FDA pulls use of breast cancer drug Avastin because of side effects

Once again, attention seems to be focused entirely on the mean (average) when the variance is just as important. Some women taking it report years of extra life over what was prognosed. Surely all should be allowed to see if they are in that lucky minority

The blockbuster drug Avastin should no longer be used in advanced breast cancer patients because of dangerous side effects. The Food and Drug Administration declared Friday there is no proof that the drug extends the lives of advanced patients.

The ruling by the FDA was long expected, but it was certain to disappoint women who say they've run out of other options as their breast cancer spread through their bodies. Impassioned patients had lobbied furiously to preserve Avastin as a last shot.

'This was a difficult decision,' said FDA Commissioner Margaret Hamburg. She added that 'it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks.'

Those risks include severe high blood pressure, massive bleeding, heart attack or heart failure, and perforations in parts of the body such as the stomach and intestines, Ms Hamburg said.

Avastin is the world's best-selling cancer drug, and also is used to treat certain forms of colon, lung, kidney and brain cancers. So even though FDA formally revoked its approval of the drug to treat breast cancer, doctors still could prescribe it — but insurers may not pay for it. Including infusion fees, a year's treatment with Avastin can cost $100,000.

Some insurers already had quit covering the drug's use in breast cancer after FDA's advisers twice- once last year and once last summer- urged revoking the approval. But Medicare said Friday that it will keep paying for now.

Medicare 'will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies,' said spokesman Don McLeod.

In 2008, the FDA allowed Avastin to be marketed as a treatment for breast cancer that has spread, or metastasized, to other parts of the body and is generally considered incurable.

The approval came under a special program that allows patients access to promising treatments while their makers finish the studies needed for final proof that they really work as promised.

When Avastin manufacturer Genentech did those studies, the data showed only a small effect on patients' tumor growth, not that they were living longer or had a better quality of life and not enough benefit to outweigh such severe side effects, FDA concluded.

Genentech, part of Swiss drug maker Roche Group, had argued that Avastin should remain available while it conducts more research to see if certain groups of patients might benefit from the drug. Ms Hamburg encouraged Genentech do those studies

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Credulous woman makes scurrilous accusations against parents who feed kids fast food

She believes official pronouncements -- despite their changeability. The first thing my son learned to say was his McDonald's order and he had negligible health problems and is now a perfectly fit and healthy young man

SOME popular kids' fast food has almost triple the recommended levels of saturated fat and twice the salt. The findings prompted The Biggest Loser trainer Michelle Bridges to liken parents who fed their children excessive fast food to child abusers.

The Herald Sun can reveal that the worse fast-food companies are McDonald's and Hungry Jack's. Some of their children's meals are more than 1000 kilojoules above levels recommended for children to eat in one sitting. Some of their meals have more saturated fat and salt in one serve than children aged four and eight are supposed to eat in an entire day.

The NSW Cancer Council assessed the nutritional composition of 199 children's meals from six fast-food chains: Chicken Treat, Hungry Jack's, KFC, McDonald's, Oporto and Red Rooster. It found the younger the child, the greater the difference between recommended and actual levels. For example, for four-year-olds, the average meal from McDonald's and Hungry Jack's had three times the recommended saturated fat.

All chains except McDonald's had meals with too much sugar, and all chains had meals with almost double the recommended salt levels. Healthier options were meals with water, milk or juice, small amounts of chicken nuggets or wraps.

One in four Australian children and 43 per cent of teenagers eat fast food at least once a week.

Ms Bridges said she was "not anti-fast food" but condemned parents who regularly fed children junk. "When you look at the low nutritional value of what some parents feed kids regularly, it's like child abuse," Ms Bridges said. "It's highly addictive and changes a kid's tastebuds, so that's what they crave instead of healthy food. "Some parents and their kids get takeaway every night - they don't even need to read the drive-through menu, they know it by heart."

Cancer Council nutritionist Kathy Chapman said the solution was not to criticise parents, but promote fruit, vegetables and salad in such meals. "There also needs to be easy nutrition information at the point of sale and traffic-light labels to make decision-making easier," Ms Chapman said.

A spokeswoman for McDonald's said parents, "often swap in healthier options to suit their children - over a third of every Happy Meal sold includes a healthier choice".

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