Amgen's unethical practices

[TheGame]

Amgen and a principle investor, Weisel, identified competitive sport as a potentially huge avenue for profit, especially once they had taken a most unlikely canditate for sporting success - former cancer patient Armstrong - and used their drug to transform him into sporting superman. How far would they go to make this happen and maintain it? For the answers, you'll have to ask them. Or maybe we can just wait and let the investigators ask . . . .

Far more complicated than that. Armstrong was identified early on as the candidate, but his brashness and arrogant attitude led him to be shipped out to France. It was the cancer that made him marketable. Weisel invested in far more than just Amgen, he also invested in companies linked to Nicomed Saluzar (Actovigen), as well as creating the US Cycling Foundation, investing heavily in US Cycling, putting members of his companies on the board. At one point most of the board of USC was made up of either sponsors of US Postal, Employees of Lances various companies, or board members on Wiesels companies.

 

[D-Queued]

Conspiracy theories are plausible if you don't have any facts. Amgen's agreement with J&J gave Amgen exclusive rights to sell the drug for renal anemia. This is a $3 Billion market in the US alone. They were willing to give J&J all other uses because capturing renal anemia market share would be a home run for the startup. The notion that the company pinned their ROI hopes on an emerging black market among professional athletes doesn't make sense. What size - at best - is that market? Why would Amgen not care about EVERY OTHER legitimate medical market re the J&J deal? The answer is simple: because renal anemia was a big enough market.

Amgen entered the ToC sponsorship deal once it realized it had misses an enormous market: anemia in chemotherapy patients. They did it to promote their 'breakaway from cancer' campaign to compete against J&J and increase sales of Aranesp. 75% of cancer patients experience anemia - consider the size of that market compared to at most a few hundred or thousand athletes. Suggesting they did this to market the drug to athletes as a PED is ridiculous given the potential markets of these alternatives.

Sorry, while I anticipate that you are intelligent, this is stupid. Perhaps you don't work for a for profit enterprise or a publicly traded company.

There is unavoidable pressure to increase profits at higher returns than the S&P. There is even higher pressure on any tech darling, including a biotech.

How fast does the Renal Anemia market in the US grow? US Population has grown faster than other western countries over the last decade, but is still shy of 10%.

Amgen's current sales are $4.3 billion per quarter, and Epogen itself is at $2b/annually. If they were restricted to a share of a $3 billion market, they would have plateaued years ago.

Is Amgen publicly traded?

Tick.

"EPOGEN® (epoetin alfa) sales increased 3 percent driven by reductions in customer discounts and a favorable change in accounting estimates, offset largely by a reduction in dose utilization."

Ok, so they fiddled with their accounting estimates. Otherwise, we are looking at a reduction in dose utilization. Dose utilization is a revenue problem. How do you increase dose utilization?

Dave.

 

[mastersracer]

Sorry, while I anticipate that you are intelligent, this is stupid. Perhaps you don't work for a for profit enterprise or a publicly traded company.

There is unavoidable pressure to increase profits at higher returns than the S&P. There is even higher pressure on any tech darling, including a biotech.

How fast does the Renal Anemia market in the US grow? US Population has grown faster than other western countries over the last decade, but is still shy of 10%.

Amgen's current sales are $4.3 billion per quarter, and Epogen itself is at $2b/annually. If they were restricted to a share of a $3 billion market, they would have plateaued years ago.

Is Amgen publicly traded?

Tick.

"EPOGEN® (epoetin alfa) sales increased 3 percent driven by reductions in customer discounts and a favorable change in accounting estimates, offset largely by a reduction in dose utilization."

Ok, so they fiddled with their accounting estimates. Otherwise, we are looking at a reduction in dose utilization. Dose utilization is a revenue problem. How do you increase dose utilization?

