Category Archives: News Analysis: Interviews, Op-eds, & Editorials

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.

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.

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.

FDA Deal Would Relax Rules on Reporting Medical Device Problems

Sheila Kaplan, The New York Times: July 11, 2017

WASHINGTON — Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress.

Device makers will still have to quickly report any injuries or deaths related to their products. They would have more time, though, to file reports on devices that may not be working properly, and have the potential for injury.

The deal is part of a pact between the F.D.A. and the $148 billion device industry. Renegotiated every five years, the agreement includes the fees that device makers must pay for the agency to review their products. It is scheduled for a vote in the House of Representatives on Wednesday. […]

But consumer advocates point to recent problems where initial reports of device malfunctions did not involve any injuries, but later evidence — sometimes additional devices showing flaws or reports indicating patients were harmed — began to surface. They pointed to cardiac defibrillators that ran out of batteries; the power morcellator, designed for laparoscopic surgery to remove uterine fibroids, which spread cancer through patients’ bodies; a type of breast implant that is linked to a rare cancer; and the superbug-bearing duodenoscope, whose design flaws made it virtually impossible to disinfect. […]

Textured breast implants have been linked to a rare form of cancer.Critics of relaxing the rules say this is not the right time to ease oversight when so much already goes undetected.

“It often takes months or even years for the F.D.A. to detect patterns of failure,” said Jack Mitchell, director of health policy for the National Center for Health Research in Washington. “Post-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” […]

 Read the original article here.

FDA Eases Notice Requirement on More Than 1,000 Medical Devices

Mike Stankiewicz, Bloomberg BNA: July 10, 2017

More than one thousand medical devices, including umbilical clamps, menstrual cups, and dentures, will be exempt from an FDA clearance process.The Food and Drug Administration removed 510(k) notification requirements for some moderate-risk devices under steps established by the 21st Century Cures Act ( Pub. L. No. 114-255), a 2016 law intended to speed new drugs and devices to the market and reduce regulatory burdens. The newly exempt devices include commonly used items like dentures, menstrual cups and scented menstrual pads, umbilical clamps, and certain hearing aids. […]

The 21st Century Cures Act requires the FDA to determine which class II devices no longer require the premarket clearance.The FDA said the exemption will help industry by eliminating costs and time required to comply with regulations. […]

Industry, Consumer Reactions

The Advanced Medical Technology Association, a medical device industry group, praised the FDA’s move.

“This action supports a risk-based review process for identifying lower-risk, well-established products for exemption and allows FDA to better focus its review resources to support the public health,” Janet Trunzo, senior executive vice president of technology and regulatory affairs at AdvaMed, told Bloomberg BNA July 10.

But Diana Zuckerman, president of the National Center for Health Research, a Washington-based nonprofit, said the FDA is going in the wrong direction because patients could be hurt by the moderate-risk devices.

“In addition to risks to patients, these FDA actions mean even less information about the devices that will be available to doctors and their patients,” she told Bloomberg BNA July 10. “How can doctors and patients make informed medical decisions without any any public information about these products? And how can medical care in the U.S. be made more affordable without requiring scientific evidence about safety or effectiveness for treatments that physicians are choosing for their patients?” […]

Read the original article here.

Special Report: Many Expensive New Cancer Drugs Are Useless (or Worse)

Bottom Line Inc., July 3, 2017

First comes the shock of a cancer diagnosis. Then comes the flurry of questions: Is there a cure? Is there a treatment? What drug do I take? Will it work?

Sometimes the answers are easy to find. People with chronic myeloid leukemia, for example, can take imatinib (Gleevec) and have an 80% chance of surviving for 10 years. 

But other cancer patients aren’t so lucky. They may be given an option of taking a chemotherapy medication that won’t help them live longer—and that will make their lives more miserable in the bargain. […]

We asked Diana Zuckerman, PhD, president of the National Center for Health Research, a nonprofit organization in Washington, DC, to explain why many new cancer medications have so few benefits…and what you or your loved ones can do to get the treatment you need and deserve—at a reasonable cost.

