Thursday, January 2, 2014

Tilting at Straw Windmills: Medical Writers Defend Pharma

I'm grateful to Dr. Michael Altus, a frequent contributor of thoughtful comments, for sending me a copy of the December 2013 issue of Medical Writing, the journal of the European Medical Writers Association (available to members only according to the website). The major theme of the issue is "Good Pharma" and the various authors, most of whom express pride in working for the pharmaceutical industry, want to defend that industry from the unfair slings and arrows recently aimed in its direction. I'll focus on just a few of the articles, which sadly suggest that these folks would rather defeat straw men, or tilt at windmills, or choose your cliché, than take on seriously the criticisms raised by us pharmascolds. (I'll mention one possible exception at the end.)

Two editorials, by Adam Jacobs and Wendy Kingdom, set the tone. The points they jointly make should be very familiar and by now quite threadbare:
  • The drug companies have admittedly committed some misdeeds, which no person of good character would want to defend.
  • On balance these misdeeds are heavily outweighed by all the good done by the industry.
  • A few bad apples work for the industry, but most of the employees are decent, hardworking people.
  • The tight regulations under which the industry functions leave little room for any of the misdeeds alleged by critics.
Perhaps the most ridiculous would-be defense of the industry is this, from Kingdom: "In the particular case of the pharmaceutical industry, the company's medical director is at personal risk of criminal prosecution for any breaches of the advertising code, which is an effective incentive (if one were needed) for ensuring that any claims made in marketing materials can be substantiated."

Now, as Dr. Roy Poses over at Health Care Renewal has gone blue in the face repeating, and as this blog in its own humble way has tried to confirm, count up all the times in the last decade that a drug firm has been found to be criminally responsible for marketing practices. Then count up the number of individual executives in those firms that have suffered any criminal penalties whatsoever, personally. (Hint: You don't need the fingers of any hands to do this.) So whence comes this nonsense that drug execs run any personal risk of punishment for false marketing? Mostly they seem instead to be at risk for higher bonuses.

Another straw man thrown into the mix is that maybe it's just that we pharmascolds are ignorant of basic human biology. We apparently don't realize that it's the case that drugs have possible side effects. So when, unfortunately, a patient suffers from one of these side effects, we decide immediately that the industry is evil.

Now, it's one thing to say that unfortunately, good prescription drugs have occasional, ideally rare, side effects. It's quite another thing, as we've recently discussed, to address the sobering data suggesting that prescription drugs, taken correctly, might be the 4th or even the 3rd leading cause of death in the U.S. That latter possibility is nowhere addressed or even hinted at by these highly skilled medical writers.

To add a bit of scholarly heft, the issue includes a piece by a professor of English in the U.S., Robert Blaskiewicz, who has studied conspiracy theories. He characterizes the current wave of attacks on the drug industry as a typical conspiracy-theory exercise. I read through the piece looking for evidence of conspiratorial thinking from any of the prominent pharmascold writers that I've had occasion to quote in this blog, but found none. Eventually Prof. Blaskiewicz gets around to giving a concrete example of what he has in mind--the claim that the industry has actually discovered cures for dread diseases like cancer, but has suppressed these cures so that they can go on selling today's generation of expensive, imperfect drugs. I agree that such thinking counts as conspiracy theory, but I cannot recall any legitimate pharmascold ever making any such claim. To find fault with today's drug industry, you hardly need to go to such lengths.

I promised that I'd get around to something a bit more substantive. An article by Art Gertel accuses those of us who complain about ghostwriting of medical journal articles being simply out of date--he claims that these practices have effectively been dealt with and essentially are no more. I can see a potential justification for such a claim. Since drug firms don't exactly take out ads to announce ghostwriting, the way such practices commonly come to light is through legal discovery of company insider documents during litigation, and such litigation commonly addresses activities that were carried out several years earlier. If, in fact, ghostwriting is now a thing of the past, it would probably take the rest of us a while to find out that this was so--especially if we are inclined, for what I believe are solid reasons, to distrust the public proclamations of the industry as to its own bona fides.

As an apparent counterpoint to Gertel's piece, the magazine reprints the only true pharmascold, scholarly paper in the collection--one we reviewed previously, by Stern and Lemmens proposing legal remedies for ghostwriting (http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001070). Now, if what Gertel says is true, then Stern and Lemmens, who presumably looked into the issue at some length, would have had no reason for writing their paper. Be that as it may, I will try to contact Gertel and see if he can provide any backup for his claims, and if so will pass the word.

5 comments:

Michael S. Altus, PhD, ELS said...

You’re welcome, and thank you, Howard.

Here I provide context into the EMWA (European Medical Writers Association; www.emwa.groups.com) December 4, 2013, theme issue, “Good Pharma,” of its journal, Medical Writing.

But first, I provide background about myself. As a freelance medical writer-editor who is concerned about ethical issues facing medical writers, such as ghostwriting, I first need to acknowledge that I have ghostwritten in the past. I regret that I did it. As a sort of expiation, I wrote a in a 24-part series, “Ghostwriting, medical writers, and ethics,” which included what I did in some of the entries. These posts can be read at the Yahoo Groups Medical_Writing. If you are not already a Yahoo Group user, then you can sign up for free at http://groups.yahoo.com/neo. Then go to to join the Medical_Writing group.

In addition, I wrote AMWA Ethics FAQs for the American Medical Writers Association (http://www.amwa.org/amwa_ethics_faqs; September 2009).

