Wednesday, August 5, 2009

Ghostwriting for Premarin: Steroids on Steroids

Today's New York Times reveals the not particularly astonishing fact that Wyeth Pharmaceuticals engaged a medical writing company to produce 26 articles pushing Premarin as Hormone Replacement Therapy (HRT) in women from 1998-2005. The articles were outlined and written by writers employed by Design Write, and then were sent to top academics in the Ob/Gyn field, who reviewed them, rubber stamped them with occasionally minor edits, and submitted them to journals under their names. In no case was Wyeth's involvement in funding the articles disclosed.

We've heard this sordid tale before. Last year, an article in JAMA revealed that Merck commissioned ghostwriters to produce dozens of articles pushing Vioxx (see the NY Times coverage here--you'd need a subscription to JAMA to read the original paper by Joseph Ross); Eli Lilly paid ghostwriters to push Zyprexa; and Pfizer-funded ghostwriters generated the majority of articles about Zoloft in the late 1990s, according to the British Journal of Psychiatry.

What to make of all this? The best analysis I've heard yet was provided by Dr. Joseph Ross of Mt. Sinai Hospital in New York, who was quoted in today's paper:

“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

In this case, since Premarin is a steroid, Wyeth put its own steroids on steroids. As with baseball players on steroids, when companies pour marketing money into ghostwriting campaigns, they change the rules of the academic game. The playing field is no longer level; the drug company's version of the truth gains the upper hand. Sometimes, their truth really is the truth, but sometimes it's a carefully crafted lie. Sorting it out is difficult even for physicians who specialize in the area being written about. It's essentially impossible for the average generalist physician, to say nothing of patients who did not have the advantage of attending medical school.

As the New York Times article says, some journals now require that all authors detail precisely who wrote what and who was paid by whom before considering manuscripts. It is time for all journals to institute this policy. In addition, several academic medical centers now forbid their faculty from engaging in ghostwriting, a trend that will continue.
As I've said before, it would be nice if those who are caught with their hands in the cookie jar would have the courage to apologize. But nobody involved in this latest scandal is willing to so. Design Write, the company that did Wyeth's dirty work, said that:

[the company ] “has not, and will not, participate in the publication of any material in which it does not have complete confidence in the scientific validity of the content, based upon the best available data.”

Dr. Gloria Bachmann, a professor of Ob/Gyn who rubber stamped an article pushing Premarin for hot flashes and other symptoms, said:

“There was a need for a review article and I said ‘Yes, I will review the draft and make sure it is accurate,’ ” Dr. Bachmann said in an interview Tuesday. “This is my work, this is what I believe, this is reflective of my view.”

And Wyeth's spokesman said that
"the articles on hormone therapy were scientifically sound and subjected to rigorous review by outside experts on behalf of the medical journals that published them."

Actually, the proper collective response from all of these participants should have been: "We sincerely apologize for having deceived the medical community by engaging in ghostwriting without disclosure. We have contributed to the erosion of the public's trust in medicine, and we regret it."


16 comments:

Gina Pera said...

"Wyeth put its own steroids on steroids." Very clever, Dr. C. I don't know how you manage to turn out so many cogent posts.

But here's what I don't understand about the medical field: Why does pharma get all the heat when the docs were rubber-stamping?

Here's how it works in the newsroom: An editor or reporter receives a press release and possibly uses the information as the launch point for a story. They don't run the darn press release, because they know it's not the story and, in fact, the real story might be quite the opposite.

Oh, wait. Some do run the press release. Because they're lazy and they think no one's watching, or they're sorely overworked or because corporate America has all but decimated good journalists' ability to do their job.

But even when that happens, who would be so silly as to blame the flaks who sent out these press releases? No one.

Yes, I know the analogy doesn't strictly apply. But there are other comparisons to be made with good reporters. For example, reputable papers will never allow their reporters to be treated to lunch by a source. And pandering press releases will find their way to the Wall of Shame, with all sorts of humorous replies scribbled on them.

Again, let's look at the participating physicians here as well as the content of these papers. If they are fairly written and have been approved, what's the big deal? Writing clearly is time-consuming and, for some physicians, just not in their skill set.

But if the papers are incomplete and misleading and have been rubber-stamped, let's look to the physicians who did so. If we keep scapegoating everyone but the true perpetrators, we're never going to have meaningful healthcare reform.

Gina Pera said...

"In addition, several academic medical centers now forbid their faculty from engaging in ghostwriting, a trend that will continue."

Do you honestly think this is a good idea? Have you ever edited manuscripts from physicians?

Shouldn't clear communication have a place here somewhere?

berensma said...

I agree with Gina's last comment. Also, strictly speaking, what the academics would be doing is "ghost authoring" if they put their name on a paper they did not write.

Daniel Carlat, M.D. said...

I don't see anything wrong with a researcher hiring a medical writer to help with the tedious process of putting scientific data into a readable form. You can call this editorial assistance or collaboration. As long as the journal and the readers know exactly who has done what, and whether writers were paid by marketing companies, and everything is disclosed properly, I support such a system.

That's a far cry from what Wyeth did with the Premarin papers, however. The journal editors and the eventual physician-readers had no inkling that marketing companies had hired writers to do the heavy lifting. If the editors had known the truth, they would certainly have given the papers extra scrutiny, and may have ended up not publishing many of them. If the readers had been informed, they could have used this information to more skeptically evaluate these papers' conclusions.

It's a question of basic scientific integrity.

MedInformaticsMD said...

“There was a need for a review article and I said ‘Yes, I will review the draft and make sure it is accurate,’ ” Dr. Bachmann said in an interview Tuesday. “This is my work, this is what I believe, this is reflective of my view.”

