Archive for September, 2007

Ghosts in the Literature

The Sept issue of Public Library of Science Medicine includes an essay by Sergio Sismondo on “Ghost Management” of the medical literature by the pharmaceutical industry. Dr. Sismondo reports data suggesting that as many as 40% of published articles focusing on specific drugs are ghost authored/managed (ie, company controls or directs multiple steps in the research, analysis, writing, and publication of articles). No matter their derivation, these articles genuinely affect physician behavior in treatment planning and prescribing – and the ghost managed manuscripts are most definitely designed to manipulate this behavior.

How can I say this so authoritatively? I was briefly a ghost in the machine many years ago.

The pay is obscene, so pharma will have no trouble finding willing ghosts. My company offered to double my payments if I’d keep writing for them when I said no thanks after a couple of assignments. Essentially, for purely ghosted manuscripts such as mine, I’d be told to write a X,000-word review article on topic XYZ (bulleted outline of major points to cover provided – including clinical practice points) for Journal ABC. I didn’t know the term for what they were doing, but I quickly realized it wasn’t right (for me or whoever was getting their name slapped on these papers). At my current institution, faculty participation on pharm-ghosted papers is verboten – a policy that can be fairly well overseen when you not only use a standard ethical industry contract template so deviations are obvious but also have someone in a leadership position who monitors manuscripts accepted for publication by health sciences faculty.

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NIGMS Strategic Plan

Thanks to PhysioProf for pointing out the availability of the NIGMS Strategic Plan for review. I especially liked PhysioProf’s observation that “It really contains a beautiful explanation of the importance of basic research, and how essential it is for advances in clinical medicine.”

You can submit your own comments on the Plan online.

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NIH Extramural Nexus – Workforce Concerns etc.

September issue available for your perusal.

Right off the bat, a question sure to generate some commentary: “Will we have enough new investigators to carry out the health-related research of the future?”

Dr. Bravo does go on to discuss the increase in graduate students and postdocs as well as the decline in academic positions available to these trained scientists – FASEB data previously noted here & in Nature. She goes on to say that the NIH is “looking at key personnel involved in the research supported by NIH grants in FY 2006″ as part of a means to examine the biomedical workforce needs & distribution of effort (she estimates that PIs account for about one-sixth of those persons supported via NIH extramural awards). An RFI on this issue is in the works, no doubt.

Other pieces include a chat with Dr. OPASI, policy updates on rDNA use and GWAS data sharing, and the bad news that PureEdge will be with us until March 2008. As usual, many additional useful tidbits as well.

Of note is a new Excel spreadsheet summarizing FY06 & FY07 award data for individual RFAs and PAs. Caveat emptor: this is a 19 MB file that I have been unable to open, no doubt due to the squirrel getting tired in my ancient home-based PC. Update: In case you’re not following the squirrelly comments below, the file can be opened (either downloaded first or direct from link) but with a long delay, so be patient.

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Youth Culture of Misconduct

Update: The 5th annual Junior Achievement/Deloitte Teen Ethics Survey finds that 38% of teens who “feel fully prepared to make ethical decisions when they enter the workforce” also believe it is sometimes necessary to cheat, plagiarize, lie or even behave violently in order to succeed. Among all teens surveyed, 24% think cheating on a test is acceptable on some level, and 54% give their personal desire to succeed as the rationale.

Perhaps research on research integrity needs to take a page from the NSF playbook and start during the K-12 period.

In June 2007, nine 17-year-old male students from Hanover High School (NH) used stolen keys to break into a teacher’s filing cabinet and take final exams first from various high-level math courses; chemistry final exams were stolen in like manner five days later. About 50 students are suspected to have participated directly in the theft, as look-outs, and/or as recepients of ill-gotten exam answers. Because the incident involved breaking and entering, it was reported to the police, much to the fury of parents, who feel the misdemeanor charges will impact their children’s acceptance at desirable colleges.

Apparently, mere cheating isn’t worth a second thought. Honor system? When it doesn’t interfere with ambitious plans perhaps. In an interview on NPR All Things Considered, Aine Donovan, executive director of the Dartmouth College Ethics Institute, said “kids today are more apt to rationalize their behavior as a means to an end; and they seem to have invented their own particular code of right and wrong.”

The Detroit Free Press published statistics from a Josephson Institute of Ethics report that found “entrenched habits of dishonesty” among young people. About 28% of 36,122 public and private high school students who were surveyed admitted stealing from a store within the past year; 23% said they stole something from a parent or other relative; 82% said they lied to a parent about something significant; 60% said they cheated on a test.”

I went to a pretty high-powered college that made a huge deal about its honor system, and I personally knew of no incidents of cheating or other academic misconduct among the students. My roommates each failed a course freshman year, and I swallowed a huge dose of reality. And we all took the humbling grade point hit rather than try to better our average in a less than honorable manner. This was well before these kids were born, though, and these are the sort who would seek admittance at my alma mater. One wonders whether current students are willing to accept grades below a B … or an A … or if they take “justifiable” steps to better their standing for their future good.

So they get over the hurdle of admission to Harvard or Princeton and years later face the pressure of getting “good” data to publish and support a grant application – with the same ingrained rationalizations in tow. Consider this “foundation” in light of new data suggesting mentoring has the potential to increase misconduct or recent discussion of plagiarism as a “victimless crime” at the First World Conference on Research Integrity.

Is RCR (responsible conduct of research) training at the graduate school level too late perhaps?

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Neurocognitive Correlates of Liberalism & Conservatism

Of possible interest in this month’s Nature Neuroscience:

Political scientists and psychologists have noted that, on average, conservatives show more structured and persistent cognitive styles, whereas liberals are more responsive to informational complexity, ambiguity and novelty. We tested the hypothesis that these profiles relate to differences in general neurocognitive functioning using event-related potentials, and found that greater liberalism was associated with stronger conflict-related anterior cingulate activity, suggesting greater neurocognitive sensitivity to cues for altering a habitual response pattern.

One conclusion in relatively plain English …

“This association suggests that a more conservative orientation is related to greater persistence in a habitual response pattern, despite signals that this response pattern should change.”

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Science Visualization Winners!

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Defining Wisdom

The Arete Initiative at The University of Chicago is pleased to announce a $2 million research program on the nature and benefits of Wisdom. In 2008, up to 20, two-year research grants will be awarded to scholars from institutions around the world who have received their Ph.D. within the past 10 years. Letters of Intent are due November 19, 2007. Example projects might include:

  • Wisdom in the context of risk and uncertainty; wisdom in the context of real-world unknowables;
  • Wisdom in the context of social norms;
  • Finding new wisdom in the context of optimization models in biology and computer science;
  • New wisdom in the context of changing of ethical systems and law;
  • Wisdom in selecting subjective preference weights in the context of economic models;
  • The art of balancing long-term and short term considerations and trade-offs;
  • Wisdom in the design of institutional structures;
  • New ways to learn/teach emerging kinds of wisdom;
  • Wisdom in nature;
  • Wisdom in the practice of compassion (forgiveness, international aid programs, etc.)

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FY06 Federal R&D Funding at Universities

The shocking title/conclusion of this NSF report … Universities Report Stalled Growth in Federal R&D Funding in FY 2006

“Federally funded academic R&D expenditures rose 2.9% in FY 2006 to $30.0 billion. When adjusted for inflation, this represents a 0.1% decline from FY 2005. … The most significant gain occurred in funding originating from institutions, which increased 9.7% in FY 2006 to $9.1 billion.”

And what happens when Universities spend their entire rainy day fund?

If you want to check on your home institution, the most recent profiles available are for FY04.

