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Retraction Watch. It's a blog run by two science writers, and one of them is doctor. They look for and write about retractions and changes to articles in scientific journals. The "why" is obvious in some ways and not so obvious in other ways - they explained their mission in their opening post. 

Yesterday, Retraction Watch posted a story involving asbestos and sponsored research. In this instance, there was no retraction. Instead, four articles - all from one journal - were modified to insert disclosures that the research work had been funded for litigation, and that the authors had been or would be working as consulting or testifying expert witnesses in asbestos litigation. The lessons seem apparent.

The disclosure states: 

"The publisher would like to apologise on behalf of the authors of the following 4 articles published in Inhalation Toxicology.

1. Brorby, Sheehan, Berman, Green, Holm, Re-Creation of Historical Chrysotile-Containing Joint Compounds, Inhalation Toxicology, 20: 1043–1053 (2008).

2. Bernstein, Donaldson, Decker, Gaering, Kunzendorf, Chevalier, Holm, A Biopersistence Study following Exposure To Chrysotile Asbestos Alone or in Combination with Fine Particles, Inhalation Toxicology, 20: 1009–1028 (2008).

3. Bernstein, Rogers, Sepulveda, Donaldson, Schuler, Gaering, Kunzendorf, Chevalier, Holm, The pathological response and fate in the lung and pleura of chrysotile in combination with fine particles compared to amosite asbestosfollowing short-term inhalation exposure: interim results, Inhalation Toxicology, 2010, 22(11) 937–962 (2010).

4. Bernstein, Rogers, Sepulveda, Donaldson, Schuler, Gaering, Kunzendorf, Chevalier, Holm, Quantification of the pathological response and fate in the lung and pleura of chrysotile in combination with fine particles compared to amosite-asbestos following short-term inhalation exposure, Inhalation Toxicology, 2011; 23(7):372–391 (2011).

Since publication of these 4 articles we have had a request to add the following information to the Declaration of Interest section of each paper.

The additional statement reads:

“Georgia-Pacific has not sold chrysotile-containing joint compounds for more than 30 years, but litigation is pending in which individuals claim exposure to the Company’s historic products. The articles listed above report on work that Georgia-Pacific commissioned to address issues that have arisen in that litigation. I, Stewart E. Holm, representing Georgia-Pacific, am an author on all four papers. The other authors are consulting experts retained by or on behalf of Georgia-Pacific to conduct the research and prepare the articles. Dr. Donaldson has been listed as potential testifying expert witness by Georgia-Pacific, and Dr. Bernstein has testified as an expert witness for Georgia-Pacific.”

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As we move further and further into an age of massive information sharing, it is logical that "sponsored research" remains a focal point in litigation over alleged or actual physical injuries and disease processes that evolve over time. More specifically, the pressures are growing as to medical advisors and disclosures involved in researching and communicating scientific information related to evolving disease processes and injuries. The pressures include assertions that information must be fully disclosed and should be evaluated by medical advisors who are leading experts in the area, and do not labor under conflicts of interest, whether "real" or "perceived." 

The most recent example I've seen arises in a new class action involving NFL players and concussions. The lawsuit is now pending in Philadelphia, and was filed filed by the Locks Law Firm, a significant national plaintiff's firm. The online press release also is pasted below. Note especially that the description chosen by plaintiff's counsel includes a focus on "sponsored research" and alleged conflicts of interest effecting medical professionals. 

PHILADELPHIA, Jan 19, 2012 (BUSINESS WIRE) -- Locks Law Firm attorneys Gene Locks, Michael Leh, and David Langfitt filed a class action lawsuit yesterday in Philadelphia against the NFL on behalf of all former NFL players, including seven named players and four spouses, all of whom are the class representatives. The named players include former Philadelphia Eagles Ron Solt, Joe Panos, and Rich Miano. The suit charges that the NFL and other defendants intentionally and fraudulently misrepresented and/or concealed medical evidence about the short- and long-term risks regarding repetitive traumatic brain injury and concussions and failed to warn players that they risked permanent brain damage if they returned to play too soon after sustaining a concussion.

