Difference between revisions of "Sanofi-Aventis Group"

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However, they voice concern at the actions of countries who are engaged in trying to reduce the price of pharmaceutical products. Their Annual Report states that the development of generic varieties of medicines and vaccines and the actions of 'certain countries' who try to 'circumvent patent rights to allow their underprivileged populations to gain access to medicines' are 'unfavourable factors' facing the pharmaceutical industry. In the opening statements of their Annual Report, the Chairman and CEO stresses that ensuring intellectual property rights and patents are 'critical issues' facing Sanofi-Aventis both now and in the future. They go on to report how in 2006 they succeeded in imposing a 'preliminary injunction' effectively blocking any new deliveries of a generic version of Plavix into the market from August 2006 onwards <ref>[http://en.sanofi-aventis.com/Images/sanofi_ra06_en_tcm24-17381.pdf Sanofi-Aventis Annual report 2006] pages 5 & 20. Accessed 30th November 2007.</ref>
 
However, they voice concern at the actions of countries who are engaged in trying to reduce the price of pharmaceutical products. Their Annual Report states that the development of generic varieties of medicines and vaccines and the actions of 'certain countries' who try to 'circumvent patent rights to allow their underprivileged populations to gain access to medicines' are 'unfavourable factors' facing the pharmaceutical industry. In the opening statements of their Annual Report, the Chairman and CEO stresses that ensuring intellectual property rights and patents are 'critical issues' facing Sanofi-Aventis both now and in the future. They go on to report how in 2006 they succeeded in imposing a 'preliminary injunction' effectively blocking any new deliveries of a generic version of Plavix into the market from August 2006 onwards <ref>[http://en.sanofi-aventis.com/Images/sanofi_ra06_en_tcm24-17381.pdf Sanofi-Aventis Annual report 2006] pages 5 & 20. Accessed 30th November 2007.</ref>
  
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==Fraud and Lies==
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===Plavix===
 
Plavix works by inhibiting blood clots in order to reduce the risk of strokes and heart attacks. It is distributed by:
 
Plavix works by inhibiting blood clots in order to reduce the risk of strokes and heart attacks. It is distributed by:
 
Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership
 
Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership
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:"BMS is charged with both lying to the federal government and with taking steps to conceal its false statement – both serious felonies," said Thomas O. Barnett, Assistant Attorney General in charge of the Department's Antitrust Division. "The seriousness of the offenses is compounded by the fact that BMS' obstructive conduct occurred in connection with the FTC's review of a proposed patent settlement affecting the cost of a lifesaving drug sold to tens of millions of Americans." <ref>U.S. Department of Justice [http://www.usdoj.gov/atr/public/press_releases/2007/223634.htm ‘Bristol-Myers Squibb pleads guilty to lying to the Federal Government about deal involving blood thinning drug’] 30th May 2007. Accessed 30th November 2007</ref>
 
:"BMS is charged with both lying to the federal government and with taking steps to conceal its false statement – both serious felonies," said Thomas O. Barnett, Assistant Attorney General in charge of the Department's Antitrust Division. "The seriousness of the offenses is compounded by the fact that BMS' obstructive conduct occurred in connection with the FTC's review of a proposed patent settlement affecting the cost of a lifesaving drug sold to tens of millions of Americans." <ref>U.S. Department of Justice [http://www.usdoj.gov/atr/public/press_releases/2007/223634.htm ‘Bristol-Myers Squibb pleads guilty to lying to the Federal Government about deal involving blood thinning drug’] 30th May 2007. Accessed 30th November 2007</ref>
  
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===Ketek===
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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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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>. 
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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. 
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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’.
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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’.
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:“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.”
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See [[Sanofi-Aventis Group - Fraudulent Activities]] for further details.
  
 
==Management Committee==
 
==Management Committee==

Revision as of 12:50, 27 December 2007

Sanofi-Aventis describes itself as 'one of the leading pharmaceutical companies worldwide and number 1 in Europe' [1] It was formed in 2004 when Sanofi-Synthélabo purchased Aventis. In 2006 Sanofi-Aventis had '130 sites worldwide and over 30,000 employees engaged in the production of its active ingredients and the manufacture, packaging and distribution of its pharmaceutical products and vaccines'. [2] Sanofi-Aventis Group conducts its business in the United Kingdom through its subsidiaries Aventis Pharma Limited, Sanofi-Synthelabo Ltd, Fisons Limited and May and Baker Limited.[3]

They claim to be a 'socially responsible player in the healthcare sector' with a commitment to ensuring access 'for the most underprivileged populations to vaccines and medicines'[4]

However, they voice concern at the actions of countries who are engaged in trying to reduce the price of pharmaceutical products. Their Annual Report states that the development of generic varieties of medicines and vaccines and the actions of 'certain countries' who try to 'circumvent patent rights to allow their underprivileged populations to gain access to medicines' are 'unfavourable factors' facing the pharmaceutical industry. In the opening statements of their Annual Report, the Chairman and CEO stresses that ensuring intellectual property rights and patents are 'critical issues' facing Sanofi-Aventis both now and in the future. They go on to report how in 2006 they succeeded in imposing a 'preliminary injunction' effectively blocking any new deliveries of a generic version of Plavix into the market from August 2006 onwards [5]

Fraud and Lies

Plavix

Plavix works by inhibiting blood clots in order to reduce the risk of strokes and heart attacks. It is distributed by: Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership Bridgewater, NJ 08807 [6]

The U.S. Department of Justice announced in May 2007 that Bristol-Myers Squibb Company (BMS) had agreed to plead guilty on two violations of the federal False Statements Act and pay a $1 million criminal fine for lying to the federal government about a patent deal involving Plavix. The Department of Justice reported that BMS's illegal actions threatened to reduce competition for the drug Plavix which could have led to a reduction of the cost of blood-thinning drugs sold to heart attack, stroke and other patients.

