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How to avoid being a guinea pig

MagazineJune 1994 (Vol. 5 Issue 3)How to avoid being a guinea pig

Even though you cannot count on the drug companies and the government to keep you informed about drugs side effects, there are many ways to get round this problem

Even though you cannot count on the drug companies and the government to keep you informed about drugs side effects, there are many ways to get round this problem.

Contact the American Food and Drug Association. Anyone around the world has right of access to information about drugs licenced by the FDA, courtesy of the American Freedom of Information Act. Write a letter to the address below asking for Summary Basis of Approval (SBA) on your drug (make sure to find out the American generic and brand name first, as drug names can differ on either side of the Atlantic). This will include a detailed summary of the data, including results of clinical trials, that formed the FDA's decision to approve the drug. Also ask for Adverse Drug Reactions (ADRs) unverified reports of any side effects reported including new MedWatch reports (the new database of drug reactions recently set up by the FDA). Finally, ask for any reviews or assessments of the ADRs, which will put these isolated reports of reactions in context. (Bear in mind that American drugs can be licenced in different doses than British ones and for different conditions.)You will be charged $3 per request; after the first 100 pages of photocopying and first two hours of research, which are free, you are charged $.10 per page of photocopying and a fee of $13-46 per hour, depending upon the grade level of the person required to do the research. (In your letter you can ask for an estimate of how much your search will cost.) Write to the Food and Drug Administration, Freedom of Information Office, 5600 Fishers Lane, Rockville, Md 20857. They must respond within 10 days, at least to say that your request is being investigated.

Go to the Science Reference Library in London or the equivalent in a large city. Most large science libraries will have the American Physician's Desk Reference, or the ABPI's Data Sheet Compendium on the shelf, which you can use to look up your drug entry. The British Library's medical section (Kean Street, London WC2; 071 323 7288) holds both. Another possibility is to do a Medline Search, a computerized version of the Cumulated Index Medicus, a summary of most scientific studies performed on most treatments. If your library doesn't have Medline, they probably have the Index Medicus itself, an unwieldy volume that will fill most of a shelf.

Visit a large medical bookshop. Many useful drug books are for sale in general bookshops (see our list in the WDDTY Guide to the Side Effects of Drugs) but your best source for full information about drug side effects is to own your own copy of the US Physician's Desk Reference or the UK Data Sheet Compendium. You can order the DSC from the BMJ bookshop (Tavistock Sq, London WC1; 071 387 4499), or direct from ABPI (Datapharm Publications, 12 Whitehall, London SW1; 071 930 3477) for lb32 (including postage). If you can't get hold of a PDR in Britain, ask your American friends or relations to stuff a copy into their suitcase when they come to visit you.

Order back copies of Scrip, a drug industry magazine. You can buy individual back issues from lb5 each. It receives SBAs regularly and also reports on new information that has emerged about drugs side effects (18-20 Hill Rise, Richmond, Surrey TW10 6UA 081 948 3262).


For love of helenor

Treating side effects of anti-malarial tablets

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