Category Archives: News Stories & Editorials

Policing Big Pharma’s Influence Over Doctors’ Treatment Guidelines

Ronnie Cohen, Undark: February 4, 2019.


Dr. Samir Grover was taken aback when, early in his gastroenterology career, he saw one physician speak two times and present contradictory conclusions about the same medication. Each time, the speaker presented identical data on a drug used to treat inflammatory bowel disease. First, he recommended the pharmaceutical. A week later, he deemed it ineffective. “How could this exact same data be spun in two very different ways?” asked Grover, a professor at the University of Toronto. One fact did change — the drug manufacturer that sponsored and paid for the lecture.

It’s no secret that drug makers pay doctors to hype their products to other doctors. But few outside the halls of hospitals witness physicians bending a single set of facts in opposing ways. After watching similar acts of statistical wizardry throughout his nine years of medical practice, Grover set out to investigate a more sweeping question about conflicts of interest. Do they infect clinical practice guidelines? Professional societies produce thousands of these documents every year. They steer the decisions of health care professionals and insurance companies about how to prevent and treat an ever-widening range of conditions — from diabetes, hypertension, and heart disease to arthritis, hepatitis, cancer, and depression.

Grover and his colleagues’ paper and a companion study recently published in JAMA Internal Medicine suggest that simply following clinical practice guidelines could lead doctors — even those who shun all industry gifts — to unwittingly dispense financially tainted medicine. More than half of the authors of guidelines examined in the two studies had financial conflicts of interest. In many cases, the doctors who wrote the guidelines were paid by the same companies that produced the drugs they recommended. In addition, a significant portion of the doctors who took pharmaceutical money failed to disclose the payments, many of which amounted to $10,000 or more.

The consequences of financial entanglements can be profound, warned Dr. John P.A. Ioannidis, a professor at the Stanford University School of Medicine. “Writing guidelines is like prescribing something to millions of people,” he said. For their part, medical societies acknowledge the need for impartiality in the guideline-development process. Yet many view the task of disentangling industry from clinical practice guidelines as challenging, maybe impossible. Grover believes that panels can do better, particularly when it comes to disclosing conflicts. Still, he said, “it would be very hard to find experts, particularly for high-grossing medicines, to be completely devoid of conflict.”

Grover’s study examined financial conflicts of interest for the authors of 18 clinical practice guidelines that provided recommendations for the 10 highest grossing medications of 2016. The blockbuster drugs included treatments for hepatitis C, rheumatoid arthritis, and Crohn’s disease. Nearly one third of the authors declared receiving payments from companies marketing one or more of the top-revenue medications. A separate study underscored Grover’s findings. It examined industry payments received by the authors of 15 gastroenterology guidelines published from 2014 to 2016. More than half of the gastroenterology guideline authors received money from industry. In both studies, the payments could be funds for clinical trials, or they could be for travel, honoraria, or speaking fees.

The payments could bias guideline authors’ votes on prescription recommendations, and they could also prompt guideline authors to try to sway the votes of other committee members, said Matt Vassar, the study’s senior author and a professor at Oklahoma State University Center for Health Sciences in Tulsa. Prior research suggests that doctors who receive pharmaceutical money and gifts have different prescribing patterns than their peers who don’t. A 2016 study of nearly 280,000 doctors showed that those who attended a single industry-sponsored meal, with an average value of less than $20, were more likely to prescribe a brand-name medication promoted at the event than alternatives within its class.

“Doctors who take money from companies tend to prescribe drugs from these companies more — quite a bit more,” said Diana Zuckerman, president of the National Center for Health Research, a Washington, D.C. think tank. “We have to assume the same for doctors on guidelines teams.”

Especially worrisome to Vassar was his finding that the vast majority of the gastroenterology guideline authors failed to disclose industry payments that were reported in a federal database. Grover, too, discovered a lack of disclosure among guideline authors in his study — more than a quarter with conflicts failed to report payments they took from companies marketing one of the top 10 drugs. The undisclosed payments ranged from $1,638 to $102,309. For Grover, “the issue is not the conflict,” he said. “The issue is the transparency and adequately and appropriately noting conflicts.”

For Dr. Daniel Brauner, a professor of medicine at the University of Chicago, simply disclosing conflicts isn’t a cure-all. A geriatrician, he regularly sees patients suffering from what he believes are the consequences of specialists with conflicts writing clinical practice guidelines. “It’s over-prescription and a lack of really looking out for patients,” he said. When doctors adhere to multiple clinical practice guidelines, “older patients end up being on ridiculous numbers of drugs that will interact with each other and cause harm.” Yet doctors feel compelled to follow the guidelines, Zuckerman said. If they don’t, and their patients fare poorly, they can be sued for malpractice.

Ioannidis argues for a barrier blocking industry’s participation in clinical practice. “It’s fine to do research with industry funds,” he said. But then someone else should write the clinical guidelines. How can you be objective, he asks, “when every sentence you write may affect your own revenue, your own success, your own reputation?”[…]

See the original story here.

Health Care Industry Spends $30 Billion a Year on Marketing

Liz Szabo, Kaiser Health News: January 8, 2019.


Spending on health care marketing nearly doubled from 1997 to 2016, soaring to at least $30 billion a year, according to a study published Tuesday in JAMA.

The FDA is Still Letting Doctors Implant Untested Devices into Our Bodies

Jeanne Lenzer and Shannon Brownlee, Washington Post: January 4, 2019.


Ten years ago, Kathleen Yaremchuk raced to the bedside of a patient inexplicably gasping for breath. Chair of the department of otorhinolaryngology (ear, nose and throat) at Henry Ford Hospital in Detroit, Yaremchuk performed an emergency tracheotomy on the woman, cutting a hole in her windpipe, inserting a breathing tube and saving her life. When Yaremchuk began getting more calls over the following months for mysterious cases of respiratory distress, she launched a study to figure out what was going on.

