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Alsabagh v. Takeda Pharmaceuticals

Dr. David Feigal, an expert on drug development and regulation, testifies regarding the history of warnings and testing surrounding Actos.

The Expert: Dr. David Feigal, an expert on drug development and regulation, testifies regarding the history of warnings and testing surrounding Actos.

By Dr. Gary F. Gansar, MD, FACS
Senior Physician Medical Director, AMFS

During a 2013 Nevada trial over whether Takeda’s diabetes drug, Actos, caused a user’s bladder cancer, Dr. David Feigal, an internist and expert on drug development and regulation, testifies for the defense regarding the history of warnings and testing surrounding the drug.
In this clip, the attorney and the expert explore the history of the company’s labeling concerning bladder cancer and Actos. The original labeling on the drug was from 1999. As new reports of bladder cancer developing in patients taking Actos arrived, the company investigated each one and reported their findings to the FDA. In 2003, the labeling was changed with FDA approval to reflect the fact that these reports were coming in. This new labeling cautioned about the possible association of Actos as a carcinogen.
In 2004, the label was again changed. The FDA was becoming aware of the problem occurring in drugs of the same family as Actos. These drugs work by stimulating either alpha or gamma peroxisome proliferator-activated receptors [PPAR]. In those drugs that utilize both receptors, the incidence of tumors in animal subjects was unusually high. Actos does not utilize both receptors; Actos utilizes only PPAR-gamma. But, in line with the FDA philosophy of letting people know about the facts that are known even if they don’t understand what the significance of those facts are, the cautions about this other drug, made by a different company, were included with Actos since the two drugs are in the same family.
The label was again modified in 2006. There were two concurrent studies being done on Actos. One was for liver safety and the other was a “proactive study.” Because the characteristics of these groups studied were so uniform, and they were all taking Actos, it was decided to test both groups for bladder cancer. Urine analysis for bladder cancer cells was performed, and 16 patients were positive, while 5 were positive in the control group. These were further refined to reflect only those patients that had been taking Actos for at least a year since exposure for less than that may include patients who already had bladder cancer, a slow growing malignancy, prior to exposure to Actos. Out of these 1300 patients taking Actos for more than a year, 6 were positive and 2 positive in the control group. This information was included in the label change. The expert testifies that these numbers are so low, that they could be occurring with the same frequency of a coin toss. Still the information is useful because it says that this carcinoma is not occurring very often.
Finally the doctor explains that in a situation like this, the FDA sees its role as informing doctors and patients of the facts without drawing any conclusions. The doctor and patient can then decide whether to accept the possible risk of carcinoma of the bladder based upon their own assessment of their individual situation.
The verdict came in for the defense.

About the Author Dr. Gary F. Gansar, MD, FACS

Gary Gansar, MD, is residency-trained in general surgery. He served as Chief of Surgery and Staff at Elmwood Medical Center and on the Medical Executive Committee at Touro Infirmary and Mercy Hospital in New Orleans, LA. Dr. Gansar was Board Certified in general surgery while in active practice. He joined AMFS in 2015 as a Physician Medical Director.

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