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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!
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...
It looks like they deleted the comments on this story too.
Capitalism GOOOOD!
This shows that the drug industry is only after one thing: money. And lots of it.
frist
Yet another case of the world being run by big business.
And you guys said that this feature was bad! They're just looking out for us, bless their hearts!
American public stunned that the president lied about Iraqi WMD's as a pretext for going to war.
Data, what data ?? I see no data here officer...
Guns are for wimps... Use a crossbow.. this way you can pin them to their chair when you go postal.
Someone forgot how to empty the recycle bin in other news.
The researchers must have forgotten to slide the little "write protect" tab on the diskette.
Dark Reflection
...it's easier to delete user data. :)
Kinda off-topic, but this reminds me of the time I found a usb memory stick in one of the school clusters. I was able to identify the owner and return it to him because of the "edited by" info in some of the word documents inside it.
Well, it seems like at least one of the gazillion stupid features included in Word has a use after all.
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.
they are now testing on humans...
*''I can't believe it's not a hyperlink.''
"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 ?
welcome our new heart destroying, document tampering overlords.
I'm here till Thursday, try the veal!
As someone who has suffered one CV, I say throw the book @ The S.O.B'z.
While we are @ it, throw Bush in jail, for being a Global Environmental Criminal. Just where the hell are we all supposed to live, after a Global Meltdown????
Grrrr!
Greek Geek.
Nothing like getting busted by a your own inability to use secure document authoring tools.
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.
"it looks like you're defrauding the journal"
"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."
I'm assuming that this is a word document.
.doc file.
As if I don't have enough other reasons to never use Word, my tinfoil hat always tingles whenever I have to do something with a
While I can see why knowing the author or history of a document can SOMETIMES be extremely useful, it really should be something that you have to explicitly put into the metadata. There is a huge privacy risk that is here, and MS doesn't exactly make it easy to be sure it's all turned off, if indeed it can be.
Is anyone here shocked by this?
You see it was fairly conclusive though after they omitted the whole part about people dropping dead....
Ooo man the floppy drive is broken. No wait. The computer is just upside down.
Don't they know anything? Did they take a handful of Vioxx and lose their minds?
I'm guessing the hovering cursor refers to a MS Word document. Who knows...maybe this incident could be good news for OpenOffice or some other non-MS alternative, since OpenOffice and other office apps lack such ^H^H^H^H^H^privacy issues^H^H^H^H features...
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.
It reads:
lol no its not its inconvenient data
<reality>
I'm so ashamed... but I couldn't resist the joke.
</reality>
<absurdity>
My daughter will only allow one of her dolls in her play crib at a time. I have patented this process and will be selling implementations of the "Dolly-Exclusion Priciple" in the near future.
</absurdity>
They have provided us with this dup. Nobody expects the Slashdot duplication!
Infuriate left and right
$sys$data_unfavorable_to_merck
Eloi are stupid, throw morlocks at them!
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.
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.
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
... I use LaTeX. The commented text stays only in my .tex file.
%% Write something witty that can be modded as "Funny"
"- What's so unpleasant about being drunk?"
"- You ask a glass of water."[from h2g2]
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
That does seem odd, though, because it means that unless Merck submitted camera-ready print someone had to re-type the article.
In related news the makers of Viagra were saying that their studies posted on the internet were "standing up" really well.
They don't always do this. When you then take that document and export it as text, all of the old changes come with it. Since the editors like to write their comments inline with the text...some big bloopers made it through quality control.
"I don't care if it's messed up or not, let the programmers deal with it"
"Frank doesn't know what the fuck he is talking about" and other gems. All of which made it into various parts of an educational CD-ROM. Luckily, we caught them all before going to print.
they should have deleted lore instead!
While the other one randomly lobbed missiles into the country and conducted airstrikes, to deflect attention from his then proceeding impeachment for lying under oath.
HBI's Law: Frequency of calling others Nazis is directly correlated with the likelihood of the accuser being Communist.
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.
Yeah, this is off-topic but it need to be said. Mod be down, I'm comfortable with the size of my UID.
-- I have a private email server in my basement.
Who wants some? No offer refused...
I'll bet there's a highly classified hand reciept for them stashed in some beaurocrat's desk drawer.
