The Case Of The “Missing” Vioxx Data: NEJM, CYA and PR

May 17, 2006

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. The article, written by David Armstrong, indicates that:

-NEJM may have published a December 2005 editorial “expressing concern” about the Vioxx publication to divert attention from a deposition by Executive Editor Gregory Curfman. In his deposition he admitted that the NEJM did not edit the article properly and may have helped downplay the cardiac risks associated with Vioxx.

-NEJM’s claim that the study authors deleted data from the article pertaining to Vioxx’s impact on the heart in its 2005 editorial was misleading. According to the Journal: “one of the ‘deleted items’ was a blank table that never had any data in it . . . also deleted was the number of heart attacks suffered by Vioxx users in the trial – 17.” This data was replaced with a percentage figure. .04 percent (or 17) of the 4,047 patients in the trial suffered heart attacks. Curfman later admitted that it would have been clearer to include the original figure.

-The NEJM sought counsel from a public relations consultant, Edward Caffasso, on how to manage the potential negative publicity from Curfman’s deposition. He supported the timing of the NEJM’s editorial and said it would “drive the media away from NEJM and toward the authors, Merck and plaintiff attorneys.” In addition, a list of message points provided to journal editors encouraged them to “deny that the journal’s statement was connected to the federal trial.” It is not clear who wrote the message points.

The Journal’s article does not make anyone look good. It is clear that something went wrong and that a lot of people were less than honest.

CYA At NEJM: The Buck Stops Anywhere But Here

NEJM is one of the most prestigious medical journals in the world. A vast majority of submitted articles are rejected for publication and the journal is well-respected for its editorial rigor. However, it is clear that the NEJM made some mistakes in its handling of the Vioxx article. It is also apparent that the journal is passing the buck and refusing to take responsibility for its role in the article’s publication.

Granted, the journal relies on authors to provide accurate and complete information about studies. However, given its reach and influence editors need to ensure that it asks tough questions about all studies it publishes. CYA is not an optimal strategy.

The PR Lesson: Sometimes Spin Boomerangs

The NEJM was worried that Curfman’s deposition and the timing of its editorial might make it look bad. So, it asked a public relations consultant for advice. The Journal article indicates that the consultant broke the first rule of crisis communications: tell the truth, the whole truth and nothing but the truth. It may make you look bad in the short run, but people will appreciate your candor.

The Journal article is a perfect object lesson on why telling the truth is better than spouting spin. You may get away with it initially, but things like this tend to come back to harm you when you least expect it. In 2005, Caffasso said: “The story is playing out exceptionally well.” Mr. Caffasso, that’s no longer the case.

John Mack over at the Pharma Marketing Blog and Derek Lowe at In the Pipeline have more on this story.


Strumpette-Related Comment Subterfuge

March 28, 2006

Yesterday I wrote a post focusing on some comments that Mike Driehorst made about Strumpette’s potential link to a Chicago-based company called Forward, Inc. I mentioned this issue in an attempt to garner some much needed “link-love” for some healthcare non-profit blogs.

Well, folks it looks like I was taken in. Robert French e-mailed me last night and informed me that he contacted Driehorst to ask him about his comment. Driehorst told French that the comment was from him, but the “content of the comment was denied by the guy that was mentioned in it.” Specifically Brian Connolly of Forward Inc said that someone may have been using (or was assigned) his IP address when they made the comment.

Now, I’m not an Internet technology expert, so I’ll just say this: Driehorst made the comment, but now can’t confirm that his analysis holds water. I don’t know what to make of this, so I won’t comment on it further.

Anyway, the original intent of my post still stands. Support the healthcare non-profits listed in the post by going to their sites, critiquing their blogging efforts and telling others about them.

That’s it for now, and the last I’ll say (hopefully) about Strumpette – unless she or it starts offering up valuable scoops and content that is worth talking about. In any business, sex appeal only goes so far before people start asking for substance, you know what I mean?


“Strumpette” Outed?; Valuable “Link Love”

March 27, 2006

I thought I’d add to the “explosion” (pun intended) of commentary about the latest PR blogger to hit the scene: the sexy “Strumpette” or “Amanda Chapel.” She (or it) is getting lots of buzz, so I’d thought I’d draw attention to my quiet, serious, low-circ blog by mentioning her, or it, or whatever. For anyone who cares, this is an obvious attempt to garner “link love” — but for a good cause, so read on.

Outing “Strumpette”

It appears that “Amanda” may be close to being outed. In a comment posted on Robert French’s blog infOpinions?, Mike Driehorst says:

“Now, I know relatively little about technology. So, the following may be hogwash, and no harm is meant by it. But . . .

I found the IP address for Ms. Chapel’s comment at:
http://www.contentmanager.net/community/forum/11/15/16.html
It’s a discussion through about “Miro International Supports Mambo Open Source Community in Disputing Furthermore Claims”
Ms. Chapel’s comment IP address is the same as someone named “Furthermore” in that discussion.

If you follow the link by “furthermore”:
http://www.literatigroup.com/versusmambo/content/view/54/46/1/2/
that is in that discussion, you get to a statement about Miro International. In that statement, there is reference to a Brian Connolly of Chicago-based Furthermore Inc.

