The pharmaceutical industry and the medical profession are uneasy bedfellows as Tom Jaconelli discusses

It would be hard to imagine a functioning healthcare system without medicines.  Even outside the system many of us frequently take over-the-counter drugs for common ailments: in the USA 50 billion aspirin tablets are consumed each year. (1)  Also, it is difficult to think of any kind of human experience that doesn’t come with a health warning. (2) This medicalisation of society explains why pharmaceutical companies such as GlaxoSmithKline and AstraZeneca rank in the top 10 share prices in the UK economy.  However, the nature of pharmaceutical companies as profit-driven businesses in contrast to their role as health providers heralds a seemingly intrinsic problem: is their priority health or wealth?

There are three focal points involved in this situation-the industry, the doctor and the patient.  By regulating each of these it is possible to exercise some control over the situation.  I wish to concentrate on the relationship between the clinician and the pharmaceutical industry, though I will also look briefly at the position of the industry and the patient.

The industry is regulated in the UK by various bodies.  The Association of the British Pharmaceutical Industry (ABPI) is the industry’s trade association and annually publishes codes of practice on how companies should act.  It is worth noting, however, that membership to the ABPI is voluntary.  The Pharmaceutical Price Regulation Scheme (PPRS) which operates under the Department of Health caps the profits companies can make.  Again participation in the scheme is voluntary.  The PPRS says that all scheme members will have a common Return on Capital target of 21%. (3)  These policies should be made mandatory as they are effectively window dressing unless they are explicit and vigorously observed. (4) The National Institute for Clinical Evidence (NICE), as the government’s rationing tool which assesses cost-effectiveness, has since its inception, made pharmaceutical companies more aware of their pricing methods in order to make any new drugs viable in the UK public market.  However, it has its own limitations as not all clinical practice has changed in line with NICE guidance. (5)  NICE needs to do more to increase compliance of its guidelines.

Patients are regulated in various ways as in the UK there is a standard charge for prescriptions, although certain groups such as the elderly are exempt.  It is worth noting that the elderly are the major consumers as they have multiple morbidities.  More recently many prescription-only medicines (POM) have been switched to over-the-counter (OTC) drugs, which shifts expenditure from the public to the private sector.  In the UK patients are, on the whole, not informed about drugs, as new drugs are targeted at doctors, thereby creating a paternalistic relationship between doctor and patient.  However in the USA ‘Direct to consumer advertising’ through the media is commonplace.  Finally, doctors have to abide by budgetary controls.  In the UK this applies both in hospitals and in general practice and limited lists of drugs are produced, effectively limiting the drugs a doctor can prescribe.   

Despite the aforementioned regulatory procedures in place, there are still problems that exist with the direct relationship between the pharmaceutical industry and clinicians.  These interactions are omnipresent and due to vast investment (greater than that spent on the production of medicines) in marketing and the generation, collation and dissemination of medical information. (6)

Clinical Influence
Since commencing my clinical training I have been surprised by the significant amount of contact my colleagues and I have had with the pharmaceutical industry.  Contact includes being given free lunches and gifts such as pens and medical equipment with branded drug names clearly printed on them.

Pharmaceutical companies make themselves known to students in many other ways such as sponsoring medical facilities and lecture halls and subsidising travel to medical events (thereby instilling their names in the minds of students).  Indeed the influence does not stop at undergraduate level.  The widespread influence of drug manufacturers on postgraduate medical education activities makes more stringent regulation necessary. (7) The interesting factor is that many medical students, when asked, express the belief that pharmaceutical industry contact does not have any influence on them.  However social science literature suggests that it would be surprising if doctors were not influenced by small and large services and tokens of appreciation. (8)  Gifts create relationships: they create a subconscious indebtedness and the feeling of a need to reciprocate^. (9)  This reciprocation is well documented in the form of increased prescribing of the heavily marketed drugs, even if those drugs are no more efficacious than other generics in that particular therapeutic area and do not display cost-effectiveness.

Apart from the intensive marketing that pharmaceutical companies deliver, they often claim that their clinical trials are an important source of readily available information for the busy clinician.  Indeed this is true to an extent but we must realise the flaws in their processes.  Many new drugs are compared to a placebo drug or ineffective doses of established drugs rather than the gold-standard equivalent as a comparator.  This results in the new drug being shown in a more favorable light.  Studies sponsored by the industry are four times as likely to have outcomes favouring the sponsor than are studies funded by other sources. (10)  There is also widespread evidence of negative results from trials being suppressed-a clear form of publication bias.  Also, in the realm of clinical trials erroneous data result from insufficient documenting of adverse outcomes.  This prejudices patients, as in the case of the revolutionary COX-2 selective inhibitor drugs which came on to the market a few years ago.  On release they were heavily marketed as revolutionary anti-inflammatory drugs without the gastric side effects common in the COX inhibitor class of drugs.  Yet they were later found to have detrimental effects by increasing the number of thrombotic events.  These consequences were not revealed in trial findings.

