Merck's Deleted Data 200
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'"
Nothing for you to see here. Please move along. (Score:5, Funny)
Re:Nothing for you to see here. Please move along. (Score:3, Insightful)
Re:Nothing for you to see here. Please move along. (Score:5, Funny)
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....
Re:Nothing for you to see here. Please move along. (Score:3, Informative)
On slashdot? You don't think that will be Funny? (Score:2)
Re:Nothing for you to see here. Please move along. (Score:2)
It's already happened.
It seems, after looking at the files directly, the "Halloween" memos were started at the bottom of Microsoft's employee pool and went upwards. The document was a rant about how great Linux and the entire open source movement around the GPL was. Before they were sent to Eric Raymond there are drastic edits to the memo by a user known only as SBallmer. Somehow w
Re:Nothing for you to see here. Please move along. (Score:2)
Or this might be the ammo that MS needs to combat Open Document format. (It's funny. Laugh)
no laughing matter (and how to avoid it) (Score:5, Informative)
where i work, we enforce use of the Remove Hidden Data Tool [microsoft.com] 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
Re:no laughing matter (and how to avoid it) (Score:2)
Re:no laughing matter (and how to avoid it) (Score:5, Interesting)
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.
Re:no laughing matter (and how to avoid it) (Score:2)
Re:no laughing matter (and how to avoid it) (Score:2)
Re:no laughing matter (and how to avoid it) (Score:2)
Not all changes are about illigal stuff. How about "The state agrees to pay $1,000,000^H^H^H^H^H^H^H500,000 for the whatever..."
you don't want the casual reader to be able to see what sort of numbers were in various versions of the agreement before the final public document is ready
Re:no laughing matter (and how to avoid it) (Score:2)
Re:Nothing for you to see here. Please move along. (Score:2, Interesting)
Yes, but which body done it?
We can already guess the why, which goes something like this:
(A similar thing happened at Intel years ago, but I don't think it lead to very many heart attacks.)Re:Nothing for you to see here. Please move along. (Score:5, Funny)
Actually, my Pentium tells me there were
Re:Nothing for you to see here. Please move along. (Score:2)
That's probably because Intel's having a heart attack [slashdot.org] by all those $100s that they're gonna lose.
They deleted the slashot page too! (Score:4, Funny)
Edit changes... (Score:3, Insightful)
Re:Edit changes... (Score:3, Insightful)
SonyBMG wasn't an isolated incident of cranial rectalitis.
Re:Edit changes... (Score:3, Informative)
Re:Edit changes... (Score:2)
Comment removed (Score:5, Funny)
They must have forgot... (Score:4, Funny)
Yet another reason to use OO.o (Score:2)
Re:Yet another reason to use OO.o (Score:4, Funny)
Only goes to show you that it pays to use F/OSS.
Viability of Testimony (Score:5, Funny)
The researchers still aren't sure whether Clippy's testimony will hold up in court.
.
Re:Viability of Testimony (Score:5, Funny)
Re:Viability of Testimony (Score:2)
I say well done Sir!
Re:Viability of Testimony (Score:2)
Yeah, I've seen that first hand trying to convert War and Peace from Gutenberg to Microsoft Reader, and hopefully having a nice, paginated table of context. Once you do too many things, Word lags more than correspondence chess.
Re:Viability of Testimony (Score:2)
A win for animal rights.... (Score:5, Funny)
Editors/Reviews are at fault as well (Score:3, Insightful)
"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 ?
Re:Editors/Reviews are at fault as well (Score:4, Insightful)
It was fairly conclusive though (Score:2)
You see it was fairly conclusive though after they omitted the whole part about people dropping dead....
Re:Editors/Reviews are at fault as well (Score:5, Informative)
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.
Re:Editors/Reviews are at fault as well (Score:4, Informative)
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.
Re:Editors/Reviews are at fault as well (Score:3, Interesting)
Re:Editors/Reviews are at fault as well (Score:3, Informative)
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 FD
Re:Editors/Reviews are at fault as well (Score:2)
Haha (Score:2, Interesting)
Firestone ? (Score:3, Interesting)
Could this be the drug industry's "Firestone"? Yet another example of he classic irresponsible/corrupt/greedy corp. that tries to cover up its own blunders.
Re:Firestone ? (Score:2)
If Merck is as you say, they wouldn't be running this program [cartercenter.org] for free.
Cover Up? (Score:2)
If you read the last paragraph of the it says they provided ALL the data to the FDA. I guess if you provide data publicly to a federal agency in which anyone can look it up that's a cover up nowdays. The fact that Curfman states that he is not buying into the fact that is was publicly available knowledge really shows his bias.
