Weekly Roundup – 05/09/08

J0145922It is raining buckets – reportedly 3 inches since yesterday.   The water table looks like its headed for restoration here.   Lots of thunder and lightning.  Flood AND tornado watch.  Congress is skipping town to go home to Mom.    Other than that, a quiet time here inside the Beltway.

And here is a little of what went on this week:

  • House Committee on Energy and Commerce holds hearing on DTC advertising -  It was the Subcommittee on Oversight and Investigations and to give you a flavor, here is what Congressman Dingell had to say – "Regrettably, investigations by this Committee have revealed systematic violations of these principles by a number of drug companies. Some ad campaigns have been misleading and others appear downright deceptive."  Or, if you want to see the whole Webcast, here is a link to the hearing – I had trouble accessing.  Look for lots more action on this front in months to come.  Hearing coverage made ABC World News Tonight.  It also got widespread national media coverage across the board. 
  • And the Subcommittee on Health Holds Hearing on Stem Cells – And a flavor of this hearing from Congressman Dingell – "None of us can guarantee to those suffering from Parkinson’s disease, spinal cord injuries, or multiple sclerosis that embryonic stem cell research will bring success. But we can guarantee that if we let politics, not science, guide our efforts, we consign ourselves to failure."  – As the Congress shakes the yoke of this Administration, look for lots more action on this front as well.
  • Astellas Gets Euro Nod for Mycamine – This was interesting since there have been a host of drugs that have gotten European approval, but are held up in the U.S., Astellas got approval for an antifungal in Europe which has been approved in Japan since 2002 and the U.S. since 2005.   The company reported in its release that it received approval in late April, though announced it on May 7.   The indication is for invasive candidiasis. 

That’s it for me folks.  Have a good weekend everyone.       

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One Response to Weekly Roundup – 05/09/08

  1. Kerry Donahue says:

    FDA SAYS, “WAIT” TO DYING MEN
    COAST-TO-COAST PROSTATE CANCER DEMONSTRATIONS ON MAY 30th IN PROTEST OF FDA FAILURE TO APPROVE SAFE, EFFECTIVE IMMUNOTHERAPY
    On May 30, 2008, CareToLive will take to the streets with coast-to-coast protests in Chicago, New York, Philadelphia, Cleveland, Madison, Atlanta, Seattle, Dearborn, and Tampa. Joining us will be the Cancer Cure Coalition, the Abigail Alliance, and A Right To Live. We are asking all patient advocates to come out and attend a protest.
    1 in 6 men get prostate cancer. 75 American men die from it every day. The FDA has not approved a treatment for stage IV prostate cancer in over 43 years.
    CareToLive, a not for profit corporation, seeks transparency and accountability from the FDA, as to why they disregarded the advice of their hand selected Congressionally mandated Advisory Panel of experts, who voted Provenge overwhelmingly safe and effective. Without cause or explanation, in an unprecedented action, the FDA denied licensure. We are seeking immediate access to Provenge for all men with end stage prostate cancer.
    Over a year has passed, and 27,000 American men have died without hope, since the FDA denied the licensure of Provenge, an immunotherapy the FDA panel voted 17-0 safe and overwhelmingly voted effective. This is a noninvasive, non-toxic, immune building treatment, which works by employing your own body’s healthy cells to fight the cancer.
    Men like Eduardo Garcia, who have had the 3 treatments, have gone from being incapacitated, to living healthy, productive lives, for as long as seven years and counting. Dendreon, the company that perfected this treatment, also has similar treatments for breast, ovarian, colon, lung, kidney, and cervical cancers, in their sights.
    The dysfunctional FDA’s reason for delay has never been explained, as it was not science based, since survival and safety have been clearly demonstrated.
    CareToLive filed a Citizens Petition for the FDA to reconsider the wrongful denial, (the only recourse the FDA allows), on July 26, 2007. The FDA has failed to follow Federal regulation and to this day they have not properly responded to our Petition, which seeks immediate access to Provenge for these desperate men. The FDA also refuses to respond to the CareToLive Freedom of Information Act request, which they know would prove that a few FDA insiders, who cared more about serving their own interests, rather than the best interest of the patients, purposely sabotaged Provenge.
    “In memory of our members who have recently passed away, never having been given the chance Provenge recipient Eduardo Garcia had, we will continue to fight on, every day, in every way we can. Please come out and join us,” CareToLive spokesperson, Mike Kearney, said.
    LOCATIONS:
    Seattle, Washington — 1 PM PDT
    Westlake Park (Downtown) — 400 Pine St
    Coordinator – Jason Burdine jnaburdine@comcast.net
    Chicago, Illinois — 3 PM CDT
    ASCO / McCormick Place — 2301 S. Lake Shore Drive
    Coordinator – Sean Morgan – morgan2174@yahoo.com
    Co-coordinator – Arnie Mass – Ammass14@aol.com
    Cleveland, Ohio — 4 PM EDT
    Public Square outside terminal tower — downtown
    Coordinator – Kerry Donahue – bedonwahoo@aol.com
    Co-coordinator – Mike Bauman – jmb15mjb4@gmail.com
    Dearborn, Michigan — 3 PM EDT
    Rep. John Dingell’s Office — 19855 West Outer Drive — Suite 103-E
    Coordinator – Gregg Burch – ctl-dearborn-rally@live.com
    Madison, Wisconsin — 4 PM CDT
    Wisconsin State Capitol Building — 2 East Main Street
    Coordinator – Melody Davis – MDavis@caretolive.com
    Tampa, Florida — 3 PM EDT
    H. Lee Moffitt Cancer Center & Research Institute
    University of South Florida
    12902 Magnolia Drive
    Coordinator – Ardeis Scott, MD – ardeisfka@aol.com
    Philadelphia, Pennsylvania — 2 PM EDT
    2 PM Assemble and pass out flyers at 12th & Market Street for march to FDA at
    4 PM — 200 Chestnut Street U.S. Customhouse Building
    Coordinator – Mike Kearney – publicrelations@caretolive.com
    Co-coordinator- Rory Kearney – rk@caretolive.com
    New York, NY — 9 AM ESDT
    Memorial Sloan-Kettering Cancer Center — 1275 York Avenue
    Co-Coordinators – Leslie Mulkey – lhrmulkey@aol.com
    Kevin Ward – kward3@nyc.rr.com
    Atlanta, Georgia — 3 PM EDT
    Atlanta FDA Regional Office — 60 Eighth St. N.E.
    Coordinator- Bob Madden – rjmcanoe@aol.com
    For more information go to http://www.CareToLive.com