Monday, February 06, 2006

Another Big Pharma in trouble for "doctoring" information

Merck has been found in breach of the UK drug industry's code of conduct for modifying professional advice distributed to doctors treating high blood pressure, in a way that favored one of its own drugs. See story below.

There has been much in the news about possible manipulation or concealment of clinical trials data by the pharmaceutical industry. However, that industry also devotes considerable resources to medical education and development and provision of medical guidelines to the clinical community.

It is imperative that:

1) Such information development be done in a manner above reproach, which probably means as a non-profit venture with some degree of separation from the company's profit-driven management (such as in the case of the Merck Manuals and Merck Index), and

2) That non-medical people stop being given decision-making authority over clinical matters. Here, a non-medical employee of the British Hypertension Society "had authorized the change [in the guidelines to favor Merck] at the company's suggestion." Lack of medical knowledge, the likely problem here, while a better excuse for such conduct than, for example, illegal financial incentives or improprieties, is still a poor excuse for a non-medical person holding the ability to "authorize changes to clinical guidelines," especially in a medical society. Not mentioned is what happened on the company side. It seems both the company and the society were at fault here.

This reflects a problem I have noted in the Medical Informatics occupation, where the organizational structures in healthcare organizations and pharma place people into informational leadership positions who are lacking what I consider essential education and experience in biomedical information science. Their decisions are usually deleterious to efforts at improving informational provision and flow to clinicians and scientists, and a lot of time is spent devising ways to "work around the Boss."

This is often due in part to conflation of information technology and technologists with information science and information scientists. The two are distinct, but quite common is a profoundly Procrustean belief that being an expert in IT automatically makes one an expert in information science (Merriam-Webster: Procrustean - marked by arbitrary often ruthless disregard of individual differences or special circumstances).

Applied medical informatics work in such settings can thus be described as being "Director of Workarounds to Defective Organizational Structures", since that's what the incumbent spends a lot of their time doing - instead of more creative work that can advance the organization in useful and productive ways.

-- SS

Merck in trouble for doctoring advice

Merck, the US pharmaceuticals company, has been found in breach of the UK drug industry's code of conduct for modifying professional advice distributed to doctors treating high blood pressure, in a way that favoured one of its own drugs.

The Prescriptions Medicines Code of Practice Authority, the UK drug industry's self-regulatory arm, will next week rule against the company for changing guidelines compiled by the British Hypertension Society (BHS), a group of medical specialists.

The incident highlights the close links between pharmaceuticals companies and professional medical associations, which have come under growing scrutiny as part of a broader examination of potential conflicts of interest when drug companies market their products.

The probe was sparked by Des Spence, a Scottish doctor who runs No Free Lunch UK, a group of doctors that lobbies for greater transparency in the links between the medical profession and drug companies.

Mr Spence became concerned about information sponsored by Merck and widely distributed among doctors that described the so-called "ABCD algorithm" for drug treatment developed by the BHS.

The algorithm advises doctors which drugs to use to treat patients based on their age, ethnic background and reaction to different treatments. It recommends the first treatment of choice should generally be ACE Inhibitors, a class of cheap generic drugs.

However, Merck paid for and distributed thousands of cards, posters and computer mouse-mats for doctors for reference in their practices, in which the order and phrasing of the recommended drugs was switched to give greater prominence to its own more expensive patented drug Cozaar, which generated nearly $3bn in sales last year.

Professor Neil Poulter, BHS president at the time, said the "switch" by Merck was "a shame and an error". A non-medical employee of the BHS at the time had authorised the change at the company's suggestion.

Merck UK said it would not be appealing.

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