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It’s no secret that pharmaceutical and biotechnology companies are “not in love” with social media. However, whether life sciences company like it or not, social media is beginning to affect human clinical testing with an increasing number of patients demanding access to unapproved experimental drugs to treat life-threatening illnesses. 

In a recent article that appeared in the January 15, 2010 issue of Genetic Engineering and Biotechnology News entitled “Expanded Access to Investigational New Drugs”, Natalie Douglas, CEO of UK-based Idis Pharma wrote:

"...the trend toward greater transparency of drug development pipelines and the accessibility of powerful social media tools, have led us to a more informed empowered and vocal population of patients. This, in turn, has led to increased demands for access to unapproved drugs that are in various stages of human clinical testing. “Patients can easily access information about investigational drugs via the Internet and are leveraging social media tools such as YouTube, Twitter and blog to influence companies to garner access to them” Douglas added.

This can place enormous pressure on the companies that are testing investigational new drugs because the safety and efficacy of the drug candidates has yet to be determined. Understandably, companies are loath to provide patients who don’t meet clinical trial inclusion requirements access to experimental drugs with unknown safety and efficacy characteristics. Nonetheless, if requests for access to investigational drugs are denied, social media tools can easily be used to quickly and widely publicize the denial. According to Douglas, aggressive use of social media tools by patients seeking access to investigational drugs has helped their stories make national news. This can create gargantuan regulatory and public relations problems for companies with drugs in clinical development and put them at the center of an ethical and moral firestorm—despite their best intentions to develop new drugs that eventually may help millions of patients suffering from various diseases and conditions.

Many patient advocacy groups, consumers and shareholders understand the almost limitless reach of social media and its ability to influence public opinion, discussions and trends. Whether or not drug makers are willing to use social media, many have yet to understand that they are already part of the social media conversation that is taking place daily. And, as all social media enthusiasts have realized, if you are not part of the conversation then you don’t know what is being said about you on the Internet. More importantly perhaps, is that by choosing not to participate in the conversation, companies have lost all ability to influence and manage what is being said. In other words, life sciences companies that steadfastly choose not to use social media may, paradoxically, be setting themselves up for public relations and regulatory headaches that could have easily been avoided.

While the social media frenzy may be beginning to wane, there is no question that it has changed the way people interact and influenced the way business is transacted online and in real life. Companies that insist on clinging to past business practices that are exclusive, non-interactive and designed to promote opacity are likely to lose customers and market share as 21^st century technology continues to unfold.

Hat tip to Natalie!

Until next time...

Good Luck and Good Tweeting!

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In a previous blog post, I raised the possibility that the life sciences industry may be using adverse event (AE) reporting to explain why it has been slow to adopt social media as a means of communicating and interacting with its customers and stakeholders. The industry argument against social media goes something like this: by engaging physicians, consumers and other stakeholders in social media conversations, there will be a massive and unmanageable explosion of AEs posted to social networking sites, company websites and health and science blogs. Because of this, companies will be obliged to report them to FDA. Company executives’ fear that this will be inordinately expensive, egregiously time-consuming, technologically-daunting and most importantly, expose companies to possible legal and regulatory actions. While some of these claims may have some validity, they are not as expensive, technologically-challenging or insurmountable as anti-social media advocate would have you believe. For example, while conducting an interview for Life Science Leader magazine for an article on social media and pharma, several pharma employees exploring the social media space confided that most companies already have assiduously-crafted AE reporting policies in place to easily manage and accommodate AE reporting from  websites, cell phones and even text messages! For those of you who may be wondering, before potential AEs are required to be reported to FDA it must meet the following criteria: (i) there is an identifiable patient; (ii) there is an identifiable reporter or observer; (iii) there is a specific drug or biologic involved in the event; and (iv) there is an adverse event or fatal outcome.

Jonathan Richman (social media guru and pharmaceutical marketing expert) and I have previously weighed in on the so-called “adverse event reporting myth” that has been circulating in life sciences social media circles. In fact, I posited in my previous post that adverse event reporting may actually be something of a “red herring” being used by the industry. For those of you who may not be familiar with the term, it means focusing on an obvious and easily identifiable issue or object to draw attention away from a more important central issue.  To that end, I was pleased to read a post today on Jonathan’s Dose of Digital Blog entitled 166 Reportable Adverse Events Equals One Red Herring.

In today’s post, Jonathan does some basic mathematical calculations and arrives at the conclusion (based on the occurrence and frequency of Internet-based adverse events disclosed in a recent Nielsen survey) that the likely number of adverse events posted on social media sites per day would be around 166 (for the entire industry). Doing some of my own high-level mathematical calculations; this translates into a likely total annual number of about 60,590 AEs. And, as Jonathan rightly points out, if this number is divided by the number of life sciences companies with approved drugs and devices on the market, you quickly realize that shouldn’t be that onerous, labor intensive or expensive for companies to manage AE reporting resulting from social media sources. It would be interesting and informative to compare this annual rate with the actual number of reportable annual adverse events being handled by life sciences companies today. 

Like Jonathan, I believe that the “adverse event reporting issue” is a classic example of a “red herring” being employed by the life sciences industry to explain its reluctance to jump on the social media bandwagon. Personally, what I believe is really at stake, is the systemic changes that would be required to transform a historically, opaque and unresponsive industry into a transparent, accountable and responsive one that would be required if it embraces social media as an integral part of its business model.  

Addendum:  Shortly after posting this article, a new post appeared on the Dose of Digital blog that provided an indepth analysis of the Nielsen survey and its implications.

Until next time...

Good Luck and Good Job Hunting!!!!

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