The Glade 4.0

All 400 test subjects in the first phase human trials of the generic Epogen equivalent died as a result of the variant protein substrate used to get around Amgen's patent.

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Jesus! I thought you meant the FDA killed the funding, not the subjects!

Yeah, it's one of those things we really don't hear about ...

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I'm not following your cause and effect here. First, how does the "fact" (I can find no info on this supposed mass killing whatsoever) that an FDA clinical trial failed to produce a viable drug treatment somehow make the government responsible for the situation where one must fork out six figures for a drug in order to continue living?

Second, Epogen is not what I'm talking about. The cancer "wonder drug" I'm referring to is Gleevec/Imatinib, which costs over ten times as much as Epogen does at $92,000/year. For a while it was the only effective treatment for CML, today there are several other drugs but all of them are also under patent and all are even more expensive.

Third, it's interesting you bring up Epogen, as it's a pretty fine example of what's so wrong with capitalist health care. By stringing out their patent registrations, Amgen has managed to give themselves a >30 year monopoly on the sale of any and all human erythropoietin. This is an especially egregious case, they've managed to secure a monopoly on an amino acid sequence, making billions by price gouging dying patients that are not legally allowed to receive treatment from anyone else. At least Gleevec has actual competition, Amgen gets to decide by itself who lives and who dies.

Fourth, the "median age" is totally irrelevant, you said it was impossible for someone to bankrupt themselves, and that includes everyone on the tail end of the bell curve.

What the hell does the cost of a cancer drug have to do with anything?

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“The duty of a patriot is to protect his country from its government.” - Thomas Paine

Living has always been a death sentence, last time I checked.

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I prefer to think of them as "Fighting evil in another dimension"

Actually, the Epogen situation explains why there aren't generic biologics. You don't seem to get that.It doesn't cost $92,000 a year. You don't have time to take 46000 pills in 365 days.The FDA Contributed funding to a German company attempting to develop a generic equivalent to Epogen. The 400 trial subjects died. You don't understand enough about medications and biologic medications to understand why those patents are being protecting. Their production and development is not just basic chemistry. More to the point, it's all human safe lab produced erythropoietin. The monopoly here exists solely because no one can produce a function generic.It was. The healthcare plan your defending changed that. But, you know, keep trying to us we're wrong and don't know how things work. It's 2013. The ACA was signed into law in 2010. You now have 3 years of propaganda created by immediate implementation components convincing you to support the bill. The ACA changed the ability-to-pay calculations and standards. The ACA changed Medicare Part D and Medicaid subscription subsidies. The ACA allowed providers to demand payment based on new ability-to-pay calculations and has lead to a situation wherein people are NOW going bankrupt. These were ALL intentional parts of the bill and parts of first-wave implementation.

Incidentally, I also mention Epogen because it's no long covered by Medicaid/Medicare. Amgen, in fact, is likely to go out of business because of that (which doesn't really bother me, except they're in the business of developing curative biologics and keep getting cockblocked by Sibelius). Competition doesn't work for biologics. Epogen is manufactured using a specific porcine fetal protein substrate. The only part of the process you can alter, because you're manufacturing a biologic, is the starting protein medium. Gleevec, on the other hand, is a chemical medicine and doesn't cost 92,000 a year except using projected calculations based on paying maximum MSRP per dose.

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I'm just trying to figure out how a drug with an FDA approved generic available at $2.00 per 100 mg pill costs people 92,000 a year. If I have to take 46000 of anything, including Skittles, I'm probably saying **** that ...

Even at the high end of $30.00 per pill, you'd still need 10 a day to get to $92,000.

Like most liberals, Xequecal apparently can't do basic math.

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As I've alluded to before, I know a guy in leukemia research. He's not with big pharma, and I have a lot of respect for him. He's labored over his work for over a decade, dealing with the FDA and the like, trying to get this drug to market. He's a smart guy, he could probably make a lot more money writing and/or teaching. However this quest is his life. Someday if the government lets him, I really do believe he's going to save lives.

