Thomas Dworetzky, DOTMed News: May 8, 2019.

Following the groundbreaking Kaiser Health News report exposing the scope of the little-known FDA “alternative summary reporting” program that let medical device makers “conceal millions of reports of harm and malfunctions from the general public,” the agency has now stated that it will be shutting the program down, according to KHN.

FDA cited the decision in a statement about its “new efforts to protect women’s health and help to ensure the safety of breast implants,” especially textured implants, which have been linked to a type of cancer and which the agency now plans to leave on the market as it “does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act,” Amy Abernethy, M.D., Ph.D., FDA’s principal deputy commissioner, and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement. But the announcement also addressed the way in which adverse breast implant events were reported with “alternative summary reporting,” stating that “the FDA has ended all summary reporting of breast implant medical device reports.”

The statement then addressed the controversial alternative reporting issue for devices beyond the implants, as well.

“This is part of a larger effort to end the alternative summary reporting program for all medical devices, which we intend to complete in the coming weeks,” the agency stated, continuing, “this program was established in 1997 to more efficiently review adverse events for well-established risks, but was not allowed for patient deaths and unusual, unique or uncommon adverse events, which, in the case of breast implants, included BIA-ALCL. Alternative summary reports were not previously available in our public database for medical device reports, Manufacturer and User Facility Device Experience (MAUDE) [the FDA public-facing database of device safety reports].

The Kaiser report exposed that the 20-year-old program had 1.1 million reportskept from both public and professional review since 2016.

Former FDA official Dr. S. Lori Brown told KHN that this ending was a “victory for patients and consumers.”

“The No. 1 job of the FDA — it shouldn’t be ‘buyer beware’ — is to have the information available to people so they can have information about the devices they are going to put in their body,” Brown told the investigative news group.

In March, the revelations in the KHN report prompted concern for healthcare professionals.

“The FDA absolutely should be making all of this information available,” Diana Zuckerman, president of the National Center for Health Research, told the news agency. 

The numbers of these “alternative summary reporting” (ASR) exemptions, Zuckerman added “takes my breath away,” KHN reported at the time. 

Former FDA chief Dr. Scott Gottlieb confessed to the news agency at the time that he “wasn’t aware of the full scope of the reports that weren’t going into MAUDE.”[…]

See the original story here.

Lauren Dunn, NBC News: May 3, 2019.

Almost one month after an emotional hearing on breast implant safety, the Food and Drug Administration announced it would not ban textured breast implants, which have been linked to a type of lymphoma.

Allergan’s textured implants have already been yanked off the market over safety concerns in 38 countries, including France and most recently Canada. But the FDA said Thursday there isn’t enough evidence to warrant a ban in the United States.

“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug, and Cosmetic Act,” the agency said Thursday.

The implants, which have a rough, sandpaper-like surface, are linked to breast implant associated-anaplastic large cell lymphoma or BIA-ALCL, a cancer of the immune system that can be deadly if it’s not treated early enough. In the United States, 457 women have been diagnosed with the disease. Worldwide, 17 have died.

“This disease is still so grossly underestimated and we will continue to see more deaths and diagnosed women,” Michelle Forney, who was diagnosed with BIA-ALCL last year, said. “However, not banning textured implants because it doesn’t meet a banning standard from a legislative act gives me more concern that our country cannot protect us or our children from other cancer-causing devices.“

The agency says it plans to work with patient groups and manufacturers to make changes to the labels of textured implants that could include a black box warning — the FDA’s strictest caution.

Manufacturers will also be required to submit adverse event reports instead of the current practice of quarterly summary reports, and details of these will now be made available to the public.

“We are considering these actions to help to ensure that all women who consider breast implants have the information they need to have thoughtful and balanced discussions with their health care professional about both the benefits and risks of breast implants based on clear information reflecting the most current understanding of these issues,” the FDA said in a statement.

Critics fear the moves don’t go far enough to protect women.

See the original story here.

Storm Gifford, New York Daily News: May 2, 2019.

Robert Kaplan, The Regulatory Review: May 7, 2019.

In December, 2016—a time when the U.S. Congress could barely agree on anything—the U.S. House of Representatives and the U.S. Senate came together to pass the 21st Century Cures Act. Championed by Representative Fred Upton (R-Mich.) and Representative Diana DeGette (D-Colo.), the Act uses 312 pages to outline a plan to accelerate the licensing and delivery of medical cures. It includes many attractive features. But, as I will show here, it also contains provisions that could increase risks to patients.

