Vioxx - Revision history

Claire Robinson at 14:36, 14 January 2010

2010-01-14T14:36:20Z

Marisa de Andrade at 21:35, 17 February 2009

2009-02-17T21:35:13Z

Marisa de Andrade at 21:29, 17 February 2009

2009-02-17T21:29:11Z

Claire Robinson at 18:39, 12 December 2008

2008-12-12T18:39:29Z

Claire Robinson at 18:39, 12 December 2008

2008-12-12T18:39:02Z

Claire Robinson at 18:37, 12 December 2008

2008-12-12T18:37:26Z

Marisa de Andrade at 22:02, 11 December 2008

2008-12-11T22:02:01Z

New page

‘The scale of the [[Vioxx]] case outstrips the Thalidomide scandal that led to the 1968 Medicines Act governing the way in which drugs are regulated. The [[MHRA]] which approves drugs in the UK, has launched an investigation into whether Merck deliberately withheld information on Vioxx when it applied for a British license in 1999….This case highlights the way pharmaceutical companies can distort scientific data on a product to exaggerate its benefits.’ <ref> Frith, M. [http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/exposed-how-drugs-giant-pushed-vioxx-painkiller-503793.html Exposed: how drugs giant pushed Vioxx painkiller] ''The Independent'' Accessed on May,24,2008 </ref>

Vioxx was considered a breakthrough in pain relief for arthritis sufferers as it did not have the same side effects as other drugs. It was classed as one of a new class of anti-inflammatory drugs called COX-2 inhibitors that were not only more effective than traditional painkillers, but had the added bonus of reducing the risk of ulcers and gastric problems. [[Merck]] was competing against Pfizer to bring this product to market as the first of its kind and it is alleged that in its haste for profits, it failed to tell its regulators – the [[FDA]] in America and MHRA in the UK – about known risks. <ref> BBC News [http://news.bbc.co.uk/2/hi/business/7087348.stm Vioxx settlement to total $4.85bn] Accessed on June,30,2008 </ref> Merck apparently knew Vioxx was killing Alzheimer’s patients, but hid this fact from the agencies for years. <ref> What Doctors Don’t Tell You [http://www.wddty.com/03363800369613604925/killer-drug-company-hid-deaths-from-regulator.html Killer Drug: Company hid deaths from regulator] Accessed on June, 23, 2008 </ref> One of Merck’s chief researchers, [[Nancy Santanello]], has admitted the company’s research unit had raised concerns as early as 1998 over the increased risk of heart attacks and strokes, but this data had been suppressed. Merck denies accusations of negligence and claims that it only realised there was a problem with the drug when research showed that its use could significantly increase heart attacks and strokes if taken for 18 months. A member of the MHRA says in Merck’s defence: ‘The adverse reaction with Vioxx only became evident after 18 months and the risk was an increased cardiovascular event. This was a slight risk, but a real risk. It wasn’t showing up if a patient had taken the drug for less than 18 months though, so there is a very fine balance. You have the experts, the scientific experts as employees of the MHRA and those employed on commissions to advise on the work of the MHRA and they only take decisions based on information they receive.' He raised the point that if information is suppressed, there is very little the regulator can do. However, when the regulators became aware of the situation with Vioxx, they neglected to pull the drug from the market. As a result, more than 20 million people worldwide, including 400,000 patients in the UK took Vioxx before Merck withdrew the drug in September 2004.

