Recently in Conflicts of interest Category

The Star Tribune, which has done a fine job reporting on University of Minnesota medical school conflict of interest issues, bombed on a story about problems with the FDA's medical device approval process - largely because it failed to counter the clear conflict of interest in the single source it used! Inexplicable.

Guess who serves on this conflict of interest committee???

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An interesting little fact came my way today - something I had never realized before about the University of Minnesota's conflict of interest review infrastructure.

Guess who is on the University Academic Health Center Conflict of Interest Committee? (Hint: he has been investigated by the US Senate for conflict of interest violations.)

Go to this site for a clue.

Still can't get it?

It's Dr. David Polly. If you don't know the story, you can read a Star Tribune editorial. (pdf file)

Carl Elliott, MD, PhD of the University of Minnesota (Professor, Center for Bioethics; Professor, Department of Pediatrics, University of Minnesota Medical School; Professor, Department of Philosophy, College of Liberal Arts), wrote to me this afternoon as follows:

"The biggest problem with this document is that it will do little if anything to fix the conflict of interest problems which have embarrassed the university. In addition to the problems highlighted by Steve Miles, consider these:

1) The policy places no caps on the amount of money faculty members can receive from the pharmaceutical industry as consultants. It simply lowers the reporting threshold.

2) The primary mechanisms for dealing with conflicts of interest in the draft document are disclosure and "management" by a Conflict of Interest Committee. But there is no published evidence that disclosure reduces the bias created by financial conflicts, and besides, the Academic Health Center already has a Conflict of Interest Committee. It has not exactly been a great success. Is there any reason to think that the new policy will change this?

3) For the most part, this policy still requires faculty to report potential conflicts only after they arise, rather than asking a committee to review potentially troublesome arrangements in advance. This means that troubling industry arrangement may become evident only after they are concluded.

4) The policy initially seems to limit faculty members from giving marketing talks for the pharmaceutical industry, but in fact, the conditions it outlines are unlikely to limit those talks in any meaningful way. Specifically: the policy says that such talks must reflect the speaker's views, be evidence-based, and disclose the funding for the talk. But most marketing talks for the drug industry already meet those criteria. (The problem is not that the talks are not evidence-based; the problem is the particular spin that sponsors and speakers put on the evidence.) The only new condition here is that speakers are required to disclose the specific amount of money they are being paid. This may deter some speakers, but in general, the empirical data shows that industry-funded speakers and authors rarely disclose their funding sources even when they are required to.

5) The policy will permit the pharmaceutical industry to provide educational materials to students, residents and faculty, as long as the funding is disclosed and the marketing purpose is not outwardly obvious. But the problem with industry-produced educational material is precisely that its marketing purpose is not at all obvious, even when it has been produced by the marketing department of the company.

6) The policy proposes to manage the potential conflicts of interest for medical researchers by having researchers ask research subjects if they would like to have the researcher's financial relationships disclosed to them. There is no evidence in the medical literature to suggest that this is an adequate solution. The problem with financial incentives is not secrecy; the problem is that financial incentives may lead researchers to expose subjects to interventions that are not in their best interests.

7) The first draft of these guidelines recommended that the university office of Continuing Medical Education institute a plan to be free of pharmaceutical industry funding within five years. That recommendation has disappeared."

Bioethics expert criticizes UMN conflict of interest plan

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The draft conflict of interest policy being considered by the University of Minnesota is insufficient according to Dr. Steve Miles, a UMN med school professor of medicine and bioethics. He wrote to me:


The document identified as Administrative Policy: Individual Conflicts of Interest (DRAFT 11/09/09) (text downloaded from http://blog.lib.umn.edu/bgleason/pt/Coi_draft.pdf) is an incomplete and flawed document that will do little to regulate the kinds of misconduct and concerns that have brought this University and many other United States universities before Congressional inquiries or harsh media scrutiny. I agree with those who are also frustrated with the lack of transparency of the drafting of this fourth generation document.

University collaboration with industry groups is necessary and can be ethically done. However, these relationships must be managed to prevent biasing of education, presentations to the media, testimony to public policy groups, or scientific publications. These relationships must also be done in a way that prevents research from being corrupted or that abridges protections for human subjects.

My comments arise from my perspective in the health sciences and may not apply to this policy insofar as it may affect Conflicts of Interest in other University Endeavors. My comments are not comprehensive given that it is not clear that the process is open to debate in its scope or fundamentals.

SECTION I. Reporting. By reporting rough dollar amount of income for "each compensated relationship with a business" rather than income from each business entity, it is possible for any business to slice its compensation to faculty into small pieces (i.e., discrete relationships) that understate the extent of the Conflict of Interest. For example, if BIO INC gives a faculty member $99,000 in honorariums and a 24,000 travel budget, the faculty would not trigger the Conflict of Interest review and the categorical disclosures would add up to 60,000 to 125,000. This problem with reporting has implications for the clarity of the disclosures that are addressed in SECTIONS IV and V.

