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 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

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

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

Senate panel approves tighter oversight of compounding pharmacies, but bill is under fire

Washington Post. May 23, 2013. Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks. Continue reading

FDA advisors vote against two drugs for menopausal hot flashes

Reuters. March 5, 2013. Advisers to the Food and Drug Administration on Monday voted against approval of two drugs designed to reduce the frequency and severity of hot flashes associated with menopause. “The FDA’s advisors did a great job today of carefully considering the scientific evidence,” said Diana Zuckerman, president of the National Research Center for Women & Families. Continue reading

Antibiotics: When Science and Wishful Thinking Collide

Health Affairs blog. January 25, 2013. Antibiotic resistance is a major concern confronting our health care system, and there is tremendous pressure on the Food and Drug Administration (FDA) to “do something” about it. Unfortunately, the FDA is responding by approving drugs that are likely to do more harm than good. Continue reading

Notre Dame Football Players Rape Cover-up – What’s in the News and What Isn’t

Fem2.0 January 9, 2013. The media has extensively covered the college championship football game between Notre Dame and Alabama, but few Americans aware of Notre Dame’s cover-up of rapes by Notre Dame football players. Monday’s football game is an opportunity to acknowledge that raping women is a terrible crime that needs to be taken seriously by the police, the public, and the media. Continue reading

No Need for Skin Preps to Be Sterile, FDA Told

December 13, 2012. MedPage Today. Requiring that antiseptic skin preparation products be sterile — a standard not currently mandated by the FDA — is unnecessary and wouldn’t produce a dramatic drop in infections, manufacturers, clinicians, and policy analysts told the FDA Wednesday. “We need to have better communication that a product is not sterile,” Dr. Jennifer Yttri said, adding that could come from product labeling. Continue reading

J&J Bedaquline and the Evolving Role for Accelerated Approval: Confirming Safety, Not Efficacy?

December 4, 2012. FDA Beat. Discussions during an advisory committee review Janssen’s TB drug bedaquiline showed some interesting thinking around accelerated approval and how much uncertainty can be acceptable—especially when it comes to safety. Yttri warned called “approval of drugs based on the promise of benefit” a “dangerous practice.” Continue reading

Allergan drops bid for FDA approval to promote Lap-Band for teens

October 3, 2012. LA Times. The maker of the Lap-Band weight-loss device, Allergan Inc., has dropped its controversial bid for federal approval to market the product for overweight teens. Doctors already can perform Lap-Band surgery on minors with parental consent. The FDA approval would have allowed Allergan to market Lap-Band specifically for younger people. Continue reading

Consumer group questions review of breast implants

Consumer safety advocates are questioning the Food and Drug Administration about incomplete and seemingly erroneous data used to support the safety of silicone breast implants in an agency review last year. The FDA concluded last summer that silicone-gel implants are basically safe as long as women understand they come with complications. Continue reading

FDA revokes Avastin approval for breast cancer. Decision leaves some devastated. Drug will remain available to treat other cancers.

Washington Post. November 19, 2011. “The science is clear: Breast cancer patients are more likely to be harmed than helped by Avastin,” said Diana Zuckerman, president of the National Research Center for Women & Families. “The risks of the drug are very substantial and can be fatal, killing patients long before they would otherwise die from the disease. FDA made a scientific decision, and it was absolutely the right decision.” Continue reading

Left to Their Own Devices

The Economist. September 10, 2011. Scandals, recalls, stingy customers, anxious regulators—any one of these would traumatise a chief executive. America’s industry for medical devices is suffering from all of them. Omar Ishrak, the new boss of Medtronic, the world’s biggest medical-technology company, recently described the problem succinctly to analysts: “There is a lot of work ahead of us.” Continue reading