The Act was attractive because it provides about $6.3 billion in funding, mostly for the National Institutes of Health (NIH), the major supplier of research funding for American universities and research institutions. Although the NIH faces very little political opposition, the agency had been deprived of adequate funding for at least a decade.

Beyond support for the NIH, the Act was appealing because it provides funding for mental health care. It endorses parity in payment in most private and some federal health insurance plans for physical health and mental health services and strengthened suicide prevention programs. It also provides much-needed funding to confront the opioid epidemic.

The 21st Century Cures Act had the support of patients, researchers, universities, and a broad political constituency. But there is a catch. In several key ways—including notably the use of surrogate markers instead of better forms of evidence to show the drug benefits—the Act threatens public health by lowering U.S. Food and Drug Administration (FDA) standards for new drugs and medical devices.

The Act was originated and promoted by the major pharmaceutical companies who employed over 1,300 lobbyists to promote the bill. The companies were concerned that FDA used strict methodological standards to evaluate the efficacy and safety of new pharmaceutical products. The companies argued that zealous concern for efficacy and safety deprived patients of new cures, and they succeeded in adding provisions to the Act that allow FDA to become less rigid.

Opponents were concerned that the Act deemphasized methodologies that have long been used to evaluate the safety and efficacy of new drugs. Indeed, supporters of the Act hoped to reduce reliance on the double-blind randomized clinical trial, the gold standard for establishing that medicines cause improvements in health outcome. Pharmaceutical companies regarded these methods as outdated and suggested that new drug licensing should depend on preclinical studies, including animal studies, case histories, and in some cases just the clinical experience of doctors. As it turns out, the companies’ suggestion became reality. The Act now includes a provision that allows for the consideration of “real world evidence,” which includes “sources other than randomized clinical trials.” Some of these alternative methods are associated with established biases.

Many health care researchers, including me, believe that relaxing methodological standards will put the public at risk. Risks take several forms. All drugs have potential benefits and side effects. Several systematic reviews suggest that as standards for conducting and reporting clinical trials tightened, the studies became less likely to show that treatments offer benefits to patients. Overestimating treatment benefits may harm patients by subjecting them to side effects for treatments that may not help them. When side effects are underestimated, patients may not be aware of the potential harms their medicines may cause.

Here is the crux of the issue: People use medications because they want to live longer and to feel better. Over the last few decades, FDA has put greater emphasis on measures of health outcome that are important to patients, such as length of life and quality of life.

However, drugs and devices are often evaluated on the basis of surrogate markers, including clinical lab tests that evaluate blood chemistry or tumor characters. These surrogates can be important if they are closely associated with health outcomes. But the surrogates are often uncorrelated with measures that are meaningful to patients.

For example, glycosylated hemoglobin is a good marker of diabetes control. Yet in some systematic clinical trials, patients who achieve lower glycosylated hemoglobin through aggressive medical management have a higher probability of death than those receiving usual care.

Diana Zuckerman and her colleagues at the National Center for Health Research recently studied the approval of new cancer drugs by FDA between 2008 and 2012. Among 54 new drug approvals, 36 had been evaluated on the basis of surrogate markers. In cancer studies, the surrogate measure is often tumor shrinkage. We might assume that a drug that shrinks tumors—the surrogate measure—should help people live longer higher-quality lives—the outcome. Yet, Zuckerman and her colleagues found that, for 18 of the 36 drugs, there was no evidence of improved life expectancy. The manufacturers never reported data on survival for another 13 of the drugs. It can be assumed that the companies would have reported improved survival data if such evidence existed. So, for 31 of the 36 of newly-approved cancer drugs, there was apparently no evidence that the treatment increased life expectancy.

The 18 drugs that did not improve life expectancy would still be valuable if they improved quality of life. But Zuckerman and her colleagues found only one was associated with any evidence of improved life quality. Of the 18 drugs, 15 did not improve quality of life and the remaining two drugs actually made quality of life worse. Even though the great majority of these new cancer drugs were unassociated with any benefits from the patient’s perspective, many continue to be used and are sold at a very high price. One of the drugs that reduces quality of life and does not increase life expectancy is sold for approximately $170,000 per person per year.

There at least three ways that focusing on surrogate markers rather than health outcomes can have a large negative impact on how we appraise the net benefit of medical interventions.[…]

See the original post here.

