WellPoint has shown up a couple of previous times on this site, most recently for the roll-out of what I considered a fairly innovative approach to consumer ratings of physicians via a partnership with well-known Zagats. More recently I’ve come to learn that the company landed six awards for eHealthcare Leadership at the beginning of 2008.
Today, WellPoint has announced another innovative initiative that they are undertaking with the US Food and Drug Administration (FDA), whereby WellPoint will develop, in collaboration with the FDA and academic researchers, the Safety Sentinel System (SSS). The objective of SSS is to help the FDA meet a new Congressional mandate to use advanced analytical techniques to scan computerized medical records (in this case claims and medication data) for any adverse reactions to medications. This came about from the widely publicized Vioxx withdrawal last fall and more recently concerns with the diabetes drug, Avandia and the schizophrenia drug Zyprexa.
These medication problems arise due to the whole method by which new drug candidates are assessed prior to release to the general public. Today, just prior to release, clinical phase three trials are conducted but these trials typically include no more than 1,500 candidates to test a proposed drug’s efficacy and risk. While this may seem like a large number, in the grand scheme of things it is quite small when one considers that a popular drug like Vioxx may be prescribed to millions. Therefore, their may be unique population sub-types that did not participate in the trial, but may have a serious adverse reaction to a given drug. We just do not have the resources to conduct such massive trials to eliminate all risks and we do not have the technology in place to enable personalized medicine based on an individual’s unique genetic profile to identify those unique sub-populations that may be at risk.
So what’s the next best thing? That’s where WellPoint’s SSS comes in.
Health insurers like WellPoint have boat loads of data, far more data in one central location than any other single entity. Granted, it is not clinicals but claims data, yet this is the best we have to work with until broader adoption of IT among providers occurs and may ultimately prove sufficient for what WellPoint ad the FDA intend to do. With SSS, WellPoint will be able to monitor, in an automated manner, its 35 million covered members (and their health data) for potential serious adverse reactions to a given drug therapy. Applying the appropriate computer-based analytical tools with alerting functions, it is conceivable that SSS will be able to readily identify such risks long before they become as major issue as was the case with Vioxx.
And SSS may have other applications beyond monitoring for medication risks including monitoring for risks associated with procedures and treatments. For example, a women with breast cancer is 3 times more likely to get a radical mastectomy in Longview TX than a woman in Ft Lauderdale. Is such a wide variance justified? Maybe a tool like SSS can get to the bottom of this and ultimately provide the consumer with better guidance as to what is the best choice for them.
The obvious danger here, of course, is the potential for WellPoint or other health plans to begin denying medications, treatments or procedures based on far too thin of data or data that is more circumstantial than conclusive. Hopefully, that is where the academic researchers will play an important role defining where those cut-off points will be and reserving judgment until the data is conclusive.
As much as people complain about health plans and how they contribute little but take much out of the healthcare system as they are a middleman between the consumer and provider, this example from WellPoint does demonstrate that health plans can provide a level of value that no other entity today can provide. So let us not throw out the baby with the bath water and when examples such as this, where a health plan is taking a leadership role contributing to the innovation of safe healthcare delivery, let us thank them for their contribution.
[…] timely piece in light of the joint WellPoint-FDA announcement earlier this […]