Dave.

first of all, profitability depend on market share, and not simply market growth. Even given fixed demand, increases in market share can drive profitability for decades. Second, profitability depends on entering new markets, which is why Amgen created Aranesp. The entire problem with the conspiracy theory that Amgen intentionally marketed their products as PEDs is that the market is simply too small. Besides, it is not worth the risk/reward tradeoff considering that even the possibility of a product being a PED is sufficient to drive that usage. Just look at AICAR, which was found among the BMC PEDs. Even without a single human study demonstrating any efficacy, it has been adopted as a PED despite not even being more than a research drug without regulatory approval. Same for TB-500. A company would not need to market such a drug as a PED, the market is too small to care about, and the risk of doing so would not justify a reckless move like that.

 

[thirteen]

excellent background article on it all: The Trifecta That Shaped U.S. Cycling in the Armstrong Era

and the link to Dim's incredible flowchart that really says it all!

 

[DirtyWorks]

Far more complicated than that. Armstrong was identified early on as the candidate, but his brashness and arrogant attitude led him to be shipped out to France. It was the cancer that made him marketable. Weisel invested in far more than just Amgen, he also invested in companies linked to Nicomed Saluzar (Actovigen), as well as creating the US Cycling Foundation, investing heavily in US Cycling, putting members of his companies on the board. At one point most of the board of USC was made up of either sponsors of US Postal, Employees of Lances various companies, or board members on Wiesels companies.

I'm just clarifying things a bit, not disagreeing.

Thom was in on Armstrong early. He was on Eddie B's Weisel-sponsored doping operation.

The USACDF is an incredible scam. They take most of the revenue USA Cycling generates including USOC's funding, then skim donations before they hit the USACDF as a commission for landing the donor and operate the entire thing exclusive of all the rules USA Cycling has to comply with as an USOC/IOC recognized federation. They aren't the only IOC sport doing this.

There are well meaning people further down USA Cycling. I'm sure of that. But, at the top, it's all Wiesel's friends and any sucker who gave some money to Thom to run his scam.

 

[fatandfast]

Sorry I should have been clearer.

Lance's cancer was diagnosed in 1996. It is likely that this developed as a result of the drug cocktails Eddy's program was experimenting with. Eddy got involved with Thomas Weisel around 1988. Eddy picked up Lance around 1990-1992 or so as part of the under 23 junior program.

So it's even more cynical. Once Lance overcame cancer and returned to cycling, he and Thom decided to leverage that into a great Cancer Jesus story. And Amgen also benefited from the cancer branding and exposure.

At the same time, around 1997, SCA were contracted to pay multiple millions for TdF wins, which just left UCI to take care of the "no positives" as proof of no doping as per SCA contract. And some well placed friendships and payments (read Hein) would take care of that.

And you say this because many other riders under Eddy's program also got testicular cancer? Or other forms of cancer outside the mathimatical norms for their group? Thom didn't ride his bike ever with any of the pro squads,so to or not to be the cancer Jesus was up to Armstrong. You have melded both Lance's as people often do.
The original Lance was a decently paid pro bike racer,young man,hardly educated. The returned from Cancer Lance was suddenly paid for breathing and as his fortunes grew the idea that he returned from cancer to race his bike because he had super limited options left and was replaced by the hero, super calculating mastermind of a foreseeable empire. I don't buy lots of this.
The ever growing list of average doped riders who went undetected and unpunished also says that Armstrong was not a doping guru.

All roads lead back to the UCI, then and now. Everybody from sponsors to other control groups,like USADA,WADA,IOC,ect are all echoing reality. that the UCI simply didn't do their job. THE only way this can get uglier is if Lemond era samples are evaluated under similar conditions. People vacating only the Armstrong results are myopic and political.

 

[D-Queued]

And you say this because many other riders under Eddy's program also got testicular cancer? Or other forms of cancer outside the mathimatical norms for their group? Thom didn't ride his bike ever with any of the pro squads,so to or not to be the cancer Jesus was up to Armstrong. You have melded both Lance's as people often do.
The original Lance was a decently paid pro bike racer,young man,hardly educated. The returned from Cancer Lance was suddenly paid for breathing and as his fortunes grew the idea that he returned from cancer to race his bike because he had super limited options left and was replaced by the hero, super calculating mastermind of a foreseeable empire. I don't buy lots of this.
The ever growing list of average doped riders who went undetected and unpunished also says that Armstrong was not a doping guru.

