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I congratulate the Backbench Business Committee, of which I confess I am a member, on providing this opportunity for debate. I have observed that some colleagues have used it extremely well, particularly in the case of my hon. Friend the Member for Devizes (Claire Perry), who spoke so movingly. I...
I congratulate the Backbench Business Committee, of which I confess I am a member, on providing this opportunity for debate. I have observed that some colleagues have used it extremely well, particularly in the case of my hon. Friend the Member for Devizes (Claire Perry), who spoke so movingly. I...
Member
David Amess
(Conservative)
Type
Proceeding contributions
Subjects
Compensation; Defamation; Immobilisation of vehicles; Drugs; Internet; Essex; ADHD; Private sector; Police; Pay; Public sector; Managers; Politics and government; Maldives; Rofecoxib
Date
24 May 2012
Reference
545 cc1351-3
Chamber / Committee
House of Commons chamber
House
House of Commons
To ask the Secretary of State for Health what the cost to the NHS of prescribing the drug Vioxx has been in each of the last two years.
To ask the Secretary of State for Health what the cost to the NHS of prescribing the drug Vioxx has been in each of the last two years.
Asked by
David Amess
(Conservative)
Answered by
Mike O'Brien
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
9 October 2009
For answer on
12 October 2009
Answered on
12 October 2009
The net ingredient cost (NIC) of prescription items written in the United Kingdom and dispensed in the community in England for 2007 and 2008, cannot be reported as the NIC was reimbursed for less than 50 prescription items. Reporting this figure could potentially identify individual patients.
Subjects
Rofecoxib
Date
12 October 2009
Reference
497 c770W; 292312
House
House of Commons
Deposited by
Department of Health
Type
Deposited papers
Author
Department of Health
Committed on
24 February 2009
Received on
24 February 2009
Subjects
Pharmacy; Prescription drugs; Primary care trusts; Prescriptions; Rofecoxib
Date
24 February 2009
Reference
DEP2009-0514
House
House of Commons
(2) how many (a) males and (b) females in each (i) age group and (ii) health authority have been prescribed Vioxx in each year since 1999; and how many in each category have suffered (A) heart attacks and (B) fatal heart attacks while prescribed Vioxx in each such year.
(2) how many (a) males and (b) females in each (i) age group and (ii) health authority have been prescribed Vioxx in each year since 1999; and how many in each category have suffered (A) heart attacks and (B) fatal heart attacks while prescribed Vioxx in each such year.
Asked by
David Amess
(Conservative)
Answered by
Phil Hope
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
9 February 2009
For answer on
11 February 2009
Answered on
24 February 2009
Information is not collected on either the gender or number of people prescribed a medicine, only on the number of prescription items dispensed. Information on the estimated number and net ingredient cost for Vioxx items dispensed in the community in England, by age group, from 1999, when the drug was licensed in the UK, is provided in the following table.Estimated number of prescription items (000s)1 Net ingredient cost
Prescribing activity for individual primary care trusts (PCTs) for 2004—the most recent year reportable prescribing took place, has been placed in the Library. From 2005 to 2007 less than 50 items were dispensed in the community each year in a significant number of PCTs. Releasing actual figures may potentially allow the identification of individual patients. NHS Prescription Services retains these data for 60 months on a rolling basis, therefore this information is not available at PCT level prior to 2004.Information on the number of people who have suffered heart attacks or fatal heart attacks while prescribed Vioxx is not available.
