$10 drug now $1500 after FDA grants monopoly

wn

Since the money is all coming out of our pockets anyways we should just pay for the study directly, via the FDA/whatever, and have the knowledge. If this helps freeloaders, what of it? Instead of “America – World Cop” we could be “America – World Doctor”. I’d rather be charitable to the hostages of the North Korean dictator by making cheap medicine available than condemn them and others to death merely to spite their captors.

Any system that grants monopolies on drugs (or anything) is saying to someone “Yes, we know you can make the drug, but you must sit there and die instead”. Not only is it rude, and a crime against humanity, but it’s also just not going to happen. Like the DMCA; you can’t legislate insanity and expect positive results.

As for the capitalism/government side to this discussion, you “capitalism sucks” people are missing a key point – this is unrelated to capitalism. If you got rid of capitalism you’d still have this sort of gaming of the system just under different names.

As long as we have masters (leaders, if you wish) who control what we do they’ll be tricked or bribed into screwing with us – as long as we can be distracted into allowing it.

It’s rampant corruption and cronyism that’s setting up these sweetheart deals and is killing us. No matter what the system, if it’s corrupt it can’t work.

This isn’t a pro-capitalism rant, this is a “get your lingo straight so we an all fight the same fight, together” rant.

Egypt got rid of its dictator, why can’t we do the same?

Ugly Canuck

No system for compulsory licensing?

A monopoly, and in addition to that, the complete freedom to set the price wherever one wants?

Bah!

DoctressJulia

AAAAND, the war on women and the poor continues…

Skidds

I’m just going to start to refer to corporations as government. They do control more of an individualâ€™s life than the government does so why not.

emmdeeaych

at this point it seems they control more of the -government- than the government does.

microMD

My understanding (from talking to my medical school classmates) was that when this medication was generic, companies weren’t interested in producing it and so supply was inconsistent.

The original thought behind giving exclusive rights to a pharmaceutical company was that it would create a consistent supply of a (very useful) medication.

Obviously, that didn’t work out so well. Shameful.

teapot

Someone sneak the formula to China and we will have unlimited cheap supply in no time.

Seriously… the black market is the best way to fuck these guys. If our governments and regulatory bodies are bending us over while the drug companies count their cash there should be no reason not to boycott these fuckers. Can anyone be bothered to put together a comprehensive list of KV products people should avoid? Pharmacists who care about their profession should label all KV products in their stores with little red labels that say something like “Don’t buy this product. KV would rather be rich with premature babies than poor with healthy ones. Is that a company you trust?”

Ed Ligget. Tuba.

But…it’s got what plants crave.

ogvor

How much you wanna bet that the same politicians who would undoubtedly defend this companies right to gouge customers for a medicine that prevents pre-term births would also call themselves ‘Pro-Life’.

Anonymous

The live stock price says it all. http://www.kvpharmaceutical.com/

Anonymous

Like, say, progesterone cream, which is available anywhere, costs $10-15 per bottle?

FWIW, the older moms around here swear by it.

Anonymous

It’s getting to the point where the only meaningful action citizens will have available to them in the face of increasing abuses by the government/corporations will be violence.

Patrick Nielsen Hayden

What some people posting here don’t seem to grasp is that capitalism is a creation of government regulation. Entities like the limited-liability corporation don’t come into being as the result of the operations of a stateless free market. Their continued existence requires the backing of a legal system which is itself predicated upon the state’s “monopoly of force.”

“Capitalism” doesn’t just mean “people with money do a bunch of business”; it’s a specific set of social relations which don’t happen if there isn’t a state in the mix. The entire system of property rights, patents, charters, corporate governance, stocks and bonds and other financial instruments, etc., requires massive government regulation in order to exist at all. So it’s pretty silly to claim that the problem is Government Regulation and that none of this price-gouging would be happening if those pesky regulators would just back off. Whether they admit it or not, everyone in this argument wants Big Government; we’re just arguing over who its rules should favor.

JohnAspinall

Well said, Patrick.

jackm

This rampant price gouging started with Dick Cheney’s pharmaceutical bill (one of the first things passed by the Republican “rubber stamp” congress), and then continued when the FDA became compromised by conflicts of interest.

I can remember paying $15 for a flu medication in 1999, and then getting surprised when the same flu medication in early 2002 cost Â£$156!

I think the reason why nobody is protesting this is because nobody can believe this is actually happening, that the pharmaceuticals would exploit their market so aggressively.

It doesn’t matter what the PR guys for these companies say, we know that a full quarter of their budget is spent on absolutely unnecessary TV advertisements, and God knows how much more is spent on lobbying.

And people wonder why the drug cartels of South America are switching to producing counterfeit prescription meds!

Caroline

Wait, if it’s 7 years exclusivity then it’s been classified as an “orphan drug.” That status is intended for drugs that treat very rare diseases or conditions — ones that affect less than 200k people in the US. (The idea is to encourage the development of drugs to treat these diseases, even though the market for them will be necessarily small.)

Pre-term labor can’t be that rare, so did they get it approved under the loophole that it can be classified as an “orphan drug” if more than 200k people in the US have the disease/condition, as long as the company reasonably expects it won’t recoup development costs from sales of the drug?

Or are they trying to label it specifically for some much rarer condition?

Link to the relevant act : http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/orphandrugact/default.htm

Anonymous

@gsilas

Your point about encouraging R&D and making sure medicinal chemists and biologists get paid is legitimate in general, but not in this case. KV didn’t develop this drug, so they have no R&D or study costs to recoup. They made a deal with the FDA to ensure that patients and health-care providers would have access to a reliable, consistent source of this medication, and they increased the price 150-fold.

That’s not what anyone other than KV’s CEOs would call ‘reasonable.’

Anonymous

I’d just like to point out that the March of Dimes supported this action, and was all excited when it happened.

Maybe it is time to question why a group founded to stop birth defects would want and welcome a company making a needed drug almost impossible to get into the hands of the people who would benefit the most from it.

Many of the other supporters feel blindsided, but the March of Dimes just keeps rolling along.

Oh maybe its because they are bankrolled by big pharma.

Camp Freddie

This isn’t about regulatory capture. It’s about unintended consequences. Long post follows, and may skim over or oversimplify the details.

It’s about the FDA trying to do something that the public keep asking for but being short-sighted and being outmanoeuvred by money-grubbing corporations.

