conflict of interest

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Patient Safety Scandal: Company Paid Doctor $11M In Kickback Case

(Source: C-SPAN)

(Source: C-SPAN)

File this story under, “How can you help but turn cynical when…” To complete the sentence: “…when even the very people charged with protecting patient safety appear to succumb to the corrupting effects of big money?”

Here’s an example of a recent headline, from Reuters: Carefusion to Pay $40 Million In U.S. Kickbacks Lawsuit. And on MassDevice.com: Influential Patient Safety Board Cut Ties With Doc Before Carefusion Kickbacks Case.

What’s the story? And is it, as it seems, an extraordinarily outrageous case of financial conflict of interest at the highest levels of medicine? I asked Brian Johnson, publisher of Massdevice.com, who wrote the safety board story above. Our conversation, edited.

So, Brian, just how outrageous is this case?

Large legal settlements involving kickback payments to doctors tend to happen quite frequently. The Department of Justice is very aggressive in prosecuting companies for kickbacks, off-label promotions, these types of alleged wrongdoings. This case is unique because in essence, it appears to be an attempt to influence an entire health care system by paying a key member of a very influential patient safety organization.

So there’s particular irony in the fact that it’s an organization whose existence is aimed at protecting patients, and yet a member of it allegedly put finances before safety?

Allegedly. In the settlement, CareFusion does not admit any wrongdoing. Here are the outlines of the story: On Jan. 9, the Department of Justice released a statement saying that it had settled a longstanding investigation into the sales and marketing practices of an antiseptic skin wipe made by CareFusion, called ChloraPrep. The company ended up paying out just under $41 million to settle accusations of off-label promotion and kickbacks. The statement says in part:

“The settlement resolves allegations that, under agreements entered into in 2008 by CareFusion’s predecessor, CareFusion paid $11.6 million in kickbacks to Dr. Charles Denham while Denham served as the co-chair of the Safe Practices Committee at the National Quality Forum, a non-profit organization that reviews, endorses and recommends standardized health care performance measures and practices. The government contends that the purpose of those payments was to induce Denham to recommend, promote and arrange for the purchase of ChloraPrep by health care providers.”

What sets this story apart from the usual kickback settlement?

A few things. First, the Department of Justice went out of their way to specifically name a single prominent doctor, Dr. Charles Denham, for having received 11.6 million dollars from the company.

Ullp. That’s a lot of money.

At the time that he received the payments, Denham was co-chair of the Safe Practices Committee of the National Quality Forum. The NQF is one of the most important patient safety organizations in the country. Continue reading

How Conflict Of Interest Corrodes Trust: One Patient’s Story

“Sunshine laws” are casting more light on payments that doctors receive from drug and device companies — including here in Massachusetts.

Media reports – led by ProPublica — have tended to focus on the payments themselves, listing individual doctors in public databases. But what happens when patients use the databases to check on their own doctors?

In the latest Health Affairs, Maran Wolston, a multiple sclerosis patient who has taught medical ethics, describes her own loss of trust in her neurologist. When she looked him up in Minnesota’s “Dollars for docs” database, she found he had received more than $300,000 from drug companies over three years, including the makers of the drugs he had prescribed for her. How could she help but wonder whether that money might affect his recommendations? It’s a sad and instructive story, well told by an exceptionally savvy patient. She writes:

I knew that I had felt pressured to take medications by my neurologist. When I found that he had been paid large sums of money—six times my yearly salary—to work for the manufacturers of those same drugs, my loss of faith was complete. I never returned to his neurology clinic again. Continue reading

Heart Med Study Cited As Example Of Problematic Financial Ties

Alison Bass

Alison Bass’s past as a crack Globe reporter is showing. Now an author and journalism teacher, she shows on her blog today that she can still do a bang-up super-fast write-up. She reports on a Harvard event last night titled “Dollars For Doctors: Who Owns Your Physician?” and pointed remarks at the forum by Dr. Arnold Relman, former editor of The New England Journal of Medicine.

The issue: how conflict of interest in medicine drives up costs by increasing the use of expensive new drugs when cheaper generics would do. Alison writes:

It was left to Dr. Arnold Relman, professor emeritus at Harvard Medical School, to showcase a fresh-off-the-page example of how studies that are funded by drug makers and conducted by researchers who have financial ties to the industry present skewed research results that favor expensive new drugs over generics.

His case in point: The New England Journal of Medicine published a study last week concluding that a new anticoagulant known as apixiban (brand name: Eliquis) was superior to the generic drug warfarin in preventing stroke and deaths in patients with atrial fibrillation (abnormal heart rhythm). The study was funded by Bristol Myers Squibb and Pfizer, which jointly manufacture Eliquis, and featured a lengthy roster of authors, many of whom have extensive financial ties to the drug industry (in the form of speaking and consulting fees). At least three of the authors were Bristol Myers Squibb employees, as the fine print at the end of the study disclosed. Continue reading

Harsh Reaction To Biederman’s ‘Slap On The Wrist’ From Harvard

Dr. Joseph Biederman, Professor of Psychiatry
Harvard University, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD,
Massachusetts General Hospital (Photo: MGH)

The blogosphere’s conflict-of-interest monitors have been in a tizzy since Harvard announced sanctions (some might call them minor) against Massachusetts General Hospital psychiatrist Joseph Biederman and colleagues for failing to disclose their financial ties to drug companies.

