Select Committee on Health Fourth Report

Conclusions and recommendations

1.  The industry's ability to compete internationally requires a legislative and organisational framework for research that protects the interests of all stakeholders - patients, researchers and pharmaceutical companies. (Paragraph 43)

2.  Priorities for research into medicines inevitably reflect the interests of the pharmaceutical companies and are not necessarily well aligned with the medical needs of all patients. The industry will continue to undertake the bulk of research in this area, but there are improvements which could be made. We welcome Lord Warner's recognition of this and look forward to his proposals to align more closely the drug companies' research strategies with the public health aims of the NHS. (Paragraph 189)

3.  However it occurs, the presence of many 'me-too' drugs on the market creates difficulties for prescribers and the NHS. Although this is a considerable problem, we were given no obvious solution. We expect that there will continue to be a large number of me-too drugs. The National Prescribing Centre and others should particularly consider issuing independent advice in areas where many 'me-toos' exist. (Paragraph 190)

4.  Much excellent clinical science takes place within the industry and elsewhere, but the current system of clinical testing provides ample opportunities for bias. Too many of these problems appear to persist unnoticed or unacknowledged by the organisations that are central to the co-ordination, conduct and review of the clinical trials. There is a need for more transparency and we welcome the contribution that the proposed clinical trials register should make to this approach. The regulators must check that research is designed to provide objective evidence of a drug's efficacy and safety at the time of licensing. (Paragraph 191)

5.  The aggressive promotion of medicines shortly after launch, the sheer volume of information that is received in its many forms by prescribers and the "promotional hospitality masquerading as education", in the absence of effective countervailing forces, all contribute to the inappropriate prescription of medicines. (Paragraph 232)

6.  Ghost-writing, in conjunction with suppression of negative trial results, is harmful. If prescribers do not have access to fair and accurate accounts of clinical trials they cannot be expected to make informed prescribing decisions. The guidelines on the subject of authorship and the role of professional medical writers quoted in Paragraph 199 must be followed. (Paragraph 233)

7.  The blame for inadequate or misinformed prescribing decisions does not only lie with the pharmaceutical industry, but with doctors and other prescribers who do not keep abreast of medicines information and are sometimes too willing to accept hospitality from the industry and act uncritically on the information supplied by the drug companies (Paragraph 234)

8.  The pharmaceutical industry's promotional efforts are relentless and pervasive. The evidence presented showed the lengths to which the industry goes to ensure that promotional messages reach their targets and that these targets include not only prescribing groups, but patients and the general public. (Paragraph 271)

9.  There is an urgent need for a comprehensive and informative PIL, preferably one which indicates the role of the drug in overall management of the disease. We were advised that patients themselves should be involved in the process of developing such a PIL. The MHRA's Patient Information Working Group is addressing this issue but the group is dominated by professional interests. (Paragraph 272)

10.  DTCA is inappropriate and unnecessary in the UK. The evidence reviewed above on the targeting of prospective patients, and the central emphasis on emotional appeals, leads us to believe that great caution should be exercised in any relaxation of the rules relating to provision of consumer drug information by drug companies. (Paragraph 273)

11.  The existing guidelines on disease awareness campaigns are weak and unmonitored. Drawn up after limited public consultation, they make no strict demands apart from a requirement not to mention brand names. The effectiveness of future guidelines will depend on interpretation, monitoring and enforcement. (Paragraph 274)

12.  We often do not know what funds or support in kind patient groups receive from pharmaceutical companies. Limiting or legislating against such support is not appropriate; this would disadvantage both the charities that rely on industry funding and the industry itself, by cutting off a source of valuable feedback from the eventual consumers of its products. Measures to limit the influence of industry on patient groups are needed, however. Patient groups should declare all significant funding and gifts in kind and the Government should seek to make appropriate changes to charity law to ensure this. It would in any case be greatly preferable if patient groups were funded by companies' charitable arms, rather than by companies themselves. (Paragraph 275)

13.  Post-marketing surveillance in the UK is inadequate. This has several causes: the lack of effective post-marketing investigation of drug benefits and harms in real life situations, and institutional indifference to the experience and reports of medicine users. In addition, the focus on drug licensing and on the safety profiles of individual drugs has contributed to a dearth of information about the overall impact of drug-induced illness in the community. (Paragraph 312)

14.  The reputation and credibility of the MHRA depends on its ability to communicate uniformly with its different stakeholders. These diverging messages contribute to confusion between health and trade priorities (Paragraph 313)

15.  Areas of research that are not of direct interest to the pharmaceutical industry but may significantly benefit patients, such as non-pharmacological treatments, should be funded by Government. (Paragraph 328)

16.  The interests of patients, the NHS and industry can be at odds and we have no confidence that the Department is capable of achieving the balance required. The 'cross-dressing' role of the Department in this regard does not serve the public as well as it should (Paragraph 335)

17.  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. (Paragraph 348)

18.  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. (Paragraph 355)

19.  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. (Paragraph 356)

20.  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. (Paragraph 357)

21.  We recommend that 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. (Paragraph 358)

22.   Marketing practices that appear to be illegal should be reported by the pharmaceutical industry and others to the MHRA. (Paragraph 359)

23.  We recommend a major review of the investigation of complaints (of marketing and advertising practices) to ensure the process is far quicker and effective sanctions are enforced. (Paragraph 360)

24.  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. (Paragraph 361)

25.  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. (Paragraph 363)

26.  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 (Paragraph 364)

27.  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. (Paragraph 365)

28.  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. (Paragraph 366)

29.  We 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. (Paragraph 367)

30.  We recommend that the MHRA is given the same authority to propose restrictions on drug use as it has when approving them. (Paragraph 369)

31.  We recommend that: the system of patient reporting to the Yellow Card Scheme country-wide be put in place as soon as possible; that steps be taken to improve rates of healthcare professional reporting of adverse drug reactions; that 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. (Paragraph 370)

32.  We recommend that there should be a public inquiry whenever a drug is withdrawn on health grounds. (Paragraph 371)

33.  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. (Paragraph 372)

34.  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 its 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. (Paragraph 373)

35.  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. (Paragraph 374)

36.  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; and inclusion of the public in policy-making and implementation (Paragraph 376)

37.  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. (Paragraph 378)

38.  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. (Paragraph 380)

39.  We recommend that a register of interests be maintained by the relevant professional body (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. (Paragraph 381)

40.  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. (Paragraph 382)

41.  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. (Paragraph 383)

42.  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. (Paragraph 384)

43.  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. (Paragraph 385)

44.  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; and trials of non-drug approaches to treatment. (Paragraph 388.)

45.  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. (Paragraph 389)

46.  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. (Paragraph 390)

47.  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. (Paragraph 391)

48.  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. (Paragraph 392)

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