Now for the context. A December 23, 2013, email from Phillip Leventhal, Editor-in-Chief, Medical Writing to EMWA members (I am one) explained that the theme Good Pharma, was “in response to Ben Goldacre’s book Bad Pharma, which casts a rather jaundiced eye at the publication practices of the pharmaceutical industry.... The Good Pharma issue includes several excellent articles that respond to criticisms....”

So to clarify, the open access article that you (Howard) mentioned (Stern S, Lemmens T (2011) Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles. PLoS Med 8(8): e1001070. doi:10.1371/journal.pmed.1001070; available at http://tinyurl.com/3pjkj2t) was not an original article that responded to criticism from Goldacre or others. As Stern and Lemmens explained, their article was presented at the conference, “Ethics of Ghost Authorship in Biomedical Research: Concerns and Remedies,” organized by the authors with support from the Centre for Innovation Law and Policy, The Centre for Ethics, and the Faculty of Law at the University of Toronto on May 4, 2011.

Have a look at the agenda for the conference at http://tinyurl.com/mnxj2d5. You’ll recognize some of the names, such as Alastair Matheson, whom you first mentioned, sympathetically, in the Hooked blog on November 10, 2010. (Enter “Matheson” in the search box for other mentions, also sympathetic.). Likewise for the conference’s bibliography (http://tinyurl.com/m4vgext).

I don’t understand why the EMWA Journal’s “Good Pharma” theme issue reprinted Stern and Lemmens’s article. It was an excellent article, but not among those “that respond to criticisms.”

rjblaskiewicz said...

Howdy. Bob Blaskiewicz here. I guess I don't understand your criticism of my article. When you say, "but I cannot recall any legitimate pharmascold ever making any such claim," I was, after all, talking about illegitimate criticism. :) And I give lots of examples of conspiracy mongering--suppressed cures, manufactured disease, vaccine/autism links--none of which we would call a legitimate concern. I'm not writing about the real pharmaceutical industry, I'm writing about a fictional character that has little to do with legit criticism. I happen to think that Goldacre's book illustrated how drug developers can inadvertently and deliberately fudge results and bolster the appearance of success where there may not actually be any significant improvement. But again, that's the real world, not the fairy land of woo that I am studying. I'm an English teacher. I study fictions. :)

Howard Brody said...

Thanks to Prof. Blaskiewicz for contributing his comment. I am also glad that Dr. Altus clarified the intended focus of the special issue on Ben Goldacre's book Bad Pharma.

As Prof. Blaskiewicz suggests, there are at least two groups of people who criticize the pharmaceutical industry these days. One group fits his definition of conspiracy theorists in my view and include those who believe that the industry is hiding cures so that they can go on selling the current generation of defective drugs. While Dr. Goldacre's book is in my view not one of the better ones describing problems with the pharmaceutical industry (which is why I elected not to comment on it in this blog when it was published), it is a careful effort by an informed medical scientist to assess those problems and does not, in my view, merit a "conspiracy theory" label. In Prof. Blaskiewicz's terms it's nonfiction and not fiction. This blog is intended for the nonfiction crowd.

If one attacks serious critics like Dr. Ben Goldacre, using arguments that are actually appropriate only for the conspiracy theorists, then in my view one is engaging in a straw-man argument.

Phil Leventhal said...

The question is: should Ben Goldacre always be considered a serious and informed critic?

What makes one a "serious" critic? I think that objectivity might be one criterion, and Ben Goldacre is not always objective. He makes good points but some of his interpretations are not always objective.

A second criterion might be an ability to offer workable solutions, and Ben Goldacre does not appear to have done that consistently. He has participated somewhat, but being a "pharmascold" sells more books and speaking engagements than cool objectivity. Criticism is fine, but the criticisms need to be well-founded and, in the end, constructive. Isn't the goal fixing problems and not just tearing something down because it gets people upset (and sells books)?

A third criterion might be a serious tone. Have you seen Goldacre's TED talks and his sensationalistic approach? Very entertaining, but should this always be considered serious?

A fourth criterion might be a willingness to engage with the people you are criticizing. We offered Ben a chance to participate in preparing the Good Pharma issue, but that did not happen. He initially gave a lukewarm positive response but fell off the radar screen soon after. This was his chance to participate in a meaningful discussion with 1000 professional medical writers. He has participated in some other groups, but he missed an opportunity here. Then again, why would he want to deal with people critiquing his criticisms?

I am not at all saying that Goldacre should stop criticizing the industry or that he is wrong, just that his criticisms should be carefully considered, analyzed, and countered when needed. Accordingly, the title of the issue was a bit tongue-in-cheek - Ben Goldacre's sensationalism and inflammatory book title were met with an issue with an equally sensational and controversial title.

In other words, what we want from you "pharmascolds" is a serious dialogue and constructive criticism. The goal is to help patients, and that would be rather difficult without pharmaceutical companies.

Phil Leventhal said...

PS - There were several inaccuracies regarding the journal and the issue Good Pharma. I'm the Editor-in-Chief of the journal and would be happy to have a chance to clear them up or to provide you with more information about the journal.

By the way, the Sterns and Lemmens article was in there because it was interesting, important, and tangentially related to the theme "Good Pharma", but it was not responding to "Bad Pharma". We often have off-theme articles in each issue.

Again, please feel free to write me to get direct information about Medical Writing. We are most definitely not secretive and, in fact, are very friendly and willing to respond to questions. If you like, I can also put you in touch with the guest editor of the issue, Adam Jacobs.