Can We Heal the FDA?
The FDA
“will classify every alternative practice as medicine so that only licensed
physicians can carry out the procedure AND vitamins, minerals, herbs, etc., will
suddenly become ‘untested drugs’ which will be forbidden…. Bad? Real Bad!”
So warned the first of many emails I was to receive last April concerning the
FDA’s draft
Guidance for Industry on Complementary and Alternative Medicine Products and
Their Regulation by the Food and Drug Administration, which drew a flood of
complaints by its April 30th submission deadline.
But as I learned more*, it dawned on me that my freedom to practice holistic
healthcare was not going to be taken away on April 30th. The FDA regulates the
safety and labeling of drugs and dietary supplements. It has never regulated the
practice of medicine or the off-label uses of drugs or dietary supplements—that
is what states do.
It is time that CAM practitioners and their allies show more awareness and
vision in how they approach the FDA, our bête noire. An
October 2006 Harris Poll indicated that only 45 percent of Americans trust
the FDA. The institution has lost its moral leadership and grown dysfunctional,
and I believe it is up to the CAM community to help heal it.
CAM practitioners must first acknowledge the ways in which the FDA benefits
public health, and the ways in which certain practitioners have not.
When we go the corner drugstore to buy a medication, we go with general
confidence that: 1) the amount of active ingredients per capsule are what the
label indicates, so we don’t unintentionally overdose; and 2) that the drug does
not contain mercury, lead, or other unlisted additives that might poison us. We
have this confidence thanks to the FDA. A century ago, in the days when alleged
caregivers could advertise cures for blindness and diabetes to the desperate
with impunity, and when the public was far more at risk from toxic additives,
this confidence might have been misplaced.**
We need to acknowledge that, as allopathic medicine began to take over the
healthcare industry in the beginning decades of the 20th century, not all the
herbalists, naturopaths, homeopaths, and healers whom the FDA and other federal
bodies ran out of business were angels. There are still charlatans among us (if
you don’t believe me, I’ve got a case of
“herbal tamiflu” to sell you!). The more that we CAM practitioners are
willing to face the darker aspects of our professional histories, the better we
will be able to exercise moral leadership in fundamentally reforming the FDA.
CAM practitioners need to join forces with public health activists who are
working to rescue the FDA from the pharmaceutical industry.
The part of the FDA that reviews new drugs receives over half of its budget in
“user fees” from the very pharmaceutical manufacturers it is supposed to
regulate. This industry influence has lead to fast-tracking approval of
expensive brand-name drugs, sometimes without adequate testing. Casualties of
the FDA’s rush to market include those harmed from Vioxx and other medications
whose dangers became apparent years (and billions of dollars in profits) later.
Undue influence by industry—whether it’s the pharmaceutical industry or the
dietary supplement industry—is harmful to the FDA and to public’s health. CAM
practitioners should link arms with progressive doctors and healthcare advocates
and demand that the user fee system be scrapped, and that the FDA’s 18 advisory
committees prohibit their members from working as consultants for drug or
dietary supplement companies.
CAM practitioners need to re-envision a FDA that embraces diverse healing
traditions while protecting the public from fraud and physical harm—and then
vigorously work towards that vision.
Let us imagine a FDA that is free of corporate influence and has rededicated
itself to the public’s health and well-being. A FDA whose advisors include not
only MDs, PhDs, and PharmDs, but also talented naturopathic physicians,
homeopaths, herbalists, and traditional healers (no regulation without
representation!). A FDA that acknowledges that its research methodologies have a
pharmaceutical bias, and that assuring the safety of herbal products and
evaluating their health promises present new methodological challenges that
require close collaboration with expert holistic practitioners to address. A FDA
that is as dedicated as the best CAM practitioners are to routing out fraudulent
or harmful healthcare products wherever they find them, with special citizen
panels ultimately deciding whether these products should be restricted or even
banned.
This is a FDA that the public could trust again. Good? Real Good!
*For a highly informative article on this debate, see John Weeks’s
Integrator Blog.
** For more on how the FDA was formed, see
www.fda.gov/oc/history/historyoffda/section1.html
Originally published in the Fall 2007 issue of the American Public Health Association's Alternative and Complementary Health Practices SPIG newsletter.
2009 Karlo Berger. Some rights reserved. Website Design by Solid Uncoated.
Thanks to Hannah Burr, Kristin Granli, and Jim Kelly.