All roads lead back to the UCI, then and now. Everybody from sponsors to other control groups,like USADA,WADA,IOC,ect are all echoing reality. that the UCI simply didn't do their job. THE only way this can get uglier is if Lemond era samples are evaluated under similar conditions. People vacating only the Armstrong results are myopic and political.

Armstrong is alleged to have stated to multiple people, and this is cited in Hamilton's book, that HGH (and other drugs) contributed to his testicular cancer.

For the purposes of this forum and this dialog, we can consider this as fact.

Dave.

 

[mastersracer]

Armstrong is alleged to have stated to multiple people, and this is cited in Hamilton's book, that HGH (and other drugs) contributed to his testicular cancer.

For the purposes of this forum and this dialog, we can consider this as fact.

Dave.

how so? Because Armstrong somehow is an epidemiologist? Cancer causes are complex and probabilistic - he is in no position, nor is anyone, to state categorically what caused his cancer.

 

[D-Queued]

how so? Because Armstrong somehow is an epidemiologist? Cancer causes are complex and probabilistic - he is in no position, nor is anyone, to state categorically what caused his cancer.

If he believes it, that should be good enough for you.

Besides, I believe that I have posted links in the past linking higher incidence of testicular cancer to various PED cocktails favored by Lance.

Dave.

 

[Tinman]

And you say this because many other riders under Eddy's program also got testicular cancer? Or other forms of cancer outside the mathimatical norms for their group?

We'll never know what caused Lance's cancer. Or the testicular cancer of one of his Eddy B junior team mates. Or the autoimmune diseases of the others. Or the heart diseases and subsequent deaths of other junior team mates yet again. And the pool of riders was not that big. But all of these diseases are known to be caused by PEDs.

So leave it to you to decide what you want to think.

Here is the list of Weisel & Lance teams that Eddy was a part of:
1989 Montgomery/Avenir Pro Cycling Team
1990 Subaru Montgomery Pro cycling team
1994 Montgomery Bell Pro Team
1996 US Postal Services team
2004 Discovery Channel Pro Cycling Team.


I would go one further. I would hypothesize that much of the presumed increase in incidence of young mostly male sudden cardiac death, auto immune disease and "rare" cancers can (and will over time) be attributed to PED abuse. It's rampant with the young kids, check out any suburban gym, and look at the kids' sizes and the acne on their back. That's steroids. EPO in endurance sports in certain countries I am sure is going the same way.

 

[Tinman]

how so? Because Armstrong somehow is an epidemiologist? Cancer causes are complex and probabilistic - he is in no position, nor is anyone, to state categorically what caused his cancer.

Epidemiology is pretty basic actually. In it's basic form it's about disease incidence divided by a suitable denominator. And it's the denominator where most of the discussion takes place, ie the suitable control group.

The control group here is NOT the general population, as much as Lance and Livestrong would like to you to believe that. It's Eddy B's small junior team that were exposed to PEDs. Identify who were part of this, who were likely exposed, and apply your numerator. And Bingo you have your retrospective post hoc epidemiological study. And I can almost guarantee a first class journal will publish it, as there are not that many control groups like the Eddy B junior program.

 

[Dear Wiggo]

Epidemiology is pretty basic actually. In it's basic form it's about disease incidence divided by a suitable denominator. And it's the denominator where most of the discussion takes place, ie the suitable control group.

The control group here is NOT the general population, as much as Lance and Livestrong would like to you to believe that. It's Eddy B's small junior team that were exposed to PEDs. Identify who were part of this, who were likely exposed, and apply your numerator. And Bingo you have your retrospective post hoc epidemiological study. And I can almost guarantee a first class journal will publish it, as there are not that many control groups like the Eddy B junior program.

