Medical Writing, Editing & Grantsmanship

20 Comments »

1. 

   BB said,

   May 23, 2008 @ 8:00 am

   I think we’re all so speechless we can’t think what to write. Don’t they have to fill out conflict of interest form before accepting the funds? We do here in ethically-challenged NJ.

2. 

   writedit said,

   May 23, 2008 @ 10:59 am

   Incredibly, VCU has displayed, in my opinion, even more egregiously unethical behavior by using the Richmond Times-Dispatch as a means to manipulate public understanding and opinion of this agreement through a highly contrived “news” article that mixes descriptions of industry agreements and confuses the reader into thinking the secret and unethical agreement with Philip Morris represents standard behavior between universities and industry, which, as you all very well know, could not be further from the truth.

   Today’s “News” in the Richmond Times-Dispatch misrepresents the facts to citizens in the local community who will never see the NYT article nor understand its import and provides the University with a published “factual” news item to which to link on the VCU Website and to send to Board of Visitor members, students, faculty, donors, state legislators, and other University constituents. The text published in the RTD includes no input from unbiased outside experts, no response from the other Universities named (who I think would be within their rights to file libel claims), and no evidence of fact-checking. Instead, it simply prints Macrina’s statements (conveniently not in quotes, so no accountability) as fact. Worse, the reporter does not even have a copy of the agreement on which he is reporting but relies entirely on Macrina’s characterization of the content.

   Vice president for research Macrina clearly put lessons in obfuscation and muddling understanding and opinion learned while interacting with the Philip Morris Director of Research to good use. This confusing and contradictory PR piece for the University (which belongs on the editorial page rather than the news page) represents classic tobacco industry tactics. Unconscionable that it is coming from a public university official.

   Consider the following excerpt:

   “The New York Times published a story yesterday that described VCU’s agreements with Philip Morris as “highly unusual” and “extremely restrictive.”

   But Virginia Tech, Duke University, Auburn University, Cornell University, New York City’s Rockefeller University and the State University of New York at Stony Brook are among the many universities that give corporate funders similar rights.

   The agreements often provide for the sponsors’ confidentiality.

   The standardized agreements at some schools, including the University of Texas’ Southwestern Medical Center at Dallas and the University of Louisville, make no specific provision for publication while protecting sponsors’ confidential information.

   Macrina said VCU’s basic research policy is that publication should not be restricted.”

   The basic research policy, sure - but not the unethical agreement that serves as the point of discussion.

   That a newspaper would perform this service for the University is scandalous but perhaps not a complete surprise in light of VCU’s bestowing an Alumni Star Award on the RTD publisher, Thomas Silvestri, just last week.

   And one wonders about the degree of transparency and thoroughness that will characterize the investigation of a current allegation of an improperly awarded undergraduate degree. Update: The degree was indeed improperly awarded.

   I submitted a brief comment pointing out the lack of fact-checking and reporting rigor in response to the RTD article that, shockingly, has not been posted. I invite others to try to post their comments or contact the reporter directly.

3. 

   writedit said,

   May 23, 2008 @ 11:57 pm

   Momentarily, I am going to address a question I received about research services agreements. But first.

   My engagement of this issue here does not and should not be construed to focus on an institution (VCU) or even the sole individual reported in connection with this agreement (Macrina), although his misuse of the fourth estate is profoundly disturbing. The problem most certainly is not with the researchers at this institution.

   I do believe the President (Trani) bears full responsibility for the University’s decision and action in pursuing this particular agreement as well as a close business relationship with Philip Morris in general. Trani needed their investment to save the BioTech Park (the $350 million Philip Morris Center for Research and Technology) that he spearheaded and whose oversight boards he chairs. Plus, he is personally (& significantly) financially invested in the success of the tobacco industry, and quite possibly the University is as well through its investments (which in turn would enhance his own returns).

   Nonetheless, my concern is not with his outcome, and, indeed, he does not deserve to be fired over this matter (the proven improper awarding of an undergraduate degree is another kettle of fish altogether). For a truly momentous scandal that is rocking the scientific community and absolutely does require heads to roll, take note of the Hellinga saga being discussed intensely elsewhere on this blog (start here, then read this, and finally this most recent discussion). The falsification and worse puts this essentially legal (contract) snafu in perspective. At least here, the integrity of the research record is not in question - yet (more on this in the next comment).

   However, the VCU community should most certainly hold Trani accountable for not being transparent. If there is nothing to hide, why doesn’t he post the research services agreement and the supported projects so the VCU community can see the terms for themselves and exactly what sort of research is being done and weigh in on whether this is something they want their institution to pursue, now or in the future. The faculty do have a right to express their view as to whether the University should partner with or accept funding from the tobacco industry, and Trani is obliged to abide by their decision.

