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.
It’s not hard to understand why. On many fronts, federal regulators keep life science companies on a very short leash. And getting tangled up in U.S. Food and Drug Administration rules can be deadly to a start-up that already has to endure a painfully slow, and often elusive, path to profitability.
Hence, many companies don’t want to entertain the risks that come with promoting products through tweets or interacting with the public via a Facebook wall. Most of all, the companies worry about accusations that their social media efforts would be construed as coercing people to use their products, and that they would be opening themselves up to more reports of unintended side effects from their drugs.
But there is a growing sense in the industry that companies are acting against their own self interest by shying away from social media, and also against the interest of public health.
“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.
Part of it is because biotechs — especially in the current economic environment — are lean operations, and don’t have the peoplepower to start up social media initiatives. But it also boils down to regulations the FDA does (and doesn’t) have regarding how companies can communicate with the public.
The FDA employs strict rules regarding what a company can say about a drug or a device before it is on the market. And once a product does make it to market there are rules on advertising; a company can never be seen as coercing a patient into taking a drug or using a device.
And the litany of side effects that the actors recite, for example, in a Viagra commercial to comply with FDA’s “fair balance” requirement is a lot longer than 140 characters. Then there are all the regulations surrounding clinical trials.
Also there is the mandate that a company immediately report to the FDA any new knowledge of previously unknown side effects, or “adverse events,” caused by a drug. The costs associated with more adverse event reports are in themselves reason enough for a company to decide against establishing a Facebook account, experts say.
It hasn’t helped that the FDA has been silent thus far regarding how social media can be used.
So if a patient taking a company’s drug and reports a previously unknown side effect on the company’s Facebook wall, the company could end up having to notify the FDA of the posting, which could in turn trigger an investigation.
That is just one of several concerns that companies have aired.
“There are confidentiality issues, patient issues and lots of other issues” said Dan Robitaille, the manager of business development for eStudySite, a local company that provides sites for clinical trials. “All clinical trials need to be IRB (institutional review board) reviewed, and there is no Twitter IRB.”
But there might be in the coming year. 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.”
Canady said the vast majority of so-called regulated companies are really far away from establishing a social media presence. And though the FDA’s silence on the issue is partly to blame, it’s also because the companies “just don’t get it,” she said.
“The question is do you want to start the conversation, or just constantly be doing damage control?” Canady said.
Consider the struggles Amylin Pharmaceuticals had in 2007 with the reports of pancreatitis associated with its diabetes drug Byetta. In the end, studies showed that the incidence of the condition among patients taking Byetta was rare, less than 0.2 events for every 1,000 hours of exposure to the drug.
But rumors that the condition was prevalent among Byetta users caused both sales of the drug and Amylin’s stock price to plummet. The company was criticized for being slow to react to the rumors, and the slow reaction is considered one of the factors that led to the nasty proxy battle the company’s board waged with Carl Icahn this year.
However, while Pitts and Canady argue that getting out in front of such rumors is the best tact, Scott Rieger, another industry consultant, argues that if a company was constantly confronting false rumors in a venue like Twitter, it could end up legitimizing them.
“You end up succumbing to the tyranny of the medium,” Rieger said.