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Spotlight falls on MHRA

Timely reform, but will it go far enough?

Poor at communication, questionable integrity, culture of secrecy and a purring pussycat were some of the ways in which the MHRA (Medicines and Healthcare Products Regulatory Agency) was described in an Adjournment Debate in the House of Commons on November 10th. Coincidentally, it was announced that this lamentable body will be reformed, although judgement will be reserved on how effective these reforms are likely to be.

The reforms include barring any members of the MHRA from having links in pharmaceutical companies, the establishment of a new commission to advice the Government on the safety and effectiveness of medicines which would include more lay representation. The aim is to make the body more transparent and responsive to interests other than those of the pharmaceutical industry.

Adjournment debate

Dr. Ian Gibson (Norwich, North) (Lab): The Medicines and Healthcare products Regulatory Agency—MHRA for short, although not many people know what the acronym stands for—is an executive agency of the Department of Health with trading fund status. It replaced or merged with the Medical Devices Agency, or MDA, and the Medicines Control Agency, or MCA, on 1 April 2003.

The MHRA's aims are to ensure that medicines for human use, sold or supplied in the United Kingdom, are of an acceptable standard of safety, quality and efficacy; to ensure that medical devices meet appropriate standards of safety, quality and performance; and to promote the safe use of medicines and devices. That is a sterling task. Its stated objectives are to make a major and effective contribution to public health, to provide authoritative and accessible information, to influence international regulation, to support industry and scientific innovation, to operate a successful and fully integrated business, and to minimise the cost of regulation.

My interest in this area stems from a visit I made to the MHRA during the summer. As a result of that meeting, I felt that not enough people were aware of its work, or of how medicines are regulated. Not enough is being made of its work on public health policy and it could have a far more extensive public profile. I am concerned about the bad press it has attracted recently, which is the result of underlying problems in the organisation and how it functions. Those problems must be addressed before an increasingly bad media reputation damages its future credibility. In short, the agency could be a disaster waiting to happen.

There is nothing more damaging to public trust than a regulatory system that is seen to have no clout, or that seems unwilling to use its power effectively. As the chief executive of the MHRA recently told the Health Committee, "our prime responsibility is to ensure we protect public health".

With that stated priority, and with a forthcoming public health White Paper, it seems timely to take a look at one of the major agencies charged with safeguarding it.

As I said, I decided to raise the issue in Parliament following a visit to the MHRA to see how it works and what it does. I was enthused by the resources and data that its staff had at their fingertips, but thought that much more needed to be made of it. My concern is primarily to raise the profile of the agency and to see it impact more effectively on public health policy.

I have not been impressed by the agency's communication skills since I secured today's debate. Given its recent bad press over issues such as Seroxat and the Chiron flu vaccine, I would have expected it to take the chance to come forward with some positive messages. However, it sent me a briefing that left me with the impression that it is not interested in putting its name out into the world, or simply that it does not know how to do so.

The agency points out in its briefing that it has just appointed a director of communications—a 21st century activity, and I would not argue with the need for it. I hope that the appointment is not merely cosmetic and that it is backed up by a well thought through communications strategy that can help to build public confidence and improve the flow and exchange of information. That is vital, given the growing public perception that the workings of the drugs industry and its regulators are clouded in secrecy and governed by behind-the-scenes manipulation—a well-nurtured view in communities across the country. It is also vital given that the MHRA is the only regulatory agency that is fully industry funded.

It is a difficult task to convince people that a regulator entirely funded by the industry it regulates is completely impartial. That is why transparency should be at the heart of its agenda. The MHRA is gaining a reputation for not giving out information.

Let me put the matter straight: I do not believe anything much that I read in the press, but I have not read any robust replies to the accusations. On 4 October, The Guardian revealed that the relationship between the industry through its organisation, the Association of the British Pharmaceutical Industry, and the regulator might be too close, with evidence of a joint lobbying campaign in Europe, a blueprint by industry for how the MHRA should be run and higher board level representation. Most notoriously, there has been a continuing controversy surrounding the drug Seroxat, the alleged withholding of clinical trial information by GlaxoSmithKline and questionable analysis of the data by the MHRA, as exposed and documented by "Panorama".

It is time for the culture of secrecy to be dealt with. The legal basis for the giving and withholding of information by the MHRA will change with implementation of the Freedom of Information Act 2000, but the damage done by the public believing that they have been lied to or defrauded is extremely difficult to repair. The workings of the agency need to be reviewed thoroughly. There should be more lay involvement on the committees, openly published minutes and a greater engagement with the public.

