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California company to sort out FDA adverse events reports

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Altostrata

The US effectively has no oversight of drug post-market adverse events; the FDA adverse events reporting database has long been worthless because there are no systems in place to analyze the data in it. A for-profit company is going to offer analyses of the data; likely customers may be pharmaceutical firms who want to discredit a competitor's product.

 

If all goes well, much mud will be slung among the pharmas as post-market adverse events are unearthed from the database.

 

IT vendor takes on the FDA adverse-events database

Competitive analysis of manufacturers’ products is one potential commercial offering

Date: 2011-08-10

 

Everyone associated with the current MedWatch adverse-events reporting system—including FDA—recognizes its lack of comprehensiveness, and the difficulty of extracting meaningful value from it. FDA has a years-long effort, FAERS, to update its system, along with a more far-reaching Project Sentinel to make the datagathering and analysis more effective. But a small California firm, Adverse Events, Inc. (Healdsburg, CA) expects to steal a march on these efforts by performing its own data-cleansing service, combined with commercial services to both collect adverse event reports and to provide ready-to-use data to patients, healthcare providers and manufacturers.

 

Brian Overstreet, president, says he became interested in MedWatch while attempting to get information on the adverse event a close friend seemed to be experiencing, but found no ready way to do so. “You can get an idea of the problems when you realize that one drug—Ambien—can be listed 450 ways in MedWatch,” he says. “The best reporting comes from manufacturers themselves, but there is no consistency across how events are reported, what the symptoms or underlying conditions are—even such low-level problems as keystroke errors,” he says. Overstreet looks to his prior experience as a founder of a database publisher called Sagient Research Systems, now a privately held research service for investors, as a measure of his company’s database prowess.

 

Adverse Events has spent the past two years developing what Overstreet calls RxFilter, a “17-step proprietary process” to cleanse the MedWatch data (which are updated and publicly available quarterly). The company will provide counts of adverse events by drug or condition, and part of the results will be publicly available. At the same time, it is developing a competitive-intelligence tool for pharma business managers to analyze AER trends....

 

How good will Adverse Events’ data be? That will be demonstrated by its commercial users, says Overstreet. According to him, there is no ultimate authority that validates how well AEs are reported, which is itself a problem with the system. Overstreet says the company is working with medical faculty at a university to evaluate the usability of their datasets.

 

http://pharmaceuticalcommerce.com/latest-news/it-vendor-takes-on-the-fda-adverse-events-database/

Edited by Altostrata
updated link

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Barbarannamated

Fox is still guarding the henhouse.

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Altostrata

Maybe patient groups can hire them for you-know-what.

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Barbarannamated

AAAAH, YES!

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cinephile

Maybe patient groups can hire them for you-know-what.

I must be a little slow today. What exactly do you mean here, Alto?

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Altostrata

Mine the FDA system for adverse event reports about various psychiatric drugs.

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Barbarannamated

I was going in a diff direction. There's quite a bit more data right here and in similar groups.

I don't know if the reporting system has changed much, but back in the day, patients would tell docs of AEs and docs might report to FDA or drug company or tell reps who might write it up and might actually send the report to medical dept of drug company who probably rarely reported to FDA.

I don't imagine many patients take the initiative to call the FDA themselves. Especially psych pts whose every symptom is attributed to their dx.

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Altostrata

Some basic statistics are available free from this company, which is creating and selling reports based on the data in the FDA adverse events database.

 

Go to http://www.adverseevents.com/ and click on the Patients button to get access to this information.

 

For example, if you search on "paxil" and click on "drug withdrawal syndrome," ( http://www.adverseevents.com/drugevent.php?AEDrugID=681&reac=Drug+Withdrawal+Syndrome ), you'll find

 

adverseevents.com_paxilwithdrawal.png

 

To enter an adverse event report in the FDA database, go to https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

 

Eventually, this will end up in AdverseEvents.com reports. They say they update them real-time, meaning directly from the FDA database.

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Altostrata

Update:
 

Quote

 

Advera Health scores drug costs based on the severity and frequency of adverse events

December 6, 2015

 

Advera Health (formerly, Adverse Events, Inc.) has been plugging away for nearly seven years now on methods to make the FDA Adverse Events Reporting System (FAERS) useful to drug purchasers, manufacturers and, ultimately patients. Now the company has reached the point where it says it can quickly translate and data-cleanse FAERS reports (which, usually being manually composed, have many variations in drug names, conditions and outcomes), align them with existing adverse event label warnings, identify new side effects and, with its latest announcement, align drugs with the hospital costs of treating AEs by giving them an “RxScore.” The methodology, and the RxScore for 706 branded and generic drugs, have been published in the current issue of the J. of Managed Care and Specialty Pharmacy (“A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes,” JMCP, 2015;21(12):1134-43). 
 
The Santa Rosa, CA company scored something of a coup in October, when it issued a Drug Safety Monitor Alert (one of its subscription services) on serious AEs associated with AbbVie’s Viekira Pak, the hep C treatment. Six days later (Oct. 22), FDA issued an advisory warning and a call for a label revision, based on liver damage in patients with advanced liver disease. (Viekira, of course, figures in the highly publicized controversy over the pricing of its direct competitor, Gilead’s Sovaldi, and the decision by Express Scripts to predominantly allow only Viekira on its formulary.)
 
Brian Overstreet, Advera CEO, says that in recent years, Advera’s services have become popular with payers and healthcare providers, who are under the gun not only to control healthcare spending, but also to improve the quality of service they provide. Pharma companies had been relatively indifferent to the service, “but that’s changing now, with some companies seeing that they can create a competitive advantage with better outcomes of their products.” The company is winning some business now from the medical affairs and HEOR (health economics and outcomes research) teams at pharma companies.
 
The RxScore is one of several monitoring services Advera provides; others simply count up AEs tied to specific drugs, or calculate the medical cost of drugs’ AEs. Overstreet says that the entire FAERs system points to a weakness in the clinical approval process, since many side effects don’t show up until the product is in commercial use. FDA has been developing its Sentinel program since the mid-2000s, but while a “mini-Sentinel” pilot project was successfully concluded a couple years ago, a transition to a full-blown program is still in the offing (FDA and Brookings Institution are holding their annual Sentinel meeting next February.) All this being said, AEs, and the costs associated with them, is still a challenge to track and analyze: while the number of AEs reporting to FDA has more than doubled since the mid-2000s (to almost 1.3 million in 2014), when compared against the 4 billion prescriptions issued annually, signal detection is very difficult.


 

 

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