COSTLY BENEFITS AND THE CONSPIRACY OF GOODWILL

Paper given by Charles Medawar at the annual meeting of the British Association for the Advancement of Science, Imperial College, London, 9 September 2000

 

"The operation was a great success; unfortunately the patient died." This old joke about an obviously costly benefit also makes a serious point about the relationship between, benefits, costs and risks. The question is not just what benefit, but who gains? Who defines what benefits or costs actually mean, who loses or wins? If medicine had, in fact, exceeded the worst expectations of Ivan Illich (1975), who would ever know?

It would not be common knowledge, if only because we are too much part of what Peter Medawar (1979) called the "conspiracy of good-will." My father had in mind a compact based on hopes of good health and a strong common interest in positive outcomes - the manufacturer wants his drug to work well, so does my doctor and so do I. In different roles, we join in the belief that medicine works well. That is generally how it seems and what we all need and want. We fear the consequences if medicine fails; we fervently hope it will not. 

This "kindly conspiracy in which everybody has the very best intentions" has always had something of the quality of a "Delusional Disorder" about it. Now, with the added impact of high intensity marketing and globalisation, medicine tends even more to the systematic idealisation of benefit and the routine denial of risk and cost. The whole culture of medicine is shifting towards the American way of health, and this does not altogether seem a good thing.

American Medicine might not appear a costly benefit to most US citizens, who have access to the very best of medicine. But so it would seem in international comparisons - also to the 43 million Americans whose health is uninsured. They include 2.5% of the US population whose life expectancy is "more characteristic of a poor developing country rather than a rich industrialised one" (WHO, 2000).

This combination of medicine at its best and worst leaves the USA ranked No 27 in the latest WHO tabulations of national life expectancy - and nowhere, in terms of therapeutic value for money. The table below provides some measure of the cost of national health attainment. It lists major counties with higher life expectancies than the US national average (70.0 years) in approximate order of annual national health expenditure per head of population.

 

Country

Total per capita health expenditure in international dollars

Disability-adjusted life-expectancy (overall years)

Greece

964

72.5

United Kingdom

1,193

71.7

Spain

1,211

72.8

Israel

1,402

70.4

Finland

1,539

70.5

Australia

1,601

73.2

Norway

1,708

71.7

Belgium

1,738

71.6

Iceland

1,757

70.8

Japan

1,759

74.5

Italy

1,824

72.7

Canada

1,836

72.0

Netherlands

1,911

72.0

Sweden

1,943

73.0

Austria

1,960

71.6

Luxembourg

1,985

71.1

France

2,125

73.1

Germany

2,365

70.4

Switzerland

2,644

72.5

USA

3,724

70.0

Source: Statistical Annex, Tables 5, 8, The World Health Report 2000, (Geneva, World Health Organisation, May 2000), pp. 176-182. 192-195. Omitted: Malta (70.5 years - $755/head), Andorra (72.3 - $1,216), San Marino (72.3 - $1,301), Monaco (72.4 - $1,799).

These WHO data refer to Disability Adjusted Life Expectancy (DALE). "To calculate DALE, the years of ill-health are weighted according to severity and subtracted from the expected overall life expectancy to give the equivalent years of healthy life". Thus "DALE summarises the expected number of years to be lived (for babies born in 1999) in what might be termed the equivalent of 'full health'."

The record in other countries - where American medicine would not be affordable to most - show that basic health needs can be met for a fraction of what the US spends. Portugal and Singapore (69.3 years), Cuba and Slovenia (68.4), Jamaica (67.3), Uruguay and Croatia (67.0) spend between $100 and $1,000 per head per year on health, compared to $3,724 per head in the USA.

There is no obvious reason why other countries would want to adopt an American-style system for national health. It would be more expensive but no more effective, and none of the better alternative systems would carry such a high a risk of over-dosing on health, in the sense Lewis Thomas described (1979):

"The trouble is, we are being taken in by the propaganda, and it is bad not only for the spirit of society; it will make any health-care system, no matter how large and efficient, unworkable. If people are educated to believe they are fundamentally fragile, always on the verge of mortal disease, perpetually in need of health-care professionals at every side, always dependent on an imagined discipline of ‘preventive’ medicine, there can be no limit to the numbers of doctors’ offices, clinics, and hospitals required to meet the demand. ...We are, in real life, a reasonably healthy people. Far from being ineptly put together, we are amazingly tough, durable organisms, full of health, ready for most contingencies. The new danger to our well-being, if we continue to listen to all the talk, is in becoming a nation of healthy hypochondriacs, living gingerly, worrying ourselves half to death."

