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[e-drug] Compounded drug warnings issued on hormones; inhalation meds


  • From: "Sarah Sellers" <sarahsellers@mac.com>
  • Date: Sun, 13 Aug 2006 11:26:14 -0500

E-DRUG: Compounded drug warnings issued on hormones; inhalation meds
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Dear E-Drug Colleagues,

August 2, Public Citizen's Health Research Group (www.citizen.org)
issued a statement concerning the use of broadly promoted
pharmacy-compounded hormone treatments in the US. Public Citizen's
statement, titled "DO NOT USE - Bioidentical Hormone Replacement
Therapy (BHRT) Manufactured by Compounding Pharmacists" is included at
the end of this message.

August 7, USA Today's cover story "Deaths spur debate about drugs made
in pharmacies" examines cases of Systemic Inflammatory Response
Syndrome (SIRS) alleged to be associated with pharmacy-compounded
carioplegic solutions highlighting risks associated with pharmacy-made
drugs intended to be sterile. Julie Appleby's article can be viewed
here:
<http://www.usatoday.com/news/health/2006-08-07-unsterile-drugs_x.htm>

August 10, the FDA warned three firms to stop distributing unapproved
pharmacy-compounded inhalation drugs. The FDA notice can be viewed
here: <http://www.fda.gov/medwatch/safety/2006/safety06.htm#Inhalation>
and the associated warning letters can be viewed here:
<http://www.fda.gov/foi/warning_letters/g5964d.htm> and
<http://www.fda.gov/foi/warning_letters/g5963d.htm>

August 13, three news pieces were published in Australia highlighting
loopholes in drug regulation which allow pharmacists to make and market
untested hormone concoctions. The articles draw attention to serious
health risks and cite inappropriate financial arrangements between
doctors and pharmacists, including one case where a pharmacist offered
General Practitioners "up to $11,000.00 a year in extra income and
company shares if they wrote just three prescriptions for compounded
products a day". Urgent intervention of regulators and the
de-registration of pharmacists who undermine faith in their profession
is called for.

See:
Dangerous menopause treatments need strict controls:
<http://www.theage.com.au/news/editorial/dangerous-menopause-
treatments-need-strict-controls/2006/08/12/1154803145245.html>
Urgent call on pharmacy drug labs:
<http://www.theage.com.au/news/national/urgent-call-on-pharmacy-drug-
labs/2006/08/12/1154803145320.html>
Cancer alert as "handmade hormones" tested on women:
<http://www.smh.com.au/news/national/cancer-alert-as-handmade-hormones-
tested-on-women/2006/08/12/1154803142933.html>

From Public Citizen :

DO NOT USE - Bioidentical Hormone Replacement Therapy (BHRT)
Manufactured by Compounding Pharmacists

Two industries peddling hormone replacement drugs became involved in a
conflict with one another on October 6, 2005, when the pharmaceutical
company Wyeth filed a petition with the FDA urging the agency to
“counter flagrant violations of the law by pharmacies compounding
Bioidentical Hormone Replacement Therapy Drugs (BHRT)”. The compounding
pharmacies responded swiftly to Wyeth’s petition, alleging that Wyeth’s
only motive in filing the petition was profits. The full text
of Wyeth's petition is available on the FDA’s Web site.

According to the FDA:

Pharmacy compounding, by definition, involves making a new drug whose
safety and efficacy have not been demonstrated with the kind of data
that FDA ordinarily would require in reviewing a new drug
application.... In some cases, we have reason to be concerned about the
quality of the drugs being compounded and the potential risks to
patients who may take them. In some instances, compounders may lack
sufficient controls (equipment, training, testing, or facilities) to
ensure product quality or to compound difficult products such as
sterile or modified release drugs. If compounding ...is not done
properly, compounders can expose large numbers of patients to health
risks associated with unsafe or ineffective medications.

This appears to be the classical David versus Goliath story with the
giant Goliath being Wyeth, maker of the conjugated estrogen PREMARIN
(conjugated estrogen) and the same chemical with medoxyprogesterone
called PREMPRO (conjugated estrogen with medroxyprogesterone). The
Davids are the supposedly small compounding pharmacies and health
providers who fight to prescribe “safe” BHRT to women to keep them
young and normal. Unfortunately, in this case both David and Goliath
are mainly on the wrong side and are both engaging in many anti-woman
marketing ventures.

