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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'"

14 of 200 comments (clear)

  1. Nothing for you to see here. Please move along. by NastyNate · · Score: 5, Funny

    It looks like Merck deleted this submission.

    1. Re:Nothing for you to see here. Please move along. by A+nonymous+Coward · · Score: 5, Funny

      (A similar thing happened at Intel years ago, but I don't think it lead to very many heart attacks.)

      Actually, my Pentium tells me there were .00010183 heart attacks, but I think it's estimating.

  2. Viability of Testimony by mrshoe · · Score: 5, Funny


    The researchers still aren't sure whether Clippy's testimony will hold up in court.
    .

    --
    There are two types of people in this world: those that categorize other people and those that don't.
  3. A win for animal rights.... by joe+155 · · Score: 5, Funny

    they are now testing on humans...

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    *''I can't believe it's not a hyperlink.''
  4. Re:ugh by lbrandy · · Score: 5, Insightful

    I know this thread is going to turn into a huge gripe on massive corporations and how corrupt and evil and bad they are... but... considering the company is being publicly humilated, it's stock is trading at half the price it was a 2 years ago, and it's hemorrhaging jobs. I think it's fair to say the free market is correctly punishing this big business that is supposedly "running the world". But that's just me.

  5. Re:Editors/Reviews are at fault as well by spirit_fingers · · Score: 5, Informative

    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.

  6. well... by flynt · · Score: 5, Interesting

    It wasn't so much the data that was tampered with. I can almost guarantee you that Merck was not unblinded during the trial, and therefore wouldn't know which data to change. This article is talking about a scientific publication based on the study results, there are usually many publications resulting from any study. At this point, several institutions, including Merck, a data safety board, and an independent statistical data center would complete copies of the original data, so any changes at Merck would be caught by these people (in theory).

    What the Journal found, was that someone at Merck had included a table on CV events in an early version of the manuscript, and then deleted it. So this isn't really tampering with data, it's not including all the data in your conclusions. It's not including data that shows potential harm to patients. It could be argued that this is tantamount to the same thing, which I'm not disagreeing with. Merck's defense is that the events in question occured after some pre-specified cut off date for analysis, who knows if that is true or not.

    1. Re:well... by Anonymous Coward · · Score: 5, Informative

      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.

  7. Re:ugh by Anonymous Coward · · Score: 5, Insightful

    And how many people had their health sacrificed to get us to this point? For that matter, what punishment is occurring to those who did the evil deeds?

    Nope, the free market is doing too little to late, as always.

    And, BTW - it's not the corporation that's corrupt and evil, it's the people at the top of the corporations, who are immune to the evil that they do, unless they make mistakes in covering up their deeds.

  8. no laughing matter (and how to avoid it) by conJunk · · Score: 5, Informative
    An entire multi-national corporation brought down by Microsoft's TrackChanges feature...

    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

  9. Hello chunews, by GroeFaZ · · Score: 5, Funny
    it looks like you're trying to make a joke. Would you like to...

    • insert a punchline?
    • copy a (Score:5, Funny) comment from another thread?
    --
    The grass is always greener on the other side of the light cone.
  10. Re:Sarbanes-Oxley by twotommylong · · Score: 5, Interesting
    Although targeted at financial data, legislation such as the Sarbanes-Oxley Act is precisely what is needed in such high-risk industries. It imposes strict information controls and audit requirements, and makes an effort at putting the responsibily where it belongs, namely at the Director and Executive levels.

    Err, there is the congressionally mandated little outfit called the Food and Drug Administration (FDA), and their code of federal regulations (21 CFR et al). No need for congress to rush out and write laws... the work is done.
    A quick read (chuckle) would point out that officers of a Pharma that knowingly submit incomplete or falsified data, are subject to fine and/or imprisonment, and even it was unknowingly falsified... the company can be effectively barred from producing/selling any product until the revalidation of all quality processes are complete. Not the sort of thing stockholders like to hear about.
  11. Clippy by mymaxx · · Score: 5, Funny

    It looks like you are writing a drug study document. Would you like help deleting data?

  12. Aspartame by smellsofbikes · · Score: 5, Interesting
    I'm not trying to minimize your symptoms: aspartame does have effects on people. I'm also not trying to defend Searle. The approval process for aspartame was pretty damned sketchy, with a very uncomfortable number of high-ranking people changing jobs back and forth between Searle and the FDA during and immediately after the approval process. It wasn't just Rumsfeld, it was also Ronald Reagan and Arthur Hayes who essentially ramrodded the approval process.

    With that said, aspartame *can* break down into methanol, but usually only does so at extreme pH or temperature. Warm water alone very slowly hydrolyzes aspartame. I'm trying to find some good kinetics studies; this one indicates 90% hydrolysis after 53 days at 25 degrees C which is a good argument for only drinking refrigerated pop.

    But the sheer amount you'd have to drink to produce blindness is astounding. I once calculated that with 100% hydrolysis, it would take 20 cans of pop per hour to build up and maintain harmful concentrations of methanol in the blood. EPA studies have indicated that 0.5g/kg/day doesn't result in observable health problems. There are (Google calculator r00lz) 0.014g of methanol per can of 100% hydrolyzed Coke. Hm, so that indicates that you probably don't want to drink more than 35 cans per day or you'll be above the no-observed-adverse effect level.

    The official Materials Safety Data Sheet for methanol lists "Carcinogenicity: Methyl Alcohol - Not listed by ACGIH, IARC, NIOSH, NTP, or OSHA." That doesn't mean it's not carcinogenic, but it does mean that none of them has ever found any evidence for it being carcinogenic, as opposed to things like the nitrites in bacon, which have definite carcinogenic activity. The point being: we're eating things that are probably orders of magnitude more carcinogenic than the released methyl alcohol in aspartame; our bodies produce more methyl alcohol and its metabolites naturally than any but the most aggressive pop drinker will ever experience.

    I'm not defending aspartame's use, but if you're going to attack what the FDA did when they certified it for use, attack it on other grounds, like your observed reaction to it, rather than because of methanol.

    --
    Nostalgia's not what it used to be.