The comments on a recent post raised the question of how much we can trust drug studies sponsored by the very companies that manufacture the drugs in question. On that point, a recent New York Times article
It's absolutely appropriate to be astonished, not to mention outraged at this physician. I manage industry-sponsored drug studies for a living. I create value for biotech companies by providing clear data on the drug. If it doesn't work or it hurts people, we want to know that NOW, not years from now, which would be not only unethical but in purely pragmatic terms very financially painful. The perception that we pay people to say yes makes no sense, because without real data, you don't know if your product works, and you'll be throwing literally hundreds of millions of good dollars after bad.
Furthermore, when you do drug studies, you have people whose dedicated job it is to go out to the hospitals where the research is being done, and check in the doctors' records that every last i is dotted and t is crossed. One of the things they're trained to explicitly look for is fraud. Had I worked with this guy as an investigator, we would've found him out, period. I hope that it was someone from an industry sponsor directly monitoring his work who forced him out in the open by confronting him with whistle-blow-worthy evidence. It's entirely within the law to be sent to jail for these kinds of offenses.
Peer review relies on trusting the underlying data. People have obviously faked basic science experiments that get published in Science. It's hard to know they are faking until failure to replicate occurs. A more notorious example that comes to mind is for bone marrow transplant for breast cancer. A lot of phase II data (observational) supported the idea, and a south african randomized trial suggested it worked as well. It wasn't until 4 years later, when several american trials failed to show benefit, that the South African trial was audited, and found to be fraudulent.
Bone Marrow Transplant (BMT) is a very toxic treatment. Weak ineffective pain meds aren't going to kill anyone.
Anyway, I think what the BMT story indicates, which is probably also the case here, is that it was the investigator's status whoring that caused them to fake the data more so than financial ties. I don't recall any significant financial ties for the South African investigator.
Generally, when pharm companies fudge data -- its that they don't publish everything -- two recent examples that come to mind on this are size of anti-depressant effects (if you look at FDA data vs. published data, you get a much smaller effect size) and Rosiglitzone and cardiovascular mortality (again FDA data, shows a somewhat worrying picture, vs. published data).
"rivalling drug companies should have an incentive"
Nah, because as a rival I benefit more overall from this corruption than I would from any one particular drug. So the entire industry has incentive to collude in the corruption, even if it disadvantages me in one individual competition. And it also of course helps the media via ad dollars, and doctors via perks and kickbacks. The system truly is stacked against society.
I would think the people with the power & need to clean this up would be insurance companies, who have to pay out against high-cost drug claims. But they don't say much either - I suppose their pharmacy divisions are involved somehow with sweetheart contracts due to volume purchasing? I don't know.
What about competitors? Regardless of the peer review system, rivalling drug companies should have an incentive to find out any flaws in studies like this.
Were any of Dr. Reuben's ficticious studies published in NEJM under Dr. Kassirer's watch? It seems a bit rich for him to complain about industry's influence in this particular case.
Setting aside the influence of industry on study results, when studies which never happened are published the failure is on the medical journal industry & the peer-review system. Throwing out the influence of industry here seems like a red herring.
It shouldn't matter whether the research is sponsored or not, as long as there is proper peer review and verification. As you say, the astonishing thing is how long it took someone to notice.
It's absolutely appropriate to be astonished, not to mention outraged at this physician. I manage industry-sponsored drug studies for a living. I create value for biotech companies by providing clear data on the drug. If it doesn't work or it hurts people, we want to know that NOW, not years from now, which would be not only unethical but in purely pragmatic terms very financially painful. The perception that we pay people to say yes makes no sense, because without real data, you don't know if your product works, and you'll be throwing literally hundreds of millions of good dollars after bad.
Furthermore, when you do drug studies, you have people whose dedicated job it is to go out to the hospitals where the research is being done, and check in the doctors' records that every last i is dotted and t is crossed. One of the things they're trained to explicitly look for is fraud. Had I worked with this guy as an investigator, we would've found him out, period. I hope that it was someone from an industry sponsor directly monitoring his work who forced him out in the open by confronting him with whistle-blow-worthy evidence. It's entirely within the law to be sent to jail for these kinds of offenses.
Peer review relies on trusting the underlying data. People have obviously faked basic science experiments that get published in Science. It's hard to know they are faking until failure to replicate occurs. A more notorious example that comes to mind is for bone marrow transplant for breast cancer. A lot of phase II data (observational) supported the idea, and a south african randomized trial suggested it worked as well. It wasn't until 4 years later, when several american trials failed to show benefit, that the South African trial was audited, and found to be fraudulent.
Bone Marrow Transplant (BMT) is a very toxic treatment. Weak ineffective pain meds aren't going to kill anyone.
Anyway, I think what the BMT story indicates, which is probably also the case here, is that it was the investigator's status whoring that caused them to fake the data more so than financial ties. I don't recall any significant financial ties for the South African investigator.
Generally, when pharm companies fudge data -- its that they don't publish everything -- two recent examples that come to mind on this are size of anti-depressant effects (if you look at FDA data vs. published data, you get a much smaller effect size) and Rosiglitzone and cardiovascular mortality (again FDA data, shows a somewhat worrying picture, vs. published data).
@TBA
"rivalling drug companies should have an incentive"
Nah, because as a rival I benefit more overall from this corruption than I would from any one particular drug. So the entire industry has incentive to collude in the corruption, even if it disadvantages me in one individual competition. And it also of course helps the media via ad dollars, and doctors via perks and kickbacks. The system truly is stacked against society.
I would think the people with the power & need to clean this up would be insurance companies, who have to pay out against high-cost drug claims. But they don't say much either - I suppose their pharmacy divisions are involved somehow with sweetheart contracts due to volume purchasing? I don't know.
What about competitors? Regardless of the peer review system, rivalling drug companies should have an incentive to find out any flaws in studies like this.
Were any of Dr. Reuben's ficticious studies published in NEJM under Dr. Kassirer's watch? It seems a bit rich for him to complain about industry's influence in this particular case.
Setting aside the influence of industry on study results, when studies which never happened are published the failure is on the medical journal industry & the peer-review system. Throwing out the influence of industry here seems like a red herring.
I am astonished that you are astonished.
It shouldn't matter whether the research is sponsored or not, as long as there is proper peer review and verification. As you say, the astonishing thing is how long it took someone to notice.