The focus then turned to the regulator’s role. In America in particular, the FDA was accused of withholding information much like Merck had done. [[David Graham]] from the FDA’s Office of Drug Safety testified before Congress and declared that the agency had also hidden negative data on Vioxx. <ref> Roner, L. [http://www.ethicalcorp.com/content.asp?ContentID=3364 Ethical Corporation: Big Pharma’s House of Cards] Accessed on June,11,2008 </ref> ‘He described a broken system for following up on the safety of drugs once on the market that he says is a direct result of the regulator being too cosy with the pharmaceuticals industry.’ The fact that a member of the FDA openly admits that there is an intimate relationship between the regulator and the industry suggests that there is friction between different departments within the FDA. When Graham and his team concluded the study on Vioxx for example, the Office of New Drugs allegedly pressured him to change his conclusions and recommendations and told him he would not be allowed to present his findings if he did not do as he was told. The FDA demanded that he tampered with figures estimating that users of the drug had suffered at least 38,000 excess heart attacks and sudden cardiac deaths. Graham also received an internal email from the FDA stating that the regulator was ‘not contemplating’ a warning against the use of high-dose Vioxx. <ref> Kay, J.[http://www.wsws.org/articles/2004/nov2004/viox-n22.shtml The Vioxx scandal: damning Senate testimony reveals drug company, government complicity] Accessed on June,3,2008 </ref>
The MHRA licensed Vioxx in the UK in 1999. Five years later when Vioxx was withdrawn by Merck, the EMEA decided to carry out a safety review and the MHRA was investigated by the Health Committee in the House of Commons. In its report, regulatory failure was partially blamed on the regulator’s commitment to serving the industry rather than the public. <ref> House of Commons, Health Committee [www.parliament.the-stationery-office.co.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf- The Influence of the Pharmaceutical industry] Accessed on May, 20, 2008 </ref>

==References==
<references/>

← Older revision		Revision as of 14:36, 14 January 2010
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−	~~==Introduction==~~	+	[[Vioxx]] is a powerful painkiller which was used by thousands of arthritis sufferers until it was withdrawn by its manufacturer Merck in 2004. Studies found that it almost doubled the chance of a patient suffering a heart attack and stroke.<ref> NHS Choices: Behind the Headlines [http://http://www.nhs.uk/news/2008/10October/Pages/Vioxxriskconfirmed.aspx Vioxx Risk Confirmed] Accessed on February,17, 2009.</ref>
−
−	Vioxx is a powerful painkiller which was used by thousands of arthritis sufferers until it was withdrawn by its manufacturer Merck in 2004. Studies found that it almost doubled the chance of a patient suffering a heart attack and stroke.<ref> NHS Choices: Behind the Headlines [http://http://www.nhs.uk/news/2008/10October/Pages/Vioxxriskconfirmed.aspx Vioxx Risk Confirmed] Accessed on February,17, 2009.</ref>

	==Controversy==		==Controversy==

← Older revision		Revision as of 21:35, 17 February 2009
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		+	==Introduction==
		+
		+	Vioxx is a powerful painkiller which was used by thousands of arthritis sufferers until it was withdrawn by its manufacturer Merck in 2004. Studies found that it almost doubled the chance of a patient suffering a heart attack and stroke.<ref> NHS Choices: Behind the Headlines [http://http://www.nhs.uk/news/2008/10October/Pages/Vioxxriskconfirmed.aspx Vioxx Risk Confirmed] Accessed on February,17, 2009.</ref>
		+
		+	==Controversy==
		+
	‘The scale of the [[Vioxx]] case outstrips the Thalidomide scandal that led to the 1968 Medicines Act governing the way in which drugs are regulated. The [[MHRA]] which approves drugs in the UK, has launched an investigation into whether Merck deliberately withheld information on Vioxx when it applied for a British license in 1999….This case highlights the way pharmaceutical companies can distort scientific data on a product to exaggerate its benefits.’ <ref> Frith, M. [http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/exposed-how-drugs-giant-pushed-vioxx-painkiller-503793.html Exposed: how drugs giant pushed Vioxx painkiller] ''The Independent'' Accessed on May,24,2008 </ref>		‘The scale of the [[Vioxx]] case outstrips the Thalidomide scandal that led to the 1968 Medicines Act governing the way in which drugs are regulated. The [[MHRA]] which approves drugs in the UK, has launched an investigation into whether Merck deliberately withheld information on Vioxx when it applied for a British license in 1999….This case highlights the way pharmaceutical companies can distort scientific data on a product to exaggerate its benefits.’ <ref> Frith, M. [http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/exposed-how-drugs-giant-pushed-vioxx-painkiller-503793.html Exposed: how drugs giant pushed Vioxx painkiller] ''The Independent'' Accessed on May,24,2008 </ref>

← Older revision		Revision as of 21:29, 17 February 2009
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	==References==		==References==
	<references/>		<references/>
		+	[[Category:Big Pharma]]

