Healthy Skepticism International News

July 2002

Does drug promotion adversely influence doctors’ abilities to make the best decisions for patients?

July 2002 Vol 20 No 7

Jon Jureidini and Peter R Mansfield.

Aim: To increase awareness amongst psychiatrists and trainees of the effects of pharmaceutical promotion and to stimulate careful evaluation of the relationships between psychiatry and the pharmaceutical industry.

Method: Key findings from the literature and from 20 years experience with the Medical Lobby for Appropriate Marketing are summarised.

Results: The relationship between doctors and pharmaceutical companies is shown to be problematic in a way that might negatively impact on patient care.

Conclusions: Patients may benefit if individual psychiatrists, and the profession as a whole, develop more healthy scepticism about the harm to benefit ratios of relationships with the pharmaceutical industry.

The pharmaceutical industry is huge and growing fast. Expenditure by the Australian Pharmaceutical Benefit Scheme has grown from $1.18 billion in 1989-90 [1] (9.0% of total Australian health expenditure) to $3.07 billion in 1998-99 [2] (13.2%). Consequently, the extra billions spent on drugs have been at the cost of decreased funding for hospital and community health care. This would be acceptable if it could be demonstrated that expenditure on drugs was producing better results than expenditure on other areas, but such evidence is lacking. Continuous growth of the Pharmaceutical Benefits Scheme at rates much faster than the Australian economy is not sustainable, so that some type of dramatic change is inevitable. One option is to increase patients’ co-payments but that would disadvantage poorer and sicker people disproportionately. Other initiatives aimed to slow this unsustainable growth, including the introduction of therapeutic group premiums, have not solved the problem, with 14.5% more being spent in 1999 than in 1998. [3]  Perhaps part of the problem lies in the Therapeutic Goods Administration requirement that, for a new drug to be licensed, the manufacturer only needs to demonstrate quality, safety and efficacy for at least one indication. [4]  The new drug need only be better than placebo without being shown to be as good as currently available medications. This means that new and more expensive drugs can be introduced on to the market without any potential benefit to health care. For example, one of the main drivers of increasing expenditure is use of newer antihypertensives, many of which are either unproven or are inferior to much cheaper old thiazides [5] ($0.78/month for Diclotride 12.5 mg/day versus Norvasc 5mg at $19.40/month, wholesale prices). It might make more sense to require new drugs to be demonstrated to be superior to existing medication in either safety, efficacy or price before a license is granted.

Because of this huge and increasing expenditure, it is timely to review the effects of drug promotion on psychiatrists and our patients. Sara and Prior have recently called for discussion of three options for improving drug company involvement in Continuing Medical Education for psychiatrists: prohibition, declaration and/or engagement. [6] This paper provides evidence to support that call. We also aim to show how pharmaceutical company involvement in Continuing Medical Education fits together with other (often less overt) components of drug promotion, and to stimulate reconsideration of whether or not drug promotion is good for patients. Drug promotion (“all informational and persuasive activities by manufacturers”) [7] aims to overtly and covertly alter peoples thinking and feeling, motivating them to increase the use of a product, service or idea and/or increase the price that can be obtained. Promotion is a sophisticated applied science. It has utilised not only high quality qualitative research, [8] but also controlled trials, the methodology of which was more advanced in the early 20th century than that of many current medical trials. [9]

Pharmaceutical companies use the most effective promotional methods that they can to increase sales income. They have a legal obligation to maximise profit for shareholders, as well as self-interest in maximising income for staff and for the company as a whole. [10]  If companies do not perform competitively, and grow, they get taken over. These forces acting on drug companies mean that priority is often given to short-term performance at the expense of longer term considerations. Drug companies have little choice but to do whatever works to increase the sales of more expensive drugs, regardless of the impact on health care. Thus the hard sell is an inevitable consequence of the way that drug companies are paid. It is incorrect to blame drug companies for what is really a system problem. But it would also be helpful to understand better the processes within companies that facilitate the promotion of expensive drugs. It appears that many drug company staff, especially drug representatives, genuinely believe that their drugs are superior to the alternatives, in spite of equivocal or contradictory evidence. This may arise from deliberate deception during training [11] or unintended “groupthink”. [12]  In any event, pharmaceutical companies seek to influence us through direct promotion, illness promotion, and influencing research activities. We will examine each of these strategies in turn and then comment on the ethics of the relationship between psychiatrists and pharmaceutical companies.

