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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'"
It looks like Merck deleted this submission.
I got a 404 error when clicking on the 'Read more...' link. Damned multinationals!
And you guys said that this feature was bad! They're just looking out for us, bless their hearts!
The researchers must have forgotten to slide the little "write protect" tab on the diskette.
Dark Reflection
The researchers still aren't sure whether Clippy's testimony will hold up in court.
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There are two types of people in this world: those that categorize other people and those that don't.
they are now testing on humans...
*''I can't believe it's not a hyperlink.''
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.
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.
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.
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.
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.
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.
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
The grass is always greener on the other side of the light cone.
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
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.
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!
It looks like you are writing a drug study document. Would you like help deleting data?
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.