正文
Doctors paid millions by Amgen and Johnson & Johnson to push anemia drugs
NEW YORK: 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.
NEW YORK: 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.
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