31 October 2011
Does the proposed amending directive on providing medicines information to the general public (sometimes thought of as advertising) actually enhance patients’ rights? Will it lead to good regulation? The document in question can be found here.
I’ll grant that a lot of people have been involved in this, so there must be some consensus, but is the proposed directive strictly in the patient’s best interests and how are we to truly cost the benefits?
The document itself is cumbersome as if trying very hard to close off any possible loop-hole in case advertising disguised as information might slip into the hands of an unsuspecting patient. To do this, a variety of tests are proposed, a net through which information must pass, presumably though, not advertising, that might meet these tests:
- evidence based
- up to date
- factually correct
- not misleading
- meet patients’ needs and expectations
These tests are all good things, and I have no issue with them as such; certainly one would not wish to be in favour of subjectivity, bias, opinions full of errors and likely misleading, despite being incomprehensible — I suppose much like an insurance contract.
If I prioritise the last though, meeting patients’ needs and expectations, information would need to pass these tests for a reason other than internal scientific tests, namely, that it be useful. My fear is this process will produce information that may struggle meeting the test of being understandable. The reason for giving the information itself is to help the patient after all, so starting with their needs seems to me to the test against which I would assess everything else. Of course, little in this world passes these tests anyway, or if it does only for a very short space of time, and even then, facts can be in dispute and there are differences of opinion over how to interpret them. What we are left with in this proposal is a technocratic solution for what in the end is a human need for information.
What are policy makers afraid of in drafting this directive? What do they fear should patients have more information? And have they fully costed this approach?
It all seems to very old-fashioned and dated. Like trying to put the genie back in the bottle, I think this in time will prove to be the actions which caused more harm than good. Indeed, it may be that the benefits are less than the total system wide costs.
The question, then, to ponder further, is what decisions by patients are enabled through this directive, how does it specifically enhance the rights and needs of patients (keep in mind that most health systems neither respect nor completely understand what these mean). Certainly, taking a decision-based approach, perhaps a ‘decision architecture’ which determines what information in what form is needed to help patients make what sorts of choices, then we might know better what degree of ‘coercion’ is needed, if any — but can you give me an example where it is even ethical to withhold information from a patient?
Of course, such an approach would would be in conflict with this directive which builds on the view that only health professionals know best. Hardly a firm foundation for legislative reform of this magnitude. But we need to think of whole-system regulation and the distribution of costs and benefits on that basis, and not just the information issue itself.
I am not surprised that it has come to this, as there is a sort of ‘consensus’ amongst professional vested interests that an information and advertising free for all would lead to chaos, loss of control of drug budgets, and a flood of advertising on our televisions and newspapers about drugs influencing hapless patients and consumers (as though advertising to doctors didn’t achieve similar effects). But compared to the monastic model we have now, where patients know less about the drugs they take than the amount of fat in a kilo of ground meat, it would serve to open up to greater scrutiny industry claims and counterclaims. This lack of knowledge itself has a cost and serious consequences for the costs of healthcare systems.
Recently, the Economist has noted in an article on red tape in Washington how the various costs of regulation are identified, and how wider public benefits are calculated or missed. The US Congressional Budget Office has speculated that a moratorium on DTC would likely have perverse consequences and be unlikely to lower drug prices, and only shift advertising toward physicians. This of course challenges the narrower focus (not meant pejoratively) of the Directive which clearly fails to take account of wider regulatory costs, which are ignored as they fall outside EU competency. These regulatory costs include but are not limited to:
- the potential beneficial impact on treatment costs and compliance with medicines regimes arising from wider engagement of patients in their care
- the potential corresponding (and likely beneficial) challenges to the authority of health professionals (but ignoring that many countries are seeking to encourage patient selfcare which is designed to achieve just this result), who are influenced in other ways in their choice of medicines, with considerable evidence of irrational and inappropriate prescribing, despite efforts to counter this
- greater awareness by the public of national medicines policies which may actually encourage greater cost efficiencies, such as trade-offs between medicines and inpatient care, as well as greater public scrutiny of how new drugs gain market access (a process which the public has little knowledge of and which has perverse consequences in many cases for patient access to new medicines — something an informed patient may wish to have a view on)
- greater public awareness of the decisions of health technology assessment agencies, which may raise serious social and ethical issues
- the possibility that the costs of regulation and claimed benefits to the health system may lead to the loss of research productivity and innovation from a more open environment; indeed the losses here may swamp the regulatory benefits.
I think keeping patients in the dark, as some have written, leads to greater system costs, and perverse consequences and incentives, than full and open disclosure to the public of medicines information, and indeed, even advertising. In an open environment, claims are tested in the real world and can be taken into account in whole-system benefits realisation, not exactly something that is designed to create an additional layer of regulation. In the end, the patient is excluded from playing an informed role in their own healthcare.
Want to know more?
Keeping Patients in the Dark, by Cardy, Edwards and Gay, Civitas, 2000. (Amazon sells it)
Benefits and harms of direct to consumer advertising: a systematic review, Gilbody, Wilson, Watt, Qual Saf Health Care, 2005 Aug;14(4):246-50.
Direct to Consumer Advertising is legal in the US. This is some material from the FDA: Information for Consumers: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143562.htm
US Congressional Budget Office, Potential Effects of a Ban on Direct-to-Consumer Advertising of New Prescrption Drugs, May 2011, Economic and Budget Issue Brief.