Maybe it's just a manifestation of another passing birthday, but I'm finding that more of my friends and family spend a few moments each week sorting pills and potions. Whether it's multivitamins, analgesics, or therapies for serious ailments, everyone I know has little plastic boxes labeled "M" to "S".
Recently, Bridgepoint Health in Toronto started an advertising campaign to highlight the fact that most Canadians have more than one ailment at any given moment. Across the city, you'll see billboards highlighting "arthrostrokoma" or "neurodiabesity". From Bridgepoint's perspective, the multi-disease state makes it more challenging to treat patients, but it got me thinking that in light of several highly publicized post-marketing pharmaceutical-related adverse events, this state also represents a significant challenge for the pharmaceutical industry and government regulators.
In the clinical setting, researchers control the pharmaceutical profiles of patients on whom they test new drugs. Once the medication is approved and marketed, however, the effects of new drugs combine and recombine with those of a highly variable pharmaceutical background. Where one patient may be taking diabetes therapy with heart meds and an NSAID for a tooth ache, another patient may be taking the same diabetes treatment with an anti-rheumatic and an antifungal for an ugly toenail. So when something goes wrong, what caused what?
In the October issue of DDN, we reported on efforts to develop an adverse events consortium to monitor and catalogue these events as they occur and thereby learn ways to pre-empt them. I wonder, however, how much information the group hopes to assemble for each event or how much they can handle. If a handful of patients have a heart attack while taking a new drug, was it the drug itself, the fact that the patients were also taking HRT, or a combination thereof that caused the heart attack?
(I am specifically leaving genetics, lifestyle, and environment out of the discussion to avoid mass resignations in the pharma industry.)
All of this data is critical to making the best decisions about a new or existing drug. To get this information, however, will take a monumental effort on the part of the pharmaceutical industry and regulators to first educate and then convince the medical community to work with them.
For too long and too often, the link between pharmaceutical firms and frontline healthcare workers has stopped at the sales rep. It is time for all parties to live up to the rhetoric and form a truly interactive and reciprocal partnership where information not only flows both ways, but is also actively integrated into evolving practices and processes.
A number of people, including the FDA's own Dr. Janet Woodcock, are looking to recent e-health initiatives to act as a conduit of this information transfer, or at the very least, to make things decidedly easier. For an analysis article in the latest issue of Nature Reviews Drug Discovery, Woodcock said: "The emergence of e-health records creates ways to look into drug safety that we never had before."
While I agree in principle with her statement, I question her use of tense. Based on what I've read and seen over the last few years in the e-health marketplace, I don't know if it is so much that e-health records "create" as they "will create" new opportunities. The records systems within and between hospitals and other healthcare facilities are just too disparate and the efforts simply too disconnected at this moment to generate truly meaningful information yet.
At this point, we are having trouble finding out which physician prescribed what medication when a patient visits more than one pharmacy. We'll get there—goodness knows we're spending enough money in the e-health arena—but it is still a very long trip.
Now, if you'll excuse me, it's 11 o'clock on Saturday and I have to go take a green capsule and two orange tablets.