I think you spell that kinda post

B A Z I N G A.

Post of the week, Tinman.

 

[Oldman]

Epidemiology is pretty basic actually. In it's basic form it's about disease incidence divided by a suitable denominator. And it's the denominator where most of the discussion takes place, ie the suitable control group.

The control group here is NOT the general population, as much as Lance and Livestrong would like to you to believe that. It's Eddy B's small junior team that were exposed to PEDs. Identify who were part of this, who were likely exposed, and apply your numerator. And Bingo you have your retrospective post hoc epidemiological study. And I can almost guarantee a first class journal will publish it, as there are not that many control groups like the Eddy B junior program.

thank you for pointing out the obvious. Add the behavioral choices made by the subject, LA; and you see that the clinical options to avoid cancer were not pursued. Add a touch of Ferrari and the cocktail is not working in the favor of the vulnerable. That the same recovering subject willingly embraced the same training therapy shows his idea life quality.

 

[dsut4392]

Epidemiology is pretty basic actually. In it's basic form it's about disease incidence divided by a suitable denominator. And it's the denominator where most of the discussion takes place, ie the suitable control group.

The control group here is NOT the general population, as much as Lance and Livestrong would like to you to believe that. It's Eddy B's small junior team that were exposed to PEDs. Identify who were part of this, who were likely exposed, and apply your numerator. And Bingo you have your retrospective post hoc epidemiological study. And I can almost guarantee a first class journal will publish it, as there are not that many control groups like the Eddy B junior program.

Nice synopsis for Armchair Epidemiology 101, where do I give my credit card details to download the degree?

1. Incidence is by definition a rate, i.e. the division by a denominator has already happened to calculate incidence.
2. "Denominator" and "control group" are not the same thing at all
3. However 'basic' your form of epidemiology, you need to give at least give cursory thought to the effect of sample size when trying to determine differences in incidence between sample and population or control.
4. "Retrospective" and "post hoc" are the same thing
6. Retrospective studies based on samples with known selection bias, no formal standardised treatment protocol, no control group, no standardised follow up protocol, and two post-treatment decades of confounding variables aren't particularly sought after by "first class journals".
7. If your treatment effect is big enough you can get away without paying much attention to the above, but that's not "epidemiology" it's "shooting fish in a barrel".


Disclaimer: The order of participants in the above list was randomized according to the "whatever came into my head first" principle as explained to the author by a longstanding member of another forum (pers comm. Participant 5 was excluded being lost to follow up, or perhaps author bias, take your pick.

 

[mountainrman]

Epidemiology is pretty basic actually. In it's basic form it's about disease incidence divided by a suitable denominator. And it's the denominator where most of the discussion takes place, ie the suitable control group.

The control group here is NOT the general population, as much as Lance and Livestrong would like to you to believe that. It's Eddy B's small junior team that were exposed to PEDs. Identify who were part of this, who were likely exposed, and apply your numerator. And Bingo you have your retrospective post hoc epidemiological study. And I can almost guarantee a first class journal will publish it, as there are not that many control groups like the Eddy B junior program.

Despite a lot of capable people involved, these studies are largely inconclusive in this context.There has been a long debate (outside anything to do with cycling) about the role of HgH for example in cancer. The evidence is not a slamdunk either way. If statistical significance is the problem, then only larger populations can be the answer which is hard to do in the context of a few cycling teams and dopers so the reality is if the case is not proven already despite widespread abuse, and use of drugs in sport is falling we may never know, since the "significance" measurements become ever harder..

 

[Tinman]

Nice synopsis for Armchair Epidemiology 101, where do I give my credit card details to download the degree?

[/SIZE]

Yeah, thanks, I knew that was coming after I posted. It was a quickie mail. It's not relevant to the big picture here and I simply could not be bothered, trying to keep it brief. The big picture is that the incidence of morbidity/mortality in those exposed to PEDS (eg Eddy B's group) is much much MUCH higher than in a population based (control) group. And it's the population based approach that everyone generally focuses on in the popular media.

