We’re Quoted


  • The Problem with Medical Device Approval MedShadow, January 16, 2018. To get FDA approval for a medical device, a company needs to say that its device is “substantially equivalent” to an existing one. Devices might be easily approved without further safety and effectiveness studies.
  • Why Are So Many American Women Having Mastectomies? Our Bodies Ourselves, June 15, 2017. A 2016 study of more than 37,000 women with early-stage breast cancer found that the women undergoing lumpectomies were more likely to be alive 10 years later than women with the same diagnosis who underwent a single or bilateral (double) mastectomy.
  • Former Playmate of the Year on Removing Breast Implants: ‘I Literally Thought I Was Dying’ AZ Family, May 4, 2017. As a former Playboy Playmate of the Year, McDougal was worried about removing her breast implants but her health was so bad she thought she was dying.
  • FDA Agrees with WHO, Links Breast Implants to Rare Cancer. How Worried Should Women Be? Forbes, March 22, 2017. The FDA says it now agrees with the World Health Organization that such cases of ALCL cancer are linked to the breast implants and not some unfortunate coincidence
  • Right to Try Laws allow Big Pharma to Exploit False Hope Chicago Tribune and 18 other newspapers, March 16-20, 2017. All terminally ill U.S. patients already have a right to try experimental drugs. The proposed new law is much more dangerous to all patients, and not just those facing fatal illness. Here’s why.
  • Trump’s FDA Nominee Spurs Concerns About Drug Approvals, Off-Label Promotion Bloomberg BNA, March 14, 2017. President Donald Trump’s pick to head the FDA is spurring concerns about drug approvals and off-label promotion.
  • What If Ryan Gets His Wish and Trumpcare Becomes Law MedPage Today, March 14, 2017. The Republican’s repeal and replace bill, American Health Care Act, cleared two congressional committees and the Congressional Budget Office released its scoring report, Speaker of the House Paul Ryan (R-Wisc) says passing the GOP plan is a make or break issue Congress. So it is time to ask the pundits: what will happen if this bill becomes law?
  • Amid Flurry of New Cancer Drugs, How Many Offer Real Benefits? Kaiser Health News, February 9, 2017. For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.
  • Can Breast Implants Cause Cancer? WJLA Investigates ABC7 WJLA, February 6th, 2017. Of all the potential side effects of breast implants, she did not recall her surgeon ever mentioning a small but increased risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma.
  • Congress Passes Bill with Billions for Cancer Research Consumer Reports, December 7, 2016. The most expensive and far-reaching health reform bill since the ACA, has just been passed by Congress
  • Can Having Breast Implants Lead to Suicide? 7 On Your Side Investigates WJLA ABC7, November 7, 2016. Three-hundred thousand women will get breast implants this year, making it the number one cosmetic surgery in the U.S. Research shows the typical breast implant patient has high self-esteem and good mental health, higher and better than the general population.
  • After Years of Criticism, FDA Tries to Step Up Oversight of Medical Devices Consumer Affairs, October 27, 2016. Diana Zuckerman, President of the National Center for Health Research, said about the FDA’s new site soliciting allegations of abuse in the medical device industry: “[W]ill it make a difference? Will the FDA finally stop treating device companies like their favorite customers and remember that patients and consumers are their most important customers? …More importantly, will FDA finally decide that they will no longer allow device companies to ignore patient safety?”
  • Does the FDA Have a High Enough Standard for Drug Approvals? STAT News, September 28, 2016. Is the Food and Drug Administration’s approval process broken? At a HUBweek panel hosted by STAT, experts explored that question in light of the FDA’s decision last week to approve a controversial drug for Duchenne muscular dystrophy, a rare disease.
  • Furor Over Drug Prices Puts Patient Advocacy Groups in Bind New York Times, September 27, 2016. Public anger over the cost of medical products has burned hot for a year, coursing through social media, popping up on the presidential campaign, and erupting in a series of congressional hearings, including one last week over the rising price of the allergy treatment EpiPen.
  • Feds to Crack Down on Those Who Fail to Report Clinical Trials Politico Pro, September 16, 2016. Drug companies and research institutions will have to publicly report more clinical trial data, including results that show their products or experiments failed, under new policies rolled out Friday by HHS. But NCHR president criticizes their decision not to provide summaries of treatment results that patients can understand. Read more…
  • Why We Shouldn’t Trade a Weakened FDA for More Medical Research Funds STAT, May 17, 2016. In a quest to bring new medical products to Americans, Congress is considering a grand bargain, but it may benefit pharmaceutical companies more than patients.
  • Device Recalls Surge in Recent Years, Prompting Question: Why? General Surgery News, April 12, 2016. The FDA approves or clears thousands of new medical devices each year. This highly complex process of review has garnered criticism in recent years. Dr. Diana Zuckerman weighs in on the lack of quality of clinical testing and the FDA approval process.
  • FDA to Shift Clinical Evidence for Medical Devices Toward Postmarket Medical Design Technology, April 4, 2016. The National Center for Health Research expresses that Advancing Breakthrough Devices for Patients Act of 2015 encourages companies to get medical products on the market quickly as opposed to focusing on patient safety and product efficiency.
  • Possible Drug Risks Buried in Delayed FDA ‘Watch Lists’ Medscape Medical News, March 29, 2016. Dr Diana Zuckerman explains that publication delays of drug watch lists illustrate how the FDA caters more to drug manufacturers than patients.
  • Senate Approves FDA’s ‘Breakthrough Pathway’ for Medical Devices Health Care Business, March 23, 2016. A bipartisan Senate committee has approved three bills that could help get medical devices to patients sooner by creating a “breakthrough pathway” through the U.S. Food and Drug Administration, but not everyone is happy about the actions.
