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12-25-2007, 11:15 PM
U.S. Senate Special Committee on Aging Chairman Herb Kohl (D-WI) made public copies of letters he has sent to Centers for Medicare and Medicaid Services (CMS) Acting Administrator Kerry Weems, Food and Drug Administration Commissioner Andrew von Eschenbach, and Genentech, Inc.'s President of Product Development Susan Desmond-Hellman concerning Genentech's proposed plan to limit the availability of its cancer drug Avastin to certain pharmaceutical compounding firms and pharmacies. Some physicians have charged that Genentech's intention in limiting Avastin's availability is to boost sales of Lucentis, a chemically-similar, yet far more expensive drug also produced by Genentech. An October 12, 2007 Wall Street Journal article, entitled "Genentech to Limit Avastin Availability, Use of Cancer Treatment For Eye Ailment Hurts Sales of Targeted Drug (http://online.wsj.com/public/article/SB119213222981256309.html)," stated that because Medicare is a large purchaser of Avastin, the cost to taxpayers could be as high as $1 to $3 billion dollars a year if availability of the drug is curbed.

"Any instance that could cost taxpayers potentially one to three billion dollars is of great concern to me," said Chairman Kohl in the letters. "I take very seriously the [Aging] Committee's responsibility to protect and advocate on behalf of our nation's seniors. Part of this responsibility is ensuring that seniors are receiving appropriate and cost-effective prescriptions drugs."

Earlier this year, at an Aging hearing examining the pharmaceutical industry's influence (http://aging.senate.gov/hearing_detail.cfm?id=277848&) on physicians and their prescribing behaviors, an ophthalmologic surgeon representing Physicians for Clinical Responsibility (PCR) testified before the committee. In interviews with committee staff previous to the hearing, the physician shared troubling, detailed information regarding Genentech's refusal to cooperate with or furnish drugs for a comparative clinical trial on the effectiveness of using Avastin to combat many serious eye ailments, including wet macular degeneration, many of which occur primarily in the elderly.

According to the Wall Street Journal, Avastin will only be available to hospital pharmacies and directly to doctors as of January 1, 2008. After that date, compounding pharmacies will no longer be able to obtain the drug and repackage for the treatment of eye diseases. A once-monthly dose of Avastin from these pharmacies costs roughly $40; a comparable dose of Lucentis costs approximately $2000.

As a result of this investigation, Chairman Kohl is working on legislation that would give CMS the authority to waive co-payments for patients participating in government-funded clinical trials and comparative-effectiveness studies.

October 18, 2007 Letter (http://aging.senate.gov/letters/genentechcmsltr.pdf) to CMS Acting Administrator Kerry Weems
November 7, 2007 Letter (http://aging.senate.gov/letters/genentechfdaltr.pdf) to FDA Commissioner Andrew von Eschenbach
November 14, 2007 Letter (http://aging.senate.gov/letters/genentechfdaltr2.pdf)to FDA Commissioner Andrew von Eschenbach
November 16, 2007 Letter (http://aging.senate.gov/letters/genentechltr.pdf)to Genentech, Inc. President of Product Development Susan Desmond-Hellman

http://aging.senate.gov (http://aging.senate.gov/)