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For the past several weeks, the EyeonFDA blog has been reporting on the possible regulatory impact of Google’s Sidewiki on life sciences companies. For those of you who may not be familiar with Sidewiki  (released in late September) it is a new feature of the Google toolbar which can turn a static web 1.0 website into an interactive web 2.0 experience by allowing website visitors to leave comments behind.

When you use side-wiki, you have the ability to leave your comments and associate them with a website whether or not the website owner has enabled commenting.  Since the comments are maintained by Google, there is no direct relationship with the website.  Basically, anybody who visits a website that has Sidewiki enabled can say or comment on whatever they like and immortalize it (until Google removes it) for the entire world to see. Apparently, this doesn’t sit well with many website owners and Google purportedly recently release code to disable Sidewiki at websites that don’t want to support it. However, it isn’t clear how robust the anti-sidewiki code is!

While I haven’t formulated an opinion on Side Wiki yet (mostly because it isn’t that interesting to me), it does represent a regulatory dilemma for life sciences companies with marketed drugs and devices. According to today’s EyeonFDA post “If someone writes of an adverse event on a Sidewiki, or promotes an off-label use, it is now on the company's home page.  Is the company under a duty to monitor and correct such misinformation or if they do, do they incur liability for doing so?  It is a conundrum - and there is no insight apparent from the FDA on the matter.” Further, most life sciences companies have yet to craft a legal or regulatory policy for Sidewiki usage. 

EyeonFDA has been assiduously monitoring life sciences company websites for the appearance of Sidewiki. To date EyeonFDA has found it on the following company websites:

1. Abbott
2. Amgen
3. AstraZeneca
4. Bayer
5. Baxter
6. Bristol-Myers Squibb
7. GSK
8. Johnson & Johnson
9. Lilly
10. Novartis
11. Novo Nordisk
12. Pfizer
13. Roche
14. Sanofi-Aventis
15. Takeda

While Google would like everyone to believe that Sidewiki is taking the Internet by storm and spreading like the H1N1 virus, a show of hands at yesterdays e-Patient Connections 2009 meeting in Philly, which was attended by many computer geeks and social media enthusiasts, revealed that about4 out of about 150 had heard of it! Nevertheless, it is out there and life sciences companies would be well advised to formulate internal legal and regulatory guidelines despite the fact that FDA hasn’t issued any guidance on its use.

P.S. Shortly after I posted this, @pharmaguy alerted me to an article that appeared on the today's online PharmaExec.com entitled "SideWiki: What's Pharma To Do"?

Until next time...

Good Luck and Good Commenting

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I came across a recent post on Adage.com entitled “Pharma Drops Search Advertising After FDA Warning” that revealed that paid search ads by pharmaceutical companies dropped a 84% between March 26 of this year and the end of June. As you may recall, March 26 was when 14 companies received warning letters from the US Food and Drug Administration (FDA) indicating that they had violated marketing guidelines for search ad advertising. The letters stated that sponsored-link advertisements for specific drugs were misleading due to the exclusion of risk information associated with the use of the drug -- even though the regulatory agency's guidelines are for print and broadcast, not online or social media. Pharma companies that believed they were in compliance with the unwritten "one-click rule"— taking the consumer from the ad to a site that offered fair balance and the risk information by clicking on the ad. What? Did I read that correctly; the words “unwritten and FDA” in the same sentence? This is very surprising since anybody who has worked with the agency is well aware of the “if it isn’t written it didn’t happen” principle. But I digress....

The post went on to say that pharmaceutical companies are “fearful of running afoul” of the agency again. Say what? The words “pharma and fearful” used in the same sentence? The point that I am trying to make is that pharma chose to keep things vague about web-based advertising to see how far they can push the envelope with FDA instead of taking the proverbial “bull by the horns” and directly asking FDA for guidance on web 2.0 technologies and their uses. Wouldn’t it be in everyone’s best interest if companies took a more active role to help craft new rules on the use of new media technologies rather then rely on and wait for FDA to do it for them? While the old “cat and mouse” game worked for old media, it is no longer tenable when it comes to Web 2.0 and related technologies.

