Avandia Scandal: Leading Diabetes Doc Warned FDA About Risks In 2000

May 24, 2007

For now, Avandia is the New Vioxx.

The New York Times poked around the FDA web site and unearthed a letter written in 2000 by John Buse, chief of endocrinology at the University of North Carolina in Chapel Hill, who is about to become the president of the American Diabetes Association.

He cited “a worrisome trend in cardiovascular deaths and severe adverse events” among patients using the drug. He also accused Glaxo of "pervasive and systemic" attempts to minimize Avandia's risks and overstate its benefits.

What else was found? A warning letter issued by the FDA to Glaxo in 2001, chastising the drugmaker for distributing materials at an endocrinolgoy convention that didn't carry warnings on the Avandia label, which were ordred by the FDA to highlight heart and liver risks.

Buse wrote his letter in response to an FDA citizen's petition filed by Public Citizen's Sid Wolfe, who asked the agency to place warning labels on Rezulin, Avandia and Actos.

Referring to Avandia by its generic name, rosiglitazone, and to Rezulin as troglitazone, Dr. Buse wrote in the letter, “I do not believe that rosiglitazone will be proven safer than troglitazone in clinical use under current labeling of the two products.” He added: “In fact, rosiglitazone may be associated with less beneficial cardiac effects or even adverse cardiac outcomes.”

However, The Times omitted this interesting sentence by Buse about Rezulin: "To summarize, I believe that we may one day discover that troglitazone is the most effective, safe and beneficial drug in its class."

Hmm....Anyone recall what happened to Rezulin? Hint: you can't get a prescription anymore.

Further reading...

The New York Times;

The Buse letter to the FDA;

The FDA warning letter to Glaxo.

Saludos Cordiales

Dr. José Manuel Ferrer Guerra

Purkinje Cell Activity And Saccadic Adaptation

Saccades begin as commands from the cortex and converge on motor neurons under orders from the superior colliculus via the brainstem and cerebellum. These pathways adapt over a lifetime to maintain accurate saccades. This week, Soetedjo and Fuchs asked where those adaptations occur. The authors trained monkeys to focus on jumping targets and evoked adjustments by moving the targets during horizontal saccades. They recorded from Purkinje neurons in the oculomotor vermis, cells that are thought to control saccade amplitude and participate in adaptation. In 21 of the 27 neurons hey recorded, the authors were able to determine a direction preference based on the complex spiking (CS) activity of each neuron. CS activity during adaptation did not reflect the magnitude of the error, but it did reflect the error direction. Errors in the on-direction that required backward adaptation produced greater changes in CS activity than did control saccades or forward adaptation errors.

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News Tips from The Journal of Neuroscience

Contact: Sara Harris

Society for Neuroscience

Saludos Cordiales

Dr. José Manuel Ferrer Guerra

A slip on the ice can be tough on the ankles

Most people don't often realize, warned Dairman, that sprains and fractures often occur at the same time and a bad sprain can mask a fracture. "Just because you can walk on your ankle or foot after a fall doesn't mean you don't have a fracture."

Dairman advises "anyone who falls and has a great deal of swelling, bruising, and difficulty with walking to seek medical attention," to prevent further damage that can prolong recovery.

If that's not possible, it's best to follow the RICE strategy -- an acronym for Rest, Ice, Compression, and Elevation.

"Rest it immediately after the injury; apply ice to it, 20 minutes on 20 minutes off; apply compression, usually with an ACE wrap; and elevate it above heart level or at least above the hip to reduce swelling," Dairman explained.

"Sometimes a P is added to it to make it PRICE therapy, which is protection in the form of a cast or splint," he added.

Never soak the injured ankle or foot in warm water, Dairman stressed. "That's absolutely the wrong thing to do because that will increase the swelling, increase the pain, and prolong the injury," he said.

According to the ACFAS website -- FootPhysicians.com -- symptoms of ankle sprains and fractures overlap, but, in contrast to sprains, fractures are associated with pain at the site of the fracture that can extend from the foot to the knee. Also fractures often involve significant swelling, blisters over the fracture site, and bruising soon after the injury.

A fracture is obvious if bone protrudes through the skin, which is a sign of a compound fracture. This requires immediate attention.