This past week, the practice of “ghost writing” came back into the news with an article in The New York Times on the subject. One trial lawyer who has spent the last four years documenting this practice at Wyeth (he must think it helps his case or he would not be wasting his time doing “four years of research” on the subject).
This time, the controversy swirled around Wyeth and hormone replacement therapy. Several documents were released in legal discovery showing that writers were hired to write journal review articles then shop around for authors. In one case, the physician who accepted to be author of the paper, had no edits to the paper (so apparently the writers must have done a pretty good job).
What is interesting about this story and others is the issue of “ghost writing” has been brought to the public’s attention via trial lawyers.
Publication strategies in the 1990’s and as late as 2005, were driven by manufacturing companies’ desire to see efficient dissemination of clinical trial data in multiple venues. Let’s face it, if you are going to the expense of conducting a $100 million dollar clinical trial, you want the results to get in the hands of clinicians as quickly as possible, thus ghost writing was common for many therapeutic areas.
The practice of ghost writing has all but ceased in the last five years.
The real question should not be on who wrote what but was the information valid, which for the most part no one is questioning the validity of the scientific content.
Now these lawyers I am certain are good citizens, but it does beg the question, why would trial lawyers be so interested in this topic, as for the most part, it is not germane to their main cases they are presenting.
Perhaps there are several reasons that the attorneys are so interested in this:
A) Discredit the literature — in legal terms, trial attorneys may see this as an opportunity to discredit all the “research” papers done on a particular drug if they can shed some questions in juries’ minds on authorship. If they had this article ghost written, what other papers may have troubles and which of their studies do we believe? This can be a very effective strategy with juries on complicated cases like the sales of hormone replacement therapy.
B) Discredit the witnesses – if they can show “harm” from this physician, the company may be hesitant to use them as a witness on the stand. Also, if you can make one or two examples of physicians it discourages others from helping the defense’s case. One attorney outlined that this is called the deception theory, if they are willing to put their name on one paper as lead author, what input are they really having with the other articles they published?
C) The "ghost writing" experts have friends in high places (JAMA and other Journals) that can get articles published about the evils of the practice and eventually leak out information they collect as they have done to the national public media.
D) There is a looming thought that much of this “bad” media today about the pharmaceutical and device industry is driven by others in the healthcare reform debate to say that given their “bad behavior” which we are highlighting with our friends in the media, we should be getting more from them than the $80 billion the industry has already agreed to.
What is interesting about this strategy to expose “ghost writing” is that, up to now, that strategy has not worked, as the body of evidence is so much stronger and the juries eventually figure out the ploy that the trial lawyers are attempting.
It is a pity that seated members of congress fail to see through these tactics and regularly bring up the issue of ghost writing in discussions as if this were the norm, rather than the exception, which at this point, true ghost writing is rare to non-existent.
If you look closely at the experts quoted in all these articles, on “ghost writing” it comes down to the same group of four physician plaintiff witnesses (David Egilman, Kevin P. Hill, Joseph Ross, and Harlan Krumholz) in large cases against pharmaceutical and device companies.
Joseph Ross, M.D., an Assistant Professor at Mount Sinai School of Medicine, who said in The New York Times article, “It’s almost like steroids and baseball.” “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”
David Egilman, M.D., an Associate Professor at who admitted to a jury in that he has received between $20 – 25 million in payments (that is right, $25 million) from plaintiff attorneys (no conflict here). Dr. Egilman also was recently fined $100,000 for leaking court documents to The New York Times in an effort to discredit the company.
Dr. Egilman has also taken on a new role as a family spokesman for a Neurontin case in which the “family” received pre-payments from another trial attorney and the case was subsequently dropped.
I personally think that ghost writing is a poorly thought out practice and physicians should not allow themselves to be pawns in accepting a greater role than they actually take. But the timing of all this “bad news” is suspect, to say the least, and true motives will be uncovered in the years to come (they always do).
So the next time you read a scary story about ghost writing, remember there may be other ghosts behind those ghosts….