The 'Informed Patient'

You -- the visitor to this site -- are, or want to be, an 'Informed Patient'. Were it not so, you wouldn't be visiting. Possibly, you want to be well informed before you actually become a patient, or in case you have symptoms indicating that you ought to be seeking medical advice and, if necessary, treatment.

It wasn't always so. Almost until the closing decades of the Twentieth Century, the majority of patients were content to leave health knowledge and medical information to the expert. The doctor would dispense knowledge and provide answers, preferably without being asked 'impertinent' questions by inquisitive patients. Patients were told what to do. Theirs was not to reason why. "Doctor knows best" was the rule, and on the whole patients liked it that way.

That era has passed. Society has changed. Health is no longer regarded as a matter of good fortune or even of good genes. Thanks to better public health and sanitation, and as a result of advances in medicine and surgery, we live longer. We have also become more conscious of the need for healthier life styles. The fact remains, nevertheless, that when we live longer, many of us do so burdened with chronic and incurable diseases. That can, and often does, lead to the loss of personal independence.

The extended family that would once have looked after its frail dependants, today barely exists in the industrialized world. Moreover, the decline even of the nuclear family and growth of the single-person household are putting a premium on health as the passport to work and the guarantor of independence in retirement. Health is now among the top priorities throughout life. And while we may not be able to obtain perfect health on demand, more and more patients wish to be treated as informed partners, empowered to participate in those medical decisions that affect their health or the course of their illness.

In short, The Informed Patient is here to stay.

What is 'Direct-to-Consumer' Advertising (DCTA) of prescription drugs?

'DTCA' is a method by which pharmaceutical companies inform the 'consumer' (who may or may not be a patient) about a disease and about prescription drugs -- especially new and innovative products -- that are now available for treatment of that condition. 'Direct-to-consumer' means that such information can be addressed to consumers without having to go through the normal channel of doctors, pharmacists and other health care professionals.

The way in which such knowledge is imparted to the consumer can range from plain information to overt promotion or advertising of the company's own drug. The law will impose restrictions on DTC information and/or advertising. Official control procedures and monitoring of the text of such messages will limit the scope of DTCA. Alternatively, the law may prohibit the use of certain media of communication (for example, television), or ban DTCA altogether.

How do different countries treat DTCA?

At this time, DTCA for prescription drugs (as distinct from over-the-counter medicines) is permitted only in the USA and New Zealand. The key event in the USA occurred in 1997 when the Food and Drug Administration [FDA] first allowed radio and television advertising of prescription drugs, subject to certain restrictions and to a degree of supervision to ensure truthful advertising and protect the consumer from misleading forms of promotion. Draft guidelines were issued by the FDA in 1997 and finalized in 1999. Promotional materials must be submitted for scrutiny, and the FDA receives about 32,000 such submissions each year (Scrip 2001, ¹)

In New Zealand, too, DTCA of prescription drugs has been reviewed by the Health Ministry in 2001 and is to be allowed to continue, "but with tighter rules and regulations.....to ensure that the ads provide balanced information to consumers" (Scrip 2001, ²).

In the European Union, DTCA is banned by Council Directive 92/28/EEC of March 1992, which obliges member states to "prohibit the advertising to the general public of medicinal products which are available on medical prescription only." However, a new proposal is to relax the absolute ban. Patients or patient groups will be able to request such information for drugs that have been approved for the treatment of diabetes, asthma and AIDS under a code of conduct that has yet to be agreed (Scrip 2001, ³).

This cautious move towards direct informative contact between companies and consumers is understood to be mainly the result of two influences. The first is pressure from patient groups in the disease areas that are now to be partially freed for DTCA. The second and more fundamental influence is the increasing availability of information on prescription drugs over the Internet. This makes it virtually impossible to withhold it from European consumers who seek to obtain it. Bureaucratic insistence that websites in the USA should state that the information is for U.S. residents only is widely regarded as a ludicrous anachronism: even in World War II, occupied Europe failed to take much notice of warnings not to listen to news bulletins from the BBC.

The American experience

Some facts:
Total promotional expenditure by the pharmaceutical industry in 2000 amounted to $11.8 billion of which 60% was on sales representatives and about 21% ($ 2.5 billion) on direct-to-consumer advertising (Scott-Levin 2001, ⁴). DTCA spending had risen rapidly from under $ 1 billion in 1997.

These are impressive -- some would say 'disquieting' -- figures, but they must be seen in proportion to the total market for prescription drugs. On this basis, DTCA represented less than 2% of the total value of pharmaceutical sales in the USA.

Since consumers are the targets of DTCA, what is their reaction to the practice?

