The Hunt For Gardasil Adverse Events: A Preview Of Emerging Social Media Challenges

Bachmann-based brouhaha over Merck's human papilloma virus vaccine underscores the liability risks that firms can face as possible risks for their products are discussed more widely.

The injection of controversy over Gardasil into the Republican presidential primary campaign is a painful one for Merck, but it also underscores how adverse event reporting and liability issues could change with the advent of social media.

Merck & Co. Inc. Chief Medical Officer Michael Rosenblatt discussed the issue at a Galien Foundation forum, held Sept. 27 at the Alexandria Center for Life Science in New York City. An audience member asked panelists whether the role trial lawyers play is a good or bad thing.

Rosenblatt responded that many patients who would benefit from a drug discontinue it as a result of media stories.

"So the combination often of a trial lawyer and the media sometimes is good because it shines a spotlight on the situation," he stated. "But sometimes there are unintended consequences that actually have a big impact on populations."

"Like Michele Bachmann," an audience member declared.

"Like Michele Bachmann," Rosenblatt agreed.

During a Sept. 12 debate of Republican presidential candidates, Rep. Bachmann, R-Minn., criticized Texas Governor Rick Perry for issuing an executive order mandating that girls in Texas receive Merck's human papilloma virus vaccine Gardasil.

The next day Bachmann appeared on The Today Show and said a woman came up to her after the debate and told Bachmann that her daughter had "suffered from mental retardation" after taking the vaccine ('Repoliticizing Gardasil (Part 2): It Gets Worse for Merck,' The RPM Report, Sept. 13, 2011).

Bachmann was roundly criticized for making the unfounded claim, which was refuted by the American Academy of Pediatrics.

"We're still hunting for the data," Rosenblatt said. "We haven't found it yet."

A Change In The Climate

Merck's hunt for the information on Bachmann's claims illustrates the challenges drug firms face as dissemination of information becomes more diffuse.

Companies are obligated to relay to FDA any adverse event information about their products that they become aware of, but what constitutes "awareness" when anyone with an Internet connection has access to an uncatagorizable array of data is not clearly defined at the moment.

The national media attention to Bachmann's statements seems to have made knowledge of the charges unavoidable - hence Merck's hunt for the data. But where do firms need to draw the line on what they should reasonably be aware of?

Worries about this question - along with concerns that they might be accused of off-label promotion - have caused several firms to drop their Facebook pages rather than be forced to accept comments (Also see "Firms Navigate Social Media Safely Following Loss Of Facebook Protection" - Pink Sheet, 14 Sep, 2011.).

And regardless the overall value of trial lawyers' involvement in drug development and marketing, the stark clarity of any eventual case law on the boundaries of necessary social surveillance could in time allow firms to have a more comfortable presence in social media.

Nissen Stands With Merck

Steven Nissen, chair of the Cleveland Clinic Foundation's Department of Cardiovascular Medicine, also participated in the Galien forum and said the involvement of trial lawyers is "a dual-edged sword."

"There have been times when there has been a lack of transparency" on the part of manufacturers as to what they knew about a product's safety, Nissen said. "And the presence of trial lawyers has served a positive impact because it has basically put the fear of God into people" to disclose information in order to avoid greater liability.

Nissen, who is well known for his focus on drug safety, most notably for his 2007 meta analyses of clinical trial data on GlaxoSmithKline PLC's Avandia (rosiglitazone), which showed the drug increased cardiovascular risk, said he has been contacted by trial lawyers and has refused to talk to them.

"They're vultures," Nissen said. "They're in it for the money. They are not in it for patient safety."

-- Brenda Sandburg ([email protected])