Category Archives: We’re In the News

FDA’s Special Treatment Of Big Tech Faces Mounting Scrutiny

Kevin Stawicki, Law360, November 12, 2019.


The U.S. Food and Drug Administration is taking heat from prominent lawmakers over a special approval pathway for health software products sold by Apple, Samsung and other major tech companies, opening the door to a congressional showdown over whether the agency has the right to start such a program.

The FDA has spent two years working with nine tech giants and health companies to test a new approval route for rapidly evolving health software such as artificial intelligence applications to make treatment plans, calculate heart rates and track insulin levels. In addition to Apple Inc. and Samsung Electronics Co. Ltd., participating companies include Fitbit Inc., Johnson & Johnson and Roche Diagnostics Corp.

But lawmakers and legal experts have increasingly complained that the pilot program is shrouded in secrecy. In an Oct. 30 letter, several Democratic senators — including presidential contender Elizabeth Warren of Massachusetts and Assistant Democratic Leader Patty Murray of Washington — asked the FDA whether streamlined approvals are turning Americans into guinea pigs.

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The pilot program is called Digital Health Software Precertification, or simply Pre-Cert. It covers digital health products, such as mobile medical apps, that generally fall outside the agency’s traditional approval pathways.

A key component of the pilot program is known as an “excellence appraisal.” If a company undergoes the appraisal and is deemed a reliable producer of safe, high-quality software, it becomes eligible for streamlined approvals.

But what the appraisal process looks like in practice is an open question. The agency lists product safety, proactive culture, clinical and cybersecurity responsibility as the model’s main categories and insists that there should be “flexibility in the specific mechanisms by which excellence can be demonstrated.”

In a 2018 letter, the senators were among the first to ask the FDA what that flexibility entails. The agency in June replied with a 19-page letter, but the senators apparently weren’t satisfied, responding with 10 pages of additional questions and requests in their Oct. 30 follow-up.

“The agency stated that it is ‘exploring what types of data are appropriate to demonstrate excellence,'” the senators said, adding that the agency made no attempt to “provide any additional detail on the data or evidence it used to determine companies’ adherence to the excellence principles.”

The senators aren’t alone in demanding more details.

“When it comes to medical devices, anything that’s subjective results in very low standards,” Diana Zuckerman, president of the National Center for Health Research, told Law360.

“You have this idea of precertifying companies on the basis of somebody deciding they have confidence about the company’s standards,” Zuckerman said. “But we know from experience that many times prestigious companies have covered up information about risks of their products.”

Some big-name companies that aren’t participating in the pilot program have said the metrics need work.

Lisa Bollinger, a vice president at biotech Amgen Inc., told the FDA in a letter last year, “It is not clear how an organization can demonstrate consistent, adequate evidence generation for clinical effectiveness based on the proposed appraisal elements for pre-certification.”

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Read full article here.

How the FDA and EPA’s failure to communicate could put patients in danger

Sarah Karlin-Smith, Annie Snider, and Sarah Owermohle, Politico, November 7, 2019.


For decades a chemical used to sterilize medical devices and surgery tools has been the only option to ensure safe devices for billions of critical health care procedures.

But the chemical, ethylene oxide, has been shown to cause cancer, and growing panic among people living near plants that sterilize medical devices has led to a major crackdown and the shutdown of the factories in several states.

Now the Food and Drug Administration is warning that closure of the facilities where ethylene oxide is used could threaten the lives of patients and limit their access to everything from pacemakers to equipment for hip replacements and feeding tubes that save the lives of premature babies.

The story of how American lives may be threatened over the use and production of this chemical is an example of what happens when two bureaucracies — the FDA and the Environmental Protection Agency — fail to work together. The situation raises questions about whether federal health authorities were too slow to connect the dots between the environmental concerns around the cancer-causing gas — which EPA first disclosed five years ago — and the potential consequences to the medical device industry, which uses the gas to clean roughly half of all sterile devices, or more than 20 billion products a year.

“We need to harmonize our federal agencies so they are in sync, so that one isn’t causing problems that the other has to try and fix,” said Diana Zuckerman, president of the National Center for Health Research, a watchdog group that conducts health research it can use to influence policymakers. The organization accepts no money from medical treatment companies.

Already, one sterilizing facility in Illinois has shuttered under pressure from state authorities to cut the emissions, and a second in Michigan has said it will end its sterilizing operations by the end of year. Meanwhile, the state of Georgia has temporarily closed two facilities and lawmakers there are pressing for the closure of a third.

“Without [this sterilizing technique] … the sickest patients would be most at risk,” FDA wrote in briefing documents ahead of a two-day meeting that kicked off Wednesday to obtain expert recommendations about how to reduce or eliminate ethylene oxide emissions in medical device sterilization without compromising the availability of devices.