However he doesn't "owe" anyone anything. No one has a right to the fruit of his labor just because it saves lives.

He's put in a lot of hours, with a lot of money from his backers. His backers want to (and rightly so) see a return on their investments as well.

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I prefer to think of them as "Fighting evil in another dimension"

where are you getting those numbers Khross?
I make no claims about the accuracy of this site, but:
http://healthwatched.org/2012/05/09/us- ... vec-price/
seems to indicate costs more in line with what Xequecal is citing.

edit: Ok, the generic version can run as low as $2.50 a pill (found here http://www.pharmacychecker.com/compare- ... 36/107827/ ) however the price for Gleevec is indeed in line with the originally quoted price

Again, what does the "price" of one particular treatment/drug have to do with anything?

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“The duty of a patriot is to protect his country from its government.” - Thomas Paine

http://en.wikipedia.org/wiki/Imatinib


Please, stop trying to tell me this stuff costs $92,000 a year.

Your anonymous blog vs. a double cited Wikipedia statement.

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I'm not trying to make a point. I don't really have a dog in this fight. I'm just interested in accuracy.

Fair enough.


In which case, it should be noted that while people (based on your citation) want to rage at Pharma for the cost of the drug and advocate the FDA enact a price control, it is that very FDA that prevents importation of the low-cost generic to the US.

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“The duty of a patriot is to protect his country from its government.” - Thomas Paine

By posting an obviously biased, anonymous blog page and not retracting your post when demonstrated to be wrong?

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you mean the part where I
A) acknowledged in the original post I couldn't vouch for the site
B) Kept reading after and actually went back to the original data (not just the Wikipedia article) continuing my own reading on the subject, and then editing my own post while you were busy trying to pounce on it

Yup. not interested in accuracy here. Why would I need to retract my post? I was busy editing it in the 4 minutes between when I posted and when you did.

Let me see if I have this right. Your position is essentially: "Noone else on the planet but Amgen has the capability to produce human EPO?" Just because the FDA screwed it up in one clinical trial does not mean it is impossible for anyone else to do it. I can find no info on this clinical trial where 400 people died, either.



There is no generic version of Gleevec approved for sale in the US. Gleevec is under patent protection until 2019. A generic exists, but it's sold in Europe mostly. You can't sell it here, and importing it is also illegal.



If you don't have private insurance that covers it, the only way for you to get such an expensive drug is to go on Medicaid, which means stop working. This was also true 5 years ago. Are you saying that indigent individuals got this drug for free before Obamacare, and now cannot?

And who is at fault for that. Pharma or the government?




And, again, what does the cost of one treatment/drug have to do with anything?

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“The duty of a patriot is to protect his country from its government.” - Thomas Paine

This is actually an interesting point. If political corruption results in bad laws, whose fault are they? The government officials that enacted them or the private entities that bought them?

Regardless, we need to find a happy medium between here where drug companies can demand your entire estate in exchange for life saving medicine and Europe where they just ignore patents they don't like and won't pay enough to even cover R&D costs.

Khross said that before Obamacare, it was impossible to be bankrupted by unexpected medical expenses. The existence of a $92,000/year drug (which existed before Obamacare) invalidates this point. If you can't afford it yourself and your insurance doesn't cover it, the only way to get it is to stop working and go on Medicaid.

I see, so your specific argument is that for uninsured, employed, non-Medicare cancer victims (of the specific cancer that this treats) may not qualify for financial assistance and therefore would have debts onerous enough to risk bankruptcy?

That's probably a valid, if severely limited, point.




Um, it's not "political corruption." It's "FDA safeguards." All drugs available for import must have undergone rigorous human testing of a type and duration acceptable to the FDA. This isn't just for this drug, or any other drug, and is why pharmaceutical in other countries are so much cheaper. If you develop a drug in Switzerland, for example, you have to essentially repeat testing in the United States to meet FDA requirements.

