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The public hearing held by FDA last week in Washington DC to address social media and promotional advertising in the pharmaceutical seems to have altered the agency’s perspective on all things digital. Today, according to a press release, marked the agency’s completion of a coordinated week long international effort called the International Week of Action (IIWA) that was intended to curb illegal actions involving medical and pharmaceutical products.

During the effort, the FDA's Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names. Apparently, FDA has taken to sending warning letter en masse—it previously sent identical warning letters to 14 different pharmaceutical companies for improprieties associated with Google search ads.

Is there really a sea change taking place at FDA? Will a carefully and thoughtfully- crafted guidance document on the use of social media be next; now that the agency is no longer afraid to navigate the Internet? Only time will tell....hopefully sooner, rather than later!

Until next time...

Good Luck and Good Surfing!!!!!!!!!

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e-Patients Connections 2009 (#epatcon) was held this past Monday and Tuesday at the Park Hyatt hotel in Philadelphia, PA. BioCrowd was one of several co-sponsors of the event. The theme of the conference, organized by Kevin Kruse a veteran medical communication and training expert, who now runs Kru Research, was to “reach, engage and educate empowered digital health consumers.” And, boy, did it deliver! While this was Kru Research’s first official conference, it was well organized, extremely interactive and the quality of the speakers was second to none! Topics that were featured included social media and the life sciences industry, technological advances in e-based healthcare delivery, the relationship between the news media and healthcare information and the continuing evolution of online and e-based healthcare communities.

Conference attendees included representatives from the life sciences industry, medical communications experts, advertising and marketing professionals and a multitude of social media enthusiasts and consultants who kept the Twitter screen humming throughout the meeting (a big shout out to the “troublemaking table”). And, surprisingly, there was a representative from the Division of Drug Marketing and Advertising and Communications (DDMAC) at the US Food and Drug Administration, who I believe, was one of the most sought after individuals at the meeting. CNN reporter Elizabeth Cohen who writes the Empowered Patient and racecar driver Charles Kimball, a type I diabetic and company spokesperson for Novo Nordisk also gave talks.

My favorite talks were those presented by online patient community organizers including Tricia Geoghegan of Ortho-McNeil-Janssen Pharmaceuticals who created the Facebook ADHD Allies community, Lisa Tate of WomenHeart and Robert Schumm of Bayer Consumer Care who created Facebook Strong@ Heart and Rachel Lewinson of the Juvenile Diabetes Research Organization and Susan Harrow Rago of Novo Nordisk who created Juvenation.org a website dedicated to those with Type I diabetes. These communities are outstanding examples of how partnerships between pharmaceutical companies and advocacy groups can help to better educate the public and heighten awareness about potentially life-altering diseases. Another example of a great online community and healthcare portal is Insomnia 123.com. This website was conceived and constructed by Christine Macadams and her partners’ one of whom is a practicing physician. Unlike the other online communities, which are sponsored and mainly supported by consumer healthcare division of large pharmaceutical companies, Insomnia 123.com was exclusively created by a group of concerned individuals who wanted to better educate and improve the lives of people with insomnia—a largely unreported and self-medicated condition.

On the technical side, the talks presented by Lee Segal of Klick, Kevin Durr of Avantera , Ian Kelly of Red Nucleus and Scott Ballenger of ListenLogic were illuminating and extremely informative. Some of the innovations taking place in digital media are exciting and almost overwhelming at times (even for a social media enthusiast like me). I think the company to watch is ListenLogic which uses semantic search engines to collect real time data and “chatter” on the web. This technology may provide a cost-effective solution to assuage the concerns of many life sciences companies that claim that collecting and analyzing overwhelming amounts of data is one of the main reasons why they are reluctant to entry the social media space.

Marc Monseau of Johnson and Johnson gave an illuminating talk on his experiences as a corporate blogger and Twitter user and described some of the challenges that had to be overcome before his company was able to break the “social media barrier.” Janice McCallum, an economist by training and a healthcare communications and media expert gave an informative talk about the growing role and impact of patient-generated healthcare content on patient awareness and education.

Finally, the novel and innovative Pecha Kucha sessions were outstanding and extremely well done! While all were expertly crafted, Dr. Val’s and Jonathan Richman’s Pecha Kucha were memorable. Dr. Val’s, which was extremely powerful and moving, was performed entirely in verse and Jonathan’s was—well, one of Jonathan’s always entertaining and informative presentations.

In summary, the “e-Patient Connections 2009” was a resounding success and in my opinion reached its goal to “reach engage and educate empowered digital health consumers.” That said, I can’t wait for “e-Patient Connections 2010” meeting!!!

Hat tip to @ellenhoenig and @eileenobrien for inviting me to my first tweetup (great fun) and finally meeting @janice McCallum, @christianeTrue, @stevewoodruff and Silja aka @whydotpharma! 

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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I don’t want to brag but I have been touting career options in health informatics and health information technology (HIT) for the past year or so. Today, I came across a post by CareerBuilders declaring health informatics and HIT are the hottest new career trends to hit the market in recent years. As the drive towards digitizing medical and healthcare records continue, there will be literally thousands of job opportunities for people with the right skill set. This is what the post had to say about health informatics and HIT careers and job opportunities. 

Health Informatics
Health informatics will put technology in place that provides hospitals and other health-care providers with access to an electronic network of vital patient information such as like medical histories and prescriptions. The information age finally meets healthcare administration.

