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The ''Placebo Effect'' of Avastin

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Washington, DCCancer drug Avastin, and the manufacturer's current battle with the US Food and Drug Administration (FDA) over Avastin side effects and overall effectiveness with regard to the prevention and treatment of breast cancer, echoes a similar issue from back in the spring of 2009, when pharmaceutical giant Roche purchased controlling interest in Avastin's parent, Genentech.

In the spring of 2009, Reuters reported that a major study had determined that Avastin had failed to prevent the recurrence of colon cancer in patients who had undergone surgery. In reporting the story, and the acquisition of Genentech by Roche in March of that year for a reported $46.8 billion, Reuters noted that Roche investors at the time had hoped that Avastin sales would double from $4.4 billion—but would not have enjoyed the thought of acquiring Genentech at a premium. Thus, according to the story, Roche had pulled the trigger on the Genentech purchase with high hopes for the Avastin study, expecting an acquisition prior to the study release would save them some coin.

Had Roche waited, according to the article, a positive result for Avastin might have raised the stock price for Genentech even higher, requiring greater financial resources to undertake the acquisition. Roche is reported to have raised its offer for Genentech anticipating a positive result for bevacizumab Avastin.

When, in fact the study results for Avastin were less than Roche had hoped—released, as they were following the acquisition of Genentech at a higher stock price than that initially offered—the value was negated by Avastin's poor performance in the study, which Reuters described as Avastin's ''placebo effect'' on the acquisition.

Fast forward to 2011. There is no acquisition talk this time, but Genentech is again on the defensive with its cancer drug, given the Avastin FDA issue currently at play. Two years after approving Avastin for the treatment of advanced breast cancer, the FDA in December announced that it is no longer the view of the FDA that Avastin is effective in the treatment of advanced breast cancer, that the risks and Avastin side effects outweigh the benefits, and that the product label needs to be changed to reflect that position.

The latest Avastin news has the FDA granting Genentech a hearing in June, allowing the manufacturer the opportunity to argue its case before the Commission. In the meantime, it should be noted that even with the intended label change, doctors would still have the authority to prescribe Avastin off-label for the treatment of advanced breast cancer. That said, the label change if it happens would shut out many patients from using Avastin, given that some insurers will not cover drugs ''off label.''

Nonetheless, the current Avastin FDA view is that Avastin, based on a number of clinical studies, did not do enough to improve a patient's overall survivability, or to slow disease progression, while at the same time exposing the patient to a series of potential severe Avastin side effects. That makes Avastin the worst kind of placebo, if you will—one that is thought to have little effect on the disease for which it is intended, but at the same time introduces adverse reactions that could cause a patient to become more ill in other ways. In sum, the placebo effect felt by Roche investors in 2009 with regard to Avastin for the treatment of colon cancer has returned in 2011 with similar concerns. What will it do for me v. what will it do TO me? The debate rages on…

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