Originally published June 11 2005
Medicare proposes new adverse drug reaction tracking system
by Mike Adams, the Health Ranger, NaturalNews Editor
Adverse drug reactions in the United States are currently reported through the FDA's voluntary reporting system, which generally misses about 90 percent of serious drug side effects. Medicare recently proposed using the new prescription drug program -- set to start in January -- to track the number of users on a particular drug and record adverse drug reactions. Experts say the Medicare proposal would do a much better job of tracking serious drug side effects, but the FDA's response to the proposal was mild. An FDA spokeswoman said it was too early for the FDA to commit to a new system, but it is under consideration.
For years, the Food and Drug Administration has struggled with medications that are approved for market but later turn out to have serious side effects its reporting system failed to spot.
Now, a proposal that could be a big step toward solving the problem has been offered by no less an authority than the head of the federal Medicare system.
Whether it's a suspected link between Viagra and rare cases of vision loss or heart attacks among arthritis patients using Vioxx, the FDA's current system of voluntary reporting picks up no more than 10% of serious drug reactions.
To help shrink the knowledge gap, Medicare head Mark McClellan, a doctor and an economist who once ran the FDA, has proposed a Medicare-based system to track the safety and effectiveness of medications.
McClellan proposes taking billing data from the prescription program, which will begin in January, and combining it with healthcare information already collected when Medicare users submit claims for hospital and doctors' care.
The Medicare-based system was one of several ideas discussed at a recent FDA drug safety advisory committee meeting on ways to improve monitoring and reporting.
The UnitedHealth system could cover as many as 20 million of its patients; the Medicare plan could cover as many as 43 million people, including some of the sickest and most vulnerable, whom drug companies don't usually enroll in clinical trials.
The health outcomes of patients taking each of the new drugs will be compared with results for patients using the current leading drug prescribed for the same medical problem.
Dr. John Santa, assistant director for health projects at the Center for Evidence-Based Policy at Oregon Health & Science University, said the Medicare data could prove very valuable to doctors and patients trying to sort through the claims of drug makers.
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