The Op-Ed: When Is A Conflict Not A Conflict?
9 CommentsBy Ed Silverman // August 6th, 2008 // 3:38 pm
Last month, a couple of journalists wrote a piece for Slate about a few prominent people who discussed antidepressants on a public radio show without disclosing they received funds from pharma. The article prompted debate about conflicts of interest and disclosure (back story). In the aftermath, the journalists - Jeanne Lenzer and Shannon Brownlee - promised to create a list of pharma-free experts for journalists. That created still more debate about the extent to which the people on the list are, themselves, free of conflicts if, say, they serve as expert witnesses in lawsuits filed against pharma. And so Brownlee has written a reply…
Our list seems to have created quite a stir, at least some of which is based on a poor understanding of the criteria we used to create it, and why we thought it was necessary in the first place. For anybody who wants to know the criteria we used for including the experts on the list, we refer you to www.HealthNewsReview.org, and the BMJ article at http://www.newamerica.net/publications/articles/2008/naming_names_there_unbiased_doctor_house_7652.
The most recent attacks on our list appear to be focused on the fact that a small number of the experts have served as paid experts witnesses for plaintiffs. We didn’t try to create a list of experts deemed to be in some perfect (and unachievable) state of non-bias. Our list was merely intended to be an additional resource of industry-independent experts for journalists, who currently are inundated by drug industry PR, industry-backed associations, and industry-paid key opinion leaders. We couldn’t have been more explicit about the form of bias we were attempting to rectify when we wrote in Slate, “…we’ve created for journalists an international list of prestigious and independent medical experts who declare they have no financial ties to drug and device manufacturers for at least the past five years.” We did not, and could not, assure that list members have no form of other bias.
We agree with the critics, paid legal testimony can be a conflict of interest – though it isn’t always since A.) some of the experts on the list have declined any pay for their testimony and B) some provide testimony only about appropriate use of a drug – and thus can neither be described as “pro-drug” nor “anti-drug.” We don’t want to get into an argument about whether being paid for legal testimony is a mortal sin or a venial sin; the fact is, we were creating a list of people who are as free as possible from the biases introduced by financial relationships with industry.
Researchers have all sorts of biases, of course – they’re only human. But in contrast to the multiple directions other forms of bias can take, industry bias is unidirectional: making products seem safe and effective. And let’s be honest here. The pharmaceutical industry very deliberately and systematically uses financial relationships with key opinion leaders and academic researchers to help sell its products. The industry doesn’t spend billions of dollars on clinical trials for the good of mankind. It spends that money because A) the FDA requires some of the trials, and B) many of the trials help the industry shape medical opinion and sell more drugs. Indeed, one of the reasons we created the list is to counter the ill effects of poor medical science, much of it paid for and crafted by the industry. Journalists need experts who can help them sift, as objectively as possible, the scientific wheat from the chaff.
For those who doubt that pharma is deliberately using financial conflicts of interest to bias research and sell drugs, we can recommend any number of articles on the topic. You could start with this one: http://www.newamerica.net/publications/articles/2004/doctors_without_borders
A few last clarifications. While we don’t plan to add any information to the version of the list that is currently available for all to see on HealthNewsReview.org, journalists who receive the full list not only get disclosure information about various potential conflicts of interest, they also get contact information and a description of each expert’s area of expertise.
Here is the nature of the disclosures we provide to journalists who get the list: Testifying upon occasion in court cases for pay; (some have done so but without pay and we don’t feel they need to disclose); financial conflicts with industry within the last five years. The ones who have had direct conflicts within the last five years are included on “Page 2” because they have either decided they will forego those financial relationships in the future or because they have provided unusual insights into the partnerships between industry and physicians or into data suppressed by industry.
This is not an all-inclusive list, obviously, since it is only 100 experts thus far. And it is not meant to imply that anybody who isn’t on it is second rate. There are plenty of superb researchers out there who have COIs with industry. We offer this list to our colleagues in the interest of giving them a way to find experts whose opinions might well agree with those who have conflicts, but who can say they came to their conclusions and they conducted their research without that particular bias.
Supremacy Claus
We argued that experts testifying in good faith to opposing views implied a scientific controversy. The court was not competent to resolve it. Only additional data can resolve a scientific controversy. Presumably, if the data were easy to get, one of the experts would change opinion and end the case. We argued the court should restrict itself to question within the knowledge of the jury.
Question. Are there indicia of good faith testimony and reliability?
1) Experts should have used the same facts, and had an opportunity to enumerate them to each other, as in depositions.
2) The fees should be within a third of each other. If one fee is 50% higher or more, there is a temptation to please, by testifying in bad faith. The higher fee should be reduced by the judge, to insure absence of temptation.
3) The testimony work of the expert should be below a set fraction of total income. The expert may testify under oath, without providing tax documents. I am going to arbitrarily set the maximum at 10%. If I lose that fraction, I am starting to sweat about the bills. I am open to
argument about another fraction.
