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Justinian Lane

Contention over the "pharma free" expert list.

Yesterday, I briefly wrote about a list of doctors who haven't taken money from pharmaceuticals.  I pointed out that Beck and Herrmann (two pharmaceutical defense lawyers) along with Ted Frank were combing the list to see which experts had served as expert witnesses for plaintiffs.  It's starting to get testy.  The publishers of the list posted the following at Beck & Herrmann's blog:

  • Our experts who have served as witnesses disclose on the list, and we make that information available to the journalists who have requested the list. For example, Dr. Glenmullen discloses his work as an expert witness in product liability cases.
    Some of the experts on the list have served as witnesses in order to have access to data they would not be able to get any other way.

    By Anonymous Shannon Brownlee and Jeanne Lenzer, at 7:38 PM 

     Source: Drug and Device Law: A Public Service Announcement

  • Ted, Beck, and Herrmann then proceed to lay into Brownlee and Lenzer.  You can read their comments for yourself and determine whether they have merit.

    I do want to point out something about what Brownlee and Lenzer said: "Some of the experts on the list have served as witnesses in order to have access to data they would not be able to get any other way."  The data in question is information about drug safety, much of which that pharmaceuticals haven't disclosed to the FDA. 

    What does Ted have to say about information that isn't voluntarily disclosed?

    "Students of game theory know what the refusal to disclose to skeptical sources indicates about the quality of the hidden information; the refusal tells you you can safely assume the worst..."

    If pharmaceuticals would voluntarily disclose this safety information, it would be much easier to compile a list of experts qualified to speak about drug safety who haven't served as expert witnesses.  From now on, whenever a pharmaceutical refuses to voluntarily disclose study results or other safety information, I'll "safely assume the worst" about the drug. 

    Justinian Lane: Author Bio | Other Posts
    Posted at 11:53 AM, Jul 30, 2008 in Pharmaceuticals
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    Comments

    What's the basis for this statement: "The data in question is information about drug safety, much of which that pharmaceuticals haven’t disclosed to the FDA."

    While there are some exceptions, my observation is that most information that experts obtain as witnesses that they can't obtain other ways is not data (as in either useful [clinical trial] or less so [anecdotal adverse event reports]) but rather things like marketing reports, e-mails, and the like -- stuff that the FDA has no interest in. Maybe that's useful, maybe it's not, but it's not data that the companies are supposed to submit or that the FDA wants.

    Posted by: Bill Childs | July 30, 2008 12:32 PM

    Well Professor, one instance that comes to mind was when GSK improperly used washout data in its Paxil studies. I agree that the FDA isn't interested in the majority of internal emails at pharmaceuticals. But it surely would have liked to have the GSK emails that revealed GSK was submitting a study that was "scientifically illegitimate," as one FDA staffer later put it.

    Was it ever resolved whether Sanofil withheld data from the FDA about the fake Ketek trials, or is that investigation still ongoing?

    Who can forget when Bayer "conveniently" forgot to disclose the results of its own internal study to the FDA?

    And wasn't it documents revealed through discovery that showed Merck calculated the mortality rate for Vioxx at a higher rate than it submitted to the FDA?

    Posted by: Justinian Lane | July 30, 2008 1:19 PM

    Still not sure how you get from four potential examples (none of which clearly reflect data that the companies were required to submit under the regs) to suggesting that the experts are obtaining data in litigation that should have been submitted to FDA, but now I at least see what sorts of examples you're referencing -- not, at least for the most part, clinical trial or AER data (i.e., that which is required to be submitted), but internal discussions of various issues (which is not).

    (I should presumably note that I don't necessarily agree with your characterizations of the examples you give, either, and should probably further note that I have done work for pharma, though not presently, as I disclose on the TortsProf blog but didn't on my first comment here.)

    Thanks for the clarification.

    Posted by: Bill Childs | July 30, 2008 1:39 PM

    A correction to my second post: "none of which" in the first parenthetical should read "not all of which."

    Posted by: Bill Childs | July 30, 2008 2:04 PM

    Prof.Childs: Stop repeatedly disclosing. Your statements do not depend on your past for credibility. Argument by authority has no validity outside the law, an enterprise whose sole tools are a gun and punishment. Statements depend on evidence for credibility. Aside from the Stalinist origins in self-criticism, disclosures give only the appearance of virtue.

    Real virtue is a logical impossibility, after passing 1L final exams. I can make any lawyer switch sides by my waving a few pezzuzas. I bet I can get Justinian to sue the ATLA with a retainer, once past that point, unless Ted blocks his getting a license.

    Posted by: Supremacy Claus | July 30, 2008 4:04 PM

    The task of the expert is to inform the legal body of the mainstream views of the field. These experts are left wing extremists, promoting an outlying agenda. The list is one of disqualification per se.

