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of Science Medicine shows that many drug studies submitted to and read by the U.S. Food and Drug Administration go unpublished.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.

Labels on the antipsychotic drug Zyprexa don’t warn patients of all its potential side effects.

That’s according to the FDA which says it is looking into requiring the drugs’s manufacturer, Eli Lilly,  to include information about some of the drug’s more recently publicized risks and adverse effects such as weight gain, in children, hyperglycemia, and other metabolic effects.

While Zyprexa—a potent brain tranquilizer that calms hallucinations related to schizophrenia and bipolar mania—is only approved for the treatment of schizophrenia and bipolar disorder, it was marketed for use in milder cases of bi-polar disorder and for dementia.

Also, internal Lilly documents and e-mail messages confirm Lilly marketed Zyprexa off-label. It was later found that Zyprexa can cause severe weight gain and an increase in blood sugar in many patients.  According to the American Diabetes Association, Zyprexa is likelier to cause diabetes than most other medicines for schizophrenia and bipolar disorder.

Last month, Lilly, in its ongoing Zyprexa scandal, agreed to pay $62 million to 32 states and Washington, D.C. to settle claims it improperly marketed Zyprexa.  CNN reported in an earlier release that, since 2005, Lilly has paid out over $1 billion in liability claims connected to Zyprexa.  CNN also pointed out that Lilly faces more problems, including a civil and criminal investigation led by federal prosecutors in Philadelphia.