  • Senate Committee Approves Legislation to Speed Approval of Medical Devices The Wall Street Journal, March 9, 2016. The Wall Street Journal, March 9, 2016. Patient-safety advocates, including the National Center for Health Research, warn that the bills would weaken the FDA’s ability to ensure devices’ safety.
  • FDA Aims To Speed Clinical Trials, Improve Device Safety Through Post-Market Evaluation, But Funding A Hurdle Inside Health Policy, February 16, 2016. FDA’s device center chief Jeff Shuren, in an interview with Inside Health Policy, highlighted the benefit a robust National Device Evaluation System could have in bolstering the agency’s ability to monitor devices in real-time to better inform the risk-benefit profile of approved products.
  • FDA to Create Early Warning System for Medical Devices Medscape Medical News, December 31, 2015. FDA proposes warning patients more quickly about the risks of medical devices.
  • Psst! Industry has Taken Over FDA By nominating cardiologist Robert M. Califf to be FDA’s next commissioner, the Obama Administration has taken a giant step away from the agency’s traditional avoidance of even the suspicion of coziness with the industries it regulates. This could be a problem because of Califf’s past close involvement with multiple drug and medical device companies.
  • 21st Century Cures Drug Bill Triggers a DC Dust-Up Over Relaxed Development Regs Fierce Biotech, July 10, 2005. Lawmakers in the House easily passed the 21st Century Cures Act today, a big step toward once again shaking up the legal framework built to guide drug development in the U.S. while significantly boosting the amount of funding that flows to the NIH. Consumer advocates, though, see the new development regulations as a recipe for unleashing drugs and devices that would later prove dangerous and unhelpful.
  • Breasts, Buttocks and Botox – The Surprising Trends in Plastic Surgery The American Society of Plastic Surgeons (ASPS) released the detailed figures on cosmetic surgery in 2014, and Euronews outlined seven surprising trends from the US.
  • Bill to Speed Approvals for Drugs is Cut Back New York Times, April 30, 2005. Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version with many of the most controversial provisions left out.
  • Women’s Health Advocates Question FDA About Missing Safety Data on Silicone Breast Implants Associated Press, January 5, 2012. Consumer safety advocates are questioning the Food and Drug Administration about seemingly incomplete and erroneous data used to affirm the safety of silicone breast implants last year.
  • Women’s Health: A Red-Flag Warning Seattle Post-Intelligencer, January 12, 2007. After restricting the use of breast implants since 1992, the FDA has approved the sale of breast implants again. Implant companies will be required to complete 10-year studies to determine the safety of breast implants.
  • Silicone: Now a Solid ‘Maybe’ Los Angelos Times, November 27, 2006. The breast implants’ approval by the FDA was not fine-print free. Women must weigh the impact and costs of follow-up care.
  • FDA Ends Ban on Silicone Implants The Seattle Times, November 18, 2006. The FDA is requiring that manufacturers tell women that the implants are not permanent devices.
  • Group Says FDA, Advisory Panels Show Bias Toward Drug Approvals Washington Post, August 29, 2006. The FDA has recently come under fire over drug safety issues, including its decisions to approve the popular arthritis pain medications Vioxx and Celebrex that were later associated with an increased risk of heart attacks and strokes.
  • Drug Agency’s Advisers Are ‘Rubber Stamps,’ U.S. Group Says Bloomberg, August 28, 2006. The FDA said in July that it plans to write new guidelines specifying when scientists and doctors serving on the panels should be disqualified because of conflicts of interest.
  • Implants, Mastectomies Linked to Problems Washington Post, December 5, 2005. Up to four years, about one-third developed of women develop one issue with thick, tight scarring and infections.
  • Implant Maker Fixed Samples Only Washington Post, December 5, 2005. The issue of silicone-gel bleed or diffusion is sensitive because small amounts of silicone oil are known to seep out of all implants
  • Silicone Implants Backed by FDA Panel Washington Post, April 14, 2005. A Food and Drug Administration advisory panel recommended yesterday that silicone gel breast implants made by Mentor Corp. be allowed back on the market for wider use — a surprise decision that came a day after the same panel rejected the application of a rival company.
  • FDA Panel Backs Breast Implants From One Maker Gardiner Harris, The New York Times, April 14, 2005. Dozens of women said implants had sickened them severely, and some gave gruesome testimony about silicone from ruptured implants squeezing out of their eyes and ears.
  • More Teens See Implants As a Right Knight Ridder Newspapers, December 07, 2004. More teens believe they have a right to breast implants.
  • Teens’ Cosmetic Dreams Don’t Always Come True USA Today, July 28, 2004. Teens having surgery are unnecessarily putting themselves at risk of injury or even death. Teens face different obstacles in making a decision like this, experts say. They are often insecure and naive about medical risks. And they literally are not always finished growing up.
  • FDA Rejects Silicone Gel Breast Implants Associated Press, January 9, 2004. Silicone breast implants were dealt a new blow Thursday when the Food and Drug Administration rejected Inamed Corp.’s bid to bring them back on the market a decade after earlier versions were ruled unsafe and banned.
  • Popularity of Breast Implants Rising Washington Post, September 22, 2002. Breast implants are on the rise, especially saline implants that can require more surgery within five years.
  • Silicone Implants Generate Renewed Debate HealthDay, August 2002. As federal health officials ready for hearings on whether silicone breast implants should be allowed back on the U.S. market, a new study offers evidence of a reduced rate of implant rupture.
  • All But Forgotten The Los Angelos Times, October 1, 2001. Medical device makers, scientists, and regulatory agencies debate the safety of silicone breast implants.