Essure Study Criticized

NBC News, November 4, 2013. Dr. Diana Zuckerman, who leads the National Research Center for Women and Families, a non-partisan FDA watchdog, said the survey questionnaires exhibit dubious research methods. “These studies are always done by the company that is selling the product so it is not exactly unbiased,” Zuckerman said. Continue reading

Lawsuits pile up over popular birth control pill

Chicago Tribune. September 15, 2013. Birth control pills containing drospirenone “shouldn’t be on the market because there are so many safer alternatives,” said Diana Zuckerman, president of the National Research Center for Women & Families. “We can debate how unsafe it is and for whom — more research could obviously clarify that — but there’s really no doubt that it’s not as safe as dozens of other birth control pills.” Continue reading

Letter to the editor: Still working to understand cancer

The Post article on the overdiagnosis of cancer clearly reported the need to reduce patients’ fear and confusion about “cancers” that many experts now agree are not really cancer, because they don’t spread and aren’t harmful. The major obstacle has been uncertainty about how likely these conditions are to predict cancer or change into an invasive cancer in the future. Continue reading

Comment on ‘Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism’

Mishka Terplan and Diana Zuckerman From the Journal of Family Planning & Reproductive Health Care Despite the increased interest in evidence-based medicine, many medical guidelines and statements of medical professionals are based primarily on opinion rather than scientific facts. The … Continue reading

FDA Kicks Off Women’s Health Program With Surgical Mesh Registry

FDA’s launch of a new registry for controversial surgical transvaginal mesh products as part of a new program focusing on women’s health could signal the agency is planning to prioritize sex-specific device concerns, a consumer advocate said. “If they start with new patients, it will take years before we get the information that we need,” said Diana Zuckerman, president of the National Research Center for Women & Families. Continue reading

FDA Panels: Too Many Conflicts Or Too Little Expertise?

June 2013. Should FDA Advisory Committee members be allowed to have financial conflicts of interest regarding the approval of medical products? Diana Zuckerman discusses how financial ties to pharmaceutical companies can influence the voting and discussion on drug and medical device approvals, and how misunderstandings of statistics and the value of clinical trials can lead to the approval of dangerous products. Continue reading

TN Compounder’s Steroid Sickens Patients

TN Compounder’s Steroid Sickens Patients – May 25, 2013 – “Nobody imagined that a company with the reassuringly named ‘Main Street Pharmacy’ could be shipping contaminated medical products to patients in 13 states,” said Diana Zuckerman, president of the National Research Center for Women and Families. “Unfortunately, the public is at just as much risk now as we were when patients first started dying from contaminated medicines last year.” Continue reading

Senate panel approves tighter oversight of compounding pharmacies, but bill is under fire

Washington Post. May 23, 2013. Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks. Continue reading

Angelina Jolie’s decision

Huffington Post. 16 May 2013. Dr. Diana Zuckerman writes, “Let’s use Angelina Jolie’s announcement to have a frank discussion of the treatment choices for breast cancer and to encourage women to make decisions based on their own situations not on the choice of a celebrity, however admirable she is.” Continue reading

Breast implants as therapy? Not so much

Many girls and women want breast implants because they believe it will improve their self-esteem. It is true that cosmetic surgery can help a person feel better about the body part that was “fixed,” whether it is a breast, a nose, ears, or thighs. But research shows that breast implants do NOT improve self-esteem. In fact, several studies show that breast implants LOWER self-esteem even if it makes a woman feel sexier. Continue reading

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