Select Committee on Health Fourth Report

9  Conclusions and recommendations

Conclusions

336. The UK-based pharmaceutical industry is large, profitable and highly competitive; it has understandably been described as "world class and a jewel in the crown of the UK economy".[299] The industry has an outstanding record in developing new medicines, and is a major source of funding of medical research. The industry's products include many life-saving and important drugs which greatly benefit many people and contribute substantially to national health.

337. The commercial success of the industry is not in doubt, nor is its ability to produce excellent science and important drugs; however, its ability to put the health of the nation consistently before the needs and expectations of its shareholders may be questioned. The evidence to this inquiry indicated that, in recent years, large pharmaceutical companies have become ever more focused on a marketing-based approach. In our view, this is the source of many of the problems we have identified. However, these problems are global and we received no evidence that the situation in the UK was worse than in other countries.

338. In Chapter 8 we examined the overall influence of the pharmaceutical industry. It is widely welcomed and relied on, but it is also pervasive and persistent. Our over-riding concerns are about the volume, extent and intensity of the industry's influence, not only on clinical medicine and research but also on patients, regulators, the media, civil servants and politicians. This makes it all the more important to examine critically the industry's impact on health and to guard against excessive and damaging dependencies. In some circumstances, one particular item of influence may be of relatively little importance. Only when it is viewed as part of a larger package of influences is the true effect of the company's activity recognised and the potential for distortion seen. The possibility that certain components of any such campaign are covert and their source undeclared is particularly worrying.

339. However, other factors have contributed to the excessive influence this report describes. In many ways, the industry may be seen as a scapegoat for failings elsewhere. For many years it has been left to its own devices. It is worth noting that there has been no Select Committee investigation of the industry since the Select Committee report on patent medicines in 1914. The regulatory system, the medical profession and Government have all failed to ensure that industry's activities are more clearly allied to the interests of patients and the NHS.

340. Our over-arching conclusion is that the UK pharmaceutical industry is in many ways outstanding: it conducts much excellent research, produces products which make a vital contribution to the health of the nation and is of great economic importance; however, for want of critical scrutiny by, and lack of deference and accountability to, the public and public bodies, the industry lacks the discipline and quality control that it needs but cannot itself provide. In particular:

• The influence of the pharmaceutical industry is such that it dominates clinical practice, to an extent that deprives it of independent and constructively critical feedback; this is a discipline it needs and which can help it to improve.
• The industry's complaints of excessive regulation are understandable but self regulation is not at present effective. It could take on greater responsibility for regulation when its activities are fully transparent and effectively audited.
• The regulatory authority, which is responsible for controlling much of the behaviour of the industry has significant failings. Lack of transparency has played a major part in allowing failings to continue. The traditional secrecy in the drug regulatory process has insulated regulators from the feedback that would otherwise check, test and stimulate their policies and performance. Failure can be measured by the MHRA's poor history in recognising drug risks, poor communication and lack of public trust. Regulatory secrecy also underpins publication bias, and other unacceptable practices. The closeness that has developed between regulators and companies has deprived the industry of rigorous quality control and audit.
• Other bodies are in a position to provide feedback and quality control. They include academic, research, clinical and professional institutions, as well as the media and patient groups. However, representatives of these interests have had only limited success in containing excessive industry influence. This can be partly attributed to lack of transparency, limited resources, significant dependency on industry funding, and some conflicts of interest.
• The Government and the EU appear to believe that trade imperatives and health priorities are as one. The evidence received from the Department of Health was remarkable for its denial that any significant conflict between commercial and health objectives might arise that was not properly addressed through existing process and systems. We do not doubt the legitimacy of commercial objectives, the contributions of the pharmaceutical industry to health and the overlap of commercial and health interests, but this inquiry left us in no doubt that the scope for conflict between health and trade interests is huge. We firmly believe that the Department and the MHRA should focus on health priorities.

341. The failings we have described have consequences, in particular:

• The unsafe use of drugs; and
• The increasing medicalisation of society.