@@ Line 1: / Line 1: @@
 ‘The scale of the [[Vioxx]] case outstrips the Thalidomide scandal that led to the 1968 Medicines Act governing the way in which drugs are regulated. The [[MHRA]] which approves drugs in the UK, has launched an investigation into whether Merck deliberately withheld information on Vioxx when it applied for a British license in 1999….This case highlights the way pharmaceutical companies can distort scientific data on a product to exaggerate its benefits.’ <ref> Frith, M. [http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/exposed-how-drugs-giant-pushed-vioxx-painkiller-503793.html  Exposed: how drugs giant pushed Vioxx painkiller] ''The Independent'' Accessed on May,24,2008 </ref>
-Vioxx was considered a breakthrough in pain relief for arthritis sufferers as it did not have the same side effects as other drugs.  It was classed as one of a new class of anti-inflammatory drugs called COX-2 inhibitors that were not only more effective than traditional painkillers, but had the added bonus of reducing the risk of ulcers and gastric problems.  [[Merck]] was competing against Pfizer to bring this product to market as the first of its kind and it is alleged that in its haste for profits, it failed to tell its regulators – the [[FDA|Food and Drug Administration]] in America and MHRA in the UK – about known risks. <ref> BBC News [http://news.bbc.co.uk/2/hi/business/7087348.stm Vioxx settlement to total $4.85bn] Accessed on June,30,2008 </ref> Merck apparently knew Vioxx was killing Alzheimer’s patients, but hid this fact from the agencies for years. <ref> What Doctors Don’t Tell You [http://www.wddty.com/03363800369613604925/killer-drug-company-hid-deaths-from-regulator.html  Killer Drug: Company hid deaths from regulator] Accessed on June, 23, 2008 </ref>
+Vioxx was considered a breakthrough in pain relief for arthritis sufferers as it did not have the same side effects as other drugs.  It was classed as one of a new class of anti-inflammatory drugs called COX-2 inhibitors that were not only more effective than traditional painkillers, but had the added bonus of reducing the risk of ulcers and gastric problems.  [[Merck]] was competing against Pfizer to bring this product to market as the first of its kind and it is alleged that in its haste for profits, it failed to tell its regulators – the [[Food and Drug Administration|FDA]] in America and MHRA in the UK – about known risks. <ref> BBC News [http://news.bbc.co.uk/2/hi/business/7087348.stm Vioxx settlement to total $4.85bn] Accessed on June,30,2008 </ref> Merck apparently knew Vioxx was killing Alzheimer’s patients, but hid this fact from the agencies for years. <ref> What Doctors Don’t Tell You [http://www.wddty.com/03363800369613604925/killer-drug-company-hid-deaths-from-regulator.html  Killer Drug: Company hid deaths from regulator] Accessed on June, 23, 2008 </ref>
 One of Merck’s chief researchers, [[Nancy Santanello]], has admitted the company’s research unit had raised concerns as early as 1998 over the increased risk of heart attacks and strokes, but this data had been suppressed.  Merck denies accusations of negligence and claims that it only realised there was a problem with the drug when research showed that its use could significantly increase heart attacks and strokes if taken for 18 months.