   Making the research service agreement available for public scrutiny would also ensure no concepts or statements were taken out of context, especially the elephant in the room: can faculty publish research services conducted under this agreement? The NYT quotes from the agreement itself that “without limitation [emphasis added] all work product or other material created by VCU” is defined as proprietary information belonging to Philip Morris. The discussion of the length of the review period is moot. The quote drawn by Trani from the agreement (”nothing in this agreement shall be construed as prohibiting any publication or presentation by a VCU employee” ) is also moot. Sure, faculty can publish and present all they want - so long as it does not involve any sponsor proprietary data and hence any data or findings generated in the conduct of the research service. Macrina and Solana talk about having “discussions” about what “could” be published - but ultimately, control legally rests with the company. Even true product testing for this particular industry (e.g., carcinogen levels in smoke of a new product) would be of interest and concern to the public health community but would only be made part of the research record if Philip Morris consented to dissemination. Granting such power to a corporate sponsor of any ilk is obscene (and I’m almost convincing myself this might be a firing offense for Trani given the industry involved and his personal and likely institutional financial conflict of interest).

   Transparency with regard to the contracts and awards accepted by the University could easily be achieved by restoring the annual lists of sponsored awards that were formerly available on the Office of Sponsored Programs Website. These lists should clearly distinguish research from other sponsored awards, such as educational activities (Qatar School of Arts, family medicine residency program, area health education centers, et al.), community services (e.g., community health centers, disability training, Healthy Start, et al.), and pass-through funding. These listings should not include obscurely named and therefore possibly inappropriate sponsors from whom inexplicably large lumps of money have been assigned to various senior University administrators (versus individual investigators) without explanation.

   But I digress. My interest - my passion - in addressing this issue is solely directed at the tobacco industry. Specifically, I would like it to discontinue pursuit of its business objectives (sell a highly addictive product also known to kill) through the misappropriation of tax-payer subsidized public institutions of higher education and, worse, academic medical centers who should instead be actively resisting the continued existence much less growth and expansion of an industry that thrives at the expense of the physical, mental, and economic health of the nation.

   My dream would be for the FDA to be empowered to require nicotine to be removed from all tobacco products, which could then still be sold to adult consumers. Without the addictive nicotine, it would truly be a free choice …. so long as they smoked outside - but not next to the rack where I park my bike. And no added flavorings, either genetically to the tobacco plant grown or afterward at the tobacco processing unit. Let’s sell tobacco as tobacco, not inhaled skittles or breath mints for those too young to appreciate the fine flavor of the cured leaf itself.

   Is this so much to ask?

4. 

   writedit said,

   May 24, 2008 @ 12:23 am

   Part II, with a didactic review of various academic-industry agreements to appear as a new post.

   My specific concern with the NYT report, then, resides mainly in its documentation of the fact that Philip Morris, rather than conduct research in its own brand new research facility (completed in 2007) that probably puts most public university labs to shame, again uses sophisticated legal means (the research services agreement) to control and manipulate research and its dissemination conducted at public institutions (I don’t care how secretive they are about work they pay their employees to do in their labs).

   Worse, they do so at the expense of the careers of VCU researchers who, in serving as surrogate confidentiality-bound Philip Morris employees (yet still paid public university wages & benefits), cannot publish their work or protect their intellectual property and therefore cannot use this time and effort to secure promotion and tenure or extramural grant funding for investigator-initiated research or, one assumes, train students (this is, ahem, a university) since the students cannot use the data for their thesis or dissertation. Even worse, they do so through an agreement that the University cannot even admit exists if asked (per the NYT), even to their own faculty.

   The problems with research services agreements are legion - and whether the work being done under the VCU-Philip Morris agreement even represents true research services (versus basic research that generates new generalizable knowledge) is highly questionable and therefore possibly in violation of the Tax Reform Act of 1984 (more on this scintillating topic separately).

   In a further subtle display of the degree of control in play here, Macrina would not describe to the NYT the nature of the work conducted under the agreement, but Solana (Philip Morris) was only too happy to do so. Once Philip Morris broke the ice, Macrina was willing to talk openly with the RTD. Fascinating.

   So what did they say? And, yes, this is ALL heresay: the NYT did not indicate the details of the projects themselves were documented in the agreement they received. The brief description of the work being conducted is prefaced by “Solana said” - and later, what Macrina “said” to the RTD. Heresay (again, the need for transparency is great).

   VCU researchers are “studying how to identify early warning signs of pulmonary disease, and how to reduce nitrogen and phosphorus drained in to rivers from processing tobacco leaves.”

