Category Archives: In the News

Everything is designed for men, even drugs

Producers Kim Mas and Ranjani Chakraborty, Vox: January 16, 2020


This short video explains why designing medicine around the “average man” is so dangerous. Most things in society are built for, and designed around, a specific “reference man.” This “standard human” is usually a white male in his 30s who weighs around 155 pounds. When we design everything from cars, to air-conditioned offices, to city streets, reference man is the default user. And when it comes to healthcare, that can mean deadly effects for women.  Watch the video above to find out how dosages are determined with “reference man” in mind. After dozens of women got into car accidents under the influence of sleeping pills they’d taken the night before, the FDA had to tell women to cut their dose in half; it turned out, women metabolize Ambien’s active ingredient twice as slowly as men. What was supposed to be a “gender-neutral” dose was anything but. Diana Zuckerman, president of the National Center for Health Research, explains why we need more inclusivity in clinical trials — for women, for people over 65, and for people of color.

https://www.youtube.com/watch?v=CVdn-2KE2bs

Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound

David Lim, MedTech Dive: January 10, 2020


FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward in 2020, according to device center Associate Director for Compliance and Quality Erin Keith. Warning letters are used by FDA to alert a manufacturer it “has significantly violated FDA regulations,” such as misstating what a device is indicated for or having poor manufacturing practices, according to the agency.

Warning letters are used by FDA to alert a manufacturer it “has significantly violated FDA regulations,” such as misstating what a device is indicated for or having poor manufacturing practices, according to the agency.

The downturn in Center for Devices and Radiological Health warning letters from 81 in fiscal year 2015 to nine in 2019 comes amid a major effort to reorganize the FDA device center that proved “very disruptive to the compliance office,” Keith said.

“It is organized in a different way now than it was in the past, so the processes have had to be worked out,” Keith told the Food and Drug Law Institute’s annual compliance conference in December. “We can’t issue a warning letter if we don’t do it timely, according to the evidential requirements.”

[…]

Still, some patient safety advocates are concerned the drop in warning letters cannot be entirely attributed to the restructuring changes at the agency.

“I don’t think that downward trend can adequately be explained by the reorganization that is taking place,” Public Citizen Health Research Group Director Mike Carome said.

Diana Zuckerman, president of the National Center for Health Research, said the trend is emblematic of a regulator that is overly focused on pleasing industry.

“It could have several different causes, reorganization could be one. [Medical Device User Fee Amendments] regulations could be part of it, which requires more meetings. But there is this emphasis on customer service, which is defined as making life easier for the industry. Industry is an important customer, but so is the American taxpayer,” Zuckerman said.

Over the past decade, the device center has also focused on shifting how it communicates with manufacturers, focusing on pushing companies to prioritize making decisions that improve quality and patient outcomes rather than simply achieving compliance with regulatory requirements. The goal, Keith said, is to have companies address potential issues before they rise to the warning letter stage.

“We as a philosophy for the center don’t want to have to go to enforcement,” Keith said. “We want to get to problems when they are smaller and easier to fix.”

Another method FDA has utilized is increasing the number of alternative methods of disseminating information, such as issuing Letters to Health Care Providers and Safety Communications. For example, in April 2019, the agency issued a safety communication alerting patients and providers of mammography problems at a medical clinic in Ohio, noting the facility “was unable to meet the parameters for a key quality control test on the day of the 2018 annual inspection.” FDA noted in the safety communication quality problems at East Palestine Family Medical Clinic dated back to October 2017, and recommended patients screened at the facility receive an additional mammography.

“I think it’s important that we won’t wait to let people know that there is an issue patients and providers need to know about by letting a compliance process catch up to documentation,” Keith told MedTech Dive. “Sometimes we can get what we need, have the public know what’s going on and get a change by sharing information. When it’s more appropriate to use a more traditional compliance activity, we will do that.”

[…]

Read the original story here

Schools Seek Ways to Curb Vaping Among Students

Tawnell D. Hobbs, The Wall Street Journal: January 6, 2020


[…]

An estimated 5.4 million middle- and high-school students in the U.S. recently used e-cigarettes, a vaping device, according to a federal survey released in December. That is 20% of all students, far more than the 4.3% that used cigarettes.

