US healthcare: Power to the patients?

Financial Times, May 22, 2016. Families of boys suffering from Duchenne muscular dystrophy push for approval of a new medicine because there are no other treatments. But scientists point out that there is no evidence that the drug works. Does it set a dangerous precedent for FDA to approve a new drug based on patients’ claims rather than science? Continue reading

Who’s calling the shots in state politics? Amid federal gridlock, lobbying rises in the states

The Center for Public Integrity, February 11, 2016. Across America, lobbyists for drugmakers — including Enbrel’s maker Amgen — have worked at a feverish pace to push state laws that make it harder for pharmacists to substitute cheaper biosimilars for brand-name biologic drugs, as is commonly done with regular generic drugs. Continue reading

FDA approval pending for implant to treat opioid addiction

Maine Public Broadcasting News, March 22, 2016. Dr. Tracy Rupp shares the concern that patients with the opioid addiction treatment implant needed to take additional doses of buprenorphine. From a patient safety standpoint, she expresses her concern and hopes for further studies about the risks and benefits for patients who get the implant. Continue reading

Can an implant stop heroin addiction?

The Daily Beast. March 27, 2016. Tracy Rupp told the advisory committee at the FDA that she was “disappointed to conclude” that the evidence wasn’t enough for her to endorse the opioid addition treatment. “While we all desperately want new treatments for opioid abuse, we have to be sure they are safe and effective,” she said. Continue reading

Senate approves FDA’s ‘breakthrough pathway’ for medical devices

DOTmed.com, March, 23 2016. Diana Zuckerman, president of the National Center for Health Research, wrote on behalf of the watchdog group that it was “concerned that the focus of these bills is on getting medical products to market more quickly, instead of making sure they are safe and effective.”
Continue reading

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. Continue reading

Federal health regulators plan to warn consumers more strongly about Essure, a contraceptive implant that drew thousands of complaints from women reporting chronic pain, bleeding and other health problems

U.S. News and World Report, February 29, 2016. With FDA’s plan to warn consumers about the birth contraceptive implant Essure, Diana Zuckerman at The National Center for Health Research shares: “We strongly support a black box warning, but it needs to be a very strong one.” Continue reading

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

Did FDA screw up its reporting of Essure deaths?

QMED, February 17, 2016. An independent analysis of FDA MAUDE data shows 303 fetal deaths related to the Bayer contraceptive medical device, but FDA itself has only reported five. A U.S. congressman is officially demanding answers while also alleging that some doctors implanting the device received illegal kickbacks. 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