   Sounds to me like the generation of new generalizable knowledge of broad social value (versus exclusive to Philip Morris). VCU faculty do not appear to be testing a product or analyzing a data set. They (tax-payer paid researchers) are engaging in basic research at a tax-payer subsidized facility (tax-exempt bond issues) using tax-payer purchased equipment.

   I’m sure the NHLBI and American Lung Association would love to know what VCU investigators find with regard to identifying the early warning signs of pulmonary disease … but alas, this knowledge immediately - upon generation - becomes proprietary data fully and wholly owned and controlled by Philip Morris.

   I’m sure the EPA (not to mention the likes of RJ Reynolds and other tobacco companies) would love to know what new techniques the VCU researchers devise to reduce the level of nitrogen and phosphorus in plant waste water … but again, this is immediately turned over to Philip Morris to do with as they please. Philip Morris has bought the “research service” and any data generated, knowledge gained, IP developed when VCU faculty (or - good heavens! - students!!) complete this service.

   This is what a research service agreement does: claims all work & data/results as proprietary & confidential & belonging to the company sponsor. This is why most Universities have nothing to do with this type of industry contract. It is almost impossible to guarantee in advance that absolutely no new generalizable knowledge will be generated except in very clear cases of testing well defined company products against industry standards for tensile strength and so on.

   This is why VCU should have shut the door in Philip Morris’s face (and the recipients of the other research services agreements mentioned, if they involve anything other than clearly delineated & described product testing).

   The million dollar question is whether the services Philip Morris has purchased indeed represent “narrowly focused research, such as product testing” (Macrina).

   Imagine this scenario: Philip Morris is contracting with VCU to identify early warning signs of pulmonary disease such as emphysema. Right now, we can’t identify emphysema until it’s too late - the symptoms define the disease when lung health and function is already lost and cannot be restored. Identifying emphysema - a disease, BTW, predominantly if not wholly caused by smoking - before the lung tissue is damaged beyond repair would be a huge - huge - advance in medical knowledge. In thinking about the possible definition of an “early warning sign”, a biomarker of some sort comes to mind, perhaps a unique inflammatory cytokine that can be distinguished specifically & sensitively early enough to recommend lifestyle change and prevent disease progression.

   But in this case, under this research services agreement, we have VCU researchers working to identify this critical bit of public health knowledge (e.g., identifying a biomarker for emphysema) for the same company that has created the disease - and now controls dissemination of this knowledge. For all we know, the discovery could have been made in 2007 and was never reported.

   Indeed, Macrina refers in the RTD article to data that “belonged” (past tense - game over) to a third party. Should something have been published that was not?

   Why might Philip Morris not want this disseminated? Well, if people were able to learn they were developing emphysema before they were tethered to a tank of oxygen, they might actually be motivated to quit and thus stop buying Philip Morris products and enriching Philip Morris coffers (the source of funds to pay these same VCU researchers).

   A step beyond … remember too that Philip Morris also owns the intellectual property to this discovery - I mean, research service deliverable. Such a discovery could well have implications in terms of the pathophysiological mechanisms of the disease. So now Philip Morris can not only diagnose emphysema early, it also knows where to look in developing therapeutic agents to effectively treat the disease … again, the disease they manufactured and could now profit from at several stages (initiation, diagnosis, treatment).

   And, of course, knowing the expressed protein involved gives a nice clue to the gene(s) involved, so eventually we could have Philip Morris testing all plaintiffs for genetic predisposition to emphysema, which in turn could cause their court case to be tossed out since they would have gotten emphysema even if they didn’t smoke 2 packs of Marlboros a day for 30 years. Nice.

   All this as the potential result of a “research service” to study the “onset of lung disease” performed under the highly restrictive and secretive terms of the research services agreement in effect between VCU and Philip Morris USA. Could have already happened - but we’ll never know.

5. 

   whimple said,

   May 24, 2008 @ 10:20 am

   Well… if NHLBI really cared about this research, they could have paid for it themselves and then it would all be sunnily in the public domain.

   Oh, they are funding research in this area in spades (imagine that, whimple, translational research receiving NIH support!), and I hope these groups achieve and disseminate results before Philip Morris can control any relevant IP. The point here is that this type of true research should not be conducted at a public university as a proprietary “research service” under a gag order imposed by the company. Again, the university in question here should never have signed on to this research services agreement given the nature of the work reportedly being performed. - writedit

6. 

   writedit said,

   May 24, 2008 @ 3:04 pm

   No matter the sponsor, the University of Pennsylvania does not permit the sort of agreement described in the NYT between Philip Morris and VCU (which apparently has several of these agreements with other companies). Penn calls this work what it is: Fee-for-Service (Contract Research) and “Private Business Use of Facilities.” From the Penn Handbook for Sponsored Program Agreements:

   Some research programs will entail fee-for-service or “contract research”. This sort of work often involves analysis, evaluation, or diagnostics assessment that does not represent original research. The concern is that “contract research” is inappropriate as a sponsored research activity at the University. Generally speaking, the type of research conducted at Penn should be, given Penn’s status as a non-profit institution, beneficial to the general public and not solely for the commercial benefit of a Sponsor. Contract research subverts a non-profit research institution’s obligation to do research for the benefit of the public in general.

