Thursday, March 20, 2008

Who Are You?


The other day I heard the old song by The Who “Who Are You”. It has been a while, and I can’t follow most of the lyrics on the track, but it doesn’t really matter. What struck me, as I was thinking about our business, is “Who Are You?” We each have a number of roles we play.

We are Pharmaceutical Professionals. We might be a monitor, or clinical scientist, or programmer, or data manager, or any one of a plethora of other roles. In those roles we look at scientific puzzles, and try to ask the best questions to clarify the unknown to formulate the quickest reasonably concrete result. In that world we have control – we are the scientists, the providers of answers, the managers of data, the spinners of results. We tend to think of our day-to-day existence as a set of tasks. This database must be closed. That report must get written. The other article must get published so the following ad will appear “true”. This is how we earn our living, how we pay our mortgages, how we pass the time...

We have other roles as well. Roles that only surface when things go wrong. Our parents become ill, and suddenly we are trying to find out whether the medication or combination of medications prescribed for them are likely to help and/or have intolerable side effects. Where can we find the information? Some of it is on WebMD, some in the Merck manual, some perhaps in our own company data banks, some we get from colleagues in other companies. We discover that the information is fragmented, hard to come by, spun to minimize the negative and maximize the positive.

There is often no way to tell what subsets of patients are most likely to benefit, either because the information is not published, or it is published in scientific journals not available to the general public, or it is buried in reports so dense that x-rays could not penetrate them. Or maybe the information simply doesn’t exist – no one has ever done a study to see if that particular combination of medications in that particular combination of co-morbid conditions is beneficial or harmful or ineffectual…

So where can we turn? The pharma companies, our employers, don’t have any incentive to do these studies. The government bodies such as the NIH have their own research agendas. Who can tell us? In fact, given that there is an almost infinite number of possible combinations of medications and co-morbid conditions, can we ever hope to have any solid evidence? Maybe we have to make do with fragmentary data extrapolated from studies that don’t really reflect our situation in an environment where the optimal treatment may be unidentifiable and in any case would not be covered by insurance.

Then, eventually, we become the patients. Not subjects, for those are the ones participating in the trials that may or may not provide any benefit for them as individuals. The patients. Ill, disabled, frightened, tired, without the energy or mental strength to do the research to make sure that the treatments we are prescribed (by the doctor who may have graduated bottom of the class) are not going to worsen some other condition we have, or perhaps are just the usual run-of-the-mill treatments that don’t incorporate the latest findings.

As we get older, more and more of us join the ranks of the patients. Then we retire, and find that not only are we the patients, we are also the marginalized elderly, those who don’t work, who don’t contribute, who are seen as a burden, whose “entitlements” take an ever larger chunk of the federal government’s budget. As the baby boomers grow older, and the generation following is dramatically smaller, who will pay for our aging?

It is very clear to me that we have no choice. We have a moral responsibility to our elders, to ourselves and to our children to fix this system. We have to make drug discovery, development and marketing not only faster and less costly, but even more importantly, dramatically more transparent and more driven by the needs of the patients. It may not be immediately apparent how this can be compatible with corporate goals, but I submit that if we do not find a way to satisfy both imperatives, we as employees, we as caregivers and we as patients will be among those who suffer the consequences.