J. D. Heyes
July 20, 2011
Officials with Medicare say the government health care program will continue paying for drugs even if the Food and Drug Administration revoke their safe-and-effective status.
According to Don McLeod, a spokesman for the Centers for Medicare and Medicaid, the health care programs will continue to hand over taxpayer money to doctors and pharmacies that prescribe the breast-cancer drug Avastin, even though the FDA recommended last month that it no longer be used to treat the disease because it’s not proven either safe or effective in large trials.
It’s bad enough that even if the FDA revokes its approval of Avastin that physicians will still be able to prescribe it. What’s worse is that taxpayers will continue to be on the hook for it, despite its drawbacks and ineffectiveness.
“The FDA decision, when it comes, does not affect CMS,” said McCleod. “The drug will still be on the market, doctors will still be prescribing it, and we will continue to pay for it.”
Some private insurers have also said they are likely to continue paying for the drug, regardless of the FDA’s decision, which is not due until later this year. And that’s fine; what a private company wants to do with its resources are at the discretion of its customers and investors. But when taxpayers are footing the bill (about $8,000 a month for most average Avastin users), why should they be forced to pay for ineffective or dangerous medications?
For the company, which is appealing the FDA’s decision, there are definitely financial interests at stake.
Roche’s U.S. unit Genentech, which manufactures Avastin, had $6.2 billion worth of global sales of Avastin in 2010; in the U.S. alone, sales topped $3.1 billion, Reuters reported.
With that in mind, another bid to prove the drug’s effectiveness is now in the offing. Roche – a Swiss company – is planning yet another trial, “to prove it does significantly extend the time women live without their disease getting worse,” the newswire service reported.
Even if the drug remains within the good graces of the FDA, The New York Times reported in January that the drug hasn’t been a barnstormer in terms of its intended use – to stop or delay the duration of breast cancer.
“Avastin was given accelerated approval for breast cancer in 2008 after a study showed that use of Avastin and paclitaxel together delayed the median time before the cancer worsened by 5.5 months compared to use of paclitaxel alone,” the paper said.
“Women who got both drugs also lived slightly longer, though the difference was not statistically significant,” the paper said (my emphasis).
Other studies showed Avastin, when combined with different chemotherapy agents, “showed only a small benefit in delaying disease progression and no prolongation of lives at all.”
Taxpayers should not continue to be on the hook for a drug that clearly hasn’t lived up to its billing.
This article was posted: Wednesday, July 20, 2011 at 3:00 am