I think it's pretty weak to say that just because an edit tagged as being performed by "Merck" that it had anything to do with the company. Perhaps there is other evidence, but the tag alone is easy -- intentionally or accidentally -- to fake/get wrong.
Drug companies are corrupt to the core with most of their profit going into advertising instead of Research and Development. Drug companies are nothing but "Business with disease". They promote all sorts of non-nutritional food that will eventually cause disease whether from the chemicals in the food or a vitamin/mineral diffeciency. Once your sick and go to the doctors, who are the Drug companies pawns, you will be prescribed with Drugs such as Vioxx with 1000% (not a typo) markup prices in which most of the money will go to promoting their drugs and bribing off various people such as the FDA. The Drugs you were prescribed will end up making you sicker and experience side effects. The Doctors will then give you MORE Drugs to hide the side effects of the first Drug and then the second and then the third and so on effectively locking you in a vicious cycle and all the time raking in massive profit from you. To make sure their customer base stase as large as possible they go to great lengths, with the aid of the FDA whom they effectively run, to outlaw all other treatments such as herbs and some nutritional foods such as Hemp. At the same time they make it a standard for processed food makers to use all sorts of health deteriorating products such as Apartame (which is listed in the Pentagon as an agent of chemical warfare), MSG and Hydrogenated Vegetable Oils.
At the moment the drug companies are pushing for a new law named Codex Alimentarius which would ban all supplements and natural remedies and make them a punishable offence. The previous attempt to push this law failed thanks to the efforts of Dr. Matthias Rath.
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?
The simple *IDEA* of a large company responsible for...
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! Everything comes with a risk or a side effect! Just let that data slide, we'll cover the expenses!"
Not to say that's what actually happened, but having run my own business (NOT in a realted field, but as it's said, business is business) I've even done a few "quickies" that I had to do some serious explaining about before I got my ass canned or sued. I'll bet/wager/gamble a little bit of money that Merck KNEW what they were doing, were prepared for the potential suit, and they just wrote it off as "acceptable risk."
I can only hope this "acceptable risk" of gambling with people's lives does not go unpunished.
Still waiting on Serviscope_minor to wake up to fucking reality and realize that Jessica Price isn't going to fuck him.
"OpenOffice and other office apps lack privacy is features..."
I don't get it.
Please, that is 4x funnier than practically every Score5 funny on active stories right now. At least your joke makes a point.
Hey, I'm just your average shit and piss factory.
It was meant as a joke...in other words Merck might move to Open Office since it lacks the "feature" of tracking changes. Get it...it's a "feature" in MS Office that has caused this sort of problem in the past. I think the Parent Post meant that this bad press for MS could be good press for Open Office. Relax it's Friday, laugh a little. Shhheeesh.
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!
What cover up?
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 press releases subsequently issued by Merck. We also note that these additional events did not materially change any of the conclusions in the article."
Curfman responded, "We're not buying into that."
Quality Hosting e3 Servers
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.
Let's say we do a small study. We let 100 people drink 8 oz. of name brand bottled water. Now if we find that 50 of them are dead seconds afterward we might conclude something is wrong with the water. But if all them are dead 200 years after drinking the water we don't conclude anyhting about the water. So at what point between two seconds and 200 years do you stop watching the water drinkers? The answer is "It doesn't mater but you DO have to select a time limit What happened here was that a drug company did not publish information about what heppend after the time cut off. My opinion is that this "out of bounds data" should have gone into a footnote, apendix or whatever but they have a point that what happens after the study period is over should not be included in a published account of the study.
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
It's those individuals who make stupid decisions. When businesses suffer, everyone loses, except the ones who probably deserve to lose the most.
Hello /.. I work for judges, my job is to research, draft, edit, and revise judicial opinions. We exchange multiple drafts, sometimes in Word with track changes. We publish an electronic copy of the final decision. It would be very bad if parties or others could "see through" to ealier drafts. Currently we have set word to notify if saving, mailing, or printing a document with tracked changes. Is this sufficient? We shred paper copies, but we are not as technologically savvy as the readers here clearly are. Any advice?
Better late than never.
You blame this on a free market? I just blame it on dishonesty and stupidity.
Has anyone else noticed 100 million gallons of carcenogenic fluid flowing from China lately?