There are other reasons for feeling wary about American medicine. It tends to excessive clinical intervention and over-dependence on high technology - 'defensive medicine', a response to the fear of being sued. As well as being legalistic and highly litigious, American medicine also seems riddled with conflicts of interest, and driven hard by money. The big money overwhelmingly controls the bulk of information about benefit, cost and risk.

The costs and risks are not just those born by patients. When a pharmaceutical company depends on just one or two 'blockbuster' drugs, its whole existence may be threatened by just a few reports of serious adverse reactions. It is understandable that a senior executive in Eli Lilly & Co should have warned his colleagues that, "Lilly can go down the tubes if we lose Prozac and just one event in the UK can cost us that" (Thompson, 1990). If only half of what David Healy (1999) and others believe to be true about the risks of Prozac, Eli Lilly would indeed be in serious trouble.

Depression and Dependence

But 15 years later, the antidepressant drug Prozac is still No 1 in a market dominated by American brands. Along with aggressively marketed rivals, Prozac also represents something of the spirit of American medicine. At its best, fluoxetine (Prozac) appears to work extremely well: that is what everyone wants and often enough it seems true. We tend to believe this in spite of the evidence. We act as if the science is with us, when it is not. The "serotonin hypothesis" of depression is a case in point. It developed essentially as a way of suggesting that Prozac-like drugs (Selective Serotonin Reuptake Inhibitors - SSRIs) act like essential supplements - fighting depression by augmenting depressed levels of serotonin in the brain.

"In fact, in the 1970s, Eli Lilly had a conference about a drug they had called fluoxetine which they didn't know what to do with. So they had a conference at their base in Surrey and they asked me to make a contribution. Of course I was enthusiastic about 5HT (serotonin) and the possibilities in mood disorders. I always remember the Vice-President of Research saying, 'I thank Dr Coppen for his contribution, but I can tell you we won't be developing fluoxetine as an antidepressant'." (Coppen, in Healy, 1996).

In fact, Prozac has no more effect on depression than any other antidepressant, including some 40 years old. The typical response to Prozac is little or no better than placebo (Kirsch & Sapirstein, 1998) and often worse. I also have no doubt it will be demonstrated in years to come that consumption of Prozac-like substances had far more to do with the dependence of users than with the power of the drug.

This should come as no surprise, for epidemic iatrogenic dependence has been a constant in medicine ever since the days when opium addiction was treated with morphine, heroin or cocaine. Just 20 years ago, the medical establishment was swearing blind there was no dependence on tranquillisers and history seems to be repeating itself today (Medawar, 1992, 1994, 1997-2000). The depth of the denial is deep; it involves all parties to the conspiracy of goodwill.

Although there are countless patients whose withdrawal symptoms from Prozac-like drugs signal a classic iatrogenic dependence problem, there are many more who believe the drug to work and whose main priority is continuity of supply - and doctors tend to oblige them. Most doctors and probably most patients either do not know that withdrawal symptoms from antidepressants are a commonplace, or they tend to interpret them as evidence of the drug's effectiveness - since depression and psychic distress are characteristic features of withdrawal. The general presumption is (exactly as it was with tranquillisers) that withdrawal-induced depression is in fact a "relapse" into illness - that is to say the re-emergence of the "underlying condition". The same delusional thinking justified excessive levels of tranquilliser prescribing for the best part of 30 years.

Twenty years ago, the regulators published their "systematic review" of the tranquilliser dependence problem and concluded there wasn't one. The then Committee on Review of Medicines (1980) decided this, in effect, by not testing the hypothesis that levels of dependence might be great. Instead, they compared the dearth of clinical reports of tranquilliser dependence with the vast amounts of tranquillisers prescribed.

"The number dependent on benzodiazepines in the UK from 1960 to 1977 has been estimated to 28 persons. This is equivalent to a dependence rate of 5 - 10 cases per million patient months" (CRM, 1980)

More recently, the Committee on Safety of Medicines and Medicines Control Agency concluded that the risk of dependence with antidepressants is just as small. The measurement techniques they use in this case can be shown to produce something of the order of a 100,000 per cent under-estimate of risk:

" …the low frequency of reporting per thousand prescriptions, together with the published comparative studies suggest that, overall, symptoms due to stopping an SSRI are rare. The absolute risk of a withdrawal reaction with any of the SSRIs may be so low that differences are undetectable except through spontaneous reporting where drug exposure is high." (Price et al., 1996).