Rushing Cancer Drugs to Market

One big reason these drugs aren’t very effective is a sped-up approval schedule that puts many new cancer drugs in the hands of patients before they’ve been thoroughly vetted. 

Consider this: From 2002 to 2014, the Food and Drug Administration (FDA) approved 71 drugs for a variety of types of cancer—but fewer than half of these drugs have been shown to extend patients’ lives by at least two-and-a-half months, the minimum standard. Many of them came with hefty price tags of more than $10,000 a month. For some of these chemo drugs, the story is even worse—they didn’t improve survival at all. As if that weren’t bad enough, some of these new drugs have side effects that are as dangerous as the cancer they are supposed to treat.

How did this happen? In the quest to get potentially lifesaving medications to people who desperately need them, the FDA approves drugs before the information about their real benefits has been determined. […]

While stopping tumor growth or reversing it is a promising sign, physicians know that it can be temporary and sometimes followed by rapid tumor growth. […]

If you have cancer, you’re probably more interested in living longer than in simply avoiding death from cancer. For example, if the drug you take causes liver toxicity or a stroke that can kill you before the cancer would, it’s not doing you any good.

Not All Drugs Get Follow-Up Studies

When drugs are approved only on the basis of the way cancerous tumors respond, the FDA usually requires follow-up studies to prove that the drugs are truly beneficial, such as helping patients live longer or improving their quality of life for the weeks, months or years that they have left.

That process makes sense—as long as the FDA enforces it. […]

Yet all these drugs are still on the market. One reason is that postapproval studies that could result in removing a drug from the marketplace are very difficult to conduct. Example: It is difficult to conclusively prove whether these cancer drugs are effective because patients are less willing to participate in further clinical trials on a drug that’s already been approved.

The problem may get worse. The FDA is currently evaluating ways to overhaul its processes and speed up approval of all types of drugs, including cancer treatments, in its effort to get life-saving drugs on the market faster.

Little Consideration for Quality of Life

A drug that increases a cancer patient’s well-being and comfort is also considered worthy of FDA approval even in cases where living longer is not likely. But a recent study published in JAMA Internal Medicine looked closely at 18 drugs that had no survival benefit to see what effect they had on patients’ quality of life. The majority of the drugs either contributed to a worse quality of life—for example, patients suffered from diarrhea, fatigue, sleep disturbances or memory loss—or the evidence was mixed (which means the research was inconclusive, with some studies suggesting that treatment was helpful and other studies suggesting it was harmful). […]

Making the Right Treatment Choices

A cancer diagnosis is stressful under any circumstances, but if your cancer doesn’t respond to standard treatments, the choices get tougher. The choice is always the patient’s—for some people, living another two months is worth possible side effects. But there is no excuse for chemotherapy that won’t help extend life and makes you more miserable in the final days.

Unfortunately, you can’t always count on your doctor to help you sort through the options. Many doctors will list all the drugs out there because they want you to have a say in your own care. They also assume that FDA approval means that the advantages outweigh the dangers and may not realize that the studies are inconclusive.

To make an informed decision, though, you need to know the benefits and risks of the medications that are being offered. Here’s how…

Ask your doctor specific questions. Will this drug help me live longer, or will it just cause the tumor to shrink? What are the side effects and how dangerous or unpleasant are they? If you don’t get answers, ask your health-care provider to do some research and give you a summary of the results. Then do some digging on your own.

Use reputable sources for your research. Google searches can send you straight to a misleading advertisement for a drug as well as other misinformation from a variety of sources. Go to Drugs.com instead, where you’ll find the proven risks and benefits of each medication. Look for the sections on risks, side effects, adverse events and contraindications to find out what the problems might be. Check what the drug has been approved to treat. For example, some treatments used for prostate cancer are FDA approved to treat prostate “problems” or “health” but are not proven to treat prostate cancer.

