Investigations rip FDA for laxity on asbestos-tainted talc and medical devices

FDA-logo-300x129When it comes to medical products — devices put in or substances put on our bodies — consumers may be ill-served by the federal regulators who are supposed to protect them from injury.

The federal Food and Drug Administration has taken a double hit in recent news reports, with an investigation by Reuters news service raising big doubts about the agency’s oversight of products  with supposedly safe talc — but that long may have been tainted with disease-causing asbestos. The Kaiser Health News service, meantime, has followed up on the wave of lawsuits and research that has resulted from its discovery that the FDA for years allowed device makers to hide from public view a million complaints about medical devices.

The scathing findings in these two reports, combined with other deep digs into agency work, might well prompt members of Congress to conduct hearings into whether the FDA is acting as the watchdog that the public deserves or as a lap kitten beholden to the rich, powerful, and booming medical device industry.

The FDA’s baby powder scandal

For generations, Johnson & Johnson and other giant corporations conducted major advertising and marketing campaigns targeted at women and mothers, pushing hard on the hygienic and comfort value of their regular and extensive use of a white powder for themselves and their infants.

Pediatricians over time have unhooked moms from using baby powder and seeing that it had any benefit.

But in recent days, spurred by a wave of lawsuits with huge settlements, judges, jurors, and previously unheeded researchers have raised significant concern about talc. In particular, the civil justice system has rolled up on J&J, finding the company ignored research that could have warned the company that its family-focused product too often may have been tainted with asbestos. As reporters Chad Terhune and Lisa Girion reported of this substance:

“Asbestos is a loose term for a group of six minerals that readily separate into needles or fibers. Easily inhaled, they are known to cause lung, ovarian and other types of cancer. While most people exposed never get cancer, for some, even small amounts are enough to trigger the disease. Just how small has not been established.”

The problems that asbestos can cause are not new nor unfamiliar. But it took recent court cases to unearth the discovery that makers like J&J knew of asbestos risk and had seen studies indicating that their talc too often had been tainted with asbestos. An earlier Reuters investigation (and work by the New York Times) hammered the company for its dubious efforts to quash wider public knowledge about the talc-asbestos link. And the news service said J&J now faces more than $5 billion in verdicts against it over talc — many of the cases involving women who claim they suffered cancers of their reproductive organs due to their daily dusting of themselves with baby powder.

Girion and Terhune dig deeper into the talc mess by asking the important question: Where was the FDA during the decades when federal regulators might have spared patients misery and death, if they had done their jobs with greater skepticism and rigor?

This is some of what they found:

“Over the past 50 years, the FDA has relied upon — and often deferred to — industry even as outside experts and consumers repeatedly raised serious health concerns about talc powders and cosmetics, a Reuters investigation found. Again, and again since at least the 1970s, the agency has downplayed the risk of asbestos contamination and declined to issue warnings or impose safety standards, according to documents produced in court proceedings and in response to public records requests. The agency said it lacks the authority to require manufacturers to test for asbestos in talc or report any results. And it seldom has ordered its own tests — until recently. Amid heightened scrutiny in Congress, a criminal investigation of J&J and costly jury verdicts against the company, the regulator commissioned tests that found asbestos in 11 talc-based cosmetics, including Johnson’s Baby Powder. J&J recalled 33,000 bottles … In written responses to questions from Reuters, the FDA said its resources and authority to regulate the cosmetic industry are limited. The agency said it has no power to ensure the safety of cosmetics before they are put on store shelves, nor to force companies to pull them off when potential hazards are discovered. We are dependent on manufacturers to take steps to ensure the safety of their products,” the FDA said after announcing a voluntary recall of tainted cosmetics in March.”

J&J has defended its baby powder, saying that company testing has found no evidence of harmful taint in it. The company, which also has insisted that it has followed federal regulations and points to regulators lack of action against talc as a sign of its safety, has called investigations of J&J and its products unfair and unfounded.

The latest Reuters investigation recounts in detail the many unsuccessful efforts of researchers to get the agency to consider that talc might be tainted with asbestos and risky to the public health. The news article also delves into ties between the maker and regulators, including officials’ reliance on industry help in the recent scurry by the FDA to show a newfound effort to determine if talc products contain harmful substances.

The agency has said it plans a major meeting in the spring to discuss testing and heightened oversight.

Is that the sound of a barn door swinging in the wind, open and untended?

