Trump’s pick for FDA to test ‘due diligence’ of Agency’s science – Bloomberg Law, November 25, 2024: Dr. Marty Makary has been named by Donald Trump to lead the FDA. The Johns Hopkins surgeon has been an outspoken critic of FDA’s relationships with industry and his appointment could shake up the status quo. NCHR and other experts are optimistic that Dr. Makary will encourage the agency to reduce conflicts of interest and hold industry to a higher standard for FDA approval of medical products and food safety.
Vivek Ramaswamy’s crusade to change FDA could boost biotech, and himself – The Washington Post, November 25, 2024: This news article quotes NCHR and other experts explaining that Vivek Ramaswamy is a former biotech executive who is very critical of the FDA in ways that reflect his extensive conflicts of interest. If Donald Trump follows Ramaswamy’s advice, Ramaswamy is likely to greatly increase his wealth and patients will be harmed by paying for expensive new medications that do not work.
What Trump’s election win could mean for AI, climate and health – Nature, November 8, 2024: Nature magazine news article on the impact of Trump election includes views regarding health programs. CPTF asks if RFK Jr. stated plans to “reduce corporate greed” will be implemented, given the close ties between the first Trump Administration and the pharmaceutical industry.
Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic. – October 31, 2024: MedTech Dive news article quotes industry officials and CPTF and other patient and consumer advocates about new CDRH director Michelle Tarver and hopes for greater respect for patients, consumers, and researchers during user fee negotiations and FDA decision-making regarding the safety and effectiveness standards for medical devices.
F.D.A. names a new chief of medical devices – New York Times, Oct 22, 2024: Michelle Tarver is the new director of CDRH, FDA medical device center, promoted from within the agency. We are hopeful that she will move CDRH to focus more on ensuring safe and effective medical devices, reversing the bias of former director Jeff Shuren. But given her expertise, why has the agency failed to warn Lasik patients as promised?
High Levels of Toxic Flame Retardants Found in Toys, Kitchen Utensils Made From Black Plastic – The Defender, October 2, 2024: Researchers found toxic flame retardants in everyday items made from contaminated recycled black plastic food containers, kitchen utensils, and toys. These toxins are linked to cancer, endocrine disruption, neurotoxicity, and reproductive harm. Plastic recycling is to blame. It is time to come to terms with the misinformation about plastic recycling and demand that FDA and EPA ban unsafe recycled plastic products.
FDA to launch ‘active’ monitoring system to improve medical device safety – Association of Health Care Journalists, September 18, 2024: AHCJ questions the usefulness of FDA’s new active monitoring system to improve medical device safety and NCHR and other experts do too. The FDA plans to start by monitoring two types of devices in the first year but there are thousands of devices that were never studied for safety or effectiveness so that is not going to keep patients safe anytime soon.
The untold trauma of thousands of women suffering from ‘Breast Implant Illness’, leaving them in agony for years… yet some doctors refuse to accept it is real – The Daily Mail, September 9, 2024: After making the decision to decrease her cancer risk by removing her breasts and getting implants, one woman discovered a community of women suffering from breast implant illness. Celebrities describe similar health problems from implants and recovery after implants are removed. Despite popularity of explant surgery and mounting evidence of BII, many doctors continue to dismiss breast implant illness, leaving women dependent on online support groups for information. FDA has not ensured accurate information for patients.
He Regulated Medical Devices. His Wife Represented Their Makers. – The New York Times, August 20, 2024: Ever wonder why there are so many ineffective and unsafe implants and diagnostic tests and other medical devices harming patients? This NYT investigation explains how FDA official Jeff Shuren was involved in decisions that benefited his wife — who worked for Theranos and other major device companies. Why did FDA allow that to happen year after year?
Open Letter to the FDA: You’re Protecting the Wrong People – MedShadow, July 23, 2024: We agree with Medshadow that it is outrageous that the FDA is warning companies about fraudulent tests that mean their medications may not be safe or effective but are not warning patients who are buying these medications.
Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs – BMJ, July 1, 2024: BMJ investigation reveals how revolving door and FDA Ethics office allow former FDA staff to lobby for industry and Dr. Diana Zuckerman explains how this creates conflicts of interest that undermine FDA decision-making.
