Komputer for Alle 1998 #6/1998 CD 6 (Gul).iso/web/ffa/wwwenv~1.org/arrs/digest/news39~7.htm/text0018.txt

Text File | 1998-04-03 | 16.1 KB | 414 lines

------------------------------
 05/05/1997 18:20 EST

 FDA Rejects Generic Premarin

 By JENNIFER ROTHACKER
 Associated Press Writer

 WASHINGTON (AP) -- The government rejected generic versions of the estrogen
 replacement Premarin -- the nation's most widely prescribed medicine --
saying they
 fail to exactly replicate the brand product.

 ``For something to be generic, it has to be absolutely identical and
deliver the same
 active ingredients as the original product,'' Don McLearn, a Food and Drug
 Administration spokesman, said Monday. ``They (the generics) haven't been
able to
 do that.''

 Premarin treats women with menopausal symptoms, can help prevent the
 bone-crippling disease osteoporosis and may be effective in fighting heart
disease
 and warding off Alzheimer's disease.

 Last year, the drug reaped manufacturer Wyeth-Ayerst Laboratories $860
million in
 sales, with an estimated 8 million women a year taking the tablets.

 ``We're certainly gratified that the FDA has recognized that the science
here is
 extremely important,'' said Marc Deitch, senior vice president and medical
director at
 Wyeth-Ayerst.

 But generic companies contended Monday that a heavy lobbying effort by
women's
 groups and scientists on behalf of Wyeth-Ayerst had influenced the FDA's
decision.

 ``I think this is a case of politics over science,'' said Bruce Downey,
president of
 Pomona, N.Y.-based Barr Laboratories. Barr and Cincinnati-based Duramed
 Pharmaceuticals are two companies vying to have their generic forms of
Premarin
 approved. They say a generic would cost one-half to one-third the price of
Premarin.

 But one woman's health organization said saving money isn't worth a potential
 medical risk.

 ``To take a drug that is so critical to post-menopausal woman and ... to
have a
 generic drug that is not exactly the same would be a disservice to
women,'' said
 Debora R. Judelson, president of the American Medical Women's Association,
one
 of several groups that lobbied against generic forms of Premarin.

 Premarin is a complex drug derived from the urine of pregnant mares and has a
 number of different estrogens. However, just how these estrogens act
together to
 make a successful drug like Premarin work is not completely understood.

 The generic forms of Premarin use synthetic replacements for the mare
urine. Since
 it's not fully understood how Premarin works, the FDA is legally
prohibited from
 approving a generic drug that does not contain the exact active
ingredients as the
 brand name, the agency said.

 ``They may have a product that may legitimately treat a lot of these same
symptoms,''
 noted FDA's McLearn, ``but we have to know it's bioequivalent'' to approve
it.

 Downey said his company feels its generic drug passes scientific muster
and plans
 to talk with the FDA about its decision.
Date: Mon, 5 May 1997 16:26:30 -0700
>From: [e-mail] (Elephant Advocates)
To: [e-mail]
Subject: 800 54 PONYS
Message-ID: <v01530503af93f541ddfd@[206.250.113.106]>
Mime-Version: 1.0
Content-Type: text/plain; charset="us-ascii"

WEST HOLLYWOOD, CA

On May 3rd, the City of West Hollywood sponsored pony rides and a petting
zoo for a Cinco de Mayo celebration at Plummer Park in West Hollywood.
The City paid @ $1000.00 for this "entertainment."

3 ponies and 1 burro were tied to poles and forced to walk around in a
circle from 11:00am-5:00pm, while loud music blared from the nearby stage.

I observed the following:  the black burro refused to walk in the
never-ending circle and often turned in the opposite direction, he was
removed from the rack and tied to a fence, he kicked and protested, he had
cracks in his hooves; all 4 had packed mud in their hooves, and their feet
appeared to hurt; 1 pony seemed to outgrow her harness as it cut into her
body; 1 small pony's fur looked mangy, and all four looked as if never
brushed.  Their eyes were sad and crusty they did were not fed anything for
the six hours they were exhibited.

An employee of the operation said "you would not treat your worst enemy the
way these ponies are treated...this is the 5th day in a row they have
worked... they were tired this morning before we got here..."

Children were not allowed inside the pen of the petting zoo animals.  After
the 10 lb. bucket of food ran out (in 15 min.), children picked up
branches, leaves and garbage and fed it to the goats, sheep, chicken and
ducks all day long.  The animals scarfed whatever was thrown their way.

