Friday, February 01, 2008

Avandia: "Why I sent it is a mystery" ... Elementary, My Dear Watson!

At "Why I Sent It Is a Mystery - More About Avandia, Conflicts of Interest, and Confused Thinking" Roy Poses documents a response from a prominent biomedical researcher, Steven Haffner of the University of Texas Health Science Center at San Antonio, as to why he rather blatantly breached scientific reviewer's code of conduct. This code of conduct is not a mystery and is quite explicit.

It is crystal clear he should not have FAXed anything or communicated about the paper he was reviewing in any way whatsover to GlaxoSmithKline (GSK):

'Why I sent it is a mystery,' Haffner told Nature . 'I don't really understand it. I wasn't feeling well. It was bad judgement.'

A mystery, indeed.

This statement is simply not credible on its face, coming from a scientist with high ability, a large number of federal grants, and who probably sits on many study sections where the rules are emphatically stated at every session - and where participants have to sign off in writing, as I do before a section.

I review papers too. Hypothetically speaking, what might motivate me, if I were not strongly ethical, to do something like this? Something else is likely going on here for someone to risk their reputation, and it is not credible to believe it is ideological or random due to having a bad hair day. If this clinical scientist was having a bad day, it was in "spin generation" upon confrontation when his effort was exposed. That response rates about a "0.2 out of 10" on the MedInformaticsMD Plausible Deniability Scale.

Let's not beat around the bush. This person could have slowed or halted publication through comments in his review. Something more was at stake. What would it plausibly take for a person to assume such risk? It would take a significant quid pro quo.

Again, hypothetically speaking, knowing how people (e.g., people I saw in my occupational medicine role in highly-unionized heavy industries) who get caught doing things that "they should not be doing" react, my concern is that this person could have been on an explicit retainer of some type (including and/or over and above the promise of speaking engagements), or could have had an explicit or implicit agreement to be rewarded financially (money, stock options, internal information related to investing, etc.) by pharma on a case-by-case basis to tip them off to negative publications before those publications appeared or had the chance to appear.

Of course, a pharma engaged in such activities would make sure their tracks were well-covered and create a situation of "plausible deniability." It would therefore be quite difficult to investigate this type of arrangement.

I emphasize that I have no knowledge of such activity, nor am I making an accusation. I'm just thinking as a Sherlock Holmes in a "mystery" novel might think, from the "means, motive, opportunity" angle.

That said, I hope this issue will be investigated. This affair raises a number of questions:

  • Could there be other instances of leaks to pharmas regarding other scientific papers reviewed by this individual?
  • Just how widespread is this problem?
  • Could other scientists also be "leaking" and we just have not discovered it yet?
  • Could pharmas have created a network of "advance scouts" in the biomedical/academic industry, i.e., people who have agreements to tip them off about negative publicity pre-publication ?
  • Could such a "pre-emptive strike force" be utilized for quiet monitoring of the writings of a pharma "enemies list"?
  • Could compromised reviewers be affecting or manipulating the career advancement of scientific authors behind their backs (either negatively or positively, depending on their "alignment" to the interests on pharma), e.g., via conversations with formal or informal connections, without the authors knowing about it?
An unscrupulous consultant advising pharma marketing and strategic planners on methods to "pave the road" in the biomedical literature would probably tell them to do something like this.

Considering what goes on in pharma and academia (such as at another southern university of high renown), such a discovery would disappoint me, but not at all surprise me.

Finally, I also am curious about the cirsumstances of GSK's disclosure of the leak, since the company knew or should have known that doing so would harm Haffner's reputation, perhaps irreparably. Theoretically, a company representative could have simply called him to ask he not do this again, and kept "old boys club" quiet about it.

Did the company try to protect him? How did the disclosure of the breach occur? Who was it disclosed to? Was disclosure out of honesty, or was it for some other reason (e.g., out of fear of the leak being divulged outside the company by someone who might have seen or handled the incoming FAX, perhaps)? Was the disclosure done by a disgruntled, i.e., mistreated employee? (see my post "How To Demoralize Pharma Workers in One Easy Lesson" for why an employee there might be "disgruntled."

From Nature:

Nancy Pekarek, a spokeswoman for GSK, says that the company did not offer any input to Haffner on the meta-analysis, and that she was not aware of anyone at GSK informing the NEJM of the confidentiality breach.

The circumstances surrounding disclosure of the breach are the biggest "mystery", in my opinion.


Those who might think me a flaming far leftwing totalitarian anti-pharma pajama-blogger, my "Political Compass" questionnaire results are here.

-- SS

1 comment:

Palo said...

Agree. The "why I did is a mistery" is as offensive as the misconduct. Shameful