All these patients, it turned out, had a small device implanted in the top of their spines to relieve pain. The object, used to hold a protein that stimulates bone growth, was cleared for sale by the Food and Drug Administration in 2003 without clinical testing in humans. When Yaremchuk and her colleagues reviewed the records of all 260 patients implanted with the device at Henry Ford Hospital between 2004 and 2009, they found that a significant number developed airway obstruction, trouble swallowing and respiratory failure, in some cases leading to death.

The neck implant is just one of the products associated over the past decade with 1.7 million injuries and more than 80,000 deaths. A searing global investigation last year by the International Consortium of Investigative Journalists places much of the blame on significant failings in the FDA’s oversight. The agency’s laissez faire attitude has resulted in artificial hips that cause cobalt poisoning (which can damage the heart and brain); surgical mesh that cuts through flesh and organs, causing infections and hemorrhage; and defibrillators that repeatedly shock patients beyond human endurance. Safety problems have led to recalls of devices implanted in hundreds of thousands of people. And the devices can be difficult or impossible to remove if they go bad. No wonder many patient advocates cheered when the FDA announced in November that it planned to make “transformative” changes in the way more than 80 percent of medical devices are cleared for sale in the United States. Some 32 million Americans walk around with such products in their bodies.

But the promised transformation is mere window dressing. Two key loopholes still exist, allowing most products to be approved for sale without clinical trials in humans. Although the FDA insists that high-risk devices undergo “stringent” testing to win approval, few actually do. A recent study, for example, found that only 5 percent of the highest-risk implantable cardiac devices were subjected to clinical trials on par with the testing required for drug approval.

In 1976, when medical devices first came under the regulatory control of the FDA, the agency simply grandfathered in all devices that were already on the market. Under this provision, known as the 510(k) pathway, new artificial joints, cataract lens implants and thousands of other devices developed after 1976 can win approval for sale (or “clearance” in FDA parlance) if the product is shown to have “substantial equivalence” to a previously cleared “predicate” device.” Four out of five devices are cleared for sale this way. Of those, at least 95 percent were cleared without clinical studies, according to research by Diana Zuckerman and her colleagues at the National Center for Health Research.

For some devices, that makes sense. You don’t need a clinical trial to test a new tongue depressor or hospital stretcher. But the agency also lets higher-risk devices through based on predicate devices, some of which have been recalled for safety problems. A recent study by researchers at the University of Oxford discovered that 16 percent of surgical meshes cleared for sale in the United States between 2013 and 2015 were based on products previously removed from the market because of serious complications. When one of us asked the FDA how this could happen, officials answered that the agency doesn’t evaluate the performance of the predicate when clearing devices for sale, just that there is (or was) a predicate.

According to the FDA, the “most impactful” change it is considering is recommending (not mandating) that companies cite predicate devices no older than 10 years. Yet device-makers could still cite predicates that were themselves based on earlier devices that may date back well past 10 years, something the FDA acknowledged in an email to us, stating that “devices cleared under a 510(k), regardless of how long the predicate has been on the market, have met the 510(k) regulatory review standard.”

The second loophole is the supplement pathway, which applies to new versions of the highest-risk devices, such as artificial hips, deep brain stimulators and spine implants. This process allows manufacturers to inform the FDA that they want to market an updated version of a device with minor changes — once again, allowing them to circumvent clinical trials. Researchers at Harvard found that 99 percent (5,829 of 5,906) of implanted cardiac devices, such as pacemakers and defibrillators, were approved through the supplement pathway from 1979 to 2012.

The supplement pathway has led to a number of disasters, such as one involving Medtronic’s Sprint Fidelis defibrillators, which are implanted in the chest to shock the heart if it goes into a deadly rhythm known as ventricular fibrillation. The company told the FDA in 2003 that it had updated the device to use thinner electrical leads into the heart. But the new wires were prone to fracture, hitting some patients repeatedly with shocks when their hearts were fine, and not delivering shocks to others who needed them. Doctors put the Sprint Fidelis into Bridget Robb, a patient from Pennsylvania in her early 30s. It shocked her 31 times in a span of minutes in 2007. She said in congressional testimony that it felt like being shot in the chest by a cannon at close range.

By the time Medtronic recalled the defibrillator in 2007, about a quarter-million were in circulation worldwide. Individuals implanted with it live under a sword of Damocles: They risk electrocution and possible death if they leave the Sprint Fidelis alone — and they risk death if their heart stops and the product fails. If they choose to have it removed, they face a 12 to 16 percent rate of serious complications or death from the surgery, according to a study published in 2010 in the journal Circulation.

Cases like these have received widespread coverage in the press but have had virtually no effect on FDA policy. Even a damning 2011 report by the Institute of Medicine (requested by the FDA), which deemed the agency’s 501(k) pathway so flawed it should be thrown out, fell on deaf ears.

Part of the problem lies in whom the agency believes it serves. At a recent meeting in Utah, the FDA’s device director repeatedly referred to manufacturers as the agency’s “customers” and showed a slide proclaiming “90 percent customer satisfaction.” Another slide documented the agency’s shorter and shorter approval times over the past eight years. These might not be the priorities of patients and taxpayers if they knew how often devices go on to harm people.

The FDA has become a captive agency. In 2007, Congress passed the Medical Device User Fee Amendments (MDUFA), which requires manufacturers to pay for device approvals. (Similar legislation, the Prescription Drug User Fee Act, directs money from drug companies to the FDA.) By 2018, 35 percent of the FDA’s budget for regulating devices came directly from the companies that make them. Zuckerman says that to continue collecting user fees under the MDUFA, the agency has to meet “performance goals” for faster approvals — leaving less time to evaluate products before they go on the market. It’s an inherent conflict of interest exacerbated by the revolving door of directors and commissioners who come from industry to the FDA and then go back. Before being appointed by President Trump to head the agency, Scott Gottlieb was paid millions of dollars for consultancies, directorships and other ties with some 20 health-care companies. He is a vocal supporter of Trump’s deregulation drive, arguing in 2013 that “the FDA’s caution is hazardous to our health.”

