Comments on: FDA Panels: When Is A Conflict Not A Conflict? http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/ News, Comment and Conversation Fri, 10 Feb 2012 22:19:19 +0000 http://wordpress.org/?v=2.6.2 By: Jason http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/#comment-357714 Jason Mon, 02 Jun 2008 14:24:45 +0000 http://www.pharmalot.com/?p=13837#comment-357714 http://www.investorvillage.com/smbd.asp?mb=971&mn=199584&pt=msg&mid=4888767 http://www.investorvillage.com/smbd.asp?mb=971&mn=199584&pt=msg&mid=4888767

]]> By: MyPharmalotID http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/#comment-357574 MyPharmalotID Thu, 29 May 2008 20:26:11 +0000 http://www.pharmalot.com/?p=13837#comment-357574 The Greatest Performing Artists of All Times at the FDA, for your viewing pleasure (from InvestorVillage MB) http://www.jibjab.com/starring_you/receipt/2111682 The Greatest Performing Artists of All Times at the FDA, for your viewing pleasure (from InvestorVillage MB)

http://www.jibjab.com/starring_you/receipt/2111682

]]> By: Poop Doggy http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/#comment-357573 Poop Doggy Thu, 29 May 2008 20:14:57 +0000 http://www.pharmalot.com/?p=13837#comment-357573 Hey, why not Cindi Lauper or Tiger Woods on the AC? I bet that either of them have as much or more recent experience with hematology than our favorite urologic oncologist, MaHaHa. How long...if ever...will we learn the REAL reason she was seated on this panel...and who paid to make it happen... Hey, why not Cindi Lauper or Tiger Woods on the AC? I bet that either of them have as much or more recent experience with hematology than our favorite urologic oncologist, MaHaHa. How long…if ever…will we learn the REAL reason she was seated on this panel…and who paid to make it happen…

]]> By: kyoto27 http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/#comment-357572 kyoto27 Thu, 29 May 2008 19:59:57 +0000 http://www.pharmalot.com/?p=13837#comment-357572 Let’s not be hard on Maha: She may just be ‘captured’? And in exchange for bowing to folks like Richard Pazdur and the FDA party line, she gets the inside track on who Dick Pazdur will let Pass Go, which companies she can overweight in her stock portfolio and guarantees herself and family a good lifestyle? What's wrong with that? And can we really fault Randall Lutter, Vince Tolino, Michael Ortwerth and Igor Cerny who need to grant waivers to avoid having the FDA embarrassed by any real opinions by doctors who may not want to show up just to play the party line? Or God forbid, to enrich themselves? Wasn’t it Dr Maha Hussain and Dr Howard Scher who sat on the FDA’s Provenge AC and apologized for not knowing a damn thing about cancer immunotherapies like Provenge …but said they knew a bad thing when they saw it? Or were told to say it was bad? And then kept on saying it over and over and over again? And why should Maha and Howard worry about doing the right thing when the FDA, DOJ, SEC, GAO, JAG could care less how the Mahas and Schers vote, or their COIs? Our regulators know the country is losing its edge in technology and they also know it’s only a matter of time before we end up in the toilet –after all, they’re the ones leading us there. So you can’t blame them for wanting to get it now while the getting is good? Since when is it wrong in America to be just looking out for yourself because you can’t depend on Government? And who would know that better than those in our Government? What a shame, what a tragic farce…. Let’s not be hard on Maha:
She may just be ‘captured’? And in exchange for bowing to folks like Richard Pazdur and the FDA party line, she gets the inside track on who Dick Pazdur will let Pass Go, which companies she can overweight in her stock portfolio and guarantees herself and family a good lifestyle? What’s wrong with that? And can we really fault Randall Lutter, Vince Tolino, Michael Ortwerth and Igor Cerny who need to grant waivers to avoid having the FDA embarrassed by any real opinions by doctors who may not want to show up just to play the party line? Or God forbid, to enrich themselves?

Wasn’t it Dr Maha Hussain and Dr Howard Scher who sat on the FDA’s Provenge AC and apologized for not knowing a damn thing about cancer immunotherapies like Provenge …but said they knew a bad thing when they saw it? Or were told to say it was bad? And then kept on saying it over and over and over again?

And why should Maha and Howard worry about doing the right thing when the FDA, DOJ, SEC, GAO, JAG could care less how the Mahas and Schers vote, or their COIs?

Our regulators know the country is losing its edge in technology and they also know it’s only a matter of time before we end up in the toilet –after all, they’re the ones leading us there. So you can’t blame them for wanting to get it now while the getting is good? Since when is it wrong in America to be just looking out for yourself because you can’t depend on Government? And who would know that better than those in our Government?

What a shame, what a tragic farce….

