Conflicts of Interest

February 5, 2019

Harsh reminder of opioid peril: A single smuggling bust seized fentanyl enough for 144 million fatal overdoses

If anyone around doubts still the threat that the opioid crisis poses to the nation, a drug bust involving a vegetable truck in Arizona should provide powerful persuasion: Federal agents, suspicious about the vehicle’s floor, loosed a drug-sniffing dog, resulting in the seizure of not just 395 pounds of methamphetamines but also 254 pounds of fentanyl.

Fentanyl is a synthetic opioid, a lab-created super drug that experts say is 50 times stronger than heroin and up to 100 times more potent than morphine. It packs a wallop for users in tiny grains or flecks.

The record-setting seizure at the Arizona border stop amounted to 144 or so kilograms of fentanyl, with drug enforcement officials estimating that just 1 kilogram of fentanyl can produce 1 million fatal doses. That means just this one bust had the potential to cause 144 million deaths.

February 3, 2019

Will Rx drug costs fall if U.S. puts squeeze on middlemen and curbs rebates?

by Patrick A. Malone

The Trump Administration has put out its latest prescription to try to slash out-of-control prescription drug prices: Officials want to call medication “rebates” what they say they’ve really become — “kickbacks” — and crack down on the crazy rise of profit-reaping middlemen in the drug business.

Alex Azar, secretary of the Health and Human Services Department, announced that Uncle Sam, via the giant Medicare and Medicaid plans, hopes to fix big flaws in the drug industry by barring prescription medication discounting to PBMs (prescription benefit managers). The discounts still would be available to patient-consumers. But eliminating them for PBMs could be a major step in cutting drug costs, not the least because this step could give parties in this medical “supply chain” more transparency on what products cost.

January 29, 2019

OK, you’re sick and hurting. Can’t we still hit you up about donating to our hospital?

by Patrick A. Malone

Already-admitted patients shouldn’t be flummoxed if they’re moved into a bigger, quieter, and nicer room. There, a fluffy complimentary robe may await them. They may receive a warm welcome from well-attired executives — those senior enough so their pictures may even hang in pictures on the hall walls. And, yes, make no mistake, their nurses and doctors really will be kind and attentive.

Welcome to high-roller care as it’s delivered now to a select few by staff in at least three score big hospitals and academic medical centers nationwide, including Johns Hopkins and MedStar Health in Columbia, Md.

You won’t necessarily seek out or request this special attention. It turns out that hospitals will know you’re posh enough to merit it because loopholes in privacy laws allow them, using special software, to run regular searches through patient rosters to determine which guests also might be potential and lucrative donors, reported the independent, nonprofit Kaiser Health News service in a story that appeared in the New York Times. You also may allow the pitches because, likely unbeknownst to you, you signed a form giving your permission for it in that mountain of admission paperwork.

January 21, 2019

Rich family played big role in opioid crisis, court records show

by Patrick A. Malone

A plutocratic clan that has labored to portray itself as enlightened patrons of the arts, science, and medicine, instead has been depicted in new court documents as drug profiteers, eager to exploit the misery and even deaths of tens of thousands of Americans.

The stories in the New York Times, Wall Street Journal, Washington Post, and at the online medical science news site Stat paint a damning picture of the Sackler family and their avarice with the family-owned Big Pharma firm Purdue. The company made the clan billions of dollars but also has become the focus of news stories, official investigations, and now a barrage of lawsuits, all asserting that Purdue played a crucial role in fomenting the nation’s opioid drug crisis.

The Sacklers had sought to distance themselves from the horrors unleashed by powerful opioid painkillers, including their company’s top-selling drug OxyContin. The opioid crisis last year alone claimed 70,000 lives, and the prescription and illicit painkillers of their ilk have become a leading cause of death for Americans younger than 50. Overdoses now savage white men, especially in ex-urban and rural areas; women 30 and older; blacks in big cities; and even children.

January 13, 2019

Cracking down on medical hype could cut $30 billion in wasted costs

by Patrick A. Malone

When reformers look for ways to slash the ever-higher costs of American medical care, one line item should leap from television screens, print pages, and radio broadcasts: How does the nation benefit from medical enterprises spending $30 billion annually in a growing avalanche of marketing and advertising — and why can’t this be stopped or subjected to tougher regulation?

