Seeks to Keep Track of Drug Side Effects the Way the FDA Never Could

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recovering from her illness, but Overstreet and the other co-founders he had worked with at Sageint—Henry Duong and Robert Kyle—remained intrigued by this hard-core data problem.

The scope of this data problem is daunting. For example, the sleeping pill zolpidem tartrate (Ambien) is entered in the Medwatch database under 440 different names, Overstreet says. It confuses people because it comes in different formulations, the chemical names are tricky, and there are different names for the compound in different countries. Every time someone spells it differently in a Medwatch report, it looks like a different drug. And some of the reports come in hand-written by doctors, leaving some poor bureaucrat at the FDA responsible for transcribing the doctor’s intent as best he or she can.

Medwatch reports are public records, and it wasn’t long before Overstreet and his team found a way to tap into a FDA web portal to take a deeper look. Being in the data business, they figured it would take six months to set up a SQL database to make it so doctors, pharma companies, insurers, pharmacists could run smooth queries about, say, cases of sleepwalking in people on Ambien. It ended up being an “odyssey” of 18 months of cleaning up the FDA’s data, Overstreet says.

“We’ve had to apply some heavy duty data cleaning techniques to figure out what people are trying to say,” in the Medwatch reports, Overstreet says. “Every layer we peeled back in the data got worse and worse.” raised an undisclosed amount of angel financing in the spring of 2011 when it became more clear that it was making headway on this dataset, and it plans to raise a venture round later this year, Overstreet says. The business model is a straightforward subscription model. Pharmaceutical companies, pharmacy companies, insurers will have to pay to get premium access to the database, where they can run queries about side effects of specific drugs. Patients can get data for free, although envisions a premium feature in which a patient who’s taking, say, a cholesterol-lowering drug can get an e-mail or text message alert when a worrisome pattern of adverse events starts showing up with that drug.

Patients are already using the web to report voluntarily on their side effects, outside the traditional bounds of Medwatch reports. There’s that little thing called Facebook with 800 million active users, plus websites like PatientsLikeMe which has become a highly interactive forum for patients with chronic diseases. But neither is set up to do what is trying to do, Overstreet says. “Nobody else is trying to capture adverse events in a central database like us. PatientsLikeMe is a great service that creates communities around disease groups, and allows people to share treatment options and experiences, but translating that into useable stat data which can drive actual decision making in the future is a step beyond what they focus on,” Overstreet says.

It’s hard to overstate how disruptive something like this could be to the pharmaceutical business. Pharma companies have a legal duty to report adverse events on their own products to the FDA when they become aware of them—which Overstreet says creates a powerful incentive for them to stick their heads in the sand.

“Their initial reaction is something like ‘Whoa, I don’t want to know about that,’ because when they do, they have to report it,” Overstreet says., he says, wants to persuade pharma companies that it’s in their interest to embrace the data to help foster more efficient drug development, and better manage interactions with doctors and patients. “Some people get it, and want to jump right on it,” Overstreet says. “Others say ‘I can’t talk to you, I don’t want to know anything about you.’ My candid, somewhat polite response is ‘You need to understand the data is coming. And you’ll have to deal with it.'”

Overstreet says he hasn’t yet sat down to talk with the FDA about the implications of this new searchable database, and how the U.S. drug regulator can use it, but he says he plans to meet with the agency soon. The company has already submitted a brief analysis from its database for an upcoming advisory panel the FDA is holding on osteoporosis drugs. If the database is as good as he says, I can imagine the FDA will want unfettered access. Because the FDA has made clear over the years it doesn’t like getting blindsided by side effects of blockbuster marketed drugs, and getting hauled before Congress to explain the screw-up.

How much this business could be worth, and how big its market might be, is really anybody’s guess. The answer will depend on how good the database really is at sorting through the morass of FDA Medwatch reports, and ultimately, how good it is at enticing patients and doctors to start dumping all their new adverse event reports in its simple, modern web interface. If can do that—and not get squashed by the big guys in Big Pharma, it’s conceivable that it could charge a lot for access to its data.

“No matter how you slice and dice it, proprietary data that impacts how the money flows in pharmaceuticals has potential to be very significant. We need to figure it out,” Overstreet says.

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8 responses to “ Seeks to Keep Track of Drug Side Effects the Way the FDA Never Could”

  1. Jerry Jeff says:

    Great story, and a really interesting data problem. It actually sounds like the premise for a pharmaceutical-conspiracy-theory movie with these guys as the plucky truth seekers and the FDA and big pharma would be in league to stop them!
    And to me this really sounds like a project that the FDA should want to drive internally. The database will create so much leverage that it’s hard to imagine a tiny company in wine country in charge of it.
    Best of luck to Overstreet and co. and I’m certainly curious to see how it plays out.

  2. Jean Thomas.R.N. says:

    I voluntarily walked in to a local hospital 8 months ago needing IV fluids following a 24hr bout with food poisoning.Big opportunity to fleece Medicare arose E.R  M.Ds. charts 6hrs later to discharge me home. Put in charge of hospital employed Hospitalist M.D.s Ended up with PIC line and prescribed 4 different antibiotics. They found nothing in my tests to warrant this note! I have the chart’ Cipro one of drugs I.V.Flagyl Vanco Cephaloxin and on Lovenox (warfarin product) c/o constant pain Rt. shoulder inablity ot move arm all ignored for 2 weeks,Shingles then developed from stress,senr home huge swollen lower extemities discharged on Lyrica can,t walk Rt shoulder so painful,6 weeks later to my friend radiologist for MRI 2 torn tendons Rt shoulder muscle wastting of deltoid Ortho consult and injections steroid 2 months more P.T. I cannot lift my Rt arm to the side upwards. I am disabled in this arm. I hear today on Peoples pharmacy and M.D. statement Cipro and warfarin and mixed with other drugs can cause tendonitis and tendon rupture 8 months later having spent thousands on my home care assistance and co-payments I have a Deltoid muscle wasting and cannot laterally raise my arm. Why didn,t any of the daily visiting hospitalist or the pharmacist know this drug related complication?Being given steroids in the PIC line suppressed some of the pain 4mgs IV different nurses every shift .Not my own attending Dr.This reported incident would go unoticed I guess if I didn,t hear about your wonderful site.Jean Thomas 444 at G

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