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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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May 16, 2006

The New England Journal And Its PR Flacks

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Posted by Derek

The Wall Street Journal ran an interesting article by David Armstrong the other day on the New England Journal of Medicine and the Merck/Vioxx affair. It's subscriber-only on the WSJ site, but the Pittsburgh Post-Gazette picked it up here. It brings up an angle that I hadn't completely considered:

While Merck has taken the brunt of criticism in the affair, the New England Journal's role in the Vioxx debacle has received little attention. The journal is the most-cited medical publication in the world, and its November 2000 article on Vioxx was a major marketing tool for Merck. . .Internal emails show the New England Journal's expression of concern was timed to divert attention from a deposition in which Executive Editor Gregory Curfman made potentially damaging admissions about the journal's handling of the Vioxx study. In the deposition, part of the Vioxx litigation, Dr. Curfman acknowledged that lax editing might have helped the authors make misleading claims in the article. He said the journal sold more than 900,000 reprints of the article, bringing in at least $697,000 in revenue. Merck says it bought most of the reprints.

The article goes on to detail the role of a public relations consultant in the release and timing of the "Expression of Concern", which I've expressed my own concerns about. The journal seems to have been worried about its own name, and seeking to put the focus back on Merck. And some of these efforts may have gone a bit over the line. Remember the infamous missing data?

Perhaps the most sensational allegation in the journal's expression of concern was that the authors of the November 2000 article deleted heart-related safety data from a draft just two days before submitting it to the journal for publication. The journal said it was able to detect this by examining a computer disk submitted with the manuscript.

The statement was ambiguous about what data the authors deleted, hinting that serious scientific misconduct was involved. "Taken together, these inaccuracies and deletions call into question the integrity of the data," the editors wrote.

In reality, the last-minute changes to the manuscript were less significant. One of the "deleted" items was a blank table that never had any data in it in article manuscripts. Also deleted was the number of heart attacks suffered by Vioxx users in the trial -- 17. However, in place of the number the authors inserted the percentage of patients who suffered heart attacks. Using that percentage (0.4 percent) and the total number of Vioxx users given in the article (4,047), any reader could roughly calculate the heart-attack number. . .

. . .Many news organizations, including The Wall Street Journal, misunderstood the ambiguous language and incorrectly reported that the deleted data were the extra three heart attacks -- which, if true, would have reflected badly on Merck. The New England Journal says it didn't attempt to have these mistakes corrected.

So, the matter of the missing heart attacks, which was the subject of a lot of heated language around here, appears to be closed. This sheds an interesting light on last December's "reaffirmation" of concern, where the NEJM made so much of the heart attack data and how it should have been included. Just about everyone who read that came away thinking that the whole fuss was about the deletion of the three MI events in the Vioxx treatment group. As you'll see from the comments to that post, many of us spent our time arguing about whether they should have been included or not, what the clinical cutoff date was, and so on.

We could have saved our breath. The heart attacks weren't deleted from the manuscript, and those who thought that they had been were responding to a well-thought-out public relations campaign. My opinion of the NEJM is not being enhanced by these revelations, let me tell you.

Problem is, my opinion of Merck isn't at its highest level these days, either. More on that tomorrow. . .

Comments (10) + TrackBacks (2) | Category: Cardiovascular Disease | The Dark Side | The Scientific Literature | Toxicology


COMMENTS

1. Palo on May 17, 2006 10:22 AM writes...

I was a defender of NEJM in this issue. I have to admit however, that Derek was in part right last time when he raised the possibility that the NEJM's "expression of concern" was perhaps a way of covering their legal backs.

Even when I still buy some of the reasons that Curfman advances for publishing that editorial, it really looks like the NEJM pretended to come clean while sweeping the journal's dirt (they apparently had plenty of information to sound the alarms earlier) under the carpet.

Permalink to Comment

2. D on May 17, 2006 10:28 AM writes...

What is the business justification for buying 900,000 reprints? Maybe Merck doesn't believe in pdf's. Regardless of Merck's guilt/innocence, this sounds really shady.

Permalink to Comment

3. Derek Lowe on May 17, 2006 12:18 PM writes...

Palo, it's looking like no one is going to come out of this one looking good. . .