These problems have existed in many countries. The UK may have a better record than many others. Drugs have been used unsafely in every country and we have no doubt that the drift towards medicalisation is a global phenomenon.

UNSAFE USE OF DRUGS

342. Unfortunately, a number of drugs which have been licensed and widely prescribed, have produced severe adverse reactions, and in some cases death, in large numbers of people. In this report we have highlighted the problems with SSRIs antidepressants, notably Seroxat, and the COX-2 inhibitors, Vioxx and Celebrex.

343. Problems with these and other drugs have revealed major failings not just in the pharmaceutical industry relating to the design and presentation of clinical trials and the supply of data to the regulator, but also in the regulatory system. The regulator's analysis of trial data and advice to prescribers and patients have been inadequate and its responses to indications of adverse reactions slow. Moreover, some doctors' prescribing habits and their reaction to promotional activity have been unsatisfactory.

344. The regulatory system relies mainly on scrutiny of clinical trials as a condition of drug approval. By emphasising the dominant, distinctive and more appealing characteristics of drug products, this output is inevitably focused on drug use under model and optimal conditions. The evidence overwhelmingly suggests that, under 'normal' conditions, drug problems mainly arise because of failures to understand the significance of their established effects, lack of information and transparency and flaws in communications - often closely related to (quantitatively and qualitatively) excessive promotion.

345. We know that, in the US, the manufacturers of Vioxx and Celebrex did not act in good faith in that they failed to supply all the data in their possession to the regulator at the time of licence application. This may also have been the case in the UK. Whether the MHRA effectively evaluated the benefit : risk profile of these drugs is unclear, as we cannot be certain that all studies were provided during the licensing application.

346. We can be sure, however, that the clinical trials of Seroxat and other SSRI antidepressants were not adequately scrutinised. The failings of Seroxat and other SSRIs should have been picked up by a more careful examination of the evidence presented in the Phase III clinical trials and suitable prescribing advice should have been issued on this basis.

347. Although the case of Seroxat has been described in greater detail elsewhere in this report, it is worth noting here that, in additional information provided to the Committee on the basis of the EWG's report on SSRIs, it has been shown that suicidal thoughts and hostility are twice as common in patients receiving Seroxat in the month following drug withdrawal as in those receiving placebo. Data contained in the licence application itself cited studies in which withdrawal symptoms were common. Yet for years the MHRA maintained that withdrawal symptoms were rare, affecting of the order of 0.1-0.2% of patients. The Agency now acknowledges that 20-30% of patients might experience withdrawal symptoms when stopping SSRIs.

348. Prescribers must take their share of the blame for the problems that have resulted from the prescribing of SSRI antidepressants and COX-2 inhibitors. There is no doubt that these medicines have been indiscriminately prescribed on a grand scale. This is partly attributable to intensive promotional activity, especially around the time of drug launch, but also the consequence of data secrecy and uncritical acceptance of drug company views. It seems that intensive marketing has worked to persuade too many professionals that they can prescribe with impunity. There is a huge variation in prescribing, even within a limited area. That many acted cautiously makes those who did not more open to criticism. There is a lack of any effective mechanism for tempering the prescribing explosion often seen in the months following a product launch. We have been told time and again that this is the most important period in drug promotion terms, but is also the time when least is known about the product (see Recommendations in Paragraph 358).

349. Such problems are compounded by an excessive reliance on results from pre-marketing clinical trials, together with a failing system of pharmacovigilance. The lack of pro-active and systematic monitoring of drug effects and health outcomes in normal clinical use is worrying. Improvements in post-marketing surveillance are clearly needed and would, no doubt, have led to the earlier detection of problems with SSRI antidepressants, COX-2 inhibitors and other drugs.

