WTF you all need to read this - Bigpharma vs. Compounding Pharmacies

[pmgamer18]

I just got this at the H2 group.
Phil


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To: hypogonadism2@yahoogroups.com
From: "loaded_vasdeferens" Add to Address Book Add Mobile Alert
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Date: Sat, 22 Apr 2006 01:43:00 -0000
Subject: [Hypogonadism] Issue facing Compounding Pharmacies

Firm Seeks Crackdown on Custom Made Drugs By ANDREW BRIDGES
Associated Press Writer
WASHINGTON — Thousands of women who rely on custom-made hormone
drugs for relief from menopause symptoms have flooded the government
with letters opposing a drug company's effort to get health officials
to
crack down on pharmacies that sell them. The drug company Wyeth wants
the Food and Drug Administration to rein in the market for
bio-identical
hormone replacement therapy drugs. The hormones are custom mixed or
compounded by specialized pharmacies according to a doctor's
prescription.
[http://img.coxnewsweb.com/B/00/83/44/image_3344830.jpg]
<http://www.ajc.com/hp/content/shared.../Custom_Made_\
Drugs-image.html> (enlarge photo)
<http://www.ajc.com/hp/content/shared.../Custom_Made_\
Drugs-image.html> Donna Mabin, right, and cosmotologist Gladys Ayers,
left, look over a petition that they are having signed at the Park
Layne
hair salon, Monday, Feb. 27, 2006 in New Carlisle, Ohio. Thousands of
women who rely on tailor-prepared hormones for relief from the symptoms
of menopause have flooded the federal government with letters opposing
a
drug company effort to get health officials to act against the
pharmaces
that sell the prescription preparations. (AP Photo/David Kohl)
Compounding pharmacists can alter the dosages of a medicine, prepare it
in creams or liquids that are easier to take than pills or eliminate
preservatives or other secondary ingredients that might cause allergies
in a patient. Wyeth claims that some compounding pharmacies that
prepare
customized hormone preparations are duping women with products that
pose
a serious health risk. It wants federal regulators to weigh in with
seizures, injunctions and warning letters. "FDA cannot allow this
practice to continue," the Wyeth petition, signed by Washington
attorney
Andrew S. Krulwich, reads in part. FDA spokeswoman Susan Cruzan
declined
to comment, other than to say compounded hormones are not FDA-approved.
The agency recently told Wyeth it needs more than six months to review
and respond to both the petition, filed in October, and the more than
27,000 comments it has elicited. Most are either form letters or
messages submitted through the agency's Web site. "They can't take
these
away from us. Is there anything that can be done?" said Donna Mabin,
68,
a retired cashier from New Carlisle, Ohio, who was among those to
write.
"Those drug companies want to get the money out of natural hormones and
they don't care if we get sick or not." Many women turned to the
estrogen, progesterone and testosterone products sold by compounding
pharmacies after a 2002 study, part of the massive Women's Health
Initiative that tracked 161,000 women for 15 years, found replacement
hormones made by drug companies like Wyeth raised the risk of heart
attacks, breast cancer and strokes. Critics of the compounding
pharmacies want to dispel the notion that the hormone replacement
therapies such pharmacies make necessarily work better or are safer.
"They haven't been studied for safety or effectiveness and are not
produced in facilities that meet good manufacturing practices," said
Larry Sasich, a pharmacist with the Health Research Group of the
consumer watchdog Public Citizen. "We suspect a majority of patients
aren't aware of this." Medical researchers concluded in 2003 that
hormone replacement pills should be taken only as a brief treatment to
help women weather the worst symptoms of menopause. Those findings hit
Wyeth hard. Sales of the company's Prempro and Premphase, which combine
estrogen and progestin, and its Premarin, an estrogen-only pill, fell
to
$880 million in 2004 from $2.07 billion in 2001, the year before the
Women's Health Initiative released its hormone-replacement results.
Compounding pharmacists and their backers allege that Wyeth seeks to
stifle competition by calling in the FDA. "It seems to be an attempt to
use the FDA to inappropriately to eliminate competition," said L.D.
King, executive director of the International Academy of Compounding
Pharmacists, a Sugar Land, Texas, group. Wyeth counters it wants women
to realize the risks of what a spokeswoman for the Madison, N.J.-based
company characterized as a "growing, unlawful practice." "We filed our
petition so that we can ensure that women who received these
bio-identical hormones also receive truthful information about the
risks
of therapy," Wyeth spokeswoman Candace Steele said. Thousands of
American women use the compounded hormones to alleviate the hot
flashes,
flushes, sweats, sleeplessness and other hallmarks of menopause. The
hormones are derived from soy and yam but have an identical chemical
structure to the substances found in the body. The products sold by
Wyeth are based on the urine of pregnant mares. Women who use the
bio-identical hormones, along with their doctors and pharmacists, all
say the system is a throwback to when just about every medicine was
made
to fit both a doctor's order and a patient's need. "Every woman is
different. There is blood work done to ensure where their hormone level
is at, so based on those results and their symptoms, we will come up
with a formula. It's sort of old-fashioned," said Manhattan's Dr.
Jeffrey Morrison of the process he uses with patients like Lynn
Leibowitz. The doctor-pharmacist-patient "triad" involves constant
adjustments that just can't be made to the mass-produced drugs that
Leibowitz, a Manhattan psychologist and psychoanalyst, used to take,
said David Miller, the New Jersey compounding pharmacist she uses.
"We'll keep going month after month until we find the right combination
for the patients," Miller said of his work at Millers of Wyckoff, the
New Jersey pharmacy his grandfather started in 1929. As for Leibowitz,
she says the custom-compounded hormones have left her feeling better
— and more in control — since switching a year ago. "I love
knowing what my hormone levels are," said Leibowitz, who began taking
hormones eight years ago after she underwent a hysterectomy at 48. "I
feel much safer and it's more compatible with my body chemistry." That
sort of anecdotal evidence doesn't sway other doctors. In November, the
American College of Obstetricians and Gynecologists said there is no
scientific evidence supporting claims of increased efficacy or safety
for estrogen or progesterone regimens made by compounding pharmacies
for
women. The group said women should consider compounded hormones to have
the same or even additional safety issues as FDA-approved hormone
products. That same month, the FDA sent warning letters to 16 companies
marketing unapproved alternative hormone therapies. The FDA said the
companies were selling drugs without the agency's approval. The action
mirrored in part what Wyeth requested in its petition, but was not
linked to the filing of the document just weeks earlier, said Steele,
the company spokeswoman. And a 2004 review that appeared in Menopause,
the journal of the North American Menopause Society, found little to
recommend about compounded hormones: "In the absence of a sound
scientific basis, practitioners should not advocate the practice of
compounding (hormones) because it is not in the patient's best
interest,
it is potentially harmful and it lacks a scientific underpinning," the
review concluded.


