What would impact of 21st Century Cures Act be on your healthcare costs and the lives of Alzheimer’s patients?

A controversial proposed new health law would have had a terrible impact on the lives of Alzheimer’s patients and their families, who would have spent billions on medications that don’t work and can cause cancer. Continue reading

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. Continue reading

How fast to “cures” and at what cost? Politico forum tilts toward pharma-friendly messaging

October 20, 2015. Health News Review. At an event entitled “How Fast to Cures?” hosted by Politico, the topic of discussion by four professionals from various realms of the research and health care advocacy world was the increasingly contentious 21st Century Cures Act. Continue reading

Would Washington’s FDA Fix Cure the Patients or the Drug Industry?

October 20, 2015. ProPublica. In Congress, however, things are looking better for the manufacturers. Legislation is advancing that would speed up the FDA’s approval process for medications and medical devices, offering a rare example of how major initiatives can get traction even in today’s gridlocked Washington. Continue reading

Bernie Sanders Opposes Califf for FDA Post Cites Industry Ties

October 16, 2015. Mad in America. Current presidential hopeful and longtime Vermont independent senator, Bernie Sanders, said that he will vote against Robert Califf’s nomination to lead the Food and Drug Administration (FDA). Sanders explained his opposition by citing Califf’s extensive ties to the pharmaceutical companies that he would be in charge of regulating. Continue reading

Investigation: Advisory panel suggests limited use of popular contraceptive Essure

September 29, 2015. An advisory panel is now recommending limited use of the popular birth control Essure until more is known about its safety. The advisory panel suggests women with an allergy to metal, an autoimmune disease or history of pelvic inflammatory disease stay away from Essure right now. Continue reading

Medical panel calls for further study of Bayer sterility device

September 24, 2015. The Wall Street Journal. Thirteen years after the Food and Drug Administration approved a women’s sterility device called Essure, a panel of outside medical advisers Thursday called on the agency and device-maker Bayer AG to further study why so many women are suffering severe pain from the implant. Continue reading

F.D.A. panel weighs complaints on Essure contraceptive implant

September 24, 2015. The New York Times. A panel of experts convened by the Food and Drug Administration excoriated the manufacturer of a contraceptive device for not collecting data that they say could have helped predict risks for women. The device has received thousands of complaints from women who say they were harmed by it. Continue reading

FDA revisits safety of the Essure contraceptive device

NPR, 2015: Many women rely on birth control throughout their lives to prevent unwanted or untimely pregnancies. The Essure contraceptive device is placed in the fallopian tubes essentially sterilizing the woman. This alternative to traditional sterilization methods has caused immense harm to many women and provoked strong responses from patient advocacy organizations and professionals in the health care industry. Continue reading

FDA to establish patient advisory committee on medical devices

September 19, 2015. The U.S. Food and Drug Administration on Friday announced the establishment of its first-ever patient advisory committee on medical devices. The committee, according to the FDA, is designed to inject a patient perspective into the agency’s deliberations on device development, approval and monitoring. Continue reading

Obama picks Duke physician to head FDA

CQ Roll Call, September 15, 2015. President Obama will nominate Robert Califf to be the next commissioner of the Food and Drug Administration, the White House announced Tuesday. Califf has served as the agency’s deputy commissioner for medical products and tobacco since January. In that role, he oversees the agency’s divisions responsible for tobacco, drugs, medical devices and biological treatments, areas where the FDA is currently drafting new policies and regulations. Continue reading

Michael Milken, from junk bonds to legislative advocate

Boston Globe, September 14, 2015. Not everyone is pleased with Milken’s behind-the-scenes advocacy. While supporters say the Cures Act, a version of which was passed by the House in July, would make it cheaper and faster to get cutting-edge drugs and medical devices to patients, critics warn that it would create dangerous regulatory shortcuts. Continue reading

Delayed scrutiny: Problems with birth control device expose gaps in FDA oversight

Modern Healthcare, July 25, 2015. More than 19,000 women have joined a Facebook support group called Essure Problems. Many have reported debilitating abdominal pain, heavy bleeding and large weight fluctuations. They claim these side effects were not disclosed to them by the manufacturer or their doctors, and that their complaints have been dismissed for years by the device manufacturer, physicians and the federal government. Continue reading

CMS panel moderately confident that some PAD treatments warrant national coverage

Healio, July 22, 2015. “We have a conflict between what we know logically should work [and] data that … just aren’t very good,” panel member Diana Zuckerman, PhD, president of the National Center for Health Research Cancer Prevention and Treatment Fund, said. She was one of several panelists who emphasized the need for more long-term data. Continue reading

21st Century Cures drug bill triggers a DC dust-up over relaxed development regs

Fierce Biotech, July 10, 2015. Lawmakers in the House easily passed the 21st Century Cures Act today, a big step toward once again shaking up the legal framework built to guide drug development in the U.S. while significantly boosting the amount of funding that flows to the NIH. Consumer advocates, though, see the new development regulations as a recipe for unleashing drugs and devices that would later prove dangerous and unhelpful. Continue reading

This bill promises to speed up drug approvals so much that it’s making people uncomfortable

