Medicines and Healthcare Products Regulatory Industry

Speech delivered on Wed 10th Nov 2004

Mr. Paul Burstow (Sutton and Cheam) (LD):

I thank the hon. Member for Norwich, North (Dr. Gibson) and congratulate him on securing the debate. He has given us the opportunity to explore an important watchdog regulatory function, which perhaps does not get enough attention in the House, although one or two hon. Members question the agency closely about its work. It is useful to have this debate and to have quite a bit of time to go over the details.

I want to pick up on several points. In opening the debate, the hon. Gentleman made some powerful points about the remit and work of the Medicines and Healthcare products Regulatory Agency. He posed important questions, which the Minister needs to answer, about the degree of transparency and the nature of the engagement between the regulatory agency and the industry, and between the agency, consumers and their interests. We need to ensure that the agency is not only seen to be acting in independently, but that it is acting independently. I shall return to that point in a minute.

The hon. Gentleman suggested that there needs to be an inquiry. It is worth noting that the Health Committee is conducting an inquiry into the pharmaceutical industry—it is attempting to paint a very large canvas. I have read the report of some of the evidence sessions that it has conducted so far, and it is clearly looking at the agency's role. Only time will tell whether it concludes that it or someone else needs to do more work and whether it makes specific recommendations about changing the agency and tipping the balance somewhat in favour of the consumer. However, some of the strong points that have been made in the debate lead me to the view that we need to look again at the balance of interests in the agency.

We need to ensure that the public interest is seen to be properly reflected in how medicines are made available to the public. In particular, we need to ensure that the industry is properly involved in the process. We need to consider the large sums that it invests in the development of drugs and in trials and examine how information about such issues is made available in a timely fashion to the regulatory bodies. Furthermore, I take the hon. Gentleman's point that we need to think about how consumer interests are represented. In answers to parliamentary questions, Ministers have rightly made the point that lay people have been involved in the agency since its inception. However, it is important to be clear about how much the lay and consumer interest permeates the whole organisation and its culture. That is the question being asked today and it would be useful to get a response from the Minister.

Reference has already been made to Richard Brook, who served on the Committee on Safety of Medicines working group on SSRIs—selective serotonin reuptake inhibitors. In his evidence, he said:

"The last point I would make, which I think is a very relevant point, is it takes 40 days for the MHRA on average, in the last annual report, to license a drug and yet it takes two years to review antidepressants; and so there is something about the balance that Andrew was talking about that raises a real issue. If it takes eight weeks to get a drug into the market, why does it take two years to sort out its safety afterwards?"

Some may question whether it really takes eight weeks, but it is relevant to note that Risperidone, a strong anti-psychotic drug that caused concern earlier this year—the hon. Member for Newport, West (Paul Flynn) has taken a close interest in anti-psychotic medication—was being used unlicensed in the UK to treat older people with dementia. The relevant Government watchdog received information in 2002 that the risk of strokes was three times higher among older people prescribed this medication, but it finally warned that the drug should not be used only on 9 March 2004. Patients in Canada were warned of the risk of strokes two years earlier. In an answer I received from the Department of Health on 24 March, it was said that:

"The MHRA is represented on the CPMP and its Pharmacovigilance Working Party (PhVWP), which meet monthly and provide a regular forum for discussion of drug safety issues within the European Union. An electronic communication system allows rapid exchange of drug safety information between member states."—[Official Report, 24 March 2004; Vol. 419, c. 825W.]

The point is that mechanisms are supposed to be in place to allow our regulator to be aware at an early stage of concerns and of the weight to be attached to them. The pharmacovigilance working party is apparently in regular video conference contact with the US Food and Drug Administration yet it took two years for our agencies to come to a conclusion that had already been reached across the Atlantic in Canada and the United States, and to take the necessary protective measures. How many elderly people in care homes or elsewhere suffered strokes or great disability or even lost their lives as a result of being prescribed this drug?

Dr. Gibson : Why does the hon. Gentleman think that it takes two years? Where are the pressures?

Mr. Burstow : I am drawing attention to Richard Brook's contribution and the questions he asked about pressures. I was going to end with this point, but it is worth bringing it up now to respond to that question. Brook's argument, which the Minister must address, is that the organisation is risk averse and is constantly looking over its shoulder, fearful of being a victim of legal action or a challenge in the courts for acting peremptorily.