   The inappropriateness of “contract research” is based on two considerations, which can be generalized as “academic” and “economic”.

   Academic considerations. In the typical “contract research” agreement, the Sponsor controls the scope of the research project, has complete ownership of results and any Intellectual Property (IP), and imposes confidentiality on the University. In addition, publication may be forbidden. Such provisions are unacceptable at Penn for several reasons. Penn must control the research (conduct of the research rests with the investigator) and the results of such research should be made available to the public through publication and presentation.

   Economic considerations. One economic concern is that it is inappropriate for a non-profit institution such as Penn to compete with for-profit organizations; such competition violates Federal (NSF and NIH) policies. Unless Penn owns any IP that is generated, the work could be considered to be contract research. If research is determined to be primarily for the benefit of the Sponsor and not the public, it may be considered “private business use” under IRS Revenue Procedure 97-14, and the research funds received may be subject to the Unrelated Business Income Tax. The restrictions on “private business use” of facilities financed with tax-exempt bonds are part of a larger legal framework that ensures that non-profit institutions perform research for the benefit of the general public and do not unjustly benefit for-profit entities. Too much contract research could jeopardize an institution’s non-profit status. As contract research puts non-profits in direct competition with for-profit research organizations, it can lead to legal disputes with these entities.

   Sponsored Research Agreements should avoid features that could lead to characterization of the arrangement as “contract research.” If a Sponsor defines the nature and scope of a given research project, or if an SRA grants the Sponsor the right to restrict publication of the research, or assigns to the Sponsor intellectual property created in the research, or requires deliverables that will be owned by the Sponsor, such research could be considered “contract research”. In order for research that is funded by for-profit entities to be considered part of Penn’s non-profit activities, Penn must control the research and the results of such research must be freely available to the public. Sponsors may receive certain limited rights, such as an option to negotiate to obtain a license to inventions created in sponsored research.

   So, yes, the agreement reported in the NYT between Philip Morris and VCU is abysmal from the very start in terms of academic integrity, never mind the product line of the sponsor. Shameful. And possibly in violation of tax law given the very real possibility the work being performed is not a narrowly defined service but is in fact original research to generate new knowledge. Due to the secrecy, we can’t know for sure.

   But I bet the IRS would like to know for sure, as would the Virginia Department of Taxation.

   Penn also raises the point of a non-profit (low-cost labor) University being in conflict with for-profit companies to perform research services. Surely there are companies (possibly even some neighbors in BioTech Park) who could perform the well-defined service work for Philip Morris - albeit at a higher cost.

   How much business is VCU taking from local companies in the Richmond area (and others throughout the US) because they can offer cheap access to very expensive tax-payer subsidized experts, equipment, and facilities? (not just to Philip Morris but to the sponsors of the other research services agreements)

   For those Universities that do perform contract research via research services agreements, a tremendous burden is placed on the researcher and sponsor before the agreement can be signed to ensure the work truly is narrowly focused, product-testing types of activities. This is to ensure the University is not in violation of state and federal laws (as noted by Penn above). For example, Oklahoma State University requires the following certification before any research services agreement will be considered:

   CERTIFICATION: We the following undersigned University employees, proposed Project Leader(s), Department Head, and Associate Dean of Research of the College (Division) wherein the Project is to be conducted, verify each of the following statements:

   1. The proposed Project involves only the analysis, evaluation, classification, diagnostics, or interpretation of Sponsor’s data, samples, mechanisms, procedures, products or processes.

   2. The analysis, evaluation, classification, diagnostic, or interpretation services involved in the Project will be done in accordance with the specifications or protocols which have been prepared or supplied by the Sponsor or Sponsor’s duly authorized agent(s). Neither I, nor any other University employee involved in the Project or under my direction, have prepared or provided scientific input into the Project specifications or protocol or if the specification or protocols have been prepared by me, or other University employees involved in the Project or under my direction, said specifications or protocols have been prepared using only Sponsor provided information, specifications, or protocols.

   3. I have not provided, nor will I provide, any basic or applied research in the preparation of or for the proposed Project and I will not provide any basic or applied research in the conduct of the Project. It is not likely that there will be any new knowledge, technologies, or intellectual property that will be developed by University employees in the performance of the scope of the proposed Project.
   
