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Tuesday, February 23, 2010

Why is the Avandia issue being raised again?

Dr.Mintz offers a good re-review of the literature behind the controversy regarding rosiglitazone (Avandia).
Avandia has been in the news again. See here. Dr. Mnitz says there is nothing new regarding data accumulation or analysis. So why are we hearing about it again. Why are Senators Grassley and Baucus stirring the pot again?

Any thoughts?


Roy M. Poses MD said...

Perhaps Dr Mintz may have been influenced by his financial ties to GSK (not disclosed in his blog post that you linked to, but now mentioned in the Forbes Science Business blog version of it, see here:

The undisclosed conflicts were first noted in the PharmaLot blog, see here:

Robert W Donnell said...

Dr. Poses,
Retired Doc is raising questions of whether there's anything new in the Avandia controversy that would be of interest to doctors and their patients. You seem to be raising questions about Dr. Mintz's ethics. Both are important questions, but for the sake of clarity don't you think they should be discussed separately?

Roy M. Poses MD said...

Dr Donnell -

Retired Doc was linking to a blog post by Dr Mintz that was quite optimistic about the adverse effects of Avandia, and seemed meant as a refutation of those who were repeating their concerns about the safety of Avandia again.

It seems to me only fair to readers trying to make sense out of the Avandia debate for those participating in it to disclose their financial connections with companies that stand to gain or lose based on the outcome of the debate.

I suspect that Retired Doc was unaware of Dr Mintz's financial relationships, and so he did not mention them. Since these relationships had been made public elsewhere, I thought it would help readers who might read Dr Mintz's blogging on the subject to know about them.

Robert W Donnell said...

Dr. Poses,
Thanks for your comment. I acknowledge that it's generally accepted that people should disclose nowadays. I'm not sure why Dr. Mintz didn't. Maybe it was because it was a blog post, for which disclosure standards are a little less clear.

I appreciate your concern for disclosure although I may not see it in the same perspective as you. The issue at hand in this post is whether there's anything new regarding Avandia's efficacy or safety. So, what, exactly, does the disclosure have to do with that? I didn't know about Mintz's conflicts either until you pointed them out. I had read his argument before you revealed them. I read it again after. My conclusion was no different. Why? Because Mintz pointed to the primary sources of evidence, and that evidence spoke for itself, before and after your revelation.

Dr. Mintz's conflicts, and his failure to reveal them, didn't alter his credibility in my eyes because I rely on the primary sources of evidence. Unfortunately, it did damage his "street cred."

Dr. Matthew Mintz said...

I work as full time faculty for an east coast academic medical center. I started my blog mainly for patients who would frequently call or email me with questions about the latest medical media scare they had seen or heard. I found blogging a more proactive and efficient way to communicate information to my patients. I have been very happy that patients as well as others seem to appreciate my posts. I always considered my posts my own opinions/thoughts and because my posts were not journalistic reports or peer reviewed literature, I (mistakenly)never considered disclosure.
I was quite surprised when I received an email from Forbes inviting me to contribute to their blog. Though I recognized that they were essentially asking for free content to their site, the idea seemed interesting. I sent them a full CV which did disclose research and speaking. They also had a long, multi-page contract which I admit to not reading carefully. Once approved as an official blogger, I received a link to their blog and login and password. Though I now know there was language in their contract about disclosure, this was never made clear to me, and the process of how to disclose was also not clear or specified. I never intended hide any potential conflicts of interest. All posts are approved by the editor prior to publishing. If the editor had any concerns, I really wished they had asked me before publishing my posts.
I now realize that though the idea of having posts on Forbes' blog seemed like a fun idea, I was posting content (even though still a blog) on a major media outlet and should have considered proactively disclosing conflicts, even if I had not read the contract.
Because of my oversight, I have not only been banned from Forbes (and likely any future sites) but have been damned to hell by many on other blogs.
I have certainly learned many lessons about the Internet, and the blurred lines between blogs and journalism, as well as dealing with major corporations (I have been at the same academic instituion since medical school).
I have now added a disclosure page on my own personal blog (www.drmintz.com) and will be extremely cautious in the future, especially regarding conflicts of interests, when dealing with other media outlets.

james gaulte said...

I left a comment on Dr. Mintz's blog (has not yet appeared,however,)inviting him to comment on this site since it has become a sorta mini-discussion on rosi and disclosure, etc.

In terms of personal disclosure, I have not ever received pharma money to give talks or consult or write articles.I do own a few shares in Bristol Myers Squibb and Pfizer and in a mutual fund which may own one or more pharma companies.

Robert W Donnell said...

I'd love to see a long comment thread here discussing the ins and outs of disclosure. There's always a lot of posturing on this issue but little in the way of frank, honest and respectful discussion. I'd love to see it happen here and will post a notice on my blog.

Roy M. Poses MD said...

This has become a really fascinating discussion.

I still think that it is a good idea for a person writing about health policy, as well as clinical medicine, to disclose any financial arrangements that could conceivably have influenced what he or she wrote.

Having personally had to fill out various disclosure forms for journal reviews, journal articles, meeting presentations, etc, I wholeheartedly agree that they can be complex.

I suppose one could always add a disclosure statement somewhere in the actual manuscript or presentation just to make sure one has made the best effort.

That all having been said, I must say I completely sympathize with the predicament in which Dr Mintz found himself. I have stopped negotiations about blogging for several well known commercial web-sites because the contracts they wanted me to sign would have taken hours of lawyers' time to figure out. It does seem that many people want us physicians to work for or with them, but only if we sign contracts that would cause us much legal expense simply to understand, and once understood, might be found not to be in our best interests.

I'm beginning to think that the advice my Daddy (a lawyer) told me was good: "never sign a contract that you don't understand (or haven't read." But most doctors don't have lawyers for fathers, and have never really been taught how to deal with contracts. Maybe we need to teach ourselves more.

I actually discussed how physicians often feel inadequate when confronted with contracts here:

PS - The only financial arrangement I have with any health care corporation is:
I own 3200 shares of Elan ADRs.