MEDICALISATION OF SOCIETY: 'A PILL FOR EVERY ILL'

350. A major and recurring issue raised during the inquiry is the increased 'medicalisation' of our society - the pill for every problem. With over-the-counter statins now promoted for all men over the age of 55, for example, and a vast array of preventative treatments and supplements, it is easy to believe that everybody will be self-medicating every day in the near future. We were pleased that Lord Warner seemed to share our concerns in this regard:

Certainly, if I may put it this way, as a citizen and a father, I have some concerns that sometimes we do, as a society, wish to put labels on things which are just part and parcel of the human condition[300]

351. The belief that every problem may be solved with medication seems particularly relevant in the context of antidepressants. While we readily accept that antidepressants can be effective medicines and have been successfully used by many patients, it is also clear that SSRIs, in particular, have been over-prescribed to individuals, often with mild forms of depression, who may be distressed by difficult life circumstances. Unhappiness is part of the spectrum of human experience, not a medical condition.

352. This trend has not been created by the pharmaceutical industry but it has been encouraged by it. The industry has acted, in the words of some witnesses, as a "disease-monger", with the aim of categorising an increasing number of individuals as 'abnormal' and thereby requiring (drug) treatment. This process has led to an unhealthy over-reliance on, and an over-use of, medicines. It also diverts resources and priorities from more significant diseases and health problems.

Recommendations

353. The Committee was impressed by the evidence from Sir Richard Sykes. He acknowledged problems, emphasised the industry's underlying strengths and the commitment of its employees, and defined solutions in terms of greater transparency of data and in relationships:

Today the industry has got a very bad name. That is very unfortunate for an industry that we should look up to and believe in, and that we should be supporting. I think there have to be some big changes.[301]

354. In making our recommendations we are conscious of Sir Richard's comments. We trust that they will both benefit health and encourage the development of a more successful and effective pharmaceutical industry. We consider these recommendations under the following headings:

The industry;

The regulatory system;

Prescribers;

Government and the EU.

THE INDUSTRY

Research

355. As we have seen, the industry undertakes much excellent research. However, there are failings which make an objective assessment of the efficacy and safety of drugs more difficult. The situation would be much improved by more transparency. We therefore welcome the pharmaceutical industry's acceptance of the need to establish a register of all clinical trials. The details of the proposed register are not yet clear, but it is essential that it encourages genuine transparency and accountability. We have been told that the results of trials relating to medicines that receive a licence will be posted on the register within a year of launch. We see no reason why such data should not be posted immediately. We are also concerned that the maintenance of the clinical trials register by the pharmaceutical industry itself will not inspire confidence from either the public or healthcare professionals. We recommend that the clinical trials register be maintained by an independent body and the results of all clinical trials data, containing full trials information, be put on the register at launch as a condition of the marketing licence.

356. There are other deficiencies in both the conduct and value of clinical trials. We are particularly concerned that the results obtained in clinical trials do not mimic those likely to occur in routine clinical practice. Thus the true therapeutic value of drugs is hard to assess. Clinical trials have significant limitations. We recommend that the MHRA work with the pharmaceutical industry and outside experts to design clinical trials that establish the real therapeutic value of new medicines using measures that are relevant to patients and public health. Trials should be designed to more accurately predict the performance of drugs in routine clinical settings. We recommend that research ethics committees encourage, where appropriate, the inclusion of comparator drugs and non-drug approaches in the evaluation of proposed clinical trials. Ethics committees should also require applicants to prove that the trial does not duplicate previous research and that results will be published in full.

357. More could be done assist pharmaceutical companies undertake research in the UK. Although the NHS has made progress in facilitating the conduct of medical research by the industry, notably through the UK Clinical Research Collaboration, it does not make it easy enough to conduct clinical trials and may be contributing to the movement of clinical research abroad. We recommend that the NHS take further steps to facilitate the conduct of clinical trials, with each Trust having a single point of contact for the pharmaceutical industry to approach when considering a trial.