Over the past three years, I have exchanged some 200 letters with the CSM/MCA, mainly on this issue. I can report that they are deeply out of touch with consumers and locked into processes that seems to numb human good sense. Fortified by a government that broke solemn promises to make freedom of information a reality, the regulators now show every sign of behaving as stupidly on this issue as the previous generation of regulators did with tranquillisers.

The give-away is the extraordinary energy the CSM/MCA puts into concealing information and delaying disclosure - for this long correspondence has a twist. In bending over backwards to disclose as little as possible, the regulators ultimately reveal why they are so secretive and what ill effects it has. Most of the secrecy has nothing to do with data they hold - but the lack of it and the limits of scientific quality. What the CSM/MCA are trying not to reveal is how little they know and are able to do.

The silence of the regulators also comes down to self-interest. Once the authorities have licensed a drug - in this case on the basis of evidence too skewed to reveal any risk of dependence - it is then embarrassing and costly to admit a mistake. By way of avoiding this, regulators fight shy of guiding "clinical judgement", deferring to the medical profession, instead. Meanwhile, the leadership of the medical profession - from the World Health Organisation down - becomes ever more consumed by industry money and ideas.

The power and influence of pharmaceutical companies in shaping views of benefit, cost and risk is vast - which also means it is beyond credible description at less than interminable length. All I can give are impressions from over the years, some based on experience behind the scenes. This includes inspection of 1.2 million documents disclosed by Eli Lilly in 1987, in defending claims against their anti-arthritic drug product, Opren/Oraflex (benoxaprofen). (Law Report, 1987).

Marketable products are lifeblood to the companies that invent them. Parent companies are naturally intensely protective of their products and extremely sensitive to criticism. Accordingly, major pharmaceutical companies are organised like security and intelligence agencies: they have eyes, ears and influence everywhere. This helps them to pass on news of the benefits of drugs, also to protect products if their reputations are at risk. Either way, big companies are highly effective in steering events. They have the advantage of operating in a small world, and their agents move with relative freedom in the field. Substantial resources allow companies to leave little or nothing to chance when it comes to sustaining a product's reputation.

Alongside this world of gain for those who speak up about the benefits of treatment, there is also a climate of great caution in public discussion of drug risk. My strong impression is that it borders on fear. To offer criticism of a product on which a company depends is no way up the career ladder in medicine - especially not in teaching hospitals and academic centres, where companies are often the main or only source of funds.

Whether on benefit or risk, pharmaceutical companies tend to get others to speak for them in public. Companies routinely respond to discussion of risks by orchestrating an "independent" response. Otherwise they may swamp or bury evidence, ignore it, discredit it, or come down like a ton of treacle or bricks. Within pharmaceutical organisations, loyalty to product seems to involve unusual obedience to authority, and high degrees of compartmentalisation seem to lead to marked fragmentation of personal responsibility. I have no doubt that the industry's capacity to manipulate professional opinion and to suppress honest communication is more than sufficient to make costly benefits seem bargains.

But can one blame companies for orchestrating endless demonstrations of the benefit of their products, when they are only obeying orders too? Yes, market rules and the maximisation of "shareholder value" do involve all kinds of unsavoury and unscientific practice - but it takes two to tango and medicine is more of a conga. My view of pharmaceutical companies has pretty much settled down to this. Companies behave the way they do because they are programmed to, just as my cat is programmed to chase mice. If companies want to thrive in the market - that is their raison d'Ítre, after all - they need to exploit every opportunity to demonstrate benefit, value and lack of harm. That is exactly what they do; pity they do it so well.

High intensity drug marketing has had everything to do with what Prozac and the other big brands have become. The main reason that Lilly executive thought Prozac would never be an antidepressant (Coppen, 1996) was that the science wasn't convincing, and the market for depression was then too small. So the companies expanded it. With strong support from key professional and consumer organisations, they created a new market.

Since Prozac arrived 15 years ago, the depression market has grown unrecognisably and the meanings of both "depression" and "dependence" have both radically changed. This could only have happened with the strong and active participation of the professional medical establishment, notably the American Psychiatric Association - an organisation awash with drug industry money and thick with sponsored experts.

The American Psychiatric Association has obliged the market by suggesting 309 different diagnoses of "depression" and hundreds more linked to other disorders for which Prozac and similar drugs are prescribed. At the same time, the APA (1994) gave the world a new definition of 'dependence' - one that is generally supportive of the notion that people need drugs like Prozac, like people with diabetes need insulin. A diagnosis of "dependence" was henceforth indicated only if a patient was heading in the general direction of Skid Row.