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CTSAness Part 1 – General Overview

According to the CTSA Consortium Website, this program seeks to transform “how clinical and translational research is conducted, ultimately enabling researchers to provide new treatments more efficiently and quickly to patients” and specifically to:

  • Encourage the development of new methods and approaches to clinical and translational research
  • Improve training and mentoring to ensure that new investigators can navigate the increasingly complex research system
  • Design new and improved clinical research informatics tools
  • Assemble interdisciplinary teams that cover the complete spectrum of medical research
  • Forge new partnerships with private and public health care organizations

In other words, Congress wants to see tangible evidence in their doctors’ offices of how the billions they’ve poured into bench science is benefiting their constituents. Each CTSA site is expected to provide functions that fall within the following cores:

  • Development of Novel Clinical and Translational Methodologies
  • Pilot and Collaborative Translational and Clinical Studies
  • Biomedical Informatics
  • Design, Biostatistics, and Clinical Research Ethics
  • Regulatory Knowledge and Support
  • Participant and Clinical Interactions Resources
  • Community Engagement
  • Translational Technologies and Resources
  • Research Education, Training and Career Development

A core on industry partnerships and technology transfer should probably be added to this list. In future post, I’ll write up illustrative examples of what happens in these cores – I know a few of the titles are a bit opaque, and some of these really do cool stuff.

The consortium organization chart (which leaves out the multiple workgroups) gives the barest inkling of the complexity of this program. They plan to have 60 sites in the consortium. Take a look at the size of one committee with just 24 sites signed on thus far … and imagine adding representatives from 36 more institutions … and consider attending such a meeting.

And then there are the workgroups, such as the Clinical Research Ethics Workgroup. Not only do they have a Steering Committee, they have a COI Task Force, an Education Task Force, a Consultation Task Force, and an Operations Committee. Busy folks these.

Yes, a lot going on involving a cast of hundreds … inching close to a thousand (10 cores x 60 sites plus other site reps plus all the NIH personnel).

Yes, a lot of money on the table (~$1.1B for the 24 sites funded thus far), though the initial awardees will be giving back some of their funding: “The 2006 CTSA institutions that are currently receiving increases over their pre-CTSA program levels in excess of the new guidelines will experience a budget adjustment of -5% in FY 2008.” You can imagine the level of enthusiasm greeting this announcement or the notification that they will need to ask for less money in their competing renewals.

And carryover requests? What a joy. “Processing of a carryover request that does not include an OFM-approved FSR must include the approval of the Director or Deputy GMO, OGM.”

IMHO, though, CTSA sites do not need more money (sound of lightning striking). They need less to do, especially in terms of the bureaucracy & reporting burden but also in the overall program. Surely all 60 sites do not need to excel in (or even directly contribute to) all 10 areas of interest – especially now that NCRR plans to populate most of the consortium with small-to-medium sized institutions (but, looking again at the latest awardees, partnering with multiple other small-to-medium sized institutions). The general idea of a consortium is for participating institutions to complement rather than duplicate each other’s work and thus accomplish more together than they could individually. Much of the CTSA $ is directed back to the institution itself (eg, former GCRC functions, biostat & study design, pilot funding, career development, community engagement), but not everyone has the capacity or need to develop novel translational methodologies or significantly advance the field of biomedical informatics. Future CTSAs will need to increasingly emphasize a distinct role for pediatric research, which again may not be appropriate for all applicant sites. A subset of the Consortium with high-powered children’s hospitals and over-expressed Depts of Pediatrics should be able to manage translation of bench/clinical research from adult to pint-sized populations and serve as models for how institutions can better engage pediatric researchers on a scale appropriate to each.

I think the integration of the new sites in the Consortium will be an important learning process for NCRR and the rest of the team, hopefully smoothing the path for the remaining 36 institutions with winning lottery tickets (only 3 more chances to play if they keep handing out 12 awards for each RFA).

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Med School Grades Falsified

Yowza: Grades Reported Falsified at UMDNJ, confirmed today per the Philly Inquirer.

“A report by a federal monitor … concludes [Dean Paul] Mehne doctored the grades of several medical school students, including some now practicing medicine, giving passing test scores to those who came up short on exams needed to begin specialty rotations.”

Amazing what inethical actions some of those in leadership positions can rationalize as acceptable.

I don’t think any University would like to have the 2 right-most navigation buttons at the bottom of their opening Website …

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