Powerbase - User contributions [en]

Avandia

2010-07-23T15:46:53Z

David Leloup: added link to BMJ study

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==Background==

[[Avandia]] or Rosiglitazone, is one of [[GlaxoSmithKline]]'s blockbuster drugs for type 2 diabetes. It was raking in 4.6 million pounds a day in the early months of 2007, when an independent researcher who worked at the Cleveland Clinic in America, [[Steven Nissen]], published a controversial meta-analysis of the drug in the [[New England Journal of Medicine]] ([[NEJM]]). Nissen added up heart problem data in all the previously published studies of Avandia in order to examine the drug’s safety profile. He concluded that users are 43 per cent more likely to have heart attacks and that there is an even higher increase in the risk of fatal heart problems.<ref>Nissen, S., and Wolski, K. (2007) [http://content.nejm.org/cgi/content/full/NEJMoa072761 Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes]. ''The New England Journal of Medicine'', volume 356:2457-2471.</ref>

In April 2008, The Scotsman reported on NHS Scotland's reaction to Nissen's meta-analysis.<ref>LYNDSAY MOSS and MARISA DE ANDRADE, [http://news.scotsman.com/latestnews/Doctors-demand-freeze-on-use.3953015.jp Doctors Demand Freeze on use of diabetes drug for heart patients], The Scotsman, 7 April 2008, accessed 24 Feb 2010</ref>

==Links to heart attack risks==

After a two year inquiry, the US Senate Finance Committee issued a report in February 2010 stating '''Avandia''''s manufacturer, [[GlaxoSmithKline]], knew of possible heart attack risks tied to its drug and 'tried to play down findings that the drug could increase cardiovascular risks while also working to minimize findings that a rival medication might reduce such risks'. <ref>The Washington Post (Associated Press). 21 February 2010. [http://www.washingtonpost.com/wp-dyn/content/article/2010/02/20/AR2010022003547.html Senate report ties GlaxoSmithKline diabetes drug Avandia to heart attack risks] Accessed 23 February 2010.</ref> The senate asked the [[FDA]] to explain 'why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007'.<ref>The Washington Post (Associated Press). 21 February 2010. [http://www.washingtonpost.com/wp-dyn/content/article/2010/02/20/AR2010022003547.html Senate report ties GlaxoSmithKline diabetes drug Avandia to heart attack risks] Accessed 23 February 2010.</ref> Two Food and Drug Administration (FDA) officials are recommending the drug is pulled from the market.<ref>Harris, G. ''The New York Times'' [http://www.nytimes.com/2010/02/20/health/policy/20avandia.html Research Ties Diabetes Drug to Heart Woes] Accessed 23 February 2010.</ref>

==Secret Tapes==

According to ''The New York Times'', [[Steven Nissen]] had a private meeting with four [[GSK]] executives 11 days before publishing the results of his meta-analysis and secretly recorded the discussion. During the meeting, the drug company's representatives 'repeatedly promised to begin a crucial analysis of the safety of Avandia “within days"'. Such a study has not been published in a medical journal. [[GSK]]'s chief medical officer, Dr. [[Ronald L. Krall]], also allegedly 'predicted almost exactly the results of another crucial study of Avandia that was two months from publication and whose results, according to scientific protocols and the company itself, should have been kept secret from the company.'<ref>Harris, G. ''The New York Times.'' 22 February 2010. [http://www.nytimes.com/2010/02/23/health/23niss.html?pagewanted=1 A Face-Off on the Safety of a Drug for Diabetes] Accessed 2 March 2010.</ref>
According to the newspaper report:

:'Nissen said the recording showed that the executives hoped to persuade him not to publish his study by suggesting that they had contradictory information they would share with him in a joint study. “In retrospect, it seems clear that neither statement was true,” Dr. Nissen said. “They did not have contradictory data, and they never intended to cooperate in any analyses.”'<ref>Harris, G. ''The New York Times.'' 22 February 2010. [http://www.nytimes.com/2010/02/23/health/23niss.html?pagewanted=1 A Face-Off on the Safety of a Drug for Diabetes] Accessed 2 March 2010.</ref>

==Conflicts of Interest==

In March 2010, the British Medical Journal (BMJ) published research exploring 'a possible link between authors’ financial conflicts of interest and their position on the association of rosiglitazone [Avandia] with increased risk of myocardial infarction in patients with diabetes.' <ref>Wang et al. BMJ 2010;340:c1344 [http://www.bmj.com/cgi/content/full/340/mar18_1/c1344 Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review] Accessed 21 March 2010.</ref>

The authors concluded:

: 'Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.' <ref>Wang et al. BMJ 2010;340:c1344 [http://www.bmj.com/cgi/content/full/340/mar18_1/c1344 Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review] Accessed 21 March 2010.</ref>

==Notes==
<references/>

John Lupien

2010-06-05T09:30:34Z

David Leloup: left FAO for EUFIC after scandal was revealed

'''John Lupien''' was Director of the Food and Nutrition Division (now the [[Nutrition and Consumer Protection Division]]) {{ref|1}}, [[Food and Agriculture Organization]] of the [[United Nations]] (FAO) in Rome from 1990-1999.

Mr. Lupien carried out his undergraduate and graduate studies at the University of Massachusetts, then joined the FDA in 1960, where he served as an investigator and compliance officer. In 1970, Mr. Lupien joined the FAO as a Nutrition officer, holding several other positions before returning to the FDA in Washington as Director of the International Affairs Staff in 1980. Mr. Lupien has been with the Food and Nutrition Division of FAO since 1986 {{ref|2}}.

In his FDA and FAO work Mr. Lupien has been involved in extensive nutrition-related policy formulation work. He has also carried out in-depth nutrition, food quality and food safety surveys and prepared and implemented nutrition-related projects in about 50 countries (ibid.).