Marketing

358. The marketing of medicines is strictly regulated, and sometimes excessively so, but, nevertheless, there are failings. Three are of particular concern. The first relates to the volume of promotional material. The quantity of promotional material that may be given to prescribers is limited only indirectly by the PPRS. Doctors are already deluged with promotional messages following the release of a new medicine, and nurses and pharmacists will increasingly be so in future. In the absence of information from alternative, non-industry sources, prescribing levels of new drugs may be unjustifiably high. The quality of promotional material provided to prescribers is already regulated. We recommend that, in addition, limits be set as to the quantity of material prescribers receive, particularly in the first six months after launch. Less experienced and non-specialist doctors are ill-equipped to cope effectively with the promotional material. The pressure on nurses and pharmacists is likely to intensify as their prescribing powers are further extended. Stricter controls are needed in respect of drug company representatives' promotion of their products to junior doctors and to nurses or pharmacists with new prescribing powers.

359. The second concerns the reporting of illegal marketing practices. Marketing practices that appear to be illegal should be reported by the pharmaceutical industry and others to the MHRA.

360. Thirdly, procedures for investigating complaints about breaches of regulations are too slow, poorly enforced and weakly sanctioned. We recommend a major review of the investigation of complaints to ensure the process is far quicker and that effective sanctions are enforced.

361. One of the few levers the Government has to influence the actions of the pharmaceutical industry is the Pharmaceutical Pricing Regulation Scheme (PPRS). The Scheme makes provision for allowances to companies for marketing, R&D and information. It could be used by the Government to encourage improvements in the behaviour of the industry. The PPRS should be used more effectively to influence the actions of the pharmaceutical industry in the public's interest. When companies are found to be in breach of advertising regulations or to have published misleading findings, the allowance for promotion and research, respectively, provided under the Scheme should be reduced. In addition, rewards for innovation should be limited to those drugs that are proven to offer clinical advantage.

THE REGULATORY SYSTEM

362. Our inquiry revealed major failing in the regulatory system. The organisation, process and techniques of the MHRA are focussed on bringing drugs to market fast. The stated rationale, that patients benefit from new drugs, is insufficiently qualified by considerations of relative merit or value, or therapeutic need. We have concerns about the licensing process, including the evaluation of clinical trials; the control of marketing; staffing levels, particularly in relation to post-marketing evaluation; the withdrawal of drugs; the Yellow Card system; and licensing related to generics.

363. The process by which drugs are licensed is far from transparent. There is no public access to the data presented by the pharmaceutical companies nor to the assessments undertaken by the MHRA. There is not enough involvement of patients, the public and the wider scientific community, and the Agency does not listen or communicate well. After years of intense secrecy surrounding UK drug regulation, we welcome the MHRA's commitment to improve external communications, and to give patients a greater voice, but we are not convinced that these changes will be sufficient to counter the current inadequate state of affairs. We recommend that the MHRA publishes, in some form of useable database, the material it receives from drug companies and the assessments it sends to advisory bodies at the time it sends them. We welcome the MHRA's plans to include lay members on every MHRA advisory committee, and recommend that these members receive sufficient training and support to allow them to fully contribute to decision making.

364. We are concerned that the MHRA is not permitted to routinely inspect audit reports for compliance with standards of Good Clinical Practice (GCP). The Department of Health should reconsider its agreement to waive powers to inspect, on a routine basis, audit reports of compliance with GCP standards, including standards of patient care. The Department should review all current and proposed standards developed by the International Conference on Harmonisation that impose restrictions on MHRA staff relating to inspection of company-held data and records.

365. The MHRA does not routinely examine raw data submitted with the licence application but is dependent on summaries provided by the applicant. The Expert Working Group on SSRI's report of December 2004 showed that summaries of information may not provide the detail required to assess drug risks adequately. The licensing process relies excessively on the results of trials designed and presented by companies, in the absence of independent input. Trial design and the way in which results are evaluated and reported can obscure negative results. More checks and balances on the part of the regulator would serve to reassure the public of the stringency of the licensing procedure. The MHRA should put in place systematic procedures to randomly audit raw data. The results of such audits should be published. We also recommend that, like the US Food and Drug Administration, the MHRA play a greater role during the early stages of drug development. Guidance should be provided by the MHRA to the industry as to the types of clinical trial likely to prove the degree of therapeutic gain. NICE should also be involved in this process to provide advice on the type of data more likely to lead to the drug being included in NICE guidance.

