How Social Media May Be Influencing Human Clinical Trials and Access to Potentially Life-Saving Investigational New Drugs
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 21st century technology continues to unfold.
Hat tip to Natalie!
Until next time...
Good Luck and Good Tweeting!
Earlier this week, Mark Senak who writes the EyeonFDA blog, offered his i
Mark Sendak, author of the incisive
The New York Times reported today that for the first time, Internet users are spending more time on social networking and video sites than on e-mail. According to a report by Nielsen, there was a 1,905 percentage change in the time that users spent viewing online video and an 883 percentage increase in social networking use from February 2003 to 2009.
Twitter, the microblogging platform, is the current rage in social media. According to 
The
About a year ago, I was eating lunch and bunch of pharma executives were at the table next to me. I inadvertently overhead bits of their conversation and I heard the words, Facebook, MySpace and YouTube mentioned. This suggested to me that pharma was more aware of social media (and its business implications) than pharma publicly cared to admit. Pharma has been reluctant to embrace social media because of possible legal and regulatory ramifications. Nevertheless, a few companies have decided to boldly go where no pharma company has gone before—to YouTube.
It was only a matter of time after
First, King Pharmaceuticals posted a non-branded high blood pressure video on YouTube in early 2007. Next, Novartis added a 60-second commercial (as part of its 