DIRECT PROMOTION OF DRUGS

Perhaps the most important decision all doctors must make is to choose which information sources to use for professional growth and keeping up to date. Promotional material produced by the pharmaceutical industry is a popular choice because it appears to be doctor friendly. Drug promotion does not influence all of the doctors all of the time, but is effective enough to justify average promotion costs of around 30-35% of sales. [13]  Of the $3.07 billion Australian taxpayers paid to pharmaceutical companies in 1998-99 via the Pharmaceutical Benefit Scheme, the best estimate is that about $1 billion was spent on drug promotion. In spite of doctor’s views to the contrary, there is clear evidence that such promotion is effective. [14]  In May 2000 there were 47,550 prescribing doctors in Australia including part timers. [15]  This suggests that the industry is spending on average approximately $21,000 on each doctor per year. This average figure gives only a limited picture of the situation because the range is probably very wide and the distribution skewed with a small number of opinion leaders receiving more. However, it is interesting to compare that average with the annual expenditure by government on full time medical students of about $25,000 (estimate provided per phone by a senior staff member of the Australian Medical Council). Clearly, the expenditure by government during a few years of medical education is dwarfed by the expenditure by the industry on “re-education” over a medical career. Generally “medical education” sponsored by pharmaceutical companies favours drug over non drug treatment. [16]

Many promotional activities have only a small impact on their own but have a cumulative influence when repeated and/or combined with other activities. In fact the small impact may enable the message to reach the subconscious mind under the radar of conscious critical appraisal. [17]  Those of us who do not think we are influenced by advertising may be especially vulnerable. Orlowski and Wateska studied hospital doctors who denied that going to all expenses paid seminars at popular vacation sites would influence them. However, their prescribing of the promoted drugs did increase significantly starting from immediately after they received their invitations. [18]  Stelfox et al. showed that authors supporting the use of calcium channel antagonists were significantly more likely to have a financial relationship with manufacturers of these drugs. [19]  A study of 109 advertisements in 10 leading medical journals found that 44% would lead to improper treatment if relied upon. [20]  Forty per cent of ads showed an unfair balance between benefits and adverse affects, 60% had images which inappropriately minimised concern about side effects, and 80% made unsupported claims. In a small convenience sample of drug representatives who knew they were being tape-recorded, the approved product information was contradicted at least once during 11 of 16 visits to GPs in Melbourne. [21]  A recent Australian study found that lack of scepticism about drug promotion predicted variations in GPs beliefs about the appropriateness of unproven expensive new drugs. [22] Enforcement of controls over advertising is very difficult because sales material has a very short life cycle. If there are any objections to it, by the time they are processed, the material has already been replaced.

ILLNESS PROMOTION

The pharmaceutical industry has another more subtle way of maximising profit, which can potentially adversely influence doctors’ abilities to make the best decisions for patients. Pharmaceutical companies do not just promote drugs, they also promote illness (which of course leads to increased sale of drugs). [23]  They do this by sponsoring or producing material for GPs, doctor’s waiting rooms and others that alert the medical and lay community to the existence of “new” conditions like social phobia, or “underdiagnosed” ones, like dysthymia. Of course, we doctors collude with this process by being too ready to redefine dissatisfaction with unsatisfactory predicaments as depression. Giving patients antidepressants can be a way of avoiding their misery. A favoured means of promoting new illnesses is for drug companies to invest in consumer support groups. It is cost effective for drug companies to invest in such groups without any direct promotion of their product (or indeed of drug therapy). The support groups ensure that new patients present to doctors with ready-made diagnoses. One advantage for pharmaceutical companies in using these forms of promotion is that they do not need to make a direct connection between the illness and their product. This allows them to present what they are doing as community service. The reason that they do not need to link their products to this covert promotional material is that their detailers’ orthodox promotional programmes, apparently independently but often in a well organised way, have already “educated” us doctors, so that we are ready and willing to prescribe for these disorders.