Two physician-scientists at The Center for Medicine in the Media at the Dartmouth Institute for Health Policy and Clinical Practice have published on the JAMA Network their new research, showing that:

[M]edical marketing expanded substantially [between 1997 and 2016], and spending increased from $17.7 to $29.9 billion, with direct-to-consumer advertising for prescription drugs and health services accounting for the most rapid growth, and pharmaceutical marketing to health professionals accounting for most promotional spending.

January 6, 2019

A clarion call for real safeguards for patients harmed by medical devices

by Patrick A. Malone

Medical devices race onto the market with little or no effective testing or regulatory safeguards, and a proposed “reform” of the oversight system of products that are implanted in tens of millions of Americans is a sham, safety advocates say.

That’s because there are gaping flaws in the proposal to alter the so-called 510(k) procedure under which the federal Food and Drug Administration clears medical devices for sale, say medical journalist Jeanne Lenzer (right) and health care activist Shannon Brownlee (left).

Their Op-Ed in the Washington Post is the latest salvo against FDA Commissioner Scott Gottlieb’s claims of “transformative” changes in medical device regulation by his agency. News organizations around the world in recent weeks have published investigations of how poorly such products are tested, reviewed, and then released on markets, killing and injuring patients as a result.

December 20, 2018

Price-fixing scandal ensnares ‘white-hat’ makers of lower-cost generic drugs

by Patrick A. Malone

To paraphrase what a one-time colleague once wrote about her bosses: Never trust Big Pharma, never trust Big Pharma, never trust Big Pharma. Here’s some of the latest evidence why: Even the industry’s so-called “white hats,” makers of supposedly less expensive and more patient-accessible “generic” drugs, now are ensnared in an ever-expanding investigation of illegal price fixing.

As the Washington Post reported:

What started as an antitrust lawsuit brought by states over just two drugs in 2016 has exploded into an investigation of alleged price-fixing involving at least 16 companies and 300 drugs, Joseph Nielsen, an assistant attorney general and antitrust investigator in Connecticut who has been a leading force in the probe, said in an interview. His comments … represent the first public disclosure of the dramatically expanded scale of the investigation.

December 7, 2018

When Johns Hopkins’ ambitions grew in Tampa, kids suffered, probe shows

by Patrick A. Malone

When big hospitals aim to get even more giant, they do so at risk of the quality of care they offer to their patients — and they can do much damage to their brand and hard-to-repair reputations. That may be a reality that elite Johns Hopkins may be discovering.

The Tampa Bay Times deserves credit for its detailed take-down of the “internationally renowned,” Baltimore-based medical institution for the deaths and harms suffered by child heart patients at All Children’s hospital in Florida. Johns Hopkins took it over, and, according to the newspaper, within a half dozen years made a debacle of its well-regarded pediatric heart surgery program, which worsened until youngsters were dying at a “stunning rate.”

As the newspaper reported, based on a year’s investigation of the All Children’s program:

December 4, 2018

As media expose damaging medical devices, FDA unveils regulatory revamp

by Patrick A. Malone

FDA Commissioner Scott Gottlieb

If the federal Food and Drug Administration expected any public goodwill for putting forward long-term proposals to change a fundamental way that medical devices win agency clearance, forget about it.

Instead, FDA Commissioner Scott Gottlieb and lawmakers should be reeling still from a salvo of news organization investigations into unacceptable ways that patients in this country and around the planet suffer pain, injury, and other harms from products that go in or on the body. Under industry pressure and spurred by pro-business lawmakers, the FDA, the investigations show, has exercised a weak, poor, and unacceptable oversight of medical devices, including:

November 14, 2018

Misdiagnosis: a medical menace to quality and safety of patient care

by Patrick A. Malone

If patients weren’t already unhappy with drive-by medicine, in which clinicians spend on average of 15 minutes with them in an office visit, safety experts warn that too many doctors’ providing of harried care can worsen a medical menace that’s already hard to ignore: misdiagnosis.

Figuring out what ails a patient and taking a correct course of action already is a “complex, collaborative activity that involves clinical reasoning and information gathering,” reports Liz Seegert, a seasoned health journalist and a senior fellow at the Center for Health Policy and Media Engagement at George Washington University.

But, in a briefing posted online for her journalistic colleagues, she goes on to amass some eyebrow-raising information on diagnostic errors, their frequency, harms to patients, and why experts in the field see corrections in this area needed, stat. Among the data points she reports: