Tag Archives: kinds of cancer

Avastin rejected in USA

US drug regulators have rescinded approval of a breast cancer drug, saying it is not effective enough to justify the risks of taking it.

The drug, Avastin, was approved for US use in 2008, but UK officials have also rejected claims that it prolongs life.

Further research showed it did not help patients live longer or improve quality of life, Food and Drug Administration commissioner Margaret Hamburg said.

Avastin will still be used to treat other kinds of cancer.

The drug is used to treat breast cancer that has spread to other parts of the body. It works by starving cancer cells of a blood supply.

However, its side-effects include severe high blood pressure, massive bleeding, heart attack or heart failure and tears in the stomach and intestines, FDA studies have found.

FDA approval of the drug had initially been given under a special programme that allows patients to start using promising treatments while the manufacturer finishes the studies to prove the medicine works as well as expected.

The decision to withdraw the approval – which can happen if results of the research do not match predictions – was not easy, the FDA said.

Avastin

Avastin

“With so much at stake, patients and their doctors count on the FDA to ensure the drugs they use have been shown to be safe and effective for their intended use. Sometimes, the results of rigorous testing can be disappointing,” Ms Hamburg told the Associated Press news agency.

US health insurance companies could remove the drug, which can cost as much as $100,000 (£63,342) per year, from their coverage – although doctors would still be permitted to administer the drug.

But the government-backed Medicaid programme has said it has no immediate plans to change its policy of paying for it.

Some advocates of the drug disagree with the watchdog’s decision.

“The bottom line is that they are throwing out the baby with the bathwater. There absolutely may be subsets of carefully chosen breast cancer patients who benefit from Avastin,” said Dr Elisa Port, co-director of the Dubin Breast Center of Mount Sinai Hospital in New York.

Roche, the Swiss manufacturer of the drug, has said it will undertake further study of the treatment, especially with the chemotherapy drug paclitaxel, to try to identify which patients might be best suited to benefit from use of the drug.

The company says it expects the medicine will generate $7.6bn (£4.8m) of revenue annually, despite the FDA decision.


The drug was approved on the basis of a study that showed Avastin was able to stall the growth of breast cancer by five-and-a-half months, when used together with a standard chemotherapy treatment.

But subsequent studies revised the period of delay to between one and three months, and there was no evidence to show that the drug extended patients’ lives.

The US decision comes after Avastin fell foul of health authorities in the UK and in Europe.

In February 2011, the UK’s National Institute for Health and Clinical Excellence (NICE), the NHS drugs advisory body, said Avastin should not be used to treat secondary breast cancers.

NICE, which issues guidance for NHS in England and Wales, said there was insufficient evidence that the drug prolonged life.

This guidance followed a recommendation by the European Medicines Agency (EMA) that doctors only prescribe the drug in combination with the taxane drug, paclitaxel.

Walnuts, the healthiest nut

A new scientific study positions walnuts in the number one slot among a family of foods that lay claim to being among Mother Nature’s most nearly perfect packaged foods: Tree and ground nuts. In a report given in Anaheim, California , scientists presented an analysis showing that walnuts have a combination of more healthful antioxidants and higher quality antioxidants than any other nut.

“Walnuts rank above peanuts, almonds, pecans, pistachios and other nuts,” said Joe Vinson, Ph.D., who did the analysis. “A handful of walnuts contains almost twice as much antioxidants as an equivalent amount of any other commonly consumed nut. But unfortunately, people don’t eat a lot of them. This study suggests that consumers should eat more walnuts as part of a healthy diet.”

Vinson noted that nuts in general have an unusual combination of nutritional benefits — in addition those antioxidants — wrapped into a convenient and inexpensive package. Nuts, for instance, contain plenty of high-quality protein that can substitute for meat; vitamins and minerals; dietary fiber; and are dairy- and gluten-free. Years of research by scientists around the world link regular consumption of small amounts of nuts or peanut butter with decreased risk of heart disease, certain kinds of cancer, gallstones, Type 2 diabetes, and other health problems.

Walnuts

Walnuts

Despite all the previous research, scientists until now had not compared both the amount and quality of antioxidants found in different nuts, Vinson said. He filled that knowledge gap by analyzing antioxidants in nine different types of nuts: walnuts, almonds, peanuts, pistachios, hazelnuts, Brazil nuts, cashews, macadamias, and pecans. Walnuts had the highest levels of antioxidants.

Vinson also found that the quality, or potency, of antioxidants present in walnuts was highest among the nuts. Antioxidants in walnuts were 2-15 times as potent as vitamin E, renowned for its powerful antioxidant effects that protect the body against damaging natural chemicals involved in causing disease.


“There’s another advantage in choosing walnuts as a source of antioxidants,” said Vinson, who is with the University of Scranton in Pennsylvania. “The heat from roasting nuts generally reduces the quality of the antioxidants. People usually eat walnuts raw or unroasted, and get the full effectiveness of those antioxidants.”

If nuts are so healthful and nutritious, why don’t people eat more? Vinson’s research shows, for instance, that nuts account for barely 8 percent of the daily antioxidants in the average person’s diet. Many people, he said, may not be aware that nuts are such a healthful food. Others may be concerned about gaining weight from a food so high in fat and calories. But he points out that nuts contain healthful polyunsaturated and monosaturated fats rather than artery-clogging saturated fat. As for the calories, eating nuts does not appear to cause weight gain and even makes people feel full and less likely to overeat. In a 2009 U. S. study, nut consumption was associated with a significantly lower risk of weight gain and obesity. Still, consumers should keep the portion size small. Vinson said it takes only about 7 walnuts a day, for instance, to get the potential health benefits uncovered in previous studies.