EPO use can cause.....DEATH!!!!

http://www.bloomberg.com/apps/news?p...6AI&refer=home

Amgen's, J&J's Anemia Drugs Get Stronger U.S. Warning (Update4)

By Luke Timmerman

March 9 (Bloomberg) -- The anemia drugs Aranesp and Epogen, made by
Amgen Inc., and Procrit, sold by Johnson & Johnson, will get stronger
warnings about serious health risks including death, the U.S. Food and
Drug Administration said.

The FDA also said today it is ``re-evaluating'' the safety of the
drugs. The agency is telling doctors to use the lowest doses needed to
help patients avoid blood transfusions, said Richard Pazdur, the head
of the FDA's cancer drug office, in a news conference.

``There are many questions that need to be looked at, including
additional clinical trials,'' Pazdur said.

Aranesp is Amgen's biggest-selling product, generating $4.12 billion
for the Thousand Oaks, California-based biotechnology company last
year. Aranesp and Epogen together accounted for 47 percent of the
company's revenue in 2006. Procrit, Johnson & Johnson's version of
Epogen, had $3.18 billion in sales.

Shares of Amgen fell $1.31, or 2.1 percent, to $60.86 at 4 p.m. in
Nasdaq Stock Market composite trading. Shares of Johnson & Johnson,
based in New Brunswick, New Jersey, gained 42 cents to $62.14 in New
York Stock Exchange composite trading.

Anemia drugs are the ``largest and most lucrative market in biotech,''
and sales are growing at least 6 percent to 8 percent a year, said
Jason Kantor, an analyst with RBC Capital Markets, in a January
research report. The drugs are used to treat anemia, mostly for people
with kidney disease and cancer patients undergoing chemotherapy.

Study Findings

Studies found that higher-than-approved doses of the drugs targeted by
the FDA increased the risk of death, blood clots, strokes and heart
attacks in those with chronic kidney failure, the agency said. Excess
doses led to rapid tumor growth in people with head and neck cancer.

The drugs are usually prescribed to boost levels of hemoglobin in the
blood to 12 grams a deciliter, the approved dose. Doctors may now want
to go ``no higher'' than 10 or 11 grams per deciliter, Pazdur said.

``If the target for hemoglobin is in the 10-range, then that's
definitely going to have an impact for Amgen,'' said Bill Tanner, an
analyst with Leerink Swann in New York, in a telephone interview.
Tanner's firm has done consulting for Amgen in the past year, and he
doesn't own any shares.

Epogen is the single biggest drug expense for Medicare, the U.S.
health plan for the elderly and disabled. Members of Congress have
urged Medicare to change the way it pays for the medicine to eliminate
incentives for giving higher doses.

`More is Better'

``This idea that `if some is good, more is better' is an unfortunate
theme that runs across American medicine,'' Peter Eisenberg, a cancer
physician in Marin County, California, said in a telephone interview.
``The more stuff we doctors sell, the more money we make. That's
another problem.''

The drugs are also used by some cancer patients not on chemotherapy.
Use of Aranesp for that purpose was removed in February from a list
that Medicare and insurers follow for reimbursement. Analysts estimate
that as much as $500 million a year of Aranesp sales come from that
use.

The contractor for Medicare in Northern California, Illinois,
Massachusetts, Maine and Vermont today stopped paying for Aranesp for
cancer patients not in chemotherapy. Medicare often influences
coverage decisions of private insurers.

Medicare pays close attention to FDA safety warnings, said Leslie
Norwalk, acting administrator of the Centers for Medicare and Medicaid
Services, in a statement. ``We will carefully examine our policies for
coverage'' of anemia drugs.

Company Responses

Amgen said in a statement that new information accompanying Aranesp
and Epogen will urge doctors to let patients know of the ``increased
risks of mortality'' when the drug is given in ways that are not FDA-
approved.

The company plans to update its marketing materials to reflect the new
warnings, said Trish Hawkins, a company spokeswoman. Amgen's anemia
drugs are used by about 250,000 cancer patients a year, Hawkins said.