There are lots of drugs that are prescribed off-label. They’re known anecdotally to work for a specific condition, but no-one has put the work in to prove the effect.

The public hate the idea (rightly so) that untested drugs are being given to patients.

No company will do the tests because they are expensive and the drugs are off-patent. So if they do the tests and get the drug label properly approved for a disease, then all their competitors can also use that label.

So the FDA decided that giving a limited monopoly of 7 years would allow companies to do the tests the public want and get paid for doing so.

What the FDA didn’t (and should have) realised is that asshole companies like KV will find treatments that have limited public domain data to support them. Then they’ll do a few cheap trials, get a 7-year monopoly and abuse it to charge crazy amounts of money.

I don’t know for sure how the problem can be fixed. A good solution might be forced data sharing, which is used in my industry (in some countries), agrochemicals. Agrochemicals have similar data protection rules that grant 5 or 10 year monopolies to companies that provide useful, original data. However, to prevent abuse of the monopolies, companies are forced to make good-faith efforts to share data at the market rate. If the company refuses to share the data at a reasonable price then in some countries (e.g. Canada), the regulator will assign a price to a study and allow competitors to buy access to it. This means that KV’s competitors could spend, say a million $ buying into the KV data package and sell their product for a reasonable price. It ensures that the price of a drug reflects the cost of the R&D data.

Anonymous

How’s this for a simple fix … no rules changes at all.

The FDA prevents pharmacists from compounding KV’s progesterone product. So be it. but progesterone is still used with lots of other treatments (i.e. birth control)

I seriously doubt the $10 generic can’t be made in hospitals still. The FDA controls how drugs and devices are marketed. But a doctor can prescribe anything. Anything! The pharmacy or generic drug producer can’t market progesterone for the same purpose as KV, but can still supply it. So the doctor calls up the pharmacy and orders custom drug cocktail made from birth control ingredients for his patient. That was the off-label use before, and not much to stop it from continuing.

Worse case, compound and/or deliver it differently. Progesterone + B vitamins, suppository style. Progesterone with a micro-dose of viagra (seriously, check out what it does for pre-eclampsia). And so on.

If people insist on KV’s version, then they are stupid. If doctors insist, then they are worried about being sued for using the $10 version instead of the $1500. Yup, KV could really go out of business if we had tort reform. Wow!

Anonymous

Seriously? Have you seen the exponential increases in drug prices overall. Its time for the US to go cold turkey and boycott all these bastards…

Anonymous

is anyone really surprised , its a sad fact that Pharma corporations are in business to make money not to really help you with depression or what ever else may ail you , and they will continue do this without care or regard to you or anyone else. These Pharma companies are yielding what they would like for us to believe is the “Golden Egg” but its really a “Golden Parachute” for the top tier of the company.Going from $10 to $1500, I wonder how many insurance companies just dropped this from their list of covered drugs. As time usually tells the drugs they produce are unsafe. HAS ANYONE EVER WATCHED TELEVISION AROUND 8-9 PM EVERY COMMERCIAL IS FOR A PHARMA CO. If you don’t think you are depressed , just watch prime time TV there are enough symptoms covered in these commercials to make everyone believe they are in desperate need of one concoction or another.Most of them now want you to know a side effect is “Thoughts of Suicide” What the hell are they putting in this stuff ? Then stop and ask yourself a few questions.. How many clinically trailed drugs have been pulled off of the shelves in recent years? How many commercials have I seen for Lawyers who want to “help” you get the money you deserve( by taking 33% percent of what the award is) and then read the news about the government takeover of 3 Tylenol plants controlled by Johnson and Johnson.The reason sited , Safety Violations at drug manufacturing plants, REALLY Safety Violations in Manufacturing. one in Puerto Rico and two in PA. Then ask your self the one question that is burning in my mind ” What was the last disease we cured ?” Polio, in the 1950′s Really ? YES ,REALLY 1950….So there hasn’t been a major disease cured since 1950, Technology has advanced in leaps and bounds, money is rolling in the door, and no cure in 60 years for anything. Well Why cure when you can treat , treating a disease makes money! curing a disease stops the inflow of cash.Now thats a hard pill to swallow !!!!

Anonymous

Capitalism at work! Let’s replace it, in an orderly fashion.

Anonymous

A corporate sponsored government is not a democracy, and this artcle is another fact that supports my theory.

Anonymous

Actually, Thomas Jefferson said the same thing.

Anonymous

Outrage is easy. We need to take a real, tangible action. We need an actual campaign to get this investigated. Where to start?

Anonymous

@zandar,

Before KV was awarded federally enforced monopoly rights, other companies (not pregnant women) were producing the drug in a competitive forum, which kept the price low…err that’s what I gathered from the paragraph on this site. Price gauging is more of a human problem and I think capitalism would be better understood as a system taking this fact into account, providing a means of remediation.

If this was a problem with capitalism rather than government backed monopoly rights, we’d see the price rise to $1500 internationally.

AirPillo

One of the best things we could really be doing for public health is to address the revolving door at the FDA that keeps it staffed with executives from the food and drug industries.

It’s not really clear whether situations like this arrive through incompetence or through someone involved having been previously employed by the company they handed a windfall to.

Julien Couvreur

This is predictable and goes to show the danger of government-created monopolies.
Patents and copyright fall in this category, as they do not reflect the underlying reality (if I “take” your idea, you still have it, unlike a bicycle).

blueelm

Oh I see! The government is totally on board with upping the infant mortality rate, it just wants to make sure pregnant women are impoverished and that no matter what it’s all out of their control as much as possible… oh yeah and that some private industry is making a load off of it.

Now it all makes sense.

Well as long as the rich are getting richer from the suffering and death of human beings!

g0d5m15t4k3

Well since the government won’t subsidize Planned Parenthood for abortions and birth control, its just another nail in the coffin of women’s reproductive rights. You have to kill those poor mother’s babies somehow don’t you? But you have to let nature do it. By making medication too expensive to pay for.

DrPretto

This is a CRIME against humanity.
FDA is corrupted.

gsilas

Did my citations not show up? Argh, that was a long post to retype.

Antinous / Moderator

The system holds comments with multiple links. I had to hand approve it. If that ever happens, don’t repost, because the system will just hold the new one as well. It won’t go through until someone fishes it out of the tank.

Anonymous

Not mentioned by ABC is the fact that 17p is still regularly available through creams, pill and suppository at the normal price. This is only for the branded version, Makena, that is injected once per week. Not the end of the world.

