FDA Recommends “Modernizing” Review of Devices in Wake of Global Investigation – British Medical Journal: November 27, 2018. While FDA commissioner Scott Gottlieb recommends medical device approval reform, NCHR says it is not enough.
After Years of Complaints, U.S. and U.K. Officials Say They Want to Reform the Medical Device Industry – Consumer Affairs: November 29, 2018. The US and UK are making demands to the medical device industry for safer and more effective products.
Here’s What We Know About Breast Implants and This Rare Type of Cancer – SurvivorNet: November, 2018. Ties have been made between breast implants and ALCL, a rare cancer. Patients feel betrayed by doctors who fail to warn them.
Medical Device Dangers: FDA Facing Criticism Over Missed Signs – Today News: November 26, 2018. In this news segment, NCHR’s Jack Mitchell discusses how device safety is handled by the FDA compared to other countries.
Breast Implant Injuries Hidden as Patients’ Questions Mount – Associated Press, 2018. Women have been having problems with breast implants for decades. NCHR president tells AP that the safety studies on breast implants should be questioned.
Breast Implant Illnesses: What’s the Evidence? – A large meta-analysis of the current cornerstone breast implant illnesses research studies reveals their weaknesses and highlights what is known.
Concerns That Public Hearings on Breast Implants Will Favor Implant Manufacturers – CBS News: Oct 4, 2018. Women become ill from their breast implants and we are concerned about whether the FDA is listening to patients or plastic surgeons.
Summary of Published Study by MD Anderson Physicians on the Increase in Rare Diseases Among Women with Breast Implants – We summarize the study conducted by MD Anderson Cancer Center regarding the incidence of rare diseases among women with breast implants.
Statement of Dr. Diana Zuckerman, President of the National Center for Health Research Regarding the New Study of 100,000 Women with Breast Implants – Dr. Diana Zuckerman, the president of NCHR, makes a statement in support of the newly released MD Anderson study that shows breast implants are linked to illness.
F.D.A. Targets Vaping, Alarmed by Teenage Use – New York Times: Sept, 2018. Although the FDA sees their first “crackdown” on vaping products, are they actually doing enough to protect teens and others from these harmful products?
FDA Rarely Uses Its Power to Recall Dangerous Medical Devices. Why Not? – Meg Bryant, MedTech Dive: August 31, 2018. Dr. Zuckerman remarks about the process of taking a device off the market in a recall, and why it’s rarely done.
New Drugs So Pricey They Need New Payment Plans – Sarah Owermohle, Politico: August 13, 2018. FDA intends to speed up certain early and mid-stage clinical trials for oncology drugs by merging elements typically found in phase 1 and phase 2 trials.
The Human Tragedy of Poorly Regulated Medical Devices Gets the Spotlight in a Netflix Film – Amy Martyn, CBS News: July 27, 2108. NCHR president speaks out about medical devices, spurring filmakers to make documentary available on Netflix. The documentary discusses the human side of faulty medical devices being released to the market.
FDA Expedited Approval Process Raises Concerns About Risks – Roxanne Nelson, FDA: July 18, 2018. Expedited approval process by the FDA for drugs raises concerns for safety of consumers.
To Improve Treatments, Researchers Want To Hunt For Clues In Medical Records – Richard Harris, NPR: July 15, 2018. While researchers consider using electronic medical records to improve treatments, NCHR president spreads caution.
FDA Repays Industry by Rushing Risky Drugs to Market – ProPublica, June 26, 2018. As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits.
Trump Is Promising To Lower Drug Prices, But Experts Doubt It Will Happen – BuzzFeed, May 11, 2018. “The action plan is too vague. Better negotiation of prices could mean almost anything,” Diana Zuckerman, president of the nonprofit National Center for Health Research, told BuzzFeed News. Focusing on out-of-pocket patient expenses instead of lower prices for the drugs themselves will lead to higher health insurance costs, she said.