]]> By: Moonshooter http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/#comment-357571 Moonshooter Thu, 29 May 2008 18:01:27 +0000 http://www.pharmalot.com/?p=13837#comment-357571 Maha Hussain just keeps rollin' around like a bad penny looking for a place to rest. She keeps company with a few other bad pennies. "and committee attendance is expected to be poor." Really! Would anyone wonder why after the way the opinions of the excellent experts who attended the Provenge AC were dissed and tossed aside like onion peels from grandma's kitchen. THE FDA NEEDS TO ACQUIRE SOME CLASS! TIME FOR CHANGE! Maha Hussain just keeps rollin’ around like a bad penny looking for a place to rest. She keeps company with a few other bad pennies.

“and committee attendance is expected to be poor.”

Really! Would anyone wonder why after the way the opinions of the excellent experts who attended the Provenge AC were dissed and tossed aside like onion peels from grandma’s kitchen.

THE FDA NEEDS TO ACQUIRE SOME CLASS! TIME FOR CHANGE!

]]> By: MyPharmalotID http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/#comment-357570 MyPharmalotID Thu, 29 May 2008 17:56:55 +0000 http://www.pharmalot.com/?p=13837#comment-357570 Oxymoron of the Year: FDA Ethics This would be a good time to ask what, exactly, the following individual, does for a living, day after day: Vince Tolino Director, Ethics and Integrity Staff Office of Management Programs, OM vincent.tolino@fda.hhs.gov ethics@oc.fda.gov Certainly, there's been no evidence that his office has been doing it's job since early in 2007...unless you call "rubberstamping" specious waiver requests heavy lifting in the ethics arena! If he were doing what your and my taxes allegedly are paying him to do, we might see some resolution to the well-documented conflicts of interest (COIs) cases surrounding Drs. Scher and Hussain, beginning (?) with their participation in the Provenge Advisory Committee meeting on March 29, 2007. Can I please have a tax refund? Oxymoron of the Year: FDA Ethics

This would be a good time to ask what, exactly, the following individual, does for a living, day after day:

Vince Tolino
Director, Ethics and Integrity Staff
Office of Management Programs, OM
vincent.tolino@fda.hhs.gov
ethics@oc.fda.gov

Certainly, there’s been no evidence that his office has been doing it’s job since early in 2007…unless you call “rubberstamping” specious waiver requests heavy lifting in the ethics arena!

If he were doing what your and my taxes allegedly are paying him to do, we might see some resolution to the well-documented conflicts of interest (COIs) cases surrounding Drs. Scher and Hussain, beginning (?) with their participation in the Provenge Advisory Committee meeting on March 29, 2007.

Can I please have a tax refund?

]]> By: Matt http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/#comment-357562 Matt Thu, 29 May 2008 16:19:25 +0000 http://www.pharmalot.com/?p=13837#comment-357562 The FDA needs an outside agency to monitor its ethics and conflicts of interest. It's absurd to think the FDA can do anything about its own ethics issues. The FDA needs an outside agency to monitor its ethics and conflicts of interest. It’s absurd to think the FDA can do anything about its own ethics issues.

]]> By: Chandler http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/#comment-357560 Chandler Thu, 29 May 2008 16:12:55 +0000 http://www.pharmalot.com/?p=13837#comment-357560 How can you have a stock that's worth fifty thousand to one hundred thousand dollars? This is just a way of watering down the true value of the stock that she has in the company which is probably closer to the $100,000. How can you have a stock that’s worth fifty thousand to one hundred thousand dollars? This is just a way of watering down the true value of the stock that she has in the company which is probably closer to the $100,000.

]]> By: Brad http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/#comment-357552 Brad Thu, 29 May 2008 15:41:18 +0000 http://www.pharmalot.com/?p=13837#comment-357552 You have got to be kidding me??? She is still allowed back on an AC panel, again with these conflicts of interest? Is she an expert in this field of chronic ITP? The last I checked, she was an oncologist, not an immunologist. Sound familiar?? Another prime example of these doctors who say they are protecting the public when actually they are more concerned with protecting their investments and research. Why have an AC meeting in the first place? Where is the backbone of the FDA to not allow these conflicts? Absolutely disgusting! You have got to be kidding me??? She is still allowed back on an AC panel, again with these conflicts of interest? Is she an expert in this field of chronic ITP? The last I checked, she was an oncologist, not an immunologist. Sound familiar?? Another prime example of these doctors who say they are protecting the public when actually they are more concerned with protecting their investments and research. Why have an AC meeting in the first place? Where is the backbone of the FDA to not allow these conflicts? Absolutely disgusting!

]]> By: Jason http://www.pharmalot.com/2008/05/fda-panels-when-is-a-conflict-not-a-conflict/#comment-357545 Jason Thu, 29 May 2008 15:06:09 +0000 http://www.pharmalot.com/?p=13837#comment-357545 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 www.CareToLive.com 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

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