Category Archives: In the News

The Problem with Medical Device Approvals

Suzanne Robotti, MedShadow: January 16, 2018

MedShadow doesn’t often cover medical devices, but I’ll make an exception to point out this article about Stephen Tower’s experience with an artificial hip. This is a must-read for anyone who has or anticipates getting an artificial hip or knee — or any other body part.

Stephen Tower, MD, is an orthopedic surgeon experienced in performing artificial hip replacements. Yet he found out firsthand that the hip he requested to be put in his body was defective in its design. He then worked for years to bring attention to the harm that the metal-on-metal hip from Johnson & Johnson was causing.

The interesting part of the story is how that device — and almost all medical devices — got approved by the FDA. Essentially, a device manufacturer can file a form claiming that its product is “substantially equivalent” to an existing device. If the FDA agrees, that’s it. There’s no need for testing and no follow-up studies.

In some cases the “substantially equivalent” claim makes logical sense, but doesn’t work in real life — that’s why the clinical trial process exists. The author of the op-ed, Jeanne Lenzer, explored many examples and the history of the FDA in her new book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Save It. […]

I’ll give the last word to Diana Zuckerman, the president of National Center for Health Research (NCHR), an independent nonprofit that scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. NCHR does not accept funding from device or pharmaceutical companies.

I asked Zuckerman for an example of a substantially equivalent approval that had particularly bothered her. She told me that the da Vinci Surgical System was “cleared for market” as substantially equivalent to the surgical tools it uses, such as a scalpel. But a robotic surgery system is more than just the tools it uses. The da Vinci robot was described by then-FDA Commissioner Jane Henney as the first of its kind and a product that “could change the practice of surgery.”

Although based on the 510(k) review process that rarely requires a clinical trial, the FDA required the first version of the da Vinci system to be studied in one clinical trial comparing the results to traditional surgery for gallbladder and reflux disease surgery. However, it and all future da Vinci robotic systems for all other surgeries were cleared for market by the FDA as substantially equivalent to the scalpel and other tools, and those later reviews didn’t require any clinical trials at all.

“How can a device be revolutionizing the practice of surgery and yet be substantially equivalent to tools that scientists tell us have been in use for more than 2,000 years? Does that make sense to any logical person?” […]

Read the original article here.

Which Breast Implants are Safest for Mastectomy Patients?

Diana Zuckerman, PhD, Madris Tomes, and Amelia Murphy, National Center for Health Research and Device Events

Based on the summary of book chapter in Breast Implants, Rene Simon (ed.), Nova Science Publishers, 2017.

Our new book chapter on breast implants explains that the 55-year history of breast implants reflects repeated efforts to improve their safety and effectiveness by reducing the cosmetic problems and health complications that develop during the years while they are in the human body. The most recent effort is the type of highly cohesive breast implants known as “gummy bear implants” because of the thick gel that is described as similar to gummy bear candies. The goal of the more cohesive gel is to make implants last longer and be less likely to leak. First approved in the United States in 2012, adverse event reports indicate that this newest generation of implants causes complications similar to older generations of silicone gel breast implants.

The first breast implants, made in the 1960’s, were for cosmetic enhancement. When women’s augmented breasts became hard over time, implant manufacturers responded by making the silicone gel thinner. One manufacturer, Surgitek, added polyurethane foam to the outside to make the breasts feel softer. Those design changes caused other problems, however: the thinner gel had a tendency to “bleed” through the silicone elastomer shell, which contributed to the most common complication, capsular contracture. Breast implants made with thinner gel also ruptured and leaked more easily, and the gel broke down into silicone oil which could migrate to other organs or cause silicone granulomas inside their bodies. The polyurethane foam caused other problems: implant removal was very difficult and women lost their breast tissue during explant surgery, and the foam was found to break down to a known carcinogen.

The Food and Drug Administration (FDA) did not require breast implant manufacturers to submit data to prove the implants were safe and effective until 1992. By that time, the manufacturers had developed implants with a thicker shell and a more cohesive silicone gel. However, the studies revealed that, like the earlier implants, the more cohesive implants did not “last a lifetime” as had been claimed. As a result, manufacturers continued to modify the silicone gel to make it less likely to rupture and leak.

