More About Who Had to Call Off the Dogs on an Avandia Critic

"Twice I have with my own ears heard the sound which resembled the distant baying of a hound." [The Hound of the Baskervilles: Another Adventure of Sherlock Holmes By Arthur Conan Doyle]

We just posted about a report by the US Senate Finance Committee charging that top executives of GlaxoSmithKline had tried to silence an critic of rosiglitazone (Avandia, by GlaxoSmithKline). (For our earlier discussion of the Avandia controversy, see this post and older links.) The Wall Street Journal just published a news article on Finance Committee report which provided a few more details.

Over a period of several years, drug maker GlaxoSmithKline PLC was so concerned about a prominent physician's negative views of its diabetes drug that it engaged in a concerted effort to intimidate him and stifle his opinion, a report by the U.S. Senate Finance Committee found.

The report offers a window into the rarely acknowledged practice among drug companies of monitoring and seeking to influence the opinions of leading physicians, who can make or break a drug's sales. The report alleges that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved in the intimidation.

[The report] said it feared the Avandia case was part of a 'troubling pattern of behavior by pharmaceutical executives.'

'The effect of silencing [Dr. Buse's] criticism is, in our opinion, extremely serious,' the report concludes, noting that patients may have needlessly suffered heart attacks during the period. 'Had GSK considered Avandia's increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr. Buse, instead of trying to smother an independent medical opinion, some of these heart attacks may have been avoided,' the report says.

A Glaxo spokeswoman, Nancy Pekarek, said the company strongly disputes the committee's conclusions. She said Glaxo had tried to correct Dr. Buse's 'inaccuracies' about Avandia but had never tried to intimidate or silence him. 'People at the time were very passionate about this new medicine and could perhaps have handled the interactions with Dr. Buse better,' she said. 'We did apologize to Dr. Buse for the tone of some of the conversations, and he accepted that apology eight years ago.'

She said Dr. Garnier had no additional comment. Dr. Yamada, who is now president of the global health program at the Bill & Melinda Gates Foundation, was traveling Friday and unavailable for comment, his assistant said. In an interview last month with Nature magazine, Dr. Yamada said that he never pursued any 'diabolical plot' against Dr. Buse. Dr. Buse was also traveling Friday and unavailable for comment.

The Nature interview with Dr Yamada is here. In it, Dr Yamada denied threatening Dr Buse with a lawsuit, “Nor did I ever discuss a lawsuit with anybody else … I wouldn't want the media to think it's some diabolical plot hatched by me against Dr Buse, because nothing could be further from the truth.” On the other hand, Dr Yamada favored a strategy "to launch a well-planned offensive on behalf of Avandia." Dr Buse acknowledged, "I don't think that Dr Yamada is the bad guy in this story,” but turned to Dr Yamada with his request to "call off the dogs."

Whatever the details, whether anyone threatened a lawsuit or not, it seems like Dr Buse clearly felt that someone let the dogs out to get him, and attributed to Dr Yamada the power to reduce this pressure. The Senate Finance Committee report put it a lot more strongly than that.

Therefore, this anecdote seems to demonstrate the flip side of the pharmaceutical (and biotechnology and device) industries' fascination with the use of well-paid "thought leaders" to promote its products. "Thought leaders" who criticize their products are liable to hear the dogs baying in the distance.

So, once more, with feeling, if the pharmaceutical (and biotechnology and device) industries do not want to be regarded as "shifty," (see post here) they should argue with, but not try to pressure, intimidate, threaten, or let the dogs out on people who criticize their products.

Furthermore, consider the Gates Foundation's stated guiding principles which include:

- We advocate—vigorously but responsibly—in our areas of focus.

- We must be humble and mindful in our actions and words. We seek and heed the counsel of outside voices.

- We demand ethical behavior of ourselves.

- We treat each other as valued colleagues.

Hopefully we will hear more from Dr Yamada about upholding these principles so that no one has to ever ask him again to "call off the dogs."

"We heard the hound on the moor, lo I can swear that it is not all empty superstition." [The Hound of the Baskervilles: Another Adventure of Sherlock Holmes By Arthur Conan Doyle]

ADDENDUM (20 November, 2007) - see additional comments on the Health Care Organizational Ethics blog.