``Patient safety is unquestionably our top priority,'' said Roger
Perlmutter, Amgen's head of research and development, in a statement.

Ortho Biotech, the Johnson & Johnson unit that markets Procrit, also
will change its information for physicians to include the new
information, said spokeswoman Stephanie Fagan.

``It is too early to speculate'' on the financial impact of the FDA
warning, Fagan said.

Class of Drugs

The FDA's renewed scrutiny will apply across the class of drugs to
which Aranesp, Epogen and Procrit belong. The treatments are
genetically engineered forms of the protein erythropoietin, which is
made by the kidney and increases the number of red blood cells.

Roche Holding AG is attempting to develop a rival product in the
class, Cera, and has applied for FDA approval.

The FDA will hold a meeting of cancer experts on May 10 to seek advice
on the drugs, Pazdur said.

Epogen was first approved by the FDA in 1989, and became Amgen's first
big-selling drug. Procrit is sold by Johnson & Johnson under a
marketing agreement with Amgen. Aranesp, a drug modified for less-
frequent dosing, was approved in 2001. The FDA said it revised the
warning labels on the products in 1997, 2004 and 2005 when new
information about safety came to light.

Procrit TV commercials in 2001 told consumers the drug could boost
their energy and provide ``strength for living.'' The camera showed an
elderly woman, who at first was too tired to sew her daughter's
wedding dress, dancing at the wedding thanks to Procrit, according to
an article in the FDA's consumer magazine.

Ortho Biotech stopped running the TV ads two years ago, Fagan said.

To contact the reporter on this story: Luke Timmerman in San Francisco
.

Last Updated: March 9, 2007 18:28 EST

Dumbass,

Safe as orange juice, so I hear.

Bob Schwartz

Bob Schwartz wrote:
Dumbass,

Safe as orange juice, so I hear.

Bob Schwartz

Orange juice can cause death too.

Bob Schwartz wrote:
Safe as orange juice, so I hear.

Fred Fredburger wrote:
Orange juice can cause death too.

But tea is even more dangerous, particularly when combined with polonium.

Fred Fredburger wrote:
Bob Schwartz wrote:
Dumbass,

Safe as orange juice, so I hear.

Bob Schwartz

Orange juice can cause death too.

So can cycling.

wrote:

http://www.bloomberg.com/apps/news?p...6AI&refer=home

Amgen's, J&J's Anemia Drugs Get Stronger U.S. Warning (Update4)

SNIP


If the risk for death were so serious, surely we would have seen some
pro cyclist die from it. We haven't.

Thanks,


Magilla

MMan wrote:
Fred Fredburger wrote:
Bob Schwartz wrote:
Dumbass,

Safe as orange juice, so I hear.

Bob Schwartz
Orange juice can cause death too.

So can cycling.


Yeah, but it's hell getting the bicycles to fit through those hypodermic
needles.

If the risk for death were so serious, surely we would have seen some
pro cyclist die from it. We haven't.

Thanks,


Magilla
---------
In Sweden, I think 4 or 5 died in their sleep from EPO. Their blood was
as thick as ketchup, and the heart just couldn't pump it. Horrible deaths,
in the early years of EPO.

On Mar 11, 12:18�pm, MagillaGorilla wrote:
wrote:
http://www.bloomberg.com/apps/news?p...c.tP3A6AI&refe...

Amgen's, J&J's Anemia Drugs Get Stronger U.S. Warning (Update4)

SNIP

If the risk for death were so serious, surely we would have seen some
pro cyclist die from it. *We haven't.

Thanks,

Magilla

Magilla

Not sure if you are fishing, but many have died...... starting with
1989 amateur world chump.

Callistus Valerius wrote:

If the risk for death were so serious, surely we would have seen some
pro cyclist die from it. We haven't.

Thanks,


Magilla

---------
In Sweden, I think 4 or 5 died in their sleep from EPO. Their blood was
as thick as ketchup, and the heart just couldn't pump it. Horrible deaths,
in the early years of EPO.



I also heard Rod Stewart swallowed a pint of sperm and had to go to the
hospital to get it pumped out of his stomach.

Thanks,

Magilla