The facts
The health informatics initiative won’t succeed unless employees — that’s you! — bring the specialized skills needed to build and expand the network. All other pieces are in place:

• The American Recovery and Reinvestment Act of 2009 includes $20.6 billion to help providers drive adoption and development of the IT infrastructure needed
• The U.S. Bureau of Labor Statistics (BLS) projects health information management employment to grow nearly 18 percent by 2016
• The BLS projects a need for more than 6,000 new professionals each year through 2014 — but only 2,600 graduates have entered the field this past year 

Your opportunity
To succeed, health informatics (HIM) will demand a wide variety of specialized positions across IT and health care. It will engage conventional experience from both areas — such as registered nurses and LPNs/LVNs, or IT implementation specialists and IT project managers — if you’re looking for a new twist on your current career.

But new positions will also thrive in this hybrid field. Look for new HIM job titles in your next job search, like health IT professionals, HIM coders, HIM medical records professionals and various health informatics specialists, including trainers, researchers and analysts.

Get online to check out the job titles mentioned above and listed below for related descriptions, and see if you might need any additional training to meet requirements: 

Nursing
- Telemedicine clinical professionals

- Chief nursing information officers

- Clinical IT liaisons 

Health-care administration
- Medical and health services managers

- Document scanners

- Data entry clerks

- File clerks

IT specialists
- Senior programmers

- Senior clinical analysts

- Database analysts

- Developers

- Business analysts

- Software engineers

- Data integration specialists

Not too shabby of a list! In a previous blog post I identified a variety of training options for people interested in pursuing careers in health informatics and HIT. Check it out!

Until next time....

Good Luck and Good Job Hunting!!!!!!!

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For the first time in history, more people are searching the Internet for health information than asking doctors. Web 2.0 and social media tools are allowing people to discover new ways to connect, learn and engage one other in search of healthcare and drug information.

e-Patient Connections 2009 which will be held in Philadelphia, PA on  October 26 and 27 will feature a number of leading authorities on social media and digital health  Some of the featured speakers include Wired Magazine’s Thomas Goetz, Jay
Bernhardt of the CDC, and Lee Aase of the Mayo Clinic. The conference also offers case studies, 1:1 coaching sessions with industry experts and the latest products from digital health companies.

BioJobBlog readers can use the discount code kru500 to save $500 off the current price.

See you there!

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I suspect that a majority of BioJobBlog readers have at one time or another been prescribed a drug to treat a particular medical condition or ailment. Like most of you, I assumed that my prescription information and history was private and that only healthcare professionals were privy to it. However, after reading an article in this Sunday’s NY Times, I learned how wrong I was! Much to my dismay,  I learned that prescription information including the name and dosage of a drug, the name and address of the physician who prescribed as well as a patient’s address and social security number is a commodity that is regularly bought and sold usually with a patients’ knowledge or permission. And apparently, this practice is perfectly legal as long as patient’s names are removed or encrypted before the information is sold, typically to drug manufacturers.

Unfortunately, privacy experts and information technology specialists contend that it isn’t difficult to match names, addresses, and social security numbers to reconstruct information that had supposedly been rendered anonymous. To make matters worse, until very recently, federal patient privacy and data security rules were loosely enforced and frequently abused by medical marketers, advertisers, drug manufacturers and retail pharmacies. Finally, re-identifying a patient’s prescription drug information and history provides drug makers with a powerful tool to target and market drugs to specific patient populations.

Tracking prescriptions and mining prescription data is not new—it has been big business for many decades. The major players in the drug mining business are companies like IMS Health, Verispan and CVS Caremark. Also, large discount pharmacy retailers like Walgreens and Target engage in this practice and they all sell their prescription information data to interested parties. Prescription drug data-mining companies say that their services are valuable and warranted because gathering and analyzing information from tens of thousands of patients helps drug manufacturers to identify trends and potential safety and tolerability issues with prescription drugs. Nevertheless, despite assertions that prescription drug data are anonymous when it is sold, class action and private lawsuits alleging this not to be the case have been filed against some of the major players including Walgreens, IMS Health and CVS Caremark. While this is troubling, loopholes in the current prescription drug data mining regulations allow pharmacy companies like Walgreens and others to accept money from drug manufacturers to mail advice and reminders to customers to take their medications without first obtaining their permission. The loopholes also allow drug makers to send customers’ promotional information and materials about drugs other than the ones that they are already taking.

Under the Obama Administration’s $19 billion healthcare stimulus package, selling prescription drug data to drug makers will still be allowed (only if patient’s names are removed). Also, subsidized marketing by drug makers will be allowed to continue but companies will no longer be able to promote drugs other than those the customer already buys. While the new legislation allows data mining and the sale of prescription drug information to continue, its primary goal is to tighten and insure patient privacy so that personal prescription drug history and information can no longer be used to exploit the buying habits and behaviors of individual American consumers.

Until next time...

Good Luck and Good Job Hunting!!!!

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I met Jonathan Richman,the author of the Dose of Digital blog, last week at the BDI Conference (#BDI) on Social Communication and Healthcare in NYC. BTW, for those of you who were unable to attend, you missed an informative and compelling meeting on the status of social media in the pharmaceutical and healthcare industries. Anyway back to Jonathan. He gave a great talk on pharma and social media which prompted me to visit his blog. While perusing Dose of Digital, I came upon a wiki that Jonathan maintains called --what else-- the Pharma and Healthcare Social Media Wiki.” 

It’s a comprehensive, cataloged list of social media initiatives underway at pharma, biotech and healthcare industries. Noticeably absent from the wiki, are social networking sites like BioCrowd that were specifically created for life scientists and other bioprofessionals. Hey, wait a minute, aren’t scientists the lifeblood of the life sciences industry? Would there be a life sciences industry without scientists? Hmmmm....I will have to talk to Jonathan about this!

I highly recommend you check out the wiki if you are a life sciences social media enthusiast!

Until next time...

Good Luck and Good Social Media Hunting!!!!!  

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