"BMS is charged with both lying to the federal government and with taking steps to conceal its false statement – both serious felonies," said Thomas O. Barnett, Assistant Attorney General in charge of the Department's Antitrust Division. "The seriousness of the offenses is compounded by the fact that BMS' obstructive conduct occurred in connection with the FTC's review of a proposed patent settlement affecting the cost of a lifesaving drug sold to tens of millions of Americans." [7]

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[8].

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[9].

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.

Management Committee

In their 2006 Annual Report, Sanofi-Aventis list their management committee as follows...[10]

The Annual Report continues by reporting that as of January 2007 Jean-Francois Dehecq takes on the role of Chairman of the Board of Directors.

Sanofi Pasteur is the Vaccines Division of Sanofi-Aventis [11]

Affiliations

Sanofi-Aventis is a client of Intangible Business [12]

In November 2006, Pharmafocus [13] report that Sanofi-Aventis 'has retained the agency Euro RSCG Life to promote two of its major brands around the world, insulin analogue Lantus and anti-thrombosis drug Lovenox/Clexane'. Pharmafocus describle Euro RSCG Life as 'part of the larger Havas group, one of the global giants of the communications industry competing for major accounts from pharma and other blue chip industries'. The report continues by stating that another business unit of the Havas group 'Euro RSCG C&O has also been awarded Sanofi-Aventis' corporate communications account, including internal editorial programmes and publications'.

Sanofi-Aventis claims to have strengthened its presence in the biotechnology area in 2006 through an agreement with Innogenetics and Inserm (through its affiliate Inserm Transfert) for a 2 year joint project in Alzheimer's disease. [14]

They also work in collaborative partnership with the Pediatric Dengue Fever Vaccine Initiative (PDVI), a programe of the International Vaccine Initiative financed by the Bill & Melinda Gates Foundation. [15]

In November 2007 it was announced that Sanofi-Aventis had entered into a global, strategic collaboration with Regeneron Pharmaceuticals Inc. 'to discover, develop, and commercialize fully-human therapeutic antibodies utilizing Regeneron’s proprietary VelociSuite of technologies... As part of the research agreement, sanofi-aventis will make an $85 million upfront payment to Regeneron and will fund up to $475 million of research over the next five years.[16] Smartbrief continues by reporting that 'Sanofi-Aventis will also increase its ownership of Regeneron’s outstanding common stock from approximately 4 percent to approximately 19 percent by purchasing 12 million newly issued shares of Regeneron common stock'.

Shareholders

L'Oreal & Total oil company [17]

Patient Groups

In July 2007, Sanofi-Aventis (UK) report current partnerships with the following organisations... [18]

Contact

Media Relations contact… Jean-Marc Podvin. Sanofi-Aventis, Press Relations Department, 174 Avenue de France, 75013 Paris, France.

Email: media-relations@sanofi-aventis.com Telephone: + 33 (0)1 53 77 42 23 Fax: +33 (0)1 53 77 42 65

Sanofi-Aventis in the UK

Registered address - Aventis House, 50 Kings Hill Avenue, Kings Hill, West Malling, Kent ME19 4AH

Trading address - 1 Onslow Street, Guildford, Surrey GU1 4YS.

References

  1. ↑ Sanofi-Aventis Annual report 2006 page 1. Accessed 30th November 2007.
  2. ↑ Sanofi-Aventis Annual report 2006 Page 24. Accessed 30th November 2007.
  3. ↑ Welcome to the sanofi-aventis group in the United Kingdom, accessed 12 December 2007
  4. ↑ Sanofi-Aventis Annual report 2006 page 1. Accessed 30th November 2007.
  5. ↑ Sanofi-Aventis Annual report 2006 pages 5 & 20. Accessed 30th November 2007.
  6. ↑ Plavix product details Accessed 30th November 2007
  7. ↑ U.S. Department of Justice ‘Bristol-Myers Squibb pleads guilty to lying to the Federal Government about deal involving blood thinning drug’ 30th May 2007. Accessed 30th November 2007
  8. ↑ U.S. Senate Committee on Finance (June 2006) ‘Grassley questions FDA about risks to children, infants in antibiotic drug trials’ Accessed 24th December 2007
  9. ↑ FDA Physician Sentenced for Fraud Accessed 24th December 2007
  10. ↑ Sanofi-Aventis Annual report 2006 Accessed 30th November 2007.
  11. ↑ Sanofi-Aventis Annual report 2006 Page 22. Accessed 30th November 2007.
  12. ↑ Intangible Business website Accessed 30th November 2007.
  13. ↑ Pharmafocus website Accesses 30th November 2007
  14. ↑ Sanofi-Aventis Annual report 2006. Accessed 30th November 2007.
  15. ↑ Sanofi-Aventis Annual report 2006 Page 18. Accessed 30th November 2007.
  16. ↑ http://www.smartbrief.com/news/aaaa/industryBW-detail.jsp?id=7F6F275C-8859-4732-AE08-3BC9CFA13A82 Smartbrief website] Accessed 30th November 2007.
  17. ↑ Abc Money website Accesses 30th November 2007
  18. ↑ Sanofi-Aventis UK Working in Partnership Accessed 15th December 2007
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