Caught flat-footed, FDA is now scrambling to find alternative sterilizing processes, as the Environmental Protection Agency and states consider tightening emissions standards for these facilities, potentially threatening the industry’s ability to continue operating. Experts say it is unclear if the technology even exists to reduce facilities’ emissions enough to protect nearby communities from elevated cancer risks, according to EPA’s calculations.

“Inadequate sterilization would threaten modern medicine as we know it,” said Kara Mascitti, an infectious disease specialist at St. Luke’s University Health Network, at Wednesday’s FDA meeting.

As EPA takes its time to update national emissions standards for sterilizers, states are stepping in to use their authorities to crack down.

Even though EPA found in 2014 that ethylene oxide was linked with breast cancer, leukemia and other cancers at much lower exposure levels than previously thought, and finalized that conclusion in 2016, it wasn’t until EPA released new monitoring data in August 2018 that emissions from sterilizing facilities caught the attention of state and local regulators and the public.

An outcry arose in the Chicago suburb of Willowbrook in August 2018 after the Chicago Tribune used that EPA data to report that the community faced an elevated cancer risk, thanks to a Sterigenics sterilizing facility located in the neighborhood. The facility became a major issue in Illinois’ 2018 gubernatorial election, in part because the incumbent Republican Gov. Bruce Rauner’s former private equity firm owned Sterigenics.

But it wasn’t until the newly elected Democratic governor took office in Illinois in 2019 and banned the facility from using ethylene oxide that the issue hit FDA’s radar, said Suzanne Schwartz, the deputy director of the office of strategic partnerships and technology and acting office director in FDA’s Center for Devices and Radiological Health.

Outside experts say the situation represents the pitfalls that can occur when federal agencies do not properly communicate with each other.

“EPA has had this on their radar screen, they’ve known that there is a problem. They’ve been talking about it. And somehow as far as we know that information either did not get to the FDA or did not get to the FDA in a way that anyone at the FDA said, ‘Ah, if we don’t look into this we could end up with a shortage of devices that are lifesaving and important devices,'” Zuckerman said. “How could this have not been of concern to them years ago?”

FDA says it has proactively addressed the issue since it commenced working with EPA, states and the device industry following the Willowbrook plant closure in early 2019. The agency notes it helped prevent a shortage of critical breathing equipment by working with one device manufacturer to quickly find a new sterilization site. FDA also launched two contests to develop new sterilization techniques and figure out how to minimize pollution from ethylene oxide sterilization. FDA will work with contest winners to accelerate the availability of the technology. Those initiatives are already bearing fruit, and FDA told POLITICO it believes there may be new short-term mitigation strategies that it will be able to announce in the next few months.

FDA stressed that regulating air pollution falls outside of its jurisdiction and it told POLITICO the agency doesn’t get alerted if facilities that produce medical products it oversees are violating air regulations and posing a safety concern. Therefore, Schwartz said, there’s little it could have done to foresee this crisis sooner given that EPA never changed its standards for ethylene oxide emissions.

“As part of the processes that occur with manufacturing, there are various toxins that are emitted. The key here is for the EPA to be establishing what are those standards that are allowable so that the manufacturers that are responsible for producing these products and have emissions can then be compliant with the emissions [regulations],” said FDA’s Schwartz. “Otherwise it’s outside FDA authority.”

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FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns

Sydney Lupkin, Kaiser Health News and Daily Beast: November 3, 2019.

After unanimously voting to recommend a miraculous hepatitis C drug for approval in 2013, a panel of experts advising the Food and Drug Administration gushed about what they’d accomplished. What the panelists didn’t know was that the FDA’s drug quality inspectors had recommended against approval.

They issued a scathing 15-item disciplinary report after finding multiple violations at Gilead’s main U.S. drug testing laboratory, down the road from its headquarters in Foster City, Calif. Their findings criticized aspects of the quality control process from start to finish: Samples were improperly stored and catalogued; failures were not adequately reviewed; and results were vulnerable to tampering that could hide problems.

[…]

Against that backdrop, the FDA has repeatedly found a way to approve brand-name drugs despite safety concerns at manufacturing facilities that had prompted inspectors to push to reject those drugs’ approval, an ongoing KHN investigation shows. This happened in 2018 with drugs for cancer, migraines, HIV and a rare disease, and 10 other times in recent years, federal records show. In such cases, how these issues were discussed, negotiated and ultimately resolved is not public record.

[…]

Problems with drugs can take years to discover ― and then only after patients are injured. So, many health researchers say, more caution is warranted.

“They’re doing so few of these [FDA] inspections pre-market,” said Diana Zuckerman, president of the nonprofit National Center for Health Research. “The least they can do is listen to the ones they’re doing.”