Menopause is not a disease; it is one stage in a woman’s normal life.
Drugs such as PREMARINand PREMPRO are at least approved by the Food and
Drug Administration (FDA) to manage the symptoms of menopause in the
short term at the lowest possible dose. They are effective for this
use. Any product produced by a compounding pharmacy is not FDA-approved
for any purpose.  

Wyeth had taken a hit in the wallet when the results of a large
randomized controlled clinical trial, called the Women’s Health
Initiative, showed that hormone replacement therapy (HRT) with Wyeth’s
drugs increased the risks of cancer, stroke, blood clots and heart
disease when used long term in postmenopausal women. Sales of PREMARIN
were $1 billion in 2002 and dropped to $850 million in 2004. They
recovered to $908 million in 2005.

But compounding pharmacies have their own financially driven interest
in selling untested BHRT drugs. The pharmacies do, in fact, make
unsubstantiated claims about the safety and effectiveness of their BHRT
products. The overhead is probably quite low for producing, promoting
and selling drugs that are not FDA-approved and are made from bulk drug
substances (powdered drug) of unknown quality from sometimes
questionable sources.

There are more similarities, such as economic motives and morals, than
differences between Wyeth and compounding pharmacies. Both have
advertised directly to consumers claiming that their respective
products are safe because they are “natural.” Conjugated estrogens, the
active ingredient in PREMARIN, are derived from the urine of pregnant
horses, a “natural” product.

The compounding pharmacies promote the terms “bioidentical” and
“natural” to describe their products because they use hormones claimed
to have the same chemical makeup as human hormones. In reality, though,
these products are not “natural” to humans. They are plant-derived and
processed to resemble human hormones.

Wyeth also has a history of misleading the public into thinking that
“natural” supplements could keep women young, healthy and attractive.
According to a 2002 New York Timesarticle, the son of Dr. Robert Wilson
— author of the 1966 best seller, Feminine Forever— said Wyeth paid his
father’s expenses for writing the book and paid him to lecture women’s
groups. Dr. Wilson was to say that estrogen could keep women young and
was safe because it was “natural,” having been derived from pregnant
mare urine — hence the name PREMARIN.  

It is astonishing that the FDA allows a shadow drug industry to operate
within the U.S., selling what are essentially unregulated products like
BHRT and other products produced by compounding pharmacies. Remember,
not long ago, the FDA was warning the public about the dangers of
prescription drugs regulated by the Canadian government. Yet the agency
has done nothing to warn women about the dangers of BHRT. In 1991,
Public Citizen’s Health Research Group published the Women’s Health
Alert. The largest chapter in the book was on hormone replacement
therapy. By then, the evidence was clear that these drugs caused breast
cancer and very serious doubts had been raised about their ability to
protect against heart disease. The first sentence in this chapter
began:

Female replacement hormones may someday be remembered as the most
recklessly prescribed and dangerous drugs of this century.

This prediction came to pass with the results of the Women’s Health
Initiative. But have we learned our lesson?

Proponents of BHRT, those benefiting economically from their sale,
maintain that the right of women and their doctors to choose must be
protected. This is a perversion of consumerism often put forward by
producers of shoddy products. There is a more fundamental right that is
being violated by compounding pharmacies: the right to a marketplace
free of potentially dangerous untested products promoted for
unsubstantiated uses.

What You Can Do:

Women should refrain from using bioidentical hormone replacement
therapy (BHRT) made by compounding pharmacies because they have not
been FDA-approved or tested for their safety or efficacy.

Access Public Citizen release here : http://www.citizen.org/pressroom/

[Please do not hesitate to contact me individually if you cannot access
any of the above links--I will be happy to send information directly].

Sarah

Sarah Sellers PharmD MPH
121 Rose Terrace
Barrington, IL 60010
ssellers@jhsph.edu
847-526-2248
Sarah Sellers <sarahsellers@mac.com>