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Tuesday, July 20, 2010

Cancer Treatment a Defective Drug? Avastin up for Review

In the 1950s, all an alien species had to do to lure us into a bargain we'd regret later ("To Serve Man," anyone?) was to offer a cure for cancer. It seems we'll still jump at that bargain, only now we're bartering with pharmaceutical manufacturers. One such deal was made over the drug Avastin (bevacizumab), which was given expedited approval for treating breast cancer because of its promise in treating cancer. Although many have openly and angrily criticized the drug's exorbitant price (nearly $10,000 per month's supply), it is hard to argue down the price on extra life, which preliminary studies, according to some doctors, show might be as much as five months for some types of cancer.

However, other doctors, and the FDA's own advisory panel, say the drug does not increase the lifetime of terminal breast cancer patients. Nor does it increase their quality of life during their last months. The only thing it has been definitively shown to do is to prevent tumors for growing, what is described as "progression-free survival," and it was on this basis that FDA administrators overruled their advisory panel to give the drug accelerated approval. Today, the drug manufacturer (Genentech, the bright minds behind Accutane (see also here and here)) has returned to argue for the drug's continued approval before an FDA advisory panel, armed with two more studies.

These new studies show what the earlier studies had shown: the drug increases progression-free survival by 30-36% but does not increase survival times. In fact, the studies showed the drug might decrease survival times, but this was not statistically significant. And along with taking the drug, patients experienced more serious side effects, mostly hypertension, bleeding, and febrile neutropenia, but also includes potential bowel perforations and fatal hemorrhage. And there is no evidence that the drug increases quality of life during treatment, something neither of these new studies bothers to evaluate. A drug that does not increase the length or the quality of life for terminal cancer patients, whose benefit is only visible on an x-ray or CAT scan, and that has serious side effects would seem to be a defective drug.

So, the question is, should this drug be allowed to stay on the market? Certainly, we can understand why cancer patients are willing to pay up to $10,000 per month for even false hope, but what does it say that some are willing to charge for it?

If you or a loved one has been mislead by false promises about a drug, only to suffer its dangerous side effects, you may be able to receive compensation in a pharmaceutical injury lawsuit. The Cochran Firm can help. To learn more, please call or email us today for a free initial case evaluation.

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posted by Benjamin A. Irwin at 12:30 PM

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