The main sources of information about new drugs are:
• ISDB member bulletins. It is worth finding out if an independent drug bulletin has reviewed the drug already. This may save you some work. You can do this by asking bulletin editors via the ISDB electronic network (see http://www.isdbweb.org).
• The pharmaceutical company. Write to the medical director of the company that markets the product to ask for all the preclinical and clinical trial data. You may not get what you requested, but among the information supplied you may find important data indicating negative aspects of the product, such as no efficacy and/or potential or substantial evidence of harm.
It can be interesting to see how the medicine is being promoted. If asked, the company might send copies of adverts and other promotional material (such as detail aids, mailers). You can also find evidence on how the drug is being promoted in adverts published in professional journals, in the lay press, on the company’s web site, and by collecting material sent directly to health professionals. You should critically appraise the evidence on efficacy and harm, compare the results with what the company is claiming and discuss your findings in your article. (Examples of how bulletins can deal with misleading promotional claims include. ∇ Is Yasmin a truly different pill? Drug and Therapeutics Bulletin 2002:40:57-9; ∇ Yasmin advert withdrawn - why and how. Drug and Therapeutics Bulletin 2003;41:17-18).
• Regulatory authority web sites, including the U.S. Food and Drug Administration (FDA), Japanese Pharmaceutical and Medical Device Agency (PMDA), and European Medicines Agency web sites (see the appendix at the end of the manual for addresses). Although useful, materials on these sites are usually summaries of the original full data submitted to the regulatory authority by the company that may exclude (perhaps intentionally) important findings: for example tacrolimus ointment (see Section 8An-3.5 in the annexe at the end of this chapter).
• Web sites of authoritative drug evaluation organizations, including the UK Committee on Safety of Medicines, UK National Institute for Clinical Excellence, etc. (see the appendix at the end of the manual for addresses).
• Databases of published information, e.g. PubMed. You should always do your own search to check for missing data (see Chapter 7 for a list of general sources to search).