Pharmaceutical companies are withholding the results of clinical studies that show that antidepressants are less effective than portrayed by the drug companies:
This is something I have long suspected, but when those conducting the clinical studies have a profit motive tied to the results, it is unlikely to publish information that is truthful or of any use to doctors or patients.
Drug companies have proven they cannot be trusted to conduct their own efficacy studies. This is why we need more government regulation of industry, not less. Anything less is putting the lives of patients at risk in order to maximize the profits to the stockholders.
How is this shit even legal? They’re fucking with the lives of millions of sick people. And who’s going to get punished for this? Nobody. Fucking business as usual.
I’m not sure how you could even make it illegal. You fund a study and don’t publish the results. I just can’t think what law would be broken.
I’m not sure how it is that other studies with negative results are published as if the results are positive. That might constitute fraud if numbers are actually cooked.
I think they could make some kind of law that would address this. I mean, you could “prove” anything with this method. Imagine I funded 100 studies setting out to prove that orange juice cured cancer. 99 of them failed as expected, but the last one, through some fluke, flaw in methodology, or just coincidence when a higher than normal number of patients went into remission, “proved” my point.
I could just suppress the 99 good studies, release the screwy one, and sell cancer-curing OJ. That’s kind of fucked up if you ask me.
The results of a study are not God’s Honest Truth. You can study the same drug multiple times and get multiple results. That’s why they do a bunch of them.
We’re talking about two different things here. Publishing versus FDA. Any clinical trial I run, the FDA is completely up my ass. They will see all the data, negative or positive. There is no way I could (or would) not show them negative.
You can’t just run clinical trials until you get one you want. The FDA will see all of them.
What’s the comparison between the current statistics of people taking antidepressants (and are we just talking SSRIs or others?) and the statistics of the original studies? IIRC, many studies have a very small pool of volunteers to take the drugs, and seemingly small differences can skew statistics. The larger the population, the more accurate your statistics. Currently, there are millions of people taking antidepressants, and if the numbers were showing up as poor as some of the original studies, I doubt the antidepressants would be prescribed so often.
Not my field, but if the FDA looked at the data and determined efficacy standards had been met, then it should have been approved based on the best data available. If there is fraud in the study, then I’m with you in nailing the company to the wall. If not, the body is a complicated place and we do the best we can. If anything I think the FDA is harming patients by being way too conservative with their approvals (no, I don’t work for them!).
This ain’t mouse research. Data is often very difficult to interpret. Unlike mice, people have different genetic makeups, past treatment histories, and lifestyles that make treatment much more complicated and difficult to control.
I work toward getting stuff approved for patients. Everyone I work around works for the same goal. I know people at many companies doing similar research. I don’t know a single person who would let a patient have a therapy that they didn’t think worked based on the data.
Right, and they should publish the results of all the studies so that doctors and consumers can make informed choices about them. When almost 50% of the studies give results that are inimical to the drug companies’ financial interests, and when it is almost exclusively those studies that are withheld from the public eye, it’s not unreasonable to ask whether there’s something nefarious going on.
It would be fraud regardless of falsifying the studies—to take someone’s money for a product the company knows does not serve it’s purpose, to take advantage of people’s trust in a way that puts them in possible mortal peril, is blatant fraud.
So, am i supposed to be mollified by the fact that the medical journals might actually be in on the cover-up, and that the drug companies post their results on websites that no-one ever sees while continuing to advertise their products as if there was no doubt as to their efficacy?
Again, we’re talking about two different things. Publishing a paper in a journal and sending the data to the FDA.
If I run a clinical trial, it goes to the FDA. Period. They see the data. There is no such thing as a secret clinical trial. If I submit a drug for approval, and have done the study 100 times (which would be prohibitively expensive, obviously. Most companies have to partner up to do them once.), I can’t submit the one time it worked and ignore the others. They’ll see them all.
If I publish a paper in a journal, the bar is lower. Most clinical trial papers I read show the actual data that the FDA ruled on (or will rule on, as they’re usually published in advance of the FDA). There is a tendency in publishing papers to only publish positive data. It’s not just a tendency, because few journals publish negative data; try to find a journal article in a reputable journal that is entitled “X does not affect Y”, and you’ll see that there aren’t really any.
So, I’m a little unclear on what the OP’s linked authors are saying. I think what they are saying is that the articles in journals are showing the one best clinical trial, which would be an acceptable thing in science. If I run a mouse study three times, it is common practice to show the best one, provided that it worked every time. What would be unacceptable would be to publish the one of 100 that it worked (“worked” meaning statistically significant results). Such data would probably be publishable, but would never get past the FDA.
I think the authors are arguing that companies are showing their absolute best data to the public, and setting up unrealistic expectations. Maybe there’s some truth to that. But I find it unlikely that an FDA approved drug has no efficacy and that is being swept under the rug of unpublishable papers.
On too late edit: maybe my opinion is skewed from the author’s, being that he seems to be a psychiatrist. I’m sure clinical trial outcomes for psychiatric drugs are even muddier to interpret than say tumor data. If a tumor grows slower or the patient survives longer, these are tangible benefits of a drug and would have to be replicable. I’m wondering if psychiatric outcomes might be more difficult to interpret, leading to studies that seem to not work in otherwise FDA approved drugs.
Funny, but I’m told it’s illegal to choose to not disclose that my house once had termites. As a matter of fact, I can supposedly get in Big Trouble if I forget to put that on the disclosure when I’m selling the place.
It’s nothing new for scientific journals to mostly accept papers that show a positive finding, whether for drug effects or some other scientific parameter, and to turn down papers that have negative findings. It’s not universal by any means (I can think of one recent study that tested a common prescription antidepressant against St. John’s wort, and found that neither of them had statistically significant effects against depression), but it’s a problem, and one that’s not unique to scientific publications.
I think of it as the No Parrots Died effect (with apologies to Monty Python). Stuff that didn’t work is boring, stuff that did work promotes increased readership. If you’re of a certain mindset you’ll be sure it’s all a Big Pharma conspiracy, but it’s not that simple.
It would have been helpful if the study linked in the OP had determined whether journals refused the papers with negative results or if they were never submitted in the first place. I suspect the former in most cases.
Revelations like this one (which appeared in a scientific journal by the way - how did Big Pharma miss out on suppressing it?) hopefully will embarass publications into accepting more articles unfavorable to drugs, as this sort of information does influence prescribing habits and patient demand.
