In the News

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 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 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 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 By Diana Zuckerman, 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 Chicago Tribune, By Diana Zuckerman

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…

Lack of African Americans in breast cancer studies results in less effective treatment and higher death rate The disparity in breast cancer mortality between Black and White women has widened in our country’s most populated states. Cancer experts usually conclude that although there have been advances in breast cancer screening, prevention and treatment, these advances have not been equally available to Black and White patients.
Faster Drug Approval: Winners and Losers HealthZette, June 28, 2016. By the time a drug is approved by the Federal Drug Administration, it’s been through extensive human clinical trials. There are so many obstacles to greenlighting any new medication or treatment, in fact, that it seems like it can take forever — with countless lives lost in the meantime.
Women’s Health Bills are now in Committee Legal Reader, June 28, 2016. Three important pieces of legislation, one introduced last year and two introduced this month, could change the way certain women’s health issues are handled. These women’s health bills are now in Committee.
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.
Big money stem-cell therapy push raises concerns Politico, April 29, 2016. We explain why the REGROW Act is an effort to short-circuit the FDA’s “gold standard” for drug approvals and why it shows “a lack of understanding of the importance of well-designed research.”
Summary of: Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide Breast augmentation is the most common cosmetic surgery in the United States, and many women are also encouraged to choose breast implants for reconstruction after a mastectomy. However, studies in the United States and Scandinavian countries have shown that suicide rates are higher for women with implants.
When will presidential candidates ask, “What do women want in health care?” May 2016, AJPH. Even before Nicolas Kristof asked why presidential candidates are ignoring women’s health, our guest editorial asked the candidates to ask women what they want in health care.
Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide Women’s Health Issues, April 2016. Numerous research reviews have concluded that suicide rates are higher for women with breast implants. In addition, there is evidence of an increased risk of suicide for women who undergo reconstruction with implants after mastectomy, compared to other mastectomy patients.
How the House, Senate diverge on patient safety in Cures bills American Health Line, April 19, 2016. Patient safety experts, including Dr. Diana Zuckerman, report that the the Senate’s version of the House-approved 21st Century Cures Act has been updated but still needs more changes.
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.
US device industry and FDA “colluded” on legislation to weaken regulatory oversight The BMJ, December 17. 2015. Dr. Diana Zuckerman from The National Center for Health Research shared, “There’s a world of difference between talking about approval standards in general and crafting specific legislative language. It is outrageous that FDA officials and regulated industry are sitting down to craft legislative language to give to congressional staff.”
Senate committee approves legislation to speed approval of medical devices 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.
PhRMA: Easing speech limits could reduce need for subgroups in trials InsideHealthPolicy.com, March 7, 2016. While minority, patient and consumer groups pushed for more diversity in the clinical trial phase, Jocelyn Ulrich director of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), said matching demographic subgroups based on sex, age and race, specifically the African American and Hispanic populations, to disease prevalence would extend phase III clinical trials by 20 months or longer.
Remedy for a sick industry If he were playing it safe, Dr. Vinay Prasad might be among the last to turn into a medical provocateur. Prasad’s outspokenness and willingness to criticize industrywide assumptions place him in the ranks of a small but influential group of physicians and researchers who are either having an impact on the way medicine is practiced in the United States, or tilting at windmills.
FDA aims to speed clinical trials, improve device safety through post-market evaluation, but funding a hurdle 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. Such a system, he said, could also help in the premarket approval phase to reduce the clinical trial burden on manufacturers and get products to market faster.
Cancer Moonshot misses the target February 11, 2016 – Hospitals don’t have much to gain from the moonshot, at least in the short run. There are lot of other pressing, fixable problems with cancer care that the Obama administration’s effort won’t address.
F.D.A. faulted for problems with drug tracking January 14, 2016. New York Times. Federal investigators said Thursday that there were flaws in the way the Food and Drug Administration tracked drugs after they came to market, raising questions about the agency’s effectiveness as the country’s main drug overseer.
FDA faulted for failure to track safety issues with drugs already on market January 14, 2016, Stat. Most Americans assume that drugs approved by the Food and Drug Administration are safe to take as directed. But safety concerns often arise only after the drugs go on the market, when companies or doctors tell the FDA about cases of patients who have fallen ill or died from their medications.
FDA to create early warning system for medical devices December 31, 2015, Medscape. FDA proposes warning patients more quickly about the risks of medical devices Critics, including our president, question why safety isn’t a priority.
Why the FDA wants to ban tanning beds for minors December 22, 2015, MarketWatch. The skin damage caused by tanning beds can be deadly and that’s why the FDA wants to ban minors from using them.
Politicians want to speed up drug approvals. That could backfire. November 24, 2015 To patients grappling with incurable diseases, new therapies can’t come quickly enough. But a pair of new studies found that speeding up this process could put Alzheimer’s, Parkinson’s, and depression drugs that are ineffective or harmful on the market..
What would impact of 21st Century Cures Act be on cancer and your healthcare costs? A controversial proposed new health law would have had a terrible impact on the lives of Alzheimer’s patients, who would have been more likely to develop skin cancer and at the same time had no benefit to their memory.
The 21st Century Cures Act could be a harmful step backward November 19, 2015. The Washington Post. Precision medicine is the next big thing in health care, and it’s also one of the few health goals that Congress and the White House agree on. But while we await treatments targeting the precise genetic makeups of individuals and diseases, medical researchers still are not paying enough attention to the most important kinds of differences among patients: those of sex, age and race.
Senate counterpart to 21st Century Cures bill is struggling October 25, 2015. Politico. The Senate’s companion effort to the House-passed 21st Century Cures is struggling to navigate a dramatically different political reality than the one that helped rocket the medical innovation bill through the lower chamber over the summer.
Approved but not proven: what’s up with FDA, cancer drugs? October 22, 2015. Medscape Medical News. In approving new cancer drugs, the US Food and Drug Administration (FDA) is now heavily relying on surrogate markers of effectiveness, such as tumor shrinkage, instead of proof that an agent improves survival, according to a new analysis.