Is ‘Female Viagra’ Feminist?

In These Times, February 3, 2016. It’s been called the first “Viagra for women” and hailed as a health breakthrough. But Addyi (generic name flibanserin) is sparking ire just as it claims to spark desire. Since the FDA approved Addyi in August 2015, feminist debate on these questions has raged. Continue reading

Partisan split threatens progress on bill to speed drug approvals

STAT, February 1, 2016. When Republican senators overseeing legislation to accelerate medical treatments said last month they would chop the bill into parts — rather than passing comprehensive legislation — their Democratic counterparts put on a good face. Behind the scenes, though, aides say the Democrats were blindsided by the move, and warn that the Republican decision threatens to undermine bipartisan support for one of the most significant pieces of legislation on medical research in years. Continue reading

FDA faulted for failure to track safety issues with drugs already on market

STAT, January 14, 2016. 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. Continue reading

The 21st Century Cures Act could be a harmful step backward

The Washington Post, November 19, 2015. 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

Understanding the controversies over a groundbreaking new health care law

Milbank Quarterly, August 10, 2015. The House of Representatives did something surprising: They passed a groundbreaking health care law with strong bipartisan support. That sounds like good news. However, this groundbreaking health care law is almost as controversial as the previous one. Continue reading

Approved but not proven: what’s up with FDA, cancer drugs?

Medscape Medical News, October 22, 2015. 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. Continue reading

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

Health News Review, October 20, 2015. 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?

ProPublica, October 20, 2015. 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

Mad in America, October 16, 2015. 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

Theranos Limits Use of Blood Test Technology

Medscape Medical News, October 16, 2015. Theranos, the clinical lab company revolutionizing its industry with low-cost finger-prick tests, is limiting the use of its tiny blood vials to assays approved by the US Food and Drug Administration (FDA), company CEO Elizabeth Holmes said yesterday. Continue reading

Investigation: Advisory panel suggests limited use of popular contraceptive Essure

WCBD NEWS 2, 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

Women with Essure contraceptive implant needed more surgeries, study finds

The New York Times, October 13, 2015. Women who sought permanent sterilization through a contraceptive implant called Essure were 10 times as more likely to be back for surgery within a year than women who had their tubes tied, according to a new study of 52,326 women Continue reading

How medical device companies test products out on patients—after they’re released

Pacific Standard, October 8, 2015. Federal scrutiny has been a long time coming for Essure: Since the device was approved nearly 13 years ago, thousands of women have filed complaints reporting punctured tubes, debilitating muscle fatigue, and severe pain. Continue reading

Medical panel calls for further study of Bayer sterility device

The Wall Street Journal, September 24, 2015. 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

The New York Times, September 24, 2015. 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 to establish patient advisory committee on medical devices

Star Tribune, 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

Califf nomination for FDA chief gets mostly high marks

Medpage Today, September 16, 2015. The nomination of Robert Califf, MD, as FDA commissioner is getting good reviews from most health policy and cardiology experts. One area that might cause controversy with Califf’s nomination is his ties to the pharmaceutical industry. 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

Long-Term Data on Complications Adds to Criticism of Contraceptive Implant

The New York Times, May 3, 2015. When a new contraceptive implant came on the market over a decade ago, it was considered a breakthrough for women who did not want to have more children, a sterilization procedure that could be done in a doctor’s office in just 10 minutes. 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

Is Early Stage Medical Device Development Going Overseas?

Wolters Kluwer Law & Health Blog, October 15, 2014. 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, October 6, 2014. 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

Diversity in Clinical Trials

The Wall Street Journal, August 28, 2014. In response to a law passed two years ago, the FDA was directed to assess the extent to which women and minorities are represented in clinical trials and also devise a plan to bolster their participation. The requirement was made in response to concerns that drugs and devices may often be used by subsets of the population on whom the products were not actually tested. 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

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

Clinical evidence in FDA drug approvals varies widely, study finds

Modern Healthcare, January 22, 2014. “With new drugs, there is often an exaggeration of the benefits and underreporting of the risks,” said Diana Zuckerman, president of the National Research Center for Women & Families, who has testified at several hearings on drug safety. “There’s so much emphasis on drugs being the latest, the most innovative and novel—but unfortunately this usually means it’s just new, not necessarily better.” Continue reading

BPA-Free Baby Bottles Now Law, But We’re Not in the Clear

Huffington Post, August 14, 2012. I asked Diana Zuckerman, president of the National Research Center for Women and Families if she was concerned about the substitutes being used in place of BPA: “We are very concerned that BPA could be replaced with products that are just as risky, or even more risky. The federal government is not doing what is needed to protect the American public, either in their regulation of BPA or any of these potential substitutes.” Continue reading

Essure Study Criticized

NBC News, November 4, 2013. Dr. Diana Zuckerman, who leads the National Research Center for Women and Families, a non-partisan FDA watchdog, said the survey questionnaires exhibit dubious research methods. “These studies are always done by the company that is selling the product so it is not exactly unbiased,” Zuckerman said. Continue reading

Lawsuits pile up over popular birth control pill

Chicago Tribune. September 15, 2013. Birth control pills containing drospirenone “shouldn’t be on the market because there are so many safer alternatives,” said Diana Zuckerman, president of the National Research Center for Women & Families. “We can debate how unsafe it is and for whom — more research could obviously clarify that — but there’s really no doubt that it’s not as safe as dozens of other birth control pills.” Continue reading

Letter to the editor: Still working to understand cancer

The Post article on the overdiagnosis of cancer clearly reported the need to reduce patients’ fear and confusion about “cancers” that many experts now agree are not really cancer, because they don’t spread and aren’t harmful. The major obstacle has been uncertainty about how likely these conditions are to predict cancer or change into an invasive cancer in the future. Continue reading

FDA Kicks Off Women’s Health Program With Surgical Mesh Registry

FDA’s launch of a new registry for controversial surgical transvaginal mesh products as part of a new program focusing on women’s health could signal the agency is planning to prioritize sex-specific device concerns, a consumer advocate said. “If they start with new patients, it will take years before we get the information that we need,” said Diana Zuckerman, president of the National Research Center for Women & Families. Continue reading

FDA Panels: Too Many Conflicts Or Too Little Expertise?

June 2013. Should FDA Advisory Committee members be allowed to have financial conflicts of interest regarding the approval of medical products? Diana Zuckerman discusses how financial ties to pharmaceutical companies can influence the voting and discussion on drug and medical device approvals, and how misunderstandings of statistics and the value of clinical trials can lead to the approval of dangerous products. Continue reading

TN Compounder’s Steroid Sickens Patients

TN Compounder’s Steroid Sickens Patients – May 25, 2013 – “Nobody imagined that a company with the reassuringly named ‘Main Street Pharmacy’ could be shipping contaminated medical products to patients in 13 states,” said Diana Zuckerman, president of the National Research Center for Women and Families. “Unfortunately, the public is at just as much risk now as we were when patients first started dying from contaminated medicines last year.” Continue reading