Despite claims that gummy bear implants are safer than other breast implants, a 5-year study found that the rupture rate was more than 4% for first-time augmentation patients.  The percentage of women needing additional surgery within 5 years ranged from 17% to 48%, depending on whether the patients were augmentation patients or reconstruction patients, and whether the gummy bear implants replaced previous implants. Our analysis found that from January 1, 2008 through June 30, 2017, 1298 adverse event reports for silicone gel breast implants were made to the FDA, 252 (19%) of which were for gummy bear implants. This is very high when you keep in mind that gummy bear implants were relatively rare in the U.S. prior to FDA approval in 2012. This chapter puts these statistics in the context of what is known about the safety of silicone breast implants and how that has changed over time.

Copies of the entire book chapter are available upon request at

Can the FDA Help Reduce Drug Prices or the Cost of Medical Care?

Diana Zuckerman, PhD, American Journal of Public Health: November 2017

The new US Food and Drug Administration (FDA) commissioner Scott Gottlieb has worked for pharmaceutical companies for most of his career, so it may have surprised some public health advocates when he responded to congressional pressure by taking on the hot issue of drug pricing as one of his first priorities.

In his blog written for the FDA Web site, Commissioner Gottlieb echoes the view of many public health advocates when he says: “Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. […]

I agree with Commissioner Gottlieb that these sound like useful strategies, because generic drugs have been estimated to have saved $1.2 trillion between 2003 and 2012. However, I question how much these strategies can accomplish. Is this a Band-Aid approach to a much more complex problem—and if so, is the FDA part of the problem?

Generic Drugs, Competition, and Drug Prices

The Government Accountability Office (GAO) reported in 2016 that the price of 50-milligram capsules of the antidepressant clomipramine HCL, which is used to treat obsessive-–compulsive disorder, increased by more than 2000% in one year: from 34 cents per capsule in 2013 to $8.43 per capsule in 2014.  The 20-milligram capsules of piroxicam, to treat arthritis, increased by more than 2000% from 2010 to 2015: from 9 cents to $1.82 per capsule. The price of digoxin, a commonly prescribed heart medication, increased by 2800% in a single year.  Despite these increases, the GAO found that from 2010 to 2015 the cost of generics decreased by 59%. Nevertheless, the GAO reported that the price of 315 generic drugs went up by 100% or more during those years, causing financial difficulty for many patients. […]

When a large number of generic manufacturers are making the same product, the average price usually falls to 20% of the branded price, or even lower. There are exceptions, however. For example, eight companies make ursodiol, a treatment for gallstones.  In 2013, the cost was 45 cents per capsule, but in May 2014, Lannett increased its price to $5.10 per capsule, and its competitors soon followed.

Is the FDA Part of the Problem?

The contribution of the FDA to high drug prices was noted recently when the FDA approved an old, commonly used drug for a type of Duchenne muscular dystrophy. Deflazacort had not previously been approved in the United States, but many patients imported generic versions from Europe or Canada for $1000 to $2000 for a year’s supply. When the FDA approved it, a US company gave it a new name, Emflaza, and a new price tag, $89 000 per year (more than a 6000% increase).

Another glaring example of the unpredictable impact of competition involved brand-name drugs for hepatitis C. When Gilead put Sovaldi on the market in late 2013, it cost $1000 per pill: $84 000 for a 12-week course of treatment. The public and policymakers were incensed at what was considered an outrageous cost, but experts assumed the price would soon drop because other similar drugs were in the pipeline. Instead, the official price increased, despite two competing drugs….

FDA Drug Approval

Clearly, when the FDA approves new drugs that create competition, it does not necessarily lower prices. Congress has passed laws to require the FDA to approve drugs and devices more quickly, which Commissioner Gottlieb also supports. This has resulted in lower standards over the last two decades5 and has contributed to the high cost of medical care.

Read the original article here.

