FDA advisors vote against two drugs for menopausal hot flashes

Reuters. March 5, 2013. Advisers to the Food and Drug Administration on Monday voted against approval of two drugs designed to reduce the frequency and severity of hot flashes associated with menopause. “The FDA’s advisors did a great job today of carefully considering the scientific evidence,” said Diana Zuckerman, president of the National Research Center for Women & Families. Continue reading

Antibiotics: When Science and Wishful Thinking Collide

Health Affairs blog. January 25, 2013. Antibiotic resistance is a major concern confronting our health care system, and there is tremendous pressure on the Food and Drug Administration (FDA) to “do something” about it. Unfortunately, the FDA is responding by approving drugs that are likely to do more harm than good. Continue reading

No Need for Skin Preps to Be Sterile, FDA Told

December 13, 2012. MedPage Today. Requiring that antiseptic skin preparation products be sterile — a standard not currently mandated by the FDA — is unnecessary and wouldn’t produce a dramatic drop in infections, manufacturers, clinicians, and policy analysts told the FDA Wednesday. “We need to have better communication that a product is not sterile,” Dr. Jennifer Yttri said, adding that could come from product labeling. Continue reading

J&J Bedaquline and the Evolving Role for Accelerated Approval: Confirming Safety, Not Efficacy?

December 4, 2012. FDA Beat. Discussions during an advisory committee review Janssen’s TB drug bedaquiline showed some interesting thinking around accelerated approval and how much uncertainty can be acceptable—especially when it comes to safety. Yttri warned called “approval of drugs based on the promise of benefit” a “dangerous practice.” Continue reading

Allergan drops bid for FDA approval to promote Lap-Band for teens

October 3, 2012. LA Times. The maker of the Lap-Band weight-loss device, Allergan Inc., has dropped its controversial bid for federal approval to market the product for overweight teens. Doctors already can perform Lap-Band surgery on minors with parental consent. The FDA approval would have allowed Allergan to market Lap-Band specifically for younger people. Continue reading

Consumer group questions review of breast implants

Consumer safety advocates are questioning the Food and Drug Administration about incomplete and seemingly erroneous data used to support the safety of silicone breast implants in an agency review last year. The FDA concluded last summer that silicone-gel implants are basically safe as long as women understand they come with complications. Continue reading

FDA revokes Avastin approval for breast cancer. Decision leaves some devastated. Drug will remain available to treat other cancers.

Washington Post. November 19, 2011. “The science is clear: Breast cancer patients are more likely to be harmed than helped by Avastin,” said Diana Zuckerman, president of the National Research Center for Women & Families. “The risks of the drug are very substantial and can be fatal, killing patients long before they would otherwise die from the disease. FDA made a scientific decision, and it was absolutely the right decision.” Continue reading

Left to Their Own Devices

The Economist. September 10, 2011. Scandals, recalls, stingy customers, anxious regulators—any one of these would traumatise a chief executive. America’s industry for medical devices is suffering from all of them. Omar Ishrak, the new boss of Medtronic, the world’s biggest medical-technology company, recently described the problem succinctly to analysts: “There is a lot of work ahead of us.” Continue reading

FDA: Breast Implant Safety Studies Will Continue

Web MD. August 31, 2011. After two days of testimony on what the FDA should do about troubled long-term safety studies of silicone-gel breast implants, agency officials said the studies would continue. Public health research director of the National Research Center for Women & Families, Dana Casciotti, said the 27 page questionaires that are currently being used in the studies are too long and ineffective. In order for the studies to be successful, the questionaires need to be shortened. Continue reading

FDA eyes registry for breast implants problems

Reuters. August 31, 2011. U.S. health regulators said they would consider setting up a registry that tracks safety problems with breast implants, after too many patients dropped out of company-funded studies. NRC president Diana Zuckerman brings up the fact that Allergan has three times more patients participating than the other manufacturer of silicone breast implants Mentor, and that they needed to be held responsible. Continue reading

Report Could Sway FDA Device Review Process

Reuters. July 26, 2011. President of the National Research Center for Women & Families Diana Zuckerman is critical of the FDA for not moving sooner to make changes to the device approval process. She says “the whole process is illogical” and “in some kind of ideal world the FDA would have come out with these proposals and implemented them.” Continue reading

FDA backs decision to return silicone breast implants to market, despite frequent problems

Associated Press. June 22, 2011. President of the National Research Center for Women & Families, Diana Zuckerman, explains that missing data in the largest, most important studies on silicone gel breast implants weaken the quality of the studies and, therefore, the conclusions provide inadequate, useless information for consumers, health professionals, and the public. Continue reading

Most women with silicone breast implants need more surgery

MSNBC. June 22, 2011. Diana Zuckerman, president of the National Research Center for Women & Families, says the studies the FDA used to say silicone implants are safe are incomplete. In addition, Zuckerman claims women need to understand that when they get breast implants they may need removal or replacements for the rest of their lives. Continue reading

FDA seems to take light approach to Allergan and Lap-Band

LA Times. February 22, 2011. Dr. Diana Zuckerman, president of the National Research Center for Women & Families, criticizes the FDA’s recent approval of the lap-band surgery for the less obese; there is not sufficient evidence to ensure the safety of this procedure and the time to ask for better research is before you say yes. Continue reading