The Op-Ed: 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

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

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