FDA Brings Lab Tests Under Its Oversight – April 29, 2024: FDA issues the final rule for lab-developed tests (LDTs) and we explain that the rule has a giant deadly loophole allowing thousands of diagnostic tests and genetic tests for cancer and other deadly diseases to be sold without evidence they are accurate.
Feds declare turf, rubber playgrounds “generally safe’ – Politico E&E NEWS, April 18, 2024: EPA released its 2024 report on artificial turf, which says it contains dangerous chemicals but that the exposures are “generally safe.’ NCHR’s Dr. Diana Zuckerman asks what does that mean? If it is generally safe that means it isn’t safe for everyone, but EPA doesn’t explain how many will be harmed and doesn’t explain what is known and not known. It’s not credible.
Why journalists should scrutinize the FDA’s accelerated drug approval process – March 7, 2024 article by Association of Health Care Journalists explains the problems with the FDA accelerated approval process and gives advice on how to cover the evidence accurately. NCHR’s Diana Zuckerman explains that when FDA rescinded approval of the cancer drug Pepaxto, it was an easy call because the company took it off the market 2 years ago because of the higher death rate in a clinical trial.
FDA Warned of Overstepping Authority With Lab Test Rule Proposal – Bloomberg Law, December 7: Bloomberg Law news article describes the strong opposition to FDA’s plan to regulate lab-developed tests (LDTs). We explain why patients can’t trust the results of these diagnostic tests unless FDA makes sure they are accurate.
Consumer and Public Health Groups Support FDA Proposal to Ensure Accuracy of Lab-Developed Medical Tests – September 29, 2023: A coalition of consumer advocacy groups is welcoming a proposed rule released today by the Food and Drug Administration to regulate laboratory-developed tests (LDTs), a category of diagnostic tests developed and used in a single lab.
Are PIP rubber playgrounds safe for Kingston? – October 23, 2023, CPTF president Diana Zuckerman’s oped in the Kingston (NY) Wire explains the risks to children of lead and carcinogenic chemicals in PIP rubber playground surfaces and artificial turf in Kingston and other communities.
Who gets to decide who receives experimental medical treatments? – This excellent news article by MIT Technology Review asks “Who decides who receives experimental medical treatments” and are FDA’s standards for accelerated approval too low for Duchenne Muscular Dystrophy, cancer, and other diseases. We call accelerated approval a disaster.
Biden’s Crackdown on ‘Junk’ Plans: Minimal Impact on Payers – Health Payer Specialist, July 14, 2023: The White House proposes restricting “junk” health insurance policies to 3-4 months for emergencies, instead of 3 years. These health insurance policies are supposed to be for short-term emergency coverage, not to replace comprehensive health insurance. We explain that these inexpensive policies result in patients paying much more if they have any medical needs – or going without important medical care. Don’t be fooled by misleading ads for cancer coverage or other limited coverage.
Lilly battling rivals for breast-cancer patients – Indianapolis Business Journal, June 9, 2023: We explain to the Indianapolis Business Journal that 3 drug companies are spending $millions to persuade breast cancer patients that their drug is best despite risky side effects. Their ads are confusing and misleading.
For Canadian Patients, Therapeutic Psychedelics Beset by Red Tape – Undark, March 8, 2023: Undark article reviews the red tape in Canada vs. U.S. for access to psychedelics for cancer patients and other depressed patients. In this news article, we explain FDA expanded access program, which tends to make access easier if companies agree to help patients.
Many pediatric drug study results were never posted to a U.S. government database – STAT News, January 24, 2023: Results of 43 clinical trials involving thousands of children were never reported to clinicaltrials.gov or published in a medical journal or otherwise made publicly available, as required by law. We explain how this harms children and families.
Lawmakers, advocates press for diversity in clinical trials – National Journal, February 15, 2023: NCHR joins lawmakers and other advocates in urging FDA and NIH to improve diversity in race/ethnicity, age, and sex in clinical trials as a way to improve medical care for everyone. So far, enforcement is lacking.
A Tiny Lab Finds Danger on Drugstore Shelves While the FDA Lags Behind – Bloomberg News, November 9, 2022: Valisure is a small lab that found carcinogens in Zantac, sunscreen, shampoo, sanitizers, and other products. NCHR asks: Why isn’t FDA doing these routine impurity tests? Too cozy with industry?