366. The adverse drug reactions reported in the clinical trials that are considered in the medicines licensing process typically prove unreliable as a guide to routine clinical practice. Moreover, the adverse effects that may be linked to stopping treatment are insufficiently investigated. The MHRA should focus more intensely on updating drug benefit:risk profiles in the Summary of Product Characteristics, following systematic post-marketing review.

367. Despite Prof Kent Woods' dismissal of suggestions that staffing of the MHRA was "woefully under-resourced" we do not believe that the MHRA has sufficient resources for effective post-marketing surveillance. The current process seems to be extremely passive. We therefore recommend that the MHRA employ sufficient numbers of staff to monitor effectively drugs which have been recently licensed. Given the limited value of clinical trials in predicting drug impact in naturalistic settings, the MHRA should investigate options for the development of more effective post-marketing surveillance systems. Consideration should be given to the establishment of post-marketing surveillance and drug safety monitoring systems independently of the Licensing Authority. We also recommend that the MHRA enhances its relicensing procedures five years after launch. During the renewal procedure, the MHRA should again assess in detail the product's efficacy, safety and quality.

368. Drug manufacturers provide less funding for Phase IV trials than for pre-marketing trials, possibly because such avenues of research are not profitable. The types of thorough, comparative studies needed to determine long-term efficacy, tolerance and risk of side-effects in large populations are therefore not undertaken. Independent research into these areas is limited.

369. Overwhelming evidence is required by the regulator before drug warnings are proposed or when drugs may be withdrawn, Only 19 drugs have been withdrawn between 1993 and 2004. On the other hand, medicines can be licensed in the absence of adequate data or investigation into possible adverse reactions and with proof of only limited therapeutic value. We agree that it is in the public interest to allow access to potentially life-saving therapy as quickly as possible, but timely withdrawal or provision of strict guidance on medicines that are dangerous if inappropriately prescribed is an equally life-saving pursuit. We recommend that the MHRA is given the same authority to propose restrictions on drug use as it has when approving drugs.

370. The recent review of the Yellow Card Scheme has led to a welcome increase in public access to information gleaned from the system and to the introduction of pilot schemes of patient reporting of suspected adverse reactions. However, we are concerned that these measures will not address the main failings of the Yellow Card Scheme. The rate of adverse drug effects reported by healthcare professionals is inadequate, and when they are reported they are not always investigated or pursued with sufficient robustness. We recommend that:

• the system of patient reporting to the Yellow Card Scheme be put in place country-wide as soon as possible;
• steps be taken to improve rates of healthcare professional reporting of adverse drug reactions;
• greater efforts be made to investigate signals of possible problems; and
• that maximum transparency be combined with concerted efforts to explain the uncertainties of risk.

371. After a drug is withdrawn for health reasons, there are often a number of questions in the public mind, not least because such cases typically leave behind victims injured by the drug or bereaved relatives of people who suffered fatal reactions to the drug, as well as people who are denied access to a drug they may have found beneficial. A public inquiry could answer such questions as: should the safety problems have been better predicted from the pre-market testing data? Did the regulators get full and appropriate safety and efficacy data from the manufacturer? Was the right judgement made in balancing the risks and benefits of the drug? Could the health problem with the drug have been identified and acted upon earlier? Could and should the drug have been withdrawn earlier? Was sufficient consideration given to the continued provision of the drug for patients who uniquely benefited from it after withdrawal? Such a public inquiry could not only provide understanding and a sense of justice for the public, but equally importantly would ensure that the drug regulatory agency can learn effectively from mistakes and avoid them in the future. We recommend that there should be a public inquiry whenever a drug is withdrawn on health grounds.