The FDA is holding public hearings next month to begin the process of establishing internet advertising guidelines and the use of social media in the life science industry. This offers drug and devices companies an opportunity to show FDA that they no longer want to be part of the problem but part of the solution.  I have always subscribed to the notion that “you don’t get if you don’t ask!”

Until next time...

Good Luck and Good Surfing (on the Internet that is)

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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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There has been a growing reliance on the use of online tools to teach science to primary, secondary and college students. This makes sense because anybody who has pursued a science career will tell you that using web-based programs, applications and searches is absolutely essential when conducting scientific research. To that end, Amber Johnson at onlinecourses.org sent me an article that details some really cool educational add-on tools that are available for the Firefox browser.

I highly recommend that science educators at all levels check out the post and evaluate some of these interesting tools!

Until next time...

Good Luck and Good Teaching!!!!!!!!

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Mark Senak at the EyeonFDA blog reported yesterday that the US Food and Drug Administration (FDA) is seeking public input on the use of social media in the pharmaceutical, biotechnology and medical devices/diagnostic industry. Meetings to solicit input will be held in Washington DC on November 12 and 13^th.  This will be the first opportunity for industry representatives and the public to begin a discussion with FDA on the policies that will guide the use of social media in the life sciences industry.

According to EyeonFDA, on Monday, the agency will publish a notice in the Federal Register announcing this historic event (see excerpt below)

Questions have arisen regarding the application of the prescription drug and device advertising and labeling provisions, regulations, and policies of promotion on the Internet, especially with regard to the use of emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis. This section briefly discusses the issues the agency has identified as most frequently raised by regulated companies and other interested parties. It should be noted that although a question may raise a particular issue, that does not necessarily mean that the agency will issue guidance or a regulation on that issue. The agency invites comment at the public hearing on the general concept of Internet promotion, positive or negative; on any aspect of Internet promotion that is of interest to the presenter; and on the topics outlined in the following paragraphs. We are specifically interested in data and research on the use of social media tools in promotion, including data from companies on their own experiences, the extent to which health care professionals and consumers are using and are influenced by various social media tools, and the impact of Internet and social media promotion on the public health.

For the past year or more, many bloggers and other social media enthusiasts have taken FDA to task for not taking action on the topic. Finally, the agency realized that something had to be done given the growing use and popularity of social media tools and strategies in other less regulated industries. Earlier this week, in an unexpected move, FDA launched its first Twitter feed. Perhaps this was a hint that FDA is beginning to emerge from the dark ages into the digital world of Web 2.0 and social media.

Hat tip to Mark!

Until next time...

Good Luck and Good Twittering !!!!!!!

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BioCrowd co-founder, Vincent Racaniello, and I were chatting the other day with Crowdvine’s Tony Stubblebine (the guy who created the BioCrowd software platform) about the reluctance of scientists to embrace social media. Both Vincent and I, both scientists ourselves, posited that scientists are simply asocial or at the very least not comfortable engaging in social activities whether they be online or IRL. Tony, a self-anointed software geek, wasn’t buying into to our argument and noted that even software geeks are social!

This prompted me to do a little research and I found a blog post written by Nachiket Vartak a blogger and doctoral student at the Max Planck Institute for Molecular Physiology. While the blog post focused mainly on reasons why bioscientists won’t use Twitter, I think that many of his observations can be used to generally describe the chilly relationship between many scientists and social media. Before you read on, I must inform you that I paraphrased and embellished some of Nachiket’s original ideas on the subject. That said, here are some of the reasons why bioscientists may not use social media.

