Microsoft alumni help each other out after they leave
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Jason Burdine said,Tuesday, 06-05-08 07:21FDA SAYS, ?WAIT? TO DYING MEN
Nationwide Prostate Cancer Rally MAY 30th Over FDA Failure to Approve Safe, Effective Immunotherapy.
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.
Care To Live, 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.
On May 30, 2008, CareToLive will take to the streets to protest with the men desperately seeking Provenge. 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 six 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 clearly been 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,? said CareToLive spokesperson, Mike Kearney.
Please join with me on May 30th, 2008, in Westlake Park, outside in downtown Seattle, Washington, from 1 PM to 3 PM, as a show of solidarity with our brothers who have been tossed aside by our incompetent, cold blooded health czars. Visit www.CareToLive.com for additional details.
Thank You, Jason Burdine Coordinator Seattle Jason.Burdine@gmail.com
David F. Plummer said,Monday, 05-05-08 21:26Your publication is a complete joke! No thoughtful person who resides in Bellevue thinks this is a 'great place to live'! The only people who indorse this absurd notion are the charter and invited members of the Eastside Power Brokers Association. This association (composed of the City's major land developers and business associations, and the City of Bellevue bureaucrats and City Council members) is the only group that thinks this City is a good place to live. Development driven and governed, this City is a monument to the nonsense that is passed off as 'participatory democracy;' it is a living testimony to the Robert Moses of the world, who crave to remake municipalities in their own warped images of the world. One can only hope that Washington citizens will, somehow, regain control of their own destinies before such transitory, fugitive, profit-driven groups condemn their communities to the same fate that Moses left for contemporary inhabitants of New York City, and, in Bellevue's case, Fred Herman left for current Bellevue citizens.
David F. Plummer
Bellevue, WA
paidher said,Tuesday, 29-04-08 10:47Eric, there is more to this story...March 29th marked the 1 year anniversary where an overwhelming majority of FDA experts convened and confirmed that Provenge met the safety and efficacy criteria for marketing approval. Yet, the science and normal process at the FDA was overturned by a small group of people with inordinate influence. After the overwhelming panel vote, Dr. Scher even lobbied the FDA Commissioner himself to withhold Provenge. Dr. Francesco Marincola, who himself participated in the Provenge AC, stated that his role as a member of the advisory board was ?to express his opinion during the meeting but it would be ill advised to influence the FDA decision beyond that point.?
A fiduciary duty is the highest standard of care imposed by law. As an employee of the FDA, Dr. Scher has a fiduciary duty up hold to all Americans and is expected to be loyal to and act in the best interests of all Americans. As such, Dr. Scher must put aside his own personal interests and must not profit from his position. The foundation of Dr. Scher?s position is based upon good faith, loyalty, and trust. A fiduciary must not put themselves in a position where their interest and duty conflict.
As a Board Member to ProQuest Investments, a $1 billion venture capital fund, whose largest single investment was in Novacea, and whose lead product, Asentar, is in direct competition with Provenge, Dr Scher?s fiduciary duty at the FDA conflicted with his fiduciary duty to promote the interests of ProQuest and its investment in Novacea. This is like a lawyer representing both the plaintiff and the defendant in the same legal matter. The lawyer cannot make either the plaintiff or the defendant?s interes ts a top priority if both the plaintiff and the defendant?s interests are diametrically opposed. Dr. Scher should have recused himself from the Provenge Advisory Committee.
I am unaware of any action by the FDA to investigate and correct the obvious conflicts of interest that surround Dr. Scher's participation. Justice delayed is justice denied. This principle is the basis of the right to a speedy trial. The FDA has acted too slowly in investigating this issue. Even in responding to FOIA (Freedom of Information Act) requests, the FDA has stated that they can not reply timely because it is overburdened!
