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03-09-2011, 03:28 PM   #1
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FDA Doing Something About Out Of Control Drug Pricing

By making it even more out of control!!!

QuoteQuote:
A drug for high-risk pregnant women has cost about $10 to $20 per injection. Next week, the price shoots up to $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000.

That's because the drug, a form of progesterone given as a weekly shot, has been made cheaply for years, mixed in special pharmacies that custom-compound treatments that are not federally approved.
[snip]
The FDA last month signed off and gave Makena orphan drug status. That designation ensures Ther-Rx will be the sole source of the drug for seven years.

The March of Dimes, which gets hundreds of thousands of dollars in funding from Ther-Rx, celebrated the approval in a press release, saying if all women eligible for the shots receive them, nearly 10,000 spontaneous premature births could be prevented each year.
Preemie birth preventive spikes from $10 to $1,500 - Yahoo! News

I guess Ther-Rx wasn't satisfied with the ACA give away so they needed to go back to the FDA sugar daddy for an extended monopoly period. I wonder how long it will be before drug companies are able to do what publishing companies have done with copyright protection and extend patent protection for over a century.

03-09-2011, 03:36 PM   #2
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QuoteOriginally posted by mikemike Quote
By making it even more out of control!!!


Preemie birth preventive spikes from $10 to $1,500 - Yahoo! News

I guess Ther-Rx wasn't satisfied with the ACA give away so they needed to go back to the FDA sugar daddy for an extended monopoly period. I wonder how long it will be before drug companies are able to do what publishing companies have done with copyright protection and extend patent protection for over a century.
That's capitalism for you "cost/benefit analysis........
QuoteQuote:
And it will certainly be a huge financial burden for health insurance companies and government programs that have been paying for it.

The cost is justified to avoid the mental and physical disabilities that can come with very premature births, said KV Pharmaceutical chief executive Gregory J. Divis Jr. The cost of care for a preemie is estimated at $51,000 in the first year alone
$1500 is nothing compared to what you would pay.. without it...
Maybe you and I can finally agree that our capitalistic handlers are just going too far....
QuoteQuote:
"For the first time, we have an FDA-approved treatment to offer women who have delivered a baby too soon, giving them hope that their next child will have a better chance at a healthy start in life," said Dr. Alan Fleischman, the organization's medical director.

As for the cost, he said the drug maker's financial assistance program will ensure no eligible woman is denied the drug due to inability to pay.

Some doctors said they were happy getting the cheaper version from compounding pharmacies, and Aetna's Armstrong said she was unaware of any quality concerns.

Still, doctors will use the Ther-Rx brand, in part because of legal worries.

Not that they have a choice: Last month, KV sent cease-and-desist letters to compounding pharmacies, telling them they could face FDA enforcement actions if they kept making the drug.
It's in the rule book you know.........
03-09-2011, 03:49 PM   #3
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I think this is a case of regulatory capture, not free market capitalism.

Drug companies get a monopoly over producing a drug, but compounding pharmacies have been coming under fire for competing with them in a fairly legal way. Sometimes a chemical compound, which is what has the patent protection, has multiple uses at radically different doses. The most egregious example I had heard of before today was Genentech's Avastin/Lucentis is effective as an injection for cancer and as an eyeball injection to slow macular degeneration. The cancer dose is ~1000 mg and cost more than $10,000/dose while the eyeball injection was 1.25-2.5 mg and cost $1593/dose so pharmacies were buying the cancer drug, compounding it into eyeball injections, and selling it for $42.


In a healthy free market a pharmacy can be an effective check on the power of the drug company.

Last edited by mikemike; 03-09-2011 at 03:58 PM. Reason: found case and updated to be more accurate
03-09-2011, 06:06 PM   #4
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What's a healthy free market? Never heard of such a thing.
Is it like the 'invisible hand"?
"regulatory capture" Is that the new buzz term? Who coined that?
Mostly it will be used to try and break government programs.
It's what they do.

03-09-2011, 06:54 PM   #5
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QuoteOriginally posted by mikemike Quote

In a healthy free market a pharmacy can be an effective check on the power of the drug company.

