extend the pharmaceutical companies opportunity
for a medication in the treatment of a disease is at to ‘educate’ the lay public about new drugs in the
least two positive placebo-controlled trials coupled hope that they in turn can request using them
with an adequate safety profile. By these traditional from their rheumatologist. Have you ever seen an
criteria, minocycline should be approved for RA. advertisement for minocycline?