   4. The conduct of the proposed Project will not involve or employ the use of any inventions or technologies learned, created, or developed under federally-sponsored or privately-sponsored research projects or grants in which I have been involved. A check has been made of my past and current grants and/or research projects and there do not exist any conflicting or inconsistent contractual arrangements that would prevent the University from entering into this proposed Research Services Agreement or burden or otherwise impede past and/or current grants or contractual arrangements with other parties.

   5. I have read, am knowledgeable of, and will honor the confidentiality obligations of the Project and will inform and ensure compliance with said obligations by all University employees, including students, working on or with the Project under my direction. If there are students that will be working on the Project, I have advised them of the limitations on publication(s).

   No mention of any such certification has been made at VCU, and no such form exists on the Office of Research Website (indeed, no templates for any industry research agreements or research services agreements). Note the emphasis on the belief that no intellectual property will be generated, which should always be true for work conducted under a research services agreement. Contrast this with the rationale given by VCU for accepting the publication restrictions. In the example of the waste water treatment, if VCU were simply analyzing the water to determine levels of nitrogen & phosphorus, fine - a well-defined, straightforward research service (yet surely one that could be performed at a local or regional company). But, Solana says they are “studying … how to reduce nitrogen and phosphorus drained into rivers from processing tobacco leaves” - original research that will generate IP … not fine.

   Note also the concern that all participants confirm that they do not have and have never had extramural grant funding to perform the same sort of work that is being requested as part of the research service agreement. If a University researcher is being asked to perform a service for a company, this request usually comes because said researcher has expertise in the area - and may well have received NIH, NSF, DoD, or other federal, nonprofit, or private grant funding to do similar work.

   Would a check of the VCU faculty conducting the Philip Morris-sponsored “research services” turn up evidence of past or current federal or other grant funding in the same line of work? Because it’s all a secret, we can’t know this.

   But I bet the US DHHS Office of the Inspector General might like to know.

7. 

   writedit said,

   May 27, 2008 @ 2:09 am

   Actually, the NYT editorial is short, so let’s think a little harder about why universities - especially academic medical centers - and tobacco companies don’t mix ….

   May 27, 2008
   Editorial
   Virginia Commonwealth’s Secret Deal

   While most universities are struggling to ensure that any research supported by industry remains free of corporate control, it is shocking to find Virginia Commonwealth University going in the opposite direction. It has signed a contract to do research for Philip Morris that gives the company the final say over what results, if any, can be published.

   The contract also stipulates that the university cannot respond to any news media inquiries about the deal and must promptly notify Philip Morris. That effort to hide this unsavory bargain fell apart when The Times’s Alan Finder obtained a copy under Virginia’s Freedom of Information Law.

   University officials say the restrictions on publishing research are designed to protect the company’s proprietary information. However, the contract defines all material created by the university as the company’s proprietary information — so Philip Morris will always have the final say. The first two research tasks, according to the company, involve identifying early warning signs of pulmonary disease and reducing nitrogen and phosphorus runoff from tobacco processing plants.

   At least 15 public health and medical schools, including schools at Harvard and Johns Hopkins, no longer accept tobacco money, mostly because of the industry’s history of warping research to promote smoking. Other schools, including Stanford and the University of California system, rejected bans after extensive debate.

   Virginia Commonwealth is getting only $286,000 from Philip Morris this year, roughly a tenth of a percent of its total research grants. There is speculation that the university — a public institution based in Philip Morris’s hometown of Richmond — is hoping to entice the company to support other university functions. Nothing justifies this abandonment of academic freedom.

   Schools that accept tobacco money need to be sure that their scientists have the final say in designing studies, interpreting the results and publishing the findings. Anything less undermines the credibility of their scientists’ research — and the integrity of their universities.

   Since the Roanoke Times editorial is similarly concise & well articulated:

   Sunday, May 25, 2008
   Editorial: VCU’s deal with the devil

   A public university shouldn’t sign over its rights — or those of its faculty members — to win research funding from any industry.

   It isn’t clear how much research money Virginia Commonwealth University received from Philip Morris USA.

   But whatever the amount, it could not be worth the price paid by the public university, which signed a deal with the devil to get the cash.

   The New York Times obtained a copy of the contract through the Virginia Freedom of Information Act. In exchange for an undisclosed amount of money (apparently less than $1.3 million), VCU signed over its researchers’ academic freedom.

   Professors cannot publish the results of their research, or even discuss the research with a third party, without permission from Philip Morris.

   Most of the fruits of the research — patents and intellectual property — will go to the company. The arrangement is extremely troubling, especially for a public university.

