The Bell Law Firm, PLLC

Manufacturers of dangerous drugs can be held liable to consumers who are harmed by their products. Sometimes, important products such as pharmaceuticals help some patients but provide little benefit to others, while still causing side effects. Because many pharmaceuticals are so important, however, the Food and Drug Administration will approve drugs for use as long as the benefits outweigh the risks for most patients. Pharmaceuticals are generally not considered defective for causing more harm than good in a particular patient, when otherwise prescribed appropriately.

If, after a drug has been approved, the FDA finds evidence that a drug's risks outweigh its benefits for certain patients, however, the agency can revoke its approval in order to to protect innocent people from dangerous drugs.

Recently, the FDA partially revoked its approval of the top-selling cancer drug Avastin, manufactured by Genentech, finding that its risks far outweighed the benefits for most patients in breast cancer treatment. Many women swear by its effectiveness in treating metastatic breast cancer, but in a 69-page decision by the FDA's commissioner, the agency found that most breast cancer patients treated with Avastin were put at serious risk of dangerous bleeding problems, heart attacks and other serious health issues while receiving minimal benefit from the drug.

Breast cancer is the most common form of cancer found in women. Even though patients, doctors, researchers and the pharmaceutical industry and the FDA all want to find a cancer treatment drug that is effective, the number-one concern should always be patient safety.

"Sometimes, despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing," said the FDA's commissioner. "This is the case with Avastin when used for the treatment of metastatic breast cancer."

That being said, a subgroup of women with metastatic breast cancer has been shown to respond well to Avastin, and the FDA's action will have serious consequences for those women. The cancer drug costs about $99,000 a year per patient. While for now Medicare will continue to pay for Avastin treatment for the subgroup, several insurance companies have already said they will no longer pay for the drug in breast cancer cases, and many breast cancer patients will no longer be eligible for Genentech's patient assistance program.

Avastin is still approved for treatment of other forms of cancers, so it will remain on the market. As a result, some doctors may still choose to prescribe it for breast cancer patients in a so-called "off-label" use, but they may putting their patients' health and safety at risk by doing so.

Source: Washington Post, "FDA revokes Avastin's approval breast cancer treatment," Rob Stein, Nov. 18, 2011