CONTROL OF RESEARCH

A third indirect way of maintaining profitability that threatens our capacity to make the best decisions for our patients is the way in which pharmaceutical companies are increasingly able to control the flow of information. This control arises out of the compromise made by medical researchers in accepting funding from pharmaceutical companies, and we as a profession must acknowledge our share of responsibility rather than simply blaming the pharmaceutical industry. Dr Betty Dong was funded by Boots to determine whether Synthroid was biologically equivalent to the inexpensive generic form of the compound. When Dong found that it was, she was prevented by a contract that she had signed with Boots from publishing her data. Her university initially supported her in attempting to defy the bans, but was silenced by Boots’ lawyers. [24]  Even without such contractual restrictions, the medical research system has a role in colluding with the dominance of patented over generic drugs through the reluctance of medical journals to publish negative conclusions about differences between drugs.

There is also considerable opportunity for hidden promotion in the funding of research. For example, many so-called research studies seem designed to familiarise doctors with drugs and encourage their use, rather than to contribute to scientific knowledge. This may be particularly the case where doctors are flattered (and financially rewarded) by invitations to participate in international, multicentred trials. In such cases, invited centres are not required to make any scientific contribution to the process. The first author was recently approached with a request to participate in a multicentre trial of an SSRI drug for Obsessive- Compulsive Disorder. He was offered the status of “chief investigator” if he could provide patients, even though he has no particular expertise in the area being researched, or in drug trials.

Effective promotion is not restricted to support of major research projects or offers of all expenses paid overseas travel. Even small gifts are a way of creating obligation, either consciously or sub-consciously. Gifts are different from contracts, where the obligation is known and overt. On the whole, corporations get better return from the sense of obligation that is induced by gifts than they would from overt agreements to exchange services for money. Cheap gifts should not be thought of as harmless indulgences, but as low cost, highly cost effective advertising. [25]  It is noteworthy that drug companies such as MSD have forbidden their own staff from accepting gifts, presumably because they know that gifts are effective. [26]  “Education” provided by or sponsored by drug companies is another subtle but effective gift.

THE ETHICS OF THE PSYCHIATRIST- COMPANY RELATIONSHIP

One of the important ethical issues with drug promotion is that the money being spent is public money. This raises the issue of accountability. In our dealings with consumer goods, we usually tolerate the fact that advertisers distort the profile of products, highlighting their good points and hiding their bad points. With most consumer products, this distortion is accepted because the consumer, who is paying for the goods, is often in a reasonable position to exercise his or her own judgement. In the prescription drug market, this is not the case. It is taxpayer’s money that is being spent on drugs, but the government exercises very little control over which drugs are being bought for its money. It is we doctors who write the scripts, and thereby place orders (on behalf of our patients), but we do not feel the cost. The pharmaceutical industry’s marketing plans involve the preferential promotion of more expensive drugs. Most of us like shiny new things, even if they do not do the job better. Both authors love kitchen appliances. We get a steady stream of advertising pushing us to buy newer, smarter, brighter models. We stick, somewhat reluctantly, with our old ones because we would have to pay, and advertisers have to compete against our bank managers. Such is not the case when the drug company markets drugs for our patients. Doctors take at least as much pride in our patients’ wellbeing as we do in our cooking. So, without a bank manager looking over our shoulder, we can upgrade drugs on a whim. Most of us do. But as we have argued, there is no evidence that these decisions will significantly benefit our individual patients (as exemplified by newer generation antihypertensives) and the extra costs will disadvantage the health system as a whole, and thereby potentially increase morbidity. Furthermore, the ultimate consumers - our patients - often are not in a position to make informed judgements about the product, as evidenced by the market success of benzodiazepines in the 1970s.

