Food and Drug Administration - Revision history

Claire Robinson at 23:52, 9 July 2009

2009-07-09T23:52:49Z

Claire Robinson at 20:33, 1 May 2009

2009-05-01T20:33:58Z

Marisa de Andrade: /* About */

2009-03-09T13:55:48Z

About

Marisa de Andrade: /* About */

2009-03-09T13:55:07Z

About

Marisa de Andrade at 13:54, 9 March 2009

2009-03-09T13:54:48Z

Marisa de Andrade at 21:26, 17 February 2009

2009-02-17T21:26:24Z

Lynn Hill: People

2008-03-21T12:59:27Z

People

Lynn Hill: people

2008-02-12T10:43:13Z

people

David: /* References */

2008-01-01T13:27:42Z

References

Lynn Hill: new page

2007-12-27T13:08:39Z

new page

New page

===Sanofi-Aventis - Fraudulent 'Study 3014' and the drug 'Ketek'===
In 2006, the U.S. Senate Committee on Finance (Committee) contacted the Food and Drug Administration (FDA) regarding concerns over the [[Sanofi-Aventis]] drug Ketek<ref>U.S. Senate Committee on Finance (June 2006) [http://finance.senate.gov/press/Gpress/2005/prg060806b.pdf ‘Grassley questions FDA about risks to children, infants in antibiotic drug trials’] Accessed 24th December 2007</ref>.

A pivitol study commissioned by Sanofi-Aventis (known as 'Study 3014') which has been used, and continues to be used, as evidence of the safety of the drug was found to be 'marred by fraud' in late 2003/early 2004. One of the investigators involved in the study lost his medical license and another investigator ([[Anne Campbell]]) was indicted for falsifying study data. She pleaded guilty in October 2003 and in 2004 was sentenced to 57 months in jail<ref> FDA [http://www.fda.gov/fdac/departs/2004/404_upd.html#fraud Physician Sentenced for Fraud] Accessed 24th December 2007</ref>.

Yet the fraudulent nature of the Study was not disclosed to the Anti-Effective Drugs Advisory Committee (AIDAC) who were responsible for approving the drug for use by adults in 2004. It was found that Ketek can cause serious liver damage and failure and there has been many recorded instances of the death of patients through the use of this drug.

In 2006, it is reported that Sanofi-Aventis are conducting trials to test Ketek as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries. Sanofi-Aventis has three ongoing trials in children as young as 6 months old and a fourth trial involving adolescents 13 years of age and older. The Committee voices concern that the parents of these children are unlikley to know of the risks their children are being exposed to and have called on the FDA to 'consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects’.

The Committee also voice concern at the ‘FDA’s complicity with the drug maker and subsequent failure to ensure the integrity of a pivotal study about the benefits and risks of this drug’.

:“The allegations of misconduct in this case are as bad as I’ve heard yet,” Grassley (the investigating officer) said. “It looks like the FDA caught the drug company red handed and let them get away with it. On top of that, the FDA failed to set the record straight and, in fact, continues to cite a discredited safety study as a principal reason to feel okay about using this drug.”

See [[Sanofi-Aventis Group - Fraudulent Activities]] for further details.

==References==
<references/>

[[Category:Health]]
[[Category:Pharmaceutical Policy Groups]]
[[Category:Food and Agriculture Industry]]

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 [[Category:Pharmaceutical policy groups]]
 [[Category:Food and Agriculture Industry]]
-[[Category:Big Pharma]][[Category:GM]]
+[[Category:Big Pharma]][[Category:GM]][[Category:Politicians and Regulators (GM)]]

@@ Line 33: / Line 33: @@
 [[Category:Pharmaceutical policy groups]]
 [[Category:Food and Agriculture Industry]]
-[[Category:Big Pharma]]
+[[Category:Big Pharma]][[Category:GM]]

@@ Line 1: / Line 1: @@
 ==About==
-The [[FDA]] is America's health regulator. 'It is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The [[FDA]] is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.'<ref>FDA [http://www.fda.gov/opacom/morechoices/mission.html] Accessed 9 March 2009</ref>
+The [[FDA]] is America's health regulator. 'It is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The [[FDA]] is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.'<ref>FDA [http://www.fda.gov/opacom/morechoices/mission.html FDA's Mission Statement] Accessed 9 March 2009</ref>
 ==People==

@@ Line 1: / Line 1: @@
 ==About==
-The [[FDA]] America's health regulator. 'It is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The [[FDA]] is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.'<ref>FDA [http://www.fda.gov/opacom/morechoices/mission.html] Accessed 9 March 2009</ref>
+The [[FDA]] is America's health regulator. 'It is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The [[FDA]] is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.'<ref>FDA [http://www.fda.gov/opacom/morechoices/mission.html] Accessed 9 March 2009</ref>
 ==People==