| Estimated number of prescription items (thousand)¹ | Net ingredient cost | ||||
| Children aged under 16 and 16-18 in full-time education | Elderly aged 60 and over | Adults aged 16 to 59 (ex 16-18 in full time education) | Total | NIC (£000) | |
| 1999 | 0.7 | 91.4 | 70.5 | 162.6 | 3,998.5 |
| 2000 | 2.5 | 453.4 | 328.6 | 784.5 | 20,156.0 |
| 2001 | 3.7 | 823.8 | 442.3 | 1,269.8 | 33,691.8 |
| 2002 | 4.7 | 1,170.6 | 605.5 | 1,780.8 | 47,202.8 |
| 2003 | 5.8 | 1,394.4 | 728.4 | 2,128.6 | 57,055.8 |
| 2004 | 5.3 | 1,207.0 | 619 | 1,831.3 | 50,547.0 |
| 2005 | ²— | 0.5 | 0.4 | 0.9 | 21.0 |
| 2006 | ²— | 0.1 | ²— | 0.1 | 2.5 |
| 2007 | ²— | ²— | ²— | ²— | ²— |
| ¹ Estimates are based on a 1 in 20 sample of all exempt prescriptions dispensed by community pharmacists, appliance contractors and dispensing doctors. | |||||
| ² Data have not been reported where 50 or fewer prescription items are estimated to have been dispensed during the period. | |||||
| Source: | |||||
| Prescription Cost Analysis (PCA) data |
Subjects
Rofecoxib
Date
24 February 2009
Reference
488 c667W; 256539
House
House of Commons
To ask the Secretary of State for Health (1) what the cost to the NHS of prescribing the drug Vioxx has been in each year since the drug became available on the NHS;
To ask the Secretary of State for Health (1) what the cost to the NHS of prescribing the drug Vioxx has been in each year since the drug became available on the NHS;
Asked by
David Amess
(Conservative)
Answered by
Phil Hope
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
9 February 2009
For answer on
11 February 2009
Answered on
24 February 2009
Information is not collected on either the gender or number of people prescribed a medicine, only on the number of prescription items dispensed. Information on the estimated number and net ingredient cost for Vioxx items dispensed in the community in England, by age group, from 1999, when the drug was licensed in the UK, is provided in the following table.Estimated number of prescription items (000s)1 Net ingredient cost
Prescribing activity for individual primary care trusts (PCTs) for 2004—the most recent year reportable prescribing took place, has been placed in the Library. From 2005 to 2007 less than 50 items were dispensed in the community each year in a significant number of PCTs. Releasing actual figures may potentially allow the identification of individual patients. NHS Prescription Services retains these data for 60 months on a rolling basis, therefore this information is not available at PCT level prior to 2004.Information on the number of people who have suffered heart attacks or fatal heart attacks while prescribed Vioxx is not available.
| Estimated number of prescription items (thousand)¹ | Net ingredient cost | ||||
| Children aged under 16 and 16-18 in full-time education | Elderly aged 60 and over | Adults aged 16 to 59 (ex 16-18 in full time education) | Total | NIC (£000) | |
| 1999 | 0.7 | 91.4 | 70.5 | 162.6 | 3,998.5 |
| 2000 | 2.5 | 453.4 | 328.6 | 784.5 | 20,156.0 |
| 2001 | 3.7 | 823.8 | 442.3 | 1,269.8 | 33,691.8 |
| 2002 | 4.7 | 1,170.6 | 605.5 | 1,780.8 | 47,202.8 |
| 2003 | 5.8 | 1,394.4 | 728.4 | 2,128.6 | 57,055.8 |
| 2004 | 5.3 | 1,207.0 | 619 | 1,831.3 | 50,547.0 |
| 2005 | ²— | 0.5 | 0.4 | 0.9 | 21.0 |
| 2006 | ²— | 0.1 | ²— | 0.1 | 2.5 |
| 2007 | ²— | ²— | ²— | ²— | ²— |
| ¹ Estimates are based on a 1 in 20 sample of all exempt prescriptions dispensed by community pharmacists, appliance contractors and dispensing doctors. | |||||
| ² Data have not been reported where 50 or fewer prescription items are estimated to have been dispensed during the period. | |||||
| Source: | |||||
| Prescription Cost Analysis (PCA) data |
Subjects
Rofecoxib
Date
24 February 2009
Reference
488 c667W; 256530
House
House of Commons
To ask the Secretary of State for Health what estimate he has made of the number of people who have experienced strokes related to their use of the drug Vioxx.
