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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'"

37 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 Anonymous Coward · · Score: 3, Insightful

      An entire multi-national corporation brought down by Microsoft's TrackChanges feature...

    2. Re:Nothing for you to see here. Please move along. by technoextreme · · Score: 4, Funny
      An entire multi-national corporation brought down by Microsoft's TrackChanges feature...

      Im sure a large group of people on slashdot would also like to see Microsoft be brought down by their TrackChanges feature also. This is a horribly bad joke and I doubt anyone is going to find it funny....
      --
      Ooo man the floppy drive is broken. No wait. The computer is just upside down.
    3. 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. They deleted the slashot page too! by Anonymous Coward · · Score: 4, Funny

    I got a 404 error when clicking on the 'Read more...' link. Damned multinationals!

  3. Edit changes... by Scoth · · Score: 3, Insightful

    You'd think after all the high profile cases of stuff like this happening, companies would be more careful with the revision history system. Guess not...

  4. See! by DrEldarion · · Score: 4, Funny

    And you guys said that this feature was bad! They're just looking out for us, bless their hearts!

  5. They must have forgot... by OakDragon · · Score: 4, Funny

    The researchers must have forgotten to slide the little "write protect" tab on the diskette.

  6. 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.
    1. Re:Viability of Testimony by hunterx11 · · Score: 4, Funny

      It appears that you are writing an amicus curiae brief. Are you sure you don't really want to use Word Perfect?

      --
      English is easier said than done.
  7. A win for animal rights.... by joe+155 · · Score: 5, Funny

    they are now testing on humans...

    --
    *''I can't believe it's not a hyperlink.''
  8. Editors/Reviews are at fault as well by karvind · · Score: 3, Insightful
    From TFA

    "I was somewhere between surprised and stunned," Dr. Gregory Curfman, executive editor of The Journal, says. "They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health. " (emphasis added)

    Now why would you allow to publish such inconclusive studies at all ? Is this journal peer-reviewed ? It would be interesting to see if they also publish the comments from the anonymous reviewers ? Did they agree about the paper before it got published ?

    1. Re:Editors/Reviews are at fault as well by GrnArmadillo · · Score: 3, Insightful

      All but one of the authors of the study were either employed by or consultants for Merck. The company decided that the article would technically be telling the truth (X patients died DURING THIS TRIAL) without mentioning the deaths that occured between the scheduled end of the trial and the publication of the paper. Short of the peer reviewers conducting their own clinical trial, at the cost of hundreds of millions of dollars, there was no way for them to know that information had been withheld.

    2. 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.

    3. Re:Editors/Reviews are at fault as well by lbrandy · · Score: 4, Informative

      Now why would you allow to publish such inconclusive studies at all ? Is this journal peer-reviewed ? It would be interesting to see if they also publish the comments from the anonymous reviewers ? Did they agree about the paper before it got published ?

      Do you expect scholarly journals to reproduce all experiments before publishing the data? It's only inconclusive and misleading because some data was conviniently deleted. There is no way for a journal to know this without reproducing the study.. and that is not the purpose of "peer-review" in the "peer-reviewed journal". The work, itself, is taken on honor, and the "peer-review" is there only to make sure the experiment, as explained, is scientifically interesting and accurate... the data itself is taken at face value until it is either independantly confirmed or denied.

    4. Re:Editors/Reviews are at fault as well by Boghog · · Score: 3, Informative
      http://www.corante.com/pipeline/archives/2005/12/0 9/a_vioxx_bomb_drops_or_does_it.php

      While this story makes Merck look bad, idiotically bad, on closer inspection there isn't as much here as you'd think. The data in question are three heart attacks in the final weeks of the VIGOR trial. But the adverse cardiovascular event data in the paper, as published, didn't reach statistical significance, and they don't seem to reach it with these added in, either. On top of that, these data were submitted to the FDA during the drug's approval process, and (according to Point of Law) are on the Vioxx package insert itself.

  9. 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.

  10. 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.

  11. obligatory by GungaDan · · Score: 3, Funny

    $sys$data_unfavorable_to_merck

    --
    Eloi are stupid, throw morlocks at them!
  12. Cardiovascular problems? by Zarhan · · Score: 3, Funny

    Well, I'm glad that the issues has finally come to light. I heard someone else suspected something along these lines before, but he became Fugitive when he murdered his wife.

  13. Easily Forged by ShawnDoc · · Score: 4, Insightful

    The only problem with this is that this information is easily forged. It would be VERY EASY for someone to frame someone else this way. I'm not saying Merck didn't do it in this case. I'm just saying that even someone with no computer knowledge can change their user name in Word, make some changes, and have it appear as if someone else made the edit.

