Healthy Skepticism Library item: 20463

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: Journal Article

Ed.
Secrets about drugs are not healthy
Lancet 1996 Sep 21; 348:(9030):765
http://www.lancet.com/journals/lancet/article/PIIS0140-6736%2805%2965201-4/fulltext

Abstract:

Should knowledge about the safety and efficacy of medicines be freely disseminated among professionals and public alike? In July this year (p 27), The Lancet reported, in a section of the journal dedicated to early or preliminary data, six children with severe asthma who had retarded growth and adrenal suppression after receiving high-dose inhaled fluticazone propionate. Doses of 1000 μg per day or more are used, as in the six cases, although the datasheet recommendation is 200 μg daily.
A summary of the criticisms starting on page 819 is that a conclusion cannot be drawn about the safety of fluticazone from anecdotal reports, especially when before and after data were not systematically collected. “Case reporting is an essential part of pharmacovigilance,” the original authors reply, “We made no attempt to draw generalised conclusions.” Pointedly, none of the experts ask what information the parents of the children were given about high-dose fluticazone before consenting to treatment. What advice would be proffered now?
This apparent lack of interest among experts, at least in this instance, about what information should be available leaves the way open for other interested parties. The UK’s Economic and Social Research Council (ESRC) and the Society for Individual Freedom have both recently highlighted what they see as the necessity for more and better information about medical interventions.
In a survey, the ESRC found a major difference between expert and lay perceptions of risk. This gulf probably reflects the experts’ “love” of the randomised controlled trial and the public’s desire, if media reflection is a measure, of the anecdotal case as all the “proof” needed—the two groups are using the word evidence differently. To say that the ESRC found distrust in their survey would be an understatement: “Lack of awareness by the nonexpert groups about what the Government does or does not do to control medicines safety is combined with an almost equal lack of trust in the regulatory system”. The Council seeks a new contract between patient, doctor, and regulator: in this, doctors and experts concede some power but patients bear greater responsibility for risks they take.
The Society for Individual Freedom has launched a campaign calling on the government to collect long-term results of treatments more systematically, and to make the data more openly available to doctors and patients. The UK General Practice Research Database, already available as an international resource (and used in 1995 to study venous thrombosis in women taking third-generation oral contraceptives) would meet their requirements for monitoring, containing as it does about three million current patients and 24 million person-years of data. Such cohorts can only investigate causality via a nested case-control design.
To disseminate drug information, there remains a middle person between physician and patient, applicable to most countries and respected by the public: the local pharmacist. The pharmacist rather than the doctor is often the person to whom patients direct questions about prescriptions and to whom they mention side-effects. He or she is also well placed to spot inconsistent or dangerous prescribing, whether by doctor or by patient’s self-medication.
Certainly, pharmacists will need improved training in terms of knowledge and communication skills, and they will require remuneration for extra work. Increased patients’ use of over-the-counter remedies, the latest move is a Bayer-Roche venture in the USA, is another compelling reason for a wider role for the pharmacist. Pharmacist-mediated, community-based pharmacointelligence could complete a database of patients’ details, histories, and treatments that had been started by the treating physician. The data would remain anonymised, unless independent advisers decided it was necessary to track an individual revealed to be at risk. The pharmacist would judge at what level to give information, but for those patients who wanted it, there should be full disclosure of all available data.