Archive for July, 2009

The FDA has been experimenting with new computer technology as part of a broader effort to test the safety and effectiveness of new drugs and to spot potential problems earlier on in the process.  The technology, called the Cardiovascular PhysioLab, designed by Entelos Inc. of Foster City, California, is being used with three drugs being studied for heart-related conditions.  The technology uses a mathematical model to simulate how the human body will react to certain chemical characteristics of drugs.  The goal, thus, is to use the virtual model to predict whether such drugs might cause cardiovascular problems and, if so, in what types of patients. 

While such novel efforts certainly show that the FDA is making a strong effort to research and consider the most groundbreaking technologies to ensure the safety of new drugs, it is likely that people will remain skeptic of what appears to be a computer program acting as a substitute for real patients until it has shown consistent, reliable results.  Simply punching in the characteristics of a given patient and a particular drug to obtain a computer-generated result cannot guarantee the absolute same result in a living, breathing person.  However, this could be a step forward at least in assisting the process and anticipating whether a drug could be dangerous for certain people before such adverse effects may occur.  Read more about dangerous drugs and possible side effects.

Approximately 58 billion dollars worth of privately funded prescription drug research is currently being conducted, which makes it nearly impossible for medical journals to assess and publish the clincial tests or their findings. For this reason, there are a large amount of clinical tests that are never made publically available, and clinical tests results that are unpublished may be the result of deals struck between the medical journals and pharmaceutical companies.

Medical experts at UCSF and the University of Washington have discovered that only slightly more than fifty percent of Food and Drug Administration (”FDA”) filings involving new drugs are published, and only 20% of clinical trials for cancer drugs are ever disclosed in a medical journal.  While all of the clinical trial data must be submitted to and read by the FDA, some medical policy analysts worry that failure to publish cinical trial results could lead to dangerous situations in which the public does not have adequate information about new drug side effects.

Also, researchers reviewing the FDA’s paperwork have discovered that in some clinical trials submitted for publication, results were changed and outcomes altered to make the drugs look more effective.  In 75% of the cases in which clinical trials were altered before publication, the published version of the study was more favorable and side effects were not accurately described.

But those concerned about seeing the accurate and complete results of clinical tests now have the option to do so. The FDA has imposed more stringent reporting requirements, and researchers will be forced to publish their basic results on a federal online registry maintained by the National Library of Medicine. That registry can be found at www.ClinicalTrials.gov and has already logged 65,000 studies to help create transparency between researchers and the public.