4) Prior inconsistent statements. In a similar case, with the same outcome, harm, and facts, the expert testified otherwise. OK. What explains the change? In the absence of new research data, or substantive personal experience, a prior inconsistent statement is a sign of bad faith.
4a) All the records of all the similar cases treated by the expert should be subpoenaed. If the expert failed to follow his own asserted standard of due care, a mistrial should be declared. The expert should be made to pay the expenses of both sides, and of the court, as a perjurer.
5) Repeated testimony for an attorney, or for only one side. If there is a lucrative and prolonged relationship with an attorney or one side, that is a sign, the expert does not want to end his meal ticket, and will shade his opinion to please his good customers.
Other indicia welcome. If an expert fails one of these indicia, the case should end. If the judge does not want to end the case, it may be proper for the judge to instruct the jury to discount the validity of the testimony by the strength of the failing indication.
CMC guy
I understood the criteria but protest against 1) presumption of guilt due to relationship with industry and 2) claim/impression that this list is somehow less biased when it contains a number who have obvious anti-pharma agendas.
Researchers who accept money/support from industry for services are human too and can act in ethical manner with objectivity in reviewing information regardless of that funding. There is an automatic conclusion that is highly prejudiced.
Sure profit is a motivating factor in some activities because is a business undertaking but the use of KOL and other experts are generally established to help decide how to/what works for treating patients. The questions involved is drug development are typically very complex and hard so is it not best to seek advice from those with most knowledge and skills. May be to remove taint those experts who are paid by University/Public funds perhaps should not be charging consulting fees “for the good of mankind”.
Are most Journalists so poorly trained, or unprofessional, they can not determine such information on their own and assess how important it is? Rather they now can go to a seemingly unbalanced list to find sources who at least by one narrow criteria are unblemished.
Justice in Michigan
CMC - I’m tired of this issue, so I won’t get into a further debate. I agree that there are important questions to sort through re: threshholds for disclosure in different contexts, which is pretty much what I’ve been saying all along.
But I have a more simple question. What does “CMC” stand for? I’ve been wanting to ask.
CMC guy
JIM in this context “Chemistry, Manufacturing & Controls” (if you watch PBS Carrier Series Command Master Chief the highest ranked enlisted person on board-I think).
I am not against disclosure just the arbitrary and one-sided rules that seem to be often applied.
Nathan
Brownlee writes: “We did not, and could not, assure that list members have no form of other bias.”
Correction: You did not and CHOOSE NOT TO assure that list members have no form of other bias.
Therefore, whatever bias remains in the list is unidirectional in nature.
Pharm Aid
Knowing that discredited BMJ ‘journalist’ Jeanne Lenzer is behind this certainly helps clarify the bias…and the problems.
Naturally, those who have followed pharma for a number of years are familiar with Lenzer and her limitations as a jounrnalist. Few could forget that the BMJ has had to retract her stories and apologize for her journalistic integrity. (For those unfamiliar with Jeanne Lenzer’s journalistic lapses, personal bias and ‘credibility,’ I would refer you to the Jan. 17, 2005 issue of the New York Times and an article by Barry Meier).
All of this came about because pharma advocate Peter Pitts was not identified as a shill by NPR in a story (…although it’s still not clear to me why Pitts should be responsible for how NPR reported the story in the first place). Naturally, Lenzer’s extracurricular activities are equally suspect (speaking engagements, freelance journalist projects and consulting engagements in opposition to pharma…not to mention Jeanne Lenzer’s own EXTREMELY cozy relationships with trail lawyers).
I love the word play that Lenzer and Brownlee use as describing conflicts with “industry.” What they’ve done is this: supplanted one industry (pharma) with another (plaintiff’s attorneys). And through clever word play by calling their experts “independent,” they seek to mislead people on the lack of bias of individuals on their list.
Here’s a suggestion to Brownlee and Lenzer: Rather than use the term “industry,” perhaps they could be more specific as to exactly which industry they referring to (pharma or trial lawyers). And rather than calling their list of experts “independent,” perhaps they could use the more accurate term “pharma-free.” Although, knowing Jeanne Lenzer, accuracy is not something she typically strives for.
Brownlee and Lenzer’s “independent experts” are every bit as tainted and biased as the experts pharma is putting forward. The only difference is, at this point, Lenzer and Brownlee just aren’t being as honest about it. And given Jeanne Lenzer’s personal stake with plaintiff’s attorneys, it’s not suprising why.
Shannon Brownlee and Jeanne Lenzer
Pharma-Aid has difficulty distinguishing truth from PR?
In our article in Slate http://www.slate.com/id/2190775/ about the Infinite Mind show on antidepressants we made a two key points: a.) each interviewee, the host, and the show itself (a public radio show) had received funding from drug companies that make antidepressants – funding that was not made known to listeners and b.) each interviewee and the host expressed the same opinion about antidepressants at a time when the scientific community is having a heated debate over the safety and effectiveness of antidepressants.
