Tag Archives: FDA

NCHR’s Testimony to FDA on TOOKAD to Treat Low-Risk Prostate Cancer

Diana Zuckerman, National Center for Health Research, February 26, 2020


Thank you for the opportunity to speak today.  I am Dr. Diana Zuckerman, president of the National Center for Health Research. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.

Although active surveillance is recommended for many patients with low-risk prostate cancer, some patients prefer treatment and that can be a reasonable choice as long as the treatment has a meaningful benefit and does not increase patients’ harms. However, the clinical data for TOOKAD that we are discussing today do not clearly demonstrate that its benefits outweigh its risks – efficacy is uncertain, particularly for U.S. patients, and the drug has the well-known very negative side effects typical of prostate cancer treatments.  

There are 5 major problems with the data, and the FDA did an excellent job of expressing their concerns:

#1.  There was only 1 clinical trial. Replication is the key to science, and effective treatments are available for prostate cancer, so the FDA should not approve a new treatment based on just one study.

#2.  This one trial took place in Europe, and 99.8% of participants were white.  Five patients – not 5% but only 5 men — were not white. Given the higher percentage of African American men who die of prostate cancer, this lack of diversity should not be considered acceptable, unless the FDA is considering approving this product for white men only.

#3. The accuracy of detecting cancer is one major problem. The data showed a high false negative rate. 13.5% of those in the active surveillance arm had a negative biopsy after 2 years. Since it is unlikely that the cancer would spontaneously disappear, this probably reflects false positives in the original diagnosis or false negatives in the post-test. This high false negative rate raises major concerns about the accuracy of biopsies in the treatment arm and at baseline. 

#4. Further, there was a large amount of missing data regarding biopsies at 24 months. Unfortunately, 18.4% of the patients in the treatment arm and 41.5% of those in the active surveillance arm were missing these crucial pieces of information regarding efficacy.  That makes it impossible to draw conclusions based on this one study. 

 #5. The trial was open-label, meaning patients as well as those collecting the data knew whether a particular patient was receiving the treatment or active surveillance. The decision to pursue definitive therapy  — such as surgery — was a subjective decision. Wouldn’t active surveillance patients be more likely to choose treatments later. Also, when biopsy results were uncertain, pathologists may have been biased by their knowledge of whether or not a patient was assigned to the treatment group. 

The FDA held a workshop in September 2018 to discuss issues related to clinical trials of novel treatments for localized prostate cancer.  They concluded that treatment endpoints might be clinically meaningful only if 1) the patients using the new therapy were less likely to undergo subsequent treatment (such as surgery), 2) there was an overall reduction in adverse events, and 3) there was no reduction in long-term cancer control.  However, in this trial, these criteria were not met. 95% of those treated with TOOKAD had adverse event in the weeks after treatment compared to 55% of the men on active surveillance. For many men these problems continued 2 years after treatment, when 34% continued to have urinary problems compared to 16% with active surveillance. Two years after treatment, 38% of patients treated with TOOKAD had erectile dysfunction, compared with 12% of those assigned to active surveillance. In other words, erectile dysfunction was 3x as prevalent among those treated with TOOKAD.

The long-term complications of the treatment that are unclear.  In addition to the urinary problems and ED that might be worse for those who are subsequently treated with surgery, it may be more difficult to obtain accurate biopsies. 

The American Urological Association recommends active surveillance as the best available treatment for low-risk prostate cancer patients, and the data clearly support that recommendation.  We understand that the fear of cancer can persuade men to seek treatment, but if so they should not be bamboozled by ads to choose a product that may have no benefits for them but that does have clear risks of erectile dysfunction and urinary problems. If the FDA thinks this product might have a useful benefit, they should require at least one double-blind study – preferably two – since the treatment does not involved surgery and is therefore easier to blind.  The studies should also include a patient population that represents the diversity of men with prostate cancer. There is no need to rush to approve this particular treatment based on a single, open label trial with endpoints of questionable clinical relevance and problems with inaccurate diagnoses. Better research needs to be completed before approval because the sponsor did not comply with FDA’s recommendations for the study and was even less likely to do so after the product is approved.   