I should acknowledge that there is lay representation on the Committee on Safety of Medicines, which advises the MHRA and runs the yellow card scheme for reporting suspected adverse drug reactions, in which most GPs are involved. I have examined the system and there are piles of yellow cards. The Government have just announced direct reporting by consumers, but, as Mind has stated, "consumer representation and the championing of consumer rights is not built into the MHRA's structures and processes".

There is a legal requirement to protect genuinely sensitive market information, but sharing information as openly as possible is of optimum importance. People should be able to find out easily what the organisation does, readily access its services and find out what decisions it is taking and how it is taking them. It seems that the MHRA adopts a restrictive approach to sharing information. As the 2003 National Audit Office report on the MCA pointed out, its public profile is weak compared with that of the Food and Drug Administration in the United States of America. That limits its ability to communicate safety messages to the public and engage with them as a source of information on the effects of medicines.

The exemplary model of best practice in this country is the Food Standards Agency, which states on its website that its aims are putting the consumer first, being open and accessible, and being an independent voice. It holds its board meetings and key committee meetings in public, which it advertises well in advance. The independence of the agency is reinforced by its arm's-length relationship with the Government. The FSA website states: "Although the FSA is a Government agency, it works at 'arm's length' from Government because it doesn't report to a specific minister and is free to publish any advice it issues."

Therefore, I am inclined to support Mind on that issue. It calls for a drug regulatory system that puts consumer safety before commercial pressure and cost. Such a system would require agency access to all trial results, which should be put in the domain of researchers and reviewers and, once a drug is licensed, made available to all.

There should also be a well-supported consumer committee and consumer representation on other MHRA committees. Also, membership and operations should be transparent and accountable. People should have no personal—or even non-personal—interest in the industry that they are reviewing and regulating. The information on which decisions are based should be made available in suitable form.

Such a drug regulatory system should have sufficient legal powers to ensure access to all drug trial information and adequate funding to verify the accuracy of that information. It may need enhanced legal powers to obtain the information it needs from companies and better funding to ensure it has the resources to use the information fully, act promptly on it and publicise any safety messages effectively. Trial data should be provided as soon as they are available. Finally, the system should give consumer experience of drugs comparable weighting to information from drug trials.

I am encouraged by initiatives such as the extension of the yellow card system to include direct reporting of adverse effects by patients and the new paediatric medicines initiative, but we probably need an independent inquiry on the workings of the MHRA. That is a priority. I do not in any way want to suggest anything about individuals, but I and others have looked at the records of heads of enforcement who had long careers with GlaxoSmithKline. There is also a head of licensing who held a major post with that firm. We need to ensure that the workings of the agency are investigated externally as independently as possible.

Are the organisation's aims and objectives beyond its means and is it being pulled in too many directions to be effective? Where do its priorities lie in practice? Is it serving commercial interests and arbitrary targets, such as in reclassification, at the cost of public benefit? We need to know. Do the public even know what it is and what it does, or is that brought to their notice only when things go wrong? In fact, do many MPs know about it?

Paul Flynn (Newport, West) (Lab): I congratulate my hon. Friend the Member for Norwich, North (Dr. Gibson) on securing this important debate. I question one thing that he said. When he referred to the credibility of the organisation, one was tempted to ask, "What credibility?" Recent events have proven that it is not a watchdog; it is a pussycat that purrs in front of the pharmaceutical industry and does what it is told. It has an incestuous relationship with the big pharmas and has a close association with the Association of the British Pharmaceutical Industry. It has a disgraceful recent record. We can look with gratitude to the work not of the Medicines and Healthcare products Regulatory Agency in protecting the public, but to people such as Sarah Boseley of The Guardian for her exposé of the organisation, to the television programme "Panorama" and to Richard Brook of Mind, who courageously resigned from the MHRA in disgust at its activities.

It is a matter of enormous importance that, in recent history, the regulator is not protecting the 25,000 people who suffered heart attacks and the 7,000 who died from taking a painkilling drug for arthritics that was withdrawn by Merck Sharpe and Dohme in September after being promoted by the regulator and by organisations that exist to defend arthritics. I had a conversation the day that it was withdrawn with one of the executives of Arthritis Care—a splendid organisation that I have worked with for many years. It has done pioneering work for people with arthritis, particularly in promoting the real beneficial therapies for arthritis such as exercise, losing weight and displacing the pain through coping mechanisms: all the non-drug treatments. On the day that Vioxx was withdrawn, it was interesting that those who should have been defending the patients suggested that those who were taking the drug should not panic. I should have thought that panic was the appropriate response when someone was taking a drug that was likely to kill them.

The organisations advised people not to panic, but to find another drug. Over my lifetime, 50 per cent. of medicinal drugs have had nasty, unpleasant side effects, and the other 50 per cent. have nasty side effects that are yet to be discovered. That has been the continuous history of medicinal drugs over the years. Protection did not come from the MHRA.