Statement of National Center for Health Research Supporting A CDC Review to Save Women’s Lives – The National Center for Health Research strongly supports the announcement that the Centers for Disease Control and Prevention may conduct a review of the potential benefits of biopsies for women scheduled for hysterectomy or fibroid removal. The review is essential because a recent article, published in the medical journal Obstetrics & Gynecology reports that the rate of unsuspected cancer is dangerously high in women undergoing hysterectomy. When those women undergo surgery, particularly procedures involving a medical device called a power morcellator, the cancer can spread inside the woman’s abdomen, resulting in an early-stage cancer being upstaged to a much more dangerous metastatic (stage 4) cancer. The risks are especially high for women ages 55 and older, reaching almost 10% for undiagnosed uterine cancer.
2018 Foremother and Health Policy Hero Awards Luncheon – Our Annual Awards Luncheon is on May 4! Join us to celebrate and honor #MeToo Good Girls Revolt author Lynn Povich and world famous scientist Dr. Rita Colwell.
US Regulators Float Ideas for Boosting Medical Device Safety – The Associated Press, April 17, 2018. The FDA announced a plan to improve the oversight of medical devices. NCHR president explains that the new standards are still inadequate and safety strategies are still years away from being effective.
CMS Payment Rule Seen as Bad for Some Patients – MedPage Today, April 10, 2018. New final regulations on the Affordable Care Act health insurance exchanges issued by the Centers for Medicare & Medicaid Services have drawn mixed reactions from health policy experts and others. The changes include expanding the number of “benchmark” plans, adding new “hardship exemptions,” allowing states to adjust the “medical loss ratio,” and increasing the percentage premium increase.
Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback? – Kaiser Health News, April 6, 2018. Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations. Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood.
FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions – Star Tribune, February 24, 2018. A Food and Drug Administration (FDA) proposal to let medical device makers summarize complications caused by medical devices instead of filing a report for each incident has kicked off a debate over safety. NCHR and patient and public health advocates say this would keep too many details secret.
Trump Targets Drug Prices, Right-to-Try in State of the Union – AJMC Newsroom, January 31, 2018. At the State of the Union, Trump vowed to bring down the high cost of prescription drugs and called on Congress to pass the Right to Try bill. This bill might end up doing more harm than good for patients.
Big Pharma Greets Hundreds of Ex-Federal Workers at the ‘Revolving Door’ – Kaiser Health News, January 25, 2018. A Kaiser Health News analysis shows that hundreds of people have glided through the “revolving door” that connects the drug industry to Capitol Hill and to the Department of Health and Human Services. Experts say the cozy relationships don’t necessarily mean congressional staffers do favors for lobbyists they know, but the access doesn’t hurt.
The Problem with Medical Device Approvals – 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.
Which Breast Implants are Safest for Mastectomy Patients? – November, 2017. Our new book chapter explains the risks and benefits of different types of breast implants, and challenges the myth that “gummy bear” implants are safer.
Can the FDA Help Reduce Drug Prices or the Cost of Medical Care? – American Journal of Public Health, November 2017. In a guest editorial by CPTF president Dr. Diana Zuckerman, she questions whether the FDA’s plan to get generic drugs on the market more quickly is enough to make prescription drugs – and health insurance—affordable.
Nearly a Dozen Artificial Turf Fields in DC Failed Last Round of Safety Tests – Fox 5 News, September 18, 2017. 11 artificial turf fields in DC failed their recent tests, leading to closures, replacements, and igniting another debate over the safety of synthetic turf. CPTF president points out these fields and playgrounds can cause cancer.
Safety Checks at DC Playgrounds Under Question After Boy Injured on Crumb Rubber Floor – ABC 7 News, October 27, 2017. D.C.’s Department of General Services (DGS) has never tested its rubber playground floors. NCHR’s Dr. Diana Zuckerman points out that as these playgrounds get older, they get harder, and they can be dangerous if a child falls on them.
Streamlined FDA Reviews Fail to Catch Dangerous Glitches in Health Software, Study Finds – STAT News, September 12, 2017. The Food and Drug Administration carefully polices many categories of drugs and devices. But when it comes to software, the agency’s oversight is scanty at best — something that a new study finds is resulting in failure to detect dangerous glitches in software-enabled medical equipment.
Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health – Milbank Quarterly, September 12, 2017. The innovation of medical IT has the potential to save lives, but even a small “glitch” can harm patients. Our study found hundreds of recalls of flawed devices that affected millions of patients. Examples include electronic medical records that provide info about the wrong patient and “physician support” devices that miscalculate the dosage of medication. But the FDA is set to deregulate these devices.