Only two activists protested, but four mothers & their children turned away
from the pony line as we talked.

Please write the City of West Hollywood and ask them to permenantly ban
animal acts and declare West Hollywood a cruelty-free City.  Send one copy,
it will then be distributed to ea. Councilmember and the Mayor.

City Hall
8300 Santa Monica Blvd.
West Hollywood, CA  90069-4314
Tel: [phone]
Fax: [phone]

Mayor Sal Gaurriello
Councilman Steve Martin
Councilman John Heilman
Councilman Jeffrey Prang
Councilman Paul Koretz

Please call the animal exhibitor; PRANCING PONIES at (800) 54 PONYS. Let's
give her the largest phone bill she's ever had.


Date: Mon, 5 May 1997 22:11:21 -0400
>From: mike chiado <[e-mail]>
To: [e-mail]
Subject: (US-MI) County Votes Stops Animal Sales to Research
Message-ID: <l03010d01af944239a3f2@[205.199.80.151]>
Mime-Version: 1.0
Content-Type: text/plain; charset="us-ascii"

I don't know all the details yet, but the Livingston County Commissioners
voted tonight to stop selling animals from the county pound for testing and
research.  This ruling is a big victory for activists that have been
working on pound release in Livingston county, northwest of Detroit, for
some time.

I imagine the area B dealer is not too happy.

mike


Date: Mon, 05 May 1997 20:43:50 -0700
>From: Andrew Gach <[e-mail]>
To: [e-mail]
Subject: FDA shoots down generic substitution for Premarin
Message-ID: <[e-mail]>
MIME-Version: 1.0
Content-Type: text/plain; charset=us-ascii
Content-Transfer-Encoding: 7bit

Generic forms of estrogen replacement Premarin fail to pass muster

The Associated Press

WASHINGTON (May 5, 1997 8:38 p.m. EDT) -- The government rejected
generic versions of the estrogen replacement Premarin -- the nation's
most widely prescribed medicine -- saying they fail to exactly replicate
the brand product.

"For something to be generic, it has to be absolutely identical and
deliver the same active ingredients as the original product," Don
McLearn, a Food and Drug Administration spokesman, said Monday.
"They (the generics) haven't been able to do that."

Premarin treats women with menopausal symptoms, can help prevent the
bone-crippling disease osteoporosis and may be effective in fighting
heart disease and warding off Alzheimer's disease.

Last year, the drug reaped manufacturer Wyeth-Ayerst Laboratories $860
million in sales, with an estimated 8 million women a year taking the
tablets.

"We're certainly gratified that the FDA has recognized that the science
here is extremely important," said Marc Deitch, senior vice president
and medical director at Wyeth-Ayerst.

But generic companies contended Monday that a heavy lobbying effort by
women's groups and scientists on behalf of Wyeth-Ayerst had influenced
the FDA's decision.

"I think this is a case of politics over science," said Bruce Downey,
president of Pomona, N.Y.-based Barr Laboratories. Barr and
Cincinnati-based Duramed Pharmaceuticals are two companies vying to have
their generic forms of Premarin approved. They say a generic would cost
one-half to one-third the price of Premarin.

But one woman's health organization said saving money isn't worth a
potential medical risk.

"To take a drug that is so critical to post-menopausal woman and ... to
have a generic drug that is not exactly the same would be a disservice
to women," said Debora R. Judelson, president of the
American Medical Women's Association, one of several groups that lobbied
against generic forms of Premarin. [Wonder how many of these groups got
financial support from Wyeth-Ayerst. -- AG]

Premarin is a complex drug derived from the urine of pregnant mares and
has a number of different estrogens. However, just how these estrogens
act together to make a successful drug like Premarin
work is not completely understood.

The generic forms of Premarin use synthetic replacements for the mare
urine. Since it's not fully understood how Premarin works, the FDA is
legally prohibited from approving a generic drug that does not contain
the exact active ingredients as the brand name, the agency said.

"They may have a product that may legitimately treat a lot of these same
symptoms," noted FDA's McLearn, "but we have to know it's bioequivalent"
to approve it.

Downey said his company feels its generic drug passes scientific muster
and plans to talk with the FDA about its decision.

