The subject is erythropoiesis-stimulating agents, ESAs, which stimulate the bone marrow to make more red blood cells and which were approved by the Food and Drug Administration, FDA, for use in reducing the need for blood transfusions in patients with chronic kidney failure, patients with cancer on chemotherapy, patients scheduled for major surgery (except heart surgery) and patients with HIV that are using AZT. ESAs are genetically engineered forms of erythropoietin or Epo, a substance made by the human kidney that increases the production of red blood cells.
ESA's are among the most lucrative products ever produced by the biotechnology industry [sales of the drugs worldwide totaled about $10 billion last year] and they are the largest drug expense for Medicare, which spent $2 billion in 2005 just for the use of Epogen in kidney dialysis patients, according to a report in The New York Times. There is no question that the use of ESAs is potentially life-saving, however, a number of recent studies revealed their overuse has been linked to increases in deaths, strokes and heart attacks.
Based on those studies, on March 9th, the FDA released a public health advisory and warning regarding the use of Epoetin Alfa, marketed as Epogen® (EPO) and Procrit® and Darepoetin Alfa, marketed as Aranesp®. All three drugs are manufactured by Amgen, Inc., however Procrit is marketed and sold by a subsidiary of Johnson & Johnson. And all three are used to treat anemia, a common symptom of kidney failure.
According to the FDA, recent reports of studies with ESAs have shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents. Specifically, the FDA warned that use of ESAs resulted in "an increased number of deaths and of non-fatal heart attacks, strokes, heart failure, and blood clots when ESAs were adjusted to maintain . . . hemoglobin more than 12 g/dL." The serious nature of these findings led the FDA to ask Amgen to place a black box warning [labelling] on Epogen and similar drugs’ labels, the strongest warning a prescription drug can have. The FDA also recommends using just enough ESA to maintain the lowest hemoglobin level necessary to avoid the need for transfusions and to ensure hemoglobin level does not exceed 12 grams for each deciliter. In other words, the FDA advise that doctors should prescribe the lowest possible dose of ESA's needed to help patients avoid blood transfusions.
By sheer coincidence, one problem regarding the administration of Epogen was revealed in a new study titled "Dialysis Facility Ownership and Epoetin Dosing in Patients Receiving Hemodialysis", reported in the current issue [Vol. 297, No. 15] of the Journal of the American Medical association. The purpose of the study was to examine the association between dialysis facility ownership and the dose of Epoetin administered. Based upon 2004 dialysis patient data, the researchers discovered that when compared with patients in nonprofit dialysis facilities, patients in chain-operated, for-profit dialysis centers, which handle the majority of dialysis patients, are consistently given the highest doses of Epogen, regardless of their anemia status. The researchers also discovered that for-profit centers increased the drug dose even when patients already had recommended levels of red blood cells.
So the next question is why are chain-operated, for-profit dialysis centers overdosing patients with a drug now deemed to be a killer in certain quantities? Answer: The chain-operated, for-profit dialysis centers are making millions in the process. And how does for-profit dialysis centers capitalize on sick, unsuspecting patients? Shockingly, with the help of the reimbursement or payment system authorized by Medicare. First, the for-profit dialysis chains buy the drug for less by negotiating volume discounts for Epogen from Amgen. Then, Medicare reimburses the dialysis centers a fixed amount for each treatment and Medicare also reimburse the same dialysis chains separately for the administration of Epogen. This type of payment system encourages for-profit dialysis chains, which handle the majority of dialysis patients, to be aggressive in their administration of ESA's such as Epogen.
Ignoring the issue whether non-doctors are making decisions regarding dosage of potentially lethal drugs, why should'nt corporate dialysis chains take advantage of the loopholes in the Medicare regulations? The windfall is a gift authorized and voluntarily bestowed by Medicare although not-for-profit providers have long been suggesting that the Epogen reimbursement system is flawed. Go here to learn more from a Bloomberg News report, published as early as December 2006, describing the profits being made and the possibility that Amgen's shares may fall as a result of a House House Ways and Means Committee proposal that "bundling" payments for Epogen in a set fee for treating patients whose kidneys have failed would "promote efficiency".
The FDA's March 9th warning may have placed the spotlight on Medicare to review its system of reimbursement for Epogen. Medicare spokeswoman Ellen Griffith reportedly stated the agency expects to report to Congress this summer about its dialysis payment system and plans a demonstration project of a new payment system that would include Epogen in a “bundled” reimbursement rate. Until such time that Medicare introduces a new reimbursement plan, peoples lives will remain at risk while Amgen and chain-operated, for-profit dialysis centers will continue to rake in the profits.
What should a patient that uses Epogen or other ESAs do to prevent overdose by a for-profit dialysis chain? Try to understand exactly your doctor's advice regarding recommended hemoglobin levels for your medical condition and the corresponding ESA dosage level. This way, you will know whether the dialysis center is administering the dose of Epogen or other ESA prescribed by your physician. This will also prevent for-profit dialysis chains from administering unapproved doses of ESAs and may, perhaps, dampen their pfofits.
No comments:
Post a Comment