The Oncologic Drugs Advisory Committee voted 13 to 2 against approval of TOOKAD to treat low-risk prostate cancer.

NCHR Testimony on Low Nicotine Cigarette Claim

Nina Zeldes, National Center for Health Research, February 14, 2020


Thank you for the opportunity to speak here today. My name is Dr. Nina Zeldes and I am here as a senior fellow speaking on behalf of the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from drug and medical device companies or tobacco companies, so I have no conflicts of interest.

We strongly oppose the approval of this modified risk application by the 22nd Century Group for their low-nicotine combusted filtered cigarette tobacco products. According to the FDA, a modified risk tobacco product needs to demonstrate that it (1) significantly reduces harm to smokers and (2) promotes public health. Unfortunately, evidence is lacking to support the claim that this product significantly reduces harm for smokers. At the same time, it is likely to entice people who have never smoked, especially adolescents, to start smoking.

As the applicant has pointed out, this low nicotine cigarette poses similar risks of tobacco-related disease as conventional cigarettes. Its only advantage is that it contains much less nicotine, and could therefore be less addictive. However, the claims of reduced harm seem to be based entirely on the assumption that people would smoke less often – an assumption that was not adequately supported by the applicant’s data. For example, this product was rated as less satisfying than smokers’ usual brand of cigarettes and less likely to be used again compared to nicotine gum, raising questions about whether smokers would switch completely to this product and ultimately quit smoking.

The FDA briefing document points out that nicotine is often perceived as causing smoking-related health risks. That means that a claim of a product having “95% less nicotine” will be misunderstood as being less likely to cause cancer, when in fact it just means potentially less addictive. Although the applicant provided a voluntary warning that “less nicotine does NOT mean safer”, study participants who were shown this warning still perceived this product as safer than conventional cigarettes. Additionally, the applicant only tested the claims on packaging and not how they would be used in ads and social media. We’ve all learned that the context and imagery in these ads can vastly alter how these claims are interpreted. Tobacco companies have learned how to make very persuasive ads that go beyond the specific claims that they make.

And as we all know, smoking is a habit that is very difficult to break, and addiction to nicotine is only one of the reasons that quitting is so difficult.

Most smokers start smoking as children and adolescents, and yet adolescents were not included in any of the studies provided by the applicant. Previous studies have demonstrated that this group is likely to perceive products with a risk-mitigation claim as less harmful, but that is not proven in this case.

In conclusion, while the claim that this product contains 95% less nicotine may be factually correct, the company’s claims of health benefits are based on the implied assumption that this product would help smokers quit. If that is supposed to be the benefit, their product should have sought to market this product as a cessation aid. Moreover, the packaging does not explain how to achieve this health benefit. Because of such claims, smokers interested in reducing smoking-related health risks might start using this product, instead of quitting or using available FDA-approved cessation products. Meanwhile, non-smokers, particularly adolescents, might start using this product, thinking it is a safe alternative to other tobacco products.

If we’ve learned anything from the vaping epidemic, it is that adolescents are easy to influence, and once they start a habit like smoking or vaping, they are unlikely to stop. We encourage you to let the FDA know that you do not believe that would be an acceptable outcome.

Thank you.

FDA considers black box warning for all breast implants

Mariel Carbone, WCPO Cincinnati: February 09, 2020


Although many other survivors choose implants after their mastectomies, [Lily McBreen is] adamant that she won’t. Having almost lost her life once, she’s worried the side effects of receiving breast implants could endanger it again.

[…]

“I wanted to avoid the rheumatological symptoms that have been out in the news for so many decades,” she said. “There has been so many accounts of women complaining of problems with them.”

Those symptoms, which women are calling “breast implant illness,” are among the many reasons the United States Food and Drug Administration could soon take extreme measures when it comes to educating the public about implants.

