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11/18/2010
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Online Data Instead Of Drug Retrials?

When aggregated, unstructured data from online forums for patients can reveal problems with drugs--but right now, regulators aren't accepting such data.

Unstructured data culled from online patient discussion forums and other social media is emerging as a way to identify problems with new drugs. Patients on social sites frequently compare notes on suspected side effects of drugs. When aggregated, this data can reveal suspect drugs. But the data and analysis aren't useful as long as regulators refuse to accept them as part of post-market research.

Currently, when a drug that's already on the market is suspected of not performing as promised or of causing dangerous side effects, the Food and Drug Administration requires that data to be submitted in formal reporting forms. Unstructured data pulled from patients' online discussions isn't acceptable, no matter how much of it exists.

"This is a science still in its infancy," said Dr. Roni Zeiger, Google's chief health strategist, speaking at Partners Healthcare's Connected Health Symposium last month. While it isn't clear exactly how unstructured data could be leveraged, its potential value is significant, Zeiger said. We need "large-scale methods" of monitoring online data that don't involve actual human monitoring but rather algorithms that identify the information that's useful to researchers, he said.

The FDA must look at the potential for new sources of surveillance data and come up with clinical research policies that take into account all emerging sources of patient- and consumer-related health data, Zeiger said.

Retrial Alternative

False positives are the biggest issue with unstructured data, such as when a patient thinks he's having an unusual side effect from a medication but it's actually not a reaction to the drug at all.

The structured data forms that the FDA accepts now have their own problems. For one, few patients and doctors ever use them. "I've yet to fill out an adverse event report on the FDA site," said Zeiger, who has been a practicing physician for nearly a decade.

And once the FDA has collected evidence of a problem, it then requires lengthy, expensive clinical retrials of the drug. "That's too expensive a methodology," Jay Pieper, VP of Partners Healthcare and president and CEO of Partners International Medical Services, said at the symposium. Retrials can cost drugmakers tens of millions of dollars.

Data generated on social media combined with analytics tools that would help weed out problems like false positives could provide new opportunities to take action on problem drugs without retrials, Pieper said.

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