Why are you consuming research at all? If you are a researcher considering building on someone else’s research, then you probably shouldn’t trust them and should replicate everything you really need. But you are also privy to a lot of gossip not on LW and so have a good grasp on base rates. If you are considering using a drug, then it has been approved by the FDA, which performs a very thorough check on the drug company. The FDA has access to all the raw data and performs all the analysis from scratch. The FDA has a lot of problems, but letting studies of new drugs get away with fraud is not one of them. But if you want to take a drug off-label, then you are stuck with research.
You say that you don’t trust the intentions of a multi-billion dollar corporations. Have you thought about what those intentions are? They don’t care about papers. Their main goal is to get the drug approved by the FDA. Their goal is for their early papers to be replicated by big, high quality, highly monitored studies. Whereas, the goal of multi-billion dollar universities is mainly to produce papers with too much focus on quantity and too little on replication.
I’m no researcher, and you’re right, if I did want to improve upon my study, I would, given the materials. However, I am not that affluent, I do not have such opportunities unless the research was based on coatings and adhesives (these materials I do have access to). The retraction I linked was merely presented on retraction watch as an example. An example for what? Let’s continue to...
Have you thought about what those intentions are?
My understanding is that as a public company your primary concern is bringing in enough value to the company to appease investors. A subset of that goal would be to get FDA approved.
I don’t trust the company because of the incentive system, and that is my gut reaction that stems from companies getting away with unscrupulous business practices in the past. Though now that I think about it, however, Pfizer would have nothing to gain from retracting papers they knew they couldn’t back up if someone asked them to. My guess is that either:
a) Min-Jean’s managers were planning on gambling with her research only to find out their moles in the FDA wouldn’t cooperate or,
b) there was no conspiracy, and Min-Jean was incentivized to fabricate her work on her own volition.
I do see your point, since a) is a more complicated theory in this case. But I distrust the situation. I smell a power play, at worst. But I can’t support that, unfortunately, from the articles alone. I can support power plays happening in big companies, but I can’t show those situations are related here. Not yet, anyway…
EDIT: With all that said, you seem to err on the side of trusting the FDA to do their job and trusting Pfizer to comply. Would you be able to back up that trust in this case alone?
I think waveman made my point clearer in that I don’t like the fact that I don’t know the details of the investigation. Down to the painfully detailed process of verifying image duplication. I’m not so sure a quick phone call to Pfizer or Min-Jean would help me either...
the FDA, which performs a very thorough check on the drug company
I think you have an overly sunny view of how effective the FDA is. (leaving aside the question of cost effectiveness and the opportunity cost of the delays and even outright prevention of useful drugs getting to market and their effect on the cost of drugs)
There are plenty of cases of the FDA being hoodwinked by drug companies. Regulatory capture is always a concern.
Statistical incompetence is very common. I still cannot believe that they let Vioxx on the market when the fourfold increase in heart attacks had a P value of about 10-11%. . This is the sort of stupidity that would (or should) get you as F in Statistics 101.
My experience over many decades is that over time the benefits of drugs often turn out to be way overstated and the dangers greatly underestimated.
Why are you consuming research at all? If you are a researcher considering building on someone else’s research, then you probably shouldn’t trust them and should replicate everything you really need. But you are also privy to a lot of gossip not on LW and so have a good grasp on base rates. If you are considering using a drug, then it has been approved by the FDA, which performs a very thorough check on the drug company. The FDA has access to all the raw data and performs all the analysis from scratch. The FDA has a lot of problems, but letting studies of new drugs get away with fraud is not one of them. But if you want to take a drug off-label, then you are stuck with research.
You say that you don’t trust the intentions of a multi-billion dollar corporations. Have you thought about what those intentions are? They don’t care about papers. Their main goal is to get the drug approved by the FDA. Their goal is for their early papers to be replicated by big, high quality, highly monitored studies. Whereas, the goal of multi-billion dollar universities is mainly to produce papers with too much focus on quantity and too little on replication.
I’m no researcher, and you’re right, if I did want to improve upon my study, I would, given the materials. However, I am not that affluent, I do not have such opportunities unless the research was based on coatings and adhesives (these materials I do have access to). The retraction I linked was merely presented on retraction watch as an example. An example for what? Let’s continue to...
My understanding is that as a public company your primary concern is bringing in enough value to the company to appease investors. A subset of that goal would be to get FDA approved.
I don’t trust the company because of the incentive system, and that is my gut reaction that stems from companies getting away with unscrupulous business practices in the past. Though now that I think about it, however, Pfizer would have nothing to gain from retracting papers they knew they couldn’t back up if someone asked them to. My guess is that either:
a) Min-Jean’s managers were planning on gambling with her research only to find out their moles in the FDA wouldn’t cooperate or,
b) there was no conspiracy, and Min-Jean was incentivized to fabricate her work on her own volition.
I do see your point, since a) is a more complicated theory in this case. But I distrust the situation. I smell a power play, at worst. But I can’t support that, unfortunately, from the articles alone. I can support power plays happening in big companies, but I can’t show those situations are related here. Not yet, anyway…
EDIT: With all that said, you seem to err on the side of trusting the FDA to do their job and trusting Pfizer to comply. Would you be able to back up that trust in this case alone?
I think waveman made my point clearer in that I don’t like the fact that I don’t know the details of the investigation. Down to the painfully detailed process of verifying image duplication. I’m not so sure a quick phone call to Pfizer or Min-Jean would help me either...
I think you have an overly sunny view of how effective the FDA is. (leaving aside the question of cost effectiveness and the opportunity cost of the delays and even outright prevention of useful drugs getting to market and their effect on the cost of drugs)
There are plenty of cases of the FDA being hoodwinked by drug companies. Regulatory capture is always a concern.
Statistical incompetence is very common. I still cannot believe that they let Vioxx on the market when the fourfold increase in heart attacks had a P value of about 10-11%. . This is the sort of stupidity that would (or should) get you as F in Statistics 101.
My experience over many decades is that over time the benefits of drugs often turn out to be way overstated and the dangers greatly underestimated.
I stand by my narrow claims. Here is another narrow claim: you are wrong about what happened with Vioxx.
People can read about it for themselves.
https://en.wikipedia.org/wiki/Rofecoxib