Ron Solt, age 50, was an all-star guard for the Eagles from 1988 to 1991 and also played for the Indianapolis Colts, playing 10 seasons in all from 1984 to 1993. He suffered at least one concussion during an NFL game while with the Eagles, as well as multiple head traumas and concussions during practice that were never medically diagnosed. He now suffers from substantial memory loss and persistent ringing in his ears.

Joe Panos, age 41, played as an offensive lineman in the NFL from 1994 to 2000 and was with the Eagles from 1994 to 1997. He sustained concussions while with the Eagles and Buffalo Bills. He currently experiences headaches, memory loss, irritability, rage, mood swings, and, sleeplessness.

Rich Miano, age 49, played as a defensive back for 10 seasons in the NFL between 1985 and 1995 and was with the Eagles from 1991 to 1994. He is now associate head coach of the University of Hawaii football team. He sustained at least one concussion while playing but is currently asymptomatic.

Gennaro DiNapoli, age 36, was an NFL center and guard from 1998 to 2004 who sustained repeated head impacts during his NFL career. He suffers from severe depression, memory loss, headaches, anxiety and mood swings.

Adam Haayer, age 34, was an offensive lineman from 2001 to 2006 for four teams. He had at least four concussions or concussion-like symptoms and deals with memory loss, depression, and anxiety.

Daniel Buenning, age 30, played as an offensive lineman in the NFL for four seasons from 2005 to 2008. He suffers from substantial memory loss, depression, trouble with concentration, short attention span, and mood swings.

Craig Heimburger, age 34, played on the offensive line for four teams between 1999 and 2002. He sustained multiple head impacts and concussions and suffers from dizziness, memory loss, and intense headaches.

Also named in the complaints were the wives of several players including Lori Miano, Summer Haayer, Ashley Buenning, and Dawn Heimburger.

"This action is necessary because the NFL knew about the debilitating and permanent effects of head injuries and concussions that regularly occur among professional players, yet ignored and actively concealed the risks," according to Locks.

The suit from Locks Law attorneys Gene Locks, Michael Leh and David Langfitt charges that the NFL voluntarily joined the scientific research as well as public and private discussions regarding the relationship between concussions and brain impairment when it created the Mild Traumatic Brain Injury (MTBI) Committee in 1994. Rather than naming a noted neurologist to chair this committee, it appointed Dr. Elliott Pellman, a rheumatologist who was a paid physician and trainer for the New York Jets, a conflict of interest, and had training in the treatment of joints and muscles, not head injuries. While the committee was established with the stated purpose of researching and lessening the impact of concussions on NFL players, it failed to inform them of the true risks associated with head trauma.

"Although athletes who suffered brain trauma in other professional sports were restricted from playing full games or even seasons, NFL players with similar head injuries were regularly returned to play with devastating consequences," according to Locks.

The suit was filed in U.S. District Court for the Eastern District of Pennsylvania. It seeks medical monitoring, compensation, and financial recovery for the short-term, long-term, and chronic injuries, financial and intangible losses, and expenses for the individual former and present NFL players and their spouses.

Locks Law Firm ( http://www.lockslaw.com ) also plans to file additional suits on behalf of other NFL players in the upcoming weeks.

About Locks Law Firm:

With a litigation team of 23 personal injury attorneys and nearly 100 outstanding legal professionals and auxiliary staff members, Locks Law Firm serves plaintiffs and is dedicated to victims of corporate neglect and malfeasance. The firm, with offices in Philadelphia, New York, Cherry Hill, NJ, and Englewood Cliffs, NJ, is known for groundbreaking verdicts and settlements in mesothelioma, asbestos, pharmaceutical, mass tort, personal injury, and product liability cases. For more information, please visit LocksLaw.com.

SOURCE: Locks Law Firm

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Good science depends on access to full data. A new study from the University of California at San Francisco highlights the point. In this instance, scientists wondered about the accuracy of peer-reviewed papers purporting to show relatively modest carcinogenic effects from tobacco additives. The earlier paper resulted from a study the tobacco industry called Project MIX.

So, how to figure out the truth about the results of Project MIX ? The UCSF scientists used research techniques to wade through 60 million pages of now-published tobacco industry documents obtained through litigation. The wading resulted in finding 500 key documents, including documents regarding Project MIX. The UCSF scientists analyzed the documents and the data. Guess what? Their conclusion is that the data had been manipulated when published. The manipulations, they say, lowered or hid the cancer-causing effects of numerous additives, including menthol.

