Healthy Skepticism Library item: 9347

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Kerwin , Robert .
The House of Commons Health Committee: 'The Influence of the Pharmaceutical Industry' -too much too late?
J Psychopharm 2007 Mar; 21:(2):131-133

Abstract: In March of 2005 a long awaited parliamentary Health Committee report was published on the influence of the pharmaceutical industry. This exercise arose because of increasing concern in many quarters about the probity of the pharmaceutical industries’ activities within the UK setting. The report has a good deal to say about the regulatory system. This may not be of direct interest to readers except out of prurience because the committee reserves its most scathing criticism for regulatory practices: to a much sharper degree than the criticism of pharmaceutical companies. The committee insists it has revealed ‘major failings’ in the regulatory system. One particular recommendation which confuses me, and others, is the requirement for stricter auditing of good clinical practice (GCP). It seems that the report cuts little ice at central government level and is unlikely to have any influence at the front line on future practices. Although echoing some concerns, the report didn’t contribute much to current concerns about the pharmaceutical industry. Where this document is of use is that it echoes the belief that training expectations in pharmacology are low and should be improved and this should be achieved without additional interference from the pharmaceutical Industry.

Full text:

In March of 2005 a long awaited parliamentary Health Committee report was published on the influence of the pharmaceutical industry. This exercise arose because of increasing concern in many quarters about the probity of the pharmaceutical industries’ activities within the UK setting. It is worth considering these issues in this journal because a large amount of lobbying of the committee, and evidence heard by the committee, came from psychiatrists and psychopharmacologists who have been publicly sceptical and have campaigned hard in this area (e.g. Healy, 2003; Moncrieff, 2006). I will expand in, a little further detail later, on the primary conclusions of the committee.

But first why do I choose the title ‘too much too late?’ Concerns about the activities of pharmaceutical companies go back many decades. It would probably be difficult to find many clinical academics or any other practitioners who unconditionally favour the activities of drug companies either as scientific collaborators or as consumers of prescription products. The sentiments in this document are by no means new—and some would say inaccurate in parts. A useful and more digestible review of the committee’s sentiments is expressed in a commentary by Angell (2006). In her work she highlights large margins of profit; an average 14% compared with a median of 4.5% for other industries (Fortune 500, 2004). Companies often cite risks taken in drug development as a requirement for these profits but Angell states that ‘A business that is so consistently profitable can hardly be considered risky.’ Angell (2006) also points out the problem of ‘me too’ drugs: the phrase used in the committee report is ‘evergreening’. This is the practice of slightly altering the formulation of a drug to extend the exclusivity of any intellectual properties. Such examples in psychiatry might be rapidly dissolving versions of antipsychotic drugs running out of patent or a slightly different chemical formula from the parent drug, e.g. valproate in the semisodium succinate form. These drugs are never cheaper than the original drugs. Other concerns in this field include marketing and the influence marketing has on practitioners. About one-third of pharma sales revenue apparently goes on marketing and about 14% on actual drug discovery (Henry Kaiser Foundation, 2004). Another problem and conundrum is the concept of ‘education’—all hospitals will be mandated to provide continuing postgraduate education or provide CPD courses. Sponsorship to some level is almost universal and necessary as postgraduate budgets are often very meagre.

Another perceived problem is the influence on governments. This may be particularly severe in the US where industry is allowed to lobby Congress and also provide direct funding to political parties and campaigns (Aaron and Lincoln, 2003).

So what does the actual Health Committee report say?

Its overarching conclusion although somewhat lost in the bulk of the narrative is the clear statement that the UK pharma industry provides outstanding value to patients and practitioners and is the ‘jewel in the crown’ of the UK economy. However, there are some failings.

Research: the committee recommends the establishment of a clinical trials register of pharmaceutical trials and that entry onto a register should be a condition of the marketing licence. In some ways this seems too much too late as such registers probably already do exist. All medicinal trials have to be registered with the MHRA; the centralization of ethics through the COREC system provides a means of registration and the European directive demands trial registration via its EUDRACT system.