Under the new APA definition, patients have "discontinuation symptoms" rather than "withdrawal symptoms" and doctors are no longer legally liable for creating iatrogenic dependence, whether on Prozac or Valium. At the same time, the definition permits manufacturers to correctly claim that these are not drugs of dependence, even if countless users know they are.

But perhaps all this is churlish. Maybe we should take a broader view, and just feel grateful for so many good drugs, and feel encouraged by talk of all the benefits? Indeed, the more a drug is hyped, the greater will be the placebo response. Strong, positive promotion leads both doctors and patients to feel more confident about the effectiveness of treatment, and that is fundamental to making a medicine seem to work Belief in the benefits of treatment are commitments to personal survival and professional satisfaction. So does it really matter if the benefits of a drug are illusory, if the patient gets better and the medicine seems to work?

It matters at least for two reasons. One is that the illusion of benefit involves suppression of understanding of risk. The other is to do with harm done by this grinding emphasis on the superiority of active drug over placebo. It drums home in the collective unconscious the message that health comes out of a bottle, not from within people themselves.

Instead, we should be celebrating the placebo response, for it is the prime measure of our own ability to recover from illness and find good health. The systematic denigration of the placebo response tends to undermine hope and confidence in self, undervaluing the strength and resilience of the human organism. Every gentle reminder of the need for treatment, and the perils of under-treatment, helps to persuade people they can no longer take day-to-day responsibility for their own health. The obsessional pursuit of health is becoming more and more of a disease.

And what can drugs like Prozac ever solve, anyway? Even if Prozac carried no risks and was as effective as everyone would want, where would it lead us? It would leave us with a costly benefit of paradoxical proportions. To the extent they work, drugs like Valium or Prozac inhibit adaptation and development of defence mechanisms and raise tolerance to stress. Thus they enable society to accommodate more stress and the net long-term effect is to let more stress in. However great the benefit to individuals, the long-term contribution of Prozac to society would also be to sustain and promote the very conditions it is used to treat.

Direct-To-Consumer promotion

Another thing that makes American medicine so contagious is that it is power assisted by the government's aggressive protection of the national interest in international trade. The influence of American government and commercial interests in world health extends well into the realms of what my dictionary unfashionably calls imperialism: "the policy, practice or advocacy of extension of a nation's power or influence over other territories." (Chambers, 1993).

With this in mind, I want to discuss one specific characteristic of American medicine that is just about to overtake Europe and the rest of the world. Here I suggest that the relationships between the main actors in medicine involves some great play of power & dependence (Medawar, 1992), underpinning the conspiracy of goodwill. The main actors in this play represent commercial, government and professional interests. These are the three great estates of medicine. The fourth includes you, me and everyone else - a great mass of people, patients and consumers, along with a chorus of more and less representative interests, including the media and press.

The question at the heart of this case-history is simple enough: should prescription-only medicines be promoted to the general public? At present, this is permitted only in the USA and New Zealand, but there are now proposals to legalise Direct-To-Consumer Advertising (DTCA) in the European Union. If that were to happen, DTCA would soon become global phenomenon. It would spread even to countries where basic health needs are hugely unmet, where there usually no enforcement of prescription drug laws.

Medicines like Prozac come and go, but DTCA is a costly benefit of quite different proportions. It seems to mark a real turning point in the history of medicine, heralding the celebration of market values above all. Certainly, the benefits, costs and risks of promoting prescription medicines to the public would tend to differ in different communities, but the big picture looks grim. Whatever the benefits of DTCA might be for some, the costs and risks for others might be immense.

I say "might", because the health benefits and costs of Direct-To-Consumer Advertising are barely understood - though the vested interests are pushing ahead anyway, as if it were all a matter of "win-win". Why not advertise Prozac on TV: increased levels of consumer confidence and "disease awareness" would surely increase understanding and add therapeutic value? Others believe it would be folly to permit any change in the law until the nature, extent and distribution of benefits/costs/risks were properly understood.