Permalink to Comment

4. Jim Hu on May 17, 2006 1:56 PM writes...

I'm guessing that the reprints are to hand out to doctors along with samples.

I don't know what Derek's going to say about Merck, but I thought their spin of the long-term risk study from earlier this month was not so great. From what I just posted on my blog:

Merck is saying that the observed elevation of risk is not statistically significant; others, including Dr. Steven Nissen of the Cleveland Clinic (who is leading the massive Celebrex clinical trials) disagree. I'm not an epidemiologist, but here's something I'm wondering: If the patients have elevated risk while taking the drug, isn't the null hypothesis that the risk stays the same after they stop? For example, if Vioxx (or french fries) increases atherosclerosis, you wouldn't expect that to just go away once formed. In which case the burden would be to show a statistically significant decline in risk.

This news piece in Nature may also be of interest to those following the Vioxx story.

Permalink to Comment

5. Brooks Moses on May 17, 2006 3:36 PM writes...

D: Even if they believe in pdfs, if they want to distribute 900,000 copies, they have to pay for the rights to do that. It's probably easier just to pay the journal to handle the printing, too -- the cost of the rights to print and distribute a copy to distribute is probably not much less than the cost of buying a pre-printed copy.

A guess, based on the numbers, is that these became marketing handouts -- probably given to every doctor they give samples to, and given out at conferences, and that sort of thing. That would be a pretty clear business justification for buying them.

Permalink to Comment

6. tgibbs on May 17, 2006 5:31 PM writes...

The quote from NEJM's consultant is particularly disturbing:

I believe that given what a public punching bag Merck has become, there is more than enough information and more than enough context in the statement to drive the media away from NEJM and toward the authors, Merck and plaintiff attorneys," wrote Edward Cafasso, a Boston-based public relations consultant, in a late-night email to journal staffers hours before the expression was released. Mr. Cafasso later added, "In my view, this disclosure may very well be seen as the final straw for Merck on the Vioxx matter."

In addition, it seems that the NEJM had known about the additional cardiovascular event data reported to the FDA since 2001, but didn't judge it worthy of mention, and even rejected a letter to the editor that addressed this data. The data only became important when NEJM wanted to manipulate the press.

It was clear from the fact that the NEJM would publish its "expression of concern" without giving the authors a chance to respond in the same issue that a serious ethical lapse had occurred at NEJM. But this is certainly far worse than I imagined.

Permalink to Comment

7. Angelica on August 5, 2006 9:15 AM writes...

I thought their spin of the long-term risk study from earlier this month was not so great.

Permalink to Comment

8. Danny L. McDaniel on May 16, 2007 11:18 AM writes...

I recently came across a book at a secondhand bookstore entitled, HOW TO CHEAT BY USING CHARTS, GRAPHS, AND STASTICS.

I quess it is true: When all else fails, cheat.

A book every graduate student should own!

Danny L. McDaniel
Lafayette, Indiana

Permalink to Comment

9. Danny L. McDaniel on May 16, 2007 11:21 AM writes...

I recently came across a book at a secondhand bookstore entitled, HOW TO CHEAT BY USING CHARTS, GRAPHS, AND STASTICS.

I quess it is true: When all else fails, cheat.

A book every graduate student should own!

Danny L. McDaniel
Lafayette, Indiana

Permalink to Comment

10. Deniel on July 9, 2007 8:56 AM writes...

Vioxx is the most valuable business resource we have EVER purchased. Vioxx was the best investment I ever made. Vioxx is great. I don't know what else to say.

Permalink to Comment

TRACKBACKS

Listed below are links to weblogs that reference The New England Journal And Its PR Flacks:

On Monday, the Wall Street Journal published a front-page story containing some interesting revelations about the New England Journal of Medicine’s (NEJM) handling of a November 2000 article comparing Vioxx’s impact on stomach ulcers to naproxen. ... [Read More]

Tracked on May 17, 2006 9:57 AM

NEJM and Merck from blogs for industry
Derek Lowe links this WSJ piece reprinted in the Pittsburgh Post-Gazette about the NEJM "Expression of Concern"(pdf) regarding Bombardier et al, the paper on Vioxx safety, previously blogged here and here. The WSJ writes: Internal emails show the ... [Read More]

Tracked on May 17, 2006 1:49 PM

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