And when did we ever have that??????????
in a "free economy" they could be selling cockroach poop and saying it does the same thing....w "doctor recommended and tested" labels and nobody would be the wiser.. just say "hmmm maybe you did something wrong when you took it"
03-09-2011, 10:03 PM   #6
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QuoteOriginally posted by shooz Quote
"regulatory capture" Is that the new buzz term?
Its been around for about 5 or 6 decades and it was coined by Nobel Laureate George Stigler. Given the string of epic failures we have had in heavily regulated industries (banking, BP, autos, health care, aviation) you should be familiar with the concept. Its when incumbent companies manage to gain influence over there regulators and make those regulators work to protect the industry from competition instead of protecting the public good.

A few examples:
When the regulatory body here gave the drug company a special status for their drug they were protecting them from competing with pharmacists.
When the auto industry got exclusions from CAFE for hummers and other big honkin' SUVs.
When the oil industry had the MMS rubber stamping drilling permits to feed those SUVs.
When the banks managed to throw every underwriting rule out of the window.
The way aviation companies have skirted safety inspections and rules about pilots actually being well rested before they fly a plane full of people. (this is still going on)
When PhRMA and the HICs wrote the Unaffordable Care Act. (actually I think this goes one step further than regulatory capture since they got the whole Legislative and Executive branch)

Now do you understand what "regulatory capture" is?

If your ready to get your mind blown... regulatory capture is a sign of failed socialism not failed capitalism.

QuoteOriginally posted by jeffkrol Quote
And when did we ever have that??????????
I keep forgetting that I am an oddball who actually reads the label, goes online to research drugs, and talks to the doctor and pharmacist before I swallow a pill. I hate taking medicine and I make sure I really, really need it. I feel all *yuck* just thinking about it.

-----------------------------------------------------------------------------------

Heres an interesting idea, I don't know if it would be cool with the regulators or how much cheaper it would be. How about a "Public Domain Health Plan" which only covered drugs and treatments which were not patent protected. We have made a lot of advances in the past 20 years which are patent protected but you have to wonder if the marginal benefits are worth the marginal costs of kissing the rings of drug companies and medical device manufacturers.
03-09-2011, 11:49 PM   #7
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QuoteOriginally posted by mikemike Quote
A few examples:
When the regulatory body here gave the drug company a special status for their drug they were protecting them from competing with pharmacists.
When the auto industry got exclusions from CAFE for hummers and other big honkin' SUVs.
When the oil industry had the MMS rubber stamping drilling permits to feed those SUVs.
When the banks managed to throw every underwriting rule out of the window.
The way aviation companies have skirted safety inspections and rules about pilots actually being well rested before they fly a plane full of people. (this is still going on)
When PhRMA and the HICs wrote the Unaffordable Care Act. (actually I think this goes one step further than regulatory capture since they got the whole Legislative and Executive branch)
Hmmmm.....You missed that whole part about me telling you all along, those industries are using lobbyists to let them write and re-write whatever regulations they want?
That's what self regulation gets you. That's what they use our dollars to pay for.
I consider it a kind of hidden tax. A kind of taxation without representation.
I agree, that's not capitalism. It's also not socialism.
That's plutocracy, in action.

Total un-regulation got us the kind of stuff that went on around the turn of the last century. That was capitalism gone amok.
It was progressivism that pulled us out of that one. Just ask Teddy.

03-10-2011, 08:07 AM   #8
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QuoteOriginally posted by mikemike Quote
Now do you understand what "regulatory capture" is?

If your ready to get your mind blown... regulatory capture is a sign of failed socialism not failed capitalism.
That "socialism" label is an arbitrary conclusion. Corruption of the purpose knows no political or economic "ism." Regulation is as much an expected part of capitalism as socialism. Read that communist, Adam Smith, if you don't believe me.

If the police get cozy with the criminals (which happens for the same reasons as police make alliances with informants and "former" criminals to understand sophisticated organizations), is that a socialist problem? Why is it any different for business regulation?