MrJM

$10 drug now $1500 after FDA grants monopoly

The system works.

zyodei

The question is, do we need men with guns enforcing the will of a small subset of people to have safe medicines? Safe foods? Safe anything?

What madness is this?

Haven’t we yet learned that men with guns acting in any way other than direct defense create many more problems than they solve?

http://www.myopia.org/fdaraids.htm

wn

Then people would have to be responsible for themselves – if they bought non-FDA approved food and got sick they’d want someone to blame for that.

I’ve talked to people about this before and their answer is that because they couldn’t bring themselves to avoid unchecked, unlabeled food, that you shouldn’t be allowed to sell it. Myself, I like the freedom of farmer’s markets but I want to know the risks.

As long as no more laws restrain me from dealing with the bad food/drugs (commenting, arranging boycotts, and ultimately banding together and shooting the pusher of known-bad goods) than restrain them from selling them, we’ll eventually reach a stable point.

Anonymous

To the folks pin the fault on capitalism you are horribly wrong. Take a step back and ask yourself – What/Who caused the monopoly?

The FDA.

Government intervention into the market is the opposite of Capitalism or Free Markets.

This scenario is more akin to Fascism or Crony-ism than anything even resembling the free market or Capitalism.

Antinous / Moderator

As you’ve just discovered.

Anonymous

This is my e-mail to KV Pharma investor relations:

Have you no shame whatsoever? How can you take an exclusive permit to produce a drug that costs $10 and charge $1500.00 for it? This kind of shameless corporate behavior is what is destroying America. Your offer of a patient support plan is a laugh; everyone knows you will bilk insurance companies for the cost in most cases. Iâ€™m ashamed that a company like yours is allowed to operate in the United States.

Everyone please e-mail these shameless looters.

andreinla

We now know the market price of preventing pre-term birth.

This is the essence of the “healthcare industry:” how much money can be squeezed out of people in exchange of providing healthcare services.

It is also the natural behavior of a corporation: to maximize profit in any way possible.

I am surprised that anyone is surprised.

andreinla

@Anon / Monopoly on water is already in the works. Most water supplies around the world are already owned/leased by a handful of companies, owned by a handful of people. Many, many people die every day because they have no way to pay for the water extracted from their land by these companies.

See http://www.flowthefilm.com/

Mazoola

Expect to see more of this (or similar) as the FDA works through their backlog of unapproved drugs — that is, drugs whose general availability predates the FDA but which have never been shown to be effective in a clinical trial. As Vnend mentioned at #26, colchicine underwent a relatively huge jump in price last year — although the pain of a 54x price increase is ameliorated a bit when you start at $0.09 a pill. Still, as one of the great uninsured masses, I find myself staring at my mostly empty 100-pill bottle and trying to guess whether this current flare-up, if left untreated, will most likely die back down or erupt into a full-blown gout attack.

The idea of a pharmaceutical company (URL Pharma) having exclusive US marketing rights to colchicine goes beyond absurd. The drug’s first appearance in the medical literature as a treatment for gout took place around 100 CE, while archeological evidence suggests its uses dates back at least as far as 1,500 BCE. In this country, though, it had never been approved as a stand-alone treatment for gout. As part of the FDA’s push to eliminate non-approved drugs, URL Pharma funded a token test — 117 gout patients, over a two-week period — and conclusively proved what had been known for 3,500 years: Namely, gout sufferers who take colchicine (and don’t die from the side-effects) experience less pain than those who don’t take the drug.

As thanks for having helped the FDA strike one more name from its list, URL Pharma was granted exclusive rights to market colchicine — excuse me, Colcrys™ — for three years. Not that shabby a return on investment, given the drug is prescribed in this country roughly 3.5 million times a year.

Ultimately, it’s undoubtedly far easier to absorb an additional $100 per refill than a $1,490 per-dose price hike. Still, it makes you wonder what’s next.

Anyone feel like helping me draft a double-blind proof-of-efficacy test for aspirin?

DaughterNumberThree

Late to the game, but did anyone check the KV Pharmaceuticals press release that told of their generous subsidy plan?

Under the plan, the drug is free to uninsured women with incomes under $60K and $20 for women making $60-120K. The insurance copay is $20. The droves of uninsured women making over $120K a year get to pay the full amount.

As do the insurance companies, and as Blaven #19 said above, they’ll soon stick us all with higher rates to make up for it.

My post on this topic from a few days ago here

Anonymous

The F.D.A is going to kill us all………..
It’s our own fault…………
Oh well, try to be compassionate and start a revolution.
Peace.

Anonymous

That’s lobbying for ya.

Anonymous

So for all those outraged, what are you going to do about besides complaining on the internet?

Baldhead

I assume it’s the sheer volume of stuff that the FDA has to deal with that allows stuff like this to happen, either by accident or intent on the part of someone within the FDA. But it has for years now been happening. Drugs get apparently rushed into approval then recalled when a dozen people die. Drugs considered safe by the rest of the world are banned in the US for vague reasons. Massive recalls on foods because of e.coli and other stuff- in some cases on foods that have no business being near feces in the first place. Starting to think the FDA needs a major audit as it’s not doing it’s job properly. Corruption and incompetence, while likely not affecting the majority of the organisation, is affecting more than I’m comfortable with, even though I live outside the US.

Anonymous

Way to farkin’ go,FDA! Nice kick in the medicine-buying consumers’ balls!

- Your tax dollars at work.

Anonymous

you people are absolutely, completely lost. I cant believe you wave around your freedom flag all the time, yet you let them (in a very broad sense of the word) trample over you over, and over, and over again.
is it really THAT comfortable up there? How is it that there are no protests around there for things like this? It took a right wing governor swooping away the last workers union in a state to move, what, 80k people?

I thought democracy was the right for a countrys people to govern itself.

Mobius

Disgusting! Capitalism at its worst (or best, depending on world-view, I guess).

But why then isn’t it everyone’s natural instinct to look at what natural foods could do the same thing? Sure, it is slower, but it is natural and part of a healthy diet. When a woman becomes pregnant, tell her it would be good if she increases her intake of walnuts and thyme and oregano and eat a good curry every now and then.

http://www.nativeremedies.com/ailment/increase-low-progesterone-levels.html

There are heaps of natural remedies in the market place already too (eg herbals for treating menopause – oestrogen/progesterone levels). There would then be a decreased need for the hormone injection.