Legal and research reckoning follows FDA fessing up to hiding complaints

When KHN reporter Christina Jewell caught federal regulators red-handed in allowing medical device makers for decades to stash from public view millions of grievous complaints about their products, Scott Gottlieb, the outgoing FDA commissioner, at least had the decency to order the files opened as urgently as possible.

The public, just a few months later, may be seeing the terrible consequences of bureaucrats’ permitting “malfunctions and injuries linked to 108 medical devices, including dental implants and pacemaker leads, [to be] funneled into an FDA database that few patients, doctors or even FDA officials knew existed,” as KHN reported.

Based on data that has been dug out of the secreted files, researchers have found that “the devices in the hidden database were much riskier than other devices tracked by the FDA.” Libbe Englander, the founder and CEO of Pharm3r, a medical data consulting firm, told KHN that:

[T]he devices in the hidden database were much riskier than other devices tracked by the FDA. Her firm concluded that the hidden reports were ‘more likely to be associated with life-threatening devices and to contain potentially serious problems.’ For example, just 10% of the devices tracked in the [public and widely viewed] MAUDE database are implanted in the body. But 44% of those in the hidden data are lodged in a patient’s body, including pacemakers and heart valves. The Pharm3r report also found that the devices in the hidden data were more likely to be subject to a Class 1 recall, initiated when a device problem could cause serious injury or death. The report also underscored how vast the now-open data is ― accounting for about 40% of the total device-problem reports lodged with the FDA over the past two decades.”

KHN said the secretive reports also figured into the ECRI Institute’s annual list of health technology hazards, a list circulated to hospitals and health systems. In fact, the news service reported:

[The] No. 1 hazard [on the group’s list] was misuse of the surgical stapler ― which has been linked to 412 deaths, more than 11,000 serious injuries and nearly 100,000 malfunctions since 2011, according to the FDA. ‘Most of these [stapler] reports had not previously been accessible to the public,’ the ECRI report notes. ECRI has advised doctors to have a backup plan in place in case a stapler malfunctions during surgery.”

The news article describes the pain and suffering patients have suffered due to less-known problems with the surgical stapler, including the agony that a retired doctor describes enduring after the device failed to properly seal internal tissues during a colon surgery. In a lawsuit, she asserts that the equipment failure — and the lack of information about the product’s problems — caused her great pain and led her to a longer surgical recovery, during which she had to undergo multiple corrective procedures.

KHN reported that researchers, regulators, and patients also are struggling with previously undisclosed issues with dental implants (the subject of millions of patient complaints), as well as with a fast-increasing number of women expressing serious issues with breast implants. As the news story reported:

“[U]nder scrutiny are the textured breast implants made by Allergan. The company’s Biocell implants, recalled in July, have been linked to 12 deaths and 481 of the 573 worldwide cases of ‘breast implant-associated’ lymphoma, according to the FDA. Breast implant injuries and malfunctions accounted for nearly half a million reports in the hidden database, including implants that leaked, deflated or migrated. Patients in Missouri, California, New York and Illinois have filed federal class action lawsuits against Allergan in recent weeks, each decrying the company’s heavy use of the [information hiding] ‘alternative summary reporting’ program to file injury reports ― which were analyzed by the International Consortium of Investigative Journalists.”

This all is not good. In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by defective and dangerous products, particularly those of the medical kind. Too many politicians, particularly Republicans, have nagged and prodded the FDA to be more business friendly and to ease up on what they deem to be burdensome regulation and oversight. They argue that patients should benefit from innovation, and potentially beneficial products should be raced to market, not tied up in bureaucrats’ red tape.

This argument, frequently heard, too, with FDA-regulated prescription medications, may have merit. But it also of can pose risks and cause harms — significant ones — to the health, safety, and pocketbooks patients. Alarms have been sounding for some time now that federal oversight of Big Pharma and medical device makers may have swung too far in their favor and to the detriment and danger of the public. When regulators get so cozy with those that they are supposed to oversee, that’s bad for their real and most important constituency — taxpayers and vulnerable patient-consumers. Whether it’s the booming, diversifying, and too often problematic array of therapies focused on our looks  (including  now potentially problematic hair dyes and straighteners, especially for black women) or the devices that we count on to improve our bodies’ performances from within, we’ve got a lot of work to do to ensure medical products stay as safe, accessible, and affordable as possible.

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