Inappropriate Use Of ESA Meds Was Widespread

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money-ben-franklins1The group of drugs known as ESAs are apparently being used inappropriately in cancer patients, suggesting that the expensive treatments are being wasted and exposing patients unnecessarily to serious side effects, according to a new study in the Journal of Clinical Oncology.

Specifically, the meds were administered for no more than one week in 24 percent of patients, which is an insufficient amount of time to offer a useful benefit, according to the researchers (read the abstract). Moreover, nearly eight percent of the patients received one of the drugs for more than 14 weeks, while almost 14 percent were getting the drugs when they weren’t on chemotherapy.”

The meds are approved for cancer patients who are getting chemotherapy, and recommended treatment is between two and 14 weeks. The Center for Medicare & Medicaid Services spends more than $1 billion dollars annually on ESAs, which include Epogen and Aranesp, which are sold by Amgen; Procrit, which is sold by Johnson & Johnson, and Roche’s NeoRecormon.

“These are very expensive drugs and there are a fair number of side effects,” lead author Jason Wright of Columbia University Medical Center in New York tells Reuters. “You’re subjecting patients to potential toxicity for very little clinical benefit, so it is wasted resources.”

But as Reuters notes, benefits may be uncertain and could be mitigated by such side effects as blood clots and heart problems. In some cases, the drugs might even fuel tumor growth. “Over the last five years, we have been seeing many side effects that weren’t seen in the early clinical trials,” Wright says, noting the FDA issued a warning in 2007.

In reaching their conclusion, the researchers reviewed data on 21,000 Medicare beneficiaries who were 65 years or older with breast, lung, or colon cancer diagnosed between 1995 and 2005, and who had one ESA and chemotherapy claim.

Interestingly, they found that ESA misuse was associated with MD degree, female sex of physician, and earlier year of medical school graduation. Private practice physicians and high-volume physicians were less likely to use one week or less of ESA treatment. Treatment by high-volume oncologists and by oncologists who graduated from US medical schools predicted prolonged-duration ESA use, whereas female oncologists were less likely to prescribe prolonged ESA treatment. Private practice physicians and high-volume providers were more likely to prescribe more than 24 weeks of ESA treatment.

“The really important question now is whether it is still being used routinely, because that would be a real public health concern,” Thomas George, a cancer researcher at the University of Florida who was not involved in the study, tells Reuters. “There needs to be a fairly rigorous educational program that accompanies the use of these medications so doctors know who is going to benefit.”

benjamins pic thx to amagill on flickr

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  1. Ed,

    You should take note of the time period studied for this JCO article. Your post might better be titled “Inappropriate use of ESAs was widespread.”

    While authors are probably correct that ESA use was variable and may have been inappropriate in the past, the time period of the analysis (1995-2005) pre-dated at least 6 label changes, a REMs program and a National Coverage Decision by Medicare. I understand that utilization in the oncology space has declined by almost 50% since the safety issues emerged in 2007.

    I think that it would interesting to see a follow up analysis that decribes just how signifiantly physician habits changed in light of all of these events.

  2. Erythropoiesis-stimulating agents, Procrit, Epogen, NeoRecormon and Aranesp are used for low red cell count. A lack of red blood cells can lead to anemia. EPO is a natural substance made by the kidney. It stimulates the bone marrow to make red blood cells. Healthy adults are usually at about 15 grams a deciliter. However, Erythropoiesis-stimulating agents can have an adverse impact on cancer survival. Pharmaceutical EPO can feed the growth of tumors in cancer patients (it is a “growth factor” afterall).

    A “growth factor” is about twenty small proteins that attach to specific receptors on the surface of stem cells in bone marrow and promote differentiation and maturation of these cells into morphotic constituents of blood. And blood is a circulating tissue composed of fluid plasma and cells (red blood cells, white blood cells, platelets). Problems with blood composition or circulation can lead to downstream tissue (which is made up of cells) dysfunction.

    Increasing the blood cell count (hemoglobin) level above 12 is very risky with pharmaceutical EPO. The issue is over the drugs’ safety on how big a dose to use to boost concentrations of hemoglobin. The FDA-approved level is doses sufficient to increase hemoglobin to a maximum of 12 grams a deciliter. Blood transfusions are generally needed when patients slip to less than 8 grams.

    However, the adage of some physicians was that if some improvement in hemoglobin was good, higher levels of hemoglobin would even be better. Then “greed” takes over.

  3. I’d have to agree that this study would be outdated by all that’s happened since 2005.

    I investigated and wrote about the misuse of these drugs quite a while ago. I want to say probably in 2006 or 2007.

    Public health care programs were definitely ripped off big time - I remember that much for sure.

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