But thanks for contributing. If it helps other readers then great. And feel free to contribute your expertise before I do next time

 

[Tinman]

Despite a lot of capable people involved, these studies are largely inconclusive in this context.There has been a long debate (outside anything to do with cycling) about the role of HgH for example in cancer. The evidence is not a slamdunk either way. If statistical significance is the problem, then only larger populations can be the answer which is hard to do in the context of a few cycling teams and dopers so the reality is if the case is not proven already despite widespread abuse, and use of drugs in sport is falling we may never know, since the "significance" measurements become ever harder..

Not sure which studies you are talking about?

And not sure what point you are trying to make? That PED's are probably safe? Or that they may not be dangerous?

And not sure why focus on HgH, it's the least interesting (and hardest to get a clear read out on) of the steroid, EPO, HgH trio.

The methodology I think is now pretty straight forward (with more transparency on who was using what), we can discuss, but it's the funding which I suspect is holding back the work being done.

I suspect increasing statistical significance can be better achieved by more narrowly selecting study subjects vs controls, rather than increasing study size per se. So start with highly likely PED users, such as the Eddy B cohort. And compare to age/sex/sporting profile/etc matched controls in general non PED using population.

 

[mastersracer]

Epidemiology is pretty basic actually. In it's basic form it's about disease incidence divided by a suitable denominator. And it's the denominator where most of the discussion takes place, ie the suitable control group.

The control group here is NOT the general population, as much as Lance and Livestrong would like to you to believe that. It's Eddy B's small junior team that were exposed to PEDs. Identify who were part of this, who were likely exposed, and apply your numerator. And Bingo you have your retrospective post hoc epidemiological study. And I can almost guarantee a first class journal will publish it, as there are not that many control groups like the Eddy B junior program.

Epidemiology is anything but basic. It is certainly not the simple-minded frequentist inference of the sort you suggest. Not only does that ignore a century of developments in statistical inference (Bayes, etc), but statistical dependence is simply one epidemiologic criterion necessary to establish causality (Hill's, Susser's Criteria, etc.). Causal inference in epidemiology is notoriously tricky requiring the use of complex causal models (directed acyclic graphs, nonparametric structural equation models, etc.) and is particularly difficult in cancer studies given the complex, probabilistic causal factors involved. Just look at the notoriously difficult history of making causal inferences between smoking and cancer. In the case of PEDs and Armstrong, the associations are weak - in previous posts I have cited what I believe to be the single paper on this subject - the underlying mechanisms are poorly understood, there is no prior information on how to model interaction effects among the PEDs Armstrong took, etc. Besides, causal inference is typically made at a population level, and it is fallacious to infer causation at the individual level from that. A journal would flat out reject the proposed study you suggest for these reasons (and simply for lack of statistical power even if the other limitations were not present).

 

[zigmeister]

You guys are out in left field from the topic at hand, which is Amgen and EPO.

Hey, you can make these same arguments for any drug company and drugs they produce for the most part.

So to implicate them related to cycling and EPO usage is a stretch.

They are in business to sell drugs and recoup the hundreds of millions invested in research to make a profit for shareholders.

Basically, any health care company, hospital, doctor, and drug company is lumped into this in the US.

 

[blutto]

You guys are out in left field from the topic at hand, which is Amgen and EPO.

Hey, you can make these same arguments for any drug company and drugs they produce for the most part.

So to implicate them related to cycling and EPO usage is a stretch.

They are in business to sell drugs and recoup the hundreds of millions invested in research to make a profit for shareholders.

Basically, any health care company, hospital, doctor, and drug company is lumped into this in the US.

...yeah this is just another wonderful example of the magic of the market place moving humanity forward...and anyone who doesn't think so is just a pot smoking gay socialist foreigner of some sort....and is probably contravening The Blessed Second Amendment and so on and so forth..this is American damn it, where money talks, and bull$hit walks...