This is not a new problem. Before Gottlieb, President Barack Obama appointed Margaret Hamburg, who was then a director of Henry Schein, a leading medical-device distributor, to head the FDA. And in 2005, President George W. Bush named Lester Crawford, who abruptly resigned after just two months and came under criminal investigation for making false statements to Congress concealing his ties to companies the FDA regulates.

The relationship between the agency and the device industry is so cozy that in 2015, Rob Califf, then the FDA commissioner, met secretly with the Advanced Medical Technology Association (AdvaMed), the industry trade organization, to help craft the 21st Century Cures Act, which lowered the bar of evidence needed to approve devices even further.

Last fall, the FDA and AdvaMed were aware of the planned release of the Implant Files, the report by the investigative journalists’ consortium. AdvaMed executives were so concerned that they held a meeting to discuss strategies for dealing with the anticipated stories, which made headlines around the world in November. The executives promised their member companies that they would “hit back and hit back hard.” One day after the first reports were published, the FDA issued its “transformative” changes to the 510(k) pathway.

If Americans want devices that are safe and effective, they’ll need a new kind of regulation. First, the FDA should recategorize any implanted device as a high-risk or Class III product, which would subject it to rigorous clinical trials. Data from these studies should be made publicly available, or the manufacturer would forfeit the right to sell its product. And implanted devices should be entered into registries that track outcomes; patients should be given access to a website where they can immediately report problems and receive updates.

Lawmakers should also revive the congressional Office of Technology Assessment, which the House of Representatives killed in 1995, during a fit of anti-regulation insanity inspired by Newt Gingrich’s Contract With America. The office provided an invaluable service by independently assessing evidence for a wide range of technologies.

Finally, the FDA commissioner should be a civil servant without financial conflicts, not a political appointee (a practice started under Richard Nixon).

To do all of this, the FDA needs to overcome the constant threat of losing funding if it goes against the wishes of the industry it is supposed to regulate. Congress should repeal the MDUFA (and the prescription-drug equivalent) and fully fund the agency. Until the FDA requires clinical testing of implanted devices, as it does for drug approval, we simply won’t have the evidence to prove that a device is safe or effective.

See the original article here.

29-Year-Old Fitness Model Gets Breast Implants Removed after She Says the Silicone Gave Her Seven Years of ‘Brain Fog, Bald Spots and Rashes’

Mary Kekatos, Daily Mail: December 19, 2018.


A fitness blogger said she had her breast implants removed because the silicone was ‘poisoning’ her.

Sia Cooper, the 29-year-old behind the blog Diary of a Fit Mommy, revealed she got implants in October 2011 to boost her self-confidence after weight loss left her with small breasts.

However, over the next seven years, the Florida mother-of-two struggled with extreme fatigue, facial rashes, chest pain, brain fog and even hair loss.

post-explant, 2 weeks

After undergoing multiple blood tests, diagnostic tests and X-rays that came back negative, Cooper was convinced her symptoms were related to what described as  ‘breast implant illness’.

 

FDA Recommends “Modernizing” Review of Devices in Wake of Global Investigation

Jeanne Lenzer, The British Medical Journal: November 27, 2018


The US Food and Drug Administration is making changes to how medical devices are cleared for sale after a scathing investigation into the industry.

The global investigation into the medical device industry by journalists from 36 countries, including The BMJ, BBC Panorama, and the Guardian and led by the International Consortium of Investigative Journalists, unearthed thousands of documents to reveal rising numbers of malfunctions and injuries.

Scott Gottlieb, FDA commissioner, and Jeff Shuren, director of the Center of Devices and Radiological Health, said in a statement that there would be changes to the 510(k) pathway that is used to clear four in every five devices for sale. The pathway approves devices not on the basis of testing in humans but on how similar devices are to previous devices, called “predicates,” some of which were approved decades ago.

Gottlieb and Shuren said that … they were “encouraging” manufacturers to “use more modern predicates,” [….]

However, the reform didn’t go far enough, said Diana Zuckerman, epidemiologist and president of the National Center for Health Research in Washington, DC. She told The BMJ that using more “modern” predicates says nothing about safety or effectiveness. She said that “newer doesn’t mean better” and that “since less than 5% of 510(k) devices undergo any type of clinical trials, there’s no assurance that any devices cleared through that pathway are safe or effective.”

In 1996 the US Supreme Court concluded that “since the 510(k) process is focused on equivalence, not safety . . . if the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”

A recent study found that 16% of mesh clearances were based on recalled devices. When the FDA was asked why it cleared mesh implants on the basis of predicate devices that had been withdrawn because of safety concerns, the agency said that it didn’t evaluate the performance of predicate devices when clearing devices for sale.

A study of high risk implanted cardiac devices found that only 5% underwent clinical testing that even partly approximated the testing required for drug approvals.

Nor is safety surveillance reliable. A Government Accountability Office analysis found that 99% of device related “adverse events” were never reported to the FDA and that the “more serious the event, the less likely it was to be reported.”

Read the original article here.

Here’s What We Know About Breast Implants and This Rare Type of Cancer

Daisy Melamed Sanders, Survivornet: November 2018.

A series of new stories are examining the potential health risks that both silicone- and saline-filled breast implants may carry. The most serious of these is the possibility of developing a type of blood cancer. What’s not yet clear is if the evidence is significant enough for the government to issue a warning.

The blood cancer that implants may cause, called Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL, is a type of non-Hodgkins lymphoma that is not breast cancer. It is rare, and symptoms include pain, redness and swelling around the implant or breast area.