The new paper also address a second question. How did the manipulated paper make it into peer-reviewed literature?  Answer? The industry data was published in a journal for which they found myriad links to the tobacco industry.  Indeed, according to the paper:   "The scientist and leader of Project MIX Edward Carmines described the process of publication as "an inside job.""  

The UCSF paper also is noteworthy for a third reason. The authors published in on PLoS so the full text of the article is freely available in full text.  And, even better, the article is supported by online links to images of the papers they cite in their paper. So, it's no longer a game of  creating spin. Instead, the evidence is laid out for all to see.  

What did the UCSF researchers conclude - here's the short version: 

"What Do These Findings Mean?

These findings show that the tobacco industry scientific research on the use of cigarette additives cannot be taken at face value: the results demonstrate that toxins in cigarette smoke increase substantially when additives are put in cigarettes. In addition, better powered studies would probably have detected a much broader range of adverse biological effects associated with the additives than identified to those identified in PM's published papers suggesting that the published papers substantially underestimate the toxic potential combination of cigarette smoke and additives.

Regulatory authorities, including the FDA and similar agencies elsewhere who are implementing WHO FCTC, should conduct their own independent analysis of Project MIX data, which, analyzed correctly, could provide a strong evidence base for the elimination of the use of the studied additives (including menthol) in cigarettes on public health grounds." 

In short, more reasons to wonder why modern studies are allowed to be published without putting full data online. One might also wonder why the tobacco industry is allowed to exist. 

The full article is freely available in full text at this page of PLoS - the Public Library of Science. Set out below is a larger section of the key, summary portion of the article.  But the full article is well worth reading. And, again, note that UCSF authors provide online links to actual, complete  images of the underlying documents they cite in their paper. Now that's good science !!

"What Did the Researchers Do and Find?

The researchers systematically examined tobacco industry documents in the University of California San Francisco Legacy Tobacco Documents Library (then about 60 million pages made publicly available as a result of litigation) and used an iterative process of searching, analyzing, and refining to identify and review in detail 500 relevant documents.

The researchers found that in the original Project MIX analysis, the published papers obscured findings of toxicity by adjusting the data by total particulate matter (TPM) concentration. When the researchers conducted their own analysis by studying additives per cigarette (as was specified in the original Project MIX protocol), they found that 15 carcinogenic chemicals increased by 20%. The researchers also reported that, for unexplained reasons, Philip Morris deemphasized 19 of the 51 chemicals tested in the presentation of results, including nine that were substantially increased in smoke on a per cigarette basis of additive-added cigarettes, compared to smoke of control cigarettes.

The researchers explored the possibility that the failure of Project MIX to detect statistically significant changes in the toxicity of the smoke from cigarettes containing the additives was due to underpowered experiments rather than lack of a real effect by conducting their own statistical analysis. This analysis suggests that a better powered study would have detected a much broader range of biological effects associated with the additives than was identified in Philip Morris' published paper, suggesting that it substantially underestimated the toxic potential of cigarette smoke and additives.

The researchers also found that Food and Chemical Toxicology, the journal in which the four Project MIX papers were published, had an editor and 11 of its International Editorial Board with documented links to the tobacco industry. The scientist and leader of Project MIX Edward Carmines described the process of publication as “an inside job.”

What Do These Findings Mean?

These findings show that the tobacco industry scientific research on the use of cigarette additives cannot be taken at face value: the results demonstrate that toxins in cigarette smoke increase substantially when additives are put in cigarettes. In addition, better powered studies would probably have detected a much broader range of adverse biological effects associated with the additives than identified to those identified in PM's published papers suggesting that the published papers substantially underestimate the toxic potential combination of cigarette smoke and additives.

Regulatory authorities, including the FDA and similar agencies elsewhere who are implementing WHO FCTC, should conduct their own independent analysis of Project MIX data, which, analyzed correctly, could provide a strong evidence base for the elimination of the use of the studied additives (including menthol) in cigarettes on public health grounds.