The issue here has little to do with the quality of information in single advertisements. The issue is not "misleading advertising", indeed there is probably some nourishing information in most individual Direct-To-Consumer promotions. The real concern is about the overall impact of DTCA, and in the longer term. What happens when predominantly commercial messages become the dominant feature of the overall information diet? All kinds of questions about possible costs and risks arise, but they are not being addressed. For example:

Support for DTCA

The pressure to promote Direct-To-Consumer Advertising (DTCA) in the European Union (EU) and elsewhere dates from the mid-1990s. Several factors explain it, not least the rise of 'evidence-based medicine' and the growth of 'health maintenance' and 'managed care'. Both threaten sales, while DTCA makes it possible to expand drug markets even more. One way and another, the pressure to legalise DTCA has come overwhelmingly from the pharmaceutical industry - though much of the orchestration appears to come from elsewhere. The following, the first of several excerpts from Pharmaceutical Marketing magazine, explains from an inside perspective how this is done:

"Direct To Patient communication has become a prime objective for the Association of the British Pharmaceutical Industry (ABPI) … Now the ABPI has announced that it is launching the final stages of a campaign before it tackles the Government and the EU head on ... It is the spearhead of a carefully thought-out campaign. The ABPI battle plan is to employ ground troops in the form of patient support groups, sympathetic medical opinion and healthcare professionals - known as 'stakeholders' - which will lead the debate on the informed patient issue. This will have the effect of weakening political, ideological and professional defenses … Then the ABPI will follow through with high-level precision strikes on specific regulatory enclaves in both Whitehall and Brussels. The news was broken to members of the Pharmaceutical Marketing Society … " (Jeffries, 2000).

The general trend to extend patient rights and to inform patients more about the medicines they use has also encouraged the industry's plans to expand. The rapid growth of the Internet has helped too - partly because it has become an important source of drug information, also because it has suddenly made law enforcement extremely complicated. How would individual nation states be able to control DTCA when billions of messages now fly across national borders - and when the boundaries between drug advertising and information have become so blurred? American dominance of the Internet is posing problems for the rest of the world.

The watershed for DTCA came in August 1997 when, after a 15-year moratorium, the US Food and Drug Administration (FDA) relaxed its rules on prescription drug advertising on TV. Within a few months, the amount spent on direct appeals to the public exceeded what the industry spent on advertising in medical journals. DTCA has become an integral part of drug marketing, with an annual budget in the USA of nearly $2billion/year.

On that side of the Atlantic, companies talk of DTCA more openly in terms of increased sales, premium prices, "patient pull", consumer brand awareness and (often huge) returns on investment. Over here, the pharmaceutical industry emphasises that its interest in DTCA has much more to do with promoting patients' best interests. Indeed, earlier this year, two companies (Biogen and Schering) were recently censured by the Medicines Control Agency, in effect, for setting up "consumer groups" to lobby for increased access to their products (Dillon & Gould, 2000). Their industry association has been more discrete:

"The ABPI was now approaching the issue by enlisting patient support groups as part of the Informed Patient Initiative. Patient organisations, with their own clinical advisers, were already starting to fight their case for access to drug information. 'Patient groups offer us a big opportunity to provide them with authoritative information for them to use objectively in a way that benefits their members', he said." (Dr. Trevor Jones, ABPI Director, quoted in Pharmaceutical Marketing, May 2000).

It is not surprising the industry has been getting important support from consumer/patient organisations: many patient groups struggle for survival and DTC advertising campaigns can empower them. Directly and indirectly, these campaigns draw attention to the needs of special and deserving interests and the disadvantages they face - especially if confronted with "postcode prescribing." For the groups that represent them, DTCA can bring in more members, and perhaps more column-inches and sound-bites, greater prominence and sense of achievement - and big "unrestricted grants" from companies too.

The downside is loss of independence and critical faculties - and how far does it go? To what extent, for example, would Depression Alliance be in a position to speak out when pharmaceutical companies provide up to one-quarter of its income, handle its parliamentary representation, pay for its annual meeting, and also sponsor its chairman and chief medical adviser? What room is left for real independence of thought when this happens on the American scale?

"The National Alliance for the Mentally Ill (NAMI) bills itself as 'a grassroots organisation of individuals with brain disorders and their family members …18 drug firms gave NAMI a total of $11.72 million between 1996 and mid-1999 … NAMI's leading donor is Eli Lilly and Company, maker of Prozac, which gave £2.87million during that period." (Silverstein, 1999)

Meanwhile, in Britain, the pharmaceutical industry already considers patient and consumer groups sufficiently on-side to start working on the other centres of power:

"The first phase of aligning the Industry with the Informed Patient Initiative campaign began in 1998 and was now largely completed said Professor Jones … Focus groups with patient groups appear to have surprised the ABPI by their open-minded attitude to the idea. It had been expecting much more mistrust of the industry's motives, which earlier research had thrown up …

Phase two of the campaign is now involved in seeking alliances with patient groups, the BMA (British Medical Association), Royal Colleges (of health professionals), media and others. A recent publication by the ABPI, The Expert Patient, is part of a softening-up assault to be mounted through those interested parties and opinion leaders by stimulating public debate." (Pharmaceutical Marketing, May 2000).