Last edited by GeneV; 03-10-2011 at 08:22 AM.
03-10-2011, 08:15 AM   #9
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Regulatory capture.. like wall street????
Why Isn't Wall Street in Jail? | Rolling Stone Politics
Regulatory capture - Wikipedia, the free encyclopedia
American Examples
Federal Aviation Administration (FAA)
Federal Communications Commission (FCC)
Food and Drug Administration (FDA)
Interstate Commerce Commission (ICC)
Minerals Management Service
in the aftermath of the 2010 Deepwater Horizon oil spill, the Minerals Management Service, which had regulatory responsibility for offshore oil drilling, was widely cited as an example of regulatory capture
Securities and Exchange Commission (SEC)
My goodness even Bush was a socialist......... WOW "blows my mind" where's my chalkboard...
03-11-2011, 09:54 AM   #10
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QuoteOriginally posted by GeneV Quote
That "socialism" label is an arbitrary conclusion. Corruption of the purpose knows no political or economic "ism." Regulation is as much an expected part of capitalism as socialism. Read that communist, Adam Smith, if you don't believe me.

If the police get cozy with the criminals (which happens for the same reasons as police make alliances with informants and "former" criminals to understand sophisticated organizations), is that a socialist problem? Why is it any different for business regulation?
I would say government regulators are socialist institutions, and that is what american liberals wish we had more of.

My perspective of the political/economic spectrum is like so:
Communism|----------------------------------|Laissez-faire

With all point in between being socialism to some degree. Colloquially, the further towards communism you are though the more socialist the system is and the further "left" or "liberal" the system is. History has shown that neither extreme works very well for very long. The reason that the far left doesn't work is because either power gets concentrated in the hands of a few government officials and their circle of friends like we see in Venezuela or China or it is sold to the highest bidder like we see in the US.

Deep down I don't think there is trust for the US government to be an effective regulator on the left or the right of the american public or the american political class. I think the fear is a little bit different, on the left the fear is more of plutocracy and on the right the fear is of a kleptocracy but either way the answer is a limited government with a weaker role in the economy.
03-11-2011, 10:11 AM   #11
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QuoteOriginally posted by mikemike Quote
My perspective of the political/economic spectrum is like so:
Communism|----------------------------------|Laissez-faire
However I do not think Laissez-faire is on the far right, rather it is a pro-property form of socialism. Namely, for Laissez-faire to operate there need to be regulations and enforcement of property rights and exchanges, and to enforce the aquiescence of the population to business dictates.

To the right of this exist property-socialist might makes right schemes, where bands of individuals exercise their power in an essentially a-legal environment. To the right of that is despot-socialist order where a society is wholly organized on behalf of a king or dictator. This indicates to me we're getting to the far right as this obviously merges with the far left communism, as practiced historically.

The fact of the matter is, we can't get away from 'socialism' as even the hypothetical cave-man lived in a group with group rules and common weal. Even our ape relations are socialist in this sense.
03-11-2011, 10:36 AM   #12
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QuoteOriginally posted by mikemike Quote
I would say government regulators are socialist institutions, and that is what american liberals wish we had more of.

My perspective of the political/economic spectrum is like so:
Communism|----------------------------------|Laissez-faire
I'd say you are unclear on the concept of capitalism, socialism and, to some extent, liberalism.

In the Right hand portion of that graph, are there police? laws? Does capitalism have rules at all, or are we talking total anarchy as a capitalist goal.
03-11-2011, 11:11 AM   #13
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QuoteOriginally posted by GeneV Quote
I'd say you are unclear on the concept of capitalism, socialism and, to some extent, liberalism.

In the Right hand portion of that graph, are there police? laws? Does capitalism have rules at all, or are we talking total anarchy as a capitalist goal.
Yes, on the right hand the police and laws are socialist institutions but they really only come down on the worst villains.

I think its more of a wild-west kind of scenario or something like you see in the early phases of the internet where the police and regulators were very hands off. Now ISPs have to deal with all kinds of regulations for wiretapping and pulling users' email and browsing records, internet companies have to keep abreast of and comply with laws regarding censorship around the world, there are pushes to tax eCommerce, DMCA, and other things that as the government gets more and more involved it is harder and harder to start an internet business. The g-man is always there but in a lot of ways, back then if you had a problem with someone trying to hack your site you just took care of it yourself by fixing your security holes because there was little that the police could do about it or even knew about it.
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