The pharma companies have literally nothing to do with it, and many of them actually want these rules to go away.

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“The duty of a patriot is to protect his country from its government.” - Thomas Paine

That's been the point for years now. "Our healthcare system is broken because in the right combination of circumstances, a person with exactly the right disease can only obtain medicine by going on medicaid".

It also raises the question of how many people needing a drug that costs $92,000 a year can really continue to work anyhow.

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"Hysterical children shrieking about right-wing anything need to go sit in the corner and be quiet while the adults are talking."

I wouldn't limit it to only uninsured and underinsured people, before Obamacare lifetime payout caps were pretty ubiquitous and when you have cancer and end up on that kind of medication, you're probably going to hit it. But I am aware that it's not a large number of people, and wasn't expecting that first post to become a huge argument, he just said it was impossible which is clearly incorrect so I decided to address that.



I find this pretty surprising. Why would a pharmaceutical company want to undermine their own patent monopoly by allowing cheap generics to be imported?

It's not just that, either. Everyone assumes I support Obamacare completely. While I agree with the idea of a mandate that requires people to purchase health care, Obamacare has way too many provisions that I can come up with no explanation for why they exist other than that the legislators got bought. The 80/20 rule is basically United Healthcare getting Congress to legislate all their competition out of existence, for example.

Because at $30 per 100mg dose (current US pricing), you need 3066 doses in a calendar year to reach $92,000. Do you have any idea how unreasonable that dosing calculation is, TheRiov?

Xequecal:

You likely won't come across information on those clinical trials unless you have access to FDA and international drug control publications. We don't make public knowledge the vast majority of clinical trials in the United States, either. And the FDA just contributed the majority of funding to the generic's development, and they did it in a non-US test market for a wide variety of reasons, namely better trial privacy protections in Germany and other places. That said, you don't seem to understand the difference between biologic and chemical medications. Biologics, like Embrel and Epogen, do not work in the same manner as acetaminophen or even Gleevec. It's not a chemical medication. Epogen is a laboratory replicated human protein: it behaves in your body primarily as if your body had produced the EPO itself. Changing the manufacturing process changes how it works. Changing the base protein medium from a porcine fetal protein medium to any other protein medium has had disastrous effects, even when the resultant EPO appeared identical, because Epogen, like most biologics, affects RNA and mitochondrial DNA behaviors. These drugs are not things with side effects and toxicity levels and a standard list of controlled substance considerations; these drugs are synthesized agents present in our bodies naturally that are used to jump start normal processes in our bodies that would otherwise be untriggerable. Epogen forces your body to create new, healthy red blood cells.

Secondly, you can't get generic Gleevec in the United States because of the FDA. In fact, you would have been able to buy generic Gleevec a week from yesterday, the original patent expires 28 May 2013; except, it was awarded a patent extension in 2006.

Thirdly, I'm not sure you understand how private medication insurance works, nor am I convinced you really understand how payment works in this country. There are all sorts of ways to get access to medication in the advent you can't pay, especially mission critical medications like Epogen. So, like I said, total ignorance of indigent care relief. I'm sorry you think EMTALA is the only option people had; I'm also sorry you're a Democrat, because that means you hate the largest charity healthcare provider in the US.

And, no, Gleevec doesn't invalidate my point that it was impossible to go bankrupt for medical reasons unless you were just grossly ignorant. It seems to me, Xequecal, all you're proving in this thread is ...

"We have to pass laws because uninformed people make uninformed decisions." Well, I'm sorry, but ignorance isn't an excuse. Hire a better lawyer; get better medical care providers. As DFK has mentioned, one of the good things about the ACA is requiring providers to explain charity and alternative funding measures to patients. Whether they are complying or not, is another matter.

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Actually, that's not true. This drug and its successors were called wonder drugs/miracle drugs for a reason. This cancer used to be highly debilitating and killed you in months, on these drugs you can live almost a normal lifespan and remain relatively healthy.