And while getting breast implants certainly does not definitively mean you’ll definitely get this type of lymphoma, it’s a dangerous illness for those who do get it. “ALCL is rare, but for those who get ALCL from their breast implants, it is very frightening and potentially fatal,” says Diana Zuckerman, PhD, President of the National Center for Health Research.

Here’s what we do know: The Food and Drug Administration—responsible for regulating medications and medical devices—has acknowledged that it has known of a potential relationship between breast implants and increased risk of ALCL since 2011. The risk involves both textured and smooth implants but the FDA’s position is that the textured kind may have a higher likelihood of causing the disease. The FDA also notes that incomplete or inefficient monitoring of, and reporting on, these health issues on a national level has meant that many women do not know all the facts when choosing to have implants for either cosmetic or reconstructive reasons.

According to the FDA, “In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. Precise risks are difficult to determine due to lack of information about how many patients have received breast implants in the US and worldwide.”

In an interview conducted prior to recent news, Dr. Andrea Pusic, Chief of Plastic Surgery at Brigham and Women’s Hospital, told SurvivorNet that breast implants are generally considered safe—but they do require monitoring by a doctor. The FDA also states that breast implants are “not lifetime devices,” and that the longer a patient has them, the more likely they are to rupture or experience other complications.

With regards to the safety of implants, Dr. Darrick Antell, a private practice plastic surgeon in New York City, cites the rarity of these instances as part of the reason implants are not excessively dangerous. “Textured surface implants have rarely been noted to develop ALCL, at a rate of 1 in 30,000—I would even recommend them to a family member,” he says. “Multiple leading institutions from around the world have shown them to be safe.”

But, as Dr. Zuckerman urges, it’s important to discuss the risk with your doctor before getting implants, because some women felt blindsided and uninformed about the disease possibility. “We know women who, when they developed ALCL, felt betrayed because their doctors hadn’t warned them of the risks.”

Breast implants also have the possibility of causing other health or physical issues. These issues have not been fully studied, but Zuckerman and the NCHR recently released a paper that discusses some of the possible side effects.

The risks that come with implants are real for all women, Dr. Zuckerman tells SurvivorNet, but these risks increase with a personal or family history of autoimmune or connective tissue symptoms or diseases. They can happen soon after getting implants or years later, and are especially likely when a silicone gel implant breaks—most likely after three years. Another issue is that leaking silicone can migrate into the lymph nodes, and, “from there, the silicone can get into the lungs, liver, or other organs.” Broken saline implants, she continues, offer less risk when they leak, but can cause health issues from the silicone shell, other chemicals, as well as from bacteria, fungus and mold issues that develop over time.

This isn’t the first time instance of concern regarding breast implants and potential health risks. Throughout the 1980’s and early 1990’s, a company called Dow Corning was named in a number of class-action lawsuits claiming that their breast implants were the cause of a number of health issues.

In 1992, the FDA mandated that silicone implants be removed from the market, but they were re-introduced in 2006 following stricter regulations around tracking patients for at least 10 years after their surgeries. However, because monitoring the implants and patients with them is not always thorough nor properly reported, it is difficult to know for sure what side effects implants are having in the long term.

The best idea, as always, is to discuss all the possible risks and benefits of implants with your doctor before any procedures, and be on alert for any symptoms that indicate a medical issue, suggests Dr. Zuckerman. “If a woman with implants starts to have any of the autoimmune symptoms that we’ve described in our report, she should consider having her implants removed.”

See the original story here.

Medical Device Dangers: FDA Facing Criticism Over Missed Signs

Today News: November 26, 2018.


Americans undergo hundreds of thousands of surgeries involving medical devices every year – but does the system that regulates the devices put patients at risk? An NBC News investigation, in conjunction with the International Consortium of Investigative Journalists, takes a closer look at one type of hip device that caused a world of pain for patients, including former Olympic gymnast Mary Lou Retton. NBC’s Stephanie Gosk reports for TODAY. NCHR’s Jack Mitchell explains to the Today Show why metal on metal hip replacements were used in US after warnings were released in other countries.

See the original story here.

Breast Implant Injuries Hidden as Patients’ Questions Mount

Meghan Hoyer, Associated Press: November, 26 2018.


WASHINGTON (AP) — To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or so complaints annually — a tiny fraction of the hundreds of thousands of implant surgeries performed each year.

Then last fall, something strange happened: Thousands of problems with breast implants flooded the FDA’s system. More than 4,000 injury reports filed in the last half of 2017. Another 8,000 in the first six months of 2018.

Suddenly, women like Jamee Cook had evidence suggesting their suffering might be linked to their breast implants. An emergency room paramedic, Cook had quit her job because of a vague but persistent array of health problems that stretched over a decade, including exhaustion, migraines, trouble focusing and an autoimmune disorder diagnosis.

Why had it taken so long for complaints like hers to see the light of day?

Makers of breast implants were required to track patients and their health. But for more than a decade, manufacturers with high numbers of recurring problems — in the case of implants, ruptures that required surgery to remove — were allowed to report issues in bulk, with one report standing in for thousands of individual cases and no way for the public to discern the true volume of incidents.

That agreement stood even as the FDA began closely monitoring a rare type of cancer and acknowledged in 2011 that it might be linked to breast implants.

“It looked like these devices had become safer, but they hadn’t,” Cook told The Associated Press. “The data was hidden. It’s a deceptive practice.”

Once Cook’s textured saline implants were removed, she said the majority of her symptoms disappeared. Her experiences prompted her to become a patient safety advocate, lobbying lawmakers and organizing groups of women online who have concerns about breast implants.

Public health advocates who’ve watched the debate over breast implant safety rage for nearly three decades say summary reporting is yet another way that information about the devices has been elusive for patients.