372. As we mentioned earlier, Lord Warner told us that he was considering, "some kind of restrictions around the class of doctors who could prescribe particular products for a period of time".[302] We welcome such restrictions. They need to be combined with curbs on the promotion of such products. The intensive marketing which encourages inappropriate prescribing of drugs must be curbed. Present methods of supplying independent information, as described by Lord Warner, are inadequate. We recommend that all the promotional material for a new product be pre-vetted by the MHRA prior to publication, and that consideration be given to limiting those who can prescribe a new drug in the two years following launch. Drug and Therapeutics Committees would be well-placed to implement this. Wider prescribing rights would be permitted once comparative studies, and trials investigating the potential adverse effects of the medicine in large populations, had been undertaken and after formal evaluation of the value of the product in clinical practice had been confirmed by the Licensing Authority and/or NICE.

373. The PMCPA and MHRA do not effectively co-ordinate their work in the assessment and approval of medicines advertising and promotional material. The defences in place against the inappropriate or misleading promotion of medicines are weak. The MHRA, which has admitted it cannot vet all such material, seems reluctant to punish companies that commit offences in the promotion of medicines in a swift and effective manner. Publishing upheld complaints on the MHRA website is an inadequate response; so is forcing companies to make minor changes to their advertising catchphrases. We recommend that the MHRA and the PMCPA better co-ordinate their work relating to the promotion of medicines to avoid duplication. Complaints should be investigated swiftly, particularly when claims for new drugs are involved. When the PMCPA has evidence that a company has breached the regulations it should inform the MHRA of their findings. When companies are found to be in breach of advertising or marketing regulations by the MHRA, we recommend that corrective statements always be required and that such statements are given as much prominence as the original promotional piece. The publication of misleading promotional material is a criminal offence and the punishment should befit such a status.

374. A healthy generics market is important for the NHS and patients. We recommend a systematic review of so-called evergreening and other practices that impede the entry of generic drugs on to the market.

375. The MHRA, like many regulatory organisations, is entirely funded by fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income. This situation has led to concerns that it may lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies. No evidence was submitted with proposals for a better system for funding the MHRA, but it is important to be aware of the dangers of the present arrangements. These dangers make our other recommendations for improving the regulatory system all the more important.

376. During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency's attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA. The earlier review by the National Audit Office was designed expressly to assess the public expenditure aspects of the work of the agency; a more wide-reaching and in-depth review needs to be carried out to determine whether the processes now used for decision-making are adequate and reflect patients' health needs and society's expectations. The following principles should govern the review:

• The need for greater independence from Government
• The need for greater independence from the pharmaceutical industry
• The need for policies of greater transparency and accountability in light of recent freedom of information legislation
• The effectiveness of the post-licensing department and the need for the MHRA to become pro-active rather than re-active
• Scrutiny of the regulatory standards underpinning clinical and non-clinical new drug review
• The reporting and evaluation of adverse drug reactions
• The prioritisation of new marketing applications
• Inclusion of the public in policy-making and implementation

377. Major changes in the functioning of the MHRA after the review has been conducted and its findings implemented should enable it to make the improvements that we have recommended in this report.

MEDICAL PRACTITIONERS

378. Prescription rates and prescribing quality vary considerably between GPs and between clusters of GPs. Although positive changes have occurred since the establishment of PCTs, over-prescribing and inappropriate prescribing are still common in some areas. This has several causes including the difficulty in getting accurate information about the merits of medicines, the influence of promotional material, and failings in education. It is a matter of concern that some GPs and other prescribers are unable to evaluate information independently, recognise and report adverse reactions to drugs, deal with drug company marketing techniques and take evidence-based decisions about drugs. Some medical schools run relevant courses, but we understand that this approach is not widespread. This implies a major deficiency in the education of healthcare professionals. We recommend that all medical students be taught how to judge clinical trial results effectively, recognise adverse drug reactions and deal with drug company representatives. There should be mandatory post-graduate training for all prescribers to keep up-to-date with prescribing changes. In addition, stricter regulation of individual prescriber's practices is required.

