ARE ME-TOO DRUGS JUSTIFIED

The successful progress of pharmacology in the treatment of several di seases has led to the development of a powerful pharmaceutical industr y with an estimated market of over $250 billion. It is therefore under standable that as drug development and marketing has become a major bu siness it has adopted the rules common to other commercial fields. Thi s is a potentially dangerous trend because it undermines what should b e the main goal of drug development, i.e. to make active medicinal age nts available to the patient with precise and reliable information, at the lowest possible cost, particularly when a national health system has to supply the drugs to patients who have too low an income to pay for them. The huge drug market has also set in motion a competition am ong pharmaceutical firms. This has meant that as soon as a prototype d rug becomes available several other similarly active compounds immedia tely follow. These followers are usually called ''me-too drugs''. Me-t oo drugs can be broadly defined as chemically related to the prototype , or other chemical compounds which have an identical mechanism of act ion. This increasing marketing of me-too drugs has been questioned, so pharmaceutical firms are justifying the development of not-so-innovat ive drugs. The most common arguments can be summarized as follows: me- too drugs offer an improvement on the efficacy of the prototype; they show a different profile of adverse effects; they are effective in pat ients resistant to the prototype; they improve compliance in long-term treatment; they are less expensive than the prototype, It is the purp ose of this paper to review the evidence substantiating these statemen ts, giving some figures regarding me-too drugs and presenting a few ex amples.