When Recalls Fail: Many harmful products remain in homes and stores. Why that happens, what needs to change, and how to protect yourself.

Rachel Rabkin Peachman, Consumer Reports: October 31, 2019


Antibiotic-resistant strains of salmonella are linked to contaminated chicken, sickening many and hospitalizing more than 200 people for almost a year and a half, though it was known that the plants processing the chicken had failed federal food safety standards. Why did the outbreak go on for so long before the unsafe chicken was pulled from store shelves?

breast implant lacking premarket safety research is linked to a rare cancer, but years pass and women die before regulators acknowledge the connection and a manufacturer recalls the devices. Why did it take patient outcry before the potentially deadly implants were taken off the market?

An inclined sleeper for babies is put on the market without adequate safety testing or adherence to infant sleep guidelines. Over the next decade, as the sleeper becomes a best seller, dozens of babies die while using it. Why did it take public exposure before the manufacturer recalled the product?

In 21st century America, it’s easy to assume that the products we put on our plates, in our homes, and in our bodies are safe and effective. Many people expect that we have robust consumer protections in place—a system that vets products thoroughly before allowing them to be sold and that recalls products swiftly if they prove to be dangerous.

But product safety regulation and the recall process are part of a complicated and imperfect system that varies widely depending on the type of product, the industries involved, and the government agencies tasked with overseeing it. For instance, a recall does not get put into motion automatically when a product is known to cause harm. Recalls, if they happen at all, can take years to be initiated, often only after public protest and sometimes following injuries or deaths.

Moreover, when a recall is issued, consumers often aren’t made aware. Almost 70 percent of Americans said that they had not heard about a recall in the past five years for any product they own, according to a Consumer Reports nationally representative survey of 1,010 adults, though millions of products are recalled each year. And only 21 percent of Americans said they had heard about a recall and responded to it in that time frame. Of those, about two-thirds said the issue had to do with their car, 19 percent said it involved food, 9 percent a health product, and 9 percent a children’s product.

That disparity is not surprising, says David Friedman, CR’s vice president of advocacy and a former acting administrator of the National Highway Traffic Safety Administration. Unlike other federal agencies, NHTSA requires manufacturers to notify car owners directly about recalls. To track recalls, it helps that every car has a unique vehicle identification number and every owner has a registration. Other agencies—the Food and Drug Administration, the Department of Agriculture, and the Consumer Product Safety Commission—generally have fewer tools and requirements for recalls. In some cases, laws can actually shield agencies from accountability and protect companies from liability, Friedman says.

Even when consumers learn about a recall, they often aren’t given simple, effective ways to respond. Some entail disassembling and mailing in part of the product for a refund, or not using the product until a replacement part is mailed—a process that can take months. As a result, many recalled products remain in use, risking further injury.

How, then, can consumers ensure that the products they buy have been safety tested and have not caused problems since their release? In some cases, it’s impossible to fully know. But the examples described here provide a sense of how regulatory oversight sometimes works for—and against—consumers. Plus, we share steps you can take to protect yourself and your family.

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Dangerous Breast Implants

Raylene Hollrah was 33 years old in 2007 when she was diagnosed with breast cancer and underwent a mastectomy. A year and a half later, when she was ready for reconstructive surgery, she chose a silicone-filled implant with a textured surface made by Allergan. Hollrah, from Hermann, Mo., believed a selling point of the implant was that she’d automatically be enrolled in a 10-year study “so I could help other women,” she says.

What Hollrah didn’t know is that medical devices—including breast implants, artificial joints, and pacemakers—are subject to much less rigorous premarket testing than drugs are. That’s partly because the FDA didn’t begin regulating medical devices or requiring research on their efficacy and safety until 1976, after many devices were already in use.

Silicone breast implants were introduced in the 1960s with little to no safety research, says Diana Zuckerman, Ph.D., president of the National Center for Health Research. Even after the FDA began regulating them, the agency didn’t require premarket studies until 1991—when it determined there was insufficient safety research, and soon after put a moratorium on sales.

In 2006, when the FDA did approve silicone implants, it was on the condition that manufacturers conduct post-market studies, one of which included Hollrah. But that wasn’t made clear to her early on. And as time passed, more problems emerged. In 2011, the FDA announced a link between silicone- and saline-filled implants and a form of cancer called anaplastic large cell lymphoma (ALCL).

But Hollrah didn’t learn about breast implant associated ALCL, or BIA-ALCL, until 2013, when one of her implants swelled and she tested positive. “I removed breast cancer,” Hollrah says, “and then I put something right back in my body that gave me cancer again.”