   Sheldon Krimsky, a professor at Tufts University who is an expert on corporate influence on medical research, told The Times, “When universities sign contracts with these covenants, they are basically giving up their ethos, compromising their values as a university. There should be no debate about having a sponsor with control over the publishing of results.”

   Indeed, there appears to have been little debate at VCU, despite the fact that the arrangement violates the university’s own rules and standards — which require ensuring that professors and students are free to publish results of research they conduct.

   The guidelines for industry-sponsored research also mandate that the university retain patents and intellectual property rights.

   “There is restrictive language in here,” Francis L. Macrina, Virginia Commonwealth’s vice president for research, told The Times. “In the end, it was language we thought we could agree to. It’s a balancing act.”

   There is no balance, though. The power all rests with Philip Morris. It gets the legitimacy conferred by research conducted by a public university without sacrificing any control.

   The Times performed an invaluable public service by exposing this contract, which had gotten little notice and no debate among the university’s faculty.

   That debate should start now. Scientific inquiry at a public university should not be a business undertaking.

   If Philip Morris — or any other corporation — wants such restrictions, it should find private consultants to do the work.

   And VCU should look for research funding that comes with fewer strings — and no acrid smell of sulphur (or is that just tar and nicotine?).

8. 

   BB said,

   May 27, 2008 @ 12:15 pm

   My ethically-challenged university in ethically-challenged NJ doesn’t accept tobacco funding.

   Maybe VCU will be last-U standing with regard to tobacco funding; when outside-VCU scientists can no longer collaborate with VCU scientists because of PM’s hold on data, we may see some changes.

9. 

   writedit said,

   May 27, 2008 @ 11:51 pm

   So, the Altria Annual Shareholders Meeting is in Richmond today, which should make it very convenient for all the stockholders on the VCU Medical Center Campus (aka MCV Campus), including those in BioTech Park (home of the Philip Morris Center for Research and Technology), who will only need to walk a couple of blocks to attend.

   Perhaps they will have in hand an alleged request reported to me from several independent sources for major Philip Morris funding ($30 million? VCU definitely couldn’t settle for anything less than what PM gave to UVa last year) of a center to research the causes of disparities in infant mortality rates and poor pregnancy outcomes in the City of Richmond. Perhaps such research might find that genetics and poor oral hygiene play a greater role than prenatal smoking.

   How ironic that Philip Morris might now be concerned about the health of two of its most heavily targeted consumer markets: women and African Americans. Toss in adolescent girls while we’re at it.

   Addendum: I should note that if Philip Morris wishes to, as a good corporate citizen, donate $30 million directly to local nonprofit community organizations (e.g., Healthy Start) who provide front-line services to underserved women in need of better pre- and postnatal care, I would applaud their generosity. What I do not want to see is their gaining academic legitimacy through affiliation with articles published and presentations made by VCU researchers or, worse, misusing these findings to downplay the harms caused by their tobacco products through comparison with other contributors to preterm birth and infant mortality and thus perpetuate its muddling of the public policy decision-making process.

10. 

    dramatist said,

    May 28, 2008 @ 9:12 am

    dramatist says : I absolutely agree with this !

11. 

    ram fan said,

    May 28, 2008 @ 9:32 am

    According to Style Weekly Trani has received more than $1 million from big tobacco. Wow!

    http://www.styleweekly.com/article.asp?idarticle=17075

    Thanks for contributing this, ram fan. To my mind, the most startling part of this piece is the ignorance of (or lack of concern about) the issues at play here:

    “But Trani, VCU’s president, has gotten more from the tobacco industry than a million bucks. In fact, Trani is the tobacco industry.

    As a member of the board of directors of Universal Corp. [leaf tobacco merchant and processor], Trani receives an annual retainer of $40,000, including stock options. He also receives a fee of $2,000 for each board of directors’ meeting he attends and another $1,500 for attending committee meetings. …

    “I don’t see any connection between these two,” university spokeswoman Pam Lepley says. “And his being on the board doesn’t really pertain to the university.””

    Perhaps she should attend Dr. Macrina’s RCR lecture on conflict of interest.

12. 

    writedit said,

    May 29, 2008 @ 12:17 pm

    For an outstanding review of the many - and snowballing - unethical facets of the VCU-PM situation in Richmond, please see this commentary by an adjunct professor in the VCU School of Medicine Dept of Internal Medicine.

    Also an older blog commentary on why there is no academic freedom in partnering with the tobacco industry, and this excellent coverage of the tobacco industry’s manipulation of both the scientific community & public perception of their products.