Anonymous

Talk to me once you’ve been in preterm labor. I’ve had 2 kids that I went into preterm labor multiple times with. I’ve had this shot. It’s not a one time deal thing.
Antinous / Moderator

No. Just no.
- zyodei
  
  That’s a bit dogmatic, eh?
  
  If something is effective, and safe, why not promote it’s use whenever possible?
  
  I can’t speak for others. I can’t say that it’s a good idea for, for instance, pregnant women (in fact, pregnant women have to be particularly careful about what herbs they take). But for myself, I have used only herbal remedies for everything for about ten years. And they always seem to work much faster than whatever pharmacy stuff I used to use. Just a week ago I had a painfully infected and swollen finger…taking heavy doses of neem, white oak bark, astragalus, and topical tea tree oil..and doing nothing else…within 48 hours it was 100% healed.
  
  I haven’t gone to the doctor in many years..except to get tests for Lyme disease, which, according to subsequent tests, I was able to treat effectively with herbs. I did seriously consider taking antibiotics for that, however.
  
  Speaking only for myself, cheap herbal remedies have shown themselves to be effective at least a dozen times.
travtastic

Rainbow suppositories?
AnthonyC

Some herbal remedies may very well be effective… but we won’t know which ones unless someone funds a double-blind study of them. Who would you like to fund these studies? If the answer isn’t “Government,” or “Charity,” then how do you propose we compensate them? Grant a monopoly on production of herbs and spices?
- Anonymous
  
  In response to AnthonyC, if we have a monopoly on herbs and spices, I would suggest that Colonel Sanders administer the program!
- zyodei
  
  What? How hard is it?
  
  A company could fund a study, and if it was successful demand would rise. This would increase the price. Other competitors might jump on board, but the rising tide would lift all boats. The first and largest player in the market would bear the greatest fruits.
  
  Of course, there are large non-profits that would be very happy to do studies like this.
  
  What tremendous lack of imagination or simply problem solving skills on the part of people who can’t think how something could be accomplished without introducing the monopoly of violence of government to solve the problem.
- travtastic
  
  Never, sir! The spice must flow!

paogle

I don’t mind a drug company who develops a drug, spending hundreds of millions in the process, charging for that drug. But this is lunacy…..I wish there were more on this here.

Anonymous

The FDA needs to get yanked back to its orgins. They don’t do what you think they do. THey don’t test drugs routinely, the rely on the honor system to approve drugs; they hide quality control problems from consumers.

It’s time to return the point and purpose of the FDA to ensuring that all ingredients are listed and are contained in a drug as advertised – that is, they should be responsible for ensuring quality control standards are kept.

Safety and effectiveness trials are a joke, they are so rigged and poorly run. I’d rather take my chances with the tort system sorting out the bad.

The grandfathered drug issue is horrifying. It’s a pure power and money grab.

davidcjones

As a maternal-fetal medicine specialist who treats women with complicated pregnancies, I view this as a travesty. There was already enough data for most of us (including the American College of Obstetricians & Gynecologists) to recommend this treatment years ago. We had an inexpensive and effective therapy, whose only down side was that it had to be compounded at a “compounding pharmacy.” In my rural state, there are only a few of these, but still we had a mechanism to get a therapy to women for $300 that was effective (remember, most of the published trials were based on “compounded” preparations, not a commercially available one). Usually drug companies go out of their way NOT to seek FDA approval for a drug, because they know if the drug is already available for one indication, we can use it “off label” for any indication for which it has been shown to be safe and effective. The drug company knows we will use it, buy the drug, and if something goes wrong, they are protected from litigation because they never sought approval for that indication. In this case, a company has taken the alternative approach, and made a careful calculation. They knew how relatively inexpensive their trial would be to get FDA approval (since there were a number of studies already out there), and they knew the payoff would be huge. So they decided to pursue this strictly for a profit. I am not against profits, it drives innovation. But this is not innovation, it is merely identifying a way to take a reasonably available drug that you already knew worked and corner the market at 10X the price.

If they had no exclusivity, then we could actually decide if having a commercially available product was worth $30,000 compared to a $300 locally compounded product. But now, we do not have that choice. The cost of medical care has been artificially inflated, and those are real dollars that will not be going to providing better care. I have to hand it to themâ€”very clever. But every one of my colleagues and my professional organizations are quite upset by how this turned out.

gsilas

I hate to dissent, but I think all of you have gotten worked up over nothing. Take a deep breath, and think about this for a second.

The FDA is a good thing. Otherwise, we’d all be taking Vioxx and unknowingly predisposing ourselves to heart failure (and pregnant women thalidomide, having flipper babies). Or, we wouldn’t have any drugs being developed at all, and our survival rate would drop dramatically (imagine no antibiotics, no chemotherapeutics…).

Clinical trials are required in order to show the efficacy of drugs, and the safety. This drug had been abandoned, and had never been shown to be clinically safe and effective. Yes, people had been taking it, but there could have been a myriad number of harmful side effects. KV Pharmaceuticals paid for the clinical trials in order to prove safety and efficacy. Therefore, they deserve patent protection in order to recoup the money spent.

Imagine if the clinical trials had revealed severe toxicity in a small portion of the population, then KV Pharmaceuticals would be applauded, yes?

Additionally, for those in low income and without insurance, they will still be able to buy the subsidized medicine, so no one will be denied access. The only people getting “screwed” are those with higher insurance premiums to make up for the cost increase. But isn’t this how all drugs work, and how all insurance programs work?

And for those of you who want to dissolve the FDA and overthrow capitalism… Well, you can all take your drugs without proven safety or efficacy, and die early. And imagine a world without new development of antibiotics (see MRSA post earlier in the day).

grimc

RTFA. KV hasn’t paid for squat. It’s all pure profit for them. Well, aside from whatever their lobbyists and astroturfers cost.
- gsilas
  
  The article is then incorrect.
  
  The NIH did not pay for the clinical trials, as far as I have read elsewhere, KV Pharmaceuticals did.
  - grimc
    
    All that says it that KV is a sponsor, nothing about actually funding the trials.
    
    The most trustworthy source on the record is still the good doctor from Emory.
    - gsilas
      
      Sponsor is who is paying for the clinical trials.
      