Neither did protection come with Seroxat. When business collapsed in the House on one day in March, we had an hour and a half to discuss Seroxat at some length. The contribution of the regulatory body has been derisory. Given the lamentable performance of its group when it gave evidence to the Health Committee, I hope that the Committee will produce a hard-hitting report that will finally put the last nail in the coffin. I do not think that the body can be reformed. We have to set up another. We cannot have the public exposed to the greed of the pharmaceutical industry any longer without protection.

That is not a criticism. My hon. Friend the Member for Norwich, North is a distinguished scientist. There is no criticism of the science and the quality of the miraculous discoveries that have been made over the past 200 years in pharmaceuticals. However, there is serious criticism of the marketing of those products, which has been based at obtaining maximum profits, with only a cursory glance at safety.

Seroxat is a licensed drug that is proved to have significant side effects and to induce suicide, particularly in young people. Data have been held on this since 1990. We now know that the MHRA reviewed it five times and always gave it a clean bill of health. However, that organisation, which treats itself seriously and is proud of its qualifications, held information on Seroxat for 10 years, which suggested that dosages above 20 mg were unnecessary and possibly dangerous. Consequently many people may have been wrongly prescribed. It did not do anything about that until 2003.

We believe that 17,000 people were prescribed doses above that level and advice was given very late in the day to doctors to remind them of the recommended dose. It was not the official watchdog that caused something to be done; it was publicity by energetic, intelligent, resourceful journalists—people we often criticise. The real watchdogs are those journalists and organisations such as Mind. It is not an insignificant consideration that Mind does not take a penny in support or sponsorship from the pharmaceutical industry.

It is interesting that Arthritis Care, which promoted Vioxx over the years, states on its website: "The redevelopment of Arthritis Care's website has been made possible with support from Merck Sharp & Dohme Limited."

The Depression Alliance Cymru takes very little money from the drugs industry, but the Depression Alliance nationally takes 80 per cent. of its funds from the pharmaceutical industry. As far as I can see its mouth has been bandaged against any criticism of any drug. I have never known it to criticise any drug at any time. That incestuous relationship is something else that the Health Committee is examining.

It is almost laughable to see the interests of the members of the MHRA. They will all tell us that they are professional people and that they can be regulators at one moment and servants of the pharmaceutical industry the next. However, it is difficult to believe that they can carry out their jobs independently when we look at the relationship of the committee and its sub-committees with the pharmaceutical industry. In the 2002 annual report, 17 of the 34 members of the main committee declare personal interests, which include receiving travel expenses and fees, employment as consultants and the ownership of shares. Fourteen declare non-personal interests such as the receipt of research grants.

All the main pharmaceutical companies are represented, from AstraZeneca to Roche and the trend continues through the sub-committees of the committee on the safety of medicine. The biological sub-committee has 11 members: 10 of them declare personal interests and three declare non-personal interests. These interests run to several pages. I do not want to weary the Chamber, but the chemistry, pharmacy and standards committee has 14 members, seven declaring personal interests and nine declaring non-personal interests. The pharmacovigilance committee has eight members: two have declared personal interests and six have declared non-personal interests.

The whole body is part of the pharmaceutical industry, an industry that has a dreadful record of overselling its products, of disease mongering, of trying to encourage a therapy culture in society by convincing every human being that for every moment of pain, boredom, distress, anxiety they feel in their life, they should take a pill of some kind. The whole myth has been built up, not to help humanity, but to serve the greedy interests of the pharmaceutical industry. Many of the marvellous advances that have been made have been damaged by the overselling of many dangerous and damaging drugs. The problems that we now have with selective serotonin reuptake inhibitors reveal how the system has not worked in the interests of patients and how the agency has been colonised by the drugs companies, whose commercial interests have been protected as a result.

The agency has shown itself not to be worthy of our respect or of continuing its role. At best, it is ramshackle and ineffective; at worst, it could be corrupt. We cannot give examples by which we can say, "Things haven't happened." I do not think that my hon. Friend the Member for Norwich, North mentioned any names, although I am sorely tempted to. In a newspaper article on 4 October, Sarah Boseley mentioned the name of someone who was in the extraordinary position of advising and serving a drugs company while working for the agency at the same time. That cannot be right. However, the issue would have remained unnoticed had it not been brought to our attention by that newspaper.

Almost everyone in the country relies on medicinal drugs at some time in their lives, and we deserve protection. We deserve a body whose independence is beyond question, but we do not have one now. We have been badly served by the MHRA.

Other MPs spoke in the debate. The full debate can be found at

www.parliament.uk.