In his evidence to the Select Committee on 14 October, Richard Brook said:

"Every time we made difficult decisions, there was always this issue of: 'We have got to be very careful because the pharmaceutical companies will sue us if we get this wrong; they will take us to court and take us through legal processes'; and it was very clear that the MRHA officials were very mindful of the whole time of that dimension, to my view, more than the dimension of public health and public responsibility of the public."

He continued that

"it is a very difficult thing to be confident about the transparency of the regulator when so many people have got long histories, career histories, in the pharmaceutical company."

That pressure, real or imagined, is clearly having an effect—certainly in Mr. Brook's view.

Dr. Gibson : Is the hon. Gentleman saying that he could never foresee a situation arising in which John Humphrys faced up to Sir John Krebs of the Food Standards Agency and asked, "Come on, have the sheep got BSE?" and Krebs said, "Quite honestly, I really don't know."? Is the Committee on Safety of Medicines so frightened to tell the truth about the accuracy of the data or does it dodge giving any messages at all? Has it ever appeared on Radio 4?

Mr. Burstow : I listen to Radio 4 quite a bit, but not enough to say whether the CSM has appeared on it. The hon. Gentleman's point about a communications director having only recently been appointed says a lot about the organisation's posture. Is it a public-facing organisation or is it an industry-facing organisation? Perhaps it urgently needs to take advantage of that appointment to ensure not only that it informs Members of its work more effectively, but that it makes the public more aware.

To come to my second point, the Government have indicated their willingness in principle for the patient—the consumer—to be much more directly involved in the reporting of adverse reactions, through the yellow card system or a parallel system. That has to be welcome. A number of those who submitted evidence to the Select Committee said that the best way to ensure that more information about adverse reactions was captured in the system would be to involve the person affected directly. The people concerned have the greatest vested interest in reporting, but they are out-with the system.

We know from parliamentary answers that more than 150 people a day are admitted to hospital because of bad reactions to medicine. Approximately 20,000 adverse drug reactions a year are reported to the MHRA and the CSM through the yellow card scheme, of which approximately 3 per cent. are suspected adverse drug reactions with a fatal outcome.

Mr. Iain Luke (Dundee, East) (Lab): The hon. Gentleman is making an important point about communication with individual patients, but does he not also think that the organisation should liaise more closely with the user groups that have sprung up to draw attention to the SSRIs that my hon. Friend the Member for Newport, West mentioned? For instance, the Seroxat group is keen for the new body to take cognisance of its troubles when it regulates new drugs.

Mr. Burstow : The organisation must be seen as genuinely even-handed in its treatment of all parties. It must be more permeable and open to engagement with consumer and interest groups of the kind that the hon. Gentleman mentioned. His point is fair and must be part of any review of how the new body works. That is something that I hope the Select Committee will consider carefully, especially given the recent experiences that the hon. Member for Newport, West described.

I was outlining some of the figures. There were 722 fatal suspected adverse drug reactions in 2003, the last year for which figures are available.

Paul Flynn : Will the hon. Gentleman give way?

Mr. Burstow : Let me finish the figures, then I will be happy to give way. Back in 1997, the figure was 446, so there has been a 62 per cent. increase in the number of reported adverse drug reactions with a fatal outcome. That is a significant increase. Adverse drug reactions make up 6 per cent. of hospital admissions, but they are, according to a study by researchers from the university of Liverpool in the British Medical Journal earlier this year, in most cases avoidable. Nearly 10 per cent. of adverse drug reactions were definitely avoidable through drug treatment procedure that is consistent with knowledge of good medicine practice, whereas nearly two thirds—63 per cent.—were possibly avoidable.

I recently asked a parliamentary question about what plans the Government had to introduce a system to use the yellow card system to learn about correct dosage and prescribing methods, particularly for children. The answer that I received said:

"The yellow card scheme is not designed to enable lessons to be drawn about correct dosage or prescribing methods for medicines for children. There are no plans to introduce a system of learning in this context."—[Official Report, 3 November 2004; Vol. 426, c. 319W.]

However, the research shows clearly that an awful lot of poor prescribing practice results in people being admitted to hospital. Surely the Government have an interest in reducing inappropriate admissions as a result of such prescribing practices. Will the Minister say whether the Government might still consider action on that?

Paul Flynn : I remind the hon. Gentleman of a previous Minister's answer to my question about the number of deaths from a particular drug. He might be pleased to know that the yellow card figure showed that the number of deaths went down last year from 62 to 48. However, the true figure obtained from coroners' courts showed that the number of deaths had risen from 580 to 640. The yellow card scheme has never given anything but a ludicrous underestimate—a snapshot—of the figures. The system has no credibility.

