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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'"
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.
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.)A feeling of having made the same mistake before: Deja Foobar
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.
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
Maybe they just deleted the table from the article because they couldn't figure out how to format it in LaTEX.
The data was about events that occured after the study, so while Merck was technically correct to delete the data, there is an air of amorality about it. Dr. Claire Bombardier's, and the University of Toronto's reputations are going to be severly tarnished by this incident. Now because people have presumably died or have been physically injured because of the ommission of the data it isn't a streach to imagine neglegent homicide and criminal conspiracy to be looked at by prosecuters. Even if Merck had final edit rights on the paper and a NDA, I'm sure that Bombardier is going to wish she had written a letter to the editor about the data occuring after the study ended. The, they the article refers to is Merck/Bombardier, not the peer reviewers. There is no way for the peer reviewers to have known that pertainent data was withheld, the NEJM seems to be on solid ground here. This is a Good reason to use LaTeX!
Apocalypse Cancelled, Sorry, No Ticket Refunds
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!
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.
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.
I would agree with Parent's Post.
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 ourselves ranked fairly low in the industrial countries in terms of actual health?
Is it any suprise that many countries ban advertising of drugs, while in our country samples are given to doctors and ads are placed where consumers will see them, while at the same time Journal writers are on the drug companies pay roll, and members of the FDA have stock portfolios filled with thier (guess what) former employers, the drug companies?