Once a trial has been written up it is usually published in a major medical journal.  However, 75% of clinical trials published in major journals are funded by the industry^11.  An additional number of these have further bias from the professionals conducting the trials who have conflicts of interest (e.g. as shareholders).  Even though they have to declare any interests, this is not always complied with.  Richard Smith, former editor of the British Medical Journal, told BBC news that the journal was too dependent on pharmaceutical industry advertising revenue to be considered impartial.  This means that industry-sponsored trials and the journals they are displayed in should be regarded with considerable scepticism.

How does this affect medical students?
The above entanglements between the industry and doctors apply even more so to medical students, as they have the longest “prescribing life” and so are key targets for pharmaceutical representatives. (12) With the advent of nurse and pharmacist prescribers this dimension can only increase.  Medical students are also at their most naïve, as they are formulating views on the industry and rapidly expanding their drug knowledge.  As such, medical students need to think actively about their relationship with the industry, in the same way that they consider the doctor-patient relationship.  They need clear guidance on how to interact with the pharmaceutical industry from an early stage.  With regard to the above issues, a non-exhaustive list of guidance would include the following:

• Approach the pharmaceutical industry with caution in all dealings with it.  As profit-driven companies their priority is not that of health, but wealth.
• Realise that free gifts, however useful, are targeted at medical students for the sole reason of modifying future prescribing behaviour and are an example of marketing and product placement.
• Understand that, however much you believe that incentives and gifts will not modify behaviour, research shows that they subconsciously change prescribing behaviour.
• Industry-sponsored clinical trials should be analysed critically and not taken at face value.  They should not be the sole source of information for evidence-based decision-making.
• Use relatively less biased publications such as BMJ Clinical Evidence.  If possible, the raw published data from clinical trials should also be viewed.

I believe medical schools should take a more active role in ensuring medical students are educated about the pharmaceutical industry.  In particular, they should publish polices to provide a point of reference for occasions when their students have dealings with the industry (e.g. sponsorship of sporting events).  I contacted five UK medical schools at random and none had an active policy in place about how medical students should interact with pharmaceutical companies.  Evidence suggests that these entanglements should be explicitly addressed at the level of policy and education. (13) This would enable standardisation in any dealings with the pharmaceutical industry and control the industry’s influence over medical students.

Get Involved
There are many organisations which have been set up to increase awareness about the industry.  If you are interested please support the following organisations:

PharmAware UK
This organisation is part of Medsin and aims to change health care professionals’ relationships and interactions with the pharmaceutical industry and educate and raise awareness of worldwide pharmaceutical issues.  There are branches at most UK medical schools.  Visit www.pharmaware.co.uk

No Free Lunch
This is an American organisation committed to raising awareness about the influence of the pharmaceutical industry on prescribing habits.  The website encourages healthcare professionals to hand in their drug branded pens in the ‘No Free Lunch Pen Amnesty Program’.  This is a very good website with a lot of resources.  Visit ww.nofreelunch.org

No Free Lunch-UK
This is the British branch of the above organisation.  It campaigns for complete transparency through a public register of all contact, hospitality and payments received by health professionals from the industry.  Visit www.nofreelunch-uk.org

Healthy Skepticism
Healthy Skepticism (formerly known as MaLAM) is an international non-profit organisation for health professionals and everyone with an interest in improving health. It aims to improve health by reducing harm from misleading drug promotion both in developed and developing countries.  Visit www.healthyskepticism.org

Tom Jaconelli
Fourth Year Medical Student
Hull York Medical School,
UK
thomas.jaconelli@hyms.ac.uk

Competing interests: None declared.

(1) A.S. Harding. Milestones in Health and Medicine. Phoenix Oryx Press, 2000.

(2) F, Furedi. Conference: Health: An Unhealthy Obsession. London. Feb 2005.

(3) Medicines, Pharmacy And Industry Group Summary Of The Pharmaceutical Price Regulation Scheme 2005 Department of Health

(4) Kamran Abbasi, Richard Smith. No more free lunches. BMJ 2003;326:1155-6.

(5) Sheldon TA, Cullum N, Dawson D, Lankshear A, Lowson K, Watt I, et al. What’s the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients’ notes, and interviews. BMJ 2004;329:999-1004.

(6) Collier J, Iheanacho I, The pharmaceutical industry as an informant. Lancet 2002;360:1405-9.

(7) Lurie N, Rich EC, Simpson DE, et al. Pharmaceutical representatives in academic medical centers. JGenIntern Med. 1990;5:240-243.

(8) Blumenthal, David MD. Doctors and Drug Companies. New England Journal of Medicine. October 28, 2004.

(9) Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioeth 2003; 3: 39-46                                           

(10) Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326:1167-70.

(11) House of Commons Health Committee The Influence of the Pharmaceutical Industry-Fourth Report of Session 2004-05 The Stationary Office Limited

(12) Chawla, R. First Pharmfree Day launched studentBMJ 2005;13:1-44

(13) Wazana A. Physicians and the Pharmaceutical Industry: Is a gift ever just a gift? JAMA. 2000;283:373-80

Bookmark on delicious | Digg

This entry was posted on Monday, January 7th, 2008 at 12:34 pm and is filed under Medical Ethics, Articles. You can follow any responses to this entry through the RSS 2.0 feed. You can trackback from your own site.