Around the time of Hollrah’s diagnosis, Allergan dropped her from its post-approval study. In fact, Allergan lost track of many participants, in part because it was difficult to follow up with the women, who were given no real incentives to stay involved in the studies, Zuckerman says. As a result, the research was never completed. Yet the FDA did not penalize manufacturers or recall the implants.

Fortunately for Hollrah, her cancer was caught early. She had her implants removed in 2013 and is now cancer-free.

But it wasn’t until July 2019 that the FDA announced the recall of Allergan’s textured implants due to a reported worldwide total of 573 BIA-ALCL cases, 481 of them from Allergan, including 33 deaths.

When asked why it took eight years after the FDA acknowledged the risk of BIA-ALCL for the agency to request a recall, an FDA spokesperson said it took the action after learning, in the spring of 2019, of “a significant increase in known cases of BIA-ALCL.”

Though the recall is a victory for women affected by BIA-ALCL, other concerns remain. For one, “when medical devices are recalled, there’s typically not a rigorous process to reclaim the flawed products,” says Lisa McGiffert, a co-founder of the Patient Safety Action Network and a former patient-safety expert at CR.

There’s also no established system for device manufacturers to find and notify doctors and patients about a recall. Hollrah notes that she has yet to receive a recall notification from Allergan.

For its part, Allergan says that “patient safety is a priority” and that it is committed to ensuring the safe and effective use of its products.

Still, hundreds of thousands of women are estimated to have a recalled device in their bodies and no easy choices. The FDA recommends implant removal only for women with a diagnosis of BIA-ALCL. But women don’t always have obvious symptoms. “Although BIA-ALCL is treatable if caught early, no one wants to wait to see if they get cancer,” says Sara Castro, an attorney at Farr law firm in Punta Gorda, Fla., who is working with affected women.

Another hurdle: Though Allergan will pay for replacement implants in the case of a cancer diagnosis or implant defect, it doesn’t cover the surgical costs of preventive implant removal. Most insurers won’t cover it, either.

Scot Glasberg, M.D., past president of the American Society of Plastic Surgeons and a consultant for Allergan, says that “if a woman has any concerns whatsoever, she should see a plastic surgeon who is board certified,” specializes in breast implants, and is knowledgeable about BIA-ALCL to go over her screening and testing options.

Women considering breast-implant surgery (or any medical device procedure) should ask their surgeon for an informed consent form that details what the device contains, and known risks. “This form is not mandated yet,” says Hollrah, who did not have that protection before her surgery and has since worked with Zuckerman, Glasberg, and others to develop a patient form and clearer warnings. And they have made progress on that front: On October 24, 2019, the FDA recommended that patient labeling for breast implants include a patient decision checklist, a boxed warning, an information booklet, and a patient device card. A final decision on that recommendation isn’t expected until 2020 at the earliest. 

Madris Tomes, a former program manager at the FDA who now runs Device Events—which gathers adverse event reports on medical devices—recommends researching your device. One free source is an online FDA database called MAUDE (Manufacturer and User Facility Device Experience). “Two-thirds of all recalls begin as an adverse event report,” Tomes says.

[…]
Read the original article here.

FDA calls for new warnings for breast implants

Laurie McGinley, The Washington Post: October 23, 2019.


The Food and Drug Administration, under fire from women who say they were harmed by breast implants, proposed on Wednesday that manufacturers detail possible complications from the devices, including rare cancers, a range of other symptoms and the need for additional surgeries.

The agency recommended that manufacturers use a boxed warning — the FDA’s strictest caution — to clearly spell out the risks of implants, including that they are not lifetime devices and that the chances of complications increase over time. The warning also would list the devices’ association with a rare form of lymphoma and say some patients have reported fatigue, muscle aches and joint pain.

The agency also proposed that patients be given a checklist to guide conversations with their surgeons about the risks and benefits of implants before women put down deposits for their surgeries. The move is a response to complaints from patients who said they weren’t adequately told about potential problems before surgery.

“We have heard from many women that they are not fully informed of the risks when considering breast implants,” FDA Principal Deputy Commissioner Amy Abernethy and Jeff Shuren, director of the agency’s Center for Devices and Radiological Health, said in a statement. The new recommendations are “designed to help inform conversations between patients and health care professionals when breast implants are being considered,” they added.

The FDA’s steps are the latest effort to deal with reports of complications involving devices that have been at the center of sometimes angry debate and legal actions for decades. The devices are used in about 400,000 surgeries in the United States every year, with 75 percent of the women involved getting implants for cosmetic reasons. Most of the rest get them as part of reconstruction after surgery for breast cancer.

Over the past few years, patients who say they were harmed by the devices have become increasingly active on social media sites that have enabled tens of thousands of patients to exchange information. The emergence of a rare cancer linked to implants in recent years also has drawn more attention to potential health problems associated with implants.