"Nevertheless, the additional events were disclosed to the FDA in 2000, presented publicly to the FDA's Advisory Committee in February 2001 and included in numerous pre
Re:Firestone ? (Score:2)
I wonder which politician was in bed with them at the time...after all, Rumsfeld did the nearly the same thing with GD Searle, who at the time was trying to get Nutrasweet approved.
Re:Firestone ? (Score:2)
But Ford suffered virtually no ill effects from this, in spite of all the deaths they caused. So if this current scandal is Merck's Firestone, I guess some other co
Re:Firestone ? (Score:2)
The vehicles tended to slip when turning at full tire pressure, so they specified a lower pressure. Ford initially estimated that the increased wear from the lower than recommended tire pressure was an acceptable tradeoff. Of course, if they'd bothered to mention that explicitly somewhere, they wouldn't have been as exposed, but they probably also wouldn't have sold as many units.
also, an experiment I don't recommend you try: let out some pressure on your own tires and see h
The Merck knows. Oh it knows. (Score:3, Funny)
"At 3:00 P.M. today, Curfman and two other editors released an editorial on The New England Journal's Web site entitled "Expression of Concern," which calls on the VIGOR authors to submit a correction of the 2000 manuscript. "Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article," it read. "
The editorial, however, is also strangely missing. In its place was a message: "Silly Scientists - morality is for kids! Love, Merck."
well... (Score:5, Interesting)
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.
Re:well... (Score:5, Informative)
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.
Re:well... (Score:2)
Re:well... (Score:2)
I don't agree with your logic. When the cost of liability is so high it should encourage companies to play it safe and pull drugs as soon as they suspect there might be an issue, because in that case they can legitimately claim t
Re:well... (Score:2)
Re:well... (Score:2)
If you have a 30 day mouse study, and a mouse dies on day 31, when it goes to publication the mouse "survived the study."
Now I don't know what kind of study merck was doing, and I don't know that they had this cut-off date pre-specified, but the possibility that there was such a cutoff date and that these heart attacks just happened to fall after and were therefore excluded it is
obligatory (Score:3, Funny)
Cardiovascular problems? (Score:4, Funny)
Easily Forged (Score:5, Insightful)
Re:Easily Forged (Score:2)
Re:Easily Forged (Score:2)
I recall doing IT for a relatively small shop in the early
eighties, and after a while, I stopped putting user's names
on the software installed. I just put in the company name
for the user name as well. I can imagine that a big place
like Merck might well stockpile and "recycle" machines,
and would probably not put user names in, not having them
at the time of setup.
So, now to the hopefully humourous part:
To properly incriminate someone, run some incriminating
go
Re:Easily Forged (Score:2)
Re:Easily Forged (Score:2)
It would not have occured to me, until this thread.
Re:Easily Forged (Score:2)
Re:Easily Forged (Score:2)
Time stamps in the software indicated that the table was deleted two days before the manuscript was submitted to The New England Journal on May 18, 2000
So, using your line of thinking, did someone with no computer knowledge go back in time 5 years and change these things? Because, after all time travel is such a common occurance it is only logical that after the confusion came out last september about vioxx, that someone would go back in time to plant evidence against merck.
But they were clever about i
Sarbanes-Oxley (Score:3, Interesting)
Re:Sarbanes-Oxley (Score:5, Interesting)
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.
Unlikely the researchers did it (Score:2)
I don't believe the researchers deleted the text. It was probably a manager handling the submission. If the researchers wanted to supress the data they would have just left it out of the article altogether.
The submission was on paper and on diskette. The paper version was edited, and that's what was used for publication. The diskette version was not edited and had the complete original text. http://news.yahoo.com/s/nm/20051209/hl_nm/medical _ journal_says_merck_deleted_dc_1 [yahoo.com]
That does seem odd, though,
Contrast that with the Viagra makers studies (Score:4, Funny)
oh no! (Score:3, Funny)
It's happened before... R. G. Serle (Score:5, Interesting)
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".
Re:It's happened before... R. G. Serle (Score:2)
Re:It's happened before... R. G. Serle (Score:2)
http://europa.eu.int/comm/food/fs/sc/scf/out155_en
The interesting thing about all of the websites that make threats about aspartame is the huge range of effects described:
Aspartame (Score:5, Interesting)
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 [nih.gov] 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 [epa.gov] 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 [bu.edu] 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.