By JENNIFER ROTHACKER, The Associated Press
Date: Mon, 05 May 1997 20:49:03 -0700
>From: Andrew Gach <[e-mail]>
To: [e-mail]
Subject: Business and Medicine
Message-ID: <[e-mail]>
MIME-Version: 1.0
Content-Type: text/plain; charset=us-ascii
Content-Transfer-Encoding: 7bit

Cancer patients trapped in patent fight

The Associated Press

WASHINGTON (May 5, 1997 6:26 p.m. EDT) -- Desperate cancer patients
including children with leukemia are caught in the middle in a fight
between a drug giant and a biotechnology company over a patent for
better bone-marrow transplants.

Doctors for one side say the court fight could kill patients by yanking
the therapy off the market.  The other company accuses those doctors of
scare tactics. Now, some U.S. senators and patient
advocates are pushing the government to intervene, in a complex battle
that illustrates how business and medicine often intertwine.

The case "could be precedent-setting," said Washington patent attorney
Kate Murashige. "It's a pretty extreme case, where you've got a real
public interest here in people's health."

CellPro Inc.'s Ceprate system won Food and Drug Administration approval
in December as the first device to purify the cells vital for a
bone-marrow transplant to succeed. Purification significantly
cuts the severe side effects that cancer victims suffer when their
bone-marrow cells are reinfused after chemotherapy, the FDA said.

In addition, 60 clinical trials nationwide are testing other life-saving
uses. They include an Emory University attempt to save children dying of
leukemia who cannot find matching bone marrow.
Another trial involves "purging" cancer that lurks in transplant cells,
an experiment that CellPro's own president believes saved him from
otherwise untreatable lymphoma.

The problem: A federal judge this spring ruled that CellPro used
technology it knew was patented by Johns Hopkins University and licensed
to Baxter International.

Now Baxter has asked for an injunction on Ceprate sales. But CellPro
says that would put it out of business -- and consequently take a
life-saving product off the market.

"We won't be able to offer treatment to any of these children" if that
happens, said Emory's Dr. Kent Holland. In a small pilot trial, he found
the experimental treatment saved about 40 percent of certain leukemic
children "who have no other therapy that they could even attempt to
undergo."

A furious Baxter accuses CellPro of unfairly scaring vulnerable
patients. Attorney Donald Ware argues Baxter would allow limited Ceprate
sales, with fair compensation, and continued experimental access to
Ceprate until Baxter's own cancer treatment wins FDA approval. That
could be two years away.

"I'm offended and hurt by the implication that I would be part of
anything that would hurt a patient," said Dr. Curt Civin, the Johns
Hopkins pediatric oncologist who patented the technology.

Nevertheless, CellPro has taken the unprecedented step of asking the
federal government to allow Ceprate sales to continue under an obscure
law that essentially could repossess the patent.

Lawmakers including Sen. Alfonse D'Amato, R-N.Y., and the American
Cancer Society are lobbying Donna Shalala, the Health and Human Services
secretary, to take that step.

It's a case that illustrates how medicine is business -- because
lucrative patent laws, not some charitable instinct, provide the
incentive to create treatments, explained Paul Root Wolpe of the
University of Pennsylvania's Center for Bioethics.

CellPro is "not the poor innocent company who got shafted," he said.
"Everybody in business knows you don't use a patented product without a
license. As so often is the unfortunate result, the people who end up
suffering are the patients."

At issue is purifying stem cells, the progenitors of blood and immune
cells found in bone marrow and certain types of blood.

Patients typically freeze bone marrow before high-dose chemotherapy, and
then get back the thawed cells, but remaining traces of toxic
preservatives can cause serious side effects.

CellPro's therapy uses a monoclonal antibody, a "cellular bloodhound"
that latches onto the stem cells -- the only cells the body really needs
-- and, with a magnetized machine, pulls the thimble-full
of life-saving cells from a liter of marrow. The result is safer
treatment.

But Hopkins' Civin discovered the first stem cell antibody in 1981,
winning a patent to the entire class of cell hunters, including the one
CellPro later used. Yet CellPro rejected as too expensive a
Baxter offer for a patent sublicense in 1991, fighting the patent as too
broad.

Baxter counters that CellPro should have simply spent its estimated $10
million in attorneys' fees on a patent license.

CellPro President Rick Murdock argues the court action could end
exciting Ceprate experiments. Emory's Holland, for example, is creating
matching stem cells for leukemic children who can't find a
matching bone-marrow donor.

And Murdock used Ceprate to purge from his own stem cells traces of
cancer that had leaked into his bloodstream before his chemotherapy. He
is in remission a year later.

"We're going to prevail when it gets to the appeals court," Murdock
predicted. "But if they take us off the market in the meantime, we won't
survive."

By LAURAN NEERGAARD, The Associated Press



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