[paula_w]

"Boys will be boys, a dog is a dog, it's what they do."
Same mentality as television, turn it into a battle for the same seat...musical chairs anyone?

Amgen-Funded Docs A Majority On NKF Panel Reviewing Amgen’s Drug
Yes, Virginia, there can be too much of a good thing." by Merrill
Goozner

http://www.agoravox.com/article.php3?id_article=5380

LA Times

http://www.latimes.com/business/la-f...3958585.story?
page=1&coll=la-headlines-business

Amgen facing ill winds
Safety concerns, patent expirations and new rivals are putting the
heat on the biotech firm.
By Daniel Costello
Times Staff Writer

December 6, 2006

Amgen Inc., the Thousand Oaks-based biotech behemoth, has been a
shining star in the drug industry for more than two decades.
Recently, it isn't burning so brightly.

This morning, Congress begins hearings about cost and safety concerns
around two of the company's top-selling drugs, Epogen and Aranesp,
which are used to treat nearly 2 1/2 million dialysis and cancer
patients with anemia in the U.S. each year.

Last month, two research studies in the New England Journal of
Medicine found those who received higher doses of anemia drugs die or
suffer heart attacks and strokes more often than patients who
received lower doses.

Should lawmakers signal that they want to curtail the amount of
anemia drugs doctors prescribe — which the federal government could
do by lowering reimbursement rates through Medicare — it would
clearly pose a significant threat to Amgen's bottom line. The
company's anemia lineup makes up almost half of its sales and 60% of
its profit.

Such a move would be the latest in a string of negative events for
the company. Some of Amgen's most important international anemia
patents have recently expired, and its domestic one will probably
follow in just a few years. And the newly Democratic-controlled
Congress has signaled it may soon introduce legislation to allow
generic competition in the biotech industry, something the federal
government hasn't done before.

Meanwhile, the company is under attack from a host of competitors
that threaten to do more than just nip at its heels. At the top of
the list is Swiss drug maker Roche Holding, which has developed its
own anemia drug, Cera, which could get federal approval as early as
next year. Amgen has filed a patent infringement suit and a court
case is expected in a few months; it's anyone's guess who will
prevail.

Perhaps most worrisome is the strength of Amgen's once-storied
research pipeline. Some analysts say Amgen is having more difficulty
than its competitors in finding new blockbusters to ensure the robust
sales growth it has long been known for, especially in the oncology
sector, the biotech industry's most lucrative field.

That may be why the company's stock has languished. Although the Amex
index of 20 major biotech stocks is up 14% this year, Amgen's stock
has declined 12%.

"I don't see much reason to think they're going to get the kind of
momentum they had a few years ago anytime soon," said James Reddoch,
a biotech analyst with Friedman Billings Ramsey.

It's possible the company could surprise its skeptics and the
industry. After all, since the company was founded in 1980, it has
grown into the world's largest biotechnology company and boasts one
of the biggest stock market values of any drug company. Last year,
Amgen earned $3.7 billion on revenue of $12.4 billion.

With the company having cash to spare, executives have the means to
find and acquire heaps of new drugs. Several of the company's
products are in late-stage clinical trials, and its recent
acquisition of Fremont, Calif.-based Abgenix, which has several
promising monoclonal antibodies to treat cancer and other diseases,
could eventually pay off handsomely.

Willard Dere, Amgen's senior vice president of global development and
chief medical officer, said the company was investing $3 billion in
research this year and was confident about the number and quality of
drugs it has on the market or in clinical trials. Among them: a new
colon cancer drug, Vectibix, that came on the market this fall.
Several possible breakthrough therapies for osteoporosis, cancer and
other diseases could be on pharmacy shelves as early as 2009.

"Our portfolio is filled with novel targets, not me-too drugs," Dere
said, referring to the trend among pharmaceutical companies to make
copycat versions of available drugs that don't provide significant
clinical gains.

But confidence is one thing; results are another. And the company
must deal with current challenges. The two New England Journal of
Medicine trials have created a firestorm of controversy around the
firm and its chief anemia products, Epogen and Aranesp. Aranesp is a
longer-acting version of the drug.

Anemia is a condition in which people don't produce enough red blood
cells, or hemoglobin, increasing their risk of infections, stroke and
death. Amgen's erythropoietin, the basis for its anemia products,
stimulates bone marrow to produce red blood cells. Johnson & Johnson
markets the same drug under the name Procrit, although it is produced
by Amgen.

A healthy adult has a hemoglobin level around 15 grams per deciliter.
The . Food and Drug Administration recommends doctors prescribe
dosage to anemic patients so that they have a hemoglobin level of 10
to 12 grams per deciliter.

One of the studies in the New England journal found patients given
higher doses of the drug to increase their hemoglobin levels to 13.5
grams per deciliter were more likely to die, have a heart attack or
stroke or be hospitalized than patients treated to produce moderate
hemoglobin levels of 11.3 grams per deciliter.

Physicians say providing medication in excess of those
recommendations is common, especially with patients who are on
dialysis. Indeed, a recent study published in the journal Health
Affairs found the average Epogen dose quadrupled between 1991 and
2003.

Still, a panel of doctors with the National Kidney Foundation this
year further changed its anemia drug dosing recommendations, which
many doctors strongly take into account, suggesting it was safe to
provide patients with up to 13 grams per deciliter.

