Disappointing Cancer Study Results Go Unreported 77
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."
Re:More complaining and second-guessing (Score:2, Informative)
Maybe try reading the article?
FTFA:
"Of particular concern," they argue, is the especially poor showing by industry-sponsored trials, since they tended to probe the value of patented drugs -- "many of which are in clinical use."
I would say that's newsworthy if not all that surprising. Just another case of big drug companies screwing over the general population to make a buck. They run studies to test their drugs and if the results are unfavorable they just bury the study while keeping the drug in circulation.
Re:Nothing new (Score:5, Informative)
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they didn't even look at the actual worrisome situation where there are a few published positive studies and many more unpublished negative studies, for the same treatment.
Re:Negative results (Score:5, Informative)
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.
Re:Negative results (Score:5, Informative)
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.
Re:First Post ... sadly (Score:4, Informative)
Anyone doing this should get put in jail for a long, long time. It may not be fraud in the sense that they're publishing fraudulent results, but by not publishing results they're creating fraudulent overall data, with possibly deadly results. This needs to stop.
That's a bit simplistic - often nobody is directly responsible for not publishing results, it comes about because major medical journals are not interested in pubishing negative findings. There are of course exceptions, when the negative findings come as a big surprise or there is a lot of anticipation about them, like the reports of the Alzheimer's disease vaccination not working earlier this year.
The medical journals themselves know this is a problem, but they aren't sure what to do about it. One suggestion has been the journals should make a 'commitment to publish' for a trial based on its design and importance, and then publish the findings whatever they are, but that would of course mean they'd be publishing a lot less interesting stuff.
Also scientists can't be bothered to write up negative findings, because there are proportionally so many more of them than positive ones.
There is a problem of pharma companies suppressing bad findings or writing misleading journal articles, but that's a wholly independant issue and should be dealt with by the schemes in develpment for enforcing results to be left in public databases after the trials are finishsed. The problem with that is that not many GPs will be searching through these databases
The real solution is probably for doctors not to rely on scientific journals for information (which they often don't really understand), but to wait for advice from bodies like the National Institute for Clinical Excellence [nice.org.uk] or the Cochrane Collaboration [cochrane.org] who do very thorough searches and synthesis.
Re:Nothing new (Score:4, Informative)
"Published" in a major journal. ALL of the studies were published in the registry. As I said, you can't ask the major journals to publish every failed study.
If you want to try and standardize trials, go for it. I wish you luck. Speaking as someone who actually does them, it won't happen. There are all sorts of reasons why trials are difficult to compare. Different centres, different technology, different standards of care. Ethics committees in different places demand different things. Not to mention you rarely have a situation where many trials are testing exactly the same thing. Most meta-analyses look at trials that are designed to look at slightly different things and then try to compensate for the differences in study design.