Medicines contribute enormously to the health of the nation. The discovery, development and effective use of drugs have improved many people's quality of life, reduced the need for surgical intervention and the length of time spent in hospital and saved many lives. Our consumption of drugs is vast and is increasing. About 650 million prescriptions are written each year by GPs alone. Medicines cost the NHS in England over £7 billion every year, 80% of which is spent on branded (patented) products. The industry which has produced these drugs has understandably been described as "world class and a jewel in the crown of the UK economy". It is the third most profitable economic activity after tourism and finance. While the United States is the industry's largest market and is the site of most drug research and development, the UK industry, nevertheless, has a remarkably impressive record. It is a centre of world class science, accounting for 10% of global pharmaceutical R&D expenditure. It has been estimated to fund 65% of all health-related R & D in the UK.
However, there are disadvantages in the increasing use of and reliance on medicines. The inappropriate or excessive use of medicines can cause distress, ill-health, hospitalisation and even death. Adverse drug reactions are responsible for about 5% of all admissions to hospitals in the UK.
The interests of pharmaceutical companies and those of the public, patients and the NHS often overlap but they are not identical. For the industry, medical need must be combined with the likelihood of a reasonable return on investment. An effective regulatory regime to ensure that the industry works in the public interest is essential. Unfortunately, the present regulatory system is failing to provide this. The system is at times frustrating, arguably with excessive attention to unimportant detail, but it is, as we describe below, insufficiently effective.
The Department of Health has for too long optimistically assumed that the interests of health and of the industry are as one. This may reflect the fact that the Department sponsors the industry as well as looking after health. The result is that the industry has been left to its own devices for too long. It may be relevant that this is the first major select committee inquiry into the pharmaceutical industry for almost one hundred years - the last was undertaken by the Select Committee on Patent Medicines which reported in August 1914.
The consequences of lax oversight is that the industry's influence has expanded and a number of practices have developed which act against the public interest. The industry affects every level of healthcare provision, from the drugs that are initially discovered and developed through clinical trials, to the promotion of drugs to the prescriber and the patient groups, to the prescription of medicines and the compilation of clinical guidelines. We heard allegations that clinical trials were not adequately designed - that they could be designed to show the new drug in the best light - and sometimes fail to indicate the true effects of a medicine on health outcomes relevant to the patient. We were informed of several high-profile cases of suppression of trial results. We also heard of selective publication strategies and ghost-writing. The suppression of negative clinical trial findings leads to a body of evidence that does not reflect the true risk:benefit profile of the medicine in question. Guidance produced by NICE and others relies on the published evidence. If all the evidence is not published, or if negative findings are hidden, accurate guidance cannot be issued and prescribers cannot make truly evidence-based decisions.
Once licensed, medicines are intensely promoted to prescribers. The very high costs of developing a new drug make it vital that a company recoups its costs as quickly as possibly after licensing. Coupled with company-sponsored information from medical journals and supplements, 'medical education' materials, advertisements and sponsorship to attend conferences, workshops and other events, it is little wonder that prescribing practices are affected. GPs are particular targets; they have more prescribing freedom than hospital specialists and their prescribing practices are not limited to hospital formularies. Promotion of medicines to patients and links between drug companies and patient organisations may add to this problem, leading patients to demand new drugs from their doctors. The problem is far less to do with any particular activity; rather the volume may distort prescribing practice. At the heart of the problem may be the trend for the industry to become ever more driven by its marketing force.
The most immediately worrying consequence of the problems described above is the unsafe use of drugs. Over-prescription of the COX-2 inhibitors, Vioxx and Celebrex, has been linked to thousands of deaths and many more cases of heart failure. These case illustrate a series of failures. Manufacturers are known to have suppressed certain trials for these drugs in the US and may have done the same in the UK. In addition, there were inadequacies in the licensing and post-marketing surveillance procedures and excessive promotion of the drugs to doctors.
What has been described as the 'medicalisation' of society - the belief that every problem requires medical treatment - may also be attributed in part to the activities of the pharmaceutical industry. While the pharmaceutical industry cannot be blamed for creating unhealthy reliance on, and over-use of, medicines, it has certainly exacerbated it. There has been a trend towards categorising more and more individuals as 'abnormal' or in need of drug treatment.