[…]

Currently, the black box warning exists only as a draft while the FDA continues to consider its implementation.

The draft warning outlines three main concerns.

First, “breast implants are not considered life time devices” and women may require more surgery if complications occur.

It also states that implants have been associated with BIA-ALCL.

[…]

Finally, it describes how some patients have reported a variety of symptoms, including “joint paint, muscle aches, confusion, chronic fatigue, autoimmune disease and others.”

The FDA is also proposing a patient decision checklist, which would include situations in which the device should not be used, considerations for a successful breast implant candidate, risks of surgery, the importance of using an appropriate physician, the risk of BIA-ALCL and other symptoms and discussion of other options.

Still, some have said these proposals don’t go far enough, including Diana Zuckerman who is President of the National Center for Health Research. The center initiated the Breast Implant Working Group, which is made up of six experts including patient advocates and plastic surgeons.

“The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients,” the working group said in a statement. “The FDA draft Black Box states that ‘breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).’ Association implies correlation rather than causation. In fact, the evidence is clear that breast implants can cause BIA-ALCL.”

Read the original story here.

Artificial Intelligence Is Rushing Into Patient Care – And Could Raise Risks

Liz Szabo, Kaiser Health News,


Health products powered by artificial intelligence, or AI, are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots.

IBM boasted that its AI could “outthink cancer.” Others say computer systems that read X-rays will make radiologists obsolete.

“There’s nothing that I’ve seen in my 30-plus years studying medicine that could be as impactful and transformative” as AI, said Eric Topol, a cardiologist and executive vice president of Scripps Research in La Jolla, Calif. AI can help doctors interpret MRIs of the heartCT scans of the head and photographs of the back of the eye, and could potentially take over many mundane medical chores, freeing doctors to spend more time talking to patients, Topol said.

Even the U.S. Food and Drug Administration—which has approved more than 40 AI products in the past five years—says “the potential of digital health is nothing short of revolutionary.”

Yet many health industry experts fear AI-based products won’t be able to match the hype. Many doctors and consumer advocates fear that the tech industry, which lives by the mantra “fail fast and fix it later,” is putting patients at risk—and that regulators aren’t doing enough to keep consumers safe.

[…]

Relaxed AI Standards At The FDA

The FDA has come under fire in recent years for allowing the sale of dangerous medical devices, which have been linked by the International Consortium of Investigative Journalists to 80,000 deaths and 1.7 million injuries over the past decade.

Many of these devices were cleared for use through a controversial process called the 510(k) pathway, which allows companies to market “moderate-risk” products with no clinical testing as long as they’re deemed similar to existing devices.
In 2011, a committee of the National Academy of Medicine concluded the 510(k) process is so fundamentally flawed that the FDA should throw it out and start over.

Instead, the FDA is using the process to greenlight AI devices.

Of the 14 AI products authorized by the FDA in 2017 and 2018, 11 were cleared through the 510(k) process, according to a November article in JAMA. None of these appear to have had new clinical testing, the study said. The FDA cleared an AI device designed to help diagnose liver and lung cancer in 2018 based on its similarity to imaging software approved 20 years earlier. That software had itself been cleared because it was deemed “substantially equivalent” to products marketed before 1976.

AI products cleared by the FDA today are largely “locked,” so that their calculations and results will not change after they enter the market, said Bakul Patel, director for digital health at the FDA’s Center for Devices and Radiological Health. The FDA has not yet authorized “unlocked” AI devices, whose results could vary from month to month in ways that developers cannot predict.

To deal with the flood of AI products, the FDA is testing a radically different approach to digital device regulation, focusing on evaluating companies, not products.

The FDA’s pilot “pre-certification” program, launched in 2017, is designed to “reduce the time and cost of market entry for software developers,” imposing the “least burdensome” system possible. FDA officials say they want to keep pace with AI software developers, who update their products much more frequently than makers of traditional devices, such as X-ray machines.