Opposition to DTCA

Not all consumer groups have welcomed the prospect of DTCA, and there has been significant opposition in both the USA and New Zealand, the only places where DTCA is allowed. In both countries, the criticism has focused mainly on the poor quality of information provided - not only on the basis of published enforcement findings, but also from surveys of advertising.

In Britain, the ABPI has anticipated resistance to DTCA on grounds of lack of information quality. They have emphasised that UK patients would get a better deal than their counterparts in the USA:

"In contract, the ABPI's direct-to-patient approach would be a 'responsible and factually based' communication about drugs and illness, said Dr Jones. It would be designed to complement information already provided by healthcare workers. He said patients wanted to know what drugs were available, how effective they were and learn about their side effects. The industry was the most authoritative source for that information. 'Yet we have this mark of Zorro on our foreheads,' he said, because as 'industry' they were regarded with suspicion." (Pharmaceutical Marketing, May 2000).

My strong suspicion is that DTCA would positively subtract from the officially approved drug information that companies already provide in product data sheets and patient information leaflets. The terms in which the ABPI has described its own initiatives in this area lead irresistibly to that conclusion:

"Patient packs are the best, simplest and most convenient method of ensuring that patients get full details about their medicine - including how and when to take it, where to store it, possible side effects and other information." (ABPI press release, 27 April 1998)

"Patients throughout the country can access for the first time comprehensive and authoritative details about their medicines at the touch of a button, thanks to the launch today of a new service by the pharmaceutical industry … By using the Internet, the new Electronic Medicines Compendium (eMC) will provide an entirely new, free service to patients, doctors and other healthcare professionals seeking information about prescription medicines. Because the information contained on the site has been officially approved by the Department of Health, it is uniquely authoritative - and new search facilities make it easy to find." (ABPI press release, 24 January 2000).

Establishment response?

Meanwhile, neither health professionals nor governments have welcomed proposals for DTCA, without reservation. In Britain, both seem to be waiting nervously in the wings. Perhaps the dominant concern for professionals has been the prospect of being challenged, badgering from patients for brand-name products, and erosion of doctor-patient relationships. Still, it seems unlikely that the main professional associations will obstruct the industry's plans, because it would probably take concerted opposition to halt them. That seems unlikely and would put at risk current levels of sponsorship from the industry that most medical associations and their members now enjoy.

Governments also tend to be torn. On the one hand, most major nations are, in economic terms, highly dependent on pharmaceutical companies. On the other hand, many governments support public health systems and all are short of funds. Governments of the main industrialised nations are only now waking up to the prospect of DTCA bringing increased demand for health services and a substantial increase in the national drug bill. They have had no guidance from WHO.

This dilemma is paramount in the UK, since the pharmaceutical industry contributes hugely to national output and export earnings - but where the government is also under much pressure to improve its stewardship of the National Health Service and to reduce the national drug bill (about £6bn/year). What evidence there is suggests HM Government has given the matter little thought. At this stage of the game, that could be tantamount to letting DTCA right in.

The Medicines Control Agency "has not made any detailed assessment of the benefits, risks and costs that might follow should the current law be changed" (MCA, 2000). Nor has HM Treasury (2000) yet undertaken any analysis of the financial implications, though they do seem to recognise the problems there could be. Inertia is probably all it will take for the legalisation of DTCA to follow.

Meanwhile, the European Commission (EC) has begun its own enquiries. It acts through the Directorate-General for "Enterprise" (competition and industrial policy), rather than "Health and Consumer Protection". In March 2000, the EC convened a working group on information/advertising and on electronic commerce. They followed up this meeting by agreeing to send out "a questionnaire asking concrete questions and proposing concrete options on possible ways forward", by way of consultation. None of the 14 questions that materialised mentioned DTCA. The questions seem notable mainly for their obliqueness and painful use of English. For example:

"Do you think that it could be useful to give possibilities for the Marketing Authorisation Holder to give more information?

"Do you think it would have a public interest as far as certain classes of medicinal products are concerned?

"If yes, on which classes of medicinal products could it be possible to start?"

