One of the most important jobs of the FDA is to provide the public with clear information about drug safety. Another mission is to reveal what it knows about potentially defective drugs.

How well the FDA is doing with its primary mission is being questioned by Representative Joe Barton (R-Texas) who wrote a letter to the US Government Accountability Office: asking is the FDA telling us everything it knows?

The GAO is being asked to review the FDA’s handling of the contaminated heparin problems of 2007 and 2008. In his letter, Barton notes that the FDA’s statements to the media in July 2008 indicate that the agency had “conclusively linked” deaths of three patients to oversulfated chondroitin sulfate found in specific lots of the drug, which is manufactured by Baxter Healthcare.

Yet when Barton requested information, the agency told him in October 2008 that it was merely “possible” that heparin caused two of the deaths and that it could not assess whether heparin caused the third death, while Baxter’s investigation of the situation concluded that it was unlikely that heparin had caused any of the three deaths.

The FDA did not interview Baxter to get more information about the deaths and that inconsistency troubles Barton.

Could drug companies be cooking the books where it comes to getting FDA approval for new drugs?

Recent research published in the journal Public Library of Science Medicine shows that many drug studies submitted to and read by the U.S. Food and Drug Administration go unpublished.

In addition to that, some that are published sport inconsistencies between the study that was submitted and the study that was subsequently released. Changes included additions and/or deletions, statistical alterations of outcomes and changes in trial conclusions.

In general, reports that show the studied drug in a favorable light are much more likely to be published. Of forty-three trials that showed no benefit to the test drug, only half were published.

This kind of dishonesty in the medical field can be very dangerous, possibly misleading doctors and patients alike while they make important decisions about the patient’s health. Unfortunately, discrepancies such as these can be very hard to detect or prosecute.

The Texas defective drug attorneys at Cappolino, Dodd & Krebs are concerned about your health. Have you been injured by a defective drug? Contact us today.

The US Food and Drug Administration (FDA) is trying to determine if television drug advertisements should be required to include a toll-free number that consumers can use to report side effects associated with their medications.

While this seems to be a good idea, opponents believe that the information could “distract” consumers away from important drug safety information.  Print ads currently contain the toll-free number, and the FDA is now required by law to include the number on their TV ads. However, the FDA has had an extension in testing the effects of the number and is expected to being a study shortly. They plan on showing fictitious ads to consumer groups and then interview those groups to determine comprehension levels.

Critics of the current advertising practices claim that situations in which medications are over-prescribed before full effects are known occur too frequently. They contend that educating consumers on how to report side effects to the FDA will lead to quicker action in addressing safety problems. Right now, consumers generally tell their prescribing physician of a drug side effects, and that information is not always reported to the FDA.