Transparency & Clinical Trials

This morning’s WSJ’s Science Journal takes a particularly harsh and somewhat uncharacteristic (at least for WSJ) look at the pharmaceutical industry’s practice of sequestering less than favorable clinical trials’ results.  Appears that the sheer volume of clinical trials today, 50K ongoing among some 2.3M patients creates an enormous amount of data and subsequently reports.  What researchers have found, at least according to the article, is that the vast majority of results are never published.

Surprise, surprise, the vast majority of research that never sees the light of day (75% according to one study) are unfavorable results.

Making matters worse, of those that are published, quite a bit of “creative editting” occurs to insure that clinical trial results are cast in the most favorable light.

What I can not fathom though is why the author of this article did not bother to talk to any payers to solicit their perspective on the issue. Ultimately, they are often the ones that do the comparative effectiveness analysis of a new drug. Do not fully understand why they are not on top of this issue themselves as they certainly have a lot to gain (or lose)?

Current buzz from DC is that the Obama transition team is looking to overhaul the FDA putting in a more aggressive leader.  Two candidates being considered are Steve Nissen of the Cleveland Clinic and Joshua Sharfsteir of the Baltimore Dept of Health. Both have been quite critical of pharmaceutical industry practices.

Stay up to the minute.

Fortuitous or Planted Story on EmergingMed

Read in the WSJ this morning an interesting article on new approaches that are being taken to introduce/solicit consumers to participate in clinical trials. The problem seems to be that consumers actually have little reluctance to participate in such trials. The problem is, they just don’t know what trials are occurring that may be pertinent to their profile (needs, condition, physical attributes, etc.). This is one area where start-ups such as PatientsLikeMe are looking to leverage their communities.

In the article, the reporter goes into some depth explaining how the company, EmergingMed works to match a consumer’s profile to the enrollment criteria of a clinical trial for cancer. The company uses online and call-in technicians to provide an appropriate match based on cancer, stage, and other factors. Company has been in business since 2000 and claims to have placed over 115,000 people into clinical trials. Decent story overall and a great example of where PHRs can play an important role in the future – provided of course that the consumer chooses whether or not to opt-in and having their records used in this manner.

But what really got to me was later today I was alerted to this press release. Now was it just coincidence that the WSJ would publish a story on EmergingMed the exact same day that this press release was released, or is there something else going on?

Smells awfully fishy to me and not unlike payola for DJs (or for that matter doctors) – just wonder how much the WSJ got paid for this placement?

Really a shame as I have been a subscriber to the WSJ for years. Now under new ownership, I have seen a number of changes at the WSJ, none of which I am fond of. Hmmm, maybe time to switch to the NYT.