The Centers for Disease Control and Prevention reported 2,561 cases of hospitalizations for lung injury involving e-cigarettes, and 55 deaths, as of Dec. 27. The majority of cases are linked to products containing THC, the psychoactive ingredient in marijuana.

School administrators say vaping is more challenging to tackle on campus than regular cigarettes. Vape devices are typically battery-powered and made to look like everyday items, such as pens, lipstick cases and USB drives.

They come in child-friendly flavors, from bubble gum to strawberry cheesecake, and have pleasant smells. Students can take quick whiffs undetected while sitting in class or walking down a hallway, with exhaled vapor dissolving quickly into the air or held in to be absorbed, unlike lingering smoke from lit cigarettes.

School resource officers in Chico, Calif., use 18-years-olds, under the nicotine purchasing age of 21, as decoys to bust businesses selling tobacco products used for vaping; officials said eight clerks have been cited. The officers also allow students to trade vape devices for coupons for pizza and smoothies, with no questions asked. In four weeks, about 50 vapes were turned in, said Sgt. Greg Rogers.

“We’re just trying something different,” Sgt. Rogers said. “We wanted it to not be punitive.”

Jupiter Community High School in Palm Beach County, Fla., in October banned students from using the restroom during class periods unless for emergencies and with an administrative escort. The rule has since been lifted.

“Parents were frustrated with the fact that their children weren’t just allowed to go to the restroom,” said June Eassa, a Palm Beach school assistant superintendent.

Plainwell Community Schools in Michigan is starting random nicotine testing of high-school students in extracurricular activities in January. Students testing positive are restricted in participating in their activity.

[…]

Juul Labs said that it has suspended broadcast, print and digital product advertising in the U.S. “We are focused on resetting the vapor category in the U.S. and earning the trust of society by working cooperatively with regulators, public health officials, and other stakeholders to combat underage use,” the company said.

According to Juul’s website, “one 5% strength JUUL pod is designed to replace one pack of cigarettes in nicotine strength,” and saves money.

Researchers are concerned that there doesn’t seem to be a standard of what should be a normal vape dose, leaving students to grossly overuse the product.

“There’s a certain understanding that you don’t smoke more than a pack a day,” said Diana Zuckerman, president of the National Center for Health Research. “With vaping, because it’s new and because all these products vary, there aren’t the sorts of standards that help people restrict what they’re doing.”

[…]

Read the original story here

Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels

Maria Rachal, MedTech Dive: December 23, 2019


It was a busy year for FDA’s expert advisory committees, called on to tackle many of its biggest medical device questions in 2019, new and old.

The Circulatory System Devices Panel met in June in reaction to a concern that emerged in late 2018 after a meta-analysis found a late mortality signal in patients receiving paclitaxel-coated devices. Other topics, like the benefit-risk profile of transvaginal mesh, had been hashed out in numerous meetings over the past few decades.

​Repeated meetings aren’t necessarily a negative, said Diana Zuckerman, president at the National Center for Health Research since 1999.

“We can’t think of these public meetings as a bad outcome … We wish that people weren’t being harmed by breast implants, by mesh, by Essure, and so on. But if they are being harmed, then I’d much rather there be a public meeting about it then to have it covered up,” Zuckerman said. “For breast implants especially, it’s made an enormous difference in terms of public awareness.”​

Of all the device meetings this year, none seemed to draw as much attention as a March meeting on breast implant safety. It came amid growing recognition of a type of lymphoma that can develop around the devices called breast implant associated anaplastic large cell lymphoma, or BIA-ALCL, as well as a vast collection of potentially related symptoms called breast implant illness.

In one of the clearer impacts from an advisory panel this year, FDA followed up months later by asking Allergan to initiate a worldwide recall of certain textured implants, and issuing a draft guidance outlining a black box warning and patient safety informed consent checklist to be included with the implants.

