Beware the eMail trail

Jun/20/2008 05:48 Filed in: Legal issues
images
Pharma should be watching the recent arrests of two Bears Stearns executives very carefully. The case revolves around two executives who said, in eMails, that the bond market that funded the housing market was near collapse even though they told investors that everything was normal and on track. Pharma should be watching this trial very carefully as the eMail exchanges within the organization could potentially lead to a windfall for the legal profession.

When I was working at Lilly I remember getting an eMail from our legal department informing all employees not to destroy any eMails associated with Zyprexa due to ongoing litigation. The legal team wanted to review all eMails to ensure that there were not any issues and comply with the request for information.

Now imagine if you would an eMail from a physician enrolled in a clinical trial about potential side effects of a new drug. Many years after the drug gets approved that side effect surfaces in litigation and attorneys manage to get their hands on that eMail and shout “ah-ha, we got ya !” It could happen and I imagine that there is enough “gold” in old company eMails to keep lawyers in new Mercedes leases for quite awhile.

Could this lead to new policy of not using eMail for adverse drug reporting within pharma? Could pharma start to limit the use of eMail within the organization itself for fear of someone saying something that could be used against the company in the future?

This of course is up for debate but within science one cannot take one incident and lead to conclusions. Let’s say that a person enrolled in a clinical trial dies while taking the medication. First the clinical people need to determine the correlation between the data and the event. Then they need to look within the whole population within the clinical trial to determine if there is fact a correlation. Science is the search for facts and it’s not always easy to get these facts. Just look at the labels for the top 10 drugs. Most all of them have the same side effects like diarrhea and nausea, but are these in fact real or “psychological” side effects ?

There is of course no excuse for wanting to bury potential side effects in data analysis and I think is where the concern really is. Can we trust pharma to “tell us the truth” when it comes a top selling drug that earns billions of dollars in revenue? The track record is not good in this area as all roads point to a concern to keep drugs as top sellers rather than informing patients about potential newly reported side effects. The public has a right to be concerned here as it is perceived that pharma puts profits above patients all the time. The eMail trail could prove to be embarrassing for pharma if there are any issues that were reported but never made public. For now the lawyers are the only winners here but you had better believe that some new guidelines involving eMail are sure to come.
|