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Wednesday, 15 August 2012

Dr Jon Jureidini, child psychiatrist describes FIDDAMAN book as "comic and tragic" - but not scientific

The Foreword is by Dr Jon Jureidini, child psychiatrist and clinical Professor, Discipline of Psychiatry, University of Adelaide, South Australia.

source -

I owe Jon a great debt as it was he who set up the whole editing process [from Kindle version to paperback]

Here's his foreword.

Bob Fiddaman’s account of his interaction with the Medicines and Health Care Products Regulatory Agency (MHRA) over the antidepressant Seroxat (and of his blogging of that interaction) is comic and tragic in equal measures.

Charles Medawar, whose Antidepressant Web was godparent to Fiddaman’s blog, spoke of a ‘conspiracy of goodwill’ arising out of the wish of all parties (doctors, funders, manufacturers and users) that antidepressants be safe and effective. Fiddaman shows us that there is also ‘bad will’ in this case, identifying cynical and exploitative behaviour by those who we should be able to trust.

Around half of serious adverse affects of drugs are not identified until the medication has been used for a considerable time. This delay is understandable because research to bring a drug onto the market only involves hundreds or thousands of patients, whereas a successfully marketed drug will be taken by millions. Therefore rarer adverse effects sometimes do not become apparent for several years after a medication becomes widely available. By this time many may have been adversely affected by the drug without they or their doctors recognising that it is harmful. And when a drug is very widely prescribed (millions were taking Seroxat), every delay of a day in discovering harms means that thousands more people will suffer. Therefore pharmacovigilance (the detection and analysis of adverse effects of medications once they come into widespread use) has to be central to drug development and research if we are to reduce harm from medication.

But in spite of the fact that pharmaceutical companies have an obligation to monitor adverse effects of their drugs, they invest only a trivial sum in pharmacovigilance. Their priority is the much more profitable enterprise of developing and especially marketing new drugs, where they make huge investment. This imbalance is understandable (though not acceptable) in the light of their need to turn a profit, and reflects the lack of any significant disciplining of their activities by regulatory bodies.

One person’s reported experience with a drug proves little but Fiddaman shows us what we can learn when we collect together the experience of many users. Patients’ collective experiences with their drugs constitute a gold mine of information for the health system and pharmaceutical industry, but we doctors and scientist make barely any effort to collect the data and make sense of it. It is left to small heroes like Bob Fiddaman to irritate the system. A more rigorous and informative examination of patients’ experiences with drugs could prevent countless crippling adverse events. If we do ever achieve a truly effective system of pharmacovigilance, then Bob Fiddaman’s blog will have played an important part in this outcome.

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