From: Jaffe, Lyle D Sent: Tuesday, October 12, 2004 8:06 AM To: Dockets, FDA Subject: FW: [Aspartame Support] Here is an example of typical FDA perfidy -----Original Message----- From: Dr. Betty Martini [mailto:Bettym19@mindspring.com] Sent: Friday, October 08, 2004 1:02 PM To: DHATTAN-CFSAN.FDA.GOV; Jaffe Lyle D; RXH-CFSAN.FDA.GOV Subject: Fwd: [Aspartame Support] Here is an example of typical FDA perfidy Well said! You people are responsible for unsafe food and drugs, for as long as aspartame remains on the market to interact with other drugs as brought out in Dr. Roberts medical text, no drug is safe. I don't know how you sleep at night. Dr. Betty Martini >X-Yahoo-Newman-Property: groups-email >X-Sender: bryanth@presidiotex.com >X-Apparently-To: aspartame@yahoogroups.com >To: "Aspartame Support Group" >Cc: "Activist List" >X-Mailer: Microsoft Outlook Express 6.00.2800.1437 >X-eGroups-Remote-IP: 64.26.0.17 >From: "E Bryant Holman" >X-Yahoo-Profile: ebholman >Mailing-List: list aspartame@yahoogroups.com; contact >aspartame-owner@yahoogroups.com >Delivered-To: mailing list aspartame@yahoogroups.com >List-Unsubscribe: >Date: Fri, 8 Oct 2004 08:05:09 -0500 >Subject: [Aspartame Support] Here is an example of typical FDA perfidy >X-ELNK-AV: 0 > > >We don't have to wonder why it is that aspartame continues to recieve the >approval of FDA. They continue to have a legacy as an organ of the >government which is not concerned with protecting the public's health and >safety, but rather with betraying the public's health and safety: >************************************************** > >http://www.canada.com/health/story.html?id=d7708d86-a83d-454f-8fa3-1de5260bba4c > > >FDA silenced expert who raised concerns about Vioxx: U.S. Senator > >Canadian Press > >Thursday, October 07, 2004 > >WASHINGTON (AP) - The U.S. Food and Drug Administration silenced one of >its drug experts who raised safety concerns weeks before Merck & Co. >yanked the blockbuster drug Vioxx due to increased risks for heart attack >and strokes, the chairman of the U.S. Senate finance committee said Thursday. > >Dr. David Graham, associate director for science in the FDA Drug Center's >Office of Drug Safety, told Senate investigators he faced stiff resistance >within the regulatory agency to his findings. > >"Dr. Graham described an environment where he was 'ostracized, subjected >to veiled threats' and 'intimidation,"' Senator Chuck Grassley of Iowa >said in a statement after finance committee investigators interviewed the >researcher Thursday. > >Graham said Grassley's characterization was accurate. Raising safety >concerns within the agency is "extremely difficult," the 20-year employee >said, declining further comment. > >In a prepared statement, the FDA said it "values open discussion and frank >exchange about scientific and medical issues" and subjects its scientists >to "more rigorous" scrutiny than typical scientific peer reviews. > >The Government Accountability Office, an investigative arm of Congress, >already has been asked to look into whether the FDA muzzled another >staffer who linked antidepressants to raising the odds of children >suffering suicidal tendencies. When Merck voluntarily pulled Vioxx from >the market Sept. 30, the GAO was asked to roll the FDA's handling of that >controversy into its inquiry. > >That report is not expected for months. Grassley's committee is one of >three in Congress also scrutinizing the FDA's actions. > >A "picture is emerging of an agency that can't see the forest for the >trees," Grassley said. > >"Merck knew it had trouble on its hands and took action. At the same time, >instead of acting as a public watchdog, the Food and Drug Administration >was busy challenging its own expert and calling his work 'scientific rumour."' > >Graham was lead author on a research project that studied the records of >1.39 million Kaiser Permanente patients, including 40,405 treated with >Pfizer's Celebrex and 26,748 treated with Vioxx. The study found high >doses of Vioxx, known as rofecoxib, tripled risks of heart attacks and >sudden cardiac death. > >The research team's original conclusion said high doses of Vioxx should >not be prescribed or used. > >Graham, scheduled to present those findings in late August during an >epidemiology conference in France, said he ran into resistance when the >FDA reviewed his abstract. > >"I think the recommendation about high dose rofecoxib is unnecessary and >particularly problematic since FDA funded this study and David's travel to >France to present it," Anne Trontell, deputy director of the FDA's Office >of Drug Safety, wrote in an Aug. 12 e-mail. > >The internal e-mail exchange was released by Grassley. > >In the e-mail, Trontell suggested Graham defer his presentation in favour >of a journal article so dissenting scientists - including within the FDA - >could comment. > >She also said Merck should be alerted before the findings became public >"so they can be prepared for extensive media attention that this will >likely provoke." > >Others within the agency suggested Graham's conclusion was too strongly >worded, given the FDA had not added such warnings to Vioxx labels. > >"I've gone about as far as I can without compromising my deeply held >conclusions about this safety question," Graham replied in an Aug. 13 e-mail. > >The FDA said such discussions are typical before scientific findings are >published. > >The conclusion Graham presented in France was revised: "This and other >studies cast serious doubt on the safety" of Vioxx doses higher than 25 >mg. a day. > >The FDA said Graham decided to revise his abstract conclusion. > >"He did so voluntarily," the agency said. > >In testimony before a congressional panel in mid-September, Andrew >Mosholder, an FDA epidemiologist, said his bosses asked him to soften >recommendations about antidepressants. > >Mosholder's analysis pointed to increased suicidal thoughts and behaviours >among children taking antidepressants well before federal advisers pushed >for strident warnings on the drugs. He suggested preferential use of >Prozac, the only drug approved to treat depressed children and - his >review said - the one with the lowest risk. > >His supervisors within the FDA told him to suggest children use such >medications "with caution," Mosholder told the congressional panel. > >Dr. Paul Seligman, acting director of the FDA's Office of Drug Safety, >said the agency did not pressure Mosholder to change his conclusion. >© The Canadian Press 2004 > > > > >Copyright © 2004 CanWest Interactive, a division of CanWest Global >Communications Corp. All rights reserved. > >[Non-text portions of this message have been removed] > > > >------------------------ Yahoo! Groups Sponsor --------------------~--> >$9.95 domain names from Yahoo!. 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