The committee also recommends that each Trust has a single point of contact. Again a majority of Trusts already have clinical trial coordinators often through the R & D system.

Stricter controls are asked for with respect to promoting products, particularly to new prescribers. However the ABPI has a self-regulating code of conduct in place already.

One recommendation suggests illegal marketing should be handled by the MHRA and not the ABPI.

The report has a good deal to say about the regulatory system. This may not be of direct interest to readers except out of prurience because the committee reserves its most scathing criticism for regulatory practices: to a much sharper degree than the criticism of pharmaceutical companies. The committee insists it has revealed ‘major failings’ in the regulatory system. One particular recommendation which confuses me, and others, is the requirement for stricter auditing of good clinical practice (GCP). I am facing a random MHRA audit and my understanding is that the powers developed by the International Conference on Harmonization already allows for this. The committee feels that the pharmaco-vigilance duties of the MHRA are ‘woefully under-resourced’ and calls for further government funding.

The committee had a lot to say about marketing, including a recommendation that stricter vetting of materials should be in place, possibly facilitated by local drug and therapeutics committees.

Perhaps one of the most important statements is the recommendation for improved training to medical students and juniors in clinical pharmacology and that training should be mandatory. This is highly relevant to the situation in our speciality and the Colleges’ view of clinical psychopharmacology. It is particularly noteworthy that the report recommends greater involvement of the Royal Colleges in this process. There are many other recommendations relating to the role of NICE, the role of the Trade and Industry department, the government, the EU etc., but I’ll pause here.

So what?

Despite the zealotry for curbing the activities of pharma companies there are others who take a more sanguine view, for example Stano (2000). He cites some widespread misconceptions. He argues that while profits provide a ‘FL’ of controversy they have been the subject of oversimplified accounting assumptions. The 13.3% margin of profits is well below that in other sectors, such as software corporations (22.6%) and the oil industry (15.8%) (Clarkston, 1996).

Anyway, he argues that 90% of all health-care costs are spent in the non-pharmaceutical sectors. The elimination of unproductive spending here is a greater fiscal emergency than spending on drugs. Drugs are also relatively cost effective compared to other non-pharmaceutical costs such as public health promotion and surgery (Flech and Miller, 1999), and Tengs et al. (1995) study of 500 interventions suggests a high potential for substitution of other technologies to drugs in a way that may be cost effective.

What do the ABPI think of the report?

In a press release of April 2005, the industry self-regulatory group, the Association of the British Pharmaceutical Industries (ABPI), wholeheartedly supported and warmly welcomed much of the report but then pointed out some factual errors.

Namely, that ‘consumption of drugs is vast and increasing’.

The UK is at the bottom of the European league in per capita spending on drugs and is stable at 12% of the total NHS bill. ‘The prescribing explosion often seen in the months following launch’. This is a myth. The UK has the lowest take up on any new medicines introduced across Europe. ‘Intensive marketing-encourages inappropriate prescribing’. Surveys say doctors value the educational value of the clinical and product information.

The release goes on to suggest that adoption of the recommendations would have a restrictive effect on prescribing and would be a backward step in the NHS’s bid to prevent disease and raise access to best quality treatment.

What does the government think?

The UK government published its response to the Health Committee Report in 2005. It is a large document at least as lengthy as the report itself. Its responses to the 27 recommendations can be broadly categorized in three ways: frankly disagree, agree but the changes suggested have already been implemented by the Government, agree and the issues will be further analysed. Most responses fall into the first two categories. The broad conclusion is that current practice is already sufficient. Thus:

CONCLUSION The current practice that governs how the government relates to the Pharmaceutical industry and the commitments given in response to the committee’s recommendations can reassure patients that this government is working to provide the innovative and safe medicines that they have the right to expect. It is in the interests of patients, the government, the NHS and the industry to work constructively to ensure that this remains the case in the future. I read this as a brush off.

Some examples

Recommendation 1 — me too drugs should be curbed.