1. The reputation of social networking sites
Many scientists disdain social networks because they believe that social networking sites and microblogging platforms like Twitter are nothing more than places to waste time. Those scientists who use social media usually do it in-between experiments and when planning activities which usually involve copious quantities of alcohol, for after laboratory hours fun. In other words, social media is for fun not for work. Also, many so-called serious scientists contend that “real science discussions” only happen on closed e-mailing lists or forums and not in the “open” on social networking sites.

2. The social activation barrier
According to Nachiket, the stereotype that scientists are asocial is well.....err...true! He asserts that many scientists feel more comfortable focusing on themselves (and their research) rather than interacting with others to learn what they have to say or what they may be thinking. And, many times, unless an individual can demonstrate that they are “smart” they probably aren’t worse listening to anyway. Finally, scientists train for years to become independent investigators. Not surprisingly, there is very little emphasis and importance placed on teamwork or social interactions with others scientists or lay people for that matter. Therefore, it should come as no surprise that many scientists aren’t particularly social or inclined to participate in extracurricular social activities.

3. Privacy aka “secrecy”
Science is a highly competitive endeavor and, in many cases, the discoveries that are made represent many years of sacrifice, blood, sweat and tears. With this in mind, nobody wants to be scooped or beat out by their competitors. Consequently, scientists are generally instructed to be very hush-hush when it comes to sharing any information or data that might give the competition a “leg up” in the competition. Any leak, large or small, could mean the difference between fame and failure and, perhaps more importantly, a successful career as a scientist.

In marked contrast, the success of social media is contingent upon its openness, sharing and transparency. Thus, as Nachiket aptly pointed out social media is antithetical to the very nature of science and scientists.

4. Legitimate channels of communication
The only acceptable and legitimate means of scientific communications are presentations at meetings and publications in peer reviewed journals. These forms of communication are the lifeblood of scientific community and critical to the success of all scientists. If you aren’t published, you have no credibility as a scientist. The scientific publishing and communication industry is big business and “the rules of engagement” in the industry have been well established and institutionalized. Unfortunately, social media threatens to destabilize the science publishing world both financially and philosophically and possibly change the way science information is communicated. Therefore, it should come as no surprise that there is little support for social media in scientific publishing world and the science community in general.

While the number of science blogs and podcasts continue to increase daily, scientific social networking sites continue to struggle. This is because the information flow in blogs and similar forms of social media can be easily monitored and controlled. This is not the case for social networking sites like BioCrowd and microblogging platforms like Twitter.
However, if scientists are truly asocial beings then none of the existing science social networking sites will gain traction and be successful. Call me crazy, but I think social networking is an ideal medium for scientists to exchange information, ideas and develop relationships that can help them jumpstart their careers!

Until next time...

Good Luck and Good Networking!!!!!!!!!!

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We were able to entice Berci Mesko —a Hungarian medical student who writes at ScienceRoll and is founder of Webicina —to chat with us about the transection of Web 2.0, science and medicine.

Berci, who only sleeps four hours each night, is a medical section editor at Wikipedia, runs courses in Second Life (and real life at his medical school) and can frequently be found on Twitter enlightening his followers on topics ranging from personalized RSS feeds for physicians to the latest breakthroughs in medical genetics. While this ought to be enough for most people, Berci told us that he always wanted to be a scientist and— to realize this dream— will be entering a PhD program next fall. He is a very bright, energetic and engaging fellow whose understanding of the relationships between physicians and patients are insightful and instructive.

Have a listen and also check out BioCrowd!

Until next time…

Good Luck and Good Listening!!!

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Vincent Racaniello, a pioneer in RNA virology and world class researcher on the pathogenesis of polio, believes that social media can be used to enhance scientific research and improve science education. Vincent recently blogged about this on his virology blog and graciously allowed me to repost it to BioJobBlog. It is an interesting perspective from an innovative and creative scientist.

Science and the Social Web

In a previous post about why I blog and podcast, I discussed how these activities allow me to think more about virology and to teach far more people than I ever could in a laboratory or classroom. Is there even more value in the web for scientists?

