Risk Analysis Symposium - Topics Include "Sponsored Research," Nanoparticle Risks, and Carcinogen Issues

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. "

Glaxo, Sponsored Writing and Paxil

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.)

Scientific Papers and Clinical Trials - Issues Regarding Insider Knowledge and Disclosures by Researchers

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:

"Recognizing these challenges for researchers, at least one scientific society has taken a strong stand on researcher- investor relationships. The American Society of Clinical Oncology (ASCO) recently issued recommendations for how its members should conduct themselves in relation to investment analysts. First and foremost, it is on record as discouraging its members from establishing “relationships with investment firms that put them at risk.”However, realizing that such researchers are free to engage in discussions with investors, the society cautions its members to “beware of the underhanded approaches used by investment firms to to obtain nonpublic information.” It also “require[s] that relationships with investment advisors be disclosed in the context of ASCO activities,” such as reviewing papers, serving on society committees, and advising on society meeting programs. Although this is a good beginning, other societies whose members conduct clinical trials also need to take similar action."

Asbestos Litigation Data - Navigant Database

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.

Not a Good Week for Pharma - Criminal Law Intersecting with - Maybe - Sponsored Research ?

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.

Medical Students Raise Issues Regarding Pharma Payment Disclosures by Physicians

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.