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

Statement of Dr. Diana Zuckerman on FDA Approval of new Silicone-Gel Breast Implant Natrelle 410

February 21, 2013. Yesterday the FDA quietly approved yet another questionable style of breast implants, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant made by Allergan, Inc. Unfortunately, Allergan’s studies did not compare the safety and effectiveness of the Natrelle 410 implant to other previously approved silicone gel-filled breast implants on the market. Continue reading

Notre Dame Football Players Rape Cover-up – What’s in the News and What Isn’t

Fem2.0 January 9, 2013. The media has extensively covered the college championship football game between Notre Dame and Alabama, but few Americans aware of Notre Dame’s cover-up of rapes by Notre Dame football players. Monday’s football game is an opportunity to acknowledge that raping women is a terrible crime that needs to be taken seriously by the police, the public, and the media. Continue reading

Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants

Tens of thousands of defective silicone breast implants were recalled in Europe in 2011–12 soon after the FDA’s unrelated announcement that a rare cancer of the immune system was associated with all saline and silicone gel breast implants. These developments raised questions about whether U.S. and European regulations were protecting patients from unsafe medical implants. 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

What the Health Care Decision Means to Us

Huffington Post, July 3, 2012. The term “Obamacare” began as an insult, but now it’s the name almost everyone uses to describe the healthcare reform law. Earlier this year, some of Mitt Romney’s critics called it RomneyCare, because it was, after all, a descendent of the healthcare program that Mitt Romney developed for Massachusetts. (An excellent program that Romney now says he opposes.) Continue reading

Study Suggests Women Have Higher Risk of Hip Implant Failure

A February 2013 study in JAMA shows that women have a higher risk of implant failure than men following total hip replacement. In a commentary, NRC President Diana Zuckerman stresses that long-term comparative effectiveness data would enable patients and their physicians to choose the hip devices and surgical techniques that are most likely to be successful for a longer period. Continue reading

New Review Shows FDA is Missing Crucial Safety Information on Breast Implants

January 5, 2011. A closer examination of the data regarding the FDA-approved breast implants made by Mentor and Allergan, however, indicates numerous errors and missing information in the FDA’s most recent research summary (published online in June 2011), as well as in the information the agency provided to their Advisory Panel that met to discuss breast implants in August 2011. 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

Medical Device Recalls and the FDA Approval Process

February 14, 2011. Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk. Continue reading

New Study Shows that Most Medical Devices Recalled for Life-Threatening Problems Were Not Tested on Patients

EMBARGOED FOR RELEASE: 4 P.M. (EST), MONDAY, FEBRUARY 14, 2011. A new study released today finds that most medical devices recalled during the last five years for “serious health problems or death” were originally cleared (approved) by the Food and Drug Administration (FDA) using a less stringent process that does not require testing in patients. The study, released on-line prior to publication in the Archives of Internal Medicine, was co-authored by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women & Families and Dr. Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. Continue reading