Raylene Hollrah, a breast cancer and BIA-ALCL survivor who has advocated that FDA improve breast implant safety, said that while the advocacy community has made significant strides with regulators and plastic surgeons this year, language in FDA’s draft guidance regarding breast implants’ risks is “way too vague.” Comments on that proposal are due Monday.​

“I am definitely not anti-implant,” she said. “I want women to have a choice but I want it to be a safe one.”

Better transparency on the chemicals and metals contained in breast implants remain at the top of advocates’ list, Hollrah said.

Eight months after the breast implants meetingFDA asked its Immunology Devices Panel to weigh immunological responses to devices based on different metal elements in implants.

Zuckerman said that meeting represented the first time she’d heard high-level FDA scientists and officials link certain immunological responses to devices and vocalize a need to better understand what causes that link, and which patient and product factors increase risk.

“It was very interesting because it wasn’t specific to any particular product,” Zuckerman said. “[When] there’s an advisory committee on one product, there always seems to be a lot of caution about suggesting immunological responses to implants,” adding that panelists seemed “much more open-minded about these issues than they usually are.”

One undercurrent across many meetings was inadequacy of post-approval studies and spotty adverse event reporting, leading to incomplete data with which panelists could form opinions. Once a device is commercialized, it’s very difficult to complete postmarket studies, Zuckerman said.

Even if those postmarket studies and other forms of surveillance are happening, “it’s too late for the patients being harmed,” Zuckerman said. “Most of us would much rather know that some implant that’s going into our body was adequately tested before it was put in our body. Not that it might be tested a year or two later.”

[…]

Read original story here.

I Visited a ‘Private ER’ Where People Pay Up to $5,000 a Year to Skip the Hospital— Take a Look

Hilary Brueck, Insider: December 19, 2019


In the shadow of the World Trade Center in downtown Manhattan, right down the block from a Target store, there’s a secret emergency room, tucked away on the fifth floor of an office tower.

Here, Sollis Health is staffed 24/7 with doctors who are trained in emergency medicine. They’re on-call for an elite membership of hundreds of wealthy clients who pay to skip dealing with their local ERs, where staff say conditions are like a “war zone.”

“The ER system is broken, I think everybody agrees to that,” Diana Zuckerman, president of the National Center for Health Research, told Insider, saying the country’s emergency medicine system is misused, overused, and wildly expensive.

Patients often wait more than five hours to see a doctor in a regular New York City ER. But at Sollis Health, patients can spend as little or as long with their doctors as they want, and get most of the same type of emergency care they’d receive at a hospital in a fraction of the time.

[…]

On the Upper East Side Sollis also has an MRI machine on hand, but not here. (MRIs give more detailed images of organs and soft tissue than X-rays or CT scans can.)

“Those are very, very expensive,” Zuckerman said of the MRI, X-ray, and other imaging machines. “Unless you have a lot of patients, you’re going to have to charge an enormous amount of money for each one.”

In Tribeca, Sollis shares space with a few different health companies, including one that does “executive health exams” which include lots of testing, imaging, and blood work.

[…]

Concierge services can make managing healthcare easier for patients with chronic health issues, young children, and older people.

Estimates suggest there are about 10,000 concierge doctors at work across the country.

“We can give care in the sort of one-to-one fashion that we think we would want for ourselves or we would want for our parents, when they’re sick,” Olanow said. “Basically, have the entire experience led by a physician.”

Ranging between $250 and upwards of $400 a month, the price of this kind of private care (which is billed as out of network) isn’t exactly a bargain, nor is it a particularly fair solution to the nation’s ER crisis.

“I can’t imagine this is the best solution, because it’s obviously only for people who can afford it,” Zuckerman said. “If you’re willing to spend a few thousand dollars to participate in this program, you have the money to make sure that you don’t have to wait very long for whatever it is you need.” 

[…]

Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t.


For nearly two decades, Dr. Neal Hermanowicz has led the movement disorders program at the University of California’s Irvine campus, where he earns more than $380,000 a year in salary and bonuses. The widely respected expert on Parkinson’s and Huntington’s diseases adds to his income by consulting for drug companies.

