Monday, December 19, 2005

Authorship matters.

The whole lot of scientist involved with Hwang Woo-suk of Seoul National University and his stem cell research seem to be feeling the pull of the drain. Having admitted to fabricating some of the data in their Science paper, Hwang has agreed to withdraw it. Meanwhile, the "senior author" on the paper, Gerald Schatten, is being investigated by the University of Pittsburgh. As reported by the Washington Post:
At the very least, Schatten faces a formal reprimand once an internal school investigation is concluded.

"I will consider what disciplinary actions are appropriate in this case pending the findings," said Dr. Arthur Levine, dean of the medical school and Schatten's boss.

What's this, you say? Wasn't Schatten the whistleblower here? He was also the "senior author:
Scientists say that as "senior author" on the paper, it was his responsibility to catch the many errors Hwang has admitted.

However, Pittsburgh officials and the paper itself described Schatten's involvement in the cloning research as limited to consultation, helping the South Koreans prepare their manuscript and serving as their English-language translator.

Schatten did little, if any, actual research.

Levine said it's unclear why Schatten was given senior author status among the 24 South Korean scientists who also signed on to the paper.

"One should only be the senior author of a scientific paper when one has prepared and was responsible for all the data in that paper," Levine said. "It also implies the senior author is the chief of the lab where the experiment took place."

See? It wasn't just me saying that authorship brings certain responsibilities with it -- not just after the paper has been published, but before it's even sent off to the journal. While Schatten's level of (non-)involvement may not be unheard of for a senior author (ask around and you'll hear about lots of instances of people who are authors on a paper primarily because their high profile is hoped to increases the chances of publication), it seems to have blown up in his face rather spectacularly.

Meanwhile, the Wall Street Journal takes up the matter of scientific authorship as it plays out in ghostwritten articles for medical journals. Check out the discussion at Lawyers, Guns and Money. It's important to note that we're not just talking about ghostwriters who are employed to pretty up the prose of scientific communications -- we're talking about ghostwriters who work for drug companies. Quoting from WSJ as quoted by LG&M:
When articles are ghostwritten by someone paid by a company, the big question is whether the article gets slanted. That's what one former free-lance medical writer alleges she was told to do by a company hired by Johnson & Johnson.

Susanna Dodgson, who holds a doctorate in physiology, says she was hired in 2002 by Excerpta Medica, the El-sevier medical-communications firm, to write an article about J&J's anemia drug Eprex. A J&J unit had sponsored a study measuring whether Eprex patients could do well taking the drug only once a week. The company was facing competition from a rival drug sold by Amgen Inc. that could be given once a week or less.

Dr. Dodgson says she was given an instruction sheet directing her to emphasize the "main message of the study" -- that 79.3% of people with anemia had done well on a once-a-week Eprex dose. In fact, only 63.2% of patients re-sponded well as defined by the original study protocol, according to a report she was provided. That report said the study's goal "could not be reached." Both the instruction sheet and the report were viewed by The Wall Street Journal. The higher figure Dr. Dodgson was asked to highlight used a broader definition of success and excluded patients who dropped out of the trial or didn't adhere to all its rules.

The instructions noted that some patients on large doses didn't seem to do well with the once-weekly administration but warned that this point "has not been discussed with marketing and is not definitive!"

Let's be clear: There are articles in respected medical journals whose content has been spun by authors who didn't do any of the research but did get paid by drug companies with a financial stake in the research outcome reported. And, the names of these authors don't appear on the papers whose substance they have materially altered. Which means, of course, that it's really hard to hold these authors responsible for the content, since they are invisible to the other scientists relying on these published articles as sources of reliable information.

You think I'm getting carried away about this kind of ghostwriting? Here's another quote from the WSJ article:
Now questions about the practice are mounting as medical journals face unprecedented scrutiny of their role as gatekeeper for scientific information. Last week, the New England Journal of Medicine admitted that a 2000 article it published highlighting the advantages of Merck & Co.'s Vioxx painkiller omitted information about heart attacks among patients taking the drug. The journal has said the deletions were made by someone working from a Merck computer. Merck says the heart attacks happened after the study's cutoff date and it did nothing wrong.

(Bold emphasis added.)

Vioxx, baby. We're talking human lives (or, if you prefer, thousands of lawsuits that threaten the health of a major pharmaceutical company). This is not nitpicking. Scientific knowledge is only as good as the scientists who stand behind it. Ducking behind it is usually a bad sign.


At 5:47 AM, Blogger Abel PharmBoy said...

Yes, that WSJ article was a wakeup call. I do remember my profs in grad school doing some ghostwriting for extra cash, but they were also listed as authors.

Did you happen to look at the article cited therein and written by Adrienne Fugh-Berman? The ms. she was asked to ghost-author ultimately came to her as a peer reviewer for J Gen Intern Med?

I look at the screeds of "free" pubs that show up for the MD member of my household and am amazed at how prolific certain authors can be these days.

As you have pointed out so nicely, there are a number of responsibilities that come along with being a listed author - I wish more would take all aspects of it more seriously.

At 5:10 AM, Blogger Anna said...

and everybody knows about fabricating data... Clenbuterol


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