The FDA has said that 573 cases worldwide have linked the implants to a rare cancer since the agency began tracking the issue in 2011. The vast majority of those cases involved Allergan textured implants, which have been recalled. Thirty-three women have died of what’s known as breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system, the agency said. At the same time, thousands of women have complained of fatigue, brain fog and other problems that collectively are called “breast implant illness.”

Nicole Daruda, an activist from Vancouver, Canada, who runs one of the most popular websites for women who have had trouble with implants, welcomed the FDA’s announcement, but said it was long overdue. “This is what needs to happen,” said Daruda, who had her implants removed after experiencing several health problems. “But I don’t think it would have without our putting intense pressure” on the agency.

Diana Zuckerman, president of the nonprofit National Center for Health Research who has been working on implant issues for 30 years, said the FDA’s moves are “very important.” But she expressed concern they might yet be weakened, and are not legally binding because they are in the form of “guidance” to the industry. Whether the implant makers actually follow the recommendations “depends on how much pressure the FDA puts on the manufacturers,” she said.

The FDA’s steps are the latest in the agency’s stepped-up scrutiny of the devices, which included a dramatic two-day hearing in March during which many women demanded the FDA take steps to ensure patients have more information about the devices. About the same time, Zuckerman and Scot Glasberg, a past president of the American Society of Plastic Surgeons, formed a working group that included activists to make recommendations to the FDA, including for a boxed warning and a patient checklist of possible problems.

What the FDA is proposing “is very close to what we gave them,” Glasberg said, adding that other groups also made suggestions to the agency.

More than 70,000 women also signed a petition asking the FDA to require a checklist. The FDA, in issuing its recommendations on Wednesday, asked for public comment for 60 days before finalizing the guidance.

Breast implants became available in the United States in the 1960s. Three decades later, after years of reports about ruptured devices and possible links to autoimmune diseases, the FDA called for a moratorium on their use, saying manufacturers had not proved the devices’ safety and effectiveness. The devices were available only for cancer patients who were undergoing reconstructive procedures, and even then, only as part of a clinical trial. In 2006, the agency lifted the ban, approving two new silicone implants.

In 2011, the FDA issued a safety communication saying that women with breast implants might have a small increased risk of developing the rare lymphoma. In July, the implant maker Allergan announced a worldwide recall of its Biocell textured breast implants after the FDA found a sharp increase in a rare cancer and deaths linked to the products and asked the company to withdraw them from the U.S. market.

The FDA, in its proposed guidance Wednesday, also called for new screening guidelines for possible ruptures, as well as a recommendation that manufacturers include product ingredient information in the devices’ labeling that is easy for patients to understand.

Read the original article here.

Women Should Be Warned of Breast Implant Hazards, F.D.A. Says

Roni Caryn Rabin, NY Times: October 23, 2019


Women considering surgery to receive breast implants should be warned of the risk of serious complications, including fatigue, joint pain and the possibility of a rare type of cancer, the Food and Drug Administration said on Wednesday.

Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants, and to provide a checklist spelling out the risks for patients considering surgery. It will be left to doctors to review those risks with women seeking breast implants.

The measures are not mandatory and are now open to public comment and industry input. But the recommendations reflect a growing acknowledgment at the agency that implants may cause more harm in women than previously known.

Several years ago, the agency linked implants to a rare form of immune system cancer called anaplastic large cell lymphoma. In July, at the request of the F.D.A., one manufacturer, Allergan, recalled textured breast implants linked to the cancer.

More recent studies have reported higher rates of autoimmune disease among women with breast implants. Advocates for women with these complications called the F.D.A.’s proposals on Monday “an important step,” but noted that the action is only a recommendation.

“What matters most is what happens next,” said Diana Zuckerman, president of the National Center for Health Research in Washington, who has analyzed breast implant studies and has been advising patients.

She said surgeons should be required to go over the checklist with prospective patients before they put down a deposit.

“If breast implants can cause cancer of the immune system, doesn’t it make sense they can cause other systemic problems of the immune system?” Dr. Zuckerman asked.

Millions of women have implants, silicone sacks filled with saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or to rebuild them after a mastectomy for breast cancer.

Breast augmentation with implants is the most popular cosmetic surgical procedure. Some 313,000 augmentations were performed in 2018, a 4 percent increase over the number in 2017. Breast reconstruction after cancer surgery accounts for another 100,000 procedures.

But thousands of women with implants have reported developing debilitating illnesses, such as severe muscle and joint pain, weakness, cognitive difficulties and fatigue — a constellation of symptoms some experts call “breast implant illness.”

