Retractions - One now, perhaps more in the future

We've written before about article retractions and why high-profile journals like NEJM might have the highest retraction indices (figure). Yet, retractions in infection prevention are very infrequent. In fact, the one major retraction we mentioned during 7 years of blogging was not strictly a retraction, but a re-analysis of N-95 vs surgical masks.

Which brings us to a rare retraction in infection prevention, namely this 2014 AJIC study looking at zero fluid displacement intravenous needless connector and CLABSI prevention. As reported this week in Retraction Watch, the study was initially questioned because of a failure to report conflicts of interest but has now been fully retracted by AJIC since an investigation found problems with the "consistency of the statistics over various study periods as well as the methods by which study sites were chosen." Fortunately, since this study was published less than 2-years ago and only cited once, this retractions won't be particularly damaging to the field.

However, with the recent announcement that NIH is providing an additional $100 million for antimicrobial resistance (AMR) along with increases in CDC and industry funding, there are now resources to fund high-impact studies that will appear in high-impact journals. And as if those pressures are not enough, the US Government has been tasked to reduce C. difficile infection by 50%, CRE by 60% and MRSA by 50% by 2020 compared to 2011. With the unprecedented increase in funding combined with difficult to achieve targets, there will be unbelievable pressure to cut corners in study design and analysis and over-promise or over-promote results. This all represents a potential recipe for disaster if our field isn't careful. On the bright side, societies like SHEA have very strict conflict of interest reporting, so we have some checks in place to identify conflicts and bias. Of course, this won't be enough. Be careful out there.

Ask your doctor

No introduction needed apart from John Oliver - Marketing to Doctors. If you'd like to search for a specific physician or hospital, the CMS Open Payments site is now online. If you're interested in viewing the COI policy that covers "your bloggers", you can see it here.

"At the end of the day, the drug companies own medicine"

The title of this post is a quote by Eric Campbell of Harvard Medical School in an investigative piece in yesterday's Milwaukee Journal Sentinel. The article focuses on conflict of interest among physicians who write practice guidelines for academic societies.

Here's a summary graphic from the article:

This article is worth reading, but it's disturbing.

Today's Profile in Science

Today's New York Times has a lengthy interview with Arnold Relman and Marcia Angell, former editors of the New England Journal of Medicine. The interview is part of the paper's Profiles in Science series. For many years they have pointed out conflicts of interest in medicine and argued for improvements in our healthcare system. Here's a video of part of the interview:

Conflict of interest?

Sometimes a picture's worth a thousand words...

http://cleanspaces.site.apic.org/

Lying About Prognosis Might Not Be Lying

There is a lot of chatter (or here) about Lisa Iezzoni's study on physician openness and honesty, that was recently published in Health Affairs.  We've discussed the importance of disclosing medical errors numerous times, as well as the importance of disclosing financial conflicts of interest, so physicians who aren't honest in those domains, will get little sympathy here.  However, one aspect of the survey findings, I think, deserves more discussion, namely the disclosure of prognosis.

To quote from the article: "...more than half said that they had described a prognosis more positively than the facts warranted."

Is this really "lying"?  What is the importance of disclosing mean, median or mode survival?  Will patients or families even understand the difference?  How do you explain a normal or skewed survival curve?  If you can't describe the distribution or they don't understand it, is that dishonesty? Importantly, how does this all impact "hope"?

One article, written many years ago (1985) by Stephen J Gould, the Harvard evolutionary biologist, does a better job describing why "The Median Isn't the Message" than anything I could write. He tells how he reacted to his 1982 mesothelioma diagnosis. He lived until 2002. This essay has been highly influential to me throughout my medical career.

Dollars for Doctors

The NPR show On the Media aired a very interesting story today on the pharmaceutical industry's use of gifts and payments to physicians to influence drug prescribing. What I like about this interview of ProPublica journalists is that you get a sense of how nonmedical people view this issue. You can listen to the podcast here and see ProPublica's webpage on this topic here.

In the realm of infection prevention, the industries are different (e.g., microbiologic diagnostic testing supplies and equipment, cleaning products, and antimicrobial/antiseptic coated devices), but the core issue is essentially the same--allowing industry to influence practice and policy by targeting individual practitioners, professional societies and lawmakers.

Photo: ABC News

Sunshinism: Protecting Patients or Further Destroying Physician Trust?