Lupien was implicated in the covert funding by the food industry ([[ILSI]] and [[WSRO]]) of the Expert Consultation on Carbohydrates in Human Nutrition run by FAO/WHO in Rome in 1997. In 2004, a UN agency investigation, and the BBC's Panorama programme uncovered documents which revealing that the [[World Sugar Research Organisation]] and [[International Life Sciences Institute]], both funded by the sugar industry, helped pay for the Consultation. The funding for the Consultation was approved by John Lupien {{ref|3}}.

Lupien then left the FAO to become chair of scientific advisory board of the industry-funded [[European Food Information Council]] (EUFIC).

==Affiliations==
*[[European Food Information Council]] chair of scientific advisory board

==References==

#{{note|1}} FAO [http://www.fao.org/ag/magazine/0601sp1.htm 'Interview with Louise O. Fresco], accessed 1st August 2007.
#{{note|2}} Joint Institute for Food Safety and Applied Nutrition [http://web.archive.org/web/20040220173635/http://www.jifsan.umd.edu/presentations/tse/bio/lupien.htm 'John Lupien'], February 2004, accessed 5th June 2010.
#{{note|3}} BBC News [http://news.bbc.co.uk/1/hi/health/3726510.stm 'UN probes sugar industry claims'], accessed 1st August 2007.

John Lupien

2010-06-05T09:27:06Z

David Leloup: /* References */

'''John Lupien''' was Director of the Food and Nutrition Division (now the [[Nutrition and Consumer Protection Division]]) {{ref|1}}, [[Food and Agriculture Organization]] of the [[United Nations]] (FAO) in Rome from 1990-1999.

Mr. Lupien carried out his undergraduate and graduate studies at the University of Massachusetts, then joined the FDA in 1960, where he served as an investigator and compliance officer. In 1970, Mr. Lupien joined the FAO as a Nutrition officer, holding several other positions before returning to the FDA in Washington as Director of the International Affairs Staff in 1980. Mr. Lupien has been with the Food and Nutrition Division of FAO since 1986 {{ref|2}}.

In his FDA and FAO work Mr. Lupien has been involved in extensive nutrition-related policy formulation work. He has also carried out in-depth nutrition, food quality and food safety surveys and prepared and implemented nutrition-related projects in about 50 countries (ibid.).

Lupien was implicated in the covert funding by the food industry ([[ILSI]] and [[WSRO]]) of the Expert Consultation on Carbohydrates in Human Nutrition run by FAO/WHO in Rome in 1997. A UN agency investigation, and the BBC's Panorama programme uncovered documents which revealing that the [[World Sugar Research Organisation]] and [[International Life Sciences Institute]], both funded by the sugar industry, helped pay for the Consultation. The funding for the Consultation was approved by John Lupien {{ref|3}}.

==Affiliations==
*[[European Food Information Council]] chair of scientific advisory board

==References==

#{{note|1}} FAO [http://www.fao.org/ag/magazine/0601sp1.htm 'Interview with Louise O. Fresco], accessed 1st August 2007.
#{{note|2}} Joint Institute for Food Safety and Applied Nutrition [http://web.archive.org/web/20040220173635/http://www.jifsan.umd.edu/presentations/tse/bio/lupien.htm 'John Lupien'], February 2004, accessed 5th June 2010.
#{{note|3}} BBC News [http://news.bbc.co.uk/1/hi/health/3726510.stm 'UN probes sugar industry claims'], accessed 1st August 2007.

John Lupien

2010-06-05T09:26:05Z

David Leloup: /* References */ dead link replaced by Archive.org link

'''John Lupien''' was Director of the Food and Nutrition Division (now the [[Nutrition and Consumer Protection Division]]) {{ref|1}}, [[Food and Agriculture Organization]] of the [[United Nations]] (FAO) in Rome from 1990-1999.

Mr. Lupien carried out his undergraduate and graduate studies at the University of Massachusetts, then joined the FDA in 1960, where he served as an investigator and compliance officer. In 1970, Mr. Lupien joined the FAO as a Nutrition officer, holding several other positions before returning to the FDA in Washington as Director of the International Affairs Staff in 1980. Mr. Lupien has been with the Food and Nutrition Division of FAO since 1986 {{ref|2}}.

In his FDA and FAO work Mr. Lupien has been involved in extensive nutrition-related policy formulation work. He has also carried out in-depth nutrition, food quality and food safety surveys and prepared and implemented nutrition-related projects in about 50 countries (ibid.).

Lupien was implicated in the covert funding by the food industry ([[ILSI]] and [[WSRO]]) of the Expert Consultation on Carbohydrates in Human Nutrition run by FAO/WHO in Rome in 1997. A UN agency investigation, and the BBC's Panorama programme uncovered documents which revealing that the [[World Sugar Research Organisation]] and [[International Life Sciences Institute]], both funded by the sugar industry, helped pay for the Consultation. The funding for the Consultation was approved by John Lupien {{ref|3}}.

==Affiliations==
*[[European Food Information Council]] chair of scientific advisory board

==References==

#{{note|1}} FAO [http://www.fao.org/ag/magazine/0601sp1.htm 'Interview with Louise O. Fresco], Accessed 1st August 2007.
#{{note|2}} Joint Institute for Food Safety and Applied Nutrition [http://web.archive.org/web/20040220173635/http://www.jifsan.umd.edu/presentations/tse/bio/lupien.htm 'John Lupien'], Accessed 5th June 2010.
#{{note|3}} BBC News [http://news.bbc.co.uk/1/hi/health/3726510.stm 'UN probes sugar industry claims'], Accessed 1st August 2007.