Bladder cancer is a form of cancer that originates in your bladder.  Your bladder is found within your pelvic area and is an organ shaped like a balloon that stores your urine. Bladder cancer normally begins within cells which line your bladder’s insides.  It often affects older adults; however, it can happen to anyone regardless of age.

Depending on how cells appear when examined under a microscope, you can categorize bladder cancers into several types. Each responds differently to treatment.  Bladder cancer is normally described depending on how far it invades the bladder wall.  There is:

  • Non-invasive bladder cancer which still invades the transitional epithelium or inner layer of cells but hasn’t reached the deeper layers yet.
  • Invasive bladder cancer which spreads deeper into muscle layers or the lamina propria.  This type of cancer tends to spread and is harder to treat.

Other ways of describing bladder cancer are non-muscle invasive and superficial.  Both terms include both invasive tumors that have spread into the bladder’s main muscle layer and non-invasive tumors.

Bladder Cancer Types

The most common form of bladder cancer is known as Transitional cell (urothelial) carcinoma (TCC) and is found in 9 out of 10 cases of bladder cancer, or about 95 percent, according to John Hopkins Medicine. The cells from this type of cancer look similar to urothelial cells which are what line the inside of your bladder and other sections of the urinary tract like the ureters, kidneys and urethra. It’s not uncommon for TCC to spread to areas like this as well. In fact, many bladder cancer patients tend to have other tumors in areas like the ureters, urethra, and kidneys. Once cancer is found in one area of the urinary system, it is necessary for the whole urinary tract to be examined for tumors.

There are other types of bladder cancers; however they are not as common as TCC, according to the American Cancer Society. These include:

Squamous Cell Carcinoma

Only around 1-2 percent of bladder cancer cases are squamous cell carcinoma in the United States. The cells in this type of cancer when observed under a microscope look like the flat cells which are located on the skin’s surface. Just about all cases of this cancer are invasive.

Adenocarcinoma

Approximately one percent of bladder cancer cases are adenocarcinomas. The cells in this type of cancer have a lot of similarities of the colon cancer gland-forming cells. Most cases of this cancer are invasive.

Small Cell Carcinoma

Less than one percent of bladder cancer cases are small cell carcinoma. This type of cancer starts in the neuroendocrine (nerve-like) cells. It grows quickly and often requires chemotherapy treatment to manage it.

Sarcoma

Sarcoma starts in the bladder’s muscle cells and is typically rare.

With the exclusion of sarcoma, these less common forms of bladder cancers are treated in a similar fashion as transitional cell cancer, particularly when it involves early stage tumors. If chemotherapy is needed, however, different drugs may be required.

Key Bladder Cancer Statistics

According to the American Cancer Society, the estimated bladder cancer statistics for cases in the US for 2015 are:

  • Approximately 74,000 new bladder cancer cases diagnosed with nearly 57,000 of them in men and more than 17,000 in women.
  • Approximately 16,000 bladder cancer related death cases with roughly 11,500 cases in men and nearly 5,000 in women.

Over the recent years, new cancers and deaths resulting from cancer have dropped for women slightly. The rates of new incidences have decreased in men and death rates have remained stable. In the United States, over 500,000 people survive bladder cancer.

Incidences of bladder cancer increase with age affecting mostly older adults with 9 out of 10 individuals with this cancer being over 55 years old. Diagnosis is usually made around the age of 73 and men have a 3 to 4 times more chance of getting bladder cancer in their life than women. There is a one in 26 chance that men will get this cancer in their lifetime overall.

Link Between Actos and Bladder Cancer

Actos (Pioglitazone), made by Takeda Pharmaceuticals, is a drug used for treating Type 2 diabetes. It is taken orally in tablet form and is not used for treating diabetic ketoacidosis or Type 1 diabetes. Doctors usually start patients off on a 15 or 30 mg dose that they take once daily. In some cases, a stronger dose is needed and the strength of the drug can be increased in 15 mg increments. The dose usually does not exceed 45 mg.

The US Food and Drug Administration (FDA), as reported by the American Cancer Society, states that using Actos (pioglitazone) for over a year could increase the chance of bladder cancer.

There have been several studies recently that have shown a stronger link between this drug and bladder cancer than clinical trials have indicated. The FDA, back in June 2011, published the ‘Drug Safety Communication’ which indicated there was a 40 percent increase in risk of developing bladder cancer through the use of Actos based on duration of use and dosage.

Following preclinical trials which showed increases in urinary bladder tumors in rats, another study was done by Kaiser Permanente Northern California which was sponsored by the manufacturer of Actos, Takeda.  This was a 10-year study starting in 2002, which after a 5 year interim analysis showed a 40 percent increase in the risk of getting bladder cancer from the use of Actos for over 12 months.  Final results haven’t been released yet.  As of 2011, the FDA requires labels be placed on the medication regarding Actos and bladder cancer. This requirement was based off this analysis.

Actos Lawsuits and Settlements

On April 28, 2015, Louisiana’s US District Court in Lafayette, which oversaw nationwide Actos-related cases held in federal court, issued an order that recognized Takeda’s agreement for settling on all bladder cancer claims which were brought against them from users of Actos.

There are conditions that need to be met, however, to get part of the settlement which includes:

  • Use of the drug had to be before December 1, 2011.
  • Diagnosis of bladder cancer had to be on or before April 28, 2015.
  • Plaintiffs are represented by a lawyer or have retained a lawyer by May 1, 2015.

The amount of the settlement is between $2.37 billion to $2.4 billion depending on the number of claimants participating, reports The New York Times.

Representing people in the Actos (pioglitazone) case who have developed bladder cancer, Lieff Cabraser, supports the settlement and feels it is fair compensation for people participating in the case.

Average payments stand to be about $300,000, which is what the jury panel awarded John Kristufek.  Payments may increase for cases where more serious injuries were involved.  Likewise, reductions may also happen in cases where people who developed bladder cancer did so due to other risk factors, such as smoking and age.

There are around 9,000 Actos-related bladder cancer claims that are still pending against Takeda. It is said by the plaintiffs’ lawyers that the risk of cancer from this medication was concealed.  In fact, in a particular case last year that involved Eli Lilly, once co-marketer of the medication, and Takeda, a jury in Louisiana ordered Takeda to pay a combined $9 billion to Eli Lilly in punitive damages after they came to the decision that Takeda had indeed concealed the cancer risks. The award was later reduced by the judge to $36.8 million.

It was said in a news release that the decision to settle did not change Takeda’s commitment to Actos and it continues to be sold in the US, Japan and other countries.

The FDA plans to continue to monitor and evaluate data received from an ongoing  Kaiser Permanente Northern California (KPNC) study.