Scott Gottlieb said in 2017 while he was FDA commissioner that government regulators need to make sure its approach to innovative products “is efficient and that it fosters, not impedes, innovation.”

Under the plan, the FDA would pre-certify companies that “demonstrate a culture of quality and organizational excellence,” which would allow them to provide less upfront data about devices.

Pre-certified companies could then release devices with a “streamlined” review—or no FDA review at all. Once products are on the market, companies will be responsible for monitoring their own products’ safety and reporting back to the FDA. Nine companies have been selected for the pilot: Apple, FitBit, Samsung, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool and Verily Life Sciences.

High-risk products, such as software used in pacemakers, will still get a comprehensive FDA evaluation. “We definitely don’t want patients to be hurt,” said Patel, who noted that devices cleared through pre-certification can be recalled if needed. “There are a lot of guardrails still in place.”

But research shows that even low- and moderate-risk devices have been recalled due to serious risks to patients, said Diana Zuckerman, president of the National Center for Health Research. “People could be harmed because something wasn’t required to be proven accurate or safe before it is widely used.”

Johnson & Johnson, for example, has recalled hip implants and surgical mesh.

In a series of letters to the FDA, the American Medical Association and others have questioned the wisdom of allowing companies to monitor their own performance and product safety.

“The honor system is not a regulatory regime,” said Jesse Ehrenfeld, who chairs the physician group’s board of trustees. In an October letter to the FDA, Sens. Elizabeth Warren (D-Mass.), Tina Smith (D-Minn.) and Patty Murray (D-Wash.) questioned the agency’s ability to ensure company safety reports are “accurate, timely and based on all available information.”

[…]

Read original story here.

NCHR Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut

National Center for Health Research, January 21, 2020


National Center for Health Research’s Public Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen® Snuff Fine Cut

Thank you for the opportunity to comment on the FDA Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We strongly oppose the approval of this modified risk application for Copenhagen Snuff Fine Cut with the claim “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer” for the following reasons:

  • This safety claim could result in a higher number of dual users, and there is not sufficient evidence to suggest that dual use would reduce the risk of lung cancer. 
  • Even if an individual’s complete switch from combustible tobacco products to this product reduces a user’s risk of lung cancer, we agree with the FDA’s own website, which indicates that the use of smokeless tobacco products increases the risks of other types of cancers, such as oral, esophageal, and pancreatic cancer, as well as other diseases.
  • Because snuff has risks, data are needed to ensure that the marketing of this product as a modified risk product would not increase the number of non-smokers who would start using tobacco products. Increased use is likely, especially among teens and young adults, because, as with vaping, when people hear claims that a product is “safer,” they often misinterpret that to mean the product is “safe.”
  • Research has already shown that individuals who start using smokeless tobacco products, such as this product, are more likely to start using combustible tobacco products.
  • The modified risk statement could be interpreted as suggesting that Copenhagen Snuff Fine Cut can be used as a smoking cessation strategy. However, the sponsor has not provided scientific evidence that using this product helps people stop smoking. 
  • Although smoking and lung cancer deaths have both gone down in Sweden and Norway, the company has not provided evidence that these “favorable public health outcomes” are due to smokeless tobacco products. In addition, there is no evidence that additional reductions would occur in the U.S. market if this modified risk reduction application is approved, because the healthcare system, tobacco reduction campaigns, popular products and cultural influences are different than they are in Sweden and Norway.

In summary, a modified risk statement may encourage people who do not smoke to begin using this tobacco product and could lead to more dual usage, therefore, this product would not reduce the health risks for lung cancer.

For questions or more information, please contact Nina Zeldes, PhD at the National Center for Health Research at nz@center4research.org or at (202) 223-4000.