Some of the ailments are forms of connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune conditions.

Dr. Zuckerman has found that most breast implant studies were carried out by manufacturers or plastic surgery associations and did not track long-term outcomes, or lost so many participants to follow-up that results were not meaningful.

The studies focused on well-defined illnesses, she said, ignoring debilitating symptoms that lacked specific diagnoses, and most were too small to detect rare diseases.

Earlier this year, the agency warned two implant manufacturers that they had failed to carry out adequate long-term safety studies of implants, which had been mandated as a condition of their approval.

The proposed checklist and boxed warning were developed in response to demands by patients who testified last March at an advisory panel meeting about illnesses they blamed on their implants.

Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants


Statement of Dr. Diana Zuckerman, President, National Center for Health Research on October 23 Regarding FDA Labeling Recommendations to Improve Patient Communication Draft Guidance

We thank the FDA for proposing a black box warning and a patient Informed Consent check list that provides specific, understandable information about the risks of breast implants.  The FDA’s draft includes the types of information that we have proposed to the FDA in recent months in our work with patient advocates and plastic surgeons.  The devil is in the details, so we look forward to working with the FDA to finalize these materials so that patients can make better informed decisions in the future than most women considering breast implants have been able to make. We will  keep working closely with the FDA, patients, and plastic surgeons to make that goal a reality.

For more information see FDA’s Draft Guidance here.

Hospitals Push Women to get 3D Mammograms, Despite No Evidence they Save More Lives

Megan Henney, Fox Business, also posted in Yahoo Finance: October 20, 2019


Hospitals and doctors are aggressively promoting high-tech breast cancer screenings, spending millions of dollars to market 3D mammograms to patients — despite no evidence that they save more lives than traditional mammograms.

According to a Kaiser Health News investigation, over the past six years manufacturers of 3D equipment have paid doctors and teaching hospitals more than $240 million, including $9.2 million related to 3D mammograms. Almost half of that money went to related research, while some paid for speaking fees, consulting, travel meals or drinks.

The report found that influential journal articles, some cited hundreds of times by other researchers, were written by doctors with financial ties to the 3D industry.

Currently, Medicare and most insurance companies cover the cost of an annual screening mammogram for women over the age of 40. But 3D screenings add about $50 to the cost of a typical mammogram. Kaiser reported that Medicare, which began paying for 3D exams in 2015, spent an additional $230 million on breast cancer screenings within the first three years of coverage. By 2017, nearly half the mammograms paid for by the federal program were 3D.

Overall, 3D screenings may slightly increase the cancer-detection rate, finding about one extra breast tumor for every 1,000 women screened in the U.S., according to a 2018 analysis in the Journal of the National Cancer Institute. It can also prove more effective for women with dense breast tissue.

But new technology isn’t always better, said Diana Zuckerman, president of the Cancer Prevention and Treatment Fund at the National Center for Health Research.

“Hospitals love new gadgets, and 3D mammography has been promoted as the latest, greatest best thing,” Zuckerman told FOX Business. “It’s expensive, and then they’re going to pass those prices onto patients.”

When the Food and Drug Administration approves new technology, the agency is not required to prove that it’s better — only that it’s as good as what already exists, she said. Despite that, the new equipment is generally more expensive, sometimes ten times as much; in order to pay for it, hospitals tend to charge “quite a lot of money” to the patient, Zuckerman said, as well as use them on patients who don’t necessarily need to be tested.

“I personally find it problematic, and I can only say that if I have trouble sometimes determining how much is hype and how much is fact, I can only imagine people who don’t do this for a living have trouble figuring it out,” she said.

Read the original story here or here.

Breast implants, heavy metals & autoimmune disorders: What should be in FDA warnings?

Kris Pickel, AZ Family: October 18, 2019


As the Food and Drug Administration considers issuing stronger warnings for breast implants, there is a debate brewing over the content of those warnings.

The FDA is looking at several options.

• A checklist of possible risks. Doctors would be required to go over the checklist with patients who are considering breast implants.

• Listing the ingredients in breast implants.

• A box warning, also known as a black box warning. It’s the strongest warning the FDA issues signifying there is a risk of serious or even life-threatening adverse effects.

The FDA recently updated its websiteacknowledging what has become known as breast implant illness.

“Some breast implant patients report a variety of systemic symptoms, such as chronic fatigue, brain fog, joint and muscle pain, which may not meet the diagnostic criteria to be categorized as a disease. Patients refer to these symptoms collectively as ‘breast implant illness (BII).’ In some cases, patients report that removal of their breast implants without replacement appears to reverse their symptoms.”

The regulatory agency is reacting to pressure from a growing movement by tens of thousands of women who believe breast implants made them sick. They describe many more symptoms than what the FDA recognized.