Mr. Burstow : I am not sure that it has no credibility. The hon. Gentleman is right that it is probably not used anything like as much as it should be, and that there is significant under-reporting. The question that I have to ask the Minister—I believe that the hon. Gentleman has also asked it—is how data collected from the system are analysed and used in the public interest, and who has access to them. The Government have said that they are carrying out a review about who might have access to that data and how and when they are used.

That data could and should be a valuable tool. Some 500,000 records are kept of adverse reactions over the years, which researchers should use much more effectively to obtain a much clearer picture of why there are adverse reactions. I accept the hon. Gentleman's point that often only what amounts to the tip of the iceberg is reported, but the data could be used far better, and I hope that the Minister will say where the Government have got to with the review and when they intend to publish its conclusion. I hope that the conclusion will be that the process will be far more transparent and open.

The hon. Member for Norwich, North referred to access to information, and I was struck by some of the comments made during the Select Committee's consideration of the matter about the difference between the attitude in this country to the control of information and access to it by the public and consumer groups and the attitude across the Atlantic in the United States. The Federal Drugs Administration has a website that will put almost all this information into the public domain.

We can access the information on the FDA website, but we cannot see it on a website provided by our own regulatory agency. That is an anomalous position in a world that has the internet, which has no such boundaries. The public should be able to see our own agency providing the same sort of service to them. Will the Minister comment on that?

The problem of capturing only the tip of the iceberg needs to be addressed. The National Audit Office carried out research on this a few years ago and recommended that we need to move from a non-mandatory to a mandatory system of reporting. There is certainly a very powerful case to be made for that. France has a mandatory reporting system. When will the Government decide whether we should move away from the current voluntary arrangements?

The expansion in the number of people who can report—the inclusion of nurses and the plans to include patients—is welcome, but when will the reporting system become mandatory, given that GPs in particular say that one reason why they do not submit yellow cards is that it never comes to mind at the right time? They say that they are not sure what should be reported, that it takes too long to fill out the form, that it is not easy to find a yellow card when necessary, and that reporting generates too much extra work. Those are just some of the reasons that GPs give for not submitting their yellow cards. That cannot be an acceptable basis for a system that should be about giving clinicians information about what works and what is risky.

Dr. Andrew Murrison (Westbury) (Con): Does the hon. Gentleman agree that these vital forms might not be filled out because what is really important is sidelined in the great welter of paperwork with which GPs now have to cope?

Mr. Burstow : The hon. Gentleman makes a very fair point about the ever-growing burden of form filling and paperwork on GPs and others, and about the consequences of the target and tick-box culture that drives that. That means that yellow cards are missed on the radar, which is another reason why they must be made mandatory to ensure that more information is captured.

Only 74 incidents were reported in the first year of the electronic yellow card system, which was introduced back in October 2002. It would be useful if the Minister could tell us what is being done to promote wider use of that service and to publicise it. That uptake is surprisingly low for what should be a much simpler way of providing information to the MHRA.

I want to conclude by mentioning the relationship between the MHRA and the pharmaceutical industry. At the beginning of the year Mr. Brooks said to The Guardian:

"At present the MHRA listens far too closely to the concerns of major pharmaceutical companies and not nearly closely enough to people experiencing side effects from drugs that should be making them better, not worse."

His criticism came two months after he resigned from the MHRA experts group on selective serotonin reuptake inhibitors, claiming that it failed to protect patients from potentially harmful doses of the antidepressant Seroxat.

The debate today is about whether the agency, which is funded solely by the industry, provides the safeguards and reassurance that the public should have about the medicines being made available to them. The hon. Member for Newport, West described in very strong terms the concerns that those outside the agency have about its role. It might be characterised as a paper tiger, or a toothless tiger—he described it as a pussycat.

Whether it is a pussycat or a watchdog, there are serious concerns about the fact that two years are spent on some matters by an agency that can give a licence in 40 days; that will not necessarily carry public confidence. The example of the Food Standards Agency given by the hon. Member for Norwich, North is a good one. It has set a benchmark for credibility and confidence building that other Government agencies should perhaps be trying to reach. We need to maintain confidence so that the industry and the public will benefit, and, as a result, society as a whole will benefit from medicines.