Medical Device Safety

February 7, 2020

Deceptive software pushed MDs to prescribe opioids at overdose crisis’ peak

Federal 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.”

January 7, 2020

A caution about rising hype for artificial intelligence in medicine

by Patrick A. Malone

In 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 heart, CT 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.’”

December 30, 2019

Some Grinch-y news about a few popular holiday gifts

by Patrick A. Malone

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

Powerful rare-earth magnets, used in many toys and especially in shape construction kits, pose big risks to kids when swallowed.
Widely used over-the-counter genetic testing kits may subject users to major privacy concerns they never contemplated. The risks have risen enough so the Pentagon has issued a warning to service personnel.

December 29, 2019

Big cash gives Big Pharma and device makers a dubious sway over doctors

by Patrick A. Malone

Although 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).

December 12, 2019

Top experts, by failing to disclose conflicts of interest, shortchange taxpayers

by Patrick A. Malone

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.

December 8, 2019

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

by Patrick A. Malone

When 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.

December 6, 2019

Samoa, a Pacific speck, provides a big and sad lesson about vaccinations

by Patrick A. Malone

The distant nation of Samoa may have more to offer the United States than prominent athletes and warm Pacific Islander culture. Its deadly experiences with a raging outbreak of an infectious disease underscore a timely and important message: Vaccinations matter and we should all get them.

A confluence of unfortunate events has led to a measles epidemic in Samoa, news organizations reported, with more than 40 deaths and 3,000 illnesses among the nation’s 200,000 people. Schools and colleges have been shut due to the illness.

International health organizations, including the U.S. Centers for Disease Control and Prevention, are flying in medical experts to assist with the dangerous and growing epidemic, which has hit children on the island hard.

November 17, 2019

Drugs are better for heart patients than surgery (except in mid-heart attack), study finds

by Patrick A. Malone

Tens of thousands of patients with serious but stable heart disease soon may see themselves treated more with prescription drugs and less with rushed surgeries, especially bypass procedures or operations that seek to open clogged blood vessels with wire cages called stents.

A possible shift away from stents — which have come under question for some time now — may be accelerated by the just-announced findings of a $100 million, multi-year study of more than 5,000 heart patients at 320 sites and in 37 countries. The research, the New York Times reported, sought to provide rigorous and more incontrovertible evidence on procedures that now are a bulwark of heart care:

“[The study dubbed] Ischemia is the largest trial to address the effect of opening blocked arteries in non-emergency situations and the first to include today’s powerful drug regimens, which doctors refer to as medical therapy. All the patients had moderate to severe blockages in coronary arteries. Most had some history of chest pain, although one in three had no chest pain in the month before enrollment in the study. One in five experienced chest pain at least once a week. All participants were regularly counseled to adhere to medical therapy. Depending on the patient’s condition, the therapy variously included high doses of statins and other cholesterol-lowering drugs, blood pressure medications, aspirin and, for those with heart damage, a drug to slow the heart rate. Those who got stents also took powerful anti-clotting drugs for six months to a year. Patients were randomly assigned to have medical therapy alone or an intervention and medical therapy. Of those in the intervention group, three-quarters received stents; the others received bypass surgery. The number of deaths among those who had stents or bypass was 145, compared to 144 among the patients who received medication alone. The number of patients who had heart attacks was 276 in the stent and bypass group, compared with 314 in the medication group, an insignificant difference.”

November 4, 2019

Secrecy in drug and medical device lawsuits can imperil patients, experts say

by Patrick A. Malone

The civil justice system, by regularly closing off and keeping secret key parts of lawsuits involving medical devices and prescription drugs, may contribute to patients’ serious injuries and deaths, according to a “special communication” published in a noted medical journal.

The online article in JAMA Internal Medicine argues for greater transparency and disclosures, with a table of examples that includes how:

With the Prempro hormone therapy drug for women, the “Manufacturer hired vendors to publish ghost written reviews and commentaries that promoted estrogen replacement for several off-label uses, including prevention of dementia, Parkinson disease, and visual impairment, and downplayed risks of hormone-associated breast cancer.”

October 27, 2019

As FDA warns of implant perils, new questions arise about 3D mammograms

by Patrick A. Malone

Angry women, anxious that officials were failing to protect their health, besieged a federal Food and Drug Administration hearing in the spring. That unusual outcry may have helped push regulators off their bureaucratic backsides, getting them finally to warn about risks of one of the most commonly used medical devices for women: breast implants.

But will a similar gender uprising be required to quash a rising and dubious medical testing of women, the so-called “3D mammogram?”

The FDA’s sudden, fast stepping on breast implants is occurring after years of inaction. Under new rules proposed by the agency, the devices’ packaging would be required to carry “boxed warnings,” the FDA’s most serious caution. The agency also would call on surgeons to step up their discussions with women about implant risks, including for rare cancers. As the Washington Post reported, doctors also would be told to tell patients: