In Order to Monitor Drug Safety A Public Database Is Suggested


A new study just released this week in Archives of Internal Medicine offers an interesting proposal to determine a drug’s risks sooner than they might otherwise become evident so that another Vioxx mishap could be avoided. It is suggested that a system to examine widely prescribed drugs through safety analyses that would pool data as they come into view from various clinical trials of a medication and collect the information for a complete picture of a drug’s harms and benefits.

The study proposes an important and broad model for monitoring drug safety that would consist of very detailed information that could publicly be available to independent researchers to analyze it. If a database were to be made available, it could be continually updated with new information, as the results of new studies were published, to calculate a near real-time balance sheet of a drug’s risks and benefits.

Dr. Joseph S. Ross, author of the study, said the objective of the researchers was to determine whether this kind of cumulative analysis could serve as a new model for monitoring the safety of drugs after they enter the market. “How could we be doing post-market surveillance in a better way?” said Dr. Ross, an assistant professor of geriatrics and palliative medicine at Mount Sinai School of Medicine in Manhattan. “For drugs that we are concerned about, that are high risk, this could be a blueprint going forward.”


In 2007 Congress passed an amendment to the federal drug law that has given the agency authority to necessitate drug makers to place a risk management program for certain drugs and to conduct post-market safety studies. The amendment also gives the agency the power to order changes to drug labels to reflect new safety information and requires drug makers to make public the results of clinical trials.

There are some critics that say Congress should give the agency more power and more resources to provide more n depth information of the drug to doctors and consumers. More information would be helpful, say the critics because the studies are required to gain approval for a new drug is often too short in duration or too small to identify all serious side effects. Problems associated with a drug may not become known until it is used over time by several hundreds of thousands of people.

“There is this kind of dogma in medicine that you shouldn’t use any drug for the first seven years after it’s released, because it takes that long to figure out its harms and benefits,” said Dr. Michael Steinman, an assistant professor of medicine at the medical school of the University of California, San Francisco.

Elliott M. Antman, a professor of medicine at the Harvard Medical School says “There are so many drugs on the market that it would probably be impossible, if not prohibitively expensive, to cumulatively track all of them.” Antman said it would make sense for the agency to give conditional approval to certain new drugs, requiring drug makers to file cumulative analyses of safety and efficacy data several years later in order to obtain permanent approval.