To fund projects like the Cancer Moonshot, Congress had to strip away some of the FDA’s most important regulatory powers

The 21st Century Cures Act passed in the House, but comes with a lot of regulatory compromise and threats to patient safety. Most notably, Senator Warren and Senator Sanders oppose the bill along with NCHR President Diana Zuckerman due to patient safety concerns and breaks for Big Pharma. “It really is a David and Goliath issue of where the money is,” said Dr. Zuckerman. Continue reading

House passes most lobbied bill in recent history, heads to Senate

CBS News, November 30, 2016 – Dr. Diana Zuckerman of the National Center For Health Research described the Cures Act as a “misnomer to start with.” She cited two issues with the bill: it lowers the standards for medical products, drugs and devices — and the money outlined in the bill is promised, not guaranteed. Continue reading

A Frenzy Of Lobbying On 21st Century Cures

November 28, 2016, Kaiser Health News – Beyond the pharmaceutical industry, the bill’s supporters include universities, medical schools and groups representing them, as well as patient groups funded by drug and device companies. “It really is a David and Goliath issue of where the money is,” NCHR president Diana Zuckerman said. Continue reading

Law firm that believes FDA is ‘broken’ highlights Cures Act fears

November 23, 2016, Fierce Biotech- We know it’s a top priority for Congress, but a group of panelists speaking at an “emergency briefing” in the U.S. Senate this week hosted by an anti-FDA legal co have urged lawmakers to not “rush a closed-door negotiated version of the bill during the lame-duck session.” Continue reading

Conservative and Progressive Experts Join Forces to Expose Under-the-Radar Consequences of 21st Century Cures Act

November 22, 2016, PR Newswire – Experts from opposite ends of the ideological spectrum were united over concern about the 21st Century Cures Act at an emergency briefing in the U.S. Senate yesterday. While highlighting different problems, they agreed that Congress should not rush a closed-door negotiated version of the bill during the lame-duck session. Continue reading

This Tiny Plastic Implant May Disrupt America’s Opioid Addiction Problem

Motherboard by Vice, November 15, 2016 – “I think the big issue is the transition,” said Diana Zuckerman, NCHR President, who was not involved with the trials. “People are going to go from taking pills to using this implant. The implant doesn’t work immediately. It takes a while for it to work and settle into the level that it’s supposed to be. And during that time the person is still going to be taking pills, and that becomes a vulnerable time. How many pills should that person take before the implant is really working, and should they continue to take pills after it’s working?“ Continue reading

FDA hearing on off-labels use of devices explores risks to patients

Star Tribune, November 10, 2016 – NCHR President Diana Zuckerman said the Infuse Bone Graft is “contraindicated” for children. But the FDA’s 2015 warning didn’t ban the product in kids because some children have such significant bone defects or such rare bone disorders that they would be willing to accept the risks. Continue reading

Trump just dropped a big hint to the pharmaceutical industry

Washington Post, November 14, 2016 – “I think the honest answer is nobody knows” what to expect, said Diana Zuckerman, president of the National Center for Health Research. “Some members of Congress owe pharma a favor; we don’t know the Trump campaign is in that position, and they might not be — and that might give them a certain amount of flexibility. The Trump campaign is nothing if not iconoclastic.” Continue reading

After years of criticism, FDA tries to step up oversight of medical devices

ConsumerAffairs, October 27, 2016 – Diana Zuckerman, President of the National Center for Health Research, said about the FDA’s new site soliciting allegations of abuse in the medical device industry: “[W]ill it make a difference? Will the FDA finally stop treating device companies like their favorite customers and remember that patients and consumers are their most important customers? …More importantly, will FDA finally decide that they will no longer allow device companies to ignore patient safety?” Continue reading

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

National Center for Health Research Joins Other Safety Advocates to Applaud IKEA Recall, Emphasize Need for Consumer Awareness

June 28, 2016 On June 28, 2016 the Consumer Product Safety Commission (CPSC) and IKEA announced the recall of 29 million IKEA Malm dressers responsible for the deaths of three toddlers in tip-over accidents. IKEA has agreed to immediately stop selling … 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

150 experts say Olympics must be moved or postponed because of Zika

The Washington Post, May 27, 2016. More than 100 prominent physicians, bioethicists and scientists from around the world posted a letter Friday urging World Health Organization Director-General Margaret Chan to exert pressure on Olympic authorities to move the Olympics from Rio de Janeiro or delay the Games because of public health concerns over the Zika virus. 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

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

US device industry and FDA “colluded” on legislation to weaken regulatory oversight

The BMJ, December 17, 2005. Dr. Diana Zuckerman from The National Center for Health Research shared, “There’s a world of difference between talking about approval standards in general and crafting specific legislative language. It is outrageous that FDA officials and regulated industry are sitting down to craft legislative language to give to congressional staff.” Continue reading

Groups push opioid pilot effort, question REMS at FDA Science Board meeting

Inside Health Policy, March 11, 2016. Tracy Rupp from the National Center for Health Research echoed Carome’s concerns. “The goal is to reduce inappropriate opioid prescribing, but the fact is that we don’t know whether opioid REMS are effective,” she said. “In fact, in 2013 the HHS Inspector General reported that even the FDA lacks comprehensive data.” Continue reading

PhRMA: Easing speech limits could reduce need for subgroups in trials

InsideHealthPolicy.com, March 7, 2016. While minority, patient and consumer groups pushed for more diversity in the clinical trial phase, Jocelyn Ulrich director of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), said matching demographic subgroups based on sex, age and race, specifically the African American and Hispanic populations, to disease prevalence would extend phase III clinical trials by 20 months or longer. 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

Abortion clinics vs. cosmetic surgery centers: which are safer for women?

The Supreme Court is trying to decide if regulating most abortion clinics out of existence places an undue burden on women’s access to safe and legal medical care. If legislators really want to protect women’s health, I want them to know that they can protect many more women, including many of their friends and loved ones, from far more dangerous medical procedures. 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