JMBeaushrimp said:
You just said, "it doesn't", and in your next post you say you can't see how it could using a metaphor about some guy and the NHS.
So, metaphorically it "doesn't", or metaphorically "it could"?
I think Wiggo is trying to softly draw in the connections that Weisel et al had with pharma. Nothing wrong with that, and a good thing to look into...
My later post went into more detail as you saw. My point is that just because someone who works in the industry has been involved does not mean that the industry as a whole or generally is involved, as was implied by the post I replied to, or how I feel it could reasonably be read. I should point out I have a good knowledge or the industry at every level and the regulatory processes in the UK so do speak with at least a little authority on the subject. Rogue operators can be expected, mainly doctors and pharmacists, but realistically they are only peripherally related to the pharmaceutical industry, as strange as that might sound. The next part of this reply, in response to DW, might make that clearer.
The potential gain for the industry is minuscule compared to the potential risks from being caught. It's just not even likely that any company in "big pharma" even considers PED usage when developing products.
Dear Wiggo said:
In any discussion wrt this, I want to admit from the outset very little knowledge of the pharma industry per se, and stipulate a sincere intention to learn from people who know.
My first question is: how does off-label occur, without the express consent of a pharma company?
eg:
http://www.reuters.com/article/2012/12/19/us-amgen-plea-marketing-idUSBRE8BI1BT20121219
I don't recall now, but I read another report of an even larger pharma company being fined for a similar thing.
There was a report but no idea where it is that outlined the off-label vs prescribed intended use for EPO, I think. Interesting reading.
This is an interesting google search: "off-label court ruling"
Advertising off-label is something different to prescribing off-label.
A doctor can prescribe any licensed pharmaceutical for treatment of any disease. They would of course have to justify it if ever questioned but this is off-label prescribing and is how cyclists
may get hold of their PEDs. For example, no chemotherapy drug is licensed for use in children that I'm aware of (if there are any it will be few) because testing chemotherapy drugs on children is borderline unethical due to problems with consent and requirements of the testing regimes. However, many chemotherapy drugs will be prescribed for children, and work very well, by a doctor who looks at the evidence in adults and makes a decision. This is off-label prescribing at it's most obvious. It does not require permission from the pharmaceutical company, although they may be involved in discussions at some level depending on the product.
Off-label advertising is when a pharmaceutical company advertises a product for treatment of something it is not licensed for. This is illegal but does not put PEDs in the hands of athletes. That has to happen through the prescriber (Doctor or possibly pharmacist depending on the product and the regulatory laws in the country it is being prescribed). Off-label advertising carries large fines and penalties and the tiny benefits likely from off-label PED-usage advertising would be massively outweighed by the potential ramifications. The article you linked to shows Amgen advertising their product at a different dose than it was licensed for, all drugs have specific licenses that must be adhered to in the companies advertising. This is also off-label advertising but not quite as obvious, it is the most likely form of it though.
Now, it is perfectly possible someone like Weisel has access to data showing product A will give a marked increase in a particular type of athletes performance, and he could pass this information on to the athlete or his doctors, but that can't be viewed as big pharma being complicit in the same way that Harold Shipman killing people can't be viewed as the NHS being complicit.
For information, the pharmacists, at least in the UK, is always liable for what they prescribe. It is up to them to check any prescription for dose, interactions, complications etc. and contact the doctor if they see problems. This is why the pharmacist who issued Shipmans prescriptions was brought up on charges (but ultimately cleared I think).