Response — already doing this through the National Prescribing Centres and Medicines Management programme.

Recommendation for a clinical trials register.

Response — already doing this. Clinical trials database and EUDRACT. Adoption of the MHRA under European legislation as the competent authority also the establishment of the European Public Assessment Procedures.

And so it goes on.

Recommendation 5 — limitation of advertising material.

Response — current measures are in place: Medicines (Advertising) Regulations 1994; Standards of Business conduct for NHS and commercial sponsorship 2002; NHS Code of Conduct; Professionals Code of Conduct, e.g. GMC good medical practice; self-regulation through ABPI code of conduct.

Some examples of explicit disagreement.

Recommendation 12 — improve audit regimes and that the MHRA is woefully underfunded.

Response — systems and resources already in place.

Recommendation 18 — a public enquiry be held whenever a drug is withdrawn.

Response — The MHRA is already legally committed to publish an account of the circumstances of all drugs withdrawn within a year of withdrawal.

Recommendation 21 — improve training standards.

Response — current mechanisms are already fit for purpose.

Recommendation 22 — better functions of D & T and formulary committees. No drugs should be prescribed without their approval. Reponse—disagree. NICE, National Prescribing Centre, the BNF and the Drug and Therapeutic Bulletin already provide independent advice.

To conclude it seems that the report cuts little ice at central government level and is unlikely to have any influence at the front line on future practices. Although echoing some concerns, the report didn’t contribute much to current concerns about the pharmaceutical industry. Where it did articulate outright concerns, these did not elicit a response from government that suggested any further change is needed. Too much too late. The surprises in the report were the vehemence with which it attacks the regulatory authorities and the criticism of the blurred and confusing arrangements between the Department of Trade and Industry and the Department of Health.

Where this document is of use is that it echoes the belief that training expectations in pharmacology are low and should be improved starting at Royal College level and that this should be achieved without additional interference from the pharmaceutical Industry.

Statement of interest

I have received research funding from most manufacturers of antipsychotic drugs. I have also accepted honoraria for travel and lecture fees.

References

Aaron C, Lincoln T (2003) The other drug war. Drug companies deploy an army of 675 lobbyists to protect profits. Washington DC Public Citizen Congress Watch, June

Angell M (2004) Excess in the pharmaceutical industry. Canadian Medical Association Journal 12: 1451-1463

Clarkson K W (1996) The effects of research and promotion on rates of return. In Helms R B (ed.), Competitive Strategies in the Pharmaceutical Industry. American Enterprise Institute, Washington DC, pp. 238-268

Fortune 500 (2004) How the industries stack up. Fortune 149: F26

Frech H E III, Miller R D Jr (1999) Productivity of Health Care and Pharmaceuticals. American Enterprise Institute, Washington DC

Government’s Response to the Health Committee’s Report on the Influence of the Pharmaceutical Industry (2005) Her Majesty’s Stationery Office, London

Healy D (2003) In the grip of the python: conflicts at the university industry interface. Science Engineering and Ethics 9: 59-71

Henry J Kaiser Family Foundation (2004) Prescription drug trends-a chart book update. The Foundation 2001, p. 45, available online at: www.keff.org

House of Commons Health Committee (2005) The influence of the Pharmaceutical Industry. Fourth report of session, 2004-2005. The Stationery Office Limited, London

Moncrieff J (2006) Psychiatric drug promotion and the politics of neo-liberalism. British Journal of Psychiatry 188: 301-302

Stano M (2000) Regulating the pharmaceutical industry: who really benefits? American Journal of Managed Care 6: 29-31

Tengs T O, Adams M E, Pliskin J S (1995) Five hundred life saving interventions and their cost-effectiveness. Risk analysis 15: 369-390

Robert Kerwin Professor of Clinical Neuropharmacology, Institute of Psychiatry, London, UK.

Corresponding author: Robert Kerwin, Department of clinical Neuropharmacology, Institute of Psychiatry, London, UK.