@@ Line 1: / Line 1: @@
 ‘The scale of the [[Vioxx]] case outstrips the Thalidomide scandal that led to the 1968 Medicines Act governing the way in which drugs are regulated. The [[MHRA]] which approves drugs in the UK, has launched an investigation into whether Merck deliberately withheld information on Vioxx when it applied for a British license in 1999….This case highlights the way pharmaceutical companies can distort scientific data on a product to exaggerate its benefits.’ <ref> Frith, M. [http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/exposed-how-drugs-giant-pushed-vioxx-painkiller-503793.html  Exposed: how drugs giant pushed Vioxx painkiller] ''The Independent'' Accessed on May,24,2008 </ref>
-Vioxx was considered a breakthrough in pain relief for arthritis sufferers as it did not have the same side effects as other drugs.  It was classed as one of a new class of anti-inflammatory drugs called COX-2 inhibitors that were not only more effective than traditional painkillers, but had the added bonus of reducing the risk of ulcers and gastric problems.  [[Merck]] was competing against Pfizer to bring this product to market as the first of its kind and it is alleged that in its haste for profits, it failed to tell its regulators – the [[FDA]] in America and MHRA in the UK – about known risks. <ref> BBC News [http://news.bbc.co.uk/2/hi/business/7087348.stm Vioxx settlement to total $4.85bn] Accessed on June,30,2008 </ref> Merck apparently knew Vioxx was killing Alzheimer’s patients, but hid this fact from the agencies for years. <ref> What Doctors Don’t Tell You [http://www.wddty.com/03363800369613604925/killer-drug-company-hid-deaths-from-regulator.html  Killer Drug: Company hid deaths from regulator] Accessed on June, 23, 2008 </ref> One of Merck’s chief researchers, [[Nancy Santanello]], has admitted the company’s research unit had raised concerns as early as 1998 over the increased risk of heart attacks and strokes, but this data had been suppressed.  Merck denies accusations of negligence and claims that it only realised there was a problem with the drug when research showed that its use could significantly increase heart attacks and strokes if taken for 18 months. A member of the MHRA says in Merck’s defence: ‘The adverse reaction with Vioxx only became evident after 18 months and the risk was an increased cardiovascular event. This was a slight risk, but a real risk. It wasn’t showing up if a patient had taken the drug for less than 18 months though, so there is a very fine balance. You have the experts, the scientific experts as employees of the MHRA and those employed on commissions to advise on the work of the MHRA and they only take decisions based on information they receive.' He raised the point that if information is suppressed, there is very little the regulator can do. However, when the regulators became aware of the situation with Vioxx, they neglected to pull the drug from the market. As a result, more than 20 million people worldwide, including 400,000 patients in the UK took Vioxx before Merck withdrew the drug in September 2004.
+One of Merck’s chief researchers, [[Nancy Santanello]], has admitted the company’s research unit had raised concerns as early as 1998 over the increased risk of heart attacks and strokes, but this data had been suppressed.  Merck denies accusations of negligence and claims that it only realised there was a problem with the drug when research showed that its use could significantly increase heart attacks and strokes if taken for 18 months.
-The focus then turned to the regulator’s role. In America in particular, the FDA was accused of withholding information much like Merck had done. [[David Graham]] from the FDA’s Office of Drug Safety testified before Congress and declared that the agency had also hidden negative data on Vioxx. <ref> Roner, L. [http://www.ethicalcorp.com/content.asp?ContentID=3364  Ethical Corporation: Big Pharma’s House of Cards] Accessed on June,11,2008 </ref> ‘He described a broken system for following up on the safety of drugs once on the market that he says is a direct result of the regulator being too cosy with the pharmaceuticals industry.’  The fact that a member of the FDA openly admits that there is an intimate relationship between the regulator and the industry suggests that there is friction between different departments within the FDA. When Graham and his team concluded the study on Vioxx for example, the Office of New Drugs allegedly pressured him to change his conclusions and recommendations and told him he would not be allowed to present his findings if he did not do as he was told.  The FDA demanded that he tampered with figures estimating that users of the drug had suffered at least 38,000 excess heart attacks and sudden cardiac deaths. Graham also received an internal email from the FDA stating that the regulator was ‘not contemplating’ a warning against the use of high-dose Vioxx. <ref> Kay, J.[http://www.wsws.org/articles/2004/nov2004/viox-n22.shtml  The Vioxx scandal: damning Senate testimony reveals drug company, government complicity] Accessed on June,3,2008 </ref>
+The focus then turned to the regulator’s role. In America in particular, the FDA was accused of withholding information much like Merck had done. [[David Graham]] from the FDA’s Office of Drug Safety testified before Congress and declared that the agency had also hidden negative data on Vioxx. <ref> Roner, L. [http://www.ethicalcorp.com/content.asp?ContentID=3364  Ethical Corporation: Big Pharma’s House of Cards] Accessed on June,11,2008 </ref> ‘He described a broken system for following up on the safety of drugs once on the market that he says is a direct result of the regulator being too cosy with the pharmaceuticals industry.’
 ==References==
 <references/>