There are three different web activities, besides blogging and podcasting that enhance science in new ways. The first is the ability to post comments on blogs and podcasts. In so doing, people can interact in ways that were not previously possible. Scientists who have never met, or students hoping to learn, all can connect and create an instructive and creative dialog. Don’t understand something in a post? Just ask. Have something different to contribute? Post it. Science can only benefit from interactions not limited by geography or time.

The second powerful web tool for science is the social networks. We know how MySpace and Facebook made it easy to meet and interact with new people. These networks also allow scientists to connect and talk about their profession. There are various groups on Facebook that enable focused, productive discussions among scientists. Even more useful are the social networks that have been developed specifically for scientists - well over 20 according to this  blog post. These networks exist to foster interactions - meeting other scientists, looking for jobs, troubleshooting experiments, finding answers to thorny questions. The value of scientific social networks is that they enable dialogue far beyond what you could achieve on your floor, in your building, by telephone or email. The result is scientific interactions at unprecedented levels.

The third web tool for scientists is Twitter. This microblogging platform restricts users to posts of 140 characters or less - the end result is concentrated information. For scientists, Twitter can be either a distraction or a gold mine. If you choose to follow individuals who are interested in science, you will, in the course of a day, find tweets with links to interesting science - news or journal articles; comments on science; questions about science or science methods - in brief, the kind of exchange originally facilitated by email but far more immediate and pithy. Follow the right people on Twitter, and receive useful information. I keep an eye on Twitter to find tips on how scientists use the web, the latest science news, and comments on science in general. In turn, when I learn of an interesting science news event or article, I tweet it. Mr. Tweet’s discussion of  the evolution of a twitter user crystallizes this concept.

There is also great value for scientists at FriendFeed. No, it’s not a fourth category - it’s an aggregator of the three activities described above, one-stop for all your blogging, podcasting, social networking, and twittering.

These three aspects of the social web are revolutionizing science. By using them, I am learning more about my field than I ever have before. Those who choose not to take advantage of the social web will miss the opportunity to become more creative and productive scientists.

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I was reading Karen Ventii’s Science to Life blog today and she “turned me on” to a couple of new web-based tools that I think might be useful to people who work in the biosciences. I added Karen’s recommendations to a list that I was building and decided that it had reached enough of a critical mass to share it with you.

The first of these new tools is called graduatejunction.com, a research community primarily aimed at graduate students and postdoctoral fellows. According to its founders—a team of UK graduate students at Durham and Oxford universities—the intent of graduatejunction.com is build a community of graduate students and postdoctoral fellows so that members can stay abreast of research activities within in the community and to connect with other community members who share common research interests. Not a bad idea, considering that many graduate students and postdocs frequently operate in intentional mentor-induced research vacuums.

The second is called labmeeting.com. It is a novel, web-based tool that helps researchers organize (and search) personal PDF collections, share laboratory protocols, Powerpoint presentations and other scientific data with their lab mates. The software was created by graduate students at Stanford University and it aims to organize laboratory research so that it can be conducted more efficiently and at a faster pace (time is money after all). I think that this concept has legs and might be a big winner downstream (although security will be of paramount importance).

Another new tool that warrants praise is biomedexperts.com that was created by Collexis, Inc. In my opinion, biomedexperts.com is the “mother of all” publication search tools and literature management systems. Billed as the first literature-based social network, it allows users to quickly perform personalized literature searches (based on authorship and research interests) and then identify potential collaborators or competitors who have published in the same research areas. Unfortunately, while biomedexperts.com is a “monster” web-based, literature search application, the communication and interactivity between community members is extremely limited and almost non-existent.