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Law professors and amicus briefs are very much a part of the litigation industry. A recent example is here from am amicus brief on ATS issues. Now, here's this new Opinio Juris post/essay with thoughts from a larger article on when and how law professors should or should not participate in amicus briefs. The post includes links to other related writings and blog posts. 

Further questions also can be raised. Should amicus briefs be viewed as "sponsored research?"  Should there be disclosure of all past and current economic interests? 

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Update

This August 29, 2011 Financial Times article by Andrew Jack  provides an update on big pharma, litigation, disclosures and graphics on disclosed payments to doctors.

____________________________________________________________________

Kudos to two Duane Morris defense lawyers for this  pragmatic, new  National Law Journal article about industry sponsored research. The entire article should be read.  Hopefully you can be enticed to do that by this excerpt from their concluding section:

"To potentially alleviate concerns and criticisms of corporate-funded research, researchers may be required to share data and support the study's reliability in regulatory and judicial proceedings. Such openness about funding, methodology and results can help curb common criticisms regarding lack of transparency. By increasing access to privately funded data with appropriate safeguards, corporations can improve their standing with the public as well as in courtrooms across the United States. 

Corporate-sponsored research has in many instances become an indispensable aid to the advancement of knowledge in the scientific community. The stigmatization of corporate-sponsored research should not dissuade corporations and industries from continuing to invest in research, both inside and outside of the litigation context. Corporate litigants should consider taking on courts and opposing parties directly and challenging the judicial system to evaluate the merits of the studies under the standards set forth by the Supreme Court in Daubert and its progeny — regardless of the financial backing. 

Kenneth M. Argentieri is the co-chairman of the products liability group at Duane Morris and is based in the firm's Pittsburgh office. Gerald J. Schirato Jr. is a litigation associate in that office."

Sponsored research is a topic many times covered on this blog, with an emphasis on the need for disclosure and transparency - click on the "sponsored research"  topic (to the right) to see the collection. Some of the posts collect scientific articles on the subject. 

Transparency is indeed crucial. Transparency builds trust, and today, trust is a waning asset for much of corporate America, as well as government.  Over the next few years, it will be interesting to see how many such entities will follow the Duane Morris advice to share research data and disclose all payments. 

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As trust breaks down, demands increase for disclosure. Accordingly, fascinating things are happening in the US as Dodd-Frank act regulators involved with financial institutions are required to disclose meetings with constituents, such as the regulated entities and "public interest groups."  The Conglomerate blog includes this informative post to provide a primer - and much more - on the developments.  In the post, Kim Krawiec ( a Duke law professor) provides a great overview of the nature of the disclosures and the big picture view of the information revealed as of early this month. This is interesting work on an area that undoubtedly will grow in prominence. 

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Must economists and law professors disclose financial interests and conflicts of interest when they write ? Common sense says:  of course they must disclose.

History, however, shows that myriad economists and some Wall Street denizens fail to recognize or disclose conflicts of interest. An especially biting view is laid out in this wonderful post by the Epicurean Dealmaker.

But, amazingly, the disclosure topics are just now being aired by some. As to law professors,  consider this post by Erik Gerding at the Conglomerate. As to economists, consider Sewell Chan's  NYT article, also covered by Mr. Gerding. Stunningly, Mr. Chan's article reports that some economists claim to be scientists but do not want to disclose their financial sources or conflicts of interest. Mr. Chan's article also includes this key excerpt on an upcoming book:

"Since economics emerged as a modern discipline in the late 19th century, its practitioners have resisted formal ethical codes, said George F. DeMartino, an economist at the Josef Korbel School of International Studies at the University of Denver.

In “The Economist’s Oath: On the Need for and Content of Professional Economic Ethics,” to be published in January, Mr. DeMartino describes concerns dating to the 1920s about the influence of business on economic research, and cites multiple calls within the association for a code of conduct — all of which have been rebuffed."

I cannot grasp a view which says its OK not to disclose conflicts of interest, especially when it comes to sponsored research, a topic highlighted by Mr. Gerding's post and a movie on the  financial fiasco, Inside Job. Indeed, does one really need to think long about this topic after remembering that sponsored research generated by the tobacco industry  was used to create millions of excruciating cancer deaths through decades of false doubt about whether cigarettes cause cancer ?  Indeed, as described here, some publishers will no longer accept research paid for by tobacco money. Or, consider other examples of the problems flowing from undisclosed "sponsored research," a topic covered in various posts collected under that topic on the right hand side of this blog. 