BII is not a new problem

Women have expressed concerns about breast implants for decades. Many women say doctors discount any connection the implants and the issues they experience, often making them feel their illness and symptoms are psychosomatic.

Nicole Daruda is one of the key figures behind the growing number of women demanding stronger warnings.

With recent attention on symptoms and illnesses potentially caused by breast implants, hundreds of women are requesting to join her Facebook groupBreast Implant Illness and Healing by Nicole, every day.

Five years after getting implants, Daruda was too sick to work.

She says at that time, there was almost no information available on a possible link between breast implants and the often-debilitating symptoms that plague some women.

“I put the words together, ‘breast implant illness,’ because I didn’t know what else to call it,” Daruda said.

n March, the FDA held public meetings on the safety of breast implants.

Women showed up from across the country, demanding stronger warnings that list the chemicals and heavy metals contained in breast implants. And they don’t just want the cautions to come from the FDA. They believe the caveats should come from breast implant manufacturers, too.

When Daruda had her implants removed, she described them as “sticky,” with silicone coming through the shell. It’s a condition known as “gel bleed.”

While the FDA acknowledges that gel bleed happens, it does not list it as a known risk or complication of breast implants.

“I lost over a decade of my life and health to breast implants,” Daruda said. “After my explant, it took me four years to recover the better part of my health. I still have permanent damage to my kidney from heavy metal.”

[…]

An estimated 35 million women have breast implants. Many of them never reported negative health effects.

Cohen Tervaert says certain factors can increase a woman’s risk of having an adverse reaction to implants. Those factors include allergies (any type from hay fever to metal allergies), an autoimmune disease, and a family history of autoimmune diseases.

Large-scale studies need to be done, according to Cohen Tervaert, but how they are done needs to change.

After his presentation to the FDA, the agency asked registries that collect data on patients and the safety and performance of breast implants to start tracking information on autoimmune diseases.

While many health professionals and implant manufacturers are quick to note that the safety of breast implants has been studied extensively, Dr. Diana Zuckerman, president of the nonprofit National Center for Health Research and an expert on national health policy, says women cannot make informed decisions based on those studies.

The former senior policy advisor to the White House was vital in helping women with breast implant illness to organize and work with the FDA to secure the public meetings on breast implant safety.

“There are hundreds of studies of breast implants published in the last few decades, but almost all are so biased that they are fatally flawed,” she explained. “Almost all were paid for by the companies that make breast implants or the doctors whose salaries depend on those surgeries. The researchers asked the wrong questions and studied implants in ways that didn’t make sense. For example, they studied too few women, studied women with implants for a short period of time, and didn’t study the debilitating symptoms that women said they were experiencing. They also tended to study women with any kind of breast implants, instead of studying whether some breast implants were safer than others. And because of who was paying for the studies, even when the researchers found that implants caused medical problems, those findings were often misrepresented or completely covered up.”

When it comes to proving cause and effect between breast implants and illnesses, Cohen Tervaert believes the evidence is there.

Citing laboratory studies, he says mice prone to autoimmune diseases like lupus or arthritis developed the conditions after the implants were introduced. At the same time, mice that showed no prior sensitivity to autoimmune diseases did not develop health problems with the implants.

Another finding is that more protracted illness appears to result in more difficult recoveries.

“Proof that we have is, that if you remove the breast implant, breast implant illness can be reversible, especially if the period between implementation and explantation is very short,” Cohen Tervaert said. “You see, quite often, complete recovery of the symptoms.”

“If it’s, however, longer, than there is only partial recovery,” he continued. “And if you have developed an autoimmune disease, those autoimmune diseases can be difficult to treat until you remove the breast implants.”

A 2017 study found silicone from breast implants can migrate throughout a woman’s body — even if the implant was not ruptured — because silicone can “bleed” through the shell.

Silicone has been found not just in the tissue around the implants, but also in various organs throughout the body, including the central nervous system and brain.

Women studied had symptoms ranging from fatigue and cognitive impairment to headaches and body pain. The study found 60% to 80% of patients showed health improvements after their implants were removed.

The FDA has not decided if it will impose stricter guidelines on breast implant studies.

The agency issued warning letters to implant makers Mentor and Sientra in March, citing “low recruitment, poor data, and low follow-up rates in their required post-approval studies.”

The FDA gave the manufacturers a two-week deadline to fix the issues. Seven months later, no action has been taken against the manufacturers.

An FDA spokesperson tells CBS 5 Investigates they will not speculate on possible punitive actions.

Also in March, the FDA announced that it would hold future meetings to discusses material used in medical devices, including breast implants. They say they will focus on why some people have adverse reactions while others do not.