Amgen and some doctors say the shift toward more aggressive dosing is
justified because growing clinical evidence supports more assertive
treatment.

Dr. Allen Nissenson, a nephrologist and director of UCLA's dialysis
unit, said the current FDA treatment guidelines might not be
aggressive enough, pointing out that its lower hemoglobin limit of 10
grams per deciliter is below what most doctors believe is appropriate.

Critics, including other doctors and powerful lawmakers including
Rep. Bill Thomas (R-Bakersfield), chairman of the House Ways and
Means Committee, suggest that the uptick in doses in recent years has
less to do with medicine than money — and that the worrisome trend is
lining physicians' and Amgen's pockets.

Currently, dialysis centers make most of their money on the premium
they charge patients, or the federal government, for anemia drugs,
not on dialysis services. Nephrologists also make money on the
pricing arrangement. Because most dialysis centers in the U.S. are
paid for by Medicare, the payment structure is nearly universal in
the industry.

Critics say that incentive is the main reason patients are getting
more medication. They also claim industry money is why the National
Kidney Foundation upped its recommendations.

Amgen partially funds the National Kidney Foundation and research
conducted by many top doctors in the industry.

"It makes no sense to have a payment system that encourages doctors
to prescribe more medication than may be safe for patients," said Dr.
Daniel Coyne, a medical professor at Washington University in St.
Louis. "Just as bad, many of the doctors on the [Kidney Foundation]
panel have a conflict of interest to promote the drug. Do we need any
more reason to worry this system is broken?"

An Amgen spokesman said the company had always advised doctors to
strictly follow FDA label guidelines.

A spokeswoman at the National Kidney Foundation said Tuesday that
industry support from Amgen and others did not influence the
foundation's activity or the doctors serving on its advisory panels.

"These guys [at Amgen] have historically weathered anything that gets
thrown at them," Stifel, Nicolaus & Co. analyst Edward Nash said,
adding that he agrees that Amgen's slate of drugs under development
is strong. "I think they can weather this."

daniel.costello@latimes.com
----------------------------------------------------------------------

Forbes
Health
Congress To Scrutinize Amgen Drug
Kerry A. Dolan, 12.06.06, 9:50 AM ET

Burlingame, Calif. -
One of biotech powerhouse Amgen's most profitable blockbuster drugs
will come under the scrutiny of the House Ways and Means Committee in
a hearing scheduled to begin at 10:30 Wednesday morning. The hearing
isn't likely to warm the hearts of Amgen shareholders.

A report issued by the U.S. Government Accountability Office on
Tuesday provides a glimpse into the congressional committee's
thinking. The report suggests changing the way Medicare pays for
Epogen, Amgen's multibillion-dollar anti-anemia drug. The changes, if
implemented, would likely cut into Amgen's prodigious profits.

Epogen's main use is to treat anemia in patients with kidney failure,
also known as end-stage renal disease. Such patients receive Epogen
during dialysis treatments, which are usually covered by Medicare. In
2005, Medicare and Medicaid spent $2 billion on Epogen, more money
than on any other drug. This year, Epogen sales to Medicare and
Medicaid should total about $2.5 billion, accounting for 18% of
Amgen's sales and 23% of its profit, according to Sanford C.
Bernstein analyst Geoffrey Porges.

One reason Rep. Bill Thomas, the California Republican who is
chairman of the revenue-raising Ways & Means Committee, called for
the hearing was the publication last month of a study on dialysis,
the blood-cleansing treatment used for kidney patients. The New
England Journal of Medicine report found 20% of patients being
treated for dialysis have red blood cell counts associated with
increased risk of heart problems and death.

The GAO report notes that Medicare pays for certain dialysis services
under a type of bundled rate, called a composite rate. For some
dialysis-related drugs, including Epogen, Medicare also pays each
time the drug is administered. The current system provides a
financial incentive to use drugs, according to a report earlier this
year by the Medicare Payment Advisory Commission, an independent
federal body that advises Congress on issues affecting the Medicare
program. Indeed, dialysis centers get 25% of their profits from the
Medicare reimbursements they receive on Epogen, according to a Morgan
Stanley report. Perhaps unsurprisingly, the average dose of Epogen
quadrupled between 1991 and 2003.

The GAO recommended that Congress consider establishing a bundled
payment system for all kidney-failure services, "including drugs, as
soon as possible." In such a bundled payment system, a dialysis
center is given a fixed sum of money and then chooses how to spend
that sum on dialysis treatment and related drugs. Such a system gives
dialysis providers an incentive to minimize expenditures, because it
gets to keep what it doesn't spend.

Of course, that pits the treatment providers' profits against the
best interests of patients. In a statement issued in response to the
GAO report, Amgen said it is concerned that implementing a bundled
payment system "without appropriate case-mix adjusters and quality
safeguards could introduce financial incentives to underutilize
services and could decrease the quality of care."

After the Ways and Means hearing was announced last week, Sanford
Bernstein's Porges wrote, "We see no way for this to be positively
construed by Amgen ... there is significant risk to Amgen's earnings
from these hearings." Porges added that he does not expect any change
in reimbursement policy for at least two years, but "the issue adds
to the growing pressure" on Epogen.

[lou_lou]

Amgen will get what it deserves...
what goes around -comes around~
and it's coming around -finally!
JUSTICE must be served.
thank you Paula!