SECTION III. Managing Conflicts.
On the important question of the relationship between a conflict of interest review committee and the Institutional Review Board, it is left unspecified if the conflict committee is supervisory to the IRB or advisory to it. Furthermore, it is entirely unclear how a conflict of interest committee is routinely informed of human subjects research since it receives its information through the REPA system and there is no specified obligation on the part of the IRB to check back to the conflict of interest or REPA program. Finally, the most problematic studies involve the use of devices or off label uses that are not part of prospective study protocols, e.g. the much discussed INFUSE study. The Draft policy does not address non-IRB clinical innovations by researchers with conflicts of interests.


SECTION VIII, X, XI. Speaking Engagements, Commercially Produced Education Materials, Gifts etc.
The policy does not address conflicts of interest as they pertain to continuing medical education. It would be easy for the University to adopt wholesale the standards and interpretive guidelines of the Accreditation Council for Continuing Medical Education (http://www.accme.org).


SECTION XII: Nationally, there is increasing recognition that "free drug samples" are a marketing tool that promotes the more rapid introduction of costly drugs at variance with responsible practice guidelines. This is why schools like Johns Hopkins and the University of Iowa have abandoned the practice and The American Society of Health System pharmacists opposes it. The trend is clear. This draft gives no reason for electing not to lead or for narrowly restricting the kinds of free samples might be distributed (i.e., highly costly, non reimbursed drugs that have immediate life saving effect on persons with very rare conditions).


DEFINITIONS:
The Conflict Review Committee (CRC) is defined on page 12. Apparently there are many of these since the document throughout used references to an "appropriate" or "a" "conflict review committee." It is not clear whether the repeated use of the generic non-capitalized "conflict review committee[s]" meet the same membership standards and accountability of standards as the CRC.

Mammography & the corporate breast: conflicts of interest in critics

While some critics of the US Preventive Services Task Force made wild and nonspecific charges that members of the task force must have conflicts of interest, a new post on the Hastings Center's Bioethics Forum identifies specific potential conflicts of interest in some of the critics.

Dr. Adriane Fugh-Berman MD of Georgetown University Medical Center, and director of PharmedOut.org and Alicia M. Bell, project manager of PharmedOut and member of the board of directors of the National Women's Health Network, write:

"Vague, fact-free, emotionally charged statements are the language of public relations, not scientific discourse. The striking similarities in word choice among these critics could be entirely coincidental. Perhaps the congruence in their conflicts of interest is coincidental as well.


U.S. Preventive Services Task Force members are not allowed to have "substantial conflicts of interest, whether financial, professional, or other conflicts, that would impair the scientific integrity of the work of the USPSTF." Organizational or personal conflicts of interest, however, are common among critics.

Donors to the American Cancer Society Cancer Action Network (ACS CAN), the "nonprofit, nonpartisan advocacy affiliate of the American Cancer Society", include Hologic, which makes breast imaging products, and Johnson and Johnson, which makes an image-guided breast biopsy product. Donors to the American College of Radiology Imaging Network (ACRIN) Fund for Imaging Innovation include Siemens, GE Healthcare, Phillips, Hologic, and many others that make mammography machines or related products.

According to the American College of Radiology Web site, "the leaders of the ACR and ACRIN have been meeting with industry leaders from key donors to the ACRIN Fund to strengthen the relationships between the organizations and better determine how both parties can maximize this relationship." The Society of Breast Imaging is an organization managed by the American College of Radiology.

The Access to Medical Imaging Coalition is run by Tim Trysla, who works for the Alston and Bird law firm and is counsel to the "largest complex diagnostic imaging manufacturers, physician groups and providers regarding Medicare reimbursement." He directs the "Coalition of Diabetic Providers and Manufacturers opposing Medicare competitive bidding for durable medical equipment." Daniel Kopans holds patents on imaging systems. Robert Schmidt reports receiving royalties from, and being a shareholder in Hologic.

...None of these conflicts of interest have been mentioned in news coverage.

...When critics with conflicts of interest are banned from the argument, the controversy vanishes."

Call for NIH to fund research on ethics, conflicts of interest

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I was among 100 researchers, clinicians and ethicists who this week signed and sent a letter (pdf file) to the National Institutes of Health asking them to fund research on medical ethics, conflicts of interest and industry influence on prescribing behavior.

The effort was led by Dr. Adriane Fugh-Berman, who leads the PharmedOut (http://pharmedout.org) project at Georgetown University Medical Center to educate physicians about industry influence on prescribing.

The letter states:

"Between bench and bedside lies a path treacherous with ethical quandaries. NIH is the best place to launch and support a scientifically rigorous inquiry into the state of research ethics, industry-academic relationships, and the effect of these relationships on human health. There is currently no identifiable mechanism through which NIH would fund this research.


Your leadership regarding the importance of this issue as one the NIH needs to direct resources towards is essential. We hope to discuss these issues in a face-to-face meeting."

An article on TheScientist.com contains more details.

John Fauber of the Milwaukee Journal-Sentinel reports on the disconnect that can exist between the financial disclosures physicians make to their institutions and that which they make to journals where they hope to be published.

