| Previous Section | Index | Home Page |
Mr. Lansley: Does the right hon. Gentleman agree that we must be careful about criticising what are described as "me-too" drugs? They may allow incremental improvements in terms of efficacy or dosage. In the industrial context, even where branded drugs have a degree of intellectual property protection, they can disclose further evidence of the benefits of competition, and give us a handle on what would be happening in a more competitive market.
We need not rely on the National Prescribing Centre as a mechanism. We can help NICE to advance the point at which it undertakes multi-technology appraisals, and examine the cost-effectiveness for the NHS of classes of drugs taken together.
Mr. Barron: I do not disagree with that, and I do not think that anyone else would either, although obviously there is the issue of drugs coming on to the market and being patented. I am sure that the issue is considered, but not in the detail that the Committee would have liked. I am pleased that some agreement has been established.
The report also raised the issue of ghost-writing, which relates to cases in which well-known doctors or academics put their names to research articles that they did not write. They may not even have seen the data referred to. The practice was criticised in the report, and has recently received media coverage as well. The evidence taken by the Committee was led in part by the Royal College of Psychiatrists, which submitted written evidence of its concern. Last week I received a letter from its president, Professor Sheila Hollins, who wrote:
"I know that the Health Select Committee, in its report on the influence of the pharmaceutical industry, was very concerned about the failure of drug companies to publish all their findings regarding the efficacy and safety of drugs. This was also the most important issue raised in our submission to the Committee. I am aware that this situation is unlikely to have significantly changed; and many members of this college have grave concerns about the impact of selective publishing upon the trust placed in the pharmaceutical industry by patients and professionals alike."
I have a great deal of trust in the pharmaceutical industry, but I hope that my hon. Friend the Minister will address the issue—highlighted by a recent case—at some stage, if not this afternoon.
The Government's response makes no mention of ghost-writing, and does not respond to the Committee's recommendation that the industry adhere to guidance set out to ensure that publications are produced in a "responsible and ethical manner". Ghost-writing is widely thought to be standard practice in the pharmaceutical industry, as the Committee was told. As I have said, I was not a member at that time. However, witnesses from the industry denied that that was the case.
In the past few months, the media have reported a number of cases of so-called ghost-writing. In the past few days, The Times Higher Education Supplement and The Observer have reported a case in which researchers from Sheffield university, collaborating with a drug company, published findings without full access to the trial data. I do not know all the details, but I have seen the media coverage and I have received e-mails from one of the parties. I should like my hon. Friend to examine the position.
Paragraph 199 of the report states:
"Sir Ian Chalmers recommended that the industry adhere to guidelines set out in Good Publication Practice for Pharmaceutical Companies"
—that was published in 2003, in Current Medical Research and Opinion—
"that aim to ensure that publications are produced in a responsible and ethical manner. They include the need to publish results of all clinical trials of marketed products, and to report them in a balanced and objective manner. Authors should all have access to the statistical reports and data supplementing each publication. These guidelines are clear on the subject of authorship and the role of professional medical writers".
The guidelines are then listed.
I hope that the whole industry, all academics and all clinicians adhere strictly to those guidelines. It does not matter to me at this stage whether they are statutory, but I suspect that if they are not adhered to at some time in the future they may become statutory. We cannot require our clinicians, who work so hard both in hospitals and in primary care, to read everything, or cross-question on everything, that enters their domain. They need information about new drugs coming on to the market and about what they should and should not prescribe. Academics' reports, wherever they are published, should reflect accurately what has happened when a drug has come on to the market.
I would like to move on to another aspect of the report—its coverage of NICE, which the hon. Member for Windsor mentioned a few moments ago. The Select Committee recommended that NICE receive additional funding in order to issue guidance more quickly. Indeed, it recommended increased funding in order to allow NICE to evaluate more medicines more quickly and argued that the consequent improvement in prescribing standards should make NICE cost-effective.
NICE was criticised during the inquiry not for the actual work that it does—I do not think that anyone can criticise NICE for the brilliant work that it does—but in respect of the speed at which it issues guidance. Doctors, patients and the industry agreed that the wait for
8 Dec 2005 : Column 1029
guidance to be issued was unacceptable. We have all heard the comment about the phenomenon known as NICE blight, whereby the NHS will not provide a treatment until it has been approved by the institute. Several witnesses who gave evidence to the Committee referred to it. The more thorough an appraisal, of course, the longer the delay. I spoke earlier about getting the balance right between safety and efficacy, and it is important to recognise that in certain circumstances there can be delays. It is a delicate area, as we must all accept.
The Government have recently looked into the new fast-track system of assessment. Fortuitously, I received a letter from the Department this morning. I had written on behalf of a constituent who had contacted me on 15 November about a life-saving drug called Velcade. I received a reply from the Minister of State, Department of Health, my right hon. Friend the Member for Liverpool, Wavertree (Jane Kennedy), which says:
"A new, rapid process for assessing drugs and other treatments will be launched by NICE to sit alongside its standard process. The process will not be used for all appraisals but will be used initially to produce faster guidance on certain life-saving drugs used in a single disease or condition. NICE's new shorter appraisal process is designed to retain the integrity of its existing methodology but there is scope for NICE appraisals to take a longer track if the complexity of the topic warrants it. Publication of NICE guidance on specific drugs will be brought forward by between 6–15 months from the time originally planned. Work is starting immediately on five products, including Velcade"—
as my constituent will be pleased to hear. It continues:
I am very pleased about that, as it appears that the Government have seized on the issue. It is difficult on occasions to achieve the right balance, but hon. Members will know that the coverage of drug promotion in the media brings a great deal of pressure on NICE, on clinicians and, indeed, on Ministers. We have seen clear examples of that in recent weeks.
It is a difficult area to balance, but there is an issue about the funding of NICE that the Government did not properly address. It is important to consider how much research it is reasonable for NICE to conduct annually. Somewhere between 200 and 300 medicines and drugs receive a licence every year in this country, and I believe that NICE looks into between 30 and 40 of them. The new process may allow NICE to investigate more. No one would expect all licensed drugs to go through the NICE process, but it would be good if we could get rid of the NICE blight. If that is the intention of the new appraisal process, I am pleased to support it.
The report also suggested that NICE extend its role to give advice to industry on the design of clinical trials likely to yield clear results and to be useful in the production of NICE guidance. That issue was not covered in the Government's response, but I believe that it is a very good idea. On a daily basis in clinical trials, consultants and doctors throughout the country, working alongside the pharmaceutical industry, give advice about what is happening within the NHS. We do not know much about it, as it is not often discussed, but most drugs are developed in situ in our hospitals and sometimes in the primary sector. The more collaborative we can make the process, the better. We want people to have confidence in NICE and what it
8 Dec 2005 : Column 1030
does, so advice from NICE about what is going on in respect of guidelines for treatment, drugs and care is also important. Clearly, the Government and the pharmaceutical industry should look further into that in future.
I have brought up many issues in my speech and I am sure that hon. Members who were Select Committee members at the time will have further issues to debate. The investigation into the pharmaceutical industry—the first since 1914—was wide ranging. I am pleased that the Government responded well in certain respects, but they could have made a fuller response in other respects. My final comment—to the Minister, hon. Members or anyone else who is listening to or reading the debate—is that the Health Committee will be looking into the developments emerging from this report and response for many years to come.
1.46 pm
| Next Section | Index | Home Page |