Avandia warning signs seen online as early as '04

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A new report says patients began discussing the risks of GlaxoSmithKline diabetes drug Avandia in online forums and blogs well before a meta-analysis linked it to higher heart-attack risk. Neither physicians nor company officials acknowledged their worries, contributing to an alarming drop in patient sentiment and, according to authors, a lost opportunity to reach out and restore trust.

Patients first started questioning whether it was safe to take Avandia given their situation, especially those with congestive heart failure (CHF), in 2003 and 2004, but the drug was still seen as a good alternative for many with type 2 diabetes, notes the report. Negative comments began referencing Avandia risks in 2005 but were more likely to grow out of frustration with weight gain and edema—potential side effects of drugs in the thiazolidinedione (TZD) class.

The tone changed in 2006. Discussions went beyond swelling and weight gain to comparisons with other products shown to lower blood sugar without these risks, such as Eli Lilly/Amylin's Byetta and Merck's Januvia. Chatter about other side effects lit up message boards, as well. Analysis of comments shows patients connected edema to an increased risk of CHF, and some reported increased blood pressure. Anger and frustration grew, as physicians seemed disconnected from the concerns.

“We see 2006 as the ‘pivotal year,' the year where there was a rise in patient awareness of potential problems that they were left to discover on their own,” notes the report from Wool Labs, an online business intelligence firm. “This is a key point—patient anger grows because they have to figure out too much on their own.”

The following year, in the wake of Dr. Steven Nissen's meta-analysis that patients on Avandia had more heart attacks, and subsequent media coverage, patients voiced strong criticism of everyone involved in patient care—product, manufacturer and physicians. As patients became engaged in the published reports and their own experiences, the comments turned hostile: “[Patients] began to think and say that they believed that GSK, FDA, and even some doctors knew of the dangers of Avandia and felt that their health was put at risk,” according to the report.

The authors calculated a Patient Sentiment index and found that sentiment was negative but not irreversible in 2004. Even in 2006, intervention could have had at least some impact, they say. However, “By mid 2010, with the FDA's decision not to recall Avandia," they write, "there is anger now directed at the FDA, industry and GSK. But patients are also now very entrenched in their decisions and seem closed to any new arguments to sway them otherwise.”

Could GlaxoSmithKline officials have mined early web chatter to head off some of the public hostility now associated with the diabetes med? Probably not, as social media was in its infancy and the technology for monitoring it was not yet available when patients were searching for answers. That makes Avandia a cautionary tale.

“It would have been difficult to manage that chatter,” Michele Bennett, chief operating officer of Wool Labs, told MM&M in an interview Tuesday. The main message of the report is to help understand what's behind patient messages and what they signal. “In many cases, [patients] are asking for help in understanding and sifting through information and things that are meant for professional and industry consumption.”

Addressing medication issues at an early stage offers companies the chance, not only to turn around public perception, but to facilitate a better understanding of how to manage disease. In the Avandia case, because no one reached out to the patient base to explain or reassure, Bennett says, this opportunity was lost.

She doesn't advocate using social media as anything more than a gauge of consumer sentiment. “Since it's pretty early for pharma, and there are no guidelines from the FDA at this point, it's about listening, learning and adjusting other messages and media to help people better understand what they are hearing in social media,” said Bennett, whose firm uses social-cognition technology to help understand how people form opinions through online dialogue.

Now that such tools are available, companies may be able to better understand the effects of their products on patients and use the insight to communicate about disease states and drugs more insightfully.

“We don't think anybody should be engaging in social media to set the record straight,” Bennett added. “There are plenty of communication vehicles for anyone to explain more.” For example, she said, industry sends print pieces to physicians when patients are struggling to decipher a complex study or analysis.
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