I DIDN'T KNOW WHETHER to laugh, cry, or bang my head against the wall after most of the interviews I did for this issue's cover story (see page 38). Are we really looking at just a few bad apples, or has the whole barrel gone rotten on us when it comes to the integrity of clinical research data?

As example after example washed over me — such as the recent suppression of data about the adverse effects of antidepressants and anti-inflammatory pain medications, and the cases of ghost-written research reports that have been gleefully pounced upon by my ink-stained brethren in the general press — I was ready to reach for some SSRIs to deal with the psychic pain. Or not, given the recent revelations.

One has to assume that data suppression and manipulation is nothing new; the new part is that we're starting to hear about it. And we're also hearing that it's being done deliberately, not inadvertently as the result of unintentional bias because of imperfect study design and execution, which is what the Pollyanna in me wants to believe.

Are more and more researchers — and, more insidiously, research organizations — rolling over to pharma demands, rather than providing full and truthful disclosure of clinical trial results? While some pharma companies have indisputably been shucking and jiving with clinical trial results, and some researchers and their organizations have been complicit, I just cannot believe that an entire industry that exists solely to take care of people would deliberately put them in harm's way for the sake of the almighty dollar. I've met too many caring, compassionate pharma people and researchers who would rather switch to sheep-farming than do anything that would be detrimental to patients.

There are bad individuals and organizations in every field, and I'm sure this one is no exception, as recent news reports make obvious. And those who do wrong need to be dealt with, and controls need to be put in place to make sure that the cookie jar gets put on a shelf where they can't reach into it for future trials. Where there is temptation, there will always be someone to give in to it.

As to how to do that, I have no real answers, although I think it would probably help to have healthcare professionals, in addition to businesspeople, running the show at both pharma companies and research organizations. Clinicians in positions of business power could help to keep the focus where it should be when it comes to research. But that's a tiny piece of the puzzle, as are trial registries and the other solutions people I spoke with proposed. I remain hopeful that all involved will see the light so the good folks doing the good work can get back to it — and to telling us all about it.

Sue Pelletier,
(978) 448-0377
spelletier@primediabusiness.com