From The Voice of San Diego:
My Grandmother Out-Tweets Your Biotech
By DAVID WASHBURN
Wednesday, Sept. 23, 2009 | Very few industries are as willing to take risks on new technologies as the biotech industry. Companies will spend millions, and even billions, developing a drug that has a chance to cure a cancer or a device that could change the face of heart surgery.
Yet when it comes to social media, the industry has proven to be risk adverse. In fact, your grandmother is probably more likely to be active on Twitter or Facebook these days than a pharmaceutical, medical device or contract research company.
"What we've got is the social media Maginot Line," said Peter Pitts, director of global health care for the public relations firm Porter Novelli, referring to the French army's strategy of fortifying its borders during World War II.
"If they avoid social media they are safe. But what is happening is that important discussions about the medications and how they affect patients are happening minus the participation of companies," Pitts said after a panel discussion hosted Wednesday by Biocom, the local biotech industry association.
The FDA has scheduled a two-day public meeting in November to solicit views regarding how it should deal with social media. Among other things, the agency wants to discuss how companies will fulfill their fair balance obligations in social media, how they will deal with inaccurate information posted about their products as well as adverse event reporting.
The meeting, Pitts said, is an acknowledgement by FDA officials that the agency is "behind the curve," and needs to address the issue. FDA officials involved in the planning of the meeting could not be reached for comment today.
Pitts and others hope a larger embrace of social media emerges from the FDA meetings, and that the industry realizes that it is "irresponsible not to use social media." They raised the issue of benefits that a drug may have that are not officially recognized by the FDA.
Say, for example, that a clinical trial shows that a drug has an effectiveness against a certain type of cancer tumor that was not thought possible when the drug was submitted for FDA approval, and therefore isn't on the FDA label for the drug.
"If they choose not to share that information in the best way possible -- which is social media -- is that the ethical and moral thing to do?" Pitts said.
An even more vexing issue facing both the companies and the regulators is how they deal with adverse event reporting. Suppose, Pitts said, that someone taking a cancer drug develops numbness in their fingers, and then writes about it in a blog or on a Facebook wall.
"This is an opportunity in real time to understand adverse reporting issues," Pitts said.
"Rather than avoid it from a legal and regulatory standpoint, they should pursue it from a public health perspective. That, however, is a very contentious proposition."
The complete story can be found here.
My Grandmother Out-Tweets Your Biotech
By DAVID WASHBURN
Wednesday, Sept. 23, 2009 | Very few industries are as willing to take risks on new technologies as the biotech industry. Companies will spend millions, and even billions, developing a drug that has a chance to cure a cancer or a device that could change the face of heart surgery.
Yet when it comes to social media, the industry has proven to be risk adverse. In fact, your grandmother is probably more likely to be active on Twitter or Facebook these days than a pharmaceutical, medical device or contract research company.
"What we've got is the social media Maginot Line," said Peter Pitts, director of global health care for the public relations firm Porter Novelli, referring to the French army's strategy of fortifying its borders during World War II.
"If they avoid social media they are safe. But what is happening is that important discussions about the medications and how they affect patients are happening minus the participation of companies," Pitts said after a panel discussion hosted Wednesday by Biocom, the local biotech industry association.
The FDA has scheduled a two-day public meeting in November to solicit views regarding how it should deal with social media. Among other things, the agency wants to discuss how companies will fulfill their fair balance obligations in social media, how they will deal with inaccurate information posted about their products as well as adverse event reporting.
The meeting, Pitts said, is an acknowledgement by FDA officials that the agency is "behind the curve," and needs to address the issue. FDA officials involved in the planning of the meeting could not be reached for comment today.
Pitts and others hope a larger embrace of social media emerges from the FDA meetings, and that the industry realizes that it is "irresponsible not to use social media." They raised the issue of benefits that a drug may have that are not officially recognized by the FDA.
Say, for example, that a clinical trial shows that a drug has an effectiveness against a certain type of cancer tumor that was not thought possible when the drug was submitted for FDA approval, and therefore isn't on the FDA label for the drug.
"If they choose not to share that information in the best way possible -- which is social media -- is that the ethical and moral thing to do?" Pitts said.
An even more vexing issue facing both the companies and the regulators is how they deal with adverse event reporting. Suppose, Pitts said, that someone taking a cancer drug develops numbness in their fingers, and then writes about it in a blog or on a Facebook wall.
"This is an opportunity in real time to understand adverse reporting issues," Pitts said.
"Rather than avoid it from a legal and regulatory standpoint, they should pursue it from a public health perspective. That, however, is a very contentious proposition."
The complete story can be found here.