Editorial Board, The New York Times: May 4, 2019.

When the Food and Drug Administration announced last month that it couldn’t guarantee the long-term safety and efficacy of vaginal mesh products — medical devices that have been on the market for decades — the collective response from tens of thousands of women harmed by the products sounded something like this: Duh.

The mesh, which is used to hold pelvic organs in place when muscles become too weak to do the job, has long been tied to life-altering injuries, including nearly 80 deaths as of 2018. In the past decade, seven companies have spent a collective $8 billion to resolve more than 100,000 patient claims — making litigation over vaginal mesh (or pelvic mesh, as it is sometimes called) one of the largest mass tort cases in United States history. As those lawsuits have made clear, most of these medical devices were approved for market with nearly no clinical data.

It seems incredible that products meant to reside inside the human body would be used on patients without any proof of safety or efficacy. But thanks to regulatory loopholes and lax oversight, most medical devices are poorly vetted before their release into the marketplace and poorly monitored after the fact.

Problems can take years to emerge and can be impossible to correct, in part because permanent implants are not easily extracted from the body. (Removing mesh from pelvic tissue has been likened to removing chewing gum from long, thick hair). When trouble does arise, device makers often equivocate, regulators dither and patients seeking redress are forced into lengthy and expensive court battles. In the end, faulty products can remain on the market for years.

The F.D.A. finally pulled the remaining vaginal mesh products off the market last month (although most companies had already stopped selling them because of all those lawsuits). But on Thursday, the agency said it would not ban a breast implant linked to a rare form of cancer and so many other side effects that doctors have coined a new term — “breast-implant illness.” Like mesh, the breast implant was approved years back, based on meager safety evidence. Regulators now say there is not enough proof of harm to justify reversing that decision.

The risks of waiting loom large: In the past decade, nearly two million injuries and more than 80,000 deaths have been linked to faulty medical devices, many approved with little to no clinical testing, according to a global investigation by the International Consortium of Investigative Journalists.

Women are particularly well acquainted with this cycle. Essure, a permanent birth control device consisting of two metal coils injected into the fallopian tubes, has been linked to autoimmune disorders and more than 800 pregnancy losses. The product was pulled from the market last year —  by the device maker, which cited declining sales, not by the F.D.A. And the power morcellator — a spinning blade that shreds uterine tissue so it can be more easily extracted from the body — has proved deadly for some women, whose cancer was spread by the device. As The Times has reported, the morcellator was widely used for 20 years before regulators realized there was a problem.

But that’s not to suggest that only women are affected: There have been metal hips that released poisonous debris into the body, implantable defibrillators that shock people at random (causing indescribable terror) and artificial heart valves with questionable shelf lives. In operating rooms, there have been staplers that misfire; temperature control machines that spray bacteria into open chest cavities; and robotic surgeons that slap, burn and, in some cases, maim patients.

In every one of these cases, a combination of dubious regulatory approvals, skimpy post-market surveillance, and faltering responses from regulators caused irrevocable harm that might have been avoided.

After searing investigations by journalists and patient advocates, the F.D.A. has promised to make “transformative” changes to medical device regulation. But so far, the agency’s suggestions have been meager at best. And in the meantime, regulators have accelerated the device approval process, not slowed it down.

Dr. Jeffrey Shuren, head of the agency office in charge of device regulation, has suggested that the benefits of bringing innovative products to market quickly are worth the increased risks.

It’s true that devices have restored hearing, vision and the ability to walk and have provided many other benefits to millions of people. But the drive to innovate does not justify the growing catalog of medical device disasters. Patients should not have to wonder whether devices will save their lives or destroy them. Reasonable changes could greatly improve the current system.

Tighten approval standards. Regulatory loopholes — some of which date to the dawn of device regulation and were not meant to be permanent — enable companies to bring new or “updated” medical devices to market without testing them in human trials first. Companies need only to convince regulators that their products are similar to ones that are already approved, even if the other products are decades old or were subsequently pulled from the market. Eight years ago the Institute of Medicine advised the F.D.A. to abolish at least one of these loopholes, what’s known as the 510(k) pathway. It’s past time for the agency to heed that advice, and to ensure that no medical device intended for permanent residence inside a human body is used on patients without first being rigorously tested.

