Public can report medical device problems at new FDA webpage

Star Tribune, October 25, 2016 – The U.S. Food and Drug Administration has set up a new webpage where the public can report allegations of regulatory misconduct against medical device makers and marketers. “This is a good idea, but the question is: what resources will the Center [for Devices and Radiological Health] devote to this to ensure that the allegations of misconduct are followed up and dealt with accordingly?” asked Diana Zuckerman, president of the National Center for Health Research. Continue reading

With overactive bladder, drug companies helped create $3 billion market

MedPage Today & Milwaukee Journal Sentinel, October 15, 2016 – Diana Zuckerman, president of the National Center for Health Research noted there is another factor arguing against the use of drugs to treat overactive bladder. “All of these drugs have the potential for serious risk,” she said. “So what’s the actual benefit? To weigh that against risks that can be serious, it’s pretty unimpressive.” Continue reading

Anthem says will not cover Sarepta’s approved Duchenne drug

Reuters, October 7, 2016 – To keep health insurance affordable, companies need to ensure that they are paying for safe and effective treatments, said Diana Zuckerman, president of non-profit organization National Center for Health Research. “When FDA fails to ensure those standards, then ‘FDA approval’ is no longer a gold standard that insurance companies can rely on,” she said. Continue reading

F.D.A. Approves Muscular Dystrophy Drug That Patients Lobbied For

The New York Times, September 19, 2016 – The Food and Drug Administration approved the first drug to treat patients with the most common childhood form of muscular dystrophy. The agency’s approval went against the recommendation of FDA experts and the agency’s independent Advisory Committee. “The agency has set a dangerous precedent,” said Diana Zuckerman, president of the National Center for Health Research. Continue reading

Feds to crack down on those who fail to report clinical trials

Politico Pro – 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… Continue reading

Doctors Downplaying Drug’s Suicide Risks Attract FDA’s Scrutiny

Bloomberg – 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. Continue reading

FDA Grants Accelerated Approval For Sarepta Muscular Dystrophy Drug Eteplirsen

The U.S. Food and Drug Administration (FDA) has approved the first drug for treating patients with Duchenne muscular dystrophy. “The agency has set a dangerous precedent,” said National Center for Health Research president Diana Zuckerman. “To prove something works, you have to compare it to something else — a placebo or a treatment. They didn’t do that.” Continue reading

FDA Approves First Drug To Treat Rare Form Of Muscular Dystrophy

The Food and Drug Administration Monday approved the first drug to treat Duchenne muscular dystrophy, a rare and lethal muscle weakening disorder that affects about 15,000 Americans. Diana Zuckerman, president of the National Center for Health Research, said “it sets a dangerous precedent if the FDA is going to start approving drugs that aren’t compared to anything.” Continue reading

Whistleblower case contends surgical device maker misled FDA — and patients paid the price

Jerome Lew is a Hollywood screenwriter, and what happened to him could have come straight out of a horror film.

In 2009, Lew went to UCLA Medical Center for surgery to relieve numbness and pain in his hands. The operation appeared to be a success. But he later began having trouble speaking. His left eye drooped. He developed severe nerve pain and weakness in his neck, arms, and hands. Continue reading

21st Century Cures Act: Yes or No? No: Act’s promise of quick cures is a brew of ultra-hype mixed with snake oil

Imagine that you or someone you love has a fatal disease with no proven treatment. Would you rather be given an unproven experimental treatment for free or would you want to pay more than $100,000 for the drug and hope it works
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? Continue reading

What’s on the Table for the July US-EU Talks Beginning Today?

By Celia Wexler, Who.What.Why. July 11, 2016 EU Trade Commissioner Cecilia Malmström listed several priorities for the European Union when it resumes trade negotiations with the United States on July 11. They include: […] • Greater regulatory cooperation for prescription drugs and medical … Continue reading

Republicans seize on reports critiquing FDA to push for agency reforms

STAT, June 15, 2016. Has Congress’s watchdog agency just given Tennessee Senator Lamar Alexander the ammunition he needs to push a stalled biomedical reform through the Senate? The Government Accountability Office on Wednesday issued two critical reports suggesting that the Food and Drug Administration isn’t properly planning how to keep pace with medical science. Continue reading

21st Century Cures Act nears passage with little news media scrutiny

Health News Review, June 13, 2016. With the exception of STAT News, a few other mainstream media outlets, and some boosterish op-eds appearing in local papers, the news media haven’t said much about the 21st Century Cures Act over the past 6 months. It’s fair to say most Americans are in the dark about that far-reaching bill passed by the House of Representatives last summer and now winding its way through the Senate. Continue reading

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, 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