The most detailed and knowledgeable assessment comes from journalist Alison Bass, a muckraking investigative reporter and author who writes on financial shenanigans within the pharmaceutical industry. Bass calls Harvard’s sanctions “essentially a slap on the wrist.” Here’s her full take:

In 2008, Congressional investigators accused the three psychiatrists — Biederman, Thomas Spencer and Timothy Wilens — of failing to disclose more than $1 million each in payments from the drug industry. As I blogged about here, most of Biederman’s financial ties were with the makers of anti-psychotic drugs at the very same time he was promoting the use of these drugs in the treatment of childhood bipolar disorder. According to documents released in a lawsuit, Biederman also courted funding from Johnson & Johnson by promising that his work at Mass. General would promote the use of its anti-psychotic Risperdal in children. Johnson & Johnson gave the hospital $700,000 for a Biederman-led research center that did studies promoting Risperdal. All of which raises the question of whether Biederman helped the drug company illegally market the off-label use of its anti-psychotic drug in children

But rather than suspend or fire him for such unethical and possibly criminal behavior, Harvard and Mass. General let him and his two colleagues off easy. According to The Boston Globe, they required the three physicians to refrain from all paid industry-sponsored activities for one year and undergo unspecified additional training. A letter Biederman and his colleagues wrote to co-workers about the remedial actions also mentioned that they might “suffer a delay of consideration for promotion and advancement.” Continue reading

Dr. Marcia Angell: Off-Label Prescribing Of Psych Drugs Should Be Banned

Dr. Marcia Angell

I appreciate the incisive analysis in the latest installment, fresh off the presses here, of Dr. Marcia Angell’s New York Review of Books piece on the current state of psychiatry. (We wrote about the first installment here.)

But what I particularly appreciate about it is that it doesn’t stop at analysis. Yes, it lays out in sad historical detail how the financial influence of drug companies penetrated psychiatry as the field increasingly shifted from Freudian talk therapy to psychopharmacology. (As the late Harvard psychiatrist Leon Eisenberg put it with characteristic wit, the field shifted from “brainlessness” to “mindlessness.”) And yes, it documents the dangers of over-diagnosis. But then Marcia, former editor of the New England Journal of Medicine, goes on to make actual, succinct policy recommendations. Including this one about prescribing psychiatric drugs “off-label,” beyond the diagnoses the FDA has approved them for:

The original purpose of permitting doctors to prescribe drugs off-label was to enable them to treat patients on the basis of early scientific reports, without having to wait for FDA approval. But that sensible rationale has become a marketing tool. Because of the subjective nature of psychiatric diagnosis, the ease with which diagnostic boundaries can be expanded, the seriousness of the side effects of psychoactive drugs, and the pervasive influence of their manufacturers, I believe doctors should be prohibited from prescribing psychoactive drugs off-label, just as companies are prohibited from marketing them off-label.

And this one: Continue reading

Scientist Responds To Accusations Of Conflict Of Interest On Electrodes For Depression


The Knight Science Journalism Tracker, which I deeply respect as an arbiter of science journalism (and not just because it praised CommonHealth!), says that the accusations against an Emory scientist that we linked to yesterday were off base. Read the post here.

It asks for a response from journalist Alison Bass, who leveled the accusations against Dr. Helen Mayberg, an Emory neurologist who is developing a treatment for recalcitrant depression that involves implanting electrodes in the brain. The Tracker reports that contrary to Ms. Bass’s post, Dr. Mayberg was indeed clear about her results and her financial ties.

Alison Bass responds in the comment below. Readers, what do you think?

Conflict Of Interest On Brain Electrodes For Depression?

Dr. Helen Mayberg is third from left

Alison Bass, an award-winning Massachusetts-based journalist who writes about conflicts of interest and other flaws in the health care system, has a noteworthy new gotcha on her incisive blog here.

She reports that Dr. Helen Mayberg, an Emory University neurologist, spoke to a major science writers’ conference at Yale earlier this month, and described what sounded like overwhelmingly positive results with her technique of inserting electrodes into patients’ brains to alleviate depression.

The problem, Alison writes:

“Her talk was heavy on anecdotal examples but skimpy on any real evidence of efficacy. Of equal concern, Mayberg did not fully disclose the extent of her conflicts of interest. Continue reading

Book Note: ‘The Dark Side of Medicine’

Just out from Beacon Press: A book that shreds any lingering tatters of public naivete about the influence of money on medicine.

In “White Coat Black Hat: Adventures on the Dark Side of Medicine,” ethicist and New Yorker writer Carl Elliott portrays an American medical scene permeated by commerce in every corner. As I read it this weekend, I felt various Pollyanna-ish notions of mine explode. At one point, reading about the financial forces behind the kinds of medical studies I’ve written about hundreds of times, I found myself thinking, “I’m such a dewy-eyed fool.”

Elliott, a bioethics professor at The University of Minnesota, even shows how bioethics itself is subject to the swaying power of money. He divides the book into six chapters, ruthlessly summarized below. Lest the whole thing get too depressing, I’m going to write Elliott and ask him for simple suggestions on how to cure these ills:

1. The Guinea Pigs: Takes a close look at how money influences the people who sign up for clinical trials and the researchers who run them, leading to potentially distorted results.

2. The Ghosts: Describes the “medical communications” industry and the ghost writers who write up studies at the behest of drug companies — avoiding unfavorable findings — and sign on academics as “authors.”
Continue reading