Finally, for those of you who are tired of using PubMed’s arcane Boolean search algorithm to find relevant publications, you might consider trying a new free search engine (semanticmedline.com) that allows users to search MEDLINE using phrases or “conventional sentences." Cognition Technologies, creator of the site, says its “semantic natural language processing technology "incorporates word and phrase knowledge to comprehend the meaning and nuances of the English language." Although early reviews suggest that semanticmedline.com might not powerful enough for doing comprehensive science literature searches, it may be useful in situations when you are working on a time-sensitive project or you need to quickly find an article for this afternoon’s journal club meeting (that you failed  to enter into your blackberry or iPhone).

Check them out—they are all pretty cool (for scientists anyway-not that there is anything wrong with that)!

Until next time

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

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This month Kevin has reviewed an eclectic bunch of websites. Continuing with his “down under” theme from last month, Kevin offers the Australian National Herbarium and the Darwin Correspondience Project websites (okay so Darwin was English but he did visit Australia!). The Darwin site complements an interesting site called the Origin of Life Prize (check it out).  

Another Australian website called the Sea Snake Homepage covers everything you ever wanted to know about sea snakes (and then some) but as Kevin put it may not be for everyone. There is a technical site called Microscope-Microscope.org which has some terse but valuable information on well—microscopes.

My personal favorite is the Biomedia Associates Educational Biology site. Although it is a commercial site, it is an education website and offers some valuable resources for biology teachers and students.

Until next time…

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

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Kevin’s selections this month contains a wide variety of sites ranging from an Australian museum guide, to wildlife parks in Tasmania and online information-sharing and management capabilities.  If leeches are your thing check out this site and if you are a dragonfly aficionado this site will do the trick. An interesting site called the Fallacy Files provides insight into fallacies or so-called mistakes in reasoning.

As a sometimes medical writer, the site that piqued my interest was www.connotea.org— an online reference and information sharing-service.  The site provides you with easy and ready access to references, data and other information stored in your account on the site.  Kevin really likes this site and says “Connotea scores big time with this valuable tool for scientists.”  Check it out….

Until next time….

Good Luck and Good Web Surfing

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The web is filled with wonderful and interesting sites that are useful to many scientists.  Unfortunately, most of us don't have the time to surf around the web to find them!  Luckily, Kevin Ahern has the time (or more likely has found the time) to do what most of us can't. To that end, I created a new category on BioJobBlog called Around the Web to post the results of Kevin's hard and much appreciated work.

Each month, I will provide a link to Kevin's "Best of the Web" report that he creates for Genetic Engineering and Biotechnology News and provide my own commentary on the sites that he showcased that I found most useful or interesting.

Until next time....

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

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Insmed a small, Richmond Va-based biotechnology and manufacturing company has upped the ante in the fight to bring follow-on biologics to America.  After spending some time on Capitol Hill, company executives  found that “people in Washington, as well as payors and patients don’t have an understanding at a reasonable level of the debate that is going on and the issues” surrounding that follow-on biologics debate. To reach as wide an audience as possible and frame the debate on the issues” the company decided to use the Internet to take the initiative to the next level–the Internet.

A key to Insmed’s initiative is an economic study on the potential savings follow-on biologics could provide to patients, payors and healthcare providers. The study is still being conducted and its results will be published on the net when available. The campaign also includes advocacy components that like user-generated content (blogs) and social networking sites. Recently, Insmed posted a video clip on YouTube that feature one of its scientists extolling the virtues and cost-saving advantages of follow-on biologics.

As many of you may know, I have long been an advocate of legislation to allow the approval and sale of follow-on biologics in the US.  Unfortunately, until now, only one side of the debate–from big biotech and BIO–has been heard by the American public. This has largely been due to marketing muscle and deep pockets of big biotech coupled with a lack of unity among follow-on biologics advocates. Web 2.0 with its social networks, blogs and video sites allows people with the smallest voices to be heard. And, sometimes those small voices can turn into  roars!

Kudos to Insmed for having the courage to boldly go where no generics manufacturer has gone before–on YouTube! Yeah baby!!!

Until next time….

Good Luck and Good Job Hunting (see you on Web 2.0)!!!!!!!!

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