No one who follows the scientific debates over these drugs can come away saying that there is no debate. Psychiatrists, epidemiologists, and clinicians are divided over the relative safety and efficacy of the drugs. Even the usually industry-friendly FDA ordered a black-box warning about the potential risk of increased suicidality among young people taking the drugs based on a rough doubling of suicidality among depressed test subjects given antidepressants versus those given placebo – the sort of epidemiological evidence that gives most people pause.
We did not delve into the science of antidepressants (though we have elsewhere); we only sought to inform listeners and readers that a public radio show had financial backing from Pharma as did its guests. Big Pharma has become the master of stealth advertising – placing its KOLs (Key Opinion Leaders) into front organizations and in the media to promote its views – even effectively infiltrating public radio.
One physician asked us why we thought there was such a big stink after our article appeared in Slate since we are far from the first to point out that industry influence is behind a number of media reports. Our reaction was two-fold: First, most people are aware that this happens with commercial media – but we believe the extra source of distress came from finding out that even public media could be affected. Second, we think that Pharma is quite afraid that all the money (billions) that they spend on influencing public opinion could be undermined if journalists are given a ready source of non-industry experts.
After our article appeared in Slate, one of us, Lenzer, was attacked for a 2005 article published in the BMJ (formerly the British Medical Journal) http://www.bmj.com/cgi/content/full/330/7481/7 . Pharma-Aid claims that “Few could forget that the BMJ has had to retract her stories and apologize for her journalistic integrity.” First off, the BMJ on one occasion retracted one aspect of one of her stories. After that, they have continued to use her as a valued contributor. Most journalists are quite familiar with having a “correction” or “retraction” appended to any one or more of their stories. It would be the rare person indeed who could claim never to have made an error in their entire career.
One of the top science and medicine reporters at the New York Times recently had to make a serious correction to an article about tPA, a clot buster drug, used for stroke. She said that it had been shown to “save lives” and predicated the entire feature article on the idea that too many people were being denied this putatively lifesaving therapy. In fact, no such study exists and the controlled studies to date show either no effect on mortality or that tPA actually killed more people than those who received placebo. The correction at the New York Times came about because of an article written by Lenzer in Discover magazine http://discovermagazine.com/2008/jul/20-wonder-drugs-that-can-kill/article_print examining how medical studies are misinterpreted. This is the nature of medicine and journalism: corrections are made and even the best journalists fall prey to bias and error.
As for the Barry Meier article, cited by Pharm-Aid as some sort of “proof of pudding” that Lenzer is a “biased” reporter, the Meier article itself is filled with inaccuracies. Lenzer will be posting more in the future about the story behind the story that Big Pharma and its allies like to use to supposedly discredit her.
Pharma-aid and his or her allies in Big Pharma would have done better to calmly discuss the issues involved in the Slate article and the subsequent Naming Names article in the BMJ where we released a list of independent sources. Do they object to journalists being allowed to have a list of alternate sources? Do they claim that a public radio show that gave only a rosy view of antidepressants was truly “objective” and allowed all sides to be heard? Do they believe that listeners have the right to know who is funding the invited experts? If so, why did they object to our bringing this point up when it wasn’t mentioned on the show?
Instead Pharma-aid and other critics of ours have completely ignored the substantive questions we’ve raised and instead tried to impugn our reputations. We trust readers won’t be so easily diverted from the real issues at hand.
Shannon Brownlee and Jeanne Lenzer
JayInesday
Clearly we have two points of view here. Listening to each side I would have to say that if one were to err on the side of caution (at the least) consumer support should fall on the side of Brownlee and Lenzer. For my money anyway.
I agree with B and L that Pharm Aid’s only argument on this issue appears to be an obvious desire to discredit rather than an open minded discussion of the issue.
Pharm Aid
Lenzer and Brownlee finally respond. And good for them. However, they have not addressed the fundamental flaws in the accuracy of their pseudo-journalism.
I absolutely support and applaud the creation of a list of “alternative” experts. And as such, those experts should be identified as “pharm-free.” However, Lenzer and Brownlee position their list as truly “independent.” It is an intentional mis-representation of the backgrounds of their experts to support their personal agendas. Their list is as suspect as the experts pharma puts forward.
Lenzer’s difficulty with accuracy goes far beyond the one article. But don’t take my word for it, do your own search on the BMJ website (search Lenzer and Corrections). You don’t have to scroll through every page to get the idea.
There’s an anti-pharma attitude in America right now (rightly or wrongly). Therefore it’s not surprising that anti-pharma experts are given a pass on their own conflicts of interest.
Lenzer is on a personal jihad against conflicts of interest with pharma, so why is she so reluctant to make the same level of disclosure with her list? Why demand pharma disclose when you aren’t willing to do the same thing? Why the double standard?