      “Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be a governmental organization, a pharmaceutical, or biotechnology company.”
      
      http://en.wikipedia.org/wiki/Clinical_trial
      
      If you search the NIH database (all federally funded grants are published online), I can’t find any grants from the NIH to KV Pharmaceuticals, so we can drop the “usually” from the previous wikipedia quote.
      
      http://projectreporter.nih.gov/reporter.cfm
      
      Let’s drop the conspiracy theory and reread my previous post. The NIH-funded trials were deemed by peers to be inconclusive, and require further trials. Those are paid for by KV Pharmaceuticals, hence the patent protection. It’s unfortunate that the price was set so high, but this is not an isolated instance, medicine in the US is expensive.
      
      And as far as reliable sources, as a PhD chemist working in academia, I think I’m more trustworthy than a doctor quoted by abcnews.com
  - Antinous / Moderator
    
    Please provide a credible citation.
    - gsilas
      
      Currently recruiting trials by KV Pharma:
      
      http://www.clinicaltrials.gov/ct2/show/NCT01004029 (two years and running)
      http://www.clinicaltrials.gov/ct2/show/NCT01146990 (one year and running, follow-up study on previous uses)
      
      http://clinicaltrials.gov/ct2/show/NCT00457886
      This one is likely NIH funded, and focussed on studying the hormones in the blood following a dose, in an attempt to learn of the mechanism (not relevant to FDA approvals or drug safety, the FDA couldn’t care less why a drug works if it’s safe and efficacious).
      
      There were a few small trials that I found funded by the NIH, published in the New England Journal of Medicine that concludes with:
      
      “The results of our trial should be interpreted with caution. Although 17P proved to be effective in preventing preterm delivery in our cohort of women at very high risk, it may not be effective in women with a lower risk of preterm delivery, and most preterm deliveries occur in women with no previous preterm delivery. Therefore, our results may not be generalizable to women whose risk factors for preterm delivery are different from those of the women in this trial. In addition, although 17P significantly reduced the rate of preterm delivery among the women who received it, the rate of preterm delivery in this group remained very high (36.3 percent). Thus, the identification of other causes of preterm delivery and other methods of preventing it remains a pressing need.”
      
      http://www.nejm.org/doi/full/10.1056/NEJMoa035140
      
      Most damning follow-ups to that study:
      
      http://www.nejm.org/doi/full/10.1056/NEJM200309113491115
      http://www.ncbi.nlm.nih.gov/pubmed/15330887
      
      So more studies were needed, and it appears KV Pharma is paying for them.
zyodei

People faith in the religion of the state is amazing.

“Without the FDA to tell us what is safe, everyone would be eating Vioxx and dying of heart failure. Mothers would be taking thalidomide and having flipper babies. Humans are basically a hapless and stupid creature, without a strong authority to watch over us, we have no capacity for collectively figuring out what is safe and what is dangerous in the world, and would surely soon all die without the FDA to tell us not to drink bleach.”

It’s funny you mention Vioxx, because it was a great example of the failure and corruption of the FDA. I found this short article rather astonishing (the COX-2 inhibitor in question being Vioxx):

http://www.lewrockwell.com/sardi/sardi72.html
- gsilas
  
  As far as I know, Vioxx was due to Merck withholding data from the clinical trials, not a failure of the FDA. Can’t blame the regulatory agency for criminal wrongdoing of the company providing the data.

gsilas

I can’t tell if those of you who are proclaiming our current market as false, or not pure capitalism, are decrying government regulation or just pointing it out.

If you want to get rid of government regulation and have a purely capitalist economy, what will drive innovation?

In terms of most commodities, like music or electronics, then lack of government regulation likely will not make a large impact because there are still revenue streams in place (concerts or the desire to avoid cheaper knock-off electronics). However, drugs cost hundreds of millions to billions to develop, and can be knocked off by anyone with some chemicals and a garage (hence, generic price is only $10). Without government protection there will be no new drugs, no new antibiotics, and no new chemotherapeutics, etc.

Anyone with a few years training can elucidate the structure of a drug, and synthesize it independently. Not anyone can produce knock-off iPhones.

Anonymous

You blame capitalism?

No. A goverment picking one winner is not capitalism.

Tim

I…

but…

WHAT?!?

xzzy

Okay, solid proof that pharmaceutical companies are completely corrupt.

So when do we get to the point of doing anything about it?

Tongs

Do you think this is proof that pharmaceutical companies are corrupt, or proof that the U.S. government is corrupt?
Anonymous

Why are you blaming the company for using all the power the _government_ just gave it? That’s like putting a steak in front of a dog and then declaring how awful the dog is when it eats the steak.

Corporations gain their power from the GOVERNMENT, because it eliminates competition far better than with capitalism. With capitalism you have to offer a superior product at a superior price, or others business will take all your customers. But with the help of the government, you can shut down other businesses with armed thugs.

The government is not here to protect you. Repeat this until you finally get it into your head.

Anonymous

There’s a nice write-up of it at the In the Pipeline blog.

http://pipeline.corante.com/archives/2011/03/11/makenas_price_what_to_do.php

Anonymous

INCONCEIVABLE!

srsly i cannot conceive how this is considered ok by anyone

Anonymous

so what possible justification did the government have in deciding this?

Cook!EMonstA

Prices are not set by logic, they are set by charging ALL that the market will bear. Selling $0.01 real value for $100 in perceived value. That’s Capitalism Baby!!!

Anonymous

Look at what has happened. There use to be competition in the supply of this drug therefore prices were low (relatively speaking). Now the government has granted a single company a monopoly and stopped all market competition and hence the price has gone up massively. That’s the exact opposite of a free market.
Anonymous

No, it is not Capitalism. As you mentioned, capitalism involves what the market will pay, but it also involves competition. The government is PREVENTING capitalism by issuing one company a license to distribute the drug.

If there were 2, 3, 5, 10 companies able to distribute this, the price would be much cheaper and, in a capitalistic fashion, only the fittest would survive and make a profit.

No, this is not capitalism.
- Anonymous
  
  This assertion that “capitalism” doesnÂ´t also encompass the regulating institutions sort of misses the point.
Anonymous

That’s why I don’t like capitalism.
Anonymous

No, this is not capitalism. Capitalism is all about competition. When they were forced to compete, they had to charge $10. Now that capitalism has been done away with, they can charge $1500.

Donald Petersen

The outrage is easy. I am outraged. This cannot be allowed to stand.