13. 

    ram fan said,

    May 31, 2008 @ 6:30 am

    An interesting post from Sept 07 -
    http://www.prwatch.org/node/6434

14. 

    writedit said,

    June 1, 2008 @ 12:28 am

    Sent to me from various alert readers …

    Columnist from the Richmond Times-Dispatch who gets it:
    http://www.inrich.com/cva/ric/news.apx.-content-articles-RTD-2008-07-01-0059.html

    A bit more on the PM agreement as part of a discussion of the improperly awarded undergraduate degree at VCU: http://www.insidehighered.com/news/2008/06/30/vcu

    CDC is monitoring this situation … http://www2.cdc.gov/phlp/weeklynews.asp

    Must-read commentary on industry non-disclosure statements etc.:
    http://trickledown.wordpress.com/2008/05/24/the-ethics-of-non-disclosure-agreements/

    Commentary by Anne Landman in Richmond Paper: http://www.styleweekly.com/article.asp?idarticle=17152

    Excellent new editorial (June 2): http://www.dailypress.com/news/opinion/dp-ed_vcu_edit_0602jun02,0,7650644.story

    Really great research-savvy encapsulation of the situation: http://www.democraticcentral.com/showDiary.do?diaryId=2149

    Someone concerned with important research not conducted publicly:
    http://www.ohpurleese.com/month_archive_54.htm#27MAY08

    The Scientist commentary:
    http://www.the-scientist.com/blog/display/54668/

    Genome Technology short take:
    http://www.genome-technology.com/issues/blog/general/147077-1.html

    UVa talked with NYT - clean dealings:
    http://www.c-ville.com/index.php?cat=141404064432695&ShowArticle_ID=11430206083644787

    Contrasting VCU-PM dealings with a local issue in KY:
    http://www.courier-journal.com/apps/pbcs.dll/article?AID=/20080528/COLUMNISTS08/805280808

    Missing the University mission: http://www.501cfiles.com/missing-the-mission-a-university-sells-out-to-big-tobacco/

    Joe Camel Meets Academia (in this case, the Marlboro Man):
    http://www.lasvegassun.com/news/2008/may/27/joe-camel-meets-academia/

    Another short local take:
    http://www.rvamag.com/view_post.php?post_id=856&PHPSESSID=f9e5f7140327a1aeff3ff394499c1faf

    http://digg.com/general_sciences/Virginia_Commonwealth_University_in_Bed_with_Philip_Morris

15. 

    » Blog Archive » A Worse Variant of a New Species of Conflict of Interest said,

    June 1, 2008 @ 9:45 am

    [...] turns out that VCU has more extensive ties to the tobacco industry. In particular, first the Medical Writing, Editing and Grantsmanship blog, then the Richmond, VA publication Style Weekly reported that the president of VCU, Eugene Trani, [...]

16. 

    writedit said,

    June 1, 2008 @ 4:57 pm

    Just tidying up the main post …

    Update: NYT Editorial: The Editors of the NYT have picked up on the VCU-Philip Morris agreement story (May 22, commentary below). In today’s paper (May 27), the editorial Virginia Commonwealth’s Deal carries the summary line: “Most universities are struggling to ensure that their research supported by industry remains free of corporate control. Unfortunately, Virginia Commonwealth University is going in the opposite direction.” I would urge anyone who is concerned with how the University is handling this situation (attacking the NYT rather than making the agreement and project descriptions available to the faculty and rest of the public) contact the NYT in support of their (the NYT’s) coverage and in gratitude for their public service in bringing this agreement to light.

    Update: This concise editorial captures the major issues of concern in the academic community, such as: “The Times performed an invaluable public service by exposing this contract, which had gotten little notice and no debate among the university’s faculty. That debate should start now. Scientific inquiry at a public university should not be a business undertaking.”

17. 

    writedit said,

    June 3, 2008 @ 7:31 pm

    A new article in a local paper (Richmond Style Weekly) highlights the fear of the faculty at VCU to speak out against the research services agreement and/or the partnership between VCU and Philip Morris (about which they were not told before the NYT story broke). The Style Weekly reporter also provides additional detail on a request by the Dean of the VCU School of Medicine, Jerry Strauss, for Philip Morris funding of research on health disparities in women … or whatever Philip Morris will pay him to do, it seems.

    In this same issue, Anne Landman comments on the inappropriate linkage of a university with big tobacco.

18. 

    writedit said,

    June 18, 2008 @ 12:38 am

    I need to correct the blog with regard to Macrina’s relationship with the Tobacco Institute for which a query last year to the Legacy Tobacco Documents Library was not resolved - until now, since obviously my interest in this matter has been rekindled. A Legacy Library document from the Tobacco Institute files suggests he was on their Scientific Advisory Board, a fact that would not be surprising given the very active testimony by other VCU faculty on behalf of the Tobacco Institute refuting peer-reviewed reports of harm caused by second-hand smoke (e.g., Raphael Witorsch, in many depositions and formal communications such as this). However, the grouping of scientists on aforementioned Scientific Advisory Board is odd, and Macrina is the very odd man out – especially since it turns out this is part of a larger document describing the subcommittee of EPA panel examining indoor air quality that focused on total human exposure to environmental tobacco smoke. (and a bench science microbiologist would be included here because …?) I have sent another comment to the Legacy Library suggesting they include this Board’s affiliation with EPA in the document heading or title in the database.

