Tuesday, April 28, 2009

Swine Influenza and Risk Communication

Real panic calls from family members: What do you think of the swine flu cases? Is this the end of the world? My response: Not the end of the world yet and no need for such an alarm. Let's just wait and see. 

The new swine flu outbreak has not only brought more work to my table (we are preparing an article about it for the NNii Web site), but has me interested in the way these cases are reported. A few years ago, with the bird flu scare, many mistakes were made in terms of risk communication, which created panic in some, and apathy in others. The response to this new issue, of course, is varied. Not all the media react alike. But a recent article in the NYT, summarizes well our task as medical writers, informing without alarming:

The W.H.O. and public-health agencies like the Centers for Disease Control and Prevention find themselves in a delicate balance, obliged to provide information about potentially lethal diseases without causing panic.

Although health officials have held exercises to prepare for pandemics and outbreaks caused by bioterrorism, they have yet to master the necessary communications skills. They are in a “damned if they do, damned if they don’t” situation.

Check out my AMWA presentation on risk communication for some principles that you may apply if confronted with this situation. Also, read What to Say When a Pandemic Looks Imminent by risk communication experts Peter M. Sandman and Jody Lanard.

If you want to keep up with the swine flu outbreak, don't go to our local newspaper. Instead, look at a good source such as this one.

Wednesday, April 22, 2009

Medical Devices and the FDA

It is not unusual to see pharmaceutical companies under investigation for dubious practices--like obscuring data from clinical trials or outrageous marketing tactics. But in recent years, the US Food and Drug Administration has also been under the gun. 

Now, the issue is about the approval of certain medical devices. From an article in the NYT:
Nine dissident scientists signed letters to President Obama and others in the administration charging that agency officials had acted illegally and that patients were routinely put at risk by medical devices approved for sale despite significant and often unanimous objections from scientific reviewers.
The FDA will have a chance to defend itself, but these kind of news affect the public's perception of the agency and in turn, it affects medical writers, who are in the midst of the controversy. 

I wonder what circumstances surrounded the development of the regulatory documents submitted for the approval of these medical devices. Were the medical writers responsible for these documents aware of the reviewers' objections or not? 

Maybe the objections were clear in the documentation submitted but the FDA approved the devices anyway (we don't know the details). 

We'll see what comes out of this after the meeting and will know more details if the Institute of Medicine gets involved as the NYT article suggests.

Tuesday, April 14, 2009

Communications/Public Affairs Officer for Infectious Diseases Society

The Infectious Diseases Society of America (IDSA) has an opening for a communications/public affairs officer who will develop and implement communications initiatives to raise awareness about the Society and its goals among various audiences--including members, potential members, the public, policymakers and other advocacy groups. The person will serve as a primary point of contact for reporters, and will write press releases and coordinate interviews with physician spokespersons. In addition, the person will write and/or edit two monthly electronic newsletters for IDSA and the HIV Medicine Association of IDSA. The person will also be responsible for writing letters to the editor, op/eds, and similar materials.

The ideal candidate will have a degree in journalism, English, public relations or a related field, and five or more years of progressive communications experience, including significant writing/editing experience and knowledge of publications processes.

We offer an excellent benefit package (medical, dental and 401k), and a friendly, exciting, professional, Metro-accessible work environment in Arlington, Va. Please send cover letter and resume to:

Diana Olson
Vice President of Communications
Infectious Diseases Society of America
1300 Wilson Blvd., Suite 300
Arlington, VA 22209
Visit us online at www.idsociety.org and www.hivma.org.

Monday, April 13, 2009

Regulatory Writing Training for Non-Native English Speakers

This may interest some of you who have come to the US from abroad and want to pursue medical writing, especially if you are already in biomedical research. 

Monday, April 6, 2009

Forum Discussions at Medical Writing Network

From time to time I like to call attention on interesting discussions at the MWN. You may be interested in participating in this one: Writing in Big Pharma - what would you like to know?

Wednesday, April 1, 2009

Two-Day Regulatory Writing Course (INDs)

Barnett Educational Services is offering a two-day course called "Preparing IND Submissions: How to Organize, Write, Submit and Track Submissions" on June 10-11, 2009 in Philadelphia, PA. Registration is $1,595 by May 1 and $1,795 after May 1 (travel and lodging not included).

Is that too expensive? Consider taking the Regulatory Writing course at MedicalWritingTraining.com.