In short, concern about DTCA relates not only to the possible adverse effects of promoting prescription-only medicines to the public, but also to the way in which decisions relating to legalisation are being taken. The main problems are:

Clearly, most people need and want much better information about medicines and health. The question is whether this information vacuum either can, or should, be filled by advertising messages and linked promotional activities. The issue here is also to do with the interests of some consumers versus all. By analogy, the benefits we enjoy individually from cars add up to collective costs - eg relating to climate change, lack of mobility and land use - which cannot (and should not) be sustained.

Proponents of DTCA - including patient/consumer groups well funded by commercial interests - have suggested that the advantages of DTCA include the provision of useful, information helpful to patients, greater awareness of health problems and treatment options, reduced risks of under-treatment and lessening the stigma of illness and disease.

Indeed, these are potential advantages. But they deserve close scrutiny, not uncritical acceptance - if only to find out who would gain, and who would not. Until health impact assessments have been done - providing sound evidence of the net benefits of DTCA in different cultures and communities - surely we should maintain the legal status quo, strictly prohibiting the promotion of prescription-only medicines to the general public? To legalise it, in the absence of good evidence of both health benefits and lack of harm, would be to undermine the core values of medicine, science and democracy.

DTCA therefore also represents something of a test - for the hypothesis that, collectively, we are virtually incapable of understanding the relationship between the benefits, costs and risks of medicine. Individually and collectively we tend to take for granted that medicine stands for the triumph of benefit over cost and risk. To assume this is to remain largely locked in a state of ignorance of ignorance. Are we really still as "dumb" as Lewis Thomas (1979) said we used to be?

"These ought to be the best of times for the human mind, but it is not so. All sorts of things seem to be turning out wrong, and the century seems to be slipping through our fingers here at the end, with almost all promises unfulfilled. I cannot begin to guess at all the causes of our cultural sadness not even the most important ones, but I can think of one thing that is wrong with us and eats away at us: we do not know enough about ourselves.

We are ignorant about how we work, about where we fit in. and most of all about the enormous, imponderable system of life in which we are embedded as working parts. We do not really understand nature, at all. We have come a long way indeed, but just enough to become conscious of our ignorance. It is not so bad a thing to be totally ignorant; the hard thing is to be partway along toward real knowledge, far enough to be aware of being ignorant. It is embarrassing and depressing, and it is one of our troubles today.

It is a new experience for all of us. Only two centuries ago we could explain everything about everything, out of pure reason, and now most of that elaborate and harmonious structure has come apart before our eyes. We are dumb.

This is, in a certain sense, a health problem after all. For as long as we are bewildered by the mystery of ourselves, and confused by the strangeness of our uncomfortable connection to all the rest of life, and dumbfounded by the inscrutability of our own minds, we cannot be said to be healthy animals in today's world.

We need to know more. To come to realize this is what this seemingly inconclusive century has been all about. We have discovered how to ask important questions, and now we really do need, as an urgent matter, for the sake of our civilization, to obtain some answers. We now know that we cannot do this any longer by searching our minds, for there is not enough there to search, nor can we find the truth by guessing at it or by making up stories for ourselves. We cannot stop where we are, stuck with today's level of understanding, nor can we go back. I do not see that we have a real choice in this, for I can see only the one way ahead. We need science, more and better science, not for its technology, not for leisure, not even for health or longevity, but for the hope of wisdom which our kind of culture must acquire for its survival."

Amen.

 

References

American Psychiatric Association, DSM-IV, Diagnostic and Statistical Manual, 4th Edition Washington DC: APA, 1994).

Boseley S, 'Fantasy land' of medical soaps attacked, The Guardian . 8 July 1999, 5. See below.

Committee on the Review of Medicines, Systematic Review of the Benzodiazepines. Br Med J. 29 March 1980, 910-912.

A. Coppen, Biological psychiatry in Britain, interview in D. Healy, The Psychopharmacologists, London: Chapman & Hall (Altman), 1996, 279, 265-286.

J. Dillon, M. Gould: Drug firms set up 'patient' groups, The Independent, 9 April 2000 (http://www.independent.co.uk/news/UK/Health/2000-04/drugfirm090400.shtml)

European Commission, Pharmaceuticals and Cosmetics Unit, Enterprise Directorate-General (DG-III), Pharmaceutical Committee Minutes (22-23 March 2000) and Questionnaire on Advertising and E-commerce (15 May 2000). Full text available at: http://pharmacos.eudra.org/docs.htm

Gilbert D, Direct-To-Consumer advertising of prescription medicines (SCRIP Report No BS968), London: PJB Publications, 1998.

Healy D, A failure to warn (Editorial), International Journal of Risk and Safety in Medicine, 1999, 6, 151-156.