"This is MY work?"

What, exactly, was "her work?" The article itself as written by the ghosts, the "work" she did reviewing it, or her edits (if any)?

Dr. Bachmann clearly does not understand accepted practices of scientific authorship, or is simply lying to protect herself.

I'm not sure which is worse, ethically.

-- SS

MedInformaticsMD said...

Again, let's look at the participating physicians here as well as the content of these papers. If they are fairly written and have been approved, what's the big deal?

The big deal is - ethics and honesty.

Personally, I really don't trust those who claims others' work as their own, thus enhancing their pocketbooks and academic portfolios, no matter how well written.

-- SS

Gina Pera said...

"As long as the journal and the readers know exactly who has done what, and whether writers were paid by marketing companies, and everything is disclosed properly, I support such a system."

Got it, Dr. C. My scientist-friend said the same thing over guacmole, chips, and beer tonight. Then again, he said scientists wouldn't be inclined to do such things. Maybe he's right; I don't know.
He also mentioned that Elsevier had taken money from pharma to produce ersatz journals.

I surely don't understand this medical publishing business; seems akin to what chamber of commerce types want of newspapers, and too often have gotten it in recent years. Much to society's detriment.

Then again, I surely think professional writers are needed for many of these physician-authors. Else, who will read the stuff? And will the meaning be clear? And will those readers who can't assess a piece's validity on its own be unduly swayed by the disclosure of pharma assistance in the writing? This is all assuming a lot.

BTW, I'd be the last to defend pharma. I've been known to collar a certain stimulant manufacturer's reps for not telling docs that it can push people into anger, mania, and worse.

Good luck sorting it all out!

InTheWild said...

<“You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”>

If I were a doctor, this would be the stuff that keeps me up at night. Seriously, how do you docs cope with this? I believe that 99.9% of docs just want to help their patients: relieve pain and suffering, improve quality of life, and so on. And most of those docs want to practice their art based on reliable research. So how do you cope, on a day to day basis, knowing that some of your recommended treatments are based on marketing and NOT on science, and not knowing which "evidence based" practices are the real deal and which are not?

As a patient, I am beyond concerned about stuff like this, and I also feel for all the docs out there who are basing their practice on the Russian Roulette of Research--this study/intervention might be valid, but the next one might be bogus marketing (oh, and the next one might be marketing too AND it might be valid as well, but you can't tell), and there is no way to tell the knock-offs from the real goods. Sigh.

ahrcanum said...

Gee I can't wait for the peer reviews to come on pending Swine Flu vaccines! Maybe they can just use the text from the 70's research and do a rewrite.

Daniel Carlat, M.D. said...

In The Wild,

You raise a great point. Most medical researchers, whether funded by drug companies or not, are sincerely trying to answer scientific questions, but those who allow themselves to become marketers by proxy taint the entire field. It is a matter of trust. Once we clean up our act, we will enter the era of what I have called "post-deception medicine" and we will once again be able to trust our academics.

Miriam Gordon said...

Thank you for your even-handed, intelligent consideration of this matter. As a former staff medical writer for a Med Ed company, I agree with you completely.

Anonymous said...

Given the influence of the "publications planning" firms, I find it difficult to believe that the editors of major journals didn't know what was going on. Perhaps it's the difference between knowing and "knowing."

I agree that biomedical writers have an important role in helping researches communicate their data to the wider scientific community. The problem comes when their efforts are hidden, and paid for directly by industry in the context of a "strategic publications plan" whose objective is to support the marketing of a product. Unfortunately,the researchers are not in charge and are enticed into participation by the prestige of publication which in turn supports their overall academic survival.

This paradigm has been dominant in the production of papers reporting the results of industry-supported trails for decades. I can't believe for a moment that journal editors are that naive. They benefited too. After all, despite all of the rightous fury of the Marcia Angells of the world, where would medical journals be without drug advertising?

Gina Pera said...

"Once we clean up our act, we will enter the era of what I have called "post-deception medicine" and we will once again be able to trust our academics."

I don't know, Dr. C. "Trust, but verify" seems applicable here.

Some researchers are careless or not above fudging the data. Some have huge blind spots. We still need readers who can think critically and synthesize from several sources. Not sure our medical schools are teaching that.

David S. Cohen said...

I agree and I disagree. I am a social media copywriter and what some may call a ghostwriter. I've never written a medical study for a doctor, but I write blogs and updates for companies. It's their voice, their brand and their message, but I'm putting it together. I've done this writing advertising, writing marketing brochures and now in the social media space. Is what I do so different? Should every ad come from the CEO? I don't post under anyone's name, just brands, so some might call it different, some wouldn't. The point is, it's no less real. My last post on my blog talks about the "voice" of the company. I'd love to hear what you think.

A loyal reader.
David

Anonymous said...

MedInformaticsMD had written:

"Personally, I really don't trust those who claims others' work as their own, thus enhancing their pocketbooks and academic portfolios, no matter how well written."

Oh? And how about all those attending physicians who not only took credit for - and got paid for - all those H&P's, operative summaries, and discharge summaries I did for them as a medical student and resident?

Oh, that was part of the training experience.

Yeah, right. The highest-powered docs have been sloughing their scutwork on us lesser critters for decades, one way or another.

Why shouldn't that apply to the scutwork involved in hammering their research into shape for publication?

Anonymous said...

Why doesn't someone publicize how premarin is produced from the forced breeding of mares? Is anyone aware of what happens to the foals produced by the forced breeding? Does anyone care?