But while I’m outraged, I also wanna point out some bad copy by Courtney Hutchison, ABC News Medical Unit:

Diaz said if the drug had been $1500 a shot, “I think the price would of definitely locked me out, which means I could of potentially had a second or third premature child with disabilities.”

If that is, indeed, a direct quote, shouldn’t there be a [sic] or two after the ofs?

Anonymous

That’s only if competition is allowed. This is monopolistic price gouging at it’s worst and it’s waaaay beyond what the market can bear but that seems to be the standard any more.
Brendon B

It’s a transcription error. “Would of” and “Could of” is probably the writer poorly transcribing “would’ve” and “could’ve.”

It is amazing that no copy editor caught it.
- Anonymous
  
  There are no copy editors.
- Awesomer
  
  No copy editor caught it because ABC can’t afford copy editors anymoreâ€”because insurance premiums are too high.

abulafia

This story sounded a bit strange to me, a brit, knowing how much the ‘Mericans love competition.
Then I was reminded of the tale of ‘high-fructose corn syrup’, which in turn reminded me who actually makes the decisions when it comes to FDA referrals; Food Manufacturing companies and Drug companies. What could possibly go wrong with that?

Please correct me if I’m wrong. Really, please do.

Glad such things are looked after by ‘independent’ agencies.

cameronh1403

No you hit the nail on the head. The FDA is basically a b*?ch for the drug and food companies and do whatever those companies say. Protecting the health of your citizens takes a backseat to making sure your corporate overlords profit.

adralien

Nice work FDA. Expect this graph to change next year:

http://www.google.com/publicdata?ds=wb-wdi&met=sp_dyn_imrt_in&idim=country:USA&dl=en&hl=en&q=infant+mortality+rate+usa

zandar

it’s okay, pregnant women will now have extra incentive to produce an alternative product themselves and undercut KV’s product in the market! Capitalism is totally WINNING!

Anonymous

Is “winning!” said with a charlie sheen inflection?
zyodei

Inconceivable. Simply inconceivabe, mindnumbing, and astonishing that people – several people – would see a headline about a government agency giving an artificial monopoly to a firm and blame in on CAPITALISM or market forces.

These same people look at a whole system that is highly regulated and experiencing government interference at every turn, and they blame the high costs they see purely on capitalism and the ‘free market’ – even though there is no free market in medicine in this country (except for unregulated herbs and such, which are so cheap as to be virtually free).

I have explained on other posts how a free market regulatory system might work – where firms would test the safety of different products and for a fee certify them, and the consumers would buy products certified by whatever firm they trusted the most.

People dismissed it because they said it would fall to bribery and corruption.

BUT WHAT DO WE HAVE NOW? We have a system that is rendered useless by bribery and corruption, where the corrupt state allied corporations are given a license to rob the public, except that in our current state regulatory system the ability to choose anything else has been robbed from us.
- danfan
  
  You’re completely missing the point.
  
  How did regulatory agencies come to serve this role?
  
  It’s a simple concept called Regulatory Capture. This is when an industry, through promises of lucrative post-government service jobs for regulators and bribes to the right legislators, get the heads of federal agencies to do their bidding.
  
  This is 100% the result of unregulated capitalism run amok.
  
  If we had publicly-funded elections – with absolutely no private money allowed – then maybe we’d stand a chance of breaking the revolving door between government and the industries they regulate.
  
  One thing this is most definitely not is an argument for abolition of government regulations for medicines. It’s an argument for ferreting out all the corruption in our regulatory agencies.
  - Julien Couvreur
    
    danfan,
    It is illusory to hope that a better election system will remove corruption.
    Yes, it might mitigate or slow down the problem, but when the option of coercive force is legitimated and monopolized by government, people will find ways to get to it. Most likely the problem will become simply more obfuscated and harder to see.
    
    Instead, a healthier society rejects the use of aggressive force, which means a government limited to protection of property rights and contracts, at the most. No regulatory agencies such as the FDA.
    
    No FDA means no corruption of the FDA by greedy corporations. (And although too long to discuss preemptively, no FDA doesn’t mean less consumer safety).
  - zyodei
    
    And how would public funding stop the practice of lucrative post-government jobs?
    
    How are you going to get legislators who win election through private financing to support public financing, which would help their opponents?
    
    I’m sorry man, but you get the title of “worst comment of the day.” When you observe that government regulation of the market is broken, you blame it on the market instead of the inherent flaws in government regulation.
    
    Even though the system of government regulation is totally corrupt and broken, and has been for decades, you say “wait! we can fix it! really we can!”
    
    “The problem with the system of government regulation of capitalism is all because of unregulated capitalism.”
    
    W-w-w-what??
    - travtastic
      
      You’re completely right, just like always. The obvious solution is to get rid of regulation.
      
      Then we all can live happily, knowing that everything will go just fine, because the magic invisible fist of the market will fix the world for us, no planning necessary.
      
      Because hey, what makes more sense: believing in people and the systems they make to either work or be fixable; or believing in a concept which has failed to materialize since the first time someone wrote it down?
      
      No contest!
    - zyodei
      
      Believing in people and the systems they make to either work or be fixable; or believing in a concept which has failed to materialize since the first time someone wrote it down?
      
      I couldn’t have said it better myself. I absolutely believe in people to collectively and peacefully figure out what is best for themselves, as has always worked many times in human history..instead of, for instance, the FDA, which has overseen a system where now 100,000 people die from FDA approved pharmaceuticals alone.
    - travtastic
      
      The FDA is a creation of people.
      
      Why should we give faith to an unproven concept while simultaneously saying that the FDA is broken, and not worth fixing? We have a system of regulation fully capable of making things like this not happen; but it’s run by assholes, and currently does not work.
      
      Your market voodoo, on the other hand, is not fixable. Because it’s a pipe dream.
    - zyodei
      
      It’s a simple matter of peace vs violence.
      
      Of course we need trusted bodies to regulate food and medicine etc.
      
      The FDA is empowered to use violence. They have been known to come in with heavily armed federal marshalls to enforce their edict. They write letters, which if ignored will bring the wratch of, again, men with guns. It’s an insane way of providing this necessary service.
      
      “Market Voodoo” is simply providing the same service without guns.
      
      If you trust a regulator, you will buy the products they approve.
      
      You will not be forced to trust any particular regulator.
      
