Saturday, April 21, 2012

Recovering From Actos-Related Bladder Cancer: Part 2 of 2: What All Actos Users Should Know:

Actos, a drug used in the treatment of Type 2 Diabetes has been shown to carry a risk of bladder cancer, particularly among those who are elderly or who have taken the drug in higher doses or for extended periods of time (longer than one year). Although the drug has not yet been recalled by the FDA, it has fallen under intense scrutiny and has been pulled from the French and German markets. Those found to have bladder cancer will generally undergo an operation to remove the tumor however among those patients who have had their bladder tumor completely removed there is a fifty percent rate of recurrence within the first year.

Because of this extremely high level of recurrence, additional therapy is generally recommended. One of the therapies believed to significantly lower the risk of a tumor recurrence is known as BCG or Bacillus Calmette-Guerin. BCG is a form of live bacteria which is related to cow tuberculosis and is given as a vaccine against tuberculosis in several countries. Although the mechanism through which BCG works is not fully understood, it is believed to trigger the immune system in the body, directing it to destroy any potential leftover cancer cells which remain in the bladder following surgery.

What is BCG and What Does it Do?

In fact, BCG is possibly the most widely used vaccination worldwide and is made from a weak strain of Mycobacterium bovis which is a close cousin to the tuberculosis bacteria. BCG was first developed over eighty years ago and remains the only tuberculosis vaccination in use today. The BCG vaccine is not used in the United States as a TB vaccination since the disease is not prevalent in American therefore there is little chance infants and children will be exposed. Additionally, BCG can cause the skin test commonly used to detect tuberculosis to read a false positive which could render the skin test virtually useless.

Beginning in the 1980’s BCG has been used in the treatment of less serious forms of bladder cancer. BCG is widely considered to be an effective form of immunotherapy for those with more superficial forms of bladder cancer although physicians are not entirely clear about how it works. BCG is believed to use the immune system to fight cancer by recreating naturally occurring agents found in the body in the form of white blood cells and certain bacteria. The body is able to tell the difference between cancer cells and normal cells, therefore the BCG “knows” what it needs to attack. Regardless of how BCG works to prevent the recurrence of bladder cancer, it has been definitively shown to reduce the risk of the tumor returning.

What is the Effectiveness of BCG?

Studies have shown that immunotherapy using BCG can prevent recurrence in 40-67% of the less serious bladder cancer cases and has also shown promise when used in the treatment of recurring colorectal cancer. Additionally, BCG has shown promise in reducing multiple sclerosis symptoms and in the suppression of certain Parkinson’s disease symptoms. Those who are considered to be at serious risk of bladder cancer recurrence will likely be advised to begin BCG treatment within two to six weeks of the initial surgery.

The BCG therapy will be administered weekly over a period of six weeks with additional booster treatments known as maintenance therapy to follow. When used in conjunction with the transurethral resection procedure, BCG is considered to be the most efficient treatment for non-invasive types of bladder cancer and can significantly delay further tumor growth potentially decreasing the necessity of bladder removal at a later date. Due to the aggressiveness of bladder cancer tumors, it is strongly suggested that patients follow up with their physician regularly to determine whether there is any recurrence of the cancerous tumor.

What is the Process Used in the Administration of BCG?

BCG is a solution which is introduced into the bladder via a catheter. Once the liquid solution has been introduced into the bladder the patient is required to hold it there for at least two hours. Potential side effects following BCG treatment can include bladder irritation, a frequent or urgent need to urinate or pain upon urination, exhaustion, bloody urine, an elevated body temperature, chills and nausea. Body aches are a frequent side effect of BCG treatment as well, and any potential side effects will generally start within a two to four hour window following treatment. Lesser side effects should resolve on their own within two days, although patients who develop a fever higher than 100.5 degrees or drenching night sweats which continue past the initial 48 hour period should consult their doctor immediately.

More serious side effects of BCG also include the development of hepatitis or an abscess, lung tissue inflammation, inflammation of the prostate or testicles in men, or an allergic reaction to the treatment. Although rare, infection which floods the entire body has been noted following BCG treatment. Should the bladder cancer recur, doctors will generally advise removal of the bladder or another six week course of BCG. Those with a very high risk of recurrence could be advised to continue maintenance BCG treatment in hopes of delaying the recurrence. Some studies recommend BCG maintenance treatment continue for as long as a year, although in some cases maintenance treatment can continue for as long as 36 months. While the BCG treatment is not considered to be especially painful, it can cause minor to significant levels of discomfort.

Those who have taken Actos, particularly for longer than a year or in higher dosages should be diligent in having their doctor monitor them for signs of bladder cancer. While your physician will advise you of the best treatment option for your specific level and type of bladder cancer, you might want to ask about BCG and how it could fit into your treatment.

Author: Sullo & Sullo Attorneys

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