Articles Posted in Conflicts of Interest

artsacklerdc-300x129A 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.

cracktv-300x169When 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.

jeanne_lenzerbrownlee-150x150Medical 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.

genericfda-237x300To 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.

allchildrens-300x220When 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:

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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:

diagnosis-300x200If 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:

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Dr. Otis Brawley, formerly of the American Cancer Society

The rising flood of health care hype, bunk, and conflicts of interst really can harm patients, as has just been emphasized by a $105-million jury verdict, the brave actions of a leading patient advocacy expert, and the commentary of an expert health researcher and New York Times columnist.

In a more perfect world, a patient like Dawn Kali, 45, and a mother of four, wouldn’t give the time of day to the wild claims of Robert Oldham Young. Both live in San Diego, and when she was diagnosed with cancer, she told a court that she found Young persuasive.

hpvshot-300x231Women may need to double-up on their consultations with their specialists about treatment for serious gynecological concerns, as new studies have raised troubling questions about a much-touted minimally invasive surgery for early-stage cervical cancer.

These concerns, in a more perfect world, also would prompt greater questioning and oversight by doctors, hospitals, regulators, and lawmakers of surgical “innovations.”

The procedure now in question removes the uterus, part of the vagina, and other surrounding tissues via small incisions and with special laparoscopic instruments, including robots. Surgeons have advocated for this surgery rather than making a large incision in an “open” procedure, arguing the less invasive approach promotes less discomfort and faster healing for patients.

crowdfunding-300x150Although the sky-high cost of providing medical care to sick or injured friends and loved ones might seem good reason to encourage community altruism to the nth degree, new technologies that have made it easy, fast, and convenient to “crowd source” online donations also may be sending well-intentioned gifts to dubious and dangerous types of treatment.

A new  study by researchers in Atlanta and New York shows that campaigns on GoFundMe and other social media platforms, sought to raise tens of millions of dollars, and brought in millions for sketchy health-related applications. Experts found “1,059 campaigns that raised money for five unproven or possibly risky treatments: homeopathy or naturopathy for cancer, hyperbaric oxygen for brain injury, experimental stem cell therapy for brain or spinal cord injuries, and long-term antibiotics for chronic Lyme disease,” reported Stat, an online health and medicine news site.

CNN reported that online solicitations were targeted to allow patients to seek dubious therapies at “clinics” in Germany and Mexico (homeopathic or naturopathic cancer care), New Orleans (hyperbaric oxygen for brain injury), and Panama, Thailand, India, China, and Mexico (“stem cell” treatment).

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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