Since 2014, 11 pharmaceutical companies have paid him a total of at least $588,000 for consulting, speaking and honoraria, according to federal data. For example, he has received more than $225,000 in speaking and consulting fees from San Diego-based Acadia Pharmaceuticals, manufacturer of a controversial drug for Parkinson’s-related psychosis. In 2017, he was the company’s highest-paid physician consultant in the U.S. That year, he prescribed the drug more than 180 times, costing patients or their insurers more than $445,000.

Under University of California rules aimed at discouraging excessive moonlighting, Hermanowicz should not only have reported his outside income to UC Irvine; he should also have turned over more than $200,000 to the school from 2016 to 2018, according to UC Irvine policies. His academic department would then have decided how much to keep and how much to return to him. That didn’t happen. From 2014 to 2018, Hermanowicz didn’t report any payments from pharmaceutical companies on his annual “outside professional activity” forms, which ProPublica obtained through a public records request.

[…]

Approved in 2016, the drug, better known by its trade name, Nuplazid, has been associated with more than 2,000 patient deaths and 10,000 other adverse events, according to FDA data — figures that one expert has called an “important warning signal.” But for Hermanowicz, those concerns were overblown.

Nuplazid “got some attention in CNN recently with maybe an increasing risk of death, which I don’t think is valid,” he told the crowd. “They didn’t really do a careful analysis. They just said people took this medication and then they died.”

When Hermanowicz first connected with Acadia, as early as 2012, it was a relatively unknown firm, with no drugs on the market. But biotech insiders had high hopes for the company, which for over a decade had been developing Nuplazid to treat severe psychosis associated with Parkinson’s.

Hermanowicz became one of the drug’s primary advocates. Besides serving as an investigator in the trials, he also published several studies on its safety and efficacy.

In August 2015, he co-wrote an Acadia-funded study in the American Journal of Managed Care on how to manage the symptoms of Parkinson’s disease, emphasizing the need for effective treatment options. The next year, a study that he co-wrote called the drug “an important advancement” and a “first choice for treatment of Parkinson’s disease psychosis,” and he said it had a “better safety profile than current treatments.” In both studies, Hermanowicz disclosed his ties to Acadia.

The FDA’s clinical review reached a different conclusion. Conducted in 2016 by Dr. Paul Andreason, it found an increased risk of harm and death. Nuplazid failed two clinical trials, and patients experienced double the rate of adverse events of those on a placebo. Based on reviews of similar drugs, Andreason determined that Nuplazid’s safety profile was “not adequately safe” for treating Parkinson’s-related psychosis.

“We needed more controlled trial data to identify what the risk was,” said Andreason, who has since left the FDA.

When Nuplazid came before the FDA’s approval committee, Hermanowicz testified at the meeting, expressing the hope that the drug “will be available to me to provide to my patients.” In the company’s press release celebrating the approval, Hermanowicz said he was “delighted.” He was the only nonemployee quoted.

After Nuplazid hit the market, reports of deaths associated with the drug surged. “It’s a very high number” of deaths, said Diana Zuckerman, president of the National Center for Health Research. While it’s difficult to determine why there are so many fatalities, she said, the drug’s benefit isn’t worth the risk. In hundreds of cases, patients’ hallucinations, which are supposed to subside with the drug, were instead aggravated.

“This is not a particularly effective drug,” she said. “So what is the risk you are going to take?”

Last year, an FDA analysis found no “new or unexpected” safety risks related to Nuplazid. Acadia has maintained that the drug is safe for patients, and that the multitude of adverse events reflects its patient population, which is mostly elderly and in an advanced stage of Parkinson’s disease. “Our top priority is patient safety and we stand by the established efficacy and safety of Nuplazid,” said Maurissa Messier, a senior director for corporate communications at Acadia, in an emailed statement. Acadia is now seeking approval for Nuplazid to treat the millions of people who suffer from dementia-related psychosis, such as Alzheimer’s disease.

