Slashdot Mirror
Merck's Deleted Data
An anonymous reader wrote to mention a Forbes article describing a drug study tampering proven by software. From the article: "A top editor of The New England Journal of Medicine says that he was stunned to find out that data linking Vioxx to cardiovascular risk was deleted from a major study his journal published five years ago--and that it appears that Merck researchers may have deleted that data ... When you hover the cursor over the editing changes, the identity of the editor pops up, and it just says 'Merck'"
You missed the point entirely. The Journal was given a hard copy of the study by Merck four months before the issue came out. This was in the days before the publication worked from digital submissions.
Merck knowingly gave the Journal incomplete data and the editors have only now discovered the discrepancy by going back and examining the original computer document.
where i work, we enforce use of the Remove Hidden Data Tool to prevent this happening
we once got some documents from DOJ that were supposed to go up on our website that had obvious edditing changes in them
Yeah... I work in data management for a central lab, and I don't think data can really ever be "deleted". We certainly never delete ANY data (not for at least 15 years anyway), and as a central lab, we don't answer to a single sponsor and DO answer to federal regulations and are subject to random audits at any time. So, we would have the data, and the CRO (contract research organization) would have the data at least. What Merck or any other drug company does with the data is not really our concern but it's effectively impossible for clinical data to really be wiped out totally because it will be in the hands of many independent organizations.
I'm just a database monkey so I'm pretty ignorant about the process with these journals and such, but it sounds like the data was deleted because it was past a cutoff date; maybe at that level thats a no-no, but for us it's pretty much standard procedure that if we have data that has some outstanding issue and we are waiting for some confirmation/reconciliation, we just suppress it until the issue is resolved, which is preferable to sending erroneous data.
Also, to troll it up: maybe if it was possible to recall a drug without necessarily opening up yourself to billions of dollars of liability lawsuits, drug companies would have more incentive to take recall actions sooner rather than waiting until the evidence is overwhelming. By making the price of admitting there MIGHT be a problem with the drug so high, it's inevitable they would try to delay a recall for as long as possible. I'm not defending it - I'm saying it's inevitable and logical. The tort system takes it's toll in lives as well as dollars.