    Posted by: Supremacy Claus | July 31, 2008 7:49 AM

    See the discussion on Pharmalot re: this issue as well.

    In my view, there has been a great deal of idiocy over not very much. The points I have personally emphasized are:

    1. No one comes independent of their views and background, whatever they are. That has nothing to do with whether or not they are paid.

    2. As Bill Childs suggested on DDL, there is a relevant difference between someone whose working life is grounded in championing the causes of the industry - and most of whose income also is - compared with,say, someone who had a one-time expert witness gig (five years ago, two years ago, this year, etc. etc.)

    3. The discussion has mostly been "our shills" versus "your shills." That's the idiocy part. The real question becomes - what specific critieria, and under what circumstances, should trigger disclosure (and what needs to be disclosed). What is really comparable to what, and why?

    4. Thus far, no one in the discussion has wanted to pursue this question. The Us v. Them issue has pretty much been the ballgame. So there has been LOR demonizing and false equilibrating. There have accusations and innuendos which, when questioned, have led to nothing by way of documentation. In short, there has been a lot smoke and cowardice, and not much more.

    Posted by: Justice in MIchigan | August 2, 2008 1:25 PM

    Justice in Michigan slightly (and I think unintentionally) misstated my point, which could be summarized as "there are shills, and then there are shills." I think there's a difference between the one-off expert on either side and the nearly-full-time person on either side, whether obtaining a big chunk of money from pharma OR obtaining a large percentage of income from working as a plaintiffs' expert. There are people who effectively make their living as expert witnesses in big products cases, both for plaintiffs and for defendants. They're different than the one-off experts.

    In pharma litigation, it seems like the case-specific experts are almost always the one-off variety (though not, to be sure, always); the regulatory/FDA/good-or-bad company story experts tend to be the latter. Given the volume of documents and work that it takes to digest a lengthy product story, that's not terribly surprising, but they are different beasts.

    Posted by: Bill Childs | August 4, 2008 4:36 PM

    Professor Childs, is there a list of those experts who do make the majority of their living working for one side or the other?

    Posted by: Justinian Lane | August 4, 2008 4:41 PM

    Not that I know of. You can get a sense of some by following trials carefully, but of course, again, that only captures the handful who go to trial. David Egilman would, I think, fall into the category on the plaintiffs' side. I'm not sure who all falls into that category on the defense side in terms of expert work; there are a handful of regulatory experts that pop up fairly often, but I don't know what the rest of their lives are like.

    Posted by: Bill Childs | August 5, 2008 9:28 AM

    MAXIDEX WARNING

    I had eye surgery and in the post-op pack was MAXIDEX(dexamethasone) drops by ALCON LABS.

    Two days later I was BLIND

    Use Google and enter EPOCRATES MAXIDEX to verify

    Posted by: WEL | August 14, 2008 12:48 PM

    The problem with the "one-off vs. most" standard is that it's fuzzy. What if the expert makes only 10% of his income from litigation? What if he makes half of his income from litigation, but he testifies equally for both sides? And if he retires, so that he no longer draws a salary, the "percentage of income from expert witnessing" will go up even if the dollar amount does not.

    Trial is not always a useful marker, either; there are expert witnesses whose testimony may be offered early, for review or settlement purposes, but whom everybody knows will never testify at trial unless somebody is really desperate.

    Why not simply require full disclosure?

    Posted by: mythago | August 18, 2008 7:36 PM

    MAXIDEX WARNING

    I had eye surgery and in the post-op pack was MAXIDEX(dexamethasone) drops by ALCON LABS>

    Two days later I was BLIND

    Use Google and enter EPOCRATES MAXIDEX REACTION to verify

    Posted by: WEL | October 25, 2008 5:57 PM

    Invitation to visit the fort that Portugal sold with all the possession and field (Dominiun) in 1903 because don’t had money, to the port of Funchal and to recover the fort side.
    After 100 years the Portuguese government prevented the return on investment made by holders of the islet.
    After that they led to the independence and prerogatives that the Royal Charter well after the time stipulated that the Portuguese government reported that it did not want to lose any more time on that island.
    we were even prevented from competing for support of the European Union.
    If you have any doubts about the attitude and the way we were treated as despicable challenge the Portuguese government can or are available for any clarification.
    If you believe in human rights and equality of opportunity and you know of any European institution can help in this matter please.
    We do not want money or political support, only that the international community is aware of this issue.
    Then we will see what to do with this island that was the beginning of the era of discoveries, which writes that Portugal has no interest and should not be recovered, but he offered money by the same island and showed interest in buying my fort and my island.
    www.fortesaojose.com
    Best regards

    Posted by: Renato | November 10, 2008 4:44 AM