Taking Exception
Great value in clinical studies
Philadelphia Inquirer, Sept. 26, 2008
Your articles "Merck faces more criticism" (Inquirer, Aug. 19) and "Journal vs. the bad seed" (Aug. 20) drew the wrong conclusion.
The Advantage study was published by the Annals of Internal Medicine in 2003 after passing the journal's editorial and peer-review process that determined the study to be important new information for physicians. Dr. Harold Sox recently wrote in Annals that the way to identify a good clinical trial is to look at the importance of the scientific question it tries to answer.
This is the very same criterion that Annals and other medical journals use to select the studies that they publish and that Annals correctly applied in accepting the Advantage study five years ago.
Advantage was a randomized, controlled trial designed to address the scientific concerns of physicians, namely: the need to study Vioxx in osteoarthritis patients in the primary-care setting, in real-world conditions, and against a commonly used arthritis medicine, naproxen.
We are troubled by how easily the journal editors were persuaded by the conclusions of authors who were paid consultants to trial lawyers standing to profit from litigation.
[i.e., Hill et al, authors of the article "The ADVANTAGE Seeding Trial: A Review Of Internal Documents." Ann Intern Med 2008; 149:251-258 - ed.]
There is great value in conducting scientifically based clinical studies to address unanswered questions. We believe we acted appropriately in the Advantage trial, and stand behind our unwavering commitment to ethical conduct and scientific integrity.
Dr. Jonathan M. Edelman
Executive director
Global Center for Scientific Affairs
Merck Research Laboratories
Upper Gwynedd
The bulk of this op-ed, in fact, consists of a Red Herring and an Ad Hominem attack.
First, the Red Herring. The controversy is not about what the Annals published in 2003, it is not whether the science in the ADVANTAGE study was itself "good" in isolation of contextual (e.g., ethics and social policy) issues.
It is about what was written in the Annals in 2008, and the controversy over performing ADVANTAGE and other seeding trials, period -- which David Gorski at Science-Based Medicine so aptly describes as suffering from (at least) one major flaw, inherent deception:
... To boil it all down, here’s my perspective on why seeding trials such as this are inherently unethical, regardless of whether the clinical scientific question under study is worthy or the design of the trial can produce an answer to that scientific question. It all comes down to one issue: Deception. There is no way to carry out a seeding trial without deceiving virtually everyone involved below the level of study designers.
But I digress. Deception aside, it was not the words or the interpretations of the Annals 2008 authors that the ADVANTAGE trials were of questionable scientific value ...
Those words came from the head of Merck's own R&D division himself. The 2008 Annals authors are reporting the words of Merck's erstwhile head of R&D. Yet, Dr. Edelman failed to mention that highly important issue, as if it was irrelevant or immaterial. Politicians and biased journalists do this all the time - omit critical details to spin a story. It's one of the principles of effective propaganda.
From a physician/scientist, however, we expect better.
(I also note that Merck and other pharmas generally require careful vetting of materials released for publication. I assume the Edelman Inquirer op ed underwent internal peer review.)
From the New York Times:
In e-mail messages on April 7, 2001, to ... an executive vice president at Merck Research Laboratories, [President of Merck Research Labs] Dr. [Edward] Scolnick wrote that he was especially angry because the Advantage trial had no scientific purpose. In theory, Merck set up the trial to show that Vioxx caused fewer stomach problems than naproxen. But Merck had already demonstrated that with the Vigor trial, which tracked more than 8,000 patients for a year.
In pharma, the president of the research labs is usually considered "god" as far as new drugs are concerned. It was pointed out that Dr. Scolnick, largely seen as the #2 official in the company, worried that the ADVANTAGE study risked disclosing data to the Food and Drug Administration that could cause problems for Vioxx.
... [T]he reason we have resisted doing large marketing clinical studies is just this. It opens a lot of data to FDA that compromises the large clinically meaningful trials." Small marketing studies which are intellectually redundant are extremely dangerous," Scolnick wrote.
I find these statements by Merck's former head of R&D quite remarkable for many reasons, some stated in my earlier post here. In fact I completed several assignments for Dr. Scolnick and can state emphaically he was not someone easily challenged on scientific matters. He knew his stuff.
Dr. Edelman also omitted the following salient fact seen in the Annals editorial by Harold C. Sox, MD, Editor of Annals of Internal Medicine, and Drummond Rennie, MD:
No one told Annals the true purpose of ADVANTAGE. We learned about it when we received a letter to the editor from Dr. David Egilman, who was a consultant to the plaintiffs’ attorneys in the civil suits against Merck. He had access to publicly accessible trial documents, which included Merck employees’ e-mail messages that disclosed the true intent of the ADVANTAGE trial.
I note that it's unfortunate the Annals editors in 2003 did not have access to these remarkable statements and documents. This information, in fact, only saw the light of day due to the VIOXX litigation. I doubt Annals would have published in 2003 with such knowledge.
Now to the Ad Hominem in Dr. Edelman's op ed.
I find the Ad Hominem attack ("against the person") on the 2008 Annals authors, Drs. Hill, Ross, Egilman & Krumholz, disappointing (they were "paid consultants to trial lawyers standing to profit").
So what?
That is useless information in the context of their current article.
In an ad hominem attack, the character or circumstances of a person making a claim, or their actions, are impugned. This attack is taken to be evidence against the claim or argument the person in question is making or presenting.
This is an exceptionally poor form of argumentation, especially considering the current Annals article was based on an "informational infrastructure" consisting of plain-English emails and documents written by Merck officials themselves. They are available for examination at this link.
These documents, provided by the company itself under rules of legal discovery, do not appear to be taken "out of context" in any way. They appear to stand on their own merits.
The reason why an Ad Hominem (of any kind) is a fallacy is that the character, circumstances, or actions of a person do not in most cases have a bearing on the truth or falsity of the claim being made or the quality of the argument being made.
(The above explanation is from the Nizkor Project page on ad hominem attack, link. In the final example of ad hominem on the Nizkor page, substitute "lackey to the trial lawyers" for "lackey to the Pope" to better visualize just how outrageous the attack on the Annals authors is.)
Is this is the state of the art for Merck scientific debate, I ask?
If so, the company's leadership is in its ripe old age, dementia fast approaching.
If pharma wants to re-establish its credibility with physicians and patients, among others, it needs to start acting more like a concerned physician than a furiously spinning politician trying to "control the narrative."
Finally, as numerous examples on Healthcare Renewal demonstrate, there are those in prominent leadership positions in healthcare who never learned basic rules of logical thought or argumentation yet claim to proffer scientific or ethical truths, or selectively "forget" logic to advance their own agendas. At this point, I have no qualms about calling such people scoundrels.
Addendum:
I note the statement by Dr. Edelman in the Annals comments site at this link ("Merck does say no") that the 2008 Annals article by Hill et al constitutes "litigation in the name of science."
I'd opine that the article more resembles a rather straightforward exposé of probable smoking-gun internal emails and documents in the defense of science. "Investigative journalism" is an apt description.
As Roy Poses pointed out in the comments, evidence based medicine is impossible when the science is tainted in the name of commerce.
-- SS
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