Doctors are paid millions to dispense anemia drugs



Key quotes:

"... documents given to The New York Times show that at just one
practice in the Pacific Northwest, a group of six cancer doctors
received $2.7 million from Amgen for prescribing $9 million worth of the
company's drugs last year"

"The report, prepared by FDA staff scientists, said no evidence
indicated that the medicines either improved quality of life in patients
or extended their survival, while several studies suggested that the
drugs can shorten patients' lives when used at high doses."

"Combined with insurance reimbursements, the rebates enable many doctors
to profit substantially on the medicines they buy and then give to
patients."

"U.S. patients receive far more of the anemia drugs than patients
elsewhere, with dialysis patients in this country getting doses more
than twice as high as their counterparts in Europe."

------------------------------------
By Alex Berenson and Andrew Pollack
NEW YORK TIMES NEWS SERVICE

May 9, 2007

Two of the world's largest drug companies are paying hundreds of
millions of dollars to doctors every year in return for patients being
given anemia medicines, which regulators say may be unsafe at commonly
used doses.

The payments are legal, but few people outside of the doctors who
receive them are aware of their size. Critics, including prominent
cancer and kidney doctors, say the payments give physicians an incentive
to prescribe the medicines at levels that might increase patients' risks
of heart attacks or strokes.

Industry analysts estimate that such payments - to cancer doctors and
the other big users of the drugs, kidney dialysis centers - total
hundreds of millions of dollars a year and are an important source of
profit for doctors and the centers. The payments have risen over the
past several years, as the makers of the drugs, Amgen and Johnson &
Johnson, compete for market share and try to expand the overall
business.

Neither Amgen nor Johnson & Johnson has disclosed the total amount of
the payments. But documents given to The New York Times show that at
just one practice in the Pacific Northwest, a group of six cancer
doctors received $2.7 million from Amgen for prescribing $9 million
worth of the company's drugs last year.

Yesterday, the Food and Drug Administration added to concerns about the
drugs, releasing a report that suggested that their use might need to be
curtailed in cancer patients.

The report, prepared by FDA staff scientists, said no evidence indicated
that the medicines either improved quality of life in patients or
extended their survival, while several studies suggested that the drugs
can shorten patients' lives when used at high doses. Yesterday's report
followed the FDA's decision in March to strengthen warnings on the
drugs' labels.

The report was released in advance of a hearing scheduled for tomorrow
during which an FDA advisory panel will consider whether the drugs are
overused.

The medicines - Aranesp and Epogen, from Amgen, and Procrit, from
Johnson & Johnson - are among the world's top-selling drugs, with
combined sales of $10 billion last year. In the United States, they
represent the single biggest drug expense for Medicare and are given to
about a million patients each year to treat anemia caused by kidney
disease or cancer chemotherapy.

Dr. Len Lichtenfeld, the deputy chief medical officer of the American
Cancer Society, said patients and doctors would benefit from fuller
disclosure about the payments and the profits that doctors can make from
them. "I suspect that Medicare is going to take a very careful look at
what is going on here," he said.

Still, the anemia drugs can help patients' quality of life when used
appropriately, Lichtenfeld said.

Most doctors and patients say the drugs are very helpful when used to
correct severe anemia. But there is little evidence that the drugs make
much difference for patients with moderate anemia.

Federal laws bar drug companies from paying doctors to prescribe
medicines given in pill form and purchased by patients from pharmacies.

But companies can rebate part of the price that doctors pay for drugs,
like the anemia medicines, which they dispense in their offices as part
of treatment. The anemia drugs are injected or given intravenously, in
physicians' offices or dialysis centers.

Doctors receive the rebates after they buy the drugs from the companies.
But they also receive reimbursement from Medicare or private insurers
for the drugs, often at a mark-up over the doctor's purchase price.

Combined with insurance reimbursements, the rebates enable many doctors
to profit substantially on the medicines they buy and then give to
patients.

Johnson & Johnson said yesterday in a statement that its rebates were
not intended to induce doctors to prescribe more medicine. Instead, the
rebates "reflect intense competition" in the market for the drugs, the
company said.

Amgen said that rebates are normal commercial practice and that it had
always properly promoted its drugs.

Both companies' stocks fell yesterday after release of the FDA report.

Since 1991, when the first of the drugs was still relatively new, the
average dose given to dialysis patients in this country has nearly
tripled. About 50 percent of dialysis patients receive enough of the
drugs to raise their red blood cell counts above the level considered
risky by the FDA.

U.S. patients receive far more of the anemia drugs than patients
elsewhere, with dialysis patients in this country getting doses more
than twice as high as their counterparts in Europe.

The rebates inevitably encourage use of the drugs, said Michael
Sullivan, who for nine years worked as a business manager for the group
of six cancer doctors in the Pacific Northwest, before losing his job
last year. Sullivan provided the Times with documentation that shows
the size of the rebates, on the condition that the group not be
identified. "Personally, I think rebates should go away," said Sullivan,
whose late father was a kidney dialysis patient who died of a heart
attack while taking epoetin.

The anemia medicines are known generically as epoetin and darbepoetin,
and often referred to simply as EPO.

--
Juba
www.masterjuba.com


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