Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents innovative, life changing and lifesaving products from reaching the public. Most of this criticism has been targeted at the federal Food and Drug Administration, which under the Trump Administration, has promised to speed and ease its industry oversight.
But internal watchdogs for the Health and Human Services department have provided a rebuke to the move-faster crowd, detailing the costly cleanup—paid for by taxpayers like you and me— that results from defective medical devices.
The HHS inspector general’s office, in what some patient advocates are calling “a drop in the bucket” of the magnitude of this concern, has found that Medicare paid “at least $1.5 billion over a decade to replace seven types of defective heart devices [that] apparently failed for thousands of patients,” according to a story by Pro Publica, the Pulitzer Prize-winning investigative reporting web site.
The makers of the bad heart hardware were not identified by federal watchdogs, who said their cost estimates were “conservative,” and did not include $140 million or so paid out of pocket by more than 73,000 patients who struggled with “recalls, premature failures, medically necessary upgrades or infections” tied to their cardiac devices.
HHS watchdogs recommended that hospitals and doctors, as part of Medicare billings, be required to submit detailed information about medical device failures, identifying their makers and providing key data like the device serial and batch numbers.
These are just some of the steps that the federal government must take to better understand and then to address major woes with medical devices. As the Pro Publica story, carried in the New York Times, reported of devices:
[Their] recalls nearly doubled from 2003 through 2012 and … they have probably cost Medicare billions of dollars. In the past five to six years, more than 200 cardiac devices have been recalled … In most cases, manufacturers withdrew their products voluntarily after reports surfaced of injuries or malfunctions. Device makers are required to report problems they learn of, often from doctors and hospitals, to a database run by the Food and Drug Administration.
Patient safety advocates praised the watchdogs’ report but noted that it did not capture patients’ suffering and exposure to potentially severe health risks, not to mention that it zeroed in on just one category of medical devices—cardio defibrillators and pacemakers, small devices placed under the skin to help treat irregular heartbeats. The report “did not touch on other high-profile device failures, like metal-on-metal hip implants or vaginal mesh,” or unsanitary gastrointestinal scopes that sickened dozens and killed 21.
Indeed, healthnewsreview.org, a health information watchdog site, just recently has pressed its journalist readers to dig harder into problem devices, reporting that “five [recent] patient deaths linked to gastric weight loss balloon devices actually may be ‘the tip of the iceberg,’ due to weak FDA regulations that don’t require mandatory reporting of complications from healthcare providers. As a result, no one really knows how many patients have died or suffered serious complications after undergoing weight loss balloon procedures,” involving devices branded as Orbera and Reshape.
In my practice, I see not only the significant harms that patients suffer while seeking medical services but also the major damages that can be inflicted on them by dangerous and defective devices. Yes, the FDA can be an unruly, unreasonable bureaucracy, and it needs reforms. But Scott Gottlieb, the agency’s new chief, can press less for speeding and slackening oversight of medical device makers—and Big Pharma—while supporting American ingenuity and beneficial advances.
Although it’s true that the FDA, for example, has slapped at some heart device makers like St. Jude Medical, the agency has acted slowly in doing so and it’s unacceptable for too cozy relationships to burgeon between regulators and those whom they oversee.
As healthnewsreview.org has pointed out, device makers already are providing relatively spare scientific evidence about even high-risk products, and they can, effectively, boot-strap “new” and “improved” versions of their wares using already approved predecessors. They get a powerful legal shield when the FDA gives approves their devices. And the agency—in what is becoming a giant problem—must fix its seeming blindness to big problems with medical devices and drugs once reviewed and publicly available.