Thursday, December 14, 2006

More on FDA Conflicts of Interest

I mentioned yesterday that Dr. Bruce Pollock received a waiver to sit on the Advisory Committee although he was not given a vote. Even without a vote, he was obviously there to share his expert opinion with other members of the committee.

As Carl Elliott mentioned in a piece two days ago,

“In the late 1990s, worries had emerged that patients might become dependent on the SSRIs. To combat the perception that people who stopped using Paxil might experience withdrawal symptoms – or “discontinuation” symptoms, as they were often called – GlaxoSmithKline (then still known as SmithKline Beecham) hired a public relations agency called Ruder Finn. Ruder Finn drafted letters that they planned to submit to scientific journals and that downplayed the idea that Paxil was associated with discontinuation symptoms. According to internal memos, Pollock was one of four psychiatrists whom they planned to invite to “author” the letters.

A letter from Pollock eventually appeared in the Journal of Clinical Psychiatry. Although the wording of Pollock’s letter was somewhat different from the draft written by Ruder Finn, it made all the same points. It even made them in the same order. But there was no disclosure, no mention of industry funding, no mention of “editorial assistance,” and no mention of Ruder Finn. Pollock concluded his letter by saying, “Rather than directing our efforts towards the relatively infrequent, minor and transient discontinuation symptoms associated with SSRI therapy, clinicians may be well advised to focus their energies on the greater issues of efficacy, safety, and patient outcome.” The bottom line: concerns about discontinuation symptoms were overblown.”

It gets even better. Although Pollock was on the GlaxoSmithKline advisory board, he claimed he wrote the letter to the Journal of Clinical Psychiatry himself without seeing the marketing memo that made the same points as his letter. Hey, it’scertainly possible that Pollock is being absolutely honest, but one must admit that it is odd that his letter so closely follows a PR document.

It then gets yet more better (pardon the grammar), but you’ll have to read Elliott’s piece to get the full story.

And people wonder why I was concerned that the FDA panel would avoid making any recommendations that would make a pharmaceutical product appear in a bad light.

One final note. If you go through the documents related to the PR firm and the letter sent to JCP, then you'll also notice that Charles Nemeroff was apparently slated to have his name on a letter regarding this issue. A PubMed search did not find any such letter, so I assume that he did not participate. If he was asked to stick his name on a paper he did not write and he refused, then good for him. Of course, it is possible that Ruder Finn never contacted him -- I don't know. Nemeroff's behavior has been called into question on numerous occasions on this site (here and here for a small sample), and I hope that paroxetine was a case where he got it right.

1 comment:

Fid said...

It seems the FDA's equivalent in the UK, The MHRA are pretty much the same. Two of it's members, namely, Dr Ian Hudson and Sir Alisdair Breckenridge are both former employees of GSK, both worked closely with Seroxat (Paxil)