Drug Money & Prescribing For Better Outcomes
13 CommentsBy Ed Silverman // April 22nd, 2008 // 8:56 am
What can you do with $430 million? Before you make your list, consider that one option is to create an institute that will examine databases for evidence-based info on uses of various meds. And that’s what was done with the huge payout resulting from the infamous Neurontin off-label marketing case - some of the proceeds were used to establish Prescribing For Better Outcomes, which is housed at the University of North Carolina.
In its first report, the program - not surprisingly - examined Neurontin for bipolar disorder, the very same use that generated all that off-label activity. And what did they find? Some randomized trials that showed the drug, which is now available as generic gabapentin, was no better than placebo. The upshot: “No scientifically acceptable clinical trial evidence supports use” of gabpentin for bipolar disorder. (Please look here). There will be additional projects, of course, and to learn more about the overall effort, take a peek at the video*
* - If you experience difficulty, you can also look at the same video by clicking on this link.
Matt
It’s only a matter of time before drug companies buy in to the organizations and start influencing the outcomes of their reports…
PBurns
So, the company was pushing a non-cure for a very serious and very treatable illness which one could reasonably expect would result in people harming themselves or others?
Justice in Michigan
Ed - thanks for calling our attention to this.
Personally, I think this is a terrific way to use the $430 million. I guess there is no such things as an institution immune to corruption, but - from what I can tell - this looks pretty solid.
My only regret is that the Institute wasn’t situated in the original Parke-Davis/Warner-Lambert buildings, located in my fair city, where a good part of the whole saga transpired. The “campus” (which it really is) is now mostly vacant, with only a few Pfizer signs and missing jobs and mixed memories lying around.
How sweet that would have been! In lieu of that, perhaps Ed can move the Pharmalot campus here. What a deal!
Bob Freeman
Justice, RTI in NC did a nice thing for some ex-Pfizer outcomes research people whom they hired. Rather than relocate them to NC, they set up a branch office in Ann Arbor. I don’t know the headcount involved–I have a number of former colleagues who were very pleased to stay in Michigan.
Justice in Michigan
Thanks, Bob. That’s great to hear!
Jack2
Off topic-ish, but I’d take that $430 million (or, more likely a small fraction of it) to set up a uniform eprescribing system for doctors and pharmacies. I don’t think anything would improve healthcare safety more for less money - it just needs more pizaz.
Bob Freeman
Justice, I used to live in the Kalamazoo area when The Upjohn Company was strong. It’s very sad to be in the area and see the decimation that Pfizer did both in both Kzoo and Portage. A famous building, No. 88, which won major architectural awards, was razed.
Justice in Michigan
Indeed. They seem to be the Vandals of the industry. Great when you are under their protection. Disposable otherwise. When they left here, I wrote a piece called, “Our town goes generic.”
As you may know, Upjohn played a rhetorical role when Michigan’s preemption law was adopted, via Engler, in 1995. One of Engler’s aides noted it was specifically “to protect the Upjohn Company.”
Given that a lawsuit could be brought against the company in any other state, that made no sense. But then, there is much about all this that makes no sense.
Anyway, as you know, Michigan has suffered its share of out-migration. So very glad to hear about those former Pfizer folk who wanted to stay, and that they got to.
Bob Freeman
Prior to the Pharmacia & Upjohn merger (a wedding made in Hell) Upjohn was a good corporate citizen in Kzoo: they endowed the Kalamazoo Area Math & Science Center and continued to stock its corporate fleet with GM autos out of loyality to a Michigan company Those are a couple of isolated examples. I was there when the company removed its wording offering “continuous employment” (tenure, basically) from the HR manual–it was a gut-wrenching decision. It was common to see three generations of a family employed there.
Jaynesday
Sorry for my ignorance on this subject but it sounds very interesting. Could someone tell me the origin of the databases? Where does the data come from?
Thanks
Bob Freeman
Evidence-based medicine or EBM relies on conducting meta-analyses of published and unpublished studies, the selection of which is based on predetermined criteria. EBM can also come from systematic literature reviews. The difference between the two approaches is basically this: meta-analysis is a statistical protocol for combining data from studies whereas a systematic literature review is a formal, critical assessment of the findings. The study that found that SSRIs do not have the relative effectiveness over placebo was a meta-analysis that included both published and unpublished clinical trials. Previous effectiveness was estimated from published studies exclusively.
You can also do data mining to set up retrospective cohort studies. Case-control studies usually fail to establish causality because you lace a denominator to construct risk ratios, etc. Data bases may be from Medicare and Medicaid files, managed care organizations’ data sets, patient registries, etc.
Jaynesday
Bob,
Thanks for the explanation.
Bob Freeman
Jaynesday, I gave you an incomplete answer by stating the definitions without context: meta-analyses, while being strong on analytics, is relatively subjective and somewhat controversial in that it relies on the literature, which may be somewhat dated. (this is also true of systematic, critical lit reviews). This can be overcome somewhat by performing “rolling” meta-analyses that are updated as new studies come available. (See the Cochran web site for more information–Google any of the key words like “evidence-based medicine” “meta-analysis” “Cochran”)
On the issue of data sources: the FDA clinical trial registry can be accessed and additional info can be obtained under the Freedom of Information Act. Company web sites are also a source (assuming they decide to disclose negative research) under “data on file”. This is in addition to the data bases I described earlier.