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
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.