It does not seem that there is an attitude of mutual respect between doctors and drug companies. On our side, it is not uncommon to hear psychiatrists, including those receiving significant rewards from drug companies, making disparaging comments about the industry. On the other side, we are regarded somewhat cynically. According to an experienced member of the pharmaceutical industry, a drug company will hand pick doctors to fund for research and “educational” activities specifically for their supportiveness and loyalty to the company, on the basis of analysis of their prescribing habits and profiles. The industry follows the principal that 80% of the market comes from 20% of the prescribers. We are therefore categorised according to how we prescribe, from “A” (high volume prescribers) down to “C” (those not worth targeting). “A"s are well looked after, while “B"s are targeted with a view to converting them to “A"s. Drug detailers profile us during their visits according to our professional and private interests, and also obtain information about our prescribing from local pharmacies. Our names appear in company briefing documents, with notations about who has attended international and other conferences as part of their promotional package, and what the company hoped to achieve from that sponsorship. [11]  At the same time, we are the targets of advertising campaigns that do not flatter our intellect. Keizer notes

  “professional medical magazines are filled with advertisements about medication in which the doctor is approached on the level of the housewife and her washing powder ... It’s a kind of science in “drag” ... which far below the cortex, runs along its brief spinal trajectories (not one cortical neurone even shimmering briefly in this darkness) and which is taken seriously by doctors and patients. Now, the pharmaceutical industry has, after a training period lasting several centuries, developed an incredible finesse in adopting a cortical manner while selling spinal reflexes”. [27] (p67).

Lest this seem fanciful, Williams Douglas McAdams, Inc, a company that designs drug advertisements for the pharmaceutical industry, advertised their services to drug companies with an ad headed “Straight to the Hippocampus” which portrayed the hippocampus as “the prescription-writing centre of the brain”. The marketing company boasted “all our communications are focussed on making the hippocampus respond favourably to your product”, “connecting new concepts with the parts of the brain where gut instincts are formed”. [28]

Figure 1 Why the buyer/seller relationship is problematic for drugs

CONCLUSION

How then can we better manage our relationships with the pharmaceutical industry? At the national level there is an urgent need for policy development on drug promotion. One approach is increased regulation, but it must be understood that any attempts at regulation will fail unless they are well resourced to support training of regulators to the very high levels of expertise required. To be successful, regulators would need to be able and willing to impose a wide range of sanctions, including removing companies from the market. A more promising approach involves reform of the way that drug companies are paid. For example, under the capped annual contracts used in New Zealand, excessive sales are unprofitable. Under that system, company representatives visit over-prescribing doctors to encourage them to be more prudent in the interests not only of their patients but also the company. Use of capped annual contracts is a relatively simple approach but is too blunt an instrument to solve all the problems of inappropriate behaviour. It may be better, although more complex, to give drug companies the opportunity to earn a significant part of their income via bonus payments for meeting quality targets that measure their contribution towards more appropriate use of therapies.

For us as psychiatrists, there is an urgent need for research on what we can do to reduce the harm from misleading drug promotion. Meanwhile it is likely to be beneficial for patients if we achieve the golden mean in confidence levels. This is because doctors who are under confident are easily swayed but doctors who are over confident are made vulnerable by their false sense of security. Patients are likely to benefit if doctors avoid contact with drug companies when possible, become very sceptical of promotional claims from any source and gain skills at critical appraisal of both the medical literature and promotion. [29]
Affiliations

Department of Psychological Medicine, Women’s and Children’s Hospital, North Adelaide, SA 5006, Australia. Fax: (08) 8204 7032 Email: .(JavaScript must be enabled to view this email address)
Director, Medical Lobby for Appropriate Marketing, 34 Methodist St, Willunga SA 5172, Australia. Fax: (08) 8557 1040 Email: .(JavaScript must be enabled to view this email address)

Correspondence
Dr Jon Jureidini,
To cite this article
Jureidini, Jon & Mansfield, Peter
Does drug promotion adversely influence doctors’ abilities to make the best decisions for patients?.
Australasian Psychiatry 2001; 9 (2), 95-99.

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