[MPWG] Safety and efficacy - a role for MPWG?

[Patricia_DeAngelis at fws.gov]

The issues of safety and efficacy are indeed complex when it comes to
medicinal plants.  This discussion brings to my mind two seemingly
unrelated observations...

Observation One: Last week, I was contacted by a television news program
that wanted to interview me (or someone) about a dietary supplement that's
currently part of the dietary craze.  When I realized that they weren't
interested in conservation or equity issues, but rather in safety and
medical advice, I told them that I was not trained to discuss that.  As we
briefly went over the three potential contacts that I know of in the U.S.
who might speak about this supplement, the exasperated television scheduler
said, "Why is it so hard to find someone to talk about this?!"

Observation Two: One morning last year, there was breaking news about one
of those drugs (was it the cholesterol-lowering one or the pain one?) that
had been on the market for some time but whose health risks had not been
completely taken into account.  Someone from the FDA was quoted as saying,
"If we took every pharmaceutical off the market the moment that there might
be a slight risk, there wouldn't be any pharmaceuticals to fight such
diseases as cancer."

I know this statement was made because I wrote it down as it was spoken!
I'm sorry to say that, despite my academic and scientific training, I
neglected to catch the name of the speaker, to note the date it was
uttered, the news channel it was uttered upon, or anything else that might
help me to identify who this was or just what drug was being discussed.
But, maybe the speaker is better left without a face and the drug better
left unnamed - because this statement reflects what many people believe
about most pharmaceuticals.

There are (at least) two burning questions here:
1. Why does this disparity exist about acceptable risks associated with
pharmaceuticals versus botanicals?
2. Why does a large portion of our society believe in the process that has
been established to deal with botanical versus pharmaceutical safety?
I would assert that the answer to both of these questions lies in the fact
that we, for generations, have been trained to believe that herbal medicine
is inherently unsafe.  When I say "we," I am speaking about the medical
profession and the general public.  In the U.S., our medical profession
remains largely untrained in the use of botanicals, supplements,
interactions, etc (see Botanical Medicine in U.S. History).  And the
general public continues to be told that herbal medicine is unregulated
(see Dietary Supplements and Herbal Remedies).  I'm sure many of our
listserve members would beg to differ with the latter assertion!

To get back to the original point of this posting, in the United States
today, we are faced with a dirth of properly trained healthcare
professionals who not only understand botanicals but have the professional
resources to deal with the unknown, the unexplained, or the untested.  It
follows, then, that the folks who are charged with determining the safety
and efficacy of these materials might also find themselves at a similar
disadvantage.  So, what hope does the general public have in understanding
the situation to be any different than what they (we) are told?

I would like to think that MPWG or its members have a role here - I welcome
your suggestions.
-Patricia

- - - -

Botanical Medicine in U.S. History
In 1910, the U.S. healthcare system shifted away from the use of botanical
medicines.  The Flexner Report of 1910, espoused the pursuit of allopathic
conventional medicine to the exclusion of all other alternative options
(including, naturopathic medicine, chiropractic, etc.).  This evaluation of
the American medical school educational system was written by Dr. Flexner
to create a rating system for medical schools.  This system gave higher
marks to those schools advocating allopathic medicine (aka: conventional)
than to alternative (i.e. homeopathic, chiropractic, etc.) healthcare
options (Edward Fletcher, personal communication 2003; Flower 1992; Stereti
2002).  The Association of American Medical Colleges (AAMC), which sets a
wide range of standards for all medical schools (i.e. determining medical
school entrance requirements, curriculum development, post-graduate
development, etc.), adopted this ranking system and “only graduates of
those schools which received a high rating were allowed to take medical
licensing exams” (Steriti, 2002).

Slightly preceding the Flexner Report, the patent medicine industry began
its demise with the passage of the Pure Food and Drug Act in 1906.  Patent
medicines, which were once essentially folk remedies produced for mass
consumption, allowed the patent holder to control aspects of the medicine,
including its content, without regulation.  Regulation of patent medicine
began with the Pure Food and Drug Act in 1906 and ended with the Pure Food
and Cosmetic Act (1938), which rendered patent medicine illegal (Greene
1998).

The Flexner Report can be viewed on-line at:
http://www.carnegiefoundation.org/elibrary/docs/flexner_report.pdf

Flower, J.  2002.  Let’s form a circle: Excerpts from a conversation with
   C. Everett Coop, the former Surgeon General.  From an article that
   originally appeared in: The Healthcare Forum Journal 1992:35:6.
   Available on-line at http://www.well.com/user/bbear/koop.html
Greene, S. M.  1998.  Non-Timber Forest Products Marketing Systems and
   Market Players in Southwest Virginia: A Case Study of Craft, Medicinal
   and Herbal, Specialty Wood, and Edible Forest Products.  Masters Thesis,
   Virginia Tech.  Available on-line atL
   http://scholar.lib.vt.edu/theses/available/etd-1698-13636/unrestricted/ch7.pdf
Steriti, R.  2002.  Introduction to Homeopathy.  Available on-line at:
   http://www.naturdoctor.com/Chapters/Naturopathy/homeopathy.html

- - - - -

Dietary Supplements and Herbal Remedies (
http://www.pharmaceutical-liability-nationwide-attorney.com/)
     The production and sale of dietary supplements and herbal remedies is
     a huge, and largely unregulated, business in the United States. They
     are not "drugs." Instead, they are treated like food. While dietary
     supplements and herbal remedies products may be safe in most
     circumstances, they are not risk-free and can cause serious side
     effects, just as "drugs" do. Under federal law, set forth in the
     Dietary Supplement Health and Education Act of 1994, referred to as
     "DSHEA," the manufacturer is responsible for ensuring that its
     products are safe. DSHEA also sets forth rules for making claims about
     products and information that must appear on labels. If you believe
     that a dietary supplement or herbal remedy may have caused or
     contributed to your medical injury, you should consult a lawyer
     familiar with products-liability and consumer-protection law to see if
     you have a claim against the manufacturer and whether you can recover
     damages for your injuries.

- - - - -