Hermanowicz has continued to publish studies supporting Nuplazid, lead medical education courses sponsored by Acadia and receive large consulting payments from the drugmaker without disclosing them to the university.

Some faculty members do take pains to comply with the university’s policy on outside income. Dr. Anjay Rastogi, a professor and clinical chief of nephrology at UCLA medical school, meticulously tracks all payments he receives from industry in a centralized spreadsheet — and remits the required portion, which he said funds academic enrichment, teaching or research.

“We need to disclose everything, I disclose more rather than less,” he said. “In my opinion, it’s fair that we help the university, and they help us as well.”

Read original story here.

Not Just Blowing Water — Vaping Presentation Will Sort Myth and Reality


“We keep calling it vaping, and calling it vapor,” Amy Osterman said. “But it’s an aerosol. It’s more like hairspray.”

That’s an image Osterman, youth marijuana and tobacco prevention coordinator for Walla Walla County’s Department of Community Health, likes to share with parents and teens.

Osterman is one of a trio of specialists presenting a vaping prevention and education night for parents and young adults on Monday.

[…]

Vaping, for anyone who has somehow missed all the talk, is equated with the electronic cigarette trend. According to the Centers for Disease Control and Prevention, a host of names are affiliated with the subject, including vape pens, vapes, tank systems and e-hookahs.

At their core, e-cigs produce an aerosol by heating a liquid that usually contains nicotine — the addictive drug in traditional cigarettes, cigars and other tobacco products — plus flavorings and other chemicals that help to make the aerosol.

Users inhale this aerosol into their lungs, but bystanders can also breathe in this aerosol when the user exhales into the air, according to the CDC.

Vaping is not safe for teens, kids and young adults, the federal agency has decreed.

School districts nationwide have been caught flat-footed and struggle to banish vaping on campuses, said Diana Zuckerman, author and president of the National Center for Health Research.

The devices used can be as small as a USB drive or a pen. Since there is no smoke, vaping at school can be virtually undetectable, Osterman said.

“That’s one of the challenges.”

Data is showing 31% of the teens who vape have transitioned to smoking regular cigarettes within six months, Zuckerman recently said in a session for education journalists.

CDC officials have been on the front lines of a sweeping, multi-state outbreak of lung injury associated with vaping.

As of Nov. 20, nearly 3,000 cases of e-cigarette, or vaping-associated lung injuries have been reported to CDC from 49 states (Alaska has not reported any cases), Washington, D.C., Puerto Rico and the U.S. Virgin Islands.

Forty-seven deaths have been confirmed, two of those in Oregon, and more are being investigated.

According to the CDC, analysis of fluid samples collected from the lungs of patients with e-cigarette or vaping-associated lung injury identified vitamin E acetate, an additive in some THC-containing vaping fluid.

Recent CDC laboratory test results of lung fluid samples from 29 patients from 10 states found vitamin E acetate in all of the samples, THC in 82% of the samples and nicotine in 62% of the samples.

Officials have said these findings are the first time they have detected a chemical of concern in biological samples from patients with these lung injuries, and that the latest national and state findings suggest THC-containing vaping products — particularly from informal sources like friends, family or dealers online or in-person — are linked to most of the cases and play a major role in the outbreak.

Those being hospitalized are often normally healthy kids, Zuckerman said, including the high school athletes “who will never be able to play their sport again.”

Even with awareness rising, 66% of teens believe vape fluid is simply flavoring, she said.

“We know (traditional) smoking is dangerous, but that’s 20, 30, 40 years down the road. But vaping is hospitalizing kids. It’s an unprecedented epidemic.”

Osterman agrees, noting Washington’s number of kids using vape products lines up with national rates. On the most recent Healthy Youth Survey taken by Washington’s Department of Health, 21% of 10th-graders and 30% of 12th-graders reporting vaping in the 30 days prior to the survey.

“Youth of all kinds are vaping. It’s not the troubled kids, but the kids on the honor roll at Wa-Hi,” she said.

Her department works with schools across the county, and none are immune to this issue.

[…]

Read original story here.