Snowballing concerns over family docs' org Coke deal

An AP story wraps this into the historical context of the highly-criticized AMA-Sunbeam deal and the American Academy of Pediatrics-infant formula deal.

And the story states: "The Coke deal is not the only corporate alliance for the family physicians group. In 2005 it received funding from McDonalds for a fitness program. And its consumer Web site includes advertising for a variety of products, including deli meats and air freshener."

I've told my students that covering health care conflicts of interest could be a fulltime beat - and you still wouldn't keep up.

The NY Times today reports:

In the first half of this year, the drug giant Eli Lilly paid 3,971 doctors and other medical professionals an average of about $11,230 each. The payments were for participating in an average of 12 speaking or consulting engagements during those six months, according to a company spokeswoman.


Dr. Manoj V. Waikar, for example, a physician among the top five earners this year, received $74,850 for consulting and speaking at 51 events, according to Lilly's on-line faculty registry. The company caps payments at $75,000 for each health care provider in any calendar year.

He's an adjunct instructor at Stanford. Stanford's ban on regular faculty members participating in drug company speakers' bureaus doesn't apply to adjuncts - as long as they're not using the Stanford name.

As blogger Merrill Goozner writes:

Waikar gave 51 talks last year to earn that $75,000. That's one a week, week after week, all year at $1,500 a pop. Think about it. Same slides, same talk. Just show up for two hours and the check is in the mail. Do that for three companies and you're earning over $200,000 annually. And you were wondering how the man earns a living on an adjunct faculty's salary.

Meantime, it doesn't take the NY Times to dig into conflict of interest issues. A student journalist with the Minnesota Daily points out how medical students receive free textbooks from drug companies promoting their products. Case in point: an otolaryngology text given out by a company making an ear infection drug - with the company's logo on it, and with the beginning of each chapter crediting the drug company.

The student journalist also pointed out that the University of Minnesota has no policy to ban such practices.

It's good that this student journalist starts looking at conflict of interest issues now. If she stays on this beat, she's going to be busy on COI stories for a long time.

Docs quitting AAFP over Coke deal

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The Atlanta Business Chronicle reports that some physicians are discontinuing membership in the American Academy of Family Physicians over the previously-discussed Coke deal.


An article in PLoS Medicine by David Henry, Lisa Bero, Ray Moynihan and colleagues analyzes Australia's move to require disclosure of medical industry funding of any event. Their summary points:

* There are moves internationally to ensure greater disclosure of gifts and educational events for doctors paid for by pharmaceutical manufacturers. However, there is no agreement on appropriate standards of disclosure. In Australia, since mid-2007, there has been mandatory reporting of details of every industry-sponsored event, including the costs of any hospitality provided.


* Examination of the Australian data shows that although expenditure at individual events is often modest, cumulative expenditure is high, particularly in the case of medical specialists prescribing high cost drugs--oncologists, endocrinologists, and cardiologists.

* Although a significant advance, the new Australian reporting standards do not allow assessment of the educational value of sponsored events, and do not include details of speakers or educational content for most events. However, doctors in training are often present at these events.

* At present, the standards of disclosure are inadequate and should not be tied to an arbitrary monetary value of gifts or sponsorship. Reporting standards should require the names of the speakers presenting, whether sponsors played a role in suggestion or selection of speakers or the development of the content of presentations, and the nature of any direct or indirect financial ties between the speakers and the sponsors.


Last month we alerted you to news that the American Academy of Family Physicians had a six-figure deal with Coke to "develop consumer education content on beverages and sweeteners for its consumer-oriented website, FamilyDoctor.org."

Well, that deal doesn't sit well with all docs. One has started a Facebook petition to end the deal. His stated mission:

Coca Cola does not deserve to be in a partnership with family medicine, when their marketing and business practices promote obesity in our patients. I want my Academy to end this agreement.

Medical journal editors move on uniform COI disclosure

Released in the New England Journal of Medicine today:

With this editorial, which is being published simultaneously in all International Committee of Medical Journal Editors (ICMJE) journals, we introduce a new disclosure form that has been adopted by all journals that are members of the ICMJE. We encourage other journals to adopt this reporting format, and we are placing the form in the public domain.


We ask authors to disclose four types of information. First, their associations with commercial entities that provided support for the work reported in the submitted manuscript (the time frame for disclosure in this section of the form is the life span of the work being reported). Second, their associations with commercial entities that could be viewed as having an interest in the general area of the submitted manuscript (the time frame for disclosure in this section is the 36 months before submission of the manuscript). Third, any similar financial associations involving their spouse or their children under 18 years of age. Fourth, nonfinancial associations that may be relevant to the submitted manuscript.

We saw it in Minnesota. Now John Fauber continues his excellent work on the topic for the Milwaukee Journal-Sentinel, raising questions about what the U of Wisconsin med school has done, "allowing orthopedic surgeons and other doctors who implant devices to earn large sums of money making presentations for medical device companies."

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This page is an archive of recent entries in the Conflicts of interest category.

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