A Special Report: Can Breast Implants Cause Chronic Disease? – HealthCentral, October 25, 2022: This excellent review from HealthCentral.com quotes breast implant patients, NCHR and other experts responding to new FDA warnings and troubling research. We explain the research evidence of risks of breast implant illness and lymphoma and point out the misleading denials of risk by plastic surgeons.
Opinion: Are Turf Fields a Safe Place for Kids to Play in Westfield? – Dr. Diana Zuckerman, PH.D, Tap into Westfield: September 12, 2022 As a mother, I used to think that artificial turf and rubber playground surfaces were a clever and attractive alternative to grass fields. As a scientist, however, I learned that my children were being exposed to unsafe chemicals without my knowledge or consent. I recently wrote … Continue reading Opinion: Are Turf Fields a Safe Place for Kids to Play in Westfield?
Letter to the Editor: Asphalt playgrounds are bad for kids. So is artificial grass – Los Angeles Times and Yahoo News, September 7, 2022 To the editor: It’s frightening that L.A. schoolchildren are playing on sizzling asphalt, but the commentary and reporting on it miss an important part of the story. Years of research show that the school playground surfaces that are even hotter than pavement are made from artificial turf or colorful rubber. On … Continue reading Letter to the Editor: Asphalt playgrounds are bad for kids. So is artificial grass
Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust – Celine Castronuovo and Jeannie Baumann, Bloomberg Law, August, 26, 2022 A House report detailing coordinated attempts by Trump White House officials to influence the FDA’s pandemic response underscores the need for more transparency at an agency that’s facing historically low public trust, health policy analysts say. The House Select Subcommittee on the Coronavirus Crisis said this … Continue reading Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust
FDA official bolting to Big Tobacco shines a light on the agency’s revolving-door problem – Grid News, August 3, 2022: An FDA official leaving FDA’s Tobacco Science Office to work for Big Tobacco shines a light on the agency’s revolving-door problem. We explain why this undermines FDA’s authority.
Toxic chemicals lurk at playgrounds – E&E News, July 8, 2022: The sight of rubber surfaces on playgrounds concerns Dr. Diana Zuckerman, “because as president for the National Center for Health Research she has testified in front of multiple municipal and even state governments about the toxic chemicals that can lurk on those playground surfaces.” They look very pretty and feel spongy if a child falls, but the evidence shows the toxic chemicals in these surfaces can be harmful to children.
These machines to help people breathe were recalled a year ago. Many still use them – Los Angeles Times, June 23, 2022: CPAP, BiPAP, and other ventilators made by Philips that help people stay alive were recalled more than a year ago. But patients haven’t been informed and others can’t live without them unless there is a replacement device that they can afford. FDA is now pressuring Philips to replace them.
STAT Report : The need for speed and safety: A primer on the FDA’s drug approval pathways – This STAT report provides an excellent primer on FDA’s drug approval pathways, and the controversies about whether patients can be harmed when FDA standards get too lose. Dr. Diana Zuckerman describes the need for the FDA Commissioner to restore the public’s trust.
Will the FDA change how it vets drugs following the Alzheimer’s debacle? – Nature, May 13, 2022: Nearly a year after the FDA approved a controversial drug to treat Alzheimer’s disease, Congress is attempting to amend the accelerated process that led to its approval and also the approval of many cancer drugs that have not been proven to work.
Danica Patrick reveals she had breast implants removed after suffering complications – Good Morning America, May 2, 2022: Former NASCAR driver Danica Patrick revealed she had her breast implants removed after suffering medical complications she believes were caused by the implants. We explain that her symptoms of breast implant illness were typical of breast implant illness, and she immediately felt better after the implants were removed.
What’s Wrong with the FDA? – Washington Monthly, January 20, 2022: If Robert Califf, the White House nominee for commissioner of the FDA, is confirmed by the Senate, he’ll take the reins of an agency with its reputation in tatters. Once revered as the global leader in drug regulation, the FDA has approved one bad drug and medical device after another over the past 30 years, leaving staff demoralized and overseas regulators scratching their heads. NCHR and other experts provide recommendations for improvements.
Biden’s ‘Cancer Moonshot’ Turns Toward Pollution – E&E News, February 3, 2022: President Biden made an emotional pledge to “end cancer as we know it” by reinvigorating the Cancer Moonshot Initiative he first launched in 2016, just one year after his son Beau succumbed to the disease. But experts, including us, point out that there isn’t enough focus on environmental causes of cancer.