“The vast majority of patients implanted with medical devices have no adverse reactions,” the FDA said. “The device works and performs as expected to treat medical conditions or help patients better manage their health. However, a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes, causing pain and other symptoms that may interfere with their quality of life.”

A date for the meeting has not been set.

Read the original story here.

Massive Marketing Muscle Pushes 3D Mammograms, Despite No Evidence They Save More Lives, Investigation Shows

Liz Szabo, USA Today: October 18th, 2019.


When Dr. Worta McCaskill-Stevens made an appointment for a mammogram last year, she expected a simple breast cancer screening – not a heavy-handed sales pitch.

A receptionist asked if she wanted a free upgrade to a “3D mammogram,” or tomosynthesis.

“She said there’s a new approach and it’s much better, and it finds all cancer,” said McCaskill-Stevens, who declined the offer.

A short time later, a technician asked again: Was the patient sure she didn’t want 3D?

Upselling customers on high-tech breast cancer screenings is just one way the 3D mammography industry aggressively promotes its product.

A KHN investigation found that manufacturers, hospitals, doctors and some patient advocates have put their marketing muscle – and millions of dollars – behind 3D mammograms. The juggernaut has left many women feeling pressured to undergo screenings, which, according to the U.S. Preventive Services Task Force, haven’t been shown to be more effective than traditional mammograms.

[…]

The American Cancer SocietySusan G. Komen and the U.S. Preventive Services Task Force also say there isn’t yet enough evidence to advise women on 3D mammograms.

When the Food and Drug Administration approved the first 3D mammography system, made by Hologic, the agency required the technology to be safe and effective at finding breast cancer – not at improving survival.

“The companies do the minimal research needed to get FDA approval, and that usually means no meaningful evidence of how it helps patients,” said Diana Zuckerman, president of the National Center for Health Research.

Valenti said Hologic presented strong evidence to the FDA. “The data was overwhelming that 3D was a superior mammogram,” Valenti said.

Describing a breast exam as 3D may conjure up images of holograms or virtual reality. In fact, tomosynthesis is closer to a mini-CT scan.

Although all mammograms use X-rays, conventional 2D screenings provide two views of each breast, one from top to bottom and one from the side. 3D screenings take pictures from multiple angles, producing dozens or hundreds of images, and take only a few seconds longer.

Yet some studies suggest that 3D mammograms are less accurate than 2D.

A 2016 study in The Lancet Oncology found that women screened with 3D mammograms had more false alarms. A randomized trial of 29,000 women published in The Lancet in June showed that 3D detected no more breast tumors than 2D mammograms did.

And, like all mammograms, the 3D version carries risks. Older 3D systems expose women to twice as much radiation as a 2D mammogram, although those levels are still considered safe, said Diana Miglioretti, a biostatistics professor at the University of California-Davis School of Medicine.

Valenti said the newest 3D systems provide about the same radiation dose as 2D.

Diagnosing more cancers doesn’t necessarily help women, Brawley said. That’s because not all breast tumors are life-threatening; some grow so slowly that women would live just as long if they ignored them – or never even knew they were there. Finding these tumors often leads women to undergo treatments they don’t need.

2017 study estimated 1 in 3 women with breast cancer detected by a mammogram are treated unnecessarily. It’s possible 3D mammograms make that problem worse, by finding even more small, slow-growing breast tumors than 2D, said Dr. Alex Krist, vice chairman of the U.S. Preventive Services Task Force, an expert panel that issues health advice. By steering women toward 3D mammograms before all the evidence is in, “we could potentially hurt women,” Krist said.

Some experts worry that patients, who tend to overestimate their risk of dying from breast cancer, are acting out of fear when they choose treatment.

“If there was ever an audience susceptible to direct-to-consumer advertising, it’s women afraid of breast cancer,” Zuckerman said.

Some proponents of 3D mammograms imply that women who opt for 2D are taking a risk.

The first question many women have about 3D mammograms is: Are they less painful?

In ads, Hologic claims its 3D device was less painful for 93% of women. But that claim comes from a company-funded study that hasn’t been formally reviewed by outside experts, Zuckerman noted. Given the limited data provided in the study, it’s possible the findings were the result of chance, said Zuckerman, who called the ads “very misleading.”

Valenti said peer review is important in studies about cancer detection or false alarms. But when it relates to “general patient satisfaction or patient preference, those are data that we get in other ways,” he said. “Plenty of [doctors] have the [3D] system now and you can get feedback from them. “

While screenings may not generate a lot of income, they can attract patients who need other, more profitable hospital procedures.

“Anytime you diagnose more tumors, you can treat more tumors,” said Amitabh Chandra, director of health policy research at Harvard University’s John F. Kennedy School of Government.

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