To ask the Secretary of State for Health what estimate he has made of the number of people who have experienced strokes related to their use of the drug Vioxx.
Asked by
David Amess
(Conservative)
Answered by
Baroness Primarolo
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
9 February 2009
For answer on
11 February 2009
Answered on
23 February 2009
Vioxx (rofecoxib) was one of a relatively new group of anti-inflammatory medicines known as COX-2 selective inhibitors. It was licensed in the United Kingdom and many other countries for the treatment of arthritic conditions - osteoarthritis and rheumatoid arthritis—and also for the short-term treatment of some painful conditions. COX-2 selective inhibitors are effective anti-inflammatory, pain-relieving medicines that are thought to have less risk of gastrointestinal side effects, for example stomach ulcers, than conventional anti-inflammatory medicines.Since 2000, evidence from clinical trials had raised concerns about a possible increased risk of heart attacks and other cardiovascular conditions associated with Vioxx, and the Medicines and Healthcare products Regulatory Agency (MHRA)/Committee on Safety of Medicines (CSM) had continually reviewed the cardiovascular safety of this drug since it was first licensed. The product information for healthcare professionals and patients, which lists all the known side effects of the medicine, was updated on a number of occasions on the basis of emerging evidence, and in accordance with CSM's advice.Data are not available on which to base a valid estimate of the number of heart attacks, strokes and other adverse effects that may have been caused by Vioxx and other COX-2 inhibitors. The underlying medical condition of many patients treated with COX-2 inhibitors means that they are already at higher risk of heart attack and stroke than the rest of the population, and the impact of the COX-2 inhibitor on this risk is not possible to calculate.Since Vioxx was voluntarily withdrawn by the manufacturer in 2004, the safety of other COX-2 inhibitors and traditional anti-inflammatory drugs—non-selective non-steroidal anti-inflammatory drugs (NSAIDs)—has been under continual and intense assessment in the UK and Europe. The latest evidence suggests that both NSAIDs and COX-2 inhibitors might pose a small increased risk of heart attacks or strokes, although the exact level of risk may vary between medicines. The MHRA has widely communicated the latest information and advice for healthcare professionals in letters and bulletins, and other publications through liaison with the British National Formulary and National Prescribing Centre. In addition, product information (including patient information leaflets) has been updated in order to support informed decision-making in relation to the choice of anti-inflammatory medicine.
Subjects
Rofecoxib
Date
23 February 2009
Reference
488 c265-6W; 256532
House
House of Commons
To ask the Secretary of State for Health what estimate he has made of the cost to the NHS of treating those with health impairments resulting from the use of Vioxx in the last 12 months; and if he will make a statement.
To ask the Secretary of State for Health what estimate he has made of the cost to the NHS of treating those with health impairments resulting from the use of Vioxx in the last 12 months; and if he will make a statement.
Asked by
David Amess
(Conservative)
Answered by
Baroness Primarolo
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
9 February 2009
For answer on
11 February 2009
Answered on
23 February 2009
The Department has made no such estimate.
Subjects
Rofecoxib
Date
23 February 2009
Reference
488 c265W; 256531
House
House of Commons
To ask the Secretary of State for Health what discussions (a) he, (b) Ministers in his Department and (c) officials in his Department have had since June 2008 with the US administration on the drug Vioxx; and if he will make a statement.
To ask the Secretary of State for Health what discussions (a) he, (b) Ministers in his Department and (c) officials in his Department have had since June 2008 with the US administration on the drug Vioxx; and if he will make a statement.
Asked by
David Amess
(Conservative)
Answered by
Phil Hope
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
9 February 2009
For answer on
11 February 2009
Answered on
23 February 2009
Neither Ministers nor officials in the Department have held any discussions with the United States Administration on this matter.