Covid Booster Costs Spur Calls to Shift From Free Jabs for All – Bloomberg Law, April 11, 2022. The U.S. Covid-19 vaccine funding may have to shift from a model of free shots for all to one in which the government only subsidizes boosters for targeted populations, public health analysts say. Annual Covid-19 boosters for all Americans , would cost billions of dollars each year .“Given the much greater expense of Covid boosters compared to flu shots and the time needed to revise and manufacture Covid vaccines, we need to hope we won’t need annual shots,” said Diana Zuckerman, founder and president of the National Center for Health Research.
She’s the reason Arizona has a law requiring surgeons to warn patients about the dangers of breast implants – Arizona News 12 NBC: February 22, 2022. Migraines. Headaches. Insomnia. Difficulty breathing. Trouble swallowing. Robyn Towt survived three bouts with cancer. But it was breast implants that made her the sickest.
FDA’s agenda in limbo as Biden’s nominee stalls in Senate – AP and Fox13: February 8, 2022. President Joe Biden’s pick to lead the Food and Drug Administration has stalled in the narrowly divided Senate, an unexpected setback that could delay decisions on electronic cigarettes and other high-profile health issues. Will all the publicity help Califf get confirmed, given the alternatives?
Equal Access to Merck Covid Pill Imperiled by Prescribing Rules – Bloomberg Law, December 2, 2021: Merck’s antiviral drug molnupiravir—if authorized by the agency—would offer for the first time in the U.S. an at-home treatment option for patients with mild to moderate Covid-19 who are at risk of severe disease.
Biden’s Drug Agency Nominee Returns With Deeper Industry Ties – Bloomberg Business, November 23, 2021: President Biden’s choice to lead the FDA made millions of dollars from health and drug companies since his last stint in government, raising new questions about his ties to firms the agency oversees.
The road ahead for Califf’s confirmation – Axios and Yahoo News, November 15, 2021: Former FDA chief Robert Califf has been nominated to head the agency again. We tell Axios that “The public has been asking if they can trust the FDA to ensure that the benefits outweigh the risks for Alzheimer’s drugs, cancer treatments, and implanted devices”
Biden Picks Robert Califf to Head the FDA for a Second Time – The Scientist, November 12, 2021: Former FDA Commissioner Robert Califf has been nominated to be the new FDA Commissioner. He has excellent experience, but like all the FDA candidates the White House considered recently, he has close ties to industry.
Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties – The New York Times, November 12, 2021: Is Biden nominee Dr. Califf the best choice to head up the FDA. The New York Times describes his pros and cons, and we point out that the White House doesn’t mind his Pharma ties.
Biden picks ex-FDA chief Robert Califf to again lead agency – AP News, November 12, 2021: Robert Califf will be nominated as FDA Commissioner today. We told AP “He knows how the FDA works, and he avoided making any outrageous decisions as commissioner. Those are essential if the FDA is going to regain the public trust.”
Biden expected to tap Califf as FDA commissioner – Roll Call, November 12, 2021: Robert Califf will be nominated to again serve as FDA commissioner. We tell Roll Call that he’s a political compromise, close to Pharma but avoiding the controversy that happens when FDA ignores scientific evidence.
Biden chooses Robert Califf, former Obama FDA chief, as agency commissioner – Washington Post, November 12, 2021: President Biden is expected to nominate former FDA Commissioner Robert Califf to return as the agency’s head, and we explain why this political compromise makes sense despite his industry ties.
Breast Implants will now come with Black Box Warnings, List Risks – Legal Reader, November 9, 2021: Will FDA’s requirements to warn patients about the cancer risks and other serious risks of breast implants be enough to adequately warn women considering implants? Experts disagree.
Breast Implants will now come with Black Box Warnings, List Risks – Legal Reader, November 9, 2021. Will FDA’s requirements to warn patients about the cancer risks and other serious risks of breast implants be enough to adequately warn women considering implants? Experts disagree.
When it comes to clinical trials, healthcare’s diversity problem is standing in the way of medical advancement – Fortune, November 5, 2021: The lack of diversity in clinical trials is standing in the way of medical advancement. CPTF president Dr. Diana Zuckerman explains how that delayed progress in treating triple negative breast cancer, which is more common among Black women.