379. We recognise the important work done by the Drug and Therapeutics Bulletin, the Cochrane Collaboration, the BNF and the James Lind Library in providing unbiased and independent information on medicines, but we are concerned that there is little independent and easily digestible information reaching (and influencing) busy GPs and other prescribers. Some Drug and Therapeutics Committees create formularies that are used by all hospitals in the relevant Trust and affiliated PCTs. Inclusion in the formulary is strictly controlled by careful evaluation of clinical trials data divided according to an evidence hierarchy. Guidance that is sensitive to local imperatives is needed, which can be provided soon after drug launch and be distributed widely and easily accessible. Such guidance may take the form of leaflets that are produced to explain why caution may be required. The prescription rates of COX-2 inhibitors was far lower in the UCLH Trust we visited and the affiliated PCTs than the national average, and this may be ascribed to the guidance given. This impressive set-up should be replicated in all hospitals where it does not exist as effectively, including those without clinical pharmacologists.

380. There is a lack of consistent and reliable independent advice, information and oversight of prescribers. We recommend that the Department of Health look into ways of making Use of Medicines Committees/Drug and Therapeutics Committees of a uniformly high standard, so that they can reliably carry out this vital educational role. Wherever possible, clinical pharmacologists and specialist pharmacists should be included on such Committees, as should lay representatives. Formularies established in hospital Trusts should be shared with affiliated PCTs with a view to adoption by the entire local health community. Ideally, new drugs should not be prescribed until they have been approved by such a committee. New drugs that might represent significant advances should be fast-tracked through these committees.

381. During our inquiry some witnesses blamed the pharmaceutical companies for giving hospitality to prescribers and for paying what are sometimes significant sums to 'key opinion leaders'; less attention was paid to the fact that the beneficiaries of the hospitality and payments willingly accepted it. Prescribers' evaluation of the merits of drugs may be influenced by the hospitality they receive from pharmaceutical companies. Moreover, in the evaluation of clinical trial information, it may be highly relevant to know of particular investigators' affiliations with the company sponsoring the trial. We were dismayed to find that there is no register of interests to record gifts, hospitality or honoraria received by prescribers. The Royal Colleges and other professional bodies should take greater responsibility for the prescribing standards of their members. We recommend that a register of interests be maintained by the relevant professional bodies (General Medical Council, Royal College of Nursing, Royal Pharmaceutical Society of Great Britain etc), detailing all substantial gifts, hospitality and honoraria received by members. The register should be made available for public inspection. Individual practitioners should be responsible for maintaining their entry on the register. Professional bodies should provide advice to their members about the levels of hospitality and payments that are acceptable.

PATIENTS

382. Many patients want more information about diseases and their treatment. Patient organisations and disease awareness campaigns can be important vehicles for providing such information. In the absence of alternative sources of funding many depend on funding from pharmaceutical companies. Some smaller charities could not survive without it. However, some disease awareness campaigns act as a form of advertising to patients. Guidelines are already in place to ensure that individual medicines are not mentioned in material produced in relation to such campaigns, but the promotional material we requested from several pharmaceutical companies shows that targeting of patients may be a prime objective. Material relating to one brand highlighted the "missing millions" and the need to render them "open to change beliefs" so that they present to their GP. While disease awareness campaigns may be valuable, the presence of company logos and use of tactics such as those described in the marketing campaign analysed for us clearly suggests that these are not merely health promotion tools. We recommend that the current guidelines on disease awareness campaigns be strengthened. When a campaign is sponsored by a company that is developing or marketing a product to treat the condition that is the subject of the campaign, any related literature should carry a statement to this effect.

383. Patient groups, which often depend on funding from the pharmaceutical industry, are not required to make their sources of income, or funding policies, public. We recommend that patient groups be required to declare all substantial sources of funding, including support given in kind, and make such declarations accessible to the public.