Subjects
Rofecoxib
Date
23 February 2009
Reference
488 c265W; 256528
House
House of Commons
To ask the Secretary of State for Health what discussions he has had with the Legal Services Commission since June 2008 on the award of legal aid for actions involving damage to health caused to individuals by the drug Vioxx; and if he will make a statement.
To ask the Secretary of State for Health what discussions he has had with the Legal Services Commission since June 2008 on the award of legal aid for actions involving damage to health caused to individuals by the drug Vioxx; and if he will make a statement.
Asked by
David Amess
(Conservative)
Answered by
Baroness Primarolo
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
11 February 2009
For answer on
23 February 2009
Answered on
23 February 2009
We have had no such discussions. It would be inappropriate for either Ministers or Government officials to intervene in or comment on decisions made about the grant of funding by the independent Legal Services Commission in individual cases. It is important that these decisions are, and are seen to be, free from political and Government influence.[Continued in Column 267W]
Subjects
Compensation; Rofecoxib
Date
23 February 2009
Reference
488 c266W; 257581
House
House of Commons
To ask the Secretary of State for Health with reference to the answer of 17 June 2008, Official Report, column 779, on cardio-vascular incidents, what steps his Department has taken to ensure that the manufacturer of Vioxx fulfils its responsibilities to people in the UK whose health has been seriously...
To ask the Secretary of State for Health with reference to the answer of 17 June 2008, Official Report, column 779, on cardio-vascular incidents, what steps his Department has taken to ensure that the manufacturer of Vioxx fulfils its responsibilities to people in the UK whose health has been seriously...
Asked by
Jenny Willott
(Liberal Democrat)
Answered by
Baroness Primarolo
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
10 December 2008
For answer on
15 December 2008
Answered on
18 December 2008
I refer the hon. Member to the answer given by my hon. Friend the Minister of State, Department of Health, on 16 December 2008, Official Report, column 950.
Subjects
Rofecoxib
Date
18 December 2008
Reference
485 c1107W; 244046
House
House of Commons
I have no such plans. The then Under-Secretary of State for Health, my hon. Friend the Member for Bury, South (Mr. Lewis), met representatives of the company on 10 July 2008 and conveyed to them the concerns expressed by Members.
I have no such plans. The then Under-Secretary of State for Health, my hon. Friend the Member for Bury, South (Mr. Lewis), met representatives of the company on 10 July 2008 and conveyed to them the concerns expressed by Members.
Answered by
Phil Hope
(Labour)
Asked by
Tim Farron
(Liberal Democrat)
Answering body
Department of Health
Type
Oral answers to questions
Whether he plans to meet Merck, Sharpe and Dohme to discuss compensation for those affected by Vioxx.
Subjects
Side effects; Rofecoxib
Date
16 December 2008
Reference
485 c950
Chamber / Committee
House of Commons chamber
House
House of Commons
The hon. Gentleman knows that this is a very complex issue, and I have every sympathy with those UK patients—including his constituent whom he has mentioned—who believe that they have been adversely affected by Vioxx. As the hon. Gentleman knows, I cannot comment on individual cases, but I understand that the case he mentioned is not related to the matter concerning cardiovascular disease. It would be inappropriate for Ministers or Government officials to intervene in, or comment on, any current or potential claims for compensation from the company in question in this country, as they are properly for the legal system. However, patients who believe they have a case are not prevented from taking a test case to a court of law.
The hon. Gentleman knows that this is a very complex issue, and I have every sympathy with those UK patients—including his constituent whom he has mentioned—who believe that they have been adversely affected by Vioxx. As the hon. Gentleman knows, I cannot comment on individual cases, but I understand that the case he mentioned is not related to the matter concerning cardiovascular disease. It would be inappropriate for Ministers or Government officials to intervene in, or comment on, any current or potential claims for compensation from the company in question in this country, as they are properly for the legal system. However, patients who believe they have a case are not prevented from taking a test case to a court of law.
