Advocates Pursue
When can a well-designed clinical trial provide only minimal help in evaluating a new drug? It is when the trial’s results go unreported.
Medical journals are filled with reports on the safety and effectiveness of new medications, but they represent only a portion of all the studies conducted. For the most part, published reports reflect the exciting news about drugs that show therapeutic promise. Studies that cast doubt on the value of new medicines are less likely to find their way into print, but the bad news can be as important as the good news in making clinical decisions.
Drug manufacturers, pharmacy benefit managers (PBMs), pharmacist groups, and other health care industry players are all using the draft Medicare drug formulary suggested by the U.S. Pharmacopeia (USP) Convention for target practice. The USP issued its draft guidelines in mid-August 2004, then held a hearing on them in late August. The organization will publish final guidelines later this year. The Centers for Medicare & Medicaid Services (CMS) either will adopt the guidelines as is or will make some changes.
Prescription drugs represent a growing cost in the provision of health care. New drugs are now used in treatments for which older drugs were not developed. In addition, existing drug treatments are being replaced by newer, sometimes more costly, drugs.
INTRODUCTION