Cheers

blutto

 

[fatandfast]

You guys are out in left field from the topic at hand, which is Amgen and EPO.

Hey, you can make these same arguments for any drug company and drugs they produce for the most part.

So to implicate them related to cycling and EPO usage is a stretch.

They are in business to sell drugs and recoup the hundreds of millions invested in research to make a profit for shareholders.

Basically, any health care company, hospital, doctor, and drug company is lumped into this in the US.

ain't that the truth. Amgen spent millions getting drugs through trials and has looked for other uses for many of the substances they make. Many drug designers have been asked to include molecular flags for the exact purpose of a drugs misuse. Also the flag could help ID counterfeit products and the people buying,selling and using them. Amgen always resisted doing it.

Amgen has given lots to cycling directly and indirectly. Their money will be missed. The group of cycling fans that have somehow taken on that bike racing is some healthy outlet for anybody is dumb. Bike racing is very harmful,dangerous and super exciting both to participate in as well as watch. Going 50mph down a skinny road in a pair of glorified Spanx wearing a polystyrene swim floaty on your head is not healthy or safe.

Amgen could not be making any money marketing a drog like EPO (cera,micera,mycera) to pro bike racers the market even worldwide is tiny. THey can hardly be blamed for doping in bike racing anymore than kerosene distributors can be blamed for cocaine. Pro bike racing is an extreme example of an activity that is and has been an activity that billions of people have done throughout time.

The links to testicular cancer to bike riding, racing, EPO have not been studied extensively and certainly not proven. Lance's bad ball is a combination of lots of bad things,probably including luck.

as more and more sponsors,teams and races expire. Drugs are still part of the sport. The treatment and reaction to Armstrong have raised the stakes so that there use will be done even more carefully than before. Cycling better circle the wagons and come up with a plan because the plans formulated by outsiders will include the total ban on bike racing as we know it. No fans=no bike racing

 

[DirtyWorks]

Drugs are still part of the sport. The treatment and reaction to Armstrong have raised the stakes so that there use will be done even more carefully than before.

Imagine what would happen if 5 year-old samples were re-tested with today's procedures and WADA could open those cases without the UCI. From that point forward, only the very dumbest of athletes would bother doping.

As long as the UCI and IOC remain in complete control of doping control, doping will be rampant.

Bike racing happens without the UCI. No one needs them.

 

[manafana]

looking back at old samples has to be done, the fear of being caught down the line might stop some of those considering doping as they have been told they can get away with it.

 

[biokemguy]

You guys are out in left field from the topic at hand, which is Amgen and EPO.

Hey, you can make these same arguments for any drug company and drugs they produce for the most part.

So to implicate them related to cycling and EPO usage is a stretch.

They are in business to sell drugs and recoup the hundreds of millions invested in research to make a profit for shareholders.

Basically, any health care company, hospital, doctor, and drug company is lumped into this in the US.

Don't forget that they spend more money marketing drugs than on research.

 

[Maxiton]

You guys are out in left field from the topic at hand, which is Amgen and EPO.

Hey, you can make these same arguments for any drug company and drugs they produce for the most part.

So to implicate them related to cycling and EPO usage is a stretch.

They are in business to sell drugs and recoup the hundreds of millions invested in research to make a profit for shareholders.

Basically, any health care company, hospital, doctor, and drug company is lumped into this in the US.

I know of some guys around here who are in business to do the same thing, sell drugs and make a profit for their investors. (Not sure how much they put into R&D, but that's only because they aren't big enough yet.) When the police see these guys, they arrest them. Why? Because they break the law and endanger people's health. If your guys break the law (and endanger people's health), why should they be treated any differently? In fact, shouldn't they be punished to an even greater extent, because they are supposed to be responsible, and have been entrusted with our health? At least the guys over in Oakland don't pretend to be something they're not.