Answered by
Phil Hope
(Labour)
Asked by
Tim Farron
(Liberal Democrat)
Answering body
Department of Health
Type
Oral answers to questions
I thank the Minister for his answer. My constituent, Mr. David Jones of Elterwater, is just one of the many hundreds of innocent UK victims who have suffered severe health problems as a result of taking the anti-arthritis drug Vioxx. Following the landmark victory of Les Thomas in last week's court case in Cambridge and the £4.85 billion settlement already paid to American victims by Merck and Co., will the Government now put pressure on Merck to ensure that all patients whose health has been damaged by Vioxx are given the compensation they deserve?
Subjects
Side effects; Rofecoxib
Date
16 December 2008
Reference
485 c950
Chamber / Committee
House of Commons chamber
House
House of Commons
My hon. Friend speaks with great personal experience, and her question illustrates the complexity of these matters. It must, therefore, be right for it to be up to individual patients who believe that they may have been adversely affected in any such circumstance to make their own decisions about claiming for compensation and pursuing that through the legal system. It is certainly not appropriate for the Government to try to bring pressure to bear on an individual company in the circumstances my hon. Friend describes. These must be matters for clinicians and individual drug companies to decide, and it is for the National Institute for Health and Clinical Excellence to make recommendations as appropriate.
My hon. Friend speaks with great personal experience, and her question illustrates the complexity of these matters. It must, therefore, be right for it to be up to individual patients who believe that they may have been adversely affected in any such circumstance to make their own decisions about claiming for compensation and pursuing that through the legal system. It is certainly not appropriate for the Government to try to bring pressure to bear on an individual company in the circumstances my hon. Friend describes. These must be matters for clinicians and individual drug companies to decide, and it is for the National Institute for Health and Clinical Excellence to make recommendations as appropriate.
Answered by
Phil Hope
(Labour)
Asked by
Anne Begg
(Labour)
Answering body
Department of Health
Type
Oral answers to questions
I wonder where the Minister draws the line on patient responsibility when they may know the potential dangers of a drug but still wish to take it because it is effective. I should declare an interest: I took Vioxx and I found it wonderful. It probably caused an ulcer, but I still agreed with my doctor to continue to take it because of its effectiveness, despite knowing of the risks. It was then withdrawn, so I could no longer do that. Vioxx is not the only such drug; there is also co-proxamol, for example, which has been withdrawn from use, too. It is difficult for people with arthritis or joint pain to find an effective analgesic, because the ones on which they have come to rely have been withdrawn. Nevertheless, many such patients would accept the risks involved in taking those drugs and still take them.
Subjects
Side effects; Rofecoxib
Date
16 December 2008
Reference
485 c950-1
Chamber / Committee
House of Commons chamber
House
House of Commons
I understand the concerns of the hon. Gentleman and other hon. Members. My predecessor met a parliamentary delegation on the matter only this July, so representations have been made. I must emphasise to the hon. Gentleman that it is not appropriate for Ministers or for Government to intervene in, or comment on, a potential claim for compensation that might be carried out in this country and that is properly a matter for the legal system to address. I repeat to him that the Government do not have any ability to bring sanctions to bear on the company that he is describing. If patients believe that they have a case, they are not prevented from taking it forward in a court of law in this country.
I understand the concerns of the hon. Gentleman and other hon. Members. My predecessor met a parliamentary delegation on the matter only this July, so representations have been made. I must emphasise to the hon. Gentleman that it is not appropriate for Ministers or for Government to intervene in, or comment on, a potential claim for compensation that might be carried out in this country and that is properly a matter for the legal system to address. I repeat to him that the Government do not have any ability to bring sanctions to bear on the company that he is describing. If patients believe that they have a case, they are not prevented from taking it forward in a court of law in this country.
Answered by
Phil Hope
(Labour)
Asked by
Norman Lamb
(Liberal Democrat)
Answering body
Department of Health
Type
Oral answers to questions
The Minister's predecessor took a rather different view, and four years ago The Lancet concluded that:"““The licensing of Vioxx and its continued use in the face of unambiguous evidence of harm have been public health catastrophes.””"