Mr. Connolly had a couple comments on Steve Rubel’s blog in February about the Edelman Talk Shop look and brand: http://www.micropersuasion.com/2006/02/talking_shop.html

Mr. Connolly’s Furthermore Inc. publishes wepublishing.com, a platform for managing Web community information.

So, is there a legit connection between Ms. Chapel and Mr. Connolly? Or, has my inept tech expertise been exposed?”

Now For The Legit Stuff: Healthcare Non-Profits That Deserve Link Love

Robert French has been asking people to share some link love with non-profits to draw attention to their activities and to support their blogging efforts (see this post.) I’ve nearly completed my massive report on healthcare blogging and there is a big section in it on healthcare non-profit blogs. So, here’s me giving link love to the non-profit blogs I highlight in my report. Visit their blogs, support them (if you agree with their cause) and link to them. Now, the list:

Healthcare Non-Profit Blogs

-Planned Parenthood: Save Roe!
-The March Of Dimes: Share Your Story
-The Amercan Lung Association Of Minnesota
-The Hastings Center: Bioethics Forum
-The MIRACLE Campaign
-The Constellation For AIDs Competence
-Camp ASCCA Journal
-A Healthy Blog

That’s all folks. . .


Issues Management Moment: Sex and the Pill

January 31, 2006

The New York Post reports today on a new study in the January issue of The Journal of Sexual Medicine. According to the Post, the report is pretty controversial because it suggests that “30 - 40 percent of women on birth control pills have decreased libido.” WOW!

The Post also reports that a “growing number” of New York women are going off of the pill. The reasons they provide vary from wishing to go more “organic” to those who are uncomfortable putting hormones in their body.

Now I’m not sure what kind of impact the Journal of Sexual Medicine’s report is going to have on birth control pill sales, but it might be a cause for concern for those responsible for communcating about these products. The growing furvor over birth control pills is a perfect example of the type of issue — if left unchecked — can grow beyond anyone’s ability to manage it.

I wonder if we’ll start to see a counter-offensive by makers of birth control pills seeking to reassure women about the benefits and side effects of birth control pills. It would be powerful indeed if someone released data from Phase III studies that evaluated birth control pills and asked women about their sexual desire. Better yet, what if a pill existed that was proven to actually have a beneficial effect on libido?

It will be interesting to see whether and how drug makers respond to this issue.


The Pharmaceutical Industry’s Bad PR

January 30, 2006

Edwin Colyer wrote an interesting article for Business Week recently focusing on the pharmaceutical industry’s PR woes. I thought observers of this blog would be interested in reading it. Check out the comments from readers of the article below the article.

Click here to read the article.


Just Say No . . . To The Unnecessary Press Release

January 24, 2006

There is a widespread, but unacknowledged epidemic sweeping the country. It’s called Press Release Addiction or PRA. Those suffering from PRA usually display the following symptoms:

* An overwhelming compulsion to distribute a press release — no matter how newsworthy it is.

* Little understanding of how the media consumes information.

* An expectation that every press release will receive significant media coverage.

Fortunately, there are two cures for individuals and organizations suffering from PRA: knowledge and restraint.

The First Rx For PRA: Knowledge

The keys to successfully interacting with the media are understanding their environment, needs and how they use information.

The Environment: Media work in a high-pressure environment. They are responsible for quickly developing well-researched and well-written articles. In addition, they must contend with countless e-mails and phone calls from their sources, editors and people seeking publicity.

The Media’s Needs: Giving the media with what they need is the best way to capture their attention and goodwill. Provide them with relevant information and resources (e.g., spokespersons, reference information) that will help them do their job. Bombarding them with irrelevant press releases and follow-up phone calls only annoys them.

How the Media Uses Information: Recognize that the media use information in a variety of ways — even when it is useful. Sometimes a reporter will include information about your product or service in a story quickly. Other times, they may decide to use the information in a future story to provide readers with context or alternatives. Remember, coverage is valuable . . . whenever it appears.

Think about the environment, requirements and habits of the media when deciding whether to distribute a news release. It will help you to increase the odds that your information will be used.

The Second Rx For PRA: Restraint

Before sending out a press release, ask yourself a simple question: Why will anyone care about this information? This question is important, because reporters ask it everyday. The fact is if a reporter concludes that their readers won’t care about your information, they won’t use it.

Some reasons reporters may ignore a press release include:

* The information is not newsworthy (e.g., not enough people will be affected by the news or it is not local).

* The information is not relevant to the reporter (i.e., the reporter does not cover the topic or industry your release focuses on).

* The information is not material (e.g., it is not of enough import to significantly influence the organization’s profits or revenues).

Before putting together a press release, think about whether it would be better to deliver information to your stakeholders another way. For example, sending an e- mail to a carefully selected group of constituents with the news may be just as effective.

Establishing good relationships with the media is critical. Understanding the media’s needs and providing them with high-value information will earn journalists’ good will and attention. Be sure that the press releases you distribute are relevant and newsworthy to increase the odds that media will cover your product or service.