One also might think that those who fail to disclose may soon find themselves as targets in "aiding and abetting" litigation. The topic of aiding and abetting liability was previously covered here, and recently has been made more prominent by aiding and abetting claims related to Madoff's Ponzi scheme. 

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Medical research often is  "sponsored by industry," for obvious reasons. And, in general, more research is good. There are, however,  said to be "controversies " about whether all medical study information should be required to be publicly published. The topic occasionally  has been covered on this blog under the category of "sponsored research," which is available on the right side of the home page.

Now, we have scientists studying the subject and publishing objective data. The results? The authors call the results "stunning" in terms of a propensity to publish favorable data.

Specifics ? ScienceDaily brings this new article created from this press release regarding this full article.

Conclusion? Seems like publishing all research data would be a much better practice. And, publishing all data certainly would make it harder for plaintiffs to later claim that "industry" suppressed "data."

Here are key excerpts from the ScienceDaily article:

"Overall, allowing for a three-year lag time from the completion of the trial, two-thirds of the trials had published results. The industry-funded trials reported positive outcomes 85 percent of the time, as compared with 50 percent for government-funded trials and 72 percent for trials funded by nonprofits or non-federal organizations. In addition, among the nonprofit/nonfederal trials, those that had industry contributions (nearly half) were more likely than those without to report positive outcomes (85 vs. 61 percent). These differences were all statistically significant.

The researchers acknowledge that the pharmaceutical industry was probably more selective in which trials it funded, helping to account for their greater proportion of favorable outcomes. "Industry is very good at knowing what they want to study, and industry-sponsored studies are more efficient and well funded," says Bourgeois, the study's first author. "But despite these potential biases, this is a stunning result.""

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Sponsored research is a short-hand term for situations in which researchers also receive payments from pharma or other entities.  Lots of positions are taken on the topic, and the area is fraught with arguments about what is "good,"  "right,"  and "practical."

The topic has new grist for argument now that ScienceDaily for March 20 brings news of a study from Mayo Clinic doctors regarding the links between positive medical reviews and payments from pharma. The article certainly provides disquieting news on undisclosed conflicts of interest. The overall numbers make one stop and think, but overgeneralzing seems not wise.

"ScienceDaily (Mar. 20, 2010) — Virtually all (94%) of the scientific authors who provided positive results for the anti-diabetic drug rosiglitazone had financial relationships with pharmaceutical companies, according to research published online in the British Medical Journal. 

While the study acknowledges that financial relationships may not necessarily be the reason for positive research results, it concludes that further reform is needed to ensure trust in scientific work.

In 2007, a large scale review of rosiglitazone showed that use of the drug led to a significant increased risk of heart attacks. This in turn led to further studies and commentaries by scientists about the safety of rosiglitazone. Policies were also developed to encourage disclosure of such financial conflicts of interest.

But whether these policies have made any impact on the association between financial conflicts of interest and views expressed in scientific reports is still unknown.

So researchers at the Mayo Clinic in the USA assessed over 200 articles on rosiglitazone to explore a possible link between authors' financial conflicts of interest and their views on the safety of the drug.

They found that almost half of the study authors (45%) had financial conflicts of interest and almost a quarter of these (23%) did not disclose this information. Three studies included in the latter group published a statement declaring no conflicts of interest.

Almost all (94%) authors who had favourable views on the safety of rosiglitazone were more likely to have a financial conflict of interest with a pharmaceutical company than were authors who had unfavourable views.

The researchers conclude by saying: "Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors' expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies."

"These findings, while not necessarily causal, underscore the need for further progress in reporting in order for the scientific record to be trusted," they add."

