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Helen Shik

FDA guidelines on Social Media further delayed

According to a report just posted by PRWeek, the highly anticipated FDA Draft Guidance on the Internet and Social Media will not be issued on March 31. The FDA has a Facebook page and Twitter handle, although when this blog was posted, the FDA had not posted in either about the delayed release of guidance. Delayed now for a second time (originally expected by end of 2010), this continued lack of guidance means that healthcare communicators must continue to “blindly” navigate the social media waters.

Just yesterday, Schwartz co-hosted with PR Week, a webcast on social media for healthcare. Our expert panel-- including Lee Aase of the Mayo Clinic Center for Social Media and Gary Karr, EVP at AdvaMed and me—discussed strategies beyond a ‘wait and see’ approach. Just because there are no strict guidelines, doesn’t mean you have to sit on the sidelines.  But you should be smart about what you do. We’re seeing with our clients and other medical companies, that if you apply some of the rules for traditional media relations, you can effectively participate in social media.

Tags: FDA guidelines for social media, Healthcare PR

Posted by Helen Shik on March 29, 2011 at 3:33 PM
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Sleep, preemies and polio: The week in review

Here are some of the health news stories we read this week:

FDA approves injectable drug to prevent preterm birth

Great news for pregnant women at risk of preterm birth. The FDA approved the drug Makena, (hydroxyprogesterone caproate) to help prevent preterm labor before 37 weeks. Preterm birth is a prevalent problem (about half a million babies are born prematurely in the US alone) and puts preemies at risk of death and lifelong health issues. The drug was approved for women who had a previous preterm birth. Makena will be sold by KV Pharmaceuticals, once the worldwide rights to the drug are transferred from Hologic (HOLX).

New study says kids need more sleep to avoid obesity

A new study in Pediatrics says that kids who get more sleep nightly, are less likely to become obese. We all know that kids who don’t sleep enough can be cranky. But this study, which evaluated 300 kids between the ages of 4 and 10, found that those who got less sleep or irregular sleep, were at significantly higher (4.4 times) risk of obesity and diabetes. Kids in the study got 8 hours of sleep a night. The study says that those who sleep 9 or 10 hours a night have their risk considerably decreased. The good news: making up sleep on the weekends works to offset the lack of sleep during the week. So if your kids want to sleep in and miss those Saturday morning cartoons, go for it.

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Gates Foundation wants to eradicate Polio worldwide

Bill Gates appeared on The Daily Show earlier this week, telling Jon Stewart about the work of the Bill and Melinda Gates Foundation to eradicate polio in Nigeria, Pakistan, Afghanistan and India. Some are criticizing Gates for diverting attention from other health issues, and stating that his goal is unrealistic. The editor of the Lancet, Richard Horton, tweeted, that "Bill Gates's obsession with polio is distorting priorities in other critical (Gates Foundation) areas. Global health does not depend on polio eradication." There was an interesting post in the Washington Post’s Light on Leadership column, where Paul Light defends Gates’s mission. Shouldn’t you always strive to change the status quo? And how else can you really make change if you don’t shoot for the top?  As Light notes, “Great social movements demand great ambition.”

Tags: healthcare, healthcare PR, Hologic, KV Pharmaceutical, medical, preterm birth

Posted by Helen Shik on February 4, 2011 at 4:36 PM
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What you won't find in your Xmas stocking from the FDA...

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It’s true. The FDA has had 13 months to draft guidelines for healthcare companies and their use of the Internet and Social media, yet said this week that no guidelines will be announced until Q1 of 2011. Surprised? Not really. So what should we do now?

For some companies, it will be business as usual. While I think the majority of companies are taking a conservative approach to social media (limited activity on Facebook, Twitter and YouTube for instance), some companies are proving that you can and should jump into social media. TIME magazine reported on the use of social media by medical companies, and Novo Nordisk’s campaign with race car driver Charlie Kimball is a good example of what can be done, while we wait for the guidelines. As Kimball notes in the story, "It's a great way to connect with the diabetes community.”

At Schwartz, we’re finding a varied mix of “tolerance” and interest in social media among our healthcare clients. Most are at least “dipping their toes in” at this point. One thing for sure, they all agree that social media has become an integral part of how almost everyone communicates, including how consumers and patients get information about their health. So if you’re not doing at least some social media, you are missing an opportunity to connect and interact.

It will be interesting to see when guidelines come out and what is addressed first, since the FDA also noted that they would be segmenting guidelines and addressing only one aspect of social media in Q1.

In the meantime, campaigns already underway will most likely continue as they have in 2010, without clear guidelines. That’s not necessarily a bad thing either.

Tags: DDMAC, FDA guidelines for social media, healthcare PR, Medical PR, social media

Posted by Helen Shik on December 23, 2010 at 1:30 PM
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Getting to Know Jon Kamp, Dow Jones Newswires

The Schwartz Healthcare Practice has had the pleasure of working with hundreds of biopharma and medtech clients and journalists. Over the next few weeks we'll introduce you to many journalists, innovators, entrepreneurs as well as our HC Practice staff, in our "Getting to Know" series. First up is Jon Kamp with Dow Jones Newswires here in Boston:

Name: Jon Kamp
Title: Special Writer
Company: Dow Jones Newswires

My first reporting job was:
Worcester Magazine, where I interned in college and then did some post-college freelance work.

