In the News

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 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 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 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.