Yesterday, Dan posted about the new rules mandating the reporting of all physician payments from drug and device manufacturers. Generally, I've been in favor of increased transparency if, as Dan said, the "information is detailed and accurate." However, I think any system like this can and will be gamed and I suspect the results will be more destructive than constructive. For example, funding for "research" is thought to be less conflicting than direct payments to physicians for giving canned talks.  However, what about "research" support that pays for each patient enrolled and what if that payment goes directly to the enrolling physicians pocket, as would be the case in private practice? Is this such a bad thing that it needs to be constrained?

I suspect there are many other examples of how we won't be able to interpret the reports that are generated from these new rules.  I even suspect that the eventual approach to determining financial conflicts will be through opening up every physician's tax return.  That way, we can look at the true financial impact to the individual.  Pharmaceutical research that goes to a university and doesn't directly increase a physician's deans-approved salary would thus not appear on a tax return.  What about physicians that own stock in Pharma?  Wouldn't that be a more important conflict? You can see where this is going.  So someday soon, all physicians will have to share their tax returns with their patients perhaps by posting them in their waiting rooms or websites.

However, do you really think this will help root out conflicts?  What are the negative externalities of such an approach?  I suspect it will root out the caring physicians who don't want to appear to be in the pocket of pharma even if they are involved in highly important clinical studies. Which gets me to why I've been moved to write this post...

In today's NYT, David Brooks and Gail Collins debate the call to release Mitt Romney's tax return.  In the column, Brooks makes some important points, which I think are worth at least pondering in regards to the new payment disclosure rules and other examples of "sunshinism."

Brooks: "...there is a misbegotten ideology haunting the land, the ideology of sunshinism. This is the belief that everything should be made public. Sunshinism is a destructive ideology. Forcing people to financially undress in public is just one of those incursions that repels decent people..."

Could these new rules further mistrust of the medical community?  Is society better off when a patient doesn't want see an ID doc because she made $5000 enrolling patients in a trial of a new antibiotic? If she won't enroll patients, who will?

Which is a greater conflict for a physician? (a) $50,000 investigator initiated grant to a University (b) $5000 direct payment for giving a canned talk (c) $5000 for enrolling patients in a trial or (d) $50,000 stock in a pharmaceutical company that won't be disclosed under the new rules?

OK, so I think I've built a solid enough straw man.

This should be interesting...

New rules that mandate reporting of all physician payments from drug and device manufacturers should be out soon. I favor this transparency, provided the information is detailed and accurate. For example, receiving money from a company for doing a valid research study on one of their products is a bit different than receiving money to travel around the country on a speaker’s bureau. Let’s hope the publicly available data includes information about the reason for the payment, and the recipient of the payment (e.g. the medical school, to support Dr. X’s research study, or directly to Dr. X).

It will also be interesting to see if makers of diagnostic devices will be included—clearly the makers of devices that touch or are inserted into patients will be required to report payments, but it isn’t clear to me if the same holds true for makers of new diagnostic tests. As we’ve discussed before in this blog, such transparency is also extremely important.

The Affect Heuristic

Source: XKCD.com

We've discussed conflicts of interest and bias frequently, particularly in regards to guidelines.  Bob Centor has a nice post today that discusses the affect heuristic and how it might impact clinical guidelines.

The affect heuristic suggests that a good feeling or emotion towards a situation (i.e., positive affect) would result in a person having a lower risk perception and higher benefit perception than supported by an unbiased look at the data. I think this is closely related to confirmation bias, which we have written about frequently, as well.

His recommendation for selection of guideline panels - choose strong methodologists who are non-experts - is one worth pondering.

Predicting the future

There's a perspective in this month's Emerging Infectious Diseases on carbapenemase-producing Enterobacteriaceae (full text here). For the most part, it's a well written piece that focuses on the geographic spread of these organisms. Near the end, however, the authors make a pitch for active surveillance:

The prevention of spread of carbapenemase producers relies on early detection of carriers. Patients who undergo screening should include patients who were hospitalized while abroad and then transferred to another country, and patients at risk (e.g., patients in intensive care units, transplant patients, immunocompromised patients). Screened patients should be kept in strict isolation before obtaining results of the screening (at least 24–48 hours). Because the reservoir of carbapenemase producers remains the intestinal flora, fecal and rectal swab specimens are adequate for performing this screening. 

Yikes! If I followed their advice my hospital would probably be doing a few hundred tests per week. I'll leave the thorny problem of what test to do to Dan, our blog's microbiologist. But more active surveillance means more contact precautions. And we love contact precautions!