“They were told those devices were safe — the FDA would go back and say ‘We only have this many reports,’” said Madris Tomes, a former FDA staffer who founded a company to analyze medical device reports. “But data was coming in another way that wasn’t public. It leaves the patients demoralized — they don’t understand how many other people are suffering.”

The data came to light after the FDA instructed manufacturers in mid-2017 to go back and file individual reports in each case of patient injury, in response to a lawyer’s discovery that reports from his clients weren’t represented in the agency’s data. Patient advocates took up the issue, complaining about a lack of transparency and voicing concerns about a host of autoimmune problems they believed stemmed from their implants.

But even as the FDA was dealing with the problems of how breast implant manufacturers had used summary reporting, the agency was moving to expand device makers’ flexibility in how they report problems, saying it was trying to reduce the industry’s paperwork requirements.

This August, the agency began allowing roughly 90 percent of all medical devices — including all breast implants and more than 160 types of other high-risk implanted devices like artificial hips and replacement heart valves — to report malfunctions in a quarterly tally, instead of individually. They will not be able to report cases involving deaths or injuries that way, however.

The FDA rejected claims that expanding summary reporting could harm public health by making problems with devices less transparent, saying the plan “will also yield benefits . such as helping FDA process malfunction reports more efficiently and helping both FDA and the public more readily identify malfunction trends.”

FDA officials also said that the agency has closely monitored the breast implant industry in the past decade and issued updates about potential risks.

Two of the largest breast implant manufacturers, Mentor and Allergan, said they stood behind the safety of their products, citing years of studies that have led to inconclusive evidence that autoimmune problems are linked to breast implants.

“Our medical devices undergo extensive laboratory testing before they are submitted to government health experts for a science-based review,” Mentor spokeswoman Mindy Tinsley said. “Many of our devices undergo careful reviews by not just one, but multiple regulatory bodies around the world.”

Still, it can be hard for breast implant patients and advocates to track problems that do arise.

Insurance claims make no mention of the specific device or model implanted in a patient, and patients’ electronic health records aren’t required to record that either. In addition, products sold overseas can be renamed or carry a different model number, making international recalls or tracking across borders nearly impossible.

Meanwhile, the FDA’s main database on medical device problems, which requires manufacturers to report patient deaths and serious injuries to the government within 30 days, relies on hand-typed entries from a variety of people — from patients to device manufacturers — to help track troubled products. That can lead to underreporting, along with missing and flawed data.

Tomes said accurate, complete and publicly accessible data is crucial to identifying problems quickly and making sure devices are safe. The FDA numbers, she said, offer the lowest possible count of reports about problems with breast implants.

“You can assume that the numbers are probably much, much higher,” she said.

A Duke University report funded by the FDA in 2016 found that even though the agency collected data on device malfunctions for more than two decades, “reliably and efficiently tracking the medical device safety and effectiveness outcomes of most interest to patients remains a generally unfulfilled promise” that “significantly affects the public health.”

Insurers, auto buyers and regulators all use a car’s VIN number to track a vehicle’s history, down to the line it was manufactured on at a specific factory, and the FDA’s own pharmaceutical drug oversight works similarly. But medical devices didn’t have a similar unique identifier until 2015, and many of the least-risky devices won’t put an ID into use until 2020. On top of that, experts say it could be years before their use is required in patient records, on insurance claims and in the FDA’s own data.

What are the most common makes and models of breast implants reported as having caused injury? The FDA’s answer is still quite often “Unknown.”

___

The FDA requires manufacturers and medical facilities to file a report when any kind of medical device causes serious injury, death or malfunctions.

The resulting database — called MAUDE, for Manufacturer and User Facility Device Experience — is available online to the public, so consumers can search for a device type, manufacturer, the details of an incident and the date on which it occurred. That is, if the forms are filled out properly.

But categories often are left blank, with no indication of the model or who submitted the report. And device names and manufacturers also are often misspelled, making it nearly impossible for users to find all the reports of problems with a specific device or company. For example, the data contains roughly 2,000 variations of the name Medtronic plc, one of the world’s largest medical device manufacturers.

Overall, the MAUDE data contains reports of more than 1.7 million injuries and nearly 83,000 deaths over the past 10 years for all types of medical devices, according to an analysis of FDA data by the International Consortium of Investigative Journalists, which collaborated with the AP on a global investigation of medical device safety.

But in looking at problems with the MAUDE data, the investigation found an additional 2,100 cases in the past five years where people died but their deaths were misclassified as “malfunctions” or “injuries.” Of those, 220 deaths could be directly linked to medical device failure; the other reports did not include enough information to determine conclusively if the device played a role.

Beyond the misclassified data, FDA inspections at 17 hospitals in 2015 and 2016 found that only a fraction of “adverse events” were even being reported anyway. The review —which included major facilities in Los Angeles, New York, Boston and Chicago — found more than half failed to report deaths of patients with medical devices, as required by the agency’s rules. Jeffrey Shuren, the head of the FDA’s device division, said at the time that underreporting problems from hospitals was widespread. The agency enhanced compliance training for hospital employees nationwide as a result.

Part of the problem, advocates say, is that the FDA’s guidelines for reporting problem devices is vague — the agency states that reports are required from manufacturers within 30 days of an event when evidence “reasonably suggests” that a device was involved, allowing companies to make their own judgments.

S. Lori Brown, now a retired FDA senior researcher, used MAUDE for years in her studies of breast implants, ruptures and possible links to rare forms of cancer and a host of autoimmune disorders.

“It’s a difficult database to use, because there’s no good way to confirm what’s reported, and there’s no denominator — you don’t know how many people have received breast implants,” Brown said. “The MAUDE database was just not very helpful in finding out how frequently things happened or how severe the impact was.”

