Sponsored research is needed to answer some questions. This seems especially true in an age in which government budgets are less than abundant, and Congress sometimes blocks research agencies from spending money on certain topics. However, some groups continue to find ways to not succeed with sponsored research. A recent failure occurred with respect to a proposed study of  so-called moderate drinking, as highlighted in a June 15, 2018 article at the Washington Post. According to the article, one problem was secretive recruiting of sponsors:

“NIH Director Francis S. Collins said the results of the 10-year, $100 million study would not be trusted because of the secretive way in which staff at an institute under NIH met with major liquor companies, talked to them about the trial’s design and convinced them to pick up most of the tab for it.”

The failure, however, may produce something positive via an inquiry “not yet completed, [] examining the wider issue of possible industry influence on NIH-funded research overall.” Hopefully the outcome will provide some guidelines and best practice approaches for sponsored research.

Some collections of human are slow learners or have other issues. For example, Coke just took yet another public relations hit for lack of transparency when sponsoring health related research, as explained in a November 6, 2015 article in the NY Times.

Sponsored research can be a very, very good thing for myriad reasons. Indeed, sponsored research can originate in wider range of ways, ranging from the interests of labor groups to big business to people with rare diseases to wealthy donors interested in a topic for personal reasons. For example, Michael J. Fox and Sergey Brin (co-founder of Google and investor in 23andme) are both major advocates and donors for research against Parkinson’s due to present and potential health risks, as described in a June 5, 2015 article in Forbes.

But, transparency is crucial, as I’ve been saying for years under the topic “Sponsored Research”, and so have others. Apparently Coke did not get the prior memos from me, Ken Argentieri at Duane Morris, or anyone else. In a now paywalled article of August 16, 2011  in the National Law Journal, Mr. Argienteri explained his views, which can be seen in full at his page at Duane Morris under publications. A key excerpt is set out below but the entire article should be read and considered:

“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.”

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.”

Read More: http://informahealthcare.com/doi/full/10.3109/08958378.2012.655000"

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

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.

 

 

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? 

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. 

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. 

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