Recent SCIENCE Article a Potential Game Changer for Arguing Medical Causation in Cancer Cases: Stem Cell Division and “Bad Luck”

By on January 8, 2015

This month’s Science Magazine features a paper by two Johns Hopkins scientists that provides support for a more refined theory of causation in a number of types of cancer.  The article by Drs. Christian Tomasetti and Bert Vogelstein entitled “Variation in Cancer Risk Among Tissues Can Be Explained By The Number of Stem Cell Divisions” includes the following abstract:

Some tissue types give rise to human cancers millions of times more often than other tissue types. Although this has been recognized for more than a century, it has never been explained. Here, we show that the lifetime risk of cancers of many different types is strongly correlated (0.81) with the total number of divisions of the normal self-renewing cells maintaining that tissue’s homeostasis. These results suggest that only a third of the variation in cancer risk among tissues is attributable to environmental factors or inherited predispositions. The majority is due to “bad luck,” that is, random mutations arising during DNA replication in normal, noncancerous stem cells. This is important not only for understanding the disease but also for designing strategies to limit the mortality it causes.

This finding may have broad implications in determining what may cause the cancer at issue in a particular case.  This article concludes that the incidence or lifetime risk of many cancers directly correlates to the number of stem cell divisions in the tissue involved in the cancer.  This correlation appears to be, in many cases, independent of any environmental or external factors.  Because the article provides a potential explanation for the cause of many types of cancer, this may allow experts to use rate of stem cell division as a causation argument in lieu of saying the cause is “idiopathic.”

Interestingly, among the cancers that have a higher rate of stem cell divisions are acute myelogenous leukemia and chronic lymphocytic leukemia, two types of cancer that are prevalent in matters involving allegations of exposure to trace benzene. Many cancer patients use a cbd store locator to buy their natural medicine. This fact will certainly be the source of future argument regarding general causation.  We expect there to be future scientific inquiry into the findings in this article, but the findings alone do raise important issues.  Further studies in this area may provide further support for arguing against an environmental correlation between cancer risk and exposure in cases where the cancer involved has a high rate of stem cell division.  We expect that this study and future studies will have a significant effect in matters involving allegations of toxic exposure.

Filed under acute myelogenous leukemia, Benzene, Cancer, Causation, chronic lymphocytic leukemia, stem cell

Fallout From the Actos Verdict: Asbestos Plaintiffs Bar Seeks New Clients

By on June 11, 2014

The stunning $9 billion verdict in Louisiana this past April against Takeda and Eli Lilly for their manufacture and sale of Actos as a medication (Actos is a thiazolidinedione or TZD drug) for the treatment of diabetes has been well reported. Many plaintiffs firms have sought to capitalize on this result by advertising their services to prospective plaintiffs diagnosed with bladder cancer.  Published studies and the FDA have posited that prolonged use of Actos increases the risk of contracting this cancer. TV ads and proclamations of expertise abound on websites that are linked to “Actos” as a search term.

The lure to the plaintiffs bar must be compelling as the pool of prospective plaintiffs is large.  The American Cancer Society has reported that as many as 73,000 cases of bladder cancer were diagnosed in the United States in 2012.  The published five-year survival rate for bladder cancer, while good if the diagnosis is made early, is very dire if the disease is found late.

The economics of cancer research, and not just the litigation that follows the introduction of new therapies, is impressive.  An article in the June 3 San Francisco Chronicle describes the efforts of Genentech to pursue a new therapy for bladder cancer.  A new immuno-oncology treatment has shown promise and the article in the business section of the paper includes a prediction that cancer immunotherapies will be a $35 billion industry worldwide “in less than a decade.”

In the print version of this same paper, on page A10 in the opinion section, there is a large ad titled “Actos and Bladder Cancer” placed by Weitz & Luxenberg P.C. The ad proclaims, “The manufacturers and marketers of Actos have recently been found liable for Actos causing bladder cancer.”  It goes on to urge Actos users, “Even if you have not developed bladder cancer, it is in your best interest to contact us (through our website or phone) in order to receive helpful information updates in the future.”  While Weitz & Luxenberg are perhaps best known as asbestos litigation attorneys, it notes in the ad, “Weitz & Luxenberg are NATIONWIDE LEADERS in the Actos and Bladder Cancer field.”

Clearly, high stakes are involved in the development of cancer therapies, and just as clearly high stakes are involved in any potential subsequent litigation.  But if the entire worldwide market for immunotherapies over the next 10 years is predicted to be approximately $35 billion, one must wonder whether the prospect of facing a civil case verdict of as much as $9 billion might impact the decisions of companies such as Genentech in pursuing new therapies and ultimately how to price such therapies.

Filed under Cancer, Immunotherapies, Litigation, Thiazolidinedione (TZD) Drugs, U.S. Food and Drug Administration