Healthy Skepticism Library item: 20160

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: Magazine

Medwar C
Because you're worth it
Health Matters Date uncertain 20007

Abstract:

Drug companies want to expand sales by marketing their products directly to the public. Charles Medwar considers the consequences if they were to get the go-ahead.

Full text:

Do we need or what to see prescription-only medicines advertised in newspapers and magazines and on TV? How would it be if we were surrounded by advertisements for Prozac and other potent drugs? This is the prospect with with direct-to-consumer advertising (DTCA), and its moment is nigh.

At present DTCA is illegal almost everywhere. But since it became legal in the US, in 1997, there has been intense pressure to change the law elsewhere. The European Commission is now considering the matter, as is the UK government.

Overwhelmingly the pressure for DTCA has come from drug companies. In the US, multinational pharmaceutical companies have found they can hugely expand their markets by advertising prescription drugs to the public and through ‘disease awareness’ campaigns. Spending on DTCA in the US was virtually non-existent in the early 1990s; now it has grown to over $2bn.

From the companies’ point of view, this investment has been extremely rewarding, in terms of increased sales, premium prices, ‘patient pull’, brand awareness and high return on investment.

According to the US National Institute for Health Care Management, ‘the 25 drugs that contributed most to the increase in retail sales of pharmaceuticals in 1999 accounted for 40.7 percent of the overall $17.7bn rise in spending. Most of these drugs were heavily advertised to the public and experienced a sharp growth in sales – an aggregate 43 percent in a single year. In contrast, the growth in sales in all other prescription drugs from 1998 to 1999 was 13.3 percent’.

To date, the downside of DTCA has been discussed mainly in terms of stopping misleading advertising – but this is a relatively small issue. What happens when governments unleash the volume of promotion that it takes to build markets is far more important.

The Main Risks of DTCA
The health impacts of DTCA are not yet well understood – despite vested interests 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? Briefly, the risks include: *Damaging health care systems by stimulating unsustainable demand. Lewis Thomas wrote about the risks long before the advent of DTCA: “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 healthcare 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 healthcare 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’.

*Creating excessive health intervention. Would DTCA be likely to promote more rational and effective drug use? Has drug advertising to health professionals done so? Would high volumes of DTCA tend to distort public understanding of benefit and risk, and of health policies and priorities? And to what extent might DTCA promote drug treatments over possibly better alternatives, including non-intervention?

*Promoting lack of confidence in personal health. Lewis Thomas again: ‘We are, in real life, a reasonable health 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, of we continue to listen to all the talk, is in becoming a nation of health hypochondriacs, living gingerly, worrying ourselves half to death’.

*Domination of medicine by US models of healthcare. Why would any country want to embrace DTCA, such a distinctly American phenomenon, when that country has such a poor record on healthcare in terms of both access and costs? There are also many concerns about the impact of DTCA in countries that lack the protections available in the US, for example freedom of information laws and consumer rights.

*Domination of commercial values, inhibiting, if not crushing, critical thinking. With the great advertising revenues on offer, imagine what might happen for example, to the editorial independence of the media, and their coverage of health issues. The potential impact on health consumer groups is particularly disturbing.

Inflated Claims
Last year, the UK Patients Association joined forces with Pharmacia & Upjohn (P&U) in a prototype DTCA television campagin aimed at ‘raising awareness’ about urinary incontinence. The TV commercials seemed helpful and tasteful and mentioned no brand name – although patients prompted to visit the doctor would have a good chance of being prescribed the leading, and then heavily promoted, brand Detrusitol (tolterodine, made by P&U).

In fact, tolterodine is relatively ineffective. Non-drug treatments are often preferable. But far from tempering its promotion, Pharmacia & Upjohn went into overdrive – repeatedly attracting criticism for misleading advertising, notably in the US.

Between 1998 and 2000, P&U received five warning letters from the US Food and Drug Administration. In two, the company was taken to task for making headline claims about the ‘selectivity’ of its product – suggesting that it acted on the bladder, with fewer drying side effects in the mouth. P&U omitted to say that its evidence was based not on clinical trials, but on studies with cats.

The Patients Association was unaware of this until too late. It had already supported the TV campaign and accepted a large donation from P&U, and also gave the company one of its ‘platinum awards’.

Involving Patient Groups
According to ‘Pharmaceutical Marketing’, ‘Direct to patient communication has become a prime objective for the Association of the British Pharmaceutical Industry (ABPI)’. So far, the industry has mainly operated behind the scenes, orchestrating others to speak its mind.

‘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 defences… Then the ABPI will follow through with high-level precision strikes on specific regulatory enclaves in both Whitehall and Brussels’.

In the US, pharmaceutical companies already finance much activity by patient organisations. The National Alliance for the Mentally Ill (NAMI) received $11.72m from 18 drug firms between 1996 and mid-1999. Although NAMI describes itself as ‘a grassroots organisation of individuals with brain disorders and their family members’, its leading donor (providing $2.87m) during this period was Eli Lilly and Company, the manufacturers of Prozac.

In the UK, things have not yet gone that far – but they are heading in the same direction. Most patient groups struggle for survival and DTCA campaigns can empower them. Directly and indirectly, these campaigns draw attention to the needs of special and deserving interests, they bring in more members and perhaps greater media coverage, greater prominence and sense of achievement, plus big ‘unrestricted grants’ from companies (see lower left).

The record shows that the industry has gone to great and sometimes improper lengths to get consumer organisations on-side (see opposite). While individual companies have mainly wanted to promote products, industry bodies have set up international ‘patient’ federations, mainly to get their views ‘represented’ in consultations and regulatory matters.

The Regulatory Response
Public consultation on DTCA has been almost farcical. By the time the European Commission was consulting publicly on the issue, in spring 2000, the UK Medicines Control Agency and the Medicines Commission had given the question of DTCA little thought and the Treasury had prepared no estimate of the costs.

Social Audit first requested a copy of the Medicines Commission discussion document on DTCA in February 2000, but was told it was secret – as is almost everything to do with drug regulation. Following a complaint to the Parliamentary Ombudsman, a censored version of the document was released a few days before Christmas. At the time of writing, the Ombudsman’s report is due.

Meanwhile the EC has produced no background paper. Its consultation comprises a series of general questions, none of which mention DTCA by name, and most of them are incomprehensible. 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?’

The EC’s involvement is explained partly by the rapid growth of the Internet – law enforcement has become extremely complicated. One problem is the blurring of the traditional dividing line between ‘promotion’ and ‘information’: how can you control one but not the other? And enforcing national laws becomes virtually impossible because Internet traffic is global.

The general trend to extend patient’s rights and to give patients more information about the medicines they use has also encouraged the industry’s plans to expand. Yet it is deeply patronising to suggest that the information vacuum – the result of centuries of secrecy and obfuscation surrounding clinical medicine – can be filled by advertising and ‘disease awareness’ campaigns. DTCA means, in effect, a whole new system of health education for consumers. Should drug companies be mainly responsible for this?

Apply the precautionary principle
DTCA seems to herald the elevation of market values above all. Whatever the benefits of DTCA for some, the costs and risks for others could be immense. Until health impact assessments have been done – providing sound evidence of the net benefits of DTCA in different cultures and communities – we should maintain the legal status quo, strictly prohibiting the promotion of prescription-only medicines to the general public. To legalise DTCA 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.