Photo: Managed Care Matters

So let me look into my crystal ball and predict the future for our readers:

• A diagnostic testing company will develop a rapid test for the detection of these organisms
• The diagnostic testing company will become a strategic partner to A Group that Represents Infection Preventionists (AGRIP)
• AGRIP will survey all of its members on whether they have ever seen such organisms in their hospitals
• A paper will be published along with a press release revealing the shocking news from the survey that these organisms are much more prevalent than anyone ever imagined
• The strategic partner (bless their heart!) will help AGRIP educate the infection control community and the public on the dangers of this horrible organism
• I'm a little fuzzy on this prediction, but there may be a second survey
• States will pass laws requiring testing of patients admitted to hospitals to protect their citizens from the horrible organism
• The strategic partner will hire a new vice president and all will live happily ever after

I will now put the crystal ball away, return to my regular life as a horizontalist, and simply scream, WASH YOUR HANDS, PEOPLE. WASH YOUR HANDS!!!

Conflicts of Interest: Beware, you're human!

We've each posted frequently on conflicts of interest, financial and otherwise. Here, Dan Ariely talks briefly about scientific conflicts of interest - they aren't all financial - and what hope we might have to protect ourselves from other people's and our own conflicts. Dr. Ariely is the James B. Duke Professor of Psychology and Behavioral Economics at Duke University and a founding member of the Center for Advanced Hindsight.  I wonder if his Center is really good at determining if a CLABSI is secondary or not. Enjoy.

Critique of the WHO pandemic response is now out

We blogged early and often about the H1N1 pandemic, including posts about the controversy surrounding the WHO response and whether there was any industry influence at play. An independent expert panel has now released a draft report on the 2009 H1N1 response. Here are the media summaries from the NY Times, Science Magazine, and the Nature blog The Great Beyond.

Regarding the industry conflict-of-interest (COI) issue, the report takes WHO to task for poor handling of COI and lack of transparency, but concludes that there is "no evidence of attempted or actual influence by commercial interests on advice given to or decisions made by WHO." I’m not sure what such evidence would be required…direct cash payments to members of the WHO advisory committee? Anyway, given that the panel felt that WHO waited too long to call the pandemic, it is unlikely they’d conclude that this decision was driven by industry COI.

Read the report yourself—now that Iowa has thawed out and the sun has appeared, I have no time to detail all 15 of the recommendations the panel made.

IDSA Releases MRSA Treatment Guidelines

Perhaps to celebrate the 50th anniversary of MRSA's discovery in 1961, IDSA just released their first MRSA treatment guidelines. The guidelines don't discuss infection prevention strategies but rather focus on specific clinical questions such as "What is the management of skin and soft-tissue infections (SSTIs) in the era of community-associated MRSA (CA-MRSA)?"

A recommendation getting a lot of attention in the press is that you don't always have to treat MRSA with antibiotics. What! We treat viruses and pseudo-infectious syndromes with antibiotics, we should at least give antibiotics to patients with pathogenic bacteria even if they aren't needed. It's only fair! (sarcasm alert) The press attention focuses on the first recommendation in the document that says "For a cutaneous abscess, incision and drainage is the primary treatment (A-II). For simple abscesses or boils, incision and drainage alone is likely to be adequate, but additional data are needed to further define the role of antibiotics, if any, in this setting."

My favorite section deals with "Research Gaps" such as whether vancomycin should be the first drug of choice for empirical therapy or should the patient also receive a β-lactam antibiotic to cover for MSSA? The guidelines also have a "Performance Measures" section that includes weight-based dosing of vancomycin combined with trough-monitoring.

Overall, for an almost 30-page guideline (not counting references), I found it very well written and organized. Nine of 15 authors (if I counted correctly) report COI. The guidelines were endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians, and the American Academy of Pediatrics.

-Eli

Liu C. et al CID Feb 1, 2011 (full text of Guidelines)
IDSA Press release 1/5/2011

Deadly Medicine

The January issue of Vanity Fair has a very interesting investigative piece entitled Deadly Medicine (free full text here) by Donald Bartlett and James Steele, which explores the globalization of the pharmaceutical industry and the effect that has had on the drug approval process. The majority of data used in the new drug approval process now comes from other countries where regulatory oversight is scant. Moreover, they describe co-opting of the FDA by industry. In some countries, doctors enrolling patients in clinical trials can earn 25-fold more money from enrolling one patient than from their monthly salary. This creates huge conflicts of interest. And then there is the exploitation of patients who may not even understand the trial they have been enrolled in and the risks they are bearing. It's a sobering and scary piece, but well worth reading.

