Conflicts of interest: Finally a formula that solves it!

It is now difficult to know what to do with the information provided in the disclosure section of journal articles.  I am puzzled as to how are we supposed to train residents and fellows into how to incorporate this information into the decision making process.  After all, we want the readers to formulate impressions about disclosures so that they attain objectivity about content.  And objectivity is about measurement.  So how is one supposed to do so?  Until now no one knew for sure.

As background I would suggest we needed a simplified statistical system for an audience who is known on occasions to struggle with stats.  For example many very smart colleagues still struggle with the significance of the p value.  Less than 0.05 Biblical!  Anything else discard immediately...  Let alone understanding a Bonferroni correction.

So to try to solve this problem I tackled a recent paper in the NEJM where C1 inhibitor deficiency is successfully treated by a new intervention (one of 3 papers in the same issue).  (Zuraw et al N Engl J Med 2010; 363:513-522August 5, 2010).  By the way congratulations to the authors on such important study.  (This comment is about the irony of disclosures not the value of their paper, which is truly outstanding).  The methods did not tell me how to account for the disclosures (Top figure).  So if you look at the results section there were 1006 words.  The disclosure text was almost as long (798 words).  There must be a way!  After many hours I took it upon myself to calculate the significance of disclosures and suggest the following formula for correction.

For the sake of providing due credit I thought about the "CANDAB correction" which is an acronym with the first letter of some of the most intense pharmascolds. (HINT:  Solving this is much simpler than my formula).  So here it is finally! Do this for every author.  X stands for the age of the author, y is the net compensation received in the last 12 months and n is the number of times they have participated in CME or consulting.  You add it all and move the p value as many decimal points as the result shows to know the truth. 

 Late breaking news: I heard JAMA will include automatic computation in their website.

No free latte, unless you are not from the US!

A new MSNBC poll looks at the absurdity of the current regulations regarding interactions between physicians and industry.  The vast majority of poll responders agree, and  thankfully so, that the regulations have gone to far.  At medical meetings there are now booths for international attendees only.  Once you swipe your card you can go inside and get a coffee and a biscotti.  To keep this under veils they have posted guards at the entrance of these international lounges.  The general public seems to finally have gotten it and at least 80% of poll votes go for the regulations having gone too far.

Caught in the act! (Good Job Jenny)

Thought we should share this story ... Institutions have been concerned for a long time about the interactions of docs and drug reps.  After all they must be dangerous individuals (tongue in cheek) since so much credentialing is necessary for them to access hospitals and clinics.  TB testing, criminal background checking, drug testing and the like.  So we were surprised to find out that a Facebook friend, who works as a representative for a pharmaceutical company, posted a campaign to raise money for a someone diagnosed with cancer.  "It must be an aberration!"  (the critics would say).  The reality is that the current anti industry environment has created an environment for representatives of the pharmaceutical industry that is outright disrespectful and discriminatory.  She did not have to do what she is doing, but she did.  Keep up the good work Jenny!!

Names have been masked for privacy

Forbes Tackles the Off-Label Question

A great article just published in Forbes highlights an often neglected topic; that "off label" usage of medications can lead to good outcomes. The authors correctly state that "off label" accounts for about 20% of all prescription writing and in some cases up to 50% as in cancer and cardiology. There are many cancer diseases where there is no "on label" option. For many patients not having on label options will mean no treatment. There is description of how malpractice can result if the standard of care includes "off label" use and a patient is not treated with such drug.  Medicare allows for off label use and reimburses for that. Yet it is ironic that the off label aspect if often cited by industry critics as one of the key evil practices. So much so that the largest monetary settlements have occurred often associated with "off label" promotion. If the purist would insist that all CME communications be limited to on label that would be highly limited, destructive and infringing on First Amendment.   CME events will become robotic interactions that will defeat their own purpose. This is what we see now in the case of drug reps who have to stay on label. Their value goes down if they have limited freedom speech. Freedom must prevail.

Endocrine Today: ACRE Members Weigh-In

Hat-tip to the Policy and Medicine blog for their coverage of a recent article in Endocrine Today, "Conflict of interest’ outdated phrase for physician-industry relationship?", that features several ACRE members. Tom Stossel, Carey Kimmelstiel, Jeff Garber, Michael Weber, and Lance Stell provided commentary on a range of conflict of interest issues, from industry support for medical organizations to the inherent "framing bias" that the terminology "conflict of interest" sets up.  

It's worth reading the original HERE and the commentary over at  Policy and Medicine HERE.