Statement of Dr. Diana Zuckerman in Honor of Dr. Vivian Pinn – September 8, 2017. I am going to Charlottesville on September 13 to honor Dr. Vivian Pinn, our 2013 Foremother Awards honoree, as a major UVA medical school building is named in her honor. Dr. Pinn received her medical degree from the University of Virginia in 1967, where she was the only African-American and only woman in her graduating class.
Will Controversial Bill Cure or Kill Patients? – Who What Why, September 7, 2017. Diana Zuckerman, president of the National Center for Health Research, points out that drug companies rely on a three-phase clinical trial process to gain FDA approval for their products. If RTT siphoned off patients with life-threatening illnesses from clinical trials, particularly for trials of medications serving limited populations with rare diseases, drug companies might find it even harder to enroll enough patients to complete them. And health insurers will not pay for drugs that lack FDA approval.
Cigarette Maker Stocks Plunge on FDA Announcement, But Health Experts Are Skeptical – Marketwatch, July 28, 2017. An FDA announcement Friday included a proposal to lower nicotine levels in cigarettes and sent cigarette maker shares plunging.
FDA Deal Would Relax Rules on Reporting Medical Device Problems – The New York Times, July 11, 2017. Medical device makers might be able to delay reporting dangerous malfunctions to the FDA under a proposed agreement.
FDA Eases Notice Requirement on More Than 1,000 Medical Devices – Bloomberg BNA: July 10, 2017. More than one thousand medical devices, including menstrual cups, and dentures, will be exempt from an FDA clearance process.
Special Report: Many Expensive New Cancer Drugs Are Useless (or Worse) – Bottom Line Inc., July 3, 2017. We asked Diana Zuckerman, PhD, to explain why many new cancer drugs have so few benefits…and how to get the right treatment.
Morcellator Cancer Reports Drop, Essure Reports Rise – Drugwatch, June 20, 2017. While the number of morcellator cancer reports is decreasing, reports of injuries linked to Bayer’s Essure Permanent Birth Control device are on the rise.
It’s Not Safe in Soap, But You Touch It Everyday – Marketwatch, June 21, 2017. Scientists and medical professionals from around the world have signed on to a statement warning of the harmful effects of chemicals in antibacterial soaps.
Why Are So Many American Women Having Mastectomies? – Why Are So Many American Women Having Mastectomies? Our Bodies Ourselves: June 16, 2017
Misplaced Trust: Why FDA Approval Doesn’t Guarantee Drug Safety – Drugwatch: May 8, 2017. Misplaced Trust: Why FDA Approval Doesn’t Guarantee Drug Safety
Amy Reed, MD, Morcellator Opponent, Dies of Uterine Cancer – Medscape, May 25, 2017. Amy Reed, MD, Morcellator Opponent, Dies of Uterine Cancer.
A Shocking Diagnosis: Breast Implants “Gave Me Cancer” – New York Times, May 14, 2017. Breast implant-associated anaplastic large-cell lymphoma is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface, rather than a smooth covering. Texturing may cause inflammation that leads to cancer. If detected early, the lymphoma is often curable.
Medical Researchers Thankful for $2 Billion NIH Funding Increase – Modern Healthcare, May 1, 2017. “If you really want to make the most of medical funding, for NIH or for anybody else, it needs to be a steady stream of funds,” NCHR President said. “The problem is, what about next year? These are not one-year grants.”
Right to Try? Or Right to be Exploited Before You Die? – Our Bodies, Our Blog, April 17, 2017. CPTF president asks if you want your loved ones to pay $$$ for the right to try a treatment that hasn’t ever been proven to work on any patients at all?
Breast Implants Linked to Rare Cancer – Our Bodies Ourselves, March 28, 2017. The FDA now says that breast implants can cause a type of lymphoma (cancer of the immune system) called anaplastic large cell lymphoma (ALCL), although this link has been seen by experts since as early as 2010.
FDA Proposal Would Lower Requirements for Some Moderate-Risk Devices – Bloomberg BNA, March 24, 2017. FDA announced that hundreds of new, moderately risky medical devices will no longer need to be tested before being sold in the U.S. NCHR President points out the risks this causes for patients and their doctors.
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 National Law Would 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.