This year, a leading US American journal claimed that Merck had drafted ““dozens of research studies”” on Vioxx and then got prestigious doctors to put their names to them—there was ghost-writing, in other words—and had misrepresented data. Given that most of the 400-plus victims of Vioxx in this country were NHS patients, is it not incumbent on the Government to intervene in this scandal and demand that Merck treats British victims in exactly the same way as US victims have been treated in the $4.8 billion settlement from which they have benefited?
Subjects
Side effects; Rofecoxib
Date
16 December 2008
Reference
485 c951
Chamber / Committee
House of Commons chamber
House
House of Commons
I thank the Minister for his answer. My constituent, Mr. David Jones of Elterwater, is just one of the many hundreds of innocent UK victims who have suffered severe health problems as a result of taking the anti-arthritis drug Vioxx. Following the landmark victory of Les Thomas in last week's court case in Cambridge and the £4.85 billion settlement already paid to American victims by Merck and Co., will the Government now put pressure on Merck to ensure that all patients whose health has been damaged by Vioxx are given the compensation they deserve?
I thank the Minister for his answer. My constituent, Mr. David Jones of Elterwater, is just one of the many hundreds of innocent UK victims who have suffered severe health problems as a result of taking the anti-arthritis drug Vioxx. Following the landmark victory of Les Thomas in last week's court case in Cambridge and the £4.85 billion settlement already paid to American victims by Merck and Co., will the Government now put pressure on Merck to ensure that all patients whose health has been damaged by Vioxx are given the compensation they deserve?
Asked by
Tim Farron
(Liberal Democrat)
Answering body
Department of Health
Oral questions - 1st Supplementary
Status
Answered
Answered on
16 December 2008
The hon. Gentleman knows that this is a very complex issue, and I have every sympathy with those UK patients—including his constituent whom he has mentioned—who believe that they have been adversely affected by Vioxx. As the hon. Gentleman knows, I cannot comment on individual cases, but I understand that the case he mentioned is not related to the matter concerning cardiovascular disease. It would be inappropriate for Ministers or Government officials to intervene in, or comment on, any current or potential claims for compensation from the company in question in this country, as they are properly for the legal system. However, patients who believe they have a case are not prevented from taking a test case to a court of law.
Subjects
Side effects; Rofecoxib
Date
16 December 2008
Reference
485 c950
Chamber / Committee
House of Commons chamber
House
House of Commons
I wonder where the Minister draws the line on patient responsibility when they may know the potential dangers of a drug but still wish to take it because it is effective. I should declare an interest: I took Vioxx and I found it wonderful. It probably caused an ulcer, but I still agreed with my doctor to continue to take it because of its effectiveness, despite knowing of the risks. It was then withdrawn, so I could no longer do that. Vioxx is not the only such drug; there is also co-proxamol, for example, which has been withdrawn from use, too. It is difficult for people with arthritis or joint pain to find an effective analgesic, because the ones on which they have come to rely have been withdrawn. Nevertheless, many such patients would accept the risks involved in taking those drugs and still take them.
I wonder where the Minister draws the line on patient responsibility when they may know the potential dangers of a drug but still wish to take it because it is effective. I should declare an interest: I took Vioxx and I found it wonderful. It probably caused an ulcer, but I still agreed with my doctor to continue to take it because of its effectiveness, despite knowing of the risks. It was then withdrawn, so I could no longer do that. Vioxx is not the only such drug; there is also co-proxamol, for example, which has been withdrawn from use, too. It is difficult for people with arthritis or joint pain to find an effective analgesic, because the ones on which they have come to rely have been withdrawn. Nevertheless, many such patients would accept the risks involved in taking those drugs and still take them.