The industry is by no means solely to blame for the difficulties we describe. The regulators and prescribers are also open to criticism. The regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate. The MHRA Chairman stated that trust was integral to effective regulation, but trust, while convenient, may mean that the regulatory process is not strict enough. The organisation has been too close to the industry, a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff. We are concerned that a rather lax regime is exacerbated by the MHRA's need to compete with other European regulators for licence application business.
Inappropriate prescription of medicines by GPs is of particular concern. Some have prescribed SSRIs, for instance, on a grand scale. This is in part due to inadequacies in the education of medical practitioners which has meant that too few non-specialists are able to make objective assessments of the merits of drugs and too many seem not to recognise how little is known about the properties of a drug at the time of licensing, particularly about its adverse consequences. However, many prescribers have behaved responsibly and with restraint, which makes those who have not, all the more culpable. The constraints in place for hospital doctors do not apply to GPs. Drug companies are criticised for giving hospitality and recruiting 'key opinion leaders', but the prescribers must be equally to blame for accepting the hospitality and some 'key opinion leaders' for lending their names to work they did not produce, often for very considerable sums.
The Government, like the MHRA, has tended to assume that all is for the best. It states that there is no better alternative system. We agree: pharmaceutical companies will inevitably continue to be the dominant influence in deciding what research is undertaken and conducting that research, publishing it and providing information to prescribers. This does not, however, mean that no changes are required.
Our recommendations cover several areas of concern, in particular the licensing process. The key to improvement is greater transparency so that medical practitioners, experts and the public can make an independent assessment of the evidence. We welcome the industry's decision to establish a clinical register but it is important that it should be independent. We make recommendations to this effect.
Greater transparency is also fundamental to the medicines regulatory system. There has to be better public access to materials considered by the MHRA prior to licensing.
The aim of new drugs should be real therapeutic benefit for patients. Clinical trials should focus on using health outcomes that are relevant to patients. To achieve this we recommend better communication between the MHRA and companies early in the early stages of the development of a drug. Improvements in the post-licensing surveillance of medicines are also badly needed. This will require systematic appraisals of medicines.
We recommend that more research be undertaken into the adverse effects of drugs, both during drug development and medicines licensing. The Government should, as a matter of urgency, fund research into the costs of drug-induced illness.
We recommend that the MHRA find ways of ensuring greater restraint in medicines promotion, particularly soon after launch. There should also be strengthened guidelines requiring the declaration of links between pharmaceutical companies and patient groups.
In view of the failings of the MHRA, we recommend a fundamental review of the organisation in order to ensure that safe and effective medicines, with necessary prescribing constraints, are licensed.
It is extraordinary that there are stricter controls on hospital specialists prescribing than on GPs. We recommend tougher restrictions be placed on what non-specialists can prescribe and greater vigilance to guard against excessive or inappropriate prescribing. Nurse and pharmacist prescribing will need to be carefully monitored. Doctors, in particular 'key opinion leaders', should be obliged to declare significant sums or gifts they receive as hospitality. Professional bodies should maintain a register of these declarations.
Government has rightly sought to assist industry, but it needs to do more to help pharmaceutical companies conduct research. They have to cope with confusing ethics approval procedures as well as relatively few adequately trained medical researchers or specialist research facilities. The NHS should build on the success of the National Cancer Research Network to facilitate research for other treatments.
The Department of Health has not only to promote the interests of the pharmaceutical industry but also the health of the public and the effectiveness of the NHS. There is a dilemma here which cannot be readily glossed over. The Secretary of State for Health cannot serve two masters. The Department seems unable to prioritise the interests of patients and public health over the interests of the pharmaceutical industry. We therefore recommend that sponsorship of the industry pass from the Department of Health to the Department of Trade and Industry.
The UK pharmaceutical industry is in many ways outstanding. We trust that our recommendations will not only protect health but also help the industry. It is not in the long term interests of the industry for prescribers and the public to lose faith in it. We need an industry which is led by the values of its scientists not those of its marketing force. In making our recommendations we were very impressed by the comments of Sir Richard Sykes:
"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."