Of course you probabbly consider China not communist enough either.
(If at first you don't succeed, do it different next time!)
^H isn't like.. a border for removed words, dude. It's the onscreen value of the backspace character for terminals with a dumb cursor.
Here's a rundown of the FDA:
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 more dangerous than pills - hair drivers, lamps and microwave ovens. They're only sold by stores if they are UL listed. Underwriters Laboratory is a private company that has to do their job properly, competitively and at the right price. If not, competition will replace them.
The Merck problem is the FDA's fault -- it happened on their watch. Now the free market will save their asses, again, by reducing faith in Merck's honesty and hitting them where it counts -- the bank.
The Merck employee who deleted the incriminating data, and all managers in the chain of command who knowingly approved that action, should be charged with 1 count of negligent homicide for each person who died as a result of that action.
I wonder why the only result in that specific Google search is a link to the highly obfuscatory "Wikipedia:Talk" article which gives a very much more confusing picture than the actual Wikipedia article at http://en.wikipedia.org/wiki/Aspartame. By contrast many thousands of newer and less detailed Wikipedia articles on all sorts of other subjects are indexed by Google.
Nobody should feel they have to consume "diet" soft drinks to lose weight, when the most effective and safer strategy is to drink water and to eat less food.
I occasionally support the work of researchers looking for new drugs. I see them generate reams of data, looking for evidence to support the efficacy of a new drug. The basis for using Vioxx, Celebrex, Bextra and any other COX-2 inhibitor, is that they only inhibit the COX-2 enzymes, which are responsible for pain and inflammation. These drugs did not inhibit the COX-1 enzymes, that are related to stomach protection and blood clotting. If you had pain and inflammation before the COX-2 inhibitors arrived, you would take a NSAID (Non-Steriodal Anti-Inflammatory Drug such as Aspirin, Sodium Naproxen, Ibuprofen, etc.). These drugs would inhibit your COX-2 enzymes, to relieve your pain and inflammation, while at the same time inhibiting your COX-1 enzymes, thinning the mucous lining in your stomach and reducing your blood's ability to clot. As long as you didn't develop gastric problems or bleed to death, you were in good shape, but there are a large number of people that do have gastric problems or blood clotting disorders that NSAID's aggravate. Hence, Merck and many other drug companies were looking to market a drug that would only inhibit COX-2 enzymes. Bingo, they found several new drugs that met the new requirements. This is where the problems began, because these drugs worked too well. These Drug Companies
are now being sued for intentionally marketing a pain reliever without the COX-1 inhibiting side effects of the older NSAID's such as aspirin.
In my opinion FWIW, the vultures(ie. attorneys) have decided to sue Merck and others for making a pain killer that worked too well, without the side effects of previous pain killers. Never mind that some of the side effects of the older NSAID's, exacerbated stomach ulcers and prolonged clotting times. Part of the problem is that the drug companies, the doctors and the patients saw the COX-2 inhibitors as a solution to the problem of joint pain without the side effects of previous generation of drugs. What they did not see was that when they gave up the older NSAID's, they also gave up some of the side effects that were occasionally beneficial, especially for those people at an increased risk for heart attacks due to atherosclerosis.
Sure, the drug companies are not angels, but a business cannot succeed without innovation. They probably spend more money on drug advertising than they should, but lawsuits such as these will only decrease the profit margin and minimize new research. Nothing is 100% safe and effective without harmful side effects. The critics always have 20/20 hindsight, but the people with foresight rarely do.
"Endeavour to persevere"
"Endeavour to persevere"
Umm, your boy said the exact same things about Iraq to justify his random lobbing of missiles and bombings in 1998. Care to hear the tape? For that matter, it wasn't just him. Kerry, Kennedy, the whole lot were spouting off back then. For that matter, the same crew mostly was saying the same shit in 2002-03.
So, who was lying, and when?
You're so full of shit your eyes are brown, like the rest of the leftist Bush-haters.
HBI's Law: Frequency of calling others Nazis is directly correlated with the likelihood of the accuser being Communist.
The U.S. Drug companies do what they want, as they have been very powerful and wealthy for a long, long time. ... nothing is done for "free", ever. There is always a reason, and a cost to be paid back.