Dr. Scher should have recused himself from the Provenge advisory committee. He had a fiduciary duty to do so. Furthermore, it was inappropriate for Dr. Scher to lobby Dr. von Eschenbach personally to delay Provenge after the advisory committee meeting. And the leaking of letters from Dr. Scher, Dr. Maha Hussain and Dr. Thomas Fleming to the public was inappropriate, inimical to Provenge approval and dastardly. What is going on at the FDA to ignore these obvious attempts to sabotage a non-toxic treatment for terminal cancer?
paul1149 said,Tuesday, 29-04-08 10:31And add this to Scher's lilly-white resume. What a great humanitarian!:
Clinical Study of Abiraterone Acetate and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485303
Contacts
Contact: Howard Scher, MD 646-422-4323
http://clinicaltrials.gov/ct2/show/NCT00485303
This is the FDA's very Watergate of scandals, yet the press tells us, "No story here; everyone just move along."
janus said,Tuesday, 29-04-08 10:11I agree with those commenting that more journalistic research needs to be applied to this issue. Dendreon does indeed seem to have been wronged by those trusted to behave objectively. While the company and its investors have been hurt, the real victims are those that have been denied this life-saving treatment. May justice previal.
Nationwide Prostate Cancer Rally MAY 30th Over FDA Failure to Approve Safe, Effective Immunotherapy.
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.
Care To Live, 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.
On May 30, 2008, CareToLive will take to the streets to protest with the men desperately seeking Provenge. 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 six 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 clearly been 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,? said CareToLive spokesperson, Mike Kearney.
Please join with me on May 30th, 2008, in Westlake Park, outside in downtown Seattle, Washington, from 1 PM to 3 PM, as a show of solidarity with our brothers who have been tossed aside by our incompetent, cold blooded health czars. Visit www.CareToLive.com for additional details.
Thank You, Jason Burdine Coordinator Seattle Jason.Burdine@gmail.com
David F. Plummer
Bellevue, WA
A fiduciary duty is the highest standard of care imposed by law. As an employee of the FDA, Dr. Scher has a fiduciary duty up hold to all Americans and is expected to be loyal to and act in the best interests of all Americans. As such, Dr. Scher must put aside his own personal interests and must not profit from his position. The foundation of Dr. Scher?s position is based upon good faith, loyalty, and trust. A fiduciary must not put themselves in a position where their interest and duty conflict.
As a Board Member to ProQuest Investments, a $1 billion venture capital fund, whose largest single investment was in Novacea, and whose lead product, Asentar, is in direct competition with Provenge, Dr Scher?s fiduciary duty at the FDA conflicted with his fiduciary duty to promote the interests of ProQuest and its investment in Novacea. This is like a lawyer representing both the plaintiff and the defendant in the same legal matter. The lawyer cannot make either the plaintiff or the defendant?s interes ts a top priority if both the plaintiff and the defendant?s interests are diametrically opposed. Dr. Scher should have recused himself from the Provenge Advisory Committee.
I am unaware of any action by the FDA to investigate and correct the obvious conflicts of interest that surround Dr. Scher's participation. Justice delayed is justice denied. This principle is the basis of the right to a speedy trial. The FDA has acted too slowly in investigating this issue. Even in responding to FOIA (Freedom of Information Act) requests, the FDA has stated that they can not reply timely because it is overburdened!
Dr. Scher should have recused himself from the Provenge advisory committee. He had a fiduciary duty to do so. Furthermore, it was inappropriate for Dr. Scher to lobby Dr. von Eschenbach personally to delay Provenge after the advisory committee meeting. And the leaking of letters from Dr. Scher, Dr. Maha Hussain and Dr. Thomas Fleming to the public was inappropriate, inimical to Provenge approval and dastardly. What is going on at the FDA to ignore these obvious attempts to sabotage a non-toxic treatment for terminal cancer?
Clinical Study of Abiraterone Acetate and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485303
Contacts
Contact: Howard Scher, MD 646-422-4323
http://clinicaltrials.gov/ct2/show/NCT00485303
This is the FDA's very Watergate of scandals, yet the press tells us, "No story here; everyone just move along."