The Sleazy Side of Alternative Medicine
by Jonathan Collin, MD
Having thrived in the private practice of alternative
medicine for the past two decades, I have frequently found myself weighing
those aspects I have enjoyed from those that I have detested. Like many
physicians I have disliked the drug detail representatives who feel
they have a certain noblesse oblige to pander their wares under the
umbrella of scientific development. The oblige part comes when you are
handed a grocery sack of sample medications which the detailman expects
you to offer your patient, with prescription penned for refills. From
some physicians viewpoint, this seems little different from the whore's
relationship with her pimp; the doctor is being used to peddle the drug
companys pills. One would think that alternative medicine would have
little to do with this business, as the major drug houses shun the alternative
practice. Alas, nature abhors vacuums, and opportunism has created a
new entity, the alternative medicine pharmaceutical house. The difference
is that some of these pharmaceuticals are questionable in efficacy and
quality and frankly do not have any oversight as to their safety. Such
is the sad business in the recent embargo by the Center for Disease
Control in Atlanta, Georgia of alternative medicines injectable product,
adrenal cortical extract.
Adrenal cortical extract (ACE), formerly a derivative
of the adrenal gland of cow or sheep, is now formulated as an injectable
supplement of hydrocortisone. Hydrocortisone is thought to be the steroid
directly formed by the adrenal gland; in contrast, prednisone is a synthetic
analogue of hydrocortisone generally prescribed in treating inflammation
and allergy. Adrenal cortical extract injectable has been in use for
more than 40 years and has been used in conjunction with vitamin C,
magnesium, calcium, pyridoxine, B complex and vitamin B12 as an injection
for adrenal insufficiency and allergy. In the past adrenal cortical
extract was manufactured for the general medical community by at least
a few major pharmaceutical houses. However, during the last decade the
FDA has deemed that a number of proprietary preparations, including
adrenal cortical extract injection (ACE) would no longer be permissible.
Subsequently ACE was largely unavailable. At this juncture, a number
of alternative pharmaceutical houses began to market ACE through their
own independent laboratories. While the large medical pharmaceuticals
are under careful monitoring and inspection, the alternative pharmaceutical
laboratories have no similar monitoring or inspection. ACE was marketed
as the same product as was previously manufactured. But something went
desperately wrong in the manufacturing process.
Earlier this year several physicians involved in alternative
medical practices were administering ACE intramuscularly to their patients
each week. Forty or more patients developed skin abscesses at the site
of the intramuscular injection of ACE. The abscesses were cultured and
found to contain Mycobacterium abscessus. This organism is an atypical
mycobacteria, very rapidly growing, and distantly related to the tuberculosis
organism. Commonly found in soil and marine water it is usually a non-consequential
organism when it is encountered in most human experiences. However,
M. abscessus is not innocent in the surgical setting, where catheters
or prostheses lay within deep tissue. Here the organism proliferates
producing a deep abscess which is difficult to heal except with multiple-antibiotic
therapy prescribed for months and thorough drainage of the purulent
fluid as well as removal of the indwelling device. Hence, it is very
disconcerting when patients are receiving intramuscular injections of
a substance purported to stimulate their immune and endocrine system
which turns out to be the source of a very nasty infection. With weakened
patients, such an infection can be cause for their fatigue to deteriorate
further; if the patient is immunocompromised, the potential exists for
the infection to spread to the pulmonary system and elsewhere. How infuriating,
then, to discover that the vial of ACE is contaminated, and yet there
is no evidence on simple observation to note its adulteration. (The
report from MMWR of the ACE contamination is reprinted on page 104 in
this issue.) ISSUE 160
All of the aforementioned would be somewhat easier to
swallow if one could find some reason behind this contamination. And
there lies the rub no explanations are forthcoming. It is unbelievable
that we have cover-up in alternative medicine, but there is no question
that where the bottom line is concerned, deceit and chicanery definitely
play a primary role in this tale of adulteration. When I question those
parties who should know how this could happen, I am given all kinds
of glib answers. I am told that well, you know how some doctors are
they just don't watch what they are doing and they contaminate things.
I ask, why couldn't this contamination have happened at the laboratory.
Oh no, the response goes, we have a very reputable laboratory and they
check out their product for contamination and our product is definitely
clean. Well, I wonder, if that is the case, then how did they find three
vials with the putative organism? Then I am told that the doctors who
had the problem, who somehow were responsible for the problem, got them,
meaning the distributing pharmaceutical company, in trouble with the
authorities. So then I inquire as to how the companies should take responsibility
in this situation especially with the patients who developed the abscess
infections. Oh no, I am told, the company is not responsible it's all
the doctor's doing, so the doctor is responsible.
So here I am informed for the first time that when a
doctor purchases an injectable from an alternative pharmaceutical company
that the company does not stand behind the quality of its product.
At professional and public alternative medical conventions
and trade shows, hundreds, literally hundreds, of proprietary companies
are peddling injectables and oral supplements. In most circumstances,
the doctor and/or the patient are required to order these injectables
and supplements based on the labelling given on the package. Although
scientific literature supports the use of these products, no evidence
is offered by the company as to the quality and standards of its production
of the injectable or supplement. The ACE contamination story is shocking
evidence that even when contamination has been discovered in the manufacture
of a product, the proprietary owner can disclaim any responsibility
for such contamination. This callous unwillingness to be responsible
is a disgrace to the alternative community. While many parties agree
that FDA oversight is not acceptable in its current form, the laissez-faire
attitude of the entrepreneurs who peddle alternative products must come
under some level of scrutiny and the quality of the product must be
guaranteed by the company. Companies who insist that their proprietary
formula may not be subject to analysis because of concerns of competitor
advantage, should be informed that their business will not be patronized
without satisfactory disclosure. All company products should be routinely
screened for bacterial contamination. This is particularly true for
all liquid injectables as well as liquid oral vitamin/herbal supplements.
Standard chromatography should be performed during production to demonstrate
the quality of the product. Such analysis must be made available to
the doctors and patients. If a company refuses to provide such analyses,
it should be assumed correctly that the company is not conducting analysis
for contamination, thereby not assuring the safety of their product.
Additionally, companies should be encouraged to conduct analyses of
their competitor's products and provide such analyses to the doctors
and public. Given the fact that there is such unwillingness to share
this information with the professional community, it should be assumed
that most companies are doing a very poor job of providing quality control.
The Townsend Letter will offer a forum for all health professionals
and patients to provide reports of quality assessments conducted at
independent laboratories. It appears that the only means there may be
to create an improvement in the quality of this industry is to insist
on seeing reports of quality control when purchasing products.
Next time you are seen by a detail representative either
in the office or at the trade show, ask to have a quality control report
sent before you purchase the product.
Jonathan Collin, MD
Menu
"Blinded" is Right
Clinical Medicine for the Year 2000: Treating Nuclear Bomb Exposure
Fleecing of America by Pharmaceuticals
Joy Out of Soy
Letter from the Publisher
Oncologists' Guaranteed Emplyment Act of 1998
Sleazy Side of Alternative Medicine
Stop Breast Cancer in Its Tracks
Vitamin B12: injectable versus oral
Vitamin Therapy
Dr Glenn Warner