Actos News

Expert Alleges Study of Diabetes Drug Actos Hid Vital Data   
March 30, 2013

Four years ago, Marcia Angell, the former editor-in-chief of The New England Journal of Medicine, wrote a piece for The New York Review of Books in which she asserted, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.”

The case of Takeda Pharmaceutical’s diabetes drug Actos (generic name pioglitazone), which has been linked to bladder cancer and is now the subject of over 3,000 lawsuits, provides a wealth of evidence suggesting Angell was, and continues to be, right. The first of those lawsuits to go to trial was brought by a California man, Jack Cooper, who claims Actos caused his bladder cancer. The trial is currently underway in California state court in Los Angeles.  

In a report filed with the court, plaintiff’s expert James Morrison stated that a prominent clinical trial involving Actos, known as the PROactive study and published in The Lancet in October, 2005, demonstrated a link between the drug and bladder cancer – a link that Takeda concealed in its Lancet paper. The substance of Morrison’s charge deals with the following passage, taken directly from the study:

There was no difference in the overall incidence of malignant neoplasms. There were some imbalances in the incidence of individual tumours. There were more bladder tumours (14 vs six) …reported in the pioglitazone group compared with placebo.

Neoplasms and tumors both represent abnormal tissue growth, but that growth can be benign or cancerous (malignant). According to Morrison, the PROactive study “did show a significant imbalance (14 to 5) between the Actos treated arm and the non Actos arm for bladder malignancies.” But instead of reporting that the Actos group developed significantly more malignant tumors, says Morrison, “Takeda chose to emphasize the non-statistically significant nature of the bladder neoplasms, since there was one benign tumor in the non Actos arm, bringing the imbalance to 14 to 6 [which was not significant statistically].” 

In other words, Takeda, while choosing to report a non-significant finding regarding overall malignant tumors (combining bladder, breast, lung and other tumors into one statistic), as well as a non-significant “imbalance” involving malignant and benign tumors, failed to report the fact that patients who took Actos had significantly more malignant bladder tumors than those who didn’t. Employing a form of linguistic and statistical sleight-of-hand, the authors of the study were able to make an important finding “disappear.”

Did Takeda lie? Not exactly. But its study appears to have left out key data and presented findings in such a way that only the most dedicated reader, willing to delve into the actual statistics, would discover the truth.  Sadly, this is just the sort of subterfuge that led to Angell’s conclusion and contributes to keeping doctors and their patients in the dark, until lawsuits reveal the critical, but hidden, details.



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