      ‘Market Forces’ simply means the collective decisions of millions of people, as opposed to the decision of dozens of people within the state apparatus.
      
      You say the exact same thing as on the other thread – you look at a fundamentally broken system, that has been broken for a very long time, completely corrupted and ruinous to its stated purpose, and say ‘hey, don’t replace it, we can fix it, really we can.’
      
      Let me put this clearly:
      
      MARKETS are people – billions and billions of people making voluntary decisions for themselves and those who have voluntarily put their trust in them.
      
      STATES are people with guns – thousands and thousands of people enforcing their decisions on others, whether they like it or not.
      
      It’s that simple.
    - zyodei
      
      http://www.alternet.org/health/147318/100,000_americans_die_each_year_from_prescription_drugs,_while_pharma_companies_get_rich/
  - Wally Ballou
    
    It’s an argument for ferreting out all the corruption in our regulatory agencies.
    
    The corrupt, or the corruptible, eventually rise to power in (almost) any bureaucracy. Capitalist, communist, socialist, fascist, private sector, public sector, you name it.
    
    The question is not “how can we replace the corrupt with the virtuous?” Ain’t gonna happen, not in the long run.
    
    The question should be “How can we ensure that the corrupt are empowered to do the least damage?”
    - Ugly Canuck
      
      Unionize the bureaucracy’s workforce, with a proper and rigourous path laid out up the grade and pay ladder on the basis of fair examination and experience, and like the Officer Corps, they’ll self-enforce the proper rules via the pecking order…it’s the new-kid-in-the-corner-office – the political appointees that parachute in – that screw things up.
      
      They are the source of your corruption, favoritism and nepotism: and NOT those well-regulated, subject-to-clear-rules-laid-out-in-advance, competitive for advancement, bureaucrats.

Bill in STL

The pharmaceutical company, KV Pharma, is located in the St. Louis, Missouri area. See this article from Sunday’s newspaper for more perspective.

The article does not disclose how much (if anything) KV Pharma paid to get a lock-down on this particular generic drug.

http://www.stltoday.com/business/local/article_e4472916-0646-539d-b04a-520756765418.html

Caroline

Okay, that article tells a very different story than the ABC article linking to the 180-day exclusivity page implied. It sounds from there like KV Pharmaceuticals got it approved as a new drug, which means they get 7 years of exclusivity.

At this point, it sounds like KV is the company holding the spurious patent — and someone should challenge it.
- George William Herbert
  
  Not as a new drug – as an orphaned drug.
  
  This regulation was intended to give manufacturers incentive to pick up and start producing effective drugs which are out of production for some reason. New drugs get patent protection; this is sort of an analog to that.
  
  Unintended side effect. I think everyone agreed that the original intent (to bring orphaned drugs which were out of production back to market) was good. But doing 1 study and then taking ownership of essentially a public domain compounding formula seems more than a little hinky.
  - Caroline
    
    I thought that’s what “orphan drug” must mean — an out-of-production drug. But apparently “orphan drug” means a drug intended to treat a very rare disease or condition (see link in my last comment), one that affects less than 200,000 people in the US.
    
    This article gives the number of preterm births in the US as 525,000 per year: http://www.femalepatient.com/Article.aspx?ArticleId=+enshJStDy8=&FullText=1 That’s considerably more than 200,000 cases.
    
    So what justifies the orphan drug status in this case?
    - grimc
      
      The drug was abandoned by Squibb in 1999–this more widespread use for preterm labor was discovered by doctors over the past few years.
      
      At least one philanthropic org–March of Dimes, quoted in the story–supported KV Pharma, because they never expected KV would turn around and charge such an obscene price.

Anonymous

Sounds like someone at either the NIH or FDA is stupid, on the take, or (likely) both.

kibbee

I’ve always thought “what the market will bear” is non-sensical when applied to medicine. How much is your life worth? or in this case, how much is your unborn baby’s life worth? See how that doesn’t really work out? Because people will spend just about all their money, even go bankrupt and mess up their financial future if it means life or death.

Also, isn’t progesterone a natural hormone? Giving a patent on something the body already produces (or should produce) is really odd. That’s like giving a patent on blood transfusions.

Anonymous

What the market will bear makes sense, even in medicine, when you have competition. And they did before the FDA got involved.

The problem with outlawing profit in medicine is that fewer companies will be incentivized to produce medicine and care (e.g. what if we didn’t allow doctors to make over a certain amount). We do need some IP protection for drug makers so that some overseas company doesn’t just reverse engineer and sell a much cheaper version of a drug that cost billions to research and develop.

But in this case, government protection is definitely unwarranted if the government developed the drug. The FDA, along with a lot of agencies, has corrupt elements. My wife had to have these shots, so I have extra reason to be outraged by this.
Cook!EMonstA

Agreed. For profit medicine is morally repugnant. I don’t understand why we can’t just have some things shared by everyone at cost (no profits). Why does everything need to be privatized and profit seeking? It’s disgusting.

smaier69

in this kind of situation where a governing/government body and the company or corporation in question have executives in cahoots (which is much more common that most people know), it’s even more disgusting.

how much you wanna bet a handful of execs on both sides stood to profit (persoanlly) immensely from this?

reminds me of how the Dept. of Homeland Security works in regards to corrupt and nepotistic contracts.

dethbird

Ummm… is THIS part of the “War on Drugs?” America why are you so herp derp?

IronEdithKidd

Hello, completely corrupt revolving door between big business and government regulation. Nice of you to rear your ugly head, yet again.

emmdeeaych

Yes, government officials and science professionals are often ‘snookered’ by happenstance, accidentally, no back-scratch required. It’s just an honest misunderstanding, obviously.

Any doctors who work for KVPhama, you’re doing it wrong. Hospitals aren’t supposed to be casino’s. Your rules are from Hippocrates, not Hoyle. Find the money, follow it, and make this right.

Anonymous

This is NOT capitalism at work. In true capitalist states Governments do not grant monopolies.

inkfumes

It would be nice if at some point “Profit Before People” tactics became a mark of shame, disgrace, corruption, inhumanity and greed.

I have read the article and cannot find a REASON why the deal is exclusive? Why can’t another Pharmaceutical company apply to produce a generic version? Why the monopoly? That part isn’t explained…anyone?

cameronh1403

Be nice, but it will take a seismic shift of attitude for humanity (something on the level of what happened in Japan). This shift would move away from ‘having it all’ to ‘helping others out of the kindness of your heart’. Unfortunately, it appears that something like that will never happen in my lifetime :(

Anonymous

THEY FUNDED AN EXPENSIVE CLINICAL TRIAL.