Asked by
Anne Begg
(Labour)
Answering body
Department of Health
Oral questions - Supplementary
Status
Answered
Answered on
16 December 2008
My hon. Friend speaks with great personal experience, and her question illustrates the complexity of these matters. It must, therefore, be right for it to be up to individual patients who believe that they may have been adversely affected in any such circumstance to make their own decisions about claiming for compensation and pursuing that through the legal system. It is certainly not appropriate for the Government to try to bring pressure to bear on an individual company in the circumstances my hon. Friend describes. These must be matters for clinicians and individual drug companies to decide, and it is for the National Institute for Health and Clinical Excellence to make recommendations as appropriate.
Subjects
Side effects; Rofecoxib
Date
16 December 2008
Reference
485 c950-1
Chamber / Committee
House of Commons chamber
House
House of Commons
The Minister's predecessor took a rather different view, and four years ago The Lancet concluded that:"““The licensing of Vioxx and its continued use in the face of unambiguous evidence of harm have been public health catastrophes.””"
This year, a leading US American journal claimed that Merck had drafted ““dozens of research studies”” on Vioxx and then got prestigious doctors to put their names to them—there was ghost-writing, in other words—and had misrepresented data. Given that most of the 400-plus victims of Vioxx in this country were NHS patients, is it not incumbent on the Government to intervene in this scandal and demand that Merck treats British victims in exactly the same way as US victims have been treated in the $4.8 billion settlement from which they have benefited?
The Minister's predecessor took a rather different view, and four years ago The Lancet concluded that:"““The licensing of Vioxx and its continued use in the face of unambiguous evidence of harm have been public health catastrophes.””"
This year, a leading US American journal claimed that Merck had drafted ““dozens of research studies”” on Vioxx and then got prestigious doctors to put their names to them—there was ghost-writing, in other words—and had misrepresented data. Given that most of the 400-plus victims of Vioxx in this country were NHS patients, is it not incumbent on the Government to intervene in this scandal and demand that Merck treats British victims in exactly the same way as US victims have been treated in the $4.8 billion settlement from which they have benefited?
Asked by
Norman Lamb
(Liberal Democrat)
Answering body
Department of Health
Oral questions - Supplementary
Status
Answered
Answered on
16 December 2008
I understand the concerns of the hon. Gentleman and other hon. Members. My predecessor met a parliamentary delegation on the matter only this July, so representations have been made. I must emphasise to the hon. Gentleman that it is not appropriate for Ministers or for Government to intervene in, or comment on, a potential claim for compensation that might be carried out in this country and that is properly a matter for the legal system to address. I repeat to him that the Government do not have any ability to bring sanctions to bear on the company that he is describing. If patients believe that they have a case, they are not prevented from taking it forward in a court of law in this country.
Subjects
Side effects; Rofecoxib
Date
16 December 2008
Reference
485 c951
Chamber / Committee
House of Commons chamber
House
House of Commons
Whether he plans to meet Merck, Sharpe and Dohme to discuss compensation for those affected by Vioxx.
Whether he plans to meet Merck, Sharpe and Dohme to discuss compensation for those affected by Vioxx.
Asked by
Tim Farron
(Liberal Democrat)
Answered by
Phil Hope
(Labour)
Answering body
Department of Health
Oral questions - Lead
Status
Answered
Tabled on
10 December 2008
For answer on
16 December 2008
Answered on
16 December 2008
I have no such plans. The then Under-Secretary of State for Health, my hon. Friend the Member for Bury, South (Mr. Lewis), met representatives of the company on 10 July 2008 and conveyed to them the concerns expressed by Members.
Subjects
Side effects; Rofecoxib
Date
16 December 2008
Reference
485 c950; 243633
Chamber / Committee
House of Commons chamber
House
House of Commons
To ask the Secretary of State for Health with reference to the Answer of 17 June 2008, Official Report, column 799, on cardiovascular incidents, what steps his Department (a) has taken since that Answer and (b) plans to take to ensure that the manufacturer of Vioxx fulfils its responsibilities to...