How Minnesota Schools are Doubling Down on Anti-vaping Efforts

Erin Hinrichs, MinnPost: December 2, 2019


As teen vaping rates continue to rise, Minnesota educators are monitoring their classrooms and hallways for well-disguised vaping devices.

Some are shaped like USB flash drives that students can charge by plugging them in to their laptop. Others double as pens and highlighters. Some are even less conspicuous: shaped like a smart watch, an ID badge attachment and even a replacement hoodie string.

What started out as a fad marketed to youth as a safer, healthier alternative to smoking cigarettes has ballooned into a health epidemic that public health officials and politicians are scrambling to rein in. As of Nov. 20, the Centers for Disease Control and Prevention (CDC) says 2,290 injuries and 47 deaths have been reported as a result of using e-cigarette or vaping products. Teens and young adults make up the bulk of those vaping-related hospitalizations resulting from serious lung damage, says Diana Zuckerman, president of the National Center for Health Research.

“I just want to emphasize how serious this is,” she told education reporters during a recent webinar hosted by the Education Writers Association. “When we think about smoking, we know it’s dangerous 20, 30, 40 years down the road. The fact that we already have so many kids hospitalized from vaping is just an unprecedented kind of epidemic.”

Armed with this new health information, administrators and educators at many metro area schools are doubling down on their anti-vaping efforts. While the bulk of their focus remains on getting information to students and parents, many are expanding the scope of their educational outreach and shifting from a punitive disciplinary approach to one that takes a more holistic approach.

[…]

A less punitive approach

Likewise, in the Rosemount-Apple Valley-Eagan district, health staff are looking at ways to build out a more holistic approach to dealing with vaping in schools — a less punitive approach that’s better fit to address any related mental health issues.

Deb Mehr, the district’s health services coordinator, says the district recently received a grant from the county that will be used to accomplish two key things: add vaping information to the curriculum and support diversion efforts that keeps kids in school and connect them with resources to make healthier decisions.

Addressing misperceptions about the health risks associated with vaping, she says, are paramount. And it’s hard to have engaging conversations with youth when they’re too fearful of disciplinary action to seek information or help.

Her sense of urgency around addressing vaping is spurred by two recent seizure episodes at two different school sites — once this year and once last year. In other instances, she’s found students who’ve been vaping experience very high blood pressure and pulse rates.

“I think part of the problem is kids don’t know what they’re vaping,” she said.

Health officials have linked recent vaping-related lung injuries to THC and vitamin E oil, mostly found in illegal vaping products. But even legal ingredients — like nicotine and formaldehyde — are “potential carcinogens and very toxic” says Zuckerman. And manufacturers aren’t required to list all of the ingredients, since they’re considered trade secrets.

Along these lines, teaching students to be more critical consumers is key to keeping them safe, says Leslie Stunkard, a licensed drug and alcohol counselor in the Minneapolis Public Schools district.

With more than 70 schools districtwide, she says the push from her team has really been to teach students, especially the older ones, to be “skeptical about the advertising they hear.” She likes to point out how these companies are trying to market themselves as a good thing — by offering scholarships and even selling vitamins.

Offering another example of how educators in her district are getting students to think more critically about vaping, she says a science teacher at Washburn High School has created a lesson on vaping that explains the how even the name “vaping” is deceiving.

“I think one of the things that slowed us down a bit is the staff are learning — just as we and the students are learning — just how dangerous it is,” she said.

Read the original article here

Report Claims More Women than Men Injured by Medical Devices

The ICIJ used the Food and Drug Administration’s (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database to conduct the research. This data is publicly available and contains eight million reports which have been filed by doctors, patients and manufacturers when a medical device is suspected of putting someone at risk, causing injury or resulting in death.

Steps had to be taken to identify the gender of those within the database as although the FDA gathers information on the sex of patients, this data is not made publicly available. Therefore, in order to overcome this obstacle, the ICIJ realised that the sex of patients was sometimes disclosed through pronouns and adjectives within the incident reports submitted to the FDA.