Progesterone is now proven to be effective – taking it is not the same as it was before. Give them their 7 years; we have moved forward as a species. They picked their target well and took a risk — the same happened with colchicine recently.

This is how we have decided to incentivize getting the real science done. The drug is priced very high but still less than the cost of not taking it.

This is a success story.

Shawn Wolfe

I hope they’re keeping Hell hot for these people.

Anonymous

I really wish I could get a monopoly on water – let those bastards almost die of thirst and then let them buy a cup for $1500… IT’S WHAT THE MARKET WILL BEAR.

Blaven

Meh, why should I care, I got good insurance through my work.

6 months later: Why is my insurance deductible doubling?! Must be this socialist Obamacare!!1!

wiredfool

I wonder if that covers the pill version as well, which had good results for us. It’s also supplied from a compounding pharmacy, at totally reasonable cost.

There is no reason that a $10 treatment should cost $1500 for someone who makes over a threshold. I certainly believe that the better off should pay what they can, in general, but this is opportunistic price gouging.

lasttide

I’m guessing it was a phone interview, so this is a case of massive transcription fail.

Mark Frauenfelder

Here’s a news article from March 11 that says the former CEO of KN Pharmaceuticals was sentenced to one month in jail and a $1 million fine for misbranding drugs.

Mark Frauenfelder

The former CEO of KV Pharmaceuticals sports an epic beard.
- frijole
  
  Quote from that article:
  By 2008, KV was considered one of the most successful publicly traded companies based in the St. Louis area. But the criminal case against Ethex resulted in a two-year shutdown of KV’s production facilities and layoffs of three-quarters of its work force. Now, the drug company is hoping to revive itself with a new prenatal drug, Makena.
  
  Resurrect the business from the ashes by… ripping off mothers-to-be! Genius!
- Donald Petersen
  
  Now there’s a 19th-century robber baron look if ever I saw one.
- bja009
  
  I’ve met that guy. He is a massive asshole, and also not in jail for long enough.
  
  I met him because a family member worked (past tense) for KV for a few years. He was brought on to rebuild their sales after half the board and a bunch of other corporate leadership were fired for being corrupt assholes, and also incompetent. Nepotism played a large role.
  
  Unfortunately, nobody told said family member how bad things were. He got out as soon as the opportunity arose. KV is a corporation where corruption is endemic (no, not all of them are like that), and they’ve been flirting with bankruptcy for quite a while now. This is a money-grab some lawyer thought up for them, so that they can keep paying their bills while trying to convince the FDA to let them manufacture their own drugs again. (They can’t do it right because they don’t have real QC, as that would cost money.)
  
  For the record, said family member now works for a startup which, if successful, will reduce the cost and increase the safety to doctors/nurses of performing a certain type of surgery. Not all pharma is evil.

Anonymous

Given this situation, my new hourly charge for KVPharm and ChaseBank employees is now $275/hr, up from the standard $60 for people that haven’t pissed me off.

Anonymous

Yet another monopoly set up by our benevolent government. This is not a failure of free market capitalism; this is the government controlling the market and screwing over the little guy as usual. In a truly free market, copyright, patents, and all forms of IP rights would not exist.

Neon Tooth

Yet another monopoly set up by our benevolent government. This is not a failure of free market capitalism; this is the government controlling the market and screwing over the little guy as usual. In a truly free market, copyright, patents, and all forms of IP rights would not exist.

You’ve kinda got it backwards there anonymous spammer.
- Anonymous
  
  Nope. The first two lines are about right.
- Anonymous
  
  How exactly do I have it backwards? Copyright and patents are government intervention in the economy designed to create monopolies. A truly free market would not have any laws governing trade and so could not have any IP laws. I apologize for posting as anon but I do not want to register from work.

Vnend

Wow.

And I thought it was bad when colchicine went from $.22 a pill to $2.60 a pill last year. Same deal, multiple generic providers for years, then suddenly, boom! one provider and a huge increase in price.

Corporate greed in action, abetted by cronies in the government.

jenjen

Ooh, since this prevents spontaneous abortions, Georgia will probably make it MANDATORY! Profit!

doingdoing

Can we stop this?

Caroline

I was really frustrated that the article didn’t explain why KV Pharmaceuticals had been given a monopoly, so I went looking.

A link in the article implies that the exclusivity period is only for 180 days: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069964.htm

The 180-day exclusivity period is granted to a company who files for approval to market a generic drug on the grounds that the original patent is invalid. The idea (as I understand it) is that, if the original manufacturer has tried to patent something that shouldn’t really be patented, another company can correct that by challenging the patent — and that the second company should be rewarded for doing so, because they’re taking the risk that they could lose the patent lawsuit and have to pay the original manufacturer lots of money.

Presumably KV Pharmaceuticals applied for FDA approval of the drug on the grounds that the original patent (presumably owned by Squibb) is invalid, so they get the “reward.” (In this case, it’s a bit silly. The original patent owner hasn’t been selling the drug since 1999, and if it’s been compounded by pharmacies since then, that’s a pretty clear argument that the patent is invalid. It’s not like KV Pharmaceuticals is courageously standing up to someone making a lot of money off a crap patent.)

The 180-day period is counted either from the date the company begins to market the drug, or from the date that a court finds the original patent invalid, whichever comes first. It sounds like it’ll be counted from first day of marketing in this case.

Now, 180 days is a LONG time to someone who’s pregnant now and needs the injections. And $1500 is completely ridiculous. I’m now wondering how and why they arrived at the $1500 price — just pure price gouging while they have exclusivity?

But they haven’t been handed exclusive marketing rights forever. After 180 days, the FDA can let other manufacturers market it as a generic.

I wish ABC had explained any of this in the article.

g0d5m15t4k3

Thanks for the info!

cinemajay

Yeah, the price gouging reaches into the stratosphere of doucheyness.

I’d hope you’d post the article I submitted last week that had the gasps of astonishment from the docs:

< <"That's a huge increase for something that can't be costing them that much to make. For crying out loud, this is about making money," said Dr. Roger Snow, deputy medical director for Massachusetts' Medicaid program.

"I've never seen anything as outrageous as this," said Dr. Arnold Cohen, an