Doctors paid millions by Amgen and Johnson & Johnson to push anemia drugs
- From: Roman Bystrianyk <rbystrianyk@xxxxxxxxx>
- Date: 9 May 2007 05:38:33 -0700
Alex Berenson and Andrew Pollack, "Doctors paid millions by Amgen and
Johnson & Johnson to push anemia drugs", International Herald Tribune,
May 9, 2007,
Link: http://www.iht.com/articles/2007/05/09/business/anemia.php
Two of the world's largest drug companies are paying hundreds of
millions of dollars to doctors every year in return for giving their
patients anemia medicines, which regulators now say may be unsafe at
commonly used doses.
The payments are legal, but very few people aside from 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
last 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 have 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, on the West Coast of the
United States, 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 Food and Drug Administration added to concerns about the drugs,
releasing a report Tuesday suggesting 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. Tuesday'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
Thursday, 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. 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 that patients and doctors would benefit from
fuller disclosure about the payments and the profits that doctors can
make from them.
Still, the anemia drugs can help patients' quality of life, when used
appropriately, Lichtenfeld said. "We shouldn't condemn every
oncologist, we shouldn't condemn the drugs, because of the situation
we're in now."
Federal laws bar drug companies from paying doctors to prescribe
medicines that are 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.
Medicare has changed its payment structure since 2003 to reduce the
mark-up, but private insurers still often pay more. Combined with
those insurance reimbursements, the rebates enable many doctors to
profit substantially on the medicines they buy and then give to
patients.
The rebates are related to the amount of drugs that doctors buy, and
physicians that agree to use one company's drugs exclusively typically
receive higher rebates.
Johnson & Johnson said Tuesday in a statement that its rebates were
not intended to induce doctors to use more medicine. Instead, the
rebates "reflect intense competition" in the market for the drugs, the
company said.
Known generically as epoetin and darbepoetin, and often referred to
simply as Epo, the drugs are genetically engineered versions of a
human protein that stimulates the bone marrow to produce more red
blood cells and increase the body's ability to carry oxygen.
Most doctors and patients agree that the drugs are very helpful for
patients when used to correct severe anemia, which can be debilitating
and even life threatening. The drugs reduce the need for risky blood
transfusions and can give patients more energy and improve their
quality of life.
"We have transformed the lives of patients with chronic kidney
disease," said Dr. Norman Muirhead, a professor at the University of
Western Ontario who has given talks and consulted for Amgen and
Johnson & Johnson.
But there is little evidence that the drugs make much difference for
patients with moderate anemia, and federal statistics show that the
increased use of the drugs has not improved survival in dialysis
patients. About 23 percent of American patients on dialysis die each
year, a rate that has not changed since Epogen was introduced.
Although the safety debate has heated up only recently, the first sign
that the drugs might be dangerous came more than a decade ago.
That evidence emerged in a trial sponsored by Amgen that was designed
to show that dialysis patients would benefit from having their
hemoglobin raised to 14, the level in a healthy person.
But the trial, which was stopped in 1996, found that patients in that
group had more deaths and heart attacks than the group treated with a
hemoglobin goal of 10.
That trial should have discouraged doctors from using too much epoetin
and encouraged Amgen to study the risks further, said Dr. Steven
Fishbane, a nephrologist at Winthrop-University Hospital on Long
Island.
Instead, use of Epogen continued to soar. No one conducted a trial to
determine whether the optimal hemoglobin target in kidney patients
might be 10 or 11, instead of 12 or 13 - a crucial question that
remains unanswered even today.
Dr. Anatole Besarab of Henry Ford Hospital in Michigan, the lead
author of the study that was stopped in 1996, said that Amgen and
Johnson & Johnson had little incentive to conduct such a trial.
Some hospitals and doctors have used Epogen more conservatively than
the big dialysis chains.
Dr. Ronald Paulus, chief health technology officer at Geisinger Health
System, a nonprofit group that includes three hospitals in
Pennsylvania, said Geisinger had lowered its use of Epogen by 40
percent. Its doctors were able to do so simply by monitoring patients
more closely and giving them more iron, without which the body cannot
make hemoglobin. Dr. N.D. Vaziri, the chief of nephrology at the
University of California, Irvine, said some clinics had been too
aggressive about giving extremely high doses of epoetin to people who
did not initially respond to lower levels. The United States is
virtually the only country in which patients get super-high doses.
.
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