The article's citation is:

A. T Wang, C. P McCoy, M. H. Murad, V. M Montori. Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review. British Medical Journal, 2010; 340 (mar18 1): c1344 DOI: 10.1136/bmj.c1344

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A hat tip to David Zaring at The Conglomerate for this post that covers some interesting ground regarding "risk" issue, including regulatory issues and issues regarding product liability and other tort claims. One part of the post also covers a new book on the safety - or lack of safety - of imports into the US

Of perhaps greatest interest, the post educated me to an upcoming (Dec. 6-9) seminar in Baltimore by The Society for Risk Analysis. The conference agenda is here. If you see an interesting item on the agenda, you can click through links on the left side to see detailed abstracts of presentations. Some are of potential global note as they address issues regarding the use of "sponsored" research, risks of nanoparticles (some are said to be be more toxic than asbestos fibers in some settings) and on whether formaldehyde is a carcinogen. To whet your interest, pasted below is the text of one abstract regarding sponsored research:


"M2-E 10:30 AM-Noon Research Funding and Scientific Integrity: Conflicts and Criteria


M2-E.1 10:30 Proposed consensus criteria for assessing the reliability of scientific work. Conrad, Jr. JW*; Conrad Law & Policy Counsel jamie@conradcounsel.com

Abstract: Ultimately, the merits of scientific research findings are judged by the extent to which they are reproduced by other scientists. Such replication can take years, and what constitutes replication in a given case may be disputable for some time. Consequently, the scientific community has developed a variety of shorter-term approaches for assessing scientific work. Some of these approaches are designed to evaluate the validity and significance of the work, particularly in comparison to other studies addressing the same question. (These approaches are frequently termed "weight of evidence" approaches.) Other approaches are addressed to the more limited, but still vitally important, task of evaluating the reliability of the work against concerns that the results may be the product of error or may have been consciously or unconsciously influenced by conflicting interests or biases of the investigator. Some of these latter approaches have become well-established (e.g., peer review, disclosure of competing interests); others are not yet widely accepted (e.g., public registries of proposed research, free access to underlying data). This presentation will survey the approaches being suggested and will propose a set of criteria that, if they became conventionally accepted, would allow all concerned to have confidence in the reliability of scientific work regardless of who conducted or funded it. "

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This article from the Associated Press in the August 19, 2009 issue of the NYT reports on Glaxo's program in which "ghostwriters" were hired to assist doctors in writing medical journal articles regarding Paxil. The information provided is rather skimpy in terms of trying to evaluate the scope and influence of the ghost-writing and whether it actually produced incorrect statements. The article states:

August 19, 2009
Glaxo Used Ghostwriting Program to Promote Paxil
By THE ASSOCIATED PRESS
Filed at 5:07 p.m. ET
WASHINGTON (AP) -- Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.
An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.
Known as the CASPPER program, the paper explains how the company can help physicians with everything from ''developing a topic,'' to ''submitting the manuscript for publication.''
The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.
A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.
''The program was not heavily used and was discontinued a number of years ago,'' said Mary Anne Rhyne.
According to the memo, which dates from April 2000, the CASPPER program was designed to ''strengthen the product positioning and overcome competitive issues.''
At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly's Prozac and Pfizer's Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.
Drug companies frequently hire outside firms to draft a manuscript touting a company's drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work.
But the use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Sen. Charles Grassley, R-Iowa, a longtime critic of the industry's influence over physicians. Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100.
According to ghostwriting expert Dr. Leemon McHenry, Glaxo's program was unusually intertwined with its internal sales and marketing department.
''We know that GSK has engaged in ghostwriting for many years,'' said McHenry, who works as a research consultant for Baum Hedlund. ''But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients.''
McHenry acknowledged that ghostwriting is legal in principal, but said it could contribute to illegal activity if the information is misleading and causes harm.
''If these ghostwritten publications are contributing to the harm of patients because they're making false claims, then that's illegal,'' McHenry said.
Articles from the company's program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.
Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.
Publication in a medical journal also is a point of prestige for physicians, a fact Glaxo's memo seems to acknowledge: ''Physicians will be eager to participate in CASPPER regardless of their professional stature,'' the brief notes.
(This version CORRECTS spelling of 'Baum' in graf 4.)

