Articles Posted in Medical Device Safety

oighhslogo-150x150Buh-bye? Arrivederci? Sayonara? Can it be that the coronavirus pandemic puts an end to one of the disgraceful ways that Big Pharma and medical device makers push their wares on all-too malleable doctors — with big-money speaker programs?

The inspector general’s office of the giant federal Health and Human Services (HHS) agency has warned drug- and medical device-makers that these pandemic-paused marketing shams should not resume. The $2 billion that industry players have forked out for the in-person gab fests in the last three years looks sketchy at best to federal watchdogs and prosecutors, the HHS inspector general warned in a rarely issued “special fraud alert.” It reported this:

“The Office of Inspector General (OIG) and Department of Justice (DOJ) have investigated and resolved numerous fraud cases involving allegations that remuneration offered and paid in connection with speaker programs violated the anti-kickback statute. The Federal government has pursued civil and criminal cases against companies and individual [health care providers] involving speaker programs … Our enforcement experience demonstrates that some companies expend significant resources on speaker programs and that some [health care providers] receive substantial remuneration from companies. This Special Fraud Alert highlights some of the inherent fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to company-sponsored speaker programs.”

covidtestswab-282x300The federal agency that regulates nursing homes and other long-term care facilities not only has cracked down on them with tough new requirements for coronavirus testing of their staff. The Centers for Medicaid and Medicare Services also has flogged its plan to provide facilities with testing equipment and sample tests.

While owners and operators have grumbled about the whole process, the state of Nevada has gone a step further: Enough, its health officials have decided. They briefly halted as unacceptable the CMS tests for the virus because they say they are flawed and may put nursing home residents at risk.

Besides casting yet more doubt on CMS’s poor pandemic response with long-term care facilities,  Nevada’s balk — rescinded abruptly after federal threat — may offer an important take-away to members of the public, already flooded with findings about the novel coronavirus:

govhogan-283x300Maryland will take the lead among states in the area in re-opening nursing homes and other long-term care facilities from months of coronavirus-related closures to family members, guests, and other visitors.

Gov. Larry Hogan (shown, right) acted as the state, for the first time in months, reported that October started with zero Covid-19 fatalities and 76 of Maryland’s 227 nursing homes had active coronavirus cases — down from 130 on Aug. 5, the Washington Post reported.

After struggling through some of the worst outbreaks in long-term facilities in the area, Maryland will put significant resources into safeguarding nursing homes as they reopen, Hogan said.

cdcinoculate-300x240The “warp speed” race to develop a Covid-19 vaccine has gotten hit with a yellow flag.

It could be a good thing that the product’s makers — Oxford University and AstraZeneca — followed medical-scientific protocols and paused their Phase III clinical trial due to a participant’s unexplained illness.

Officially, the company offered spare information about the occurrence, especially because it affects the private medical information of a single individual.

zantac-300x169Big Pharma’s slavish devotion to maximizing profits and “enhancing shareholder value” has led industry executives to shove the manufacture of their products to far-flung shores. The dubious consequences of these moves have become clear not only with common, over-the-counter medications but also — with potentially tragic results — with drugs needed in the war on the Covid-19 pandemic.

Even before the world was terrorized by the coronavirus outbreak in China, safety advocates warned about serious “supply chain” issues in drug making, with one small lab sounding alarms about Zantac, a widely used over-the-counter heartburn pill.

Valisure, a commercial pharmacy that sought to distinguish itself by testing and assuring consumers of the quality of the drugs it sold, provided the federal Food and Drug Administration its lab tests and analyses as evidence that Zantac (aka ranitidine) was contaminated with, what the New York Times has described as, “a type of nitrosamine called N-nitrosodimethylamine, or NDMA, which is believed to be carcinogenic in humans and is found in a variety of products, including cured meats.”

practicefusion-300x169Federal prosecutors have provided 145 million reasons why enthusiasts may want to curb their exuberance about how high tech will work miracles in the U.S. health care system.

That’s because investigators have ferreted out “abhorrent” conduct by Practice Fusion, a San Francisco firm that specialized in electronic health care records software, according to the U.S. Attorney’s Office in Vermont.

“During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids,”  Christina E. Nolan, U.S. Attorney for the District of Vermont, said in a statement. Practice Fusion, she added,  “illegally conspired to allow [a] drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient’s medical care, including the need for pain medication and prescription amounts.”

hal9000-300x225In recent years, doctors, hospitals, and popular media have promoted emerging treatments to the public with enthusiasm that in each case would turn out to be overblown. Just consider the red-hot chatter that once surrounded regenerative medicine, precision medicine, gene therapy, or immunotherapy. And now, it may be the turn of artificial intelligence to be hyped hard in health care.

Caveat emptor, as Liz Szabo reported for the Kaiser Health News Service. She sets the stage, thusly, about developments in a field that might worry some who remember Hal 9000 from “2001: a Space Odyssey”:

“Health products powered by artificial intelligence, or AI, are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots. IBM boasted that its AI could ‘outthink cancer.’ Others say computer systems that read X-rays will make radiologists obsolete. ‘There’s nothing that I’ve seen in my 30-plus years studying medicine that could be as impactful and transformative’ as AI, said Dr. Eric Topol, a cardiologist and executive vice president of Scripps Research in La Jolla, Calif. AI can help doctors interpret MRIs of the heartCT scans of the head and photographs of the back of the eye, and could potentially take over many mundane medical chores, freeing doctors to spend more time talking to patients, Topol said. Even the Food and Drug Administration ― which has approved more than 40 AI products in the past five years ― says ‘the potential of digital health is nothing short of revolutionary.’”

zenmagnets-1-150x150Consumers may need to give a few seasonal gifts a second look about their safety and other health-related issues:

docprescriptionpad-300x238Although it’s always important to remember in research studies that associations don’t prove causation, findings from two separate works should raise serious concerns about doctors’ independence and judgment in prescribing drugs and reporting conflicts of interest about payments from makers of medical devices.

That’s because doctors who get money from drug makers in connection with a specific medication tend to prescribe that drug “more heavily” than colleagues who don’t get similar cash, ProPublica, a Pulitzer Prize-winning investigative site, has found.

And doctors who are among those receiving the highest compensation from surgical and medical device manufacturers show some of the biggest discrepancies between the sums they report for institutional conflicts of interest and what a federal database of payments shows, according to  physician-researchers at the University of California, Irvine (UCI).

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Elite researchers — professors and staff with ties to 20 of the nation’s top universities and the respected National Institutes of Health — may be failing to be as candid as institutions and laws require about their potential professional conflicts of interest, notably the significant sums they get from Big Pharma and medical device makers.

ProPublica, the Pulitzer Prize-winning investigative organization, and the Los Angeles Times jointly scrutinized the experts’ required disclosures, finding they not only fall short. They may fail to give the public a fair view of the credibility of their findings. And, in California, they may be a unique rip-off of the state’s top university system. The “UCs” provide research faculty with costly facilities and other support, as well as sharing its global renown — in exchange for revenue the experts may earn outside the system.

In total, after examining records on tens of thousands of university scholars and NIH experts, ProPublica not only has made public its “Dollars for Profs” database, it also quotes federal watchdogs as estimating that with the NIH alone, conflicts of interest with agency grants amounts to $1 billion.

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