The Washington Post, July 8, 2015. The bill slated to land on the House floor on Thursday seems unassailable on its face – the 21st Century Cures legislation promises to modernize medicine and speed the development of lifesaving treatments. But a vocal chorus of physicians and pharmaceutical industry watchdogs warn that the bill is full of stealth provisions that could actually put sick people in harm’s way, by speeding the development of treatments that are neither safe nor effective. Continue reading

F.B.I. investigates whether harm from surgical power tool was ignored

The New York Times, May 27, 2015. The Federal Bureau of Investigation has begun looking into whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to a power tool used during gynecologic surgery, according to two people who said they were interviewed by investigators. Continue reading

Speeding up drug-approval process could have downside

The Wall Street Journal, May 30, 2015. Would a congressional bill designed to jump-start medical innovation end up lowering standards for approving new uses of existing medicines? Consumer advocates are raising this concern about the 21st Century Cures legislation, which passed the House Energy and Commerce Committee unanimously last week and, in part, is designed to reform the approval process for drugs. Continue reading

Cur is crowdfunding a medical device that isn’t cleared by the FDA, and that’s a problem

The Verge, May 14, 2015. A company called Cur is developing a promising new pain-relieving product, according to Mashable, Fast Company, and PC World. Problem is, the company is doing it by launching a $50,000 crowdfunding campaign on its own website prior to filing for the necessary FDA clearance. The move could doom the product before it ever hits the market — or it could point to a glaring loophole in FDA regulations. Continue reading

Women share concerns about permanent birth control device with FDA

WJLA-TV (ABC NEWS), April 2, 2015. NCHR president Dr. Zuckerman accompanied women harmed by Essure permanent birth control to meet with FDA officials. They told FDA that women in terrible pain from Essure got no help from their doctors and then were dumped from the company’s clinical trials. This made the study results look better so that Essure would be approved. Continue reading

Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices

The US Food and Drug Administration (FDA) approves about 400 implanted medical devices each year through an abbreviated process called the 510(k) process, which only rarely requires clinical trials (studies of patients). Continue reading

Is Early Stage Medical Device Development Going Overseas?

Even though the FDA has recently proposed a new program to provide earlier market access to high-risk medical devices, FDA Commissioner Margaret Hamburg nevertheless came under fire for the agency being too slow to approve medical devices at the annual conference of the Advanced Medical Technology Association (AdvaMed) in Chicago. Continue reading

Medical Company May Be Falling Short Of Its Patient Safety Ideals

NPR: the Masima device company created a Patient Safety Movement Foundation but didn’t investigate reports that its devices harmed patients. “When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that’s not very credible,” Zuckerman said. “Especially when users made complaints that the company’s product put patients at risk,” she said. Continue reading

Ebola Outbreak: A Teachable Moment for Scientists

AAAS, August 2014. The media frenzy surrounding the Ebola crisis in West Africa shows that many journalists don’t understand that an experimental drug is just that – a scientific experiment. It is not a “breakthrough” drug or a “cutting-edge treatment” or a prize to be envied, unless or until it is proven to be safer and more effective than nothing. Continue reading

Johnson & Johnson Praised for Taking Uterine Surgery Tools Off Market

Johnson & Johnson, which has come under withering criticism for its response to problems with some of its medical devices, won cautious praise from critics on Thursday for its decision to withdraw three products used in uterine surgery because of a risk of spreading cancerous tissue, only months after the safety issue became widely known. Continue reading

Statement of Dr. Diana Zuckerman, President of the National Center for Health Research, in support of the SWEET Act

Statement of Dr. Diana Zuckerman July 30, 2014 The National Center for Health Research strongly supports the SWEET Act introduced by Representative Rosa DeLauro (D-CT).  Today, sugary beverages represent the largest calorie source in an American teen’s diet — and … Continue reading

Big Data Peeps At Your Medical Records To Find Drug Problems

No one likes it when a new drug in people’s medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was removed from the market over concerns that it increased the risk of heart attack and stroke. To do a better job of spotting unforeseen risks and side effects, the Food and Drug Administration is trying something new — and there’s a decent chance that it involves your medical records.
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Lawmakers Respond To Advocates’ Concerns About Innovation Initiative

Lawmakers appeared to respond to concerns that the House Energy & Commerce Committee is receiving a one-sided, industry-backed patient perspective as part of its 21st Century Cures Initiative by soliciting comments July 11 from other groups and calling for a balance between the push for more expedited approvals and public health safeguards. Continue reading

Health Care Advice That Can Save Your Life

My friend Barry just got out of the hospital, four months after having an almost deadly reaction to a prescription medication. Talking to him about his experience has made me realize how overwhelming it is for most people to figure out what medical treatments are best for them, which doctors to trust, and how to recover from a serious illness. Continue reading

Letter to the Editor: “FDA’s compassionate-use program offers early access without compromising drug trials”

Washington Post, April 24, 2014   The April 22 front-page article “FDA relents in battle against a cruel disease,” about parents urging the Food and Drug Administration to approve a promising drug for Duchenne muscular dystrophy, pulled on the heartstrings. However, there … Continue reading