Nearly a Dozen Artificial Turf Fields in DC Failed Last Round of Safety Tests

Evan Lambert, Fox 5 News: September 18, 2017

A parents’ group known as Tireless DC tells FOX 5 that 11 artificial turf fields in the District have failed their most recent round of testing, leading to closures and replacements, and igniting another debate over the safety of synthetic turf.

D.C.’s Department of General Services (DGS) maintains and tests the 50 synthetic turf fields in the city. DGS did not make a list of the 11 failing fields available to FOX 5, but a task order from DGS shared with us shows the city is spending nearly $1 million to replace four turf fields at Janney, Eaton, Ross and Tubman elementary schools.

Tireless DC tells FOX 5 those schools are among the 11 fields that failed an annual test by DGS, which essentially measures how hard the fields are. A number under 200G is considered safe by some industry experts and that is the guideline DGS uses. […]

Janney Elementary School’s principal sent a letter to parents at the start of the school year letting them know the field failed a safety test and that it would be closed for replacement. The field is nearing completion, according to a DGS spokeswoman.

Parents expressed frustration over not learning of the test results sooner and the timing of the repair during the school year.

“The timing is really what was the biggest frustration because if it was known last spring, there was a lot of downtime during the summer, and at this point, it has impacted the practices,” said Janney Elementary School parent Christine Lucy.

Dr. Diana Zuckerman, president of the National Center for Health Research, expressed concern about the fact that the synthetic turf industry faces little government regulation.

“We really know very little about what is in artificial turf, but when studies have been done, they find a wide range of very toxic materials, including materials that can cause children to have attention deficit problems, can exacerbate asthma or obesity and can even in the long run cause cancer,” Dr. Zuckerman said.

In Montgomery County, seven artificial turf fields used by the school system are tested twice yearly by the manufacturers.

Read the original article here.

Safety Checks at DC Playgrounds Under Question After Boy Injured on Crumb Rubber Floor

Q McCray, ABC 7 News: October 27, 2017

There’s no hiding 5-year-old Sam loves playing at Washington D.C. parks, but his mother can’t help but think what if.

“He fell about two and a half feet and broke his leg,” Eliza Graham explained.

Sam fell on one of D.C.’s older poured-in-place (PIP) crumb rubber floor playgrounds.

“No one in the District can speak to whether these playgrounds meet fall safety standards,” the mother of three added.

PIP and crumb rubber were D.C.’s flooring of choice for parks until a moratorium last year for health and safety reasons. One of them being attenuation.

Dr. Diana Zuckerman is President of National Center for Health Research.

“As they get older they get harder,” she said. “It can be extremely dangerous even deadly if a child falls.”

Manufacturers push “Gmax” testing to evaluate if PIP playgrounds are soft enough. Seven On Your Side found out D.C.’s Department of General Services (DGS) has never tested its rubber playground floors.

“Playgrounds do not fall under the Gmax testing for us,” DGS Director Greer Gillis said during a public hearing recently. “That’s one of the things we want to do in regards to playgrounds.” […]

Read the original article here.

Streamlined FDA Reviews Fail to Catch Dangerous Glitches in Health Software, Study Finds

Casey Ross, STAT News: September 12, 2017

The Food and Drug Administration carefully polices many categories of drugs and devices. But when it comes to software, the agency’s oversight is scanty at best — something that a new study finds is resulting in failure to detect dangerous glitches in software-enabled medical equipment.

The study comes amid ongoing debate over the FDA’s role in reviewing the booming number of software-enabled products in health care.

The study, published in Milbank Quarterly, found that 11 of the 12 software devices subjected to the highest-risk recalls between 2011 and 2015 went through a streamlined review process, known as 501(k), that didn’t require testing for safety and efficacy. The other one was completely exempted from review.

Those recalls included life-sustaining equipment such as ventilators and infusion pumps, as well as a clinical decision support software used to flag adverse drug events during surgery.

“The FDA is allowing many of these products on the market with relatively loose criteria of what is acceptable, and those are the ones that are most likely to end up causing harm,” said Diana Zuckerman, a co-author of the study and president of the National Center for Health Research.

In a response to STAT questions, a spokeswoman for the FDA acknowledged that its review process needs to be updated to reflect issues posed by software-enabled devices.

