Did Amgen and Johnson & Johnson over-promote their anemia drugs? Congress is asking the companies for documents detailing their advertising and promotions, including a "bundling" discount Amgen allegedly offered to doctors on Neupogen and Neulasta in return for Aranesp scrips. "We are concerned that such 'bundling' practices may have helped fuel excessive and dangerous off-label use of Aranesp," Rep. John Dingell [1] wrote to Amgen in a letter demanding the documents.
Meanwhile, Dingell's Energy and Commerce Committee is also asking J&J for records on its DTC ads for Procrit, which claimed the med could offer "strength for living."
The ad/promo investigation comes at a time when the anemia drugs have been under scrutiny for safety risks. The meds have been linked to increased risk of death at high doses, and have been linked to tumor growth and death risk in certain cancer patients.
- see Dingell's letter [2] to J&J (.pdf)
- check out Dingell's Amgen letter [3] (.pdf)
- read the Boston Globe article [4]
Related Articles:
Amgen--Big Biotech's Stock Report. Report [5]
FDA's worst-case anemia scenario. Report [6]
Do anemia warnings signal new limits? Report [7]
Study: Anemia meds hike death risk 10%. Report [8]
New Medicare cap on anemia drugs could hammer Amgen. Report [9]
FDA: More risks from anemia drugs. Report [10]
Links:
[1] http://www.fiercebiotech.com/press-releases/dingell-stupak-consider-changing-law-over-heparin-failures
[2] http://energycommerce.house.gov/Press_110/110-ltr.033108.ESAs.JohnsonJohnson.pdf
[3] http://energycommerce.house.gov/Press_110/110-ltr.033108.ESAs.Amgen.pdf
[4] http://www.boston.com/business/healthcare/articles/2008/04/01/congress_scrutinizes_drug_ads/
[5] http://www.fiercebiotech.com/special-reports/amgen-big-biotechs-stock-report
[6] http://www.fiercepharma.com/story/fda-s-worst-case-anemia-scenario/2008-03-12
[7] http://www.fiercepharma.com/story/do-anemia-warnings-signal-new-limits/2008-03-10?utm_medium=nl&utm_source=link
[8] http://www.fiercepharma.com/story/study-anemia-meds-hike-death-risk-10/2008-02-27?utm_medium=nl&utm_source=link
[9] http://www.fiercebiotech.com/story/new-medicare-cap-on-anemia-drugs-could-hammer-amgen/2007-05-15
[10] http://www.fiercepharma.com/story/fda-more-risks-from-anemia-drugs/2008-01-04?utm_medium=nl&utm_source=link