Thought Leader: Scientific Expression - Pharmaceutical Executive

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Thought Leader: Scientific Expression
Litigation over Vioxx continues in the courts. But another battle—between journal editors and a study's authors—is unfolding on the pages of a top-tier medical journal.

Pharmaceutical Executive


What do you see is the heart of this issue?

I think there are two separate issues. There's one about not providing accurate data. And that's what NEJM's major concern is—they're saying three events were hidden. But it's rare that companies or people in academia try to hide or not provide real data. Quite honestly, pharmaceutical companies don't do research that way.

They said that by looking at "tracked changes" on an old disk sent to them that there were tables in the article which were deleted that included these cardiovascular deaths, and that they were specifically and purposefully removed so as not to provide that information. Actually, it was an empty table that had no data in it. So the table was deleted, but there were no data—or attempt to not include data.

Now, having said that, the other issue is the interpretation of data. And that's a whole other story. I mean, companies have tried in the past to take data and make them seem more positive than they really are. But the data themselves are rarely inaccurate. So I think one just needs to understand that probably for most cases, we're not dealing with the first, we're dealing with the second.

Whose responsibility is it to ensure that the interpretation is inclusive?

There are journals and then there are reviewers. And it's really the reviewers' responsibility. But the issue of everybody's credibility is at stake. What's the credibility of Merck, of the pharmaceutical industry, of the journals and their editors and staff? No one comes out a winner in this.

How do you think the issues should be addressed?

There needs to be a discussion. Is it best to do it in the journal? I think it's best to do it in a neutral third party, because the journal clearly controls the media. And I don't think it's a disinterested client.

The reality is that there needs to somehow be a better means for dealing with the media. Scientific medical journals are accountable in a way, because they are the ones clearly controlling the expression. Some of the things they do are commendable. But it's clear that it would benefit everyone if these vehicles for expression stay relatively neutral, as opposed to trying to take sides on issues.

Why would you say it's not a disinterested client?

Probably most telling is if you look at what the guidelines are for publishing an Expression of Concern, there are very strict rules about how you do this. It was interesting because the New England Journal subsequently did the right thing when it published an Expression of Concern. [NEJM is] supposed to approach the institution at which this was done, contact the dean or the chief officer of that institution with the expression, have them do an investigation, and then [the journal is] not supposed to publish anything until it gets a report back about what happened.

But they called the lead investigator [before the first Expression of Concern was published in December] on a Wednesday and basically said, "We're going to post it tomorrow." [The investigator] said that it wasn't really fair—that we haven't had a chance to respond or see it or anything. [NEJM] said, "We feel we had to do this." And that's all they said.

Despite the issues, the withdrawal of Vioxx means one less option for pain sufferers. Why has it been so difficult for companies to develop new pain medications?

The last general pain medicine was aspirin. Non-steroidals came on in the middle of the last century, and were advances because they caused less GI problems and were tolerated better. And then the COX2s came on, and they were tolerated even better. But they're not fundamentally different from aspirin.


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