References

  1. US Food and Drug Administration. Executive Summary of USSTC MRTP Application for Copenhagen® Snuff Fine Cut. Silver Spring, MD: US Food and Drug Administration; 2020. https://digitalmedia.hhs.gov/tobacco/static/mrtpa/Copenhagen/2.3-executive%20summary%20_Redacted.pdf

No Shortage of Controversies for New FDA Commissioner

Thomas M. Burton, The Wall Street Journal: January 29, 2020


New Food and Drug Administration commissioner Stephen M. Hahn rises at 4 a.m. each day for an hour of intensive strength and stamina training. On stressful days, he fits a second workout in during the late afternoon.

Dr. Hahn, 60, takes over an FDA under fire for failing to adequately respond to the health threat from growing use of e-cigarettes and vaping products. This spring, he and the agency will face applications from e-cigarette companies and have to decide what e-cigarette products can qualify to stay on the market.

[…]

Dr. Hahn also faces thorny decisions on stem-cell research and use of cannabidiol, or CBD, that will likely put him in the hot seat between rival advocacy groups.

The man taking on these challenges comes to the FDA with a sterling reputation in medicine and management, but with no previous government experience, unlike his predecessor Scott Gottlieb. That has some concerned about his ability to tackle the issues ahead.

“Always we have concerns when someone comes in who doesn’t know the FDA, which is a complex organization,” said Diana Zuckerman, president of the public-interest research group National Center for Health Research in Washington.  “I never think it’s a good idea.”

What’s more, Dr. Hahn may not have long to make his mark if Mr. Trump fails to win re-election Nov. 3. “It’s a hard thing to come in with so little time [in the president’s term] and so little government experience,” said a former FDA commissioner, Robert Califf, who served under President Obama. “It’s so difficult to change policy with so little time.”

Dr. Hahn didn’t immediately comment for this article.

[…]

Read the original story here.

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

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.

NCHR’s Comments on the Safer Technologies Program (STeP) for Medical Devices

National Center for Health Research, November 18, 2019


National Center for Health Research’s Public Comments on 
Safer Technologies Program for Medical Devices; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability
[FDA-2019-D-4048]

Thank you for the opportunity to express our views on the proposed Safer Technologies Program (STeP) for medical devices.

The National Center for Health Research (NCHR) is a non-profit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We appreciate FDA’s efforts to get medical devices with an improved safety profile to consumers and patients more quickly. However, the mission of the FDA is to protect patients and consumers from medical products that are not proven safe or not proven effective. FDA guidance must be very clear how this program would protect patients from unsafe or ineffective medical devices. The proposed guidance is so vaguely worded that it is not possible to have confidence that patients’ needs will be protected.

We agree that increased interactions with FDA throughout the development process and more timely interactions could 1) speed development and review, and 2) improve the quality of the data available for review by providing more consideration into needed data, study design, and early detection of concerns. Unfortunately, most medical devices are cleared through review pathways that require little or no clinical data to demonstrate safety or effectiveness, and while premarket approval applications (PMA) require clinical trial data, those studies are often small, poorly designed, and lacking in appropriate control groups. Thus, while the proposed Safer Technologies Program may get medical devices to patients sooner, the program will be harmful to patients unless it also strengthens the premarket requirements for scientific evidence of safety and effectiveness.

Textured breast implants, Essure, POP mesh, and metal-on-metal hip replacements are just a few of the many examples of devices that were implanted in tens of thousands of patients and consumers prior to being removed from the market due to serious, unexpected complications. It is disturbing that the proposed guidance includes no explicit instructions aimed at reducing the harm caused when patients unwittingly serve as guinea pigs for implants and other devices that were not adequately tested prior to going on the market. It is not fair to patients or their physicians to rely primarily on post-market studies and surveillance, because too many patients will be harmed before those studies are completed, and too many of those studies will never be completed. We therefore respectfully urge the FDA to revise the proposed guidance in ways that ensure that all medical devices undergo more rigorous testing prior to being approved or cleared.

For questions or more information, please contact the National Center for Health Research at info@center4research.org or at (202) 223-4000.

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.