[Non-text portions of this message have been removed]




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[HeadDoc]

It's ironic that the pharmaco-industry is trying to legislate against its own origins. Further, they are trying to practice medicine and intervene between a doctor and his/her patient. The WHI and HERS studies had many flaws and should not be accepted as definitive in the area of female HRT.

[marianco]

Luckily, thousands of people have submitted letters and email to the FDA supporting the Compounding Pharmacists. The deadline to do so was about April 4, 2006.

Hopefully the FDA will see this as a greedy ruse by Wyeth.

Wyeth's medication, PremPro, was the one which was clearly linked to heart attacks and strokes in women in the World Health Organization's study on hormone replacement therapy.

The WHO's study paper clearly stated that they should have done the study with progesterone rather than the artifical progesterone (progestin) used in PremPro.

Progesterone is the hormone used by compounding pharmacists - not progestins.

[Millard Baker]

Originally Posted by HeadDoc

It's ironic that the pharmaco-industry is trying to legislate against its own origins. Further, they are trying to practice medicine and intervene between a doctor and his/her patient. The WHI and HERS studies had many flaws and should not be accepted as definitive in the area of female HRT.

This is one of my most critical concerns about the pharmaco-industry: their efforts to determine how medicine is practiced, both directly (through marketing arrangements euphemistically called 'physician education') and indirectly through their regulatory and political clout.

Here is the Prempro study:

http://www.mesomorphosis.com/downloads/prempro.pdf

Shortly after it was published, I requested Dr. Karlis Ullis' and Dr Josh Shackman's response:

http://www.mesomorphosis.com/article...nt-scandal.htm

[Millard Baker]

Originally Posted by marianco

Luckily, thousands of people have submitted letters and email to the FDA supporting the Compounding Pharmacists. The deadline to do so was about April 4, 2006.

Hopefully the FDA will see this as a greedy ruse by Wyeth.

Unfortunately, I am afraid that greed will win this round. The FDA is more beholden to the will of the big pharmaceutical industry (big political donations) rather than the will of the thousands who submitted letters (no donations).

I predict the FDA will side with the bigpharm and against the compounding pharmacists presumably to "protect the public". Much in the same manner they opposed the importation of pharmaceutical drugs from Canada and elsewhere.

As far as I know, the FDA has not approved any drug product produced by componding pharmacies. My understanding is that all products purchased from compounding pharmacies are "non-FDA approved" in spite of claims to the contrary. Just because Androgel or Delatestryl is FDA-approved does not automatically make a comparable product from a compounding pharmacy FDA-approved. Is this correct?

If true, this is quite telling of the FDA's position in the matter.

[The_Skeptic]

When the merger of corporate America and the federal government is complete, fascism will have officially replaced capitalism in the U.S.

Just another example of why people in this country need to wake the hell up.

[marianco]

Originally Posted by administrator

Unfortunately, I am afraid that greed will win this round. The FDA is more beholden to the will of the big pharmaceutical industry (big political donations) rather than the will of the thousands who submitted letters (no donations).

I predict the FDA will side with the bigpharm and against the compounding pharmacists presumably to "protect the public". Much in the same manner they opposed the importation of pharmaceutical drugs from Canada and elsewhere.

