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Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on May 09, 2007, 09:31:49 AM
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Doctors paid millions by Amgen and Johnson & Johnson to push anemia drugs
By Alex Berenson and Andrew Pollack
International Herald Tribune
Wednesday, May 9, 2007
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.
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.
http://www.iht.com/articles/2007/05/09/business/anemia.php