Disclosure

January 21, 2020

FDA reviews go faster — but with less proof drugs are safer or more effective

For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,” the professor observed. “And some of them [are] not so great. And a lot of them are very expensive.”

That quote, by the way, comes from a news report by NPR on so-called reforms of the federal Food Drug and Administration prescription drug oversight process. Big Pharma has howled for some time now at politicians, regulators, and the public for fixes to the system — and the industry has gotten its way.

Now, as NPR reported, based on a new study posted online on the JAMA Network:

January 8, 2020

Hospital mergers and acquisitions aren’t great for patients’ care, study finds

by Patrick A. Malone

Big hospitals keep getting bigger. But, contrary to what the suit-wearing MBAs may claim, the rising number of institutional mergers and acquisitions isn’t necessarily better for patients and their care.

At hospitals subjected to corporate wheeling and dealing, the quality of care got worse, or, at best, it stayed the same and didn’t improve, a new study in the New England Journal of Medicine reported.

Researchers scrutinized federal data “from 2007 through 2016 on performance on four measures of quality of care … and data on hospital mergers and acquisitions occurring from 2009 through 2013,” they said. These measures, the Wall Street Journal reported, included: patient satisfaction; deaths within a month of entering the hospital; return trips to the hospital within a month of leaving; and how often some heart, pneumonia, and surgery patients got recommended care. They looked at 246 hospitals involved in M&A activity, controlling their findings with data from 1,986 institutions not similarly affected.

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.’”

January 5, 2020

With teens’ health at risk, White House plays politics with vaping

by Patrick A. Malone

The Trump Administration kicked off the new year with a whimper not a bang with yet another of its attempts to corral the health nightmare of e-cigarettes and vaping by the nation’s young, while not upsetting the industry too much.

Starting Feb. 1, the federal government announced it will forbid the sale of most flavored cartridges for e-cigarette use, notably those with popular tastes like candy, fruits, and mint.

At the same time, though, vendors still can sell menthol and tobacco flavorings. And they can peddle flavored vaping liquids if they are used in the open tank systems that most often are so big, they are limited to shops or stores.

January 3, 2020

A patient’s painful and powerful reminder of harms inflicted by drug diversions

by Patrick A. Malone

Hospitals, clinics, and other health care settings — and those who staff them — aren’t immune to the ravages of the opioid crisis and its related abuse of prescription and illicit drugs. For patients, their caregivers’ addictions can have serious consequences, including a less-discussed nightmare: diversions of their drugs.

Lauren Lollini, a psychotherapist and a patient-safety advocate, has penned a powerful and scary Op-Ed for Stat, a health and medical news site. She describes how, while undergoing a relatively routine kidney stone removal at a respected Denver hospital, she was infected with hepatitis C — a draining and chronic liver disease that is blood-borne and is often associated with drug abusers. Lollini, however, had been healthy and did not use drugs. So, how did she get so sick? As she explained:

“[An investigation by the] Centers for Disease Control and Prevention, showed that I and at least 18 others had been infected with hepatitis C by Kristen Parker, a technician at Rose Medical Center who had tested positive for the disease before she was hired. She stole patients’ fentanyl-filled syringes off medication trays, injected herself with the painkiller, then refilled the syringes with saline. In the summer of 2009 — about three months after I learned I had hepatitis C — Parker was arrested in one of the biggest hospital drug diversion incidents to date. In 2010, she was sentenced to 30 years in prison.”

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 26, 2019

New warnings on how Rx and illicit drugs can be deadly, especially if mixed

by Patrick A. Malone

A widely prescribed drug, formally approved only for limited uses but now dispensed for many nerve-related conditions, can put patients at serious risk of breathing problems, especially if they are aged, suffer from all too common chronic obstructive pulmonary disease, or may also be taking opioid pain killers or other medications that depress the central nervous system.

That’s a toughened new warning about gabapentin and pregabalin from the federal Food and Drug Administration, which says it will require new packaging and cautions for the drugs. They may be better known in their branded versions as Neurontin, Gralise, Horizant (gabapentin) or Lyrica and Lyrica CR (pregabalin).

The nerve meds have been subject to “growing” medical “use as well as misuse and abuse,” the FDA said in a statement, adding:

December 24, 2019

While kids suffered harms, consumer agency cozied up to corporations

by Patrick A. Malone

One of the nation’s top consumer protection agencies cozied up to the businesses it was supposed to watch over, leaving children and other consumers vulnerable to significant harms.

That’s the disturbing conclusion of congressional staffers reporting to Maria Cantwell, the ranking Democrat on a U.S. Senate committee with oversight responsibilities for the Consumer Product Safety Commission.

The Democratic staffers ripped the agency, headed by a Republican appointee who has since resigned, for its poor performance with high-profile cases involving Britax’s BOB jogging stroller, Fisher-Price’s Rock ‘n Play inclined sleeper, and the safety of residential elevators.

December 18, 2019

When those medical bill slips and errors add up, honestly, isn’t it just fraud?

by Patrick A. Malone

If department stores, car mechanics, or restaurants billed their customers in the same way that hospitals and doctors do, prosecutors might have their hands full. That’s because what patients now accept in sheepish fashion as simple “errors” or misstatements or curious charges on their medical bills more correctly ought to be called something else: fraud.

That’s the reluctant but tough view now taken by Elisabeth Rosenthal, an editor, journalist, and onetime practicing doctor.

She has written an Op-Ed for the New York Times, her former employer, in which she recounted how she long has reported on health care costs and economics, including in her much-praised book, “An American Sickness: How Healthcare Became Big Business and How You Can Take It Back.” She said she has listened to too many patient complaints, as well as experienced problems of her own, to keep allowing establishment medicine to deem its relentless chiseling, oops, a little mistake.