Awhile back, we brought you an article about Takeda Pharmaceuticals, maker of the diabetic prescription drug Actos, discussing allegations of whether or not the company knew of the dangers of their flagship product. Central to the story is one Dr. Helen Ge, who worked for Takeda as a product reviewer. According to Dr.
IN August, when Takeda's patent on the diabetic drug Actos expired, the Food and Drug Administration (FDA) granted three pharmaceutical firms – Mylan, Ranbaxy and Teva – authorization to market their own generic version of the medication. One company's application was denied, however. That company – Watson Pharmaceutical – filed a lawsuit against the FDA in response.
It is no secret that the large pharmaceutical corporations have been caught with their pants down on numerous occasions over the past several years – and the situation just keeps getting worse. Recently, Boston University law professor Kevin Outterson prepared a compilation of data on “major violations” by major drug companies. His report included Glaxo-Smith-Kline (GSK), manufacturer of the diabetic drug Avandia – shown to significantly increase the chances of cardiac arrest.
This past August, yet another study was published demonstrating the increased risk of bladder cancer resulting from long-term use of thiazolidinedione drugs such as Actos and Avandia. This study, which came from the Perelman School of Medicine at the University of Pennsylvania, showed that 17 patients out of 10,000 taking these drugs are likely to develop bladder cancer. Diabetics are already at a higher risk, with about 4 out of 10,000 ultimately developing the disease as opposed to 3 out of 10,000 among the general population.
Recently, the U.S. Food and Drug Administration approved a generic form of the diabetic drug, Actos – despite the fact that it has been proven to cause dangerous side effects. It would seem likely that availability of the less expensive form of the drug would encourage greater use. However, according to Consumer Reports, the nearly $380 single prescription price is not likely to drop anytime soon; at present, only three manufacturers have been authorized to produce generic versions.
A recent study published in the British Medical Journal once again demonstrates a connection between use of the diabetes drug Actos (pioglitazone) and bladder cancer. Furthermore, a patient who has used the medication for two years or longer is almost twice as likely to develop the disease.
A recent study in the British Medical Journal confirms that Actos is associated with an increased risk of bladder cancer, making the drug a very risky option for Type 2 diabetics. The study, published on May 31st, involved a nested case-control design using the UK’s general practice database, the world’s largest computerized database of longitudinal records from primary care. The cohort was populated with a database of medicated diabetics, and spanned a time period of over twenty years (1988 to 2009). The results confirmed that use of Actos increases a patient’s cancer risk, s
This story isn't exactly new – it came out in the wake of an American Diabetes Association conference in San Diego in the summer of 2011 – but even now, several months later, relatively few people are aware of it.
It's a sad and all-too common story, particularly in the pharmaceutical industry. They know there is a risk or potentially dangerous side effect to one of their profitable products and they don't yank it off the market (at least until they are forced to – either for legal or economic reasons). Instead, the company's bean counters crunch some numbers and decide how much a few legal settlements would cost versus how much profits would suffer if the product was recalled or the problem addressed.