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The substance of sponsored medical literature remains a controversial issue. A 2009 article by Mark S. Frankel in the ABA's SciTech lawyer raises a variant issue. The article is titled "Clinical Trials and the Financial Markets, " and is online here. The article recounts market knowledge and manipulation issues arising from leaks of information involving sponsored clinical trials and other clinical trials. The following quote caught my eye especially since the 2009 ASCO Conference ended a few weeks ago nd I was watching articles pop up online from the conference on cancer treatments. Some of the results/articles plainly did move the markets, which of course is fine so long as the information is accurate:

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This post follows up on a prior post that described the Manville asbestos trust halting its prior practice of licensing its claims data to third parties for uses such as estimating future claim counts, seeing evidence of claiming trends, and weeding out fraudulent claims.

After the original post, I heard two sets of comments through emails, phone calls and personal conversations. First, I heard multiple comments that fall into the general category of complaints that the Manville data cutbacks are exacerbating an already difficult claims management situation arising from the absence of verifiable public data on asbestos claim payments.

Second, I heard from professionals at Navigant regarding a database of asbestos claims it is licensing to users, and its ongoing efforts to expand the scope of the database. Navigant is the name of a consulting firm that today is home for scores of professionals with massive asbestos experience. Navigant's data and professionals have roots in extensive work for insurers and insureds on asbestos claims as the claim morphed in the late 1970s and early 1980s. I'm happy to give its database a bit of a plug here because I know from personal experience that Navigant's professionals do lots of great work on asbestos claims. Indeed, back in the 1980s, I worked with several of their professionals (then at Peterson & Co.) on the dinosaur known as "asbestos-in-buildings" claims. (That species of asbestos claims long ago became extinct in the tort system due to lack of merit, but - incredibly - those claims still live on in the alternative universe of asbestos trusts. Why that is so is a story for another day. )

Marketing material for the Navigant database is available here. The gist is that the database includes a variety of useful data, with two subsets that are especially valuable. One subset consists of all mesothelioma lawsuits filed in the United States beginning in 2005. The data can be organized by state and in time sequence. These are powerful tools to evaluate the scope of recent mesothelioma claims, which today are the claims driving the majority of the costs for asbestos defendants and/or insurers. The database also identifies the entities named as defendants in each case, and to the extent available from the complaint, the nature of the plaintiff's trade and alleged dates of asbestos exposure. This information also is highly useful for assessing the relative role of a particular defendant as compared to others, and for assessing insurance issues tied to exposure date allegations.

Navigant's Brad Drew and others are responsible for the database, and tell me they are working on trying to expand the database through cooperative efforts among defendants and others. Hopefully they succeed in the far less than simple task of herding together decision-makers and information from the key players among the thousands of asbestos defendants. (Once upon a time back in the late 1980s and early 1990s, the plaintiffs were at a disadvantage because the relatively limited set of defendants and insurers actually worked pretty well together to share claims data and war stories. That stopped being true as more and more of the original original defendants fell into bankruptcy and the number of defendants exponentially expanded as plaintiff's lawyers and experts started selling the notion that even the tiniest "exposure" constitutes a "cause" of disease.)

The Navigant database also includes hundreds of thousands of old asbestos claims assembled over the many years that Navigant has been processing claims for insurers and defendants. This data also can be very valuable for estimating claims, perceiving trends and proving up facts regarding the "elephantine mass' of asbestos claims. Old claims also may be used to find fraudulent multiple claims by one person.

It's great that Navigant is making this data available. That said, it seems incongruous that there is no free, national database of objective data regarding asbestos litigation.

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The loss of the much discussed Wyeth decision has made this a bad week for pharma. It may get worse. A March 4, 2009 NYT article addresses Justice Department plans to prosecute of doctors for taking kickbacks, and states the following:

"... But within a few months, officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products."

One hopes the "consulting agreements" did not involve surgeries that ended up as data points in medical studies, and instead were limited to instances in which doctor x chose to use device A instead of device B. But if the surgeries ended up as part of studies on medical devices, then product liability issues may get even tougher for the involved institutions, especially if there are whistleblowers involved. Let's hope that is not the case.

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The March 3, 2009, Wall Street Journal includes an interesting article on medical school students wanting disclosures from physicians regarding payments from and ties to pharma companies. Thus, the article identifies a wrinkle on the general topic of sponsored research and other ties to "industry." The article provides some interesting views on differing sides of the topic, and describes actions underway at Harvard and other schools to address the concerns.

For a January 22, 2009 update on the general topic in the New England Journal of Medicine, click here.

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