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Disappointing Cancer Study Results Go Unreported
An anonymous reader writes "Science News reports on a new study showing that most cancer drug trial results are never published, probably leaving patients vulnerable to cocktails that have already been shown to be dangerous or useless."
The pharmaceutical industry HAS been caught doing some sinister things with their studies. They do ten studies and publish the three that can be interpreted positively. The seven that can't never see the light of day. Unless of course they accidentally get published on the company web page. Then the sinister part: the drug is approved and sold to treat the condition. The clinical trials registry was formed to try to clean up that particular mess.
This particular story doesn't seem to describe anything sinister. The trials were all in the registry (that's where the authors got the data for the study). Sure, the journals tended not to publish the negative results, but they were all available in the registry.
As far as I can tell from the article they didn't even look at the actual worrisome situation where there are a few published positive studies and many more unpublished negative studies, for the same treatment.
Whoever modded that down as overrated clearly didn't know enough to judge. You don't publish negative results because of the time and effort it takes to write it up.
The reasons vary for different fields. A lot of times, researchers don't bother doing proper controls until after the experiment works or doesn't. If the trial run works, you do the controls afterward to verify your result was real, if you don't get the result you expect you might try it again, doing some troubleshooting, but at some point you have to make a choice between a control that would be particularly onerous or expensive, or giving up on the experiment entirely. If you get a negative result that you're not interested in, you generally don't do the controls to prove to others it was a valid result because you don't care and have better things to do. But that's what you would have to do to publish it.
A negative but true result can also be even more difficult to prove than a positive result would be. If you are expecting one protein to interact with another one, and you get no result, it could be that they are and your test just isn't working. If you do the experiment a different way and still show no interaction that makes it a little more convincing, but doesn't prove that both systems are working. You can't say for sure they don't interact in real cells.
In clinical trials you could think of additional reasons why someone would not care to publish the negative results. The most obvious is that the drug company doesn't want to make it known that they're working on drug X. Not sure how that works, but you could imagine that they might have to patent it to keep others from using it, and then the clock on the patent starts before they actually get it working. They could spend 5 years refining it before it actually works, then more years before it gets to market, and they only have a few years before the patent runs out. If they don't patent it and aren't sure it's a complete dead-end, another company might take the results and make a working drug from it, effectively stealing the expensive work to get up to that point.
Not a lawyer or an expert on the pharmecutical industry obviously, but publishing means making it known, and they're only going to do that if they're sure they're done with it, if then.
It makes sense that they're not going to be published, and while it's less than ideal, I think it would be worse to force the pharmecuticals to publish negative results of trials. If you make the clinical trial phase that risky, companies would be more reluctant to develop new drugs that haven't already proven effective, and advances in cancer treatment would slow.
The most obvious is that the drug company doesn't want to make it known that they're working on drug X. Not sure how that works, but you could imagine that they might have to patent it to keep others from using it, and then the clock on the patent starts before they actually get it working.
Except clinical trials are not required to attain patent protection. Any drug company with good patent practitioners is going to have a patent application filed *before* clinical trials. You can always abandon it later if the clinical trials don't work out. It's much cheaper to file and then abandon an application on a drug than to miss the opportunity to get a patent on a successful drug.
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