Editorial [ Risk Benefit: Who is Responsible? ]

As in other issues of Current Drug Therapy, we find discussion of a wide spectrum of topics. In addition to the scope of subjects, we see a variety of philosophical approaches, particularly in regards to benefits and risks of drugs. Some articles, for example “Some aspects on comparative efficacy studies with inhaled corticosteroids in asthma” by Dr. Olof Selroos focus on efficacy, while others deal primarily with issues related to safety, for instance, “Controversies of dopamine agonists: somnolence, cardiac valvulopathy and repetitive behaviors”, by Dr. Samay Jain. Other articles, such as “Coenzyme Q10 Reduction: Another Pleiotropic Effect of Statins”, by Dr. Hiroshi Mabuchi delve into both efficacy and safety. What this illustrates is an understanding of benefit and risk within the medical field. Unfortunately, the importance of understanding this balance is not as widely appreciated beyond the medical field as it might be. Nothing is without risk - and that includes medical therapies. While most people readily accept the risk of an auto accident in getting to work, they are often less willing to accept risk of side effects with medication, especially those more serious. There are probably many reasons for this, discussion of which is beyond the scope of this editorial. Sometimes it seems that people only want three things when it comes to drugs: 1) that they always work, 2) that they have no significant side effects, and 3) that they are cheap. Only the first two properties relate to benefit-risk considerations in the traditional sense. Clearly, no drug will work in all cases, and some patients will have side effects - occasionally serious or lethal. Where then does the responsibility for evaluation, communication, and acceptance of benefit-risk lie? Responsibility for evaluation of risks lies primarily with manufacturers, but consumers, medical professionals and regulatory agencies have to do their part in getting information to manufacturers. Manufacturers are usually very interested in communicating benefits, but will readily describe risks. Other groups - the medical community, regulatory agencies, and the media also play an important role in communicating a balance between benefit and risk. The media can play an important role in communication of benefits and risks. While more responsible an enlightened media have addressed the issue of benefit versus risk, all too often sensational headlines only deal with safety concerns, ignoring the benefit of therapies. Acceptance of risk is the most difficult element. Should it be the manufacturer that produced and marketed the product, regulatory agencies that approved it, physicians who prescribed it, or the consumer who chose to take it? If manufacturers make all information available, regulators evaluate all data available, and physicians discuss benefits versus risks with their patients, the final responsibility must be with consumers. Much has to change before this becomes a reality. In order to empower consumers with the ability to make informed choices, all of us in the medical community - manufacturers, regulators, and prescribers must do our part. The media can be a major force in disseminating information. Ultimately, however, the consumer must accept more responsibility.