Fix post-market surveillance: Industry proponents say that medical devices can be brought to market quickly and safely by having companies conduct rigorous testing after products go to market instead of beforehand. But companies often fail to complete such studies, even when they’re ordered by regulators. What’s more, device makers frequently skirt rules requiring them to report publicly all incidents of malfunction, injury or illness — often through mechanisms that the F.D.A. itself created. And after years of wrangling, the industry and its regulators have still not fully put a system in place to better notify patients of product recalls and other safety issues.

The F.D.A. has vowed to fix some of these lapses. They’ve promised to abolish reporting exemptions that keep safety issues hidden from the public and to promote breast implant registries that monitor patient outcomes.

That’s a good start, but more can be done. An industry that prides itself on innovation, and earns some $400 billion in annual revenue, should be well equipped to build a global medical device registry where patient outcomes for all medical devices are openly monitored, and where doctors and patients can log concerns and obtain information.

Loosen industry’s grip. Dr. Shuren reportedly referred to device makers, not consumers, as his office’s main customers at a recent industry gathering. As misguided as that statement may sound, he’s not wrong: The medical device industry funds 35 percent of the office’s work, and by law, that funding is contingent upon the agency’s approving devices quickly, and through the least restrictive pathway possible.

It’s not solely those laws that give medical device makers influence over regulators. The industry maintains a well-oiled revolving door with the F.D.A. — as The Associated Press has noted, the last four people to hold Dr. Shuren’s position have gone on to lucrative industry gigs. Device makers also spent more than $300 million lobbying Congress in the decade ending in 2017, according to the Center for Responsive Politics. What’s more, they pay doctors and hospitals hundreds of millions in consulting fees every year, according to the National Center for Health Research. None of this violates any rule, but all of it contributes to the current crisis.[…]

See the original article here.

Mathew Perrone, Associated Press: May 2, 2019.

This AP story appeared in media outlets across the country, including yahoo.com and WTVD.com and in the Orlando Sentinel and NY Post.

U.S. health authorities will allow a type of breast implant linked to a rare form of cancer to stay on the market, saying its risks do not warrant a national ban.

But the Food and Drug Administration said Thursday it is considering bold warnings for the implants and requiring stricter reporting of problems by manufacturers. The announcement is the latest in the government’s decades-long effort to manage implant risks and complications that can include scarring, pain, swelling and rupture.

In recent years, the FDA and other regulators around the world have grappled with the recently confirmed link to a rare cancer and the thousands of unconfirmed complaints of other health problems that women attribute to the implants, including arthritis, fatigue and muscle pain.

FDA regulators said in a statement that while they don’t have definitive evidence that implants cause those chronic ailments, women considering implants “should be aware of these risks.” To that end, the agency said it will consider adding a boxed warning — its most serious type — to breast implants and a checklist describing various potential harms for patients considering them.

Earlier this month, French authorities issued a rare ban of breast implants associated with a form of lymphoma, including those sold by manufacturer Allergan. The FDA’s director for medical devices said the agency wasn’t ready to take that step.

“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard,” Dr. Jeffrey Shuren said in a statement.

The cancer tied to implants is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. Almost all confirmed cases involve a type of textured implant designed to prevent slippage and to minimize scar tissue.

Shuren said that variety accounts for less than 10% of the U.S. market, which is primarily smooth implants. He noted there have been cases of the cancer with smooth implants, raising questions about whether multiple factors contribute to the disease.

There have been more than 600 cases of the cancer worldwide, among an estimated 10 million women with implants.

Diana Zuckerman, who has studied breast implant safety, said a ban may not be necessary to phase out textured ones.

“I think a lot of physicians are going to avoid them and patients are going to say they don’t want them,” said Zuckerman, president of the nonprofit, National Center for Health Research, which evaluates studies and conducts its own research.

Breast augmentation is the most popular form of cosmetic surgery in the U.S., with roughly 300,000 women undergoing the procedure each year. Another 100,000 women receive implants for breast reconstruction after cancer surgery.

In a move to “promote greater public transparency,” the FDA also said Thursday that breast implant manufacturers will no longer be permitted to summarize routine injuries and complications in bulk reports. Manufacturers are required to report all serious injuries, malfunctions and deaths related to their devices. But under the FDA’s alternative summary reporting program, breast implant makers and other manufacturers could file quarterly updates representing thousands of incidents, most of which were not listed in a public database.[…]

See the original story here.

Marie McCullough, Philadelphia Inquirer: May 2, 2019.