NICE

384. NICE carries out valuable work, but it acts too slowly and covers only a proportion of the drugs available. Prescribers may be cautious in prescribing new drugs until guidance has been issued, or they may over-prescribe in the absence of sufficient supporting evidence. There would be great advantages if NICE guidance were issued promptly. The Institute needs to be better informed of medicines that are in the pipeline with a view to directing resources appropriately to accelerate the publication of its guidance. We recognise, however, that the current system of consultation and evaluation is not conducive to speed. We were also pleased to hear from Lord Warner that a more "holistic picture of what is the best therapeutic approach to particular sets of disease conditions" is being encouraged.[303] We recommend increased funding of NICE to allow it to evaluate more medicines more quickly. Consequent improvement in prescribing standards should make such investment cost-effective.

GOVERNMENT AND EU

385. The Government and European Commission see the maintenance of a large and profitable pharmaceutical industry as vital. There are additional measures that the Government could take to encourage it. We have already made recommendations to facilitate clinical trials in the UK. It is also important that it ensures that there are sufficient staff with the right variety of skills needed by the pharmaceutical industry. There is a shortage of chemists, yet some university chemistry departments are closing or under pressure to close. The Government should look at the levels and range of expertise required by the pharmaceutical industry and, with universities, take action to ensure that appropriate numbers and quality of staff are trained.

386. The Government has had considerable success in maintaining a profitable and effective pharmaceutical industry. However, it should also give equal priority to health. This it has not done. Drugs have been too readily licensed and prescribed and iatrogenic disease is an increasing problem. The Government has also done little to curb the increasing 'medicalisation' of society. Indeed it may have encouraged it. There is not and cannot be a pill for every difficulty we face. The prospect of ever more sophisticated drug development implies some urgent need to define the limits of medical intervention.

387. We know too little about the optimal uses and effects of existing drugs and in-depth investigation of existing (off-patent) treatments is uncommon. Considering, for example, the myriad uses of aspirin, many of which were discovered long after the drug was originally available, greater investigation of existing medicines is a worthwhile venture. There is also too little independent research into the use of drugs compared to non-drug approaches. Neither the illness caused by drugs nor the health effects of medicalisation have been adequately investigated.

388. Pharmaceutical companies cannot be expected to undertake in-depth research into these areas. In the absence of other sources of funding this research must be financed by the Government. We recommend that the Government fund:

• A multi-disciplinary investigation of existing medicines, combinations of medicines and medicines use where there is a reluctance of the industry to fund such research;
• Research into the adverse health effects of medicalisation;
• Trials of non-drug approaches to treatment.

389. We recommend that the extent, cost and implications of illness resulting from the use of medicines be systematically investigated by the Department of Health in conjunction with the MHRA.

390. There are a number of specific measures which may help to focus on health priorities. The World Health Organization has recommended that all countries adopt a National Drugs Policy to encourage the availability of medicines to all types of patients, the safety and efficacy of these medicines and their rational use. We recommend that the Government adopt a National Drugs Policy to encourage the availability of medicines to all types of patients, the safety and efficacy of these medicines and their rational use and to ensure that medicines are compared to non-drug approaches.

391. The NHS, despite its size, has no policy on the evaluation of drugs in treatment relative to non-pharmacological approaches. We recommend that the NHS adopt a policy regarding the role of drug treatment in relation to non-drug treatment, emphasising the importance of both approaches.

392. During this long inquiry we have become concerned that there is a fundamental weakness in the Government's dealings with the pharmaceutical industry: that is the Department of Health's dual role in promoting health and acting as 'sponsor' of the industry. These roles have not proved compatible. Health and trade priorities are not always identical and their combination leads to a lack of clarity of focus and commitment to health outcomes. We need a Secretary of State for Health who is not saddled with dual responsibilities, who is not a 'cross-dresser' but who puts health priorities first. We recommend that responsibility for representing the interests of the pharmaceutical industry should move into the remit of the Department of Trade and Industry to enable the Department of Health to concentrate solely on medicines regulation and the promotion of health.

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299   PICTF Report 2002 Back

300   Q970 Back

301   Q455 Back

302   Q916 Back

303   Q981 Back

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Prepared 5 April 2005