    But, the story does not end there. Macrina did interact regularly with a charming character at Philip Morris named Thomas Osdene, PhD, as documented in Osdene’s personal notebooks: e.g., in 1983, see #6 about three-quarters down the page, under RAC meeting at MCV (Medical College of Virginia or the VCU medical school), and 1984, see 2nd-3rd lines, which include Macrina’s office number confirming he is the person Osdene called (to answer the question, was PM hiring?).

    Osdene became involved with the company’s Environmental Tobacco Smoke (ETS) Advisory Group and the Center for Indoor Air Research (CIAR). Thus, he still may have had a hand in placing Macrina’s name on the above-mentioned EPA indoor air quality Scientific Advisory Board given that Macrina was a microbiologist studying oral bacteria (not the sort of expertise the EPA would have sought out for this panel). In addition, 2 members of this EPA Scientific Advisory Board are identified as members of Osdene’s CIAR. One wonders if Macrina even knew about this, actually. So, still something not quite right here in a tobacco sort of way, but not directly involving the Tobacco Institute other than their monitoring of this Board’s activities.

19. 

    A Worse Variant of a New Species of Conflict of Interest | Womenhealth said,

    June 24, 2008 @ 3:11 am

    [...] turns out that VCU has more extensive ties to the tobacco industry. In particular, first the Medical Writing, Editing and Grantsmanship blog, then the Richmond, VA publication Style Weekly reported that the president of VCU, Eugene Trani, [...]

20. 

    writedit said,

    June 24, 2008 @ 10:33 pm

    Trani’s Tobacco Ties Hurt MCV’s Reputation

    Anne Landman (”Tobacco U.,” Back Page, June 4) has raised a serious concern regarding Virginia Commonwealth University President Eugene Trani’s 6,250 shares of common stock in Universal Corp., described as “the country’s largest purchaser and supplier of tobacco leaf” and VCU’s research contract with Philip Morris USA.

    No medical college president should be on the payroll of a tobacco company at $40,000 a year plus $2,000 for each appearance on behalf of tobacco interests. Beyond the smoke and mirrors of a research-services agreement and investigator-initiated research, why did it take the nation’s newspaper, The New York Times, to reveal this ungainly conflict of interest? Is this not a Richmond concern? Is investigative reporting dead in Richmond, or available on a select basis?

    Patient confidence in medical protocols and outcomes is severely compromised when cancer treatments are performed as an adjunct to legally binding contractual agreements with manufacturers of a known and deadly carcinogen. You can’t have it both ways. Either there is a commitment to treat and eradicate cancer, or you participate in something that knowingly causes cancer and is marketed with the express knowledge that the user will die from using the product.

    Any notion of a pending Philip Morris Women’s Health Center at VCU is a vile insult to all women. Female mortality rates have soared solely due to tobacco consumption. How long will it take before medical-college admissions severely decline as students become aware that VCU-MCV is controlled (owned) by tobacco interests? Isn’t there anyone willing to protect the state’s investment? Let’s get the fox out of the henhouse. VCU — a taxpayer-funded entity — is not for sale at any price. Does Gov. Kaine need to clean house and appoint a new proactive board of visitors? In addition, does this need General Assembly action? Perhaps now is the time for the Medical College of Virginia to regain its name and reputation — and not be relegated as a health-sciences division or medical center in the interest of leadership — that will provide no further embarrassment to the commonwealth. Forty-nine other states are watching.

    Ronald Amon

    *****

    For every $40,000 Philip Morris gives, someone dies. That is the grim math of a product that, used exactly as intended, kills customers, and at a now highly predictable rate. About 20 billion packs are sold every year in the U.S. resulting in about 500,000 deaths. That comes to about 40,000 packs per death; those 40,000 packs don’t cause that death in that same year, but over time, it is accurate to say that for every 40,000 packs sold, someone dies. It turns out that Philip Morris makes about a dollar a pack profit, so the math works out simply and neatly: for every $40,000 Philip Morris gives for science funding, someone dies. It’s that simple. There is no other place Philip Morris gets the money from. There is no way the product can be consumed less lethally. The fact is, if Philip Morris gives $1 million of science funding to the University, 25 people had to die for that. That’s where the money came from.

    — Jonathan Krueger

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