Where it was helpful, she said, was in gathering patient stories and seeing general trends. In the 1990s, even as manufacturers claimed breast implants were durable enough to be run over by a car without breaking, MAUDE showed silicone implants leaking gel into thousands of women’s bodies.

“As a signal, it was a burning bush, for sure,” Brown said. “Because there were so many reports of ruptured implants from every manufacturer.”

After the FDA removed silicone breast implants from the market in 1992, the public attention around ruptures and leaks resulted in a huge spike in the number reports about problems. During the 1990s, silicone implants represented the third-highest number of adverse events reports in MAUDE. At the time, the data show patients also complained about other symptoms, with hundreds of reports about chronic fatigue, headaches, autoimmune problems and fibromyalgia.

In 2006, silicone implants returned to the market, under the requirement that companies track patients for at least a decade. Although more than half the women dropped out of the studies within the first two years, researchers at the University of Texas MD Anderson Cancer Center in Houston released a study this September using the data the companies did collect and found that certain rare health problems — including immune system and connective tissue disorders — might be more common with silicone gel implants. The FDA, which mandated the original data collection, later criticized the study, citing “inconsistencies in the data.”

Last year, the FDA did confirm a link between breast implants, particularly textured saline or silicone models, and anaplastic large cell lymphoma — a rare cancer documented in only a few hundred cases.

On its website, the FDA also noted more common problems with implants, such as ruptures, which can send silicone gel throughout the body. And the agency warned that implants “are not lifetime devices,” but will likely need to be removed or replaced at some point.

The return of silicone implants, which advocates say feel more natural, has fueled a surge in surgeries. The American Society of Plastic Surgeons reported 400,000 procedures took place in 2017, up nearly 40 percent since 2000.

More than three-quarters of the implant surgeries were for cosmetic, not reconstructive, reasons. And there were about 20 percent fewer removals compared to 2000, the data show.

The increase in implants worries Diana Zuckerman, a medical researcher who was a congressional staffer during the earliest contentious House hearings on breast implant safety. She said poorly performed studies, research funded directly by manufacturers and the lack of data have left most women in the dark about the risks involved.

“Somehow, it’s the most studied device and we have almost no useful information about it,” said Zuckerman, the president of the National Center for Health Research, a nonprofit think tank that performs its own research, assesses the quality of others’ research and works with patients.

Zuckerman’s center reviewed more than 20 studies it says has been used by the industry to claim there is no evidence breast implants cause connective tissue problems and other long-term illnesses. She said almost all the studies were too small to detect rare diseases and conditions, only one required that participants have a medical exam and most didn’t focus on patients who had implants long enough for problems to develop.

In September, Cook and 19 other breast implant patients-turned-health-advocates visited Washington to lobby the FDA for more stringent regulation, testing and reporting on breast implants. Among their requests — that all types of textured implants, which are more closely associated with lymphoma, be banned from the market, and that manufacturers be required to disclose the chemicals in silicone implants’ shell and gel filling, which the makers claim is a trade secret.

The FDA has scheduled an advisory committee hearing for early 2019 on breast implant safety to address some of the U.S. group’s concerns and determine whether additional actions are needed to protect public health. The agency did not rule out the possibility of including a “black box warning,” the notification it puts on its most dangerous devices to draw attention to serious risks.

However, the FDA said in a statement: “The agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases.”

Cook, who leads several breast implant groups on Facebook from her home near Dallas, said she chose to get her implants, but did so with almost no information on the potential dangers.

“If you had sat down with me and said ‘this is the list of chemicals you’re about to put in your body and you could get lymphoma,’ no way in hell I would have done it,” she said.

Her implants, a textured saline model made by Poly Implant Prothese of France, were used in the U.S. for four years before the FDA implemented more stringent standards for breast implant approval in 2000. Under the new rules, the FDA denied the company’s application to sell implants in the U.S. after officials toured the company’s French plant and cited 11 major deficiencies in quality control and manufacturing practices.

Poly Implant went bankrupt in 2010 after doctors in France noted abnormally high rupture rates of the implants, which were found to be filled with industrial-grade gel. The company’s president was found guilty of aggravated fraud, and French authorities advised tens of thousands of women to get their implants removed as a precautionary measure.

Cook, 41, said she and others who already had the saline implants never were warned of the FDA’s actions.

“I’m not going to sit back and be embarrassed about my decision when I can try to change the way that the future is going to occur for women younger than me,” she said. “We need to make sure we’re giving that patient the most safe device we possibly can. And above that, we need to make sure she understands what the risks are before she makes that choice.”

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The FDA may now require an identifying number on medical devices, but Zuckerman and other advocates note one big issue with the code associated with breast implants: The number is not actually stamped on the implant itself, but on the packaging.

“For the most part, these devices don’t cause immediate problems — they cause problems later,” Zuckerman said. “What good does it do to have these numbers if they’re not in your medical records and they aren’t on the implant itself?”

The unique device identifier, or UDI, is intended to help standardize device names and manufacturer information and make it easier to track devices to help in recall efforts and analyses of problems.

But that doesn’t work if the codes aren’t in the FDA’s own database. Tomes, whose company Device Events analyzes MAUDE data, said UDIs are still rarely included in adverse event reports and, even when they are, often are removed from the public data so they can’t be used to identify specific devices.

“The whole point of having a UDI is so that hospitals and providers and insurance companies and anyone else would be able to say ‘I’m seeing a pattern, it’s all this serial number,’” Tomes said. “But it’s redacted.”

Similarly, Tomes and others say the FDA’s expansion of summary reporting and its use of device registries — databases funded and maintained by outside organizations to track a singular specific device — may ultimately make less data available to consumers.

This fall, the agency announced a breast implant registry run through the Plastic Surgery Foundation that will collect patient and device data — including UDI numbers for breast implants — and allow surgeons to track patients’ medical history, complications and follow-up surgeries.

