Author: John R. Durant, M.D., former Executive Vice President of the American Society of Clinical Oncology (ASCO), CancerSource Medical Advisory Board member This article is nicely timed to attempt to influence the current Congressional consideration of the renewal of the arrangement by the pharmaceutical industry to help the FDA's chronic and severe underfunding problem. The goal of the legislation is to produce more timely reviews of applications for new drugs by charging a fee for the reviews. The article is begging for more information in order to correctly interpret what it means. What was the nature of the drugs that became associated with "new" side effects? Who used them? Were they given for the proper indication and under the proper conditions? Were they new molecules to be used for serious, life-threatening diseases where it is often hard to tell death from the disease from death due to the drug? For what kind of diseases were they intended? If they are agents for non-serious symptoms such as insomnia, dyspepsia, mild pain, etc., then a very rigid study of the associated side effects would be appropriate. If not, those of us in oncology are used to using the production of side effects in order to determine if an effective dose has been given. Finally, no attempt was made to compare this data with that of Europe where the review process has always been speedier but no less rigorous than that in the US. It is perfectly clear that the FDA is underfunded, and the appointment of a director is subject to political factors, often more than scientific credibility. Now there is no director, and the staff is on their own, making decisions according to rules which appear often to be characterized as "one shoe fits all." None of this is meant to imply that there are not serious side effects due to new agents and that the identification of all of them may take many years. The real concern that this reviewer has is that this article is missing some of the most important details about the drugs and circumstances in question. There is a risk that the conclusions the authors have at the end of the paper may be used to try to change public policy in important ways which may have unintended bad consequences. Life is, after all, a risky business, and the risks must be weighed against the benefits, which wasn't done in this case. I, for one, don't want someone to deprive me of great benefit in order to protect me from a small risk. I interpret this article as not being of value to patients except to remind them that side effects of all drugs exist, and one should be sure to take all drugs under the direction of a competent physician. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.