The ICIJ group followed four steps to identify the gender of those in the FDA MAUDE database:

1. Generate a set of labels

This stage involved classifying patient sex in 1,000 incident reports from the MAUDE database. Patient sex was classified as female, male or unknown.

2. Assign rules to the computer

The group used rules to train the computer to conduct automatic sex classification on the data.

3. Validate the results from the computer

Humans looked at the results from the computer and implemented additional rules to improve the quality of the results.

4. Run the code against all of the data in the FDA Maude database

Using 1997-2017 (the same time frame as the Implant Files investigation), the computer assigned a gender to 23% of patients with 96% accuracy.

The ICIJ claim that the algorithm created using the above steps was able to positively identify the sex of the patient in more than 340,000 injury and death cases. These findings reported 67% of these people were women and 33% were men.

Talking about the findings, the ICIJ stated: “The trend we noticed is consistent with studies that have shown that women experience higher rates of hip-implant failure than men and have stronger immunological reactions to metal-containing devices.”

Other experts within the industry were keen to voice their opinion over the importance of looking at the effects of medical devices on different genders. Diana Zuckerman, president of the National Center for Health Research commented: “Having information about sex is very important because some products differ in safety between men and women.”

Madris Tomes, founder and CEO of Device Events and a former FDA manager described the ICIJ’s work as critical. Tomes said: “It has long been unclear why the FDA’s device division redacts data elements that are so vital to scientific study…age, sex, and even the outcome of the adverse event are redacted by the device division but not the drug division.”

“But, if we are to look at allergy and autoimmune issues (presented in the FDA Immunology panel’s meeting on Metals in Implants) resulting from the metals and polymers in the hips, this could provide a second reason why the revision rates for women is higher than it is for men. It is an area where more research is necessary, and it shows the need for the FDA to un-redact fields which are so important for patients, physicians and hospitals to evaluate the safety of devices”, she added.

This report is part of the well-known Implant Files, which began from a report on medtech adverse events last year.

Read original story here.

FDA Challenged Over Metal Implants ‘Public Health Travesty’

Sasha Chavkin, International Consortium of Investigative Journalists: November 14, 2019


Patients who suffered debilitating immune reactions after being implanted with metal-containing devices have joined doctors, scientists and industry representatives to testify before a United States government advisory panel probing the risks of immunological responses to metals placed inside the body.

The hearing represented the most systematic look by the U.S. Food and Drug Administration at the issue of adverse reactions to metals, a problem that affects a minority of implant patients but one that can cause severe pain, neurological damage and cognitive impairments.

“I’m in a great deal of pain, so please bear with me,” testified Sue Francis, a hip implant patient who has experienced severe health effects stemming from her reaction to metal. “We need to recognize that these metals from day one are interacting with our bodies.”

Metals are a major component of common devices such as artificial hips, spinal fusion implants and the contraceptive coil Essure, but there is limited scientific research on auto-immune and allergic responses to them.

The International Consortium of Investigative Journalists reported extensively on hip implants and Essure as part of its global Implant Files investigation, which revealed massive gaps in medical device oversight that left patients vulnerable to flawed and poorly tested products.

Patients and their advocates urged the FDA to order more detailed disclosure of the metals used in devices, to require device labels to disclose the risks associated with metals, and to send a letter to doctors across the country alerting them to the threat of adverse metal reactions.

[…]

Unlike hearings earlier this year on breast implants and vaginal mesh that focused on specific products and regulatory steps, yesterday’s hearing focused on trying to understand and improve the state of scientific knowledge on metal reactions.

As such, it is unlikely to result in the short term in dramatic steps such as banning products from the market.

Experts urged the FDA to make the hearing the beginning of a sustained effort to gather data on the problem of metal reactions, including their differential effects among patients of different gender, age and socioeconomic status.

For example, the substantial majority of adverse responses to metal devices occur among women, who are generally more vulnerable to auto-immune, rheumatic and thyroid disorders.

“There’s a need for more and better pre-market research,” said Diana Zuckerman, the president of the National Center for Health Research. “We need to really have better data on diversity of patients.”

Read the original article here.