Monday, April 23, 2012

Recovering From Actos-Related Bladder Cancer: Part 1of 2: How Can I Prevent a Recurrence?

Introduction to Actos

Actos, or pioglitazone, is a prescription medicine used in the treatment of Type-2 diabetes and works by sensitizing cells to the pancreas-produced hormone known as insulin. Insulin is used by the body to regulate the amount of sugar or glucose in the body therefore when cells are more sensitive to insulin, sugar in the blood naturally moves more easily into cells. When Type-2 diabetes is left untreated, injury to the kidneys, damage to the retinas, impairment of the nerves resulting in limb amputation and acceleration of fat plaques on the interior of the arteries leading to blood clots and strokes are all possible scenarios. The use of Avandia, the sister-drug of Actos, came under fire when evidence came to light of an increased heart disease risk among those taking the drug.

Avandia’s problems actually offered a huge boost in sales of Actos which was quickly touted as a safer alternative to Avandia by its manufacturer, Takeda Pharmaceuticals. Actos was first introduced in the late 1990’s as one of essentially three drugs which were known to treat Type 2 diabetes. Rezulin was pulled from sales due to an amplified occurrence of drug-induced hepatitis while the sale of Avandia was severely restricted in the U.S. and the drug was completely withdrawn from the market in Europe. As a result Actos dominated the market, making Takeda over $3.4 billion dollars in one year alone. Although the recent issues regarding the safety of Actos have alarmed those taking the drug, safety concerns have followed Actos for several years.

Risks of Bladder Cancer: Actos Users vs. Non-Actos Users

The FDA-ordered safety reviews for Actos could hardly be considered positively conclusive however France pulled Actos from the Market in June of 2011 due to safety concerns. France took the initiative of conducting research of Actos in a huge safety study which incorporated over 1.5 million diabetic patients who were being treated with Actos. This particular study definitively correlated a higher incidence of bladder cancer with Actos, noting that risk of bladder cancer increased even more significantly among those patients taking the drug for periods longer than a year. Soon after France pulled the drug, German officials advised physicians against prescribing Actos based on the results of the French study.

The American FDA is of the opinion that the risk of bladder cancer in those taking a higher dosage or using Actos for longer than a year can be as high as 40%. The FDA also noted that the elderly carry an even higher risk and that alternative drugs should be used in older patients. While the FDA has not yet initiated a recall of Actos they are advising physicians to use caution and a full range of comprehensive assessments prior to prescribing the drug. Doctors should avoid prescribing Actos for any patient who currently has bladder cancer or has a history of bladder cancer. The American Diabetes Association studied the health history of over 30,000 diabetes patients aged 40 or younger who were treated with Actos between the years of 1997 and 2002. Patients who took Actos for more than two years showed a significant increase in the risk of acquiring bladder cancer. In another study detailed in Diabetes Care, 31 bladder cancer cases were linked to Actos use.

Risk of Recurring Bladder Cancer in Actos Users Following Remission

Bladder cancer has been powerfully connected to exposure to certain carcinogens as well as to the use of Actos, and it is believed that patients with other risk factors may be more susceptible to developing bladder cancer while taking Actos. Carcinogens such as cigarette smoke, dyes, industrial solvents, products used in the refinery of petroleum and some chemotherapeutic agents typically gain access to the urinary tract through urinary elimination. Since urine can be stored for extended lengths of time in the bladder, this makes the bladder extremely susceptible. The skin cell lining of the bladder falls under a specific category from which most forms of bladder cancer manifest. Patients who developed bladder cancer following the use of Actos, received treatment and went into remission may wonder what their chances of a return of the disease might be.

Following the removal of a tumor in the bladder the residual bladder lining still has a very real risk of suffering a reappearance of the malignancy through the formation of new tumors. Those who have continuing contact with specific toxins inflate the risk of bladder cancer recurrence yet the primary risk of recurrence is highly dependent upon the aggressiveness of the initial tumor. Additionally, since the treatment for most forms of bladder cancer involves removing the tumor through scraping, it is always possible that some cells will be dispersed into the bladder and re-attaching to the scraped area. In some cases chemotherapeutic agents are injected into the bladder following tumor resection, thereby reducing the overall risk of bladder cancer recurrence. In the face of a bladder cancer diagnosis alternate treatments for Type 2 diabetes must be sought and the use of Actos discontinued.

Is the Risk of Bladder Cancer Recurrence Lowered Through the Use of BCG?

BCG, short for Bacillus Calmette-Guerin is being used in the treatment of early stage bladder cancer as well as to prevent the recurrence of noninvasive types of bladder cancer. BCG treatment is most often used when cancerous tumors have been removed from the bladder through a process known as TUR or transurethral resection although it is used in a limited manner in those who underwent other forms of bladder cancer removal process. When used as a treatment for bladder cancer, BCG is introduced into the bladder through a urinary catheter. BCG is used in certain countries as a vaccine which provides protection against the disease of tuberculosis; the solution used to prevent bladder cancer recurrence contains live, weakened bacteria believed to stimulate the body’s immune system into destroying any recurring cancer cells in the bladder.

Once the solution is introduced into the bladder via the catheter, the patient will be required to hold the solution inside the bladder for at least two hours. Typically this procedure will be performed weekly for a period of six weeks. Studies have shown that the administration of BCG in combination with transurethral resection of the bladder tumor is the most efficient remedy for invasive levels of bladder cancer which are not muscular in nature. BCG has been proven to prevent tumors from increasing in size and severity, to lessen the need for the removal of the bladder at a later time and overall to improve survival rates in those with bladder cancer. BCG will be discussed in greater detail in Part Two of this article.

Author: Sullo & Sullo Attorneys

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