In 1999, the FDA conducted a survey of 1,081 consumers' attitudes towards DTCA (FDA website 2001, ⁵). Of the majority who had seen their doctor during the last three months, 51% answered Yes to the question "Has an advertisement for a prescription drug ever caused you to look for more information about the drug or about your health?" Of those who had looked for further information, 81% had done so by talking to a doctor and 52% to a pharmacist. These answers demonstrate a high level of realistic response to DTCA and largely contradict the view that DTCA will induce patients to by-pass health professionals. Indeed, 70% of respondents disagreed (strongly or somewhat) with the statement that "Advertisements for prescription drugs make it seem likely a doctor is not needed to decide whether a drug is right for me."

To the question "Has an advertisement for a prescription drug ever caused you to ask a doctor about a medical condition or illness of your own that you had not talked to a doctor about before?" a remarkable 27% of those who had seen a doctor during the last three months replied Yes. The survey does not reveal whether these 27% include patients who, on reading about any disease, will jump to the conclusion that they have the symptoms (most of us do, some of the time). In reality, however, medical studies in recent years have stressed the contrary: too many patients with 'silent' conditions like hypertension, elevated cholesterol, and diabetes, are unaware of them and fail to seek medical advice until much later, when the disease has advanced and has become more difficult to treat. For example, in the USA "only one fourth of patients with hypertension have their blood pressure adequately controlled" (Hyman and Pavlik 2001, ⁶).

What is the link between DTCA of prescription drugs and Health Policy?

DTCA of prescription drugs is controversial: medically, economically and politically. At the outset of a controversial discussion of DTCA in a particular country, the line-up of Those-in-Favor and Those Against is roughly as follows:

• The medical profession tends to be Against, because DTCA is believed to undermine the physician's authority and 'waste time' with nuisance questions from troublesome patients. This attitude broadly conforms to the maxim that A Little Knowledge is a Dangerous Thing.
• Patients will on the whole be In Favor, because they see greater knowledge as helpful in their quest for better health, and because DTCA is a pathway towards their empowerment. The FDA attitude survey (op.cit. 2001) demonstrates that American patients are quite strongly in favor of most aspects of DTCA. The only significant criticisms by patients in that survey are inadequate information on adverse reactions and the view that "Advertisements for prescription drugs make the drugs seems better than they really are" (58% agreed, 24% disagreed). As a result, patients want their doctors' views on such drugs and believe that the adverts "help me to have better discussions with my doctor about my health (62% of patients who saw their doctor in the last three months agreed, 23% disagreed).
• 'Consumers' (the activist consumer movement, as distinct from health advocates and patient groups) oppose DTCA, mainly on the grounds that it encourages wasteful demand and consumption of prescription drugs and lines the pockets of the pharmaceutical industry.
• The research-based pharmaceutical industry denies the first charge, and factual evidence on the whole supports the industry's view. While DTCA has unquestionably boosted sales of the drugs thus advertised (and thereby increased industry's profits), the contention that this is 'wasteful' should be challenged, because advertising of many of the prescription drugs in question helps earlier recognition of disease symptoms and prevents unnecessary worsening of health status (antihypertensives, cholesterol-lowering drugs and antidiabetics are examples). Increased consumption of such drugs is to be welcomed because it can help to reduce expenditure on hospitalization, surgery, and professional time spent on the care of outpatients.
• Government and health authorities in the USA have evidently accepted DTCA, subject to certain safeguards, restrictions and supervision. In Europe, on the other hand, the authorities fear a 'demand explosion' with consequential impact on national health care budgets.

"I am against direct marketing as massive advertising could place a lot of pressure on the health costs that are covered by public authorities." (E. Liikanen, Enterprise Commissioner, European Union, 2001, ⁷)

This unequivocal statement is representative of public sector orientation on questions of health care in Europe. Simplistically, it equates an increase in drug expenditure with pressure on the 'cost of health', apparently denying the savings that pharmaceuticals can produce in terms of integrated total health care. It also appears to negate or ignore the possibility that European patients may be willing to contribute more in the way of co-insurance or co-pay towards the cost of effective drugs, thereby relieving the public sector of some of the anticipated pressure. In essence, it is a voice from the ivory tower, remote from the real world of 'informed' and increasingly empowered patients.

In short, Direct-to-Consumer Advertising of prescription drugs is neither a perfect blessing nor an unethical practice. It has advantages and it has questionable aspects. The debate about DTCA could be made more constructive if it were treated less as a matter of marketing, budgeting, expenditure and profit, and more as a matter of patient-centered Health Policy.