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.
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.
Statement of Dr. Diana Zuckerman, President, National Center for Health Research, Regarding the American Health Care Act – March 9, 2017. The goal of the American Health Care Act is to replace the ACA with something better, but instead it represents a giant step backward for health care.
Trump Picks Scott Gottlieb to Serve as FDA Commissioner – Bloomberg Politics, March 10, 2017. While Gottlieb has focused on easing regulations, he “understands the agency and has some respect for it,” Diana Zuckerman, CPTF president, said in an interview before the news that Gottlieb is the leading candidate.
Amid Flurry of New Cancer Drugs, How Many Offer Real Benefits? – Many FDA approved cancer drugs have offered patients only marginal benefits, with no evidence that they improve survival or quality of life
Trump Calls for Lower Drug Prices, Fewer Regulations in Meeting with Pharmaceutical Executives – The Washington Post, January 31, 2017. Diana Zuckerman, Cancer Prevention and Treatment Fund President, comments on how the FDA and high drug prices could be negatively affected by the hiring freeze, despite President Donald Trump emphasizing the need for lowering “astronomical” drug prices to pharmaceutical executives.
After Mastectomies, an Unexpected Blow: Numb New Breasts – Dane’e McCree decided to have her breasts removed. Her doctor assured her that surgery would spare her nipples and leave her with natural-looking breasts.
New study explains why so many cancer drugs don’t work – Why do so many cancer patients take medications that drain their energy and joy of living but don’t benefit them? The answer: since 2008, FDA has not required new cancer drugs to prove they help patients live longer. After the drugs were approved, 18 were found to not extend patients’ lives at all, and only one of the drugs is proven to improve patients’ quality of life. But these ineffective cancer drugs cost just as much.
Actress Elisabeth Rohm Urges You to Give Back and Join the Fight Against Cancer! – Watch actress Elisabeth Rohm urge everyone to support the Cancer Prevention and Treatment Fund in her new public service announcement.
Congress Just Quietly Handed Drug Companies a Dangerous Victory – New Republic, December 14, 2016. Christmas came early for the pharmaceutical industry when Congress passed the 21st Century Cures Act. Though lauded by liberals for funding medical research, its real impact will be elsewhere, including encouraging FDA to approve cancer drugs and other “cures” that don’t work.
Trump’s Rumored FDA Candidate Strikes Nerve – December 8, 2016 – Against all expert opinion, Jim O’Neill, “a snake oil salesman” with no medical background, is rumored to head the Food and Drug Administration (FDA) in 2017
Congress Passes Bill with Billions for Cancer Research – December 7, 2016 – the 21st Century Cures Act, the most expensive and far-reaching health reform bill since the ACA, has just been passed by Congress
To fund projects like the Cancer Moonshot, Congress had to strip away some of the FDA’s most important regulatory powers – Quartz, December 1, 2016. The 21st Century Cures Act passed in the House, but comes with a lot of regulatory compromise and threats to patient safety. Most notably, Senator Warren and Senator Sanders oppose the bill along with NCHR President Diana Zuckerman due to patient safety concerns and breaks for Big Pharma. “It really is a David and Goliath issue of where the money is,” said Dr. Zuckerman.
Why the 21st Century Cures Act could be Disastrous for Medicine – Why would anyone vote against “cures,” especially “21st century cures?” Here’s why many health policy and consumer advocacy groups — including the National Center for Health Research — strongly oppose the bill and are asking senators not to pass the bill next week.
FDA hearing on off-labels use of devices explores risks to patients – Star Tribune, November 10, 2016 – CPTF President Diana Zuckerman said the Infuse Bone Graft is “contraindicated” for children. But the FDA’s 2015 warning didn’t ban the product in kids because some children have such significant bone defects or such rare bone disorders that they would be willing to accept the risks.
Trump Just Dropped a Big Hint to the Pharmaceutical Industry – Washington Post, November 14, 2016 – “I think the honest answer is nobody knows” what to expect, said Diana Zuckerman, president of the National Center for Health Research. “Some members of Congress owe pharma a favor; we don’t know the Trump campaign is in that position, and they might not be — and that might give them a certain amount of flexibility. The Trump campaign is nothing if not iconoclastic.”
Obamacare on the Chopping Block? – MedPage Today, November 9, 2016 – “I’m not sure what will happen to the Affordable Care Act.” NCHR President Diana Zuckerman noted that full repeal of Obamacare would be hard with so many people now relying on it, many of whom live in red states.
Actress Elisabeth Rohm Joins the Fight Against Cancer – Actress Elisabeth Rohm joins the fight against cancer by filming a public service announcement in support of the Cancer Prevention and Treatment Fund!
After Years of Criticism, FDA Tries to Step up Oversight of Medical Devices – ConsumerAffairs, 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?”
Obama Extends Controversial Program for Rare Pediatric Drugs – STAT, September 30, 2016. Friday, President Barack Obama signed into law a bill that will briefly extend a voucher program that rewards drug makers for rare pediatric medicines
Pro&Con: Experience Well-Suits Her to Deliver Affordable Care to All – September 23-25, 2016. Published in newspapers across the country, this syndicated column discusses the changes needed to improve the Affordable Care Act.
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…
Doctors Downplaying Drug’s Suicide Risks Attract FDA’s Scrutiny – Bloomberg, September 13, 2016. The U.S. Food and Drug Administration has a message for doctors: The money you’re taking from pharmaceutical companies may be clouding your judgment. NCHR president Dr. Diana Zuckerman points out questions about the accuracy of safety data submitted by Pfizer about Chantix, the smoking cessation drug.
Medical Devices Approved Using Low-Quality Data Affect Medicare Costs – Bloomberg BNA, September 8, 2016. High-risk medical devices are sometimes approved using low-quality clinical data and this increases Medicare costs, a member of a Medicare congressional advisory panel said Sept. 8. The session may portend a deeper examination of the device industry’s practices, which could cause Congress to change payment rates for devices and related services, as the commission’s recommendations are fairly influential. Commissioner Rita Redberg, a cardiologist at the University of California San Francisco Medical Center, called for further MedPAC examination of how to push Medicare to more broadly consider quality over an entire episode of care when deciding whether to cover a device. NCHR’s president Dr. Diana Zuckerman said “I agree completely.”
21st Century Cures Act: Yes or No? No: Act’s Promise of Quick Cures Is a Brew of Ultra-Hype Mixed with Snake Oil – July 21, 2016. Imagine that you or someone you love has a potentially fatal disease with no proven treatment, but there is a new experimental treatment available. Would you rather be given that treatment for free by a top physician who carefully monitors your treatment as part of a clinical trial to study whether it works, or, would you rather pay more than $100,000 a year for the same experimental drug and hope your doctor gives you the right dose?
Selling Side Effects: Big Pharma’s Marketing Machine – Drugwatch, July 2016. Convincing people they are sick and need a drug is a multi-billion dollar industry. In 2015, Big Pharma dropped a record-breaking $5.4 billion on direct-to-consumer (DTC) ads. And it paid off for Big Pharma. Americans spent a record $457 billion on prescription drugs. The U.S. and New Zealand are the only countries where DTC is legal. Americans also pay more for drugs and devices than any other country. Behind the drug and device ads saturating TV, radio and digital media are hidden costs and devastating side effects that companies don’t advertise. “Americans tend to think newer is better. If it costs more, therefore it’s better. If it’s new and it costs more, then certainly it is better,” Diana Zuckerman, president of the National Center for Health Research, told Drugwatch. “They sometimes…