Illich I., LIMITS TO MEDICINE Medical Nemesis: The expropriation of health, (Harmondsworth: Pelican Books, 1977), 11.

Jeffries M., The Mark of Zorro, Pharmaceutical Marketing, May 2000, 4-5.

I. Kirsch, G. Sapirstein, Listening to Prozac but Hearing Placebo; A Meta-Analysis of Antidepressant Medication, Prevention & Treatment, Volume 1, Article 0002a, posted June 26, 1998 at  http://journals.apa.org/prevention/volume1/pre0010002a.html

Law Report: Scientific journalist given access to inspect documents, The Independent, 23 January 1987

Medawar C., Power & Dependence - Social Audit on the safety of medicines (London: Social Audit, 1992); Secrecy & Medicines, Int. J. Risk & Safety in Medicine , 1996, 9, 133-141; The Antidepressant Web, Int. J. Risk & Safety in Medicine, 1997, 10, 71-126. See also http://www.socialaudit.org.uk (1998-2000).

Medawar P.B., Advice to a Young Scientist, (New York: Harper Row, 1979), 50.

Medicines Control Agency, Personal communication, letter of 20 April 2000.

Milgram S. Obedience to authority; an experimental view. (New York: Harper & Row, 1974)

Mintzes B: Blurring the Boundaries - new trends in drug promotion, Amsterdam: Health Action International, 1998. See: http://www.haiweb.org

Russell D (CEO, Consumers' Institute of New Zealand), Direct-To-Consumer advertising - a financial palliative for the pharmaceutical industry in PHARMAC (Pharmaceutical Management Agency), Annual Review, 1999 (Wellington NZ:PHARMAC, 1999) 16-18

J.S. Price, P.C.Waller, S.M. Wood (Medicines Control Agency), A.V.P. Mackay (Committee on Safety of Medicines), A comparison of the post-marketing safety of four selective serotonin reuptake inhibitors including the investigation of symptoms occurring on withdrawal, Br. J. Clin. Pharmacol., 1996, 42, 757-763.

Silverstein K, Prozac.org, MOJOwire magazine, November-December 1999. Full text at www.motherjones.com/mother_jones/ND99/nami.html

Thomas L., "The Health Care System" in The Medusa and the Snail, New York, Bantam Books, 1980, 39-40.

Thompson L, Memorandum 7/2/90, Forsyth v Eli Lilly, Plaintiff's exhibit 98, 1990-1999, cited in Healy (1999)

Treasury HM (Her Majesty's), Personal communication, letter of 11 May 2000.

WHO Expert Committee: New approaches to health education in primary health care (TRS No 690), Geneva: WHO, 1983.

WHO, The World Health Report 2000, (Geneva, World Health Organisation, May 2000), Statistical Annex, Tables 5, 8, pp. 176-182. 192-195. Omitted: Malta (70.5 years - $755/head), Andorra (72.3 - $1,216), San Marino (72.3 - $1,301), Monaco (72.4 - $1,799).

Wilkes M , Bell RA, Kravitz RL, Direct-To-Consumer Prescription Drug Advertising: tends, Impact, And Implications, Health Affairs, March/ April 2000. Full text available at: www.projhope.org/HA/marapr00/190210.htm.

 

'Fantasy land' of medical soaps attacked

Sarah Boseley

Health correspondent

Television medical soap operas such as Peak Practice were castigated by doctors yesterday for misleading the public and encouraging them to expect the impossible of their GP.

"I believe that one minute of a medical drama like Peak Practice can undo a year of arduously educating patients on the appropriate and responsible use of GP services", said Dr Chaand Nagpaul, a north London GP, at the annual representative

meeting of the British Medical Association in Belfast. He called for regulation to stop TV from depicting a medical fantasy land.

"Up to 10m viewers are paraded a world where the patient doesn't need to request a home visit, but the GP instead readily offers to pop in during those spare hours in the day for that living room consultation over a fresh cuppa".

The GP - not a surgeon - discussed the complexities of major surgery, held the patient's hand as he went into the theatre and was there with a smile as he came round from the anaesthetic. Then he visited daily as his patient recuperated.

"And of course in a serious medical emergency, including road traffic accidents, you can rely on your GP as the first port of call", as an alternative to dialling 999", Dr Nagpaul said.

The every day setting of a soap such as Peak Practice portrayed "an impression of GPs that patients would actually want but is wholly unachievable logistically within NHS resources" …".

 

 

The Guardian . 8 July 1999, 5

Contents page
What's New?