“FDA’s traditional approach to medical devices is not well-suited to these products,” the spokeswoman, Stephanie Caccomo, wrote in an emailed statement. “A new pragmatic approach must recognize the unique characteristics of digital health technology and the marketplace for these tools, so we can continue to promote innovation of high-quality, safe, and effective digital health devices.” […]

Errors and Glitches

The study examined 627 software devices recalled over the five-year period between 2011 and 2015. Most of the recalled devices (592) were classified as presenting moderate risk; 23 were classified as low risk; and 12 were deemed high risk.

The high-risk recalls involved equipment used in several different settings. Six of the devices were used in anesthesiology, including five ventilators and one decision support tool. The study reported that the software glitches in the ventilators could cause them to stop working prematurely. The decision support tool, used to flag adverse drug events in surgery, could lead to the use of the wrong patient’s data during a procedure. […]

The Impact of Cures Act

The debate over the FDA’s scrutiny of medical software and digital health products is also being played out through implementation of the 21st Century Cures Act, which includes a provision that exempts certain software devices from the agency’s jurisdiction. Zuckerman said the exemption is a step in the wrong direction at the worst possible time, when rapid innovation is producing increasingly complex devices that require deeper scrutiny.

“Our Congress should not have passed a law lowering standards in a way that could be so harmful to patients,” she said. […]

Read the original article here.

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health

Jay G. Ronquillo and Diana M. Zuckerman, Milbank Quarterly: September 12, 2017

Policy Points:

  • Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial.
  • No studies of medical devices and software assess the impact on patient safety of the FDA’s current regulatory safeguards and new legislative changes to those standards.
  • Our analysis indicates that current regulations are necessary but not sufficient for ensuring patient safety
  • New laws will reduce safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients.

Context: Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration’s (FDA’s) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy.

Methods: Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details.

Findings: A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review. The largest high-risk recall categories were anesthesiology and general hospital, with one each in cardiovascular and neurology. Five electronic medical record systems (9,347 units) were recalled for software defects classified as posing a moderate risk to patient safety.

Conclusions: Software problems in medical devices are not rare and have the potential to negatively influence medical care. Premarket regulation has not captured all the software issues that could harm patients, evidenced by the potentially large number of patients exposed to software products later subject to high-risk and moderate-risk recalls. Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk assessment and adverse event reporting, physicians and their patients are likely to be at risk from medical errors caused by software-related problems in medical devices.

Read at:

Statement of Dr. Diana Zuckerman in Honor of Dr. Vivian Pinn

September 8, 2017

I am going to Charlottesville on September 13 to honor Dr. Vivian Pinn, our 2013 Foremother Awards honoree, as a major research facility at UVA’s School of Medicine is named in her honor.  Dr. Pinn received her medical degree from the University of Virginia in 1967, where she was the only woman and only African American in her graduating class. In 2005, she returned to UVA as the University’s first African-American woman commencement speaker, and UVA’s School of Medicine named one of its 4 student advisory colleges as the “Pinn College” in her honor. UVA’s School of Medicine honored her by establishing the “Vivian W. Pinn Distinguished Lecture Series in Health Disparities.”  And now she is the first African American to have a building named in her honor at UVA’s School of Medicine.

We honored Dr. Pinn with our Foremother Award in 2013.  As the first director of the National Institute of Health’s Office of Research on Women’s Health, Dr. Pinn has had many accomplishments.  But one of her most important was her support for the Women’s Health Initiative, which was the first study to determine that women’s  hormones do not need to be “replaced” after menopause, because combined hormone therapy actually increased the risk of heart attack, stroke, and breast cancer in postmenopausal women.  This study resulted in a drop in breast cancer among women for the first time, and has saved thousands of lives.

L to R: Former NIH Director Dr. Bernadine Healy, actor Pierce Brosnan, and
Dr. Vivian Pinn at a Congressional Briefing on Women’s Health Research in 1992.

Will Controversial Bill Cure or Kill Patients?