@@ Line 1: / Line 1: @@
 ==People==
 [[Robert Langer]], who sit on the Board of Directors for [[Wyeth]] pharmaceutical company, is reported to have previously served as a member of the United States [[Food and Drug Administration]]'s (FDA) SCIENCE Board (the FDA's highest advisory board). He served on the FDA's Board from 1995-2002 and was its Chairman from 1999-2002<ref> Wyeth [http://phx.corporate-ir.net/phoenix.zhtml?c=78193&p=irol-govBio&ID=105949 Robert Langer] Accessed 6th February 2008</ref>. Langer is also Institute Professor for the [[Massachusetts Institute of Technology]] and was elected to the [[Institute of Medicine of the National Academy of Sciences]] (in 1989) and in 1992 to both the [[National Academy of Engineering]] and to the [[National Academy of Sciences]].  Langer's biography states that 'he has served at various times on 15 boards of directors and 30 Scientific Advisory Boards' but only names [[Alkermes]], [[Mitsubishi Pharmaceuticals]], [[Warner-Lambert]] and [[Momenta Pharmaceuticals]]. He has also written over 860 articles in the medical and scientific fields and has over 500 issued or pending patents worldwide.  <i>[[Forbes]]</i> and <i>[[Bio World]]</i> are reported to have named Langer as 'one of the 25 most important individuals in biotechnology in the world'.
 * [[Sharon L Cohen]] - Cohen<ref>Podesta Group [http://www.podesta.com/biopages/SharonCohen.htm Sharon Cohen] Accessed 21st March 2008</ref> who in 2008 is listed as working for PR and lobbying firm the [[Podesta Group]] is described as having 'excellent relationships with House and Senate Leadership offices, Senate Finance and [[HELP]] committees, [[House Ways]] and [[Means and Energy and Commerce]] committees as well as with officials at the [[Food and Drug Administration]] and in the Centers for Medicare and Medicaid Services'. Cohen's biography descibes her as 'one of the most experienced and well-connected health care and biotech lobbyists in Washington'. Her previous involvements include serving as Vice President for Government Relations with the [[Biotechnology Industry Organization]] (BIO), chief lobbyist for the [[Health Insurance Association of America]], Director of Congressional Relations for the [[Blue Cross Blue Shield Association]], working at the [[American Council of Life Insurers]], serving as Deputy Director of Federal Relations for the [[American Psychiatric Association]] and as Director of Health Policy for the [[Alliance for Aging Research]].
-===Sanofi-Aventis - Fraudulent 'Study 3014' and the drug 'Ketek'===
+==Controversy==
 In 2006, the U.S. Senate Committee on Finance (Committee) contacted the Food and Drug Administration (FDA) regarding concerns over the [[Sanofi-Aventis]] drug Ketek<ref>U.S. Senate Committee on Finance (June 2006) [http://finance.senate.gov/press/Gpress/2005/prg060806b.pdf ‘Grassley questions FDA about risks to children, infants in antibiotic drug trials’] Accessed 24th December 2007</ref>.
 A pivitol study commissioned by Sanofi-Aventis (known as 'Study 3014') which has been used, and continues to be used, as evidence of the safety of the drug was found to be 'marred by fraud' in late 2003/early 2004. One of the investigators involved in the study lost his medical license and another investigator ([[Anne Campbell]]) was indicted for falsifying study data.  She pleaded guilty in October 2003 and in 2004 was sentenced to 57 months in jail<ref> FDA [http://www.fda.gov/fdac/departs/2004/404_upd.html#fraud Physician Sentenced for Fraud] Accessed 24th December 2007</ref>.

← Older revision		Revision as of 21:26, 17 February 2009
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	[[Category:Pharmaceutical policy groups]]		[[Category:Pharmaceutical policy groups]]
	[[Category:Food and Agriculture Industry]]		[[Category:Food and Agriculture Industry]]
		+	[[Category:Big Pharma]]

← Older revision		Revision as of 10:43, 12 February 2008
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		+	==People==
		+	[[Robert Langer]], who sit on the Board of Directors for [[Wyeth]] pharmaceutical company, is reported to have previously served as a member of the United States [[Food and Drug Administration]]'s (FDA) SCIENCE Board (the FDA's highest advisory board). He served on the FDA's Board from 1995-2002 and was its Chairman from 1999-2002<ref> Wyeth [http://phx.corporate-ir.net/phoenix.zhtml?c=78193&p=irol-govBio&ID=105949 Robert Langer] Accessed 6th February 2008</ref>. Langer is also Institute Professor for the [[Massachusetts Institute of Technology]] and was elected to the [[Institute of Medicine of the National Academy of Sciences]] (in 1989) and in 1992 to both the [[National Academy of Engineering]] and to the [[National Academy of Sciences]]. Langer's biography states that 'he has served at various times on 15 boards of directors and 30 Scientific Advisory Boards' but only names [[Alkermes]], [[Mitsubishi Pharmaceuticals]], [[Warner-Lambert]] and [[Momenta Pharmaceuticals]]. He has also written over 860 articles in the medical and scientific fields and has over 500 issued or pending patents worldwide. <i>[[Forbes]]</i> and <i>[[Bio World]]</i> are reported to have named Langer as 'one of the 25 most important individuals in biotechnology in the world'.
		+
	===Sanofi-Aventis - Fraudulent 'Study 3014' and the drug 'Ketek'===		===Sanofi-Aventis - Fraudulent 'Study 3014' and the drug 'Ketek'===
	In 2006, the U.S. Senate Committee on Finance (Committee) contacted the Food and Drug Administration (FDA) regarding concerns over the [[Sanofi-Aventis]] drug Ketek<ref>U.S. Senate Committee on Finance (June 2006) [http://finance.senate.gov/press/Gpress/2005/prg060806b.pdf ‘Grassley questions FDA about risks to children, infants in antibiotic drug trials’] Accessed 24th December 2007</ref>.		In 2006, the U.S. Senate Committee on Finance (Committee) contacted the Food and Drug Administration (FDA) regarding concerns over the [[Sanofi-Aventis]] drug Ketek<ref>U.S. Senate Committee on Finance (June 2006) [http://finance.senate.gov/press/Gpress/2005/prg060806b.pdf ‘Grassley questions FDA about risks to children, infants in antibiotic drug trials’] Accessed 24th December 2007</ref>.

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 [[Category:Health]]
-[[Category:Pharmaceutical Policy Groups]]
+[[Category:Pharmaceutical policy groups]]
 [[Category:Food and Agriculture Industry]]