  14. Sarbanes-Oxley by DingoBueno · · Score: 3, 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.

    --
    ascii art
    1. 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.
  15. Contrast that with the Viagra makers studies by LM741N · · Score: 3, Funny

    In related news the makers of Viagra were saying that their studies posted on the internet were "standing up" really well.

  16. 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.

  17. oh no! by legalize.ganja.now. · · Score: 3, Funny

    they should have deleted lore instead!

  18. 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

    1. Re:no laughing matter (and how to avoid it) by hey! · · Score: 4, Interesting

      That's like saying that pleading the fifth means your guilty. People believe that because they're too naive to know what a skilled lawyer with money (== time) to burn can do with your normal innocent activites. Much less the ones you aren't quite sure of. So -- if you're smart, you certainly don't count on mere innocence to protect you from the prosecutor or the courtroom privateer pursuing lawsuit booty.

      It seems to me whole premise of the adversarial legal system, and the fifth ammendment, is that nobody can be trusted to give a true and honest picture. So you set up a game with opposing sides. You set up rules to avoid fabrication and actually hiding evidence, and then you need a bit more rules help the defense because from the defendant's position you can't prove a negative. And when you're done, the game is still too slanted for the prosecution, so you need to make it possible for a cautious man not to get trapped. Of course, these rules probably on the whole benefit the unscrupulous, who are naturally more cautious. But when the honest man can't be bothered to play the game anymore, the system is utterly worthless.

      --
      Post may contain irony: discontinue use if experiencing mood swings, nausea or elevated blood pressure.
  19. 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.
  20. Re:Yet another reason to use OO.o by MsGeek · · Score: 3, Funny

    Open Office is great for "fixing" broken Word documents. Macro virus? Corruption? No problem! Save as Oasis,then save back as .DOC. Problem solved. I'm sure Open Office can also "fix" version tracking as well.

    Only goes to show you that it pays to use F/OSS.

    --
    Knowledge is power. Knowledge shared is power multiplied.
  21. Re:ugh by dclydew · · Score: 4, Insightful

    I doubt the economy would keep bad people from doing bad things. However, if all corporate executives were held to task for their intentional failures, we would likely see less of this sort of thing. The problem, in my opinion, isn't capitalism, it seems more like the current incarnation of capitalism that has spawned mega-corporations where the "bad people" can often hide behind the faceless 'entity'. We're doing better now than we were at the start of the 20th century, but we still have much we can improve upon, personal responsibility and liability are at the top of the list (IMO).

    --
    Get a life, not a lifestyle. - Hikem Bey
  22. It's happened before... R. G. Serle by Jerry · · Score: 4, Interesting

    When Donald Rumsfeld was head of R.G. Serle they were doing FDA safety studies for Aspartame (later branded as NutraSweet). Several rodents in the safety study died of brain cancer, but Serle removed them from the study and the data. A PhD working on the project blew the whistle. Congress investigated, hiring two lawyers to continue their work. A couple years later the acting head of the FDA, as his final act before resigning, approved NutraSweet. He then appeared as the legal eagle for NutraSweet. Guess who his two assistants were... Right.

    Aspartame breaks down in warm water to release Methyl Alcohol, among other things, which causes cancers of the brain, eye, kidneys and liver. It can cause, like it did in me, a red flush over the upper half of the body and the face, and severe oil production by the Sebaceous glands, and a continual headach. It is associated with memory loss. My once nearly photographic memory is now gone.

    Rumsfeld got $6M for his "work".

    --

    Running with Linux for over 20 years!

  23. Clippy by mymaxx · · Score: 5, Funny

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

  24. Read "Overdosed America" by rekky · · Score: 3, Informative

    When I heard this news about Merck, my impression was "deja vu". I recently read a book entitled "Overdosed America: The Broken Promise of American Medicine" by John Abramson. The author is not some quack. He teaches medicine at Harvard Medical School. He makes a strong point that drug tests which used to be funded by unbiased sources and now mostly funded by drug companies. They tailor the tests and massage the results to arrive at the conclusions that they are looking for. Before you take any prescription medicines, I strongly recommend that you read that book!

  25. 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.
  26. exactly by rosie_bhjp · · Score: 3, Informative

    The former CEO (left early 2005) walked off with some $17 million in compensation. Merck could be penalized hard but the guy who was in charge will have absolutely nothing done to him.

    --
    A radio maverick jumps to internet only. The Future of Rock n Roll