What I like most about working in healthcare is:
Healthcare is a great reporting beat. It's inherently interesting for a broad swath of people because we're often reporting on topics that really affect peoples' lives. It can also be a fascinating and challenging beat for reporters, given the fact many of us (me included) are writers and English majors by nature, and not scientists and statisticians. Because of this, it's a beat where bad reporting is a serious risk. Healthcare reporters have to be especially diligent in their efforts to understand the subject matter and strike the right chord. I like that challenge.

When I'm not working, I like to: My wife and I are busy raising a little baby girl these days, and we spend time with friends and family when we can. I used to run and play basketball, back when I found time to exercise, and I have all sorts of plans to start that up again next year. To avoid a conflict of interest, I'm trying to not become a cardiology patient.

Who had the biggest influence on your career?:
From the early days it was always great writers, especially John Steinbeck. I was a voracious reader as a kid, and I've always wanted to be a writer. My journalism career evolved later as a practical outlet. But I read and admire a great many journalists today, too many to name, and I learn from them daily.

People would be most surprised to learn that I
: I can play "Run to You" by Bryan Adams on guitar, in its entirety, and I'm not even remotely ashamed by this. I'm still working on the rest of the Adams canon.

If I wasn't in healthcare, I would probably be: Covering some other beat for Dow Jones. I covered energy companies here for years and enjoyed it, and I imagine some day I'll delve into something else beyond health care.

You can find me at:Jon.kamp@dowjones.com; http://www.linkedin.com/pub/jon-kamp/2/598/b17
 

Tags: healthcare PR, Schwartz communications

Posted by Lauren Arnold on November 9, 2010 at 9:15 AM
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MassDevice.com visits Schwartz Communications

It was great to have Brad Perriello, executive editor and Brian Johnson, publisher of MassDevice.com out to our offices in Waltham to speak to our Healthcare PR Practice Team. As they put it, MassDevice.com is “telling the story of innovation from a business perspective” —with a comprehensive news site that gets more than 35,000 visitors monthly.

Don’t be misled by the name, MassDevice.com is not just about Massachusetts-based medical device companies, although it’s a great source of comprehensive information on the large and small medical device companies across the New England region. MassDevice.com is also reporting on all the news and events that impact the medtech industry, from the FDA’s review of the 510K process to healthcare reform to Medicare and more. Their medtech index, presented every Monday in a weekly check up, looks at the medtech industry in Massachusetts as well as Minnesota and California, two other medtech hotbeds. With a goal of becoming the premier business intelligence source for the medical device industry, they define med device to include device, diagnostics, HCIT, mobile/wireless, EMRs and lab tools.

Here are Brian and Brad discussing their new site and the top trends they are following:

Tags: healthcare PR, medical device PR

Posted by Helen Shik on June 30, 2010 at 2:39 PM
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Healthcare PR Pros: Follow the FDA on Twitter

The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is now on Twitter.

According to the FDA website, the goal for getting on Twitter is to reach regulated industry, health professionals, and others interested in the business of the center in a way convenient to them. With two handles, @FDAcdrhIndustry and @FDADeviceInfo, the FDA will be using Twitter to get out the word about product recalls, approvals, upcoming meetings and the many tools available to help users comply with regulations.

Most interesting is the FDA's acknowledgement that they're on Twitter to make things convenient for their audience. Yes! While some in the medical device industry have been hesitant to embrace social media, ironically due to regulatory concerns, FDA's move to Twitter is further confirmation that social media tools are an accepted and effective communications tool for the device industry.

Posted by Helen Shik, VP, Healthcare Practice
Tags: FDA, healthcare PR, medical device PR, Twitter

Posted by Laura Kempke on May 17, 2010 at 12:04 PM
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PR Works for Clinical Trial Patient Recruitment

As PRWeek reports, public relations can be a cost-effective, powerful and efficient way to recruit patients for a clinical trial. That’s what EnteroMedics found when they hired us for a 7-month project to help accelerate patient recruitment for its EMPOWER Study. EnteroMedics makes an implantable device that delivers VBLOC Therapy to treat obesity.

The company needed to enroll up to 300 patients by August. Beginning in January, our team executed a PR campaign targeted at national media and the 13 U.S. markets with clinical sites. As a result of the PR efforts alone, more than 2000 patients were screened and of those, 9% or 190 were prequalified for the study. The news stories on the study, both on the national and local level significantly boosted awareness and helped to drive inquiries into the website and the call center. For instance, after a front page story appeared in the San Francisco Chronicle, web hits increased 350% and after a segment on Good Morning America traffic to the site increased 600%.

We’ve been doing this type of work for some time for clients. In fact, one of the first clinical trial recruitment campaigns we executed was for Gynecare (now Ethicon/J&J) for its uterine balloon therapy for menorrhagia. For that campaign, a segment on GMA with the lead clinical investigator stimulated a flood of phone calls to the call center—enough to fill the study. We also managed a patient recruitment campaign in 20 markets for Northstar Neuroscience for its clinical trial of cortical stimulation for stroke and just wrapped a project for client BioMS, helping to recruit patients for a Phase III trial of an experimental Multiple Sclerosis drug, Dirucotide. The goal, achieved in part with our PR assistance—recruit 510 patients for 68 U.S. clinical sites.

Tags: clinical trial recruitment, EnteroMedics, healthcare PR, medical device PR, obesity device

Posted by Helen Shik on October 28, 2008 at 11:59 AM
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