The participation of plastic surgeons in the registry is voluntary, and patients also can opt out. Doctors and researchers will have access to the collected data, but the public will not.

As the FDA weighed its expansion of the summary reporting program earlier this year, Cook and a dozen other patients with medical device problems, along with the patient-advocacy group Public Citizen, urged the agency to rethink its plan.

But the FDA sided with manufacturers and industry organizations, which had asked for easier reporting requirements for malfunctions, freeing them in some cases from filing tens of thousands of individual reports a year. Under the new rules now in place, roughly 90 percent of devices can report malfunctions quarterly.

“Thousands on thousands of consumers are harmed every single year by medical devices and we are discussing making it easier to hide the information that we need to make an informed decision,” Cook wrote in her dissent to the plan.

“While the goal is not to ‘hide’ the data,” she wrote, “in essence that is what is happening.”

 

See the original story here.

Concerns That Public Hearings on Breast Implants Will Favor Implant Manufacturers

Kris Pickel, CBS News: October 4, 2018.


PHOENIX (3TV/CBS 5) — The Food and Drug Administration has agreed to hold a public hearing on Breast Implant Illness. It’s a victory for women who petitioned the FDA but CBS 5 is investigating concerns the hearings will be stacked to favor implant manufacturers.

Breast Implant Illness (BII) is not recognized as a medical condition.

It is a term used by thousands of women to describe a wide range of unexplained symptoms experienced by women who believe their implants made them sick.

Symptoms of Implant Illness

 

 

 

 

 

 

 

 

 

 

CBS 5 has been investigating BII for almost two years and has seen the number of women coming forward increase by the tens of thousands.

When our first investigation aired, the Facebook group Breast Implant Illness and Healing with Nicole, had 17,000 members. It now has more than 51,000.

News reports and social media are connecting women who believe they suffer from BII.

They are finding strength in numbers.

More than 21,000 women signed an online petition demanding the FDA hold public hearings.

The FDA agreed to meet privately with a small group of women who believe they suffer from BII.

Among the women who traveled to the District of Columbia for the September meeting at FDA headquarters were breast cancer survivors, women who believe implants made them sick, experts on breast implants and women who recently played a role in having the birth-control device Essure pulled off the market.

Women in the group say the FDA set the terms for the meeting: No cameras, no recording, no reporters allowed.

Following the September meeting, the FDA released a statementdisputing a study linking implants to illnesses.

Buried at the end of the statement, the FDA announced they would hold a public hearing on breast implants next year.

Nicole Daruda founded the website HealingBreastImplantIllness.com and the closed Facebook group Breast Implant Illness and Healing with Nicole.

Daruda say some of the issues they want to address include taking textured implants the FDA has said might be linked to the potential for a rare cancer off the market, comprehensive studies and requiring surgeons to give women a checklist of potential risks at least a week before surgery.

In the FDA’s public hearing, an advisory panel will hear from industry representatives, experts, women who believe their implants made them sick and members from the public.

Following the public hearing, that advisory panel will vote on recommendations to make to the FDA. The panel does not have the power to make changes. It will only make recommendations.

Dr. Diana Zuckerman on CBS News

Dr. Diana Zuckerman is president of the National Center for Health Research in D.C. and is responsible for a dozen Congressional investigations on a various health issues.

Zuckerman says in the past, the FDA has stacked the panels with plastic surgeons who have a financial interest in protecting breast implants. 

“Having surgeons whose entire livelihood, or almost entire livelihood, is based on breast surgery, with breast implants, can’t possibly be objective,” Zuckerman said.

She says she has witnessed multiple times where plastic surgeons advocate for implants and dominate the hearings.

“I’ve seen situations where a statistician, for example, says, ‘Look at how unsafe these products are,’ and the plastic surgeon says, ‘No. No. No. We put these in all the time and they are very safe.'”

We contacted the FDA a several times during this investigation and asked if they would be looking at the panel to eliminate possible conflicts of interest.

They responded with a link to their application for panel members, which includes a section that addresses conflict of interest.

Conflict of Interest

The FDA website lists the core group of eight voting members on the advisory panel.

CBS 5 was able to confirm at least two of the doctors perform breast implant surgeries and a regulatory expert who previously worked for Johnson & Johnson, which owns implant manufacturer Mentor.

Zuckerman says in the interest of ensuring an unbiased panel, people should contact their elected officials in Washington and ask them to  pressure the FDA to make sure no one with financial ties to the implant industry sits on the advisory panel.

One Woman’s Story

Robin Towt shares her story

Cancer survivor Robyn Towt was in the group of women who met with the FDA.

When diagnosed with breast cancer, Towt immediately opted for a double mastectomy.

She says her health issues, including anxiety and insomnia, started the day her implants were put in.

Having survived cancer before, radiation was not an option.

Towt chose not to do chemotherapy, leaving no explanation as to why she was getting sicker.

“I have been never been that miserable in my entire life and in that dark a place,” she said. “I feel horrible because my family suffered. My husband suffered. I was not a happy person. I was not a healthy person. I had no quality of life. I was desperate. I was sleep deprived.”

Towt says a friend in a cancer support group suggested she look into her implants as a source for her health problems.

After connecting with women on social media, Towt had her implants removed just four months after having them put in.

She says her symptoms disappeared within 48 hours.

CBS 5 Investigates has uncovered that while implant manufacturers are required to publish informational booklets that include warnings on potential risks of implants, plastic surgeons are not required to give the booklets to women.

Towt says after her implants were removed, she went back and asked her surgeon for the booklet so she could compare the warnings to the consent forms she signed.

Towt says the warnings in the booklet were stronger when it came to certain risks, including cancer associated with breast implants.

“I kind of felt duped when I was comparing them because if I had read the information in that booklet to start with, I would have never ever considered it,” she said.