To ask the Secretary of State for Health with reference to the Answer of 17 June 2008, Official Report, column 799, on cardiovascular incidents, what steps his Department (a) has taken since that Answer and (b) plans to take to ensure that the manufacturer of Vioxx fulfils its responsibilities to...
Asked by
Jenny Willott
(Liberal Democrat)
Answered by
Baroness Primarolo
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
3 December 2008
For answer on
8 December 2008
Answered on
10 December 2008
The Parliamentary Under-Secretary of State for Care Services, met with representatives of Merck Sharpe and Dohme UK Ltd on 10 July 2008 where he highlighted the concerns raised by hon. Members on behalf of their constituents. A representative from Merck and Co., Inc. was also present at that meeting.
Subjects
Rofecoxib
Date
10 December 2008
Reference
485 c169W; 241266
House
House of Commons
To ask the Secretary of State for Health what estimate his Department has made of the number of people in England with increased cardio-vascular risk as a result of using Vioxx.
To ask the Secretary of State for Health what estimate his Department has made of the number of people in England with increased cardio-vascular risk as a result of using Vioxx.
Asked by
Lord Field of Birkenhead
(Labour)
Answered by
Ben Bradshaw
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
3 September 2008
For answer on
10 September 2008
Answered on
10 September 2008
Vioxx (rofecoxib) was one of a group of anti-inflammatory medicines known as COX-2 selective inhibitors. It was licensed in the United Kingdom and many other countries for the treatment of arthritic conditions—osteoarthritis and rheumatoid arthritis—and also for the short-term treatment of some painful conditions. COX-2 selective inhibitors are effective anti-inflammatory, pain-relieving medicines that are thought to have less risk of gastrointestinal side effects, for example stomach ulcers, than conventional anti-inflammatory medicines.Since 2000, evidence from clinical trials had raised concerns about a possible increased risk of heart attacks and other cardiovascular conditions associated with Vioxx, and the Medicines and Healthcare products Regulatory Agency/Committee on Safety of Medicines (CSM) kept the cardiovascular safety of this drug under continual review since it was first licensed. The product information for healthcare professionals and patients, which lists all the known side effects of the medicine, was updated on a number of occasions to better reflect its cardiovascular safety, in accordance with CSM's advice.Data are not available on which to base a valid estimate of the number of people with increased risk of heart attacks, strokes and other adverse cardiovascular effects that may have been associated with Vioxx and other COX-2 inhibitors. The underlying medical condition of many patients treated with COX-2 inhibitors means that they are already at higher risk of heart attack and stroke than the rest of the population, and it is not possible to calculate the impact of the COX-2 inhibitor on this risk. Furthermore, there is insufficient evidence to determine the rate at which cardiovascular risk reduces after cessation of treatment with Vioxx, but there is evidence from one study suggesting that the risk wanes after cessation of therapy, although the exact time course for the reduction in risk is uncertain, and it is not possible to exclude persistence of risk for several months after treatment has stopped.Since Vioxx was voluntarily withdrawn by the manufacturer in 2004, the safety of other COX-2 inhibitors and traditional anti-inflammatory drugs—non-selective non-steroidal anti-inflammatory drugs (NSAIDs)—has been carefully and intensively assessed in the UK and Europe. The latest evidence suggests that both NSAIDs and COX-2 inhibitors are effective painkilling anti-inflammatory treatments but might pose a small increased risk of heart attacks or strokes, although the exact level of risk may vary between medicines. The MHRA has widely communicated the latest information and advice for healthcare professionals in letters and bulletins, and other publications through liaison with the British National Formulary and National Prescribing Centre. In addition, product information for healthcare professionals and patient information leaflets have been updated in order to support informed decision-making in relation to the choice of anti-inflammatory medicine.
Subjects
Rofecoxib
Date
10 September 2008
Reference
479 c1919-20W; 223303
House
House of Commons