The impact factor & the almighty dollar

Since the inception of this blog, we have written frequently about conflict of interest, and it seems as though new types of conflicts continue to be uncovered. There's an interesting new paper and editorial in PLoS Medicine on how industry supported clinical trials affect a journal's impact factor. The authors reviewed randomized trials in 6 major journals, including JAMA and the New England Journal of Medicine. They found that industry supported trials had more citations than those not funded by industry. What I didn't know was that "non-citable" papers (editorials, news pieces, and letters to the editor) are included in the numerator but not the denominator of the impact factor calculation. For the New England Journal, removing the non-citable pieces would lower its impact factor by 24%. So there is a conflict of interest at play here: the publication of industry-funded trials not only increases the journals' impact factors, but the journals also make money by publishing reprints. For example, nearly half of Lancet's income is derived by selling reprints. As the editorial points out, the journals have greatly increased their scrutiny of authors' conflicts of interest, but the journals and their parent organizations may not be holding themselves to the same standards.

Swine flu & conflict of interest

There is an interesting editorial in this month's Journal of Public Health that looks at conflicts of interest with regards to the swine flu pandemic. The author briefly describes some examples of organizations that manage financial and intellectual conflicts quite well. It's worth reading and the full text can be viewed here.

Thomas Jefferson and financial conflicts of interest

the Egyptian Building

While reading Peter Orszag's excellent column on the role that rising medical costs have had on the declining state-funding of state universities, I came across an interesting historical example of medical conflicts of interest.  Initially, I was trying to determine the public/private status of Mike's institution, Virginia Commonwealth University, when I learned about Augustus Warner and Thomas Jefferson.

In 1837, Dr. Augustus Warner, a surgeon at University of Virginia and graduate of the University of Maryland, became disillusioned with the clinical material available and felt that Richmond would provide a much broader patient base, so he started and became Dean of what was to become the Medical College of Virginia (VCU). Most interestingly, Dr. Warner was said to have left the University of Virginia’s medical school because he didn't agree with Thomas Jefferson’s philosophy that professors shouldn’t corrupt their teaching by making money caring for patients.

I guess I can imagine that physicians enrolling patients in RCTs might have conflicts between science and their patients (hence blinding and perhaps random assignment).  It still seems so foreign to me that this would be a financial conflict.  Wait, I guess the current medical system, where physicians are paid more if they do more procedures, leads to the conflicts that Mr. Jefferson was worrying about.  I wonder why Jefferson wasn't quoted during the recent health care reform debates?


Peter Orszag's NY Times column

VCU Surgical Department History

VCU Health Sciences page

(Financial) Conflicts of Interest: The Randomized Trial

A study out of Carnegie Mellon University in JAMA tested whether reminding pediatric and family medicine residents of their personal sacrifices might make them more willing to accept a gift from industry.  In the online survey, if the residents where asked about their sacrifices, such as work hours, hours of sleep, salary and education related debt, prior to questions about the acceptability of gifts, then 48% found the gifts acceptable vs 22% in the control group who were asked about the gifts first.

Interestingly, if the residents were also read this: "Some physicians believe that the stagnant salaries and rising debt levels prevalent in the medical profession justifies accepting gifts and other forms of compensation and incentives from the pharmaceutical industry. To what extent do you agree or disagree that this is a good justification?" then 60% found the gifts acceptable.  So reminding residents of their sacrifices, especially if they are provided a rationalization really changes their perceived acceptability of industry-sponsored gifts. Pretty scary.  But what can be done?

An accompanying editorial by Pauker and Wong from Tufts discusses, among many things, the lack of training medical students receive in managing their many conflicts "regarding ethical principles about personal economic behavior, the ethics of patient care (eg, beneficence vs autonomy), or multifaceted loyalties (eg, to patients, institutions, society, or third-party payers)."  They highlight the 'theory of constraints thinking process" (TOCTP) and it's core conflict resolution diagram, the evaporating cloud. This 'dark cloud' can be evaporated when subjected to logic techniques.  The example they provide might take a few readings to understand, but seems to make sense on paper.  I'm not sure how such techniques could be implemented, however.

Sah and Loewenstein JAMA RCT
Pauker and Wong JAMA editorial

American Academy of Pediatrics Recommends Mandatory Influenza Immunization of all Health Care Workers

We have already posted several times in the last week regarding the SHEA Position Paper.  The AAP Policy Statement comes to a similar conclusion.  They appear to come from the position that compliance with vaccine is low, low is bad and mandatory programs can increase compliance. No good information in the document regarding financial COI, but they do include a statement that they were internally disclosed and resolved through a Board-approved process.  Not being a member of AAP, I'm not sure what that means.  Perhaps someone can enlighten us.

Interestingly, the AAP paper has 24 references vs SHEA's 63.

AAP Policy Statement

Previous SHEA Position Paper posts: here, here and here.