Compounding pharmacists have their own laws to govern their activities. I am not sure that the FDA can shut them down as a result.

Estradiol, Estrone, Estriol, Progesterone, and Testosterone are all generic substances. Rather than "compounding", i.e. combining them in one pill or cream, it would be easy to create separate pills or creams. In this case, one is not "compounding" the medication. This would be one way around any FDA ruling.

Progesterone is probably the most important of the compounded hormones since it is the most important ingredient in the treatment for premenopausal and menopausal symptoms. It has been generic since the 1950s. It is even available over the counter. It would thus be difficult to stamp out - given its long history of safety.

If anything, Wyeth is attempting to stop the use of progesterone in favor of the artificial progesterones (the progestins) - which unlike progesterone, are much more likely to contribute to heart attacks and strokes. The primary reason is that progesterone cannot be patented.

I am assuming many powerful women use compounding pharmacists (hopefully some congresswomen too ) since they want to keep their youthful health. Perhaps with pressure from them, the FDA would back off.

[pmgamer18]

This country is going to shit the rich are getting richer and the middle class are dam near poor. Are Trade is out of balance and getting worse. Big money is running this country. More and more jobs are lost to foreigen countries so add this to the trade inbalance and soon no one will be able to afford the foreigen products. As it is the pawon shops are making a ton of money because people are forced to pawon there goods to buy GAS. We are not far from the whole bottom falling out. This country will never learn.

[HeadDoc]

There may yet be an other alternative for some enterprising physicans. They would need only to get pharmacy licenses and bring the compounding pharmacies within their offices. I belive Dr. Mark Gordon, who has been here a few times, has done this in CA. I am not sure if the pharmaceuticals he sells are compounded.

[marianco]

Good news!

The FDA has extended the public comment period on Wyeth's complaint until May 4, 2006!

If you want to join the fight against Wyeth complaint against compounding pharmacists, and keep your rights to compounded medications and hormone replacement therapy (including testosterone creams and gels), then write a comment to the FDA at:

http://www.accessdata.fda.gov/script...ID=&AGENCY=FDA

The Women's International Pharmacy has a complete webpage to make your comments to the FDA, your US Senators, and your US Congresspersons, along with sample letters for consumers and doctors:

http://www.womensinternational.com/bhrt.html

I would urge everyone to send their opinion in support of compounding pharmacists and their rights to hormone replacement therapy to the FDA, their Senators and their Congresspersons. I would also urge everyone to contact their friends to also support compounding pharmacists, and fight Wyeth pharmaceuticals.

[jawbone]

Head,
I believe there are some tough laws that prohibit docs that rx from filling there own rx's( at least in CA).

[HeadDoc]

Originally Posted by administrator

This is one of my most critical concerns about the pharmaco-industry: their efforts to determine how medicine is practiced, both directly (through marketing arrangements euphemistically called 'physician education') and indirectly through their regulatory and political clout.

Here is the Prempro study:

http://www.mesomorphosis.com/downloads/prempro.pdf

Shortly after it was published, I requested Dr. Karlis Ullis' and Dr Josh Shackman's response:

http://www.mesomorphosis.com/article...nt-scandal.htm

Dr. Ullis was also on consultant on the HRT study being done by Kronos in response to the WHI study. It will use bio-identical hormones.

http://www.kronosinstitute.org/1/3/2..._research.html

[Millard Baker]

Originally Posted by HeadDoc

There may yet be an other alternative for some enterprising physicans. They would need only to get pharmacy licenses and bring the compounding pharmacies within their offices. I belive Dr. Mark Gordon, who has been here a few times, has done this in CA. I am not sure if the pharmaceuticals he sells are compounded.

This seems to be the trend among the many online "longevity" and "trt" clinics that have popped up all over the place (although with an unusually high concentration in Florida).

I spoke with the CEO and owner of the now defunct Powermedica and it is his opinion that the FDA, acting on behalf of bigpharma, targeted Powermedica for this exact reason:

To make an example of clinics using pharmacy license for in-house compounding pharmacy.

Of course, there are other issues involved, but I though his characterization of the FDA action was interesting.

[Millard Baker]

Originally Posted by marianco

Compounding pharmacists have their own laws to govern their activities. I am not sure that the FDA can shut them down as a result.

Estradiol, Estrone, Estriol, Progesterone, and Testosterone are all generic substances. Rather than "compounding", i.e. combining them in one pill or cream, it would be easy to create separate pills or creams. In this case, one is not "compounding" the medication. This would be one way around any FDA ruling.

Thank you for the additional information. The regulation of compounding pharmacies will certainly come under greater scrutiny. I hope consumer access to them is not restricted.

[Millard Baker]

Originally Posted by HeadDoc

Dr. Ullis was also on consultant on the HRT study being done by Kronos in response to the WHI study. It will use bio-identical hormones.

http://www.kronosinstitute.org/1/3/2..._research.html

Thanks for this - it is good to know this research is being conducted. (Certainly, not funded by Wyeth.)