You might also search on Google Scholar or PubMed to find journal articles written by scientists and medical experts who have studied the treatment you are considering. Again, read carefully to see whether there is any evidence that the drug improves “overall survival.”  If the drug improves “progression-free survival,” that doesn’t mean patients live longer.

Get impartial help. The Cancer Prevention and Treatment Fund, the primary project of the National Center for Health Research (where I work), offers a no-cost cancer help hotline to help patients sift through their choices. This organization doesn’t accept any funds from companies that make any medical treatments. Send an email to info@stopcancerfund.org with the type of cancer treatment you’re considering, and someone will reply with relevant and meaningful information that can help you make a smart decision.

Source: Diana Zuckerman, PhD, president, National Center for Health Research and the Cancer Prevention and Treatment Fund, Washington, DC. Date: July 3, 2017 Publication: Bottom Line Health

 

Read the original article here.

Morcellator Cancer Reports Drop, Essure Reports Rise

Michelle Llamas, Drugwatch: June 20, 2017

Adverse events data collected from the U.S. Food and Drug Administration shows that reports of cancer linked to power morcellators are down while reports of injuries from Essure Permanent birth control are up in 2017.

Power morcellators are drill-like devices used to cut tissue into smaller pieces during gynecological surgeries. They have been on the market since the 90s, but it wasn’t until 2014 that the FDA warned about the risk of upstaging cancer. […]

“The decline in morcellator reports doesn’t mean women should be any less cautious,” [data analyst Madris] Tomes told Drugwatch. “Patients still need to ask questions.” […]

Essure Adverse Events on the Rise

While the number of morcellator cancer reports is decreasing, reports of injuries linked to Bayer’s Essure Permanent Birth Control device are on the rise.

Doctors implant Essure metal coils into each fallopian tube. After about three months, scar tissue builds up and prevents pregnancy. But since the device hit the market in 2002, the FDA received thousands of adverse events. […]

Data Reporting Problems at the FDA

There are several reasons why warnings about Essure and morcellators didn’t reach the public sooner.

One of the biggest issues is how the FDA receives and reports data on medical device adverse events. In fact, the FDA admitted it didn’t have the current data on the device at a 2016 meeting to discuss Essure device safety, according to Tomes.

In 2016, the FDA reported five deaths linked to Essure. Tomes did an independent data review and found more than 300 fetal deaths and more than 10,500 adverse events.

It highlighted a big problem with how the FDA managed injury reports. It also called into question how reliable the agency’s reports are. […]

To complicate matters, device manufacturers may also be holding back information. […]

Advocacy Remains a Key Force in Reducing Adverse Events

Madris Tomes attributes a number of factors to the decline in morcellator reports, including refusal of insurance companies to pay for morcellator surgeries, hospitals banning the device and FDA safety communications.

But the personal stories and convictions of women affected by these devices led to the most action. […]

Legislation Aimed at Making Devices Safer, Preserving Legal Rights

Because of women and their families who spoke out about morcellators and Essure, the issue of medical-device safety has reached Congress. Now, a number of bills aimed at improving safety are pending in Congress. […]

The Medical Device Safety Act seeks to remove this protection and allow patients to file lawsuits against manufacturers.

The bill has the support of consumer advocacy groups, including Consumers Union (the policy arm of Consumer Reports) and The National Center for Health Research (NCHR).

“If a patient dies from the use of a PMA-approved medical device, there is no accountability for that person’s surviving family,” Lisa McGiffert, director of Safe Patient Project, and Diana Zuckerman, president of NCHR, wrote in a letter to the Committee on Energy and Commerce. “H.R. 2164 merely allows states to determine how best to protect patients from unsafe medical devices, just as the law allows states to protect patients from unsafe prescription drugs.” […]

The journey has been emotionally moving for Amanda Rusmisell and her fellow advocates at Essure Problems. Even today, speaking about it brings her to tears.

“I’ve seen women from all backgrounds whose lives were ruined by Essure,” she said. “But I’ve had the opportunity to see women helping women. We’ve come together to form a grassroots organization, and we made it to Congress.”

Read the original article here.