Celia Wexler, Who What Why: September 7, 2017

In 2016, 10-year-old Joshua Hardy lost his long battle with cancer, in part because of a viral infection that resulted from a bone marrow transplant. Hardy’s family tried to get access to a new experimental antiviral drug from Chimerix, the company developing it. The company refused, not wanting to divert time and resources from its efforts to gain FDA approval for the drug. It agreed to make the drug available only after a social media campaign.

Hardy responded well to the drug, but it was too late.

Hardy’s story is one of those featured in the lobbying campaign for a federal Right to Try (RTT) bill, which passed the Senate in August and may soon get a vote in the House.

But the Senate-passed bill would not require drug companies to provide dying patients access to their experimental drugs. Instead, it largely goes after the Food and Drug Administration, and would remove FDA oversight from the process, while insulating the pharmaceutical industry and doctors from virtually any liability if patients are harmed.

RTT pits some desperate patients, along with libertarians and conservative and anti-regulation Republicans, including President Donald Trump and Vice President Mike Pence, against public health advocates, medical ethicists, and some national patient-advocacy groups.

The bill’s supporters frame the legislation as striking a blow for the rights of patients to try any drug without government interference. They predict that more pharmaceutical companies would give patients access to their unproven drugs if they weren’t worried about the FDA looking over their shoulders.

The bill’s opponents contend that any possible expansion of access comes at the cost of eliminating crucial protections for the most vulnerable patients, potentially hastening their deaths and making their end more painful.

Opponents are circulating a letter to the House this week charging that RTT should actually be called the “False Hope” bill. Indeed, given the philosophical bent of its strongest supporters, and their connection to free-market crusaders Charles and David Koch, RTT may be more about advancing a conservative, anti-government ideology than helping the terminally ill. […]

Diana Zuckerman, president of the National Center for Health Research, points out that drug companies rely on a three-phase clinical trial process to gain FDA approval for their products. If RTT siphoned off patients with life-threatening illnesses from clinical trials, particularly for trials of medications serving limited populations with rare diseases, drug companies might find it even harder to enroll enough patients to complete them. And health insurers will not pay for drugs that lack FDA approval. […]

RTT’s true beneficiaries may be new drug startups that are neither “patient-oriented nor compassionate, trying to create buzz for their product,” Zuckerman said. A biotech startup, she speculated, might be struggling with the high costs of making its product, and be happy to find wealthy, desperate patients willing to pay the freight. This might be particularly attractive since RTT gives patients only limited rights to sue, even if they are seriously harmed by defective products.

Unscrupulous doctors also might benefit, she added, since the law does not place any restrictions on the fees they may charge patients to administer the drug and monitor their progress. […]

Read the original article here.

Cigarette Maker Stocks Plunge on FDA Announcement, But Health Experts Are Skeptical

Emma Court, Marketwatch: July 28, 2017

A Food and Drug Administration announcement Friday that included a proposal to lower nicotine levels in cigarettes to non-addictive levels sent cigarette maker shares plunging. […]

Health experts said that the Friday announcement focused on important public health priorities, including examining the effect flavors, such as menthol, have in attracting young people to tobacco products and approaching any changes so as to avoid a spike in black market activity.

But they also expressed skepticism about the real-world effects of Friday’s news, and concern about its pushback of reviews for products like cigars and hookah tobacco until 2021 and things like e-cigarettes until 2022. The aforementioned products are already on the market but have come more recently under FDA regulation. […]

And the announcement’s intent matters less than “not just what they ask for, but what they require,” said Diana Zuckerman, president of the National Center for Health Research.

Extending the product review timeline keeps harmful products on the market longer, Dobbins said.

For its part, the FDA said that extending the review deadlines will give the regulator more time along with giving companies “additional time to develop higher quality, more complete applications informed by additional guidance from the agency.” […]

Though the Friday announcement appeared to be a negative for cigarette makers, it could be “an opportunity over the long term for reduced-risk products,” said Wells Fargo Securities analyst Bonnie Herzog, such as Altria and Philip Morris’ smokeless iQOS devices. “We see this as an opportune entry point for long-term investors and would recommend building positions on today’s broad weakness.” […]

Read the original article here.