Towt’s plastic surgeon did not return calls to CBS 5 inquiring when the booklets are provided to patients.

A date for the FDA’s public hearing has not been set.

The FDA says it will happen sometime in 2019.

 

Read the original article and watch the news segment here.

F.D.A. Targets Vaping, Alarmed by Teenage Use

Sheila Kaplan and Jan Hoffman, The New York Times: September 12, 2018.


WASHINGTON — The Food and Drug Administration on Wednesday declared that teenage use of electronic cigarettes has reached “an epidemic proportion,” and it put makers of the most popular devices on notice that they have just 60 days to prove they can keep their devices away from minors.

The order was part of a sweeping government action that targeted both makers and sellers of e-cigarettes. If Juul Labs and four other major manufacturers fail to halt sales to minors, the agency said, it could remove their flavored products from the market. It also raised the possibility of civil or criminal charges if companies are allowing bulk sales through their websites.

The agency said it was sending warning letters to 1,100 retailers — including 7-Eleven stores, Walgreens, Circle K convenience shops and Shell gas stations — and issued another 131 fines, ranging from $279 to $11,182, for selling e-cigarettes to minors.

Federal law prohibits selling e-cigarettes to anyone under 18. In a briefing with reporters, the F.D.A. commissioner, Dr. Scott Gottlieb, said that more than two million middle and high school students were regular users of e-cigarettes last year.

The government’s tactics underscore a dilemma in the public health community: In addressing one public health problem — cigarette smoking, which kills 480,000 people in the United States each year — e-cigarettes are creating another — hooking teenagers who have never smoked on nicotine.

E-cigarette users inhale far fewer toxic chemicals than do smokers of traditional cigarettes. But they can take in higher levels of nicotine, which is addictive.

“The developing adolescent brain is particularly vulnerable to addiction,” the F.D.A. said in its statement announcing the actions.

In particular, the agency has been watching the wildly popular Juul, which offers especially potent nicotine hits. Juul Labs launched the sleek device, which looks like a flash drive, in 2015. It comes with “pods” in eight flavors, among them mango, menthol and creme. In a short time, Juul has become the dominant seller of e-cigarettes and a fad among students. According to Nielsen data, Juul controls 72 percent of the market, and is valued by investors at $16 billion.

In an emailed statement, a Juul spokeswoman said: “Juul Labs will work proactively with F.D.A. in response to its request. We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.”

Dr. Gottlieb said the F.D.A. would look closely at whether Juul and the other manufacturers were allowing bulk purchases of products through their own websites — a practice where the buyer could then sell to minors.

If such “straw sales” are happening, it should be readily apparent to the manufacturers, he said. “If the companies don’t know, or if they don’t want to know, we’ll now be helping to identify it for them.”

The other four products facing the 60-day deadline are RJR Vapor Co.’s Vuse, Imperial Brands’ blu and devices made by Logic. They said they were working with the F.D.A. as well.

RJR, Imperial and Altria are all major tobacco companies. As smoking rates have declined, the industry sees e-cigarettes as an important piece of its survival, a fact that makes some in public health mistrustful.

“They say they’ve changed from the days of Joe Camel,” Dr. Gottlieb said. “But look at what’s happening right now, on our watch and on their watch. They must demonstrate that they’re truly committed to keeping these new products out of the hands of kids.”

Dr. Gottlieb has said many times he believes that e-cigarettes and similar products known as electronic nicotine delivery systems may be effective options for adults who want to stop smoking but still crave nicotine. But he said teenage vaping has become so concerning that regulators may have to curb the availability of the devices to keep them out of the hands of youths.

“Inevitably what we are going to have to contemplate are actions that may narrow the off-ramp for adults who see e-cigarettes as a viable alternative to combustible tobacco in order to close the on ramp for kids,” Dr. Gottlieb said. “It’s an unfortunate trade-off.”

Dr. Gottlieb’s aggressive approach against private industry is unusual for an official in the business-friendly Trump administration which has sought to roll back numerous environmental and health regulations. But critics said that his decision last summer to extend a deadline for e-cigarette manufacturers to demonstrate that their products comply with public health concerns helped perpetuate the current problem.

“It’s nice they want to do something but realistically, what are they going to accomplish this way when they could be so much more effective by following the regulatory plan that had been ready to put into place and that the commissioner postponed?” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit health policy group.

She also pointed to the popularity of vaping among young adults. Researchers generally believe that the adolescent brain continues to develop through age 26. “It’s a big epidemic among people ages 18 to 30, too,” she said.

And while the F.D.A.’s announcement struck many as tough, legal experts said the agency could face a protracted legal fight if it follows through on its threats to ban flavors and curtail marketing.

Marc J. Scheineson, a health care lawyer and a former associate F.D.A. commissioner, said that the agency was relying on public opinion and its own bully pulpit to push the targeted manufacturers into “voluntary compliance.”

Some antismoking groups, while encouraged by the F.D.A.’s actions, expressed caution: “Asking the tobacco industry to come up with solutions is the proverbial case of asking the fox to guard the hen house,” said Robin Koval, the president and chief executive of Truth Initiative. “After decades, there is no evidence that the tobacco industry is able to regulate itself.” […]

A Juul spokeswoman, Victoria Davis, said recently that the company had already stepped up its own patrol of retailers who advertise to youths or who don’t enforce age requirements, as well as social media posts. But it’s not always easy.

From Jan. 1 through July 28, Ms. Davis said, Juul asked Instagram to remove over 5,500 posts, and the social media company complied on 4,562. Facebook Marketplace was less agreeable. The company agreed to remove 45 of 144 posts. Amazon took down 13 of 33.

Dr. Gottlieb said he was not impressed by the measures Juul and the other companies have taken.

“It didn’t have the intended impact or I wouldn’t be viewing the statistics I’m now seeing,” he said.

 

Read the original article here.