Re:Aspartame (Score:2)
A conspiracy to intentionally be irresponsible with people's health and lives is still a conspiracy.
Clippy (Score:5, Funny)
I did not RTFA, Take with grain of salt. (Score:2)
A. It's profits/shareholder's profits
AND
B. the lives of others that use their product
just seems to naturally conflict with each other. In this case, it seems especially true of drug companies. Imagine this...
MERCK: "Hey! We've invented VIOXX! This will help osteo-arthritic patients!!"
RESEARCHERS: "Ahh, yes, but it *WILL* also pose a potential threat to our customer's hearts/cardiovascular system! We need more testing!"
MERCK: "Eh, forget that!
Re:I did not RTFA, Take with grain of salt. (Score:2)
Read "Overdosed America" (Score:3, Informative)
Re:Read "Overdosed America" (Score:3, Interesting)
Overdosed America is a good read. Abramson is a capable writer, and is an illuminating book both on the problems with the US health care system, and the doctor - patient relationship as well. He helps educate the reader on the disease and the history of treatment as he discusees the therapy.
I have read several resports, articles, and books on the commercialism of our health care system. Why do we spend the most money (by far) on medicine in this country only to find ourselve
The FDA is dead, long live the FDA (Score:2)
1. They are a bureacratic department that only has one power: coercion through force
2. They delay, for years, drugs that are saving lives in other countries
3. They keep drugs prescribed that are OTC in other countries, raising our prices
4. They are more interested in CYA than efficiency and lives saved
5. They are bribable as is any government official
6. They are useless
There are many here who think we need the FDA. I believe that they are useless. We use items every day far mor
Re:drugs is money (Score:2, Funny)
Re:drugs is money (Score:3, Insightful)
I could care less how you or anyone else makes money, so long as you do it legally and honestly.
Re:ugh (Score:5, Insightful)
Re:ugh (Score:5, Insightful)
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.
Re:ugh (Score:2)
I see little value in that distinction. For all intents and purposes, the executives ARE the corporation. They are responsible for what goes on. Much like the captain of a ship is responsible for the misdeeds of the lowest-ranked sailor. (Of course, executives work under the influence of the shareholders, but when the shit comes down, the executives go to jail, not the shareholders.)
Re:ugh (Score:5, Insightful)
exactly (Score:4, Informative)
Re:ugh (Score:2)
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.
Name any natural person who after killing thousands for profit would get away with only forfeiting half his assets!
There's a big chair waiting for Merck, but prosecutors will never make it sit down.
Re:It's not the business that should pay (Score:2)
It's those individuals who make stupid decisions. When businesses suffer, everyone loses, except the ones who probably deserve to lose the most.
Re:ugh (Score:2)
The invisible hand of the market can not raise the dead, and in this case, those most severely inj
Re:In other news (Score:3, Insightful)
Re:In other news (Score:2)
1) was lying about believing all of that, or
2) didn't have the backbone to do anything about it, even as Saddam was regularly shooting at the US air patrols enforcing the terms of his surrender following their ouster from Kuwait, among many other violations
He was probably too busy dealing with the terro
Re:In other news (Score:2)
I assume, of course, you mean nothing besides:
Sending over John O'Neill, director of counterterrorism for the FBI's New York office as head of an FBI team. Accompanying O'Neill to Yemen were over 100 FBI agents, laboratory experts and forensics specialists, as well as FBI Director Louis J. Freeh.
He was convinced that OB
Re:In other news (Score:2)
Have you actually listened to Freeh talk about that period? He was, and is, furious that they weren't allowed to actually do anything meaningful about the intelligence they were coming across. They weren't allowed to work directly with the CIA or DOD, and his specific recommendation was to do essentially what Bush finally did do once the shock of 9/11 cast off any ridiculous worries that getting our intelligence age
Re:the other one.... (Score:2)
Christ do you people even hear yourself talk? Putting aside the point that the targets were activly making hostile manuevers and violating air space, using the term 'randomly lobbed' clearly indicates that you are grasping at straws to 'prove' our current president isn't so bad.
Interesting that he was impeached for lying under oath about conducting an improper relation with an intern, yet the other one lies to get us into war, 1000's of americans die, gives a corporation no bid contracts a
Hello chunews, (Score:5, Funny)
Re:That's why... (Score:3, Interesting)
Re:I got 10,000 shares to unload quick... (Score:2)
Re:News for nerds? (Score:2)
Re:you Do need to have a cut off date (Score:3, Informative)
Re:you Do need to have a cut off date (Score:2, Insightful)