Envisioning 2.0

I’ll be taking a brief blogging break next week due to travel. I’ll be back the first week of June.

I’ve got some special events coming up that I’m pretty excited about. These include:

-The final post in my long-running interview series on race and medicine featuring NitroMed.

-More posts in my FDA and the Pharmaceutical Industry series, including an interview with John Powers, MD of the FDA.

-A new series, titled “Communicating Consumer-driven Healthcare.” In this series, I’ll be exploring the following questions:

1. What will it take to “train” the public to be better consumers of healthcare?

2. What types of communications tactics are appropriate for communicating messages about consumer-driven healthcare?

(P.S. If anyone is interested in submitting a guest article on this series for publication on Envisioning 2.0, please contact me at info [at] envisionsolutionsnow [dot] com.

Thanks to all my readers for making this blog so much fun to write!

See you in June!

Race-based medicine, or the practice of treating people differently based on their racial and ethnic background, has long been a subject of interest to healthcare providers, public health practitioners, communicators and others. Now, with the introduction of BiDil, the first medication approved for the treatment of a condition in a specific race (African Americans), the topic is once again gaining increased attention.

Given the intense interest in this subject, I am conducting a series of periodic interviews with physicians, social scientists and others. Each interview subject provides his or her unique perspective on race-based medicine, which I then publish on this blog. Please click here to read the other interviews in this series.

Interview Subject: Dr. Brian Smedley

About Dr. Smedley: Dr. Smedley is research director and co-founder of the Opportunity Agenda, a communications, research, and advocacy organization dedicated to building the national will to expand opportunity in America. Prior to joining the Opportunity Agenda, Dr. Smedley was senior program officer in the Division of Health Sciences Policy of the Institute of Medicine (IOM), where he was study director for the IOM report, Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care.

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Get your bi-weekly dose of health wonkiness at InsureBlog.

Last month, I posted a brief item regarding a study Schering-Plough had initiated for a new hepatitis C drug that excluded self-identified African Americans from the trial. Today, I came across an interesting post on “Open Letters” a blog written by Karama Neal, PhD. In the post, or open letter to Schering-Plough, Neal states:

“I have difficulty understanding why African-American patients are being excluded from this trial, particularly since that is the only ethnic group specifically excluded.”

It turns out that Schering-Plough was monitoring the blogosphere and decided to respond to Neal’s post. Four executives at the company participated in an April conference call where they “addressed [Neal’s] questions, and gave [Neal] a clearer understanding of their rational for this study design.”

Although Neal continues to believe that the Schering-Plough study “misuses the concept of race,” she appreciated the company taking the time to answer her questions.

I’m not surprised that pharma companies are proactively engaging bloggers, as my recent interview with NitroMed on the topic of race and medicine indicates, however, I’m always impressed when they decide to be proactive.

(By the way, if anyone from Schering-Plough is visiting this blog, you might be interested in my ongoing interview series re: race and medicine. Feel free to comment on any of the interviews I’ve published thus far.)

Click here to see Neal’s post re: the Schering-Plough conference call.

An article published in today’s New York Times reveals that there is a fierce debate going on within the American Society of Hypertension (ASH) about the organization’s relationship with the pharmaceutical industry. The heart of the issue is ASH’s efforts to develop a new definition for hypertension and the pharmaceutical industry’s support of this initiative. (Some have suggested that new definition would increase the numbers of people taking high blood pressure medication. Dr. Thomas Giles, the current president of ASH, has said that it would actually make fewer people eligible for treatment with antihypertensive medication.)

This article raises some long-standing questions about public-private partnerships. These include:

-How should non-profit organizations ensure that their actions remain independent and that they are not viewed as being overly beholden or influenced by their funders?

-With public dollars for public health efforts drying up, organizations must look to industry to fund key initiatives (and, in some cases, to survive). What procedures and processes should non-profits and industry put in place to ensure that public-private partnerships are successful? What steps should government take to make public funds easier to obtain?

Overall, we need to be realistic about the nature of public-private partnerships. Industry engages in partnerships for a variety of reasons and no one should be surprised by the fact that their dollars are going toward causes or issues they have a stake in.

Non-profits seek private dollars because — in some cases — they are easier to obtain than public funds. However, when they do, what steps should non-profits take to ensure that they are transparent about their funding sources and that initiatives are headed by a mixture of people with and without ties to commercial interests?

This is an issue that will continue to be debated across medicine, but does not have any easy solutions.

(Kevin, MD has another take on this story.)

Medpundit announced that she is closing the doors of her blog today. She will be missed. A few other medical bloggers have suggested or announced that they have or may stop blogging at some point, including:

-Kate Steadman, Healthy Policy
-”Maria,” Intueri
-Jacob Reider, MD, Family Medicine Notes

I included some of these wonderful bloggers in my report on healthcare blogs, published last month. Does the departure (or potential departure) of these bloggers make the report obsolete? I think not. The healthcare blogosphere will continue to expand and grow in influence with or without their voices. However, any loss is felt and their voices will be missed.

Race-based medicine, or the practice of treating people differently based on their racial and ethnic background, has long been a subject of interest to healthcare providers, public health practitioners, communicators and others. Now, with the introduction of BiDil, the first medication approved for the treatment of a condition in a specific race (African Americans), the topic is once again gaining increased attention.

Given the intense interest in this subject, I am conducting a series of periodic interviews with physicians, executives from medical societies, communications experts and others. Each interview subject provides his or her unique perspective on race-based medicine, which I then publish on this blog. Please click here to read the other interviews in this series.

Interview Subject: Dr. Esteban González Burchard

About Dr. Burchard: Dr. Burchard is assistant professor of medicine at the University of San Francisco Medical Center. Dr. Burchard’s research interests center around identifying “ethnic-specific” genetic and biologic risk factors for asthma, asthma severity and drug responsiveness among U.S. ethnic and racial minority groups. In addition, he focuses on how race and racially specific genetic differences influence disease and response to pharmaceutical therapies.

Read the rest of this entry »

A new study published in this week’s edition of the Journal of the American Medical Association (JAMA) indicates that studies published by not-for-profit organizations tend to be less favorable than those supported by for-profit institutions. The study also found that trials that used surrogate endpoints rather than clinical criteria tended to be more positive – regardless of the funding source.

Adil Shamoo, professor of biochemistry at the University of Maryland has suggested that clinical trial design may impact trial results. He said: “The outcome can be tremendously influenced literally by the A-to-Z of a clinical trial, by the type of question, the design of experiment, the type and characteristics of the human subjects selected, how you massage the data and analyze it, and where and what portion you publish.”

Pharmaceutical industry trade group PhRMA said that the study “is informative and supports the fact that America’s pharmaceutical research companies conduct top-quality, cutting-edge research on life-saving medicines.”

My View: These data are not surprising given that conducting clinical trials is an expensive enterprise and few for-profit organizations want to pursue trials that may not pan out. In addition, many companies decide not to publish negative data on existing and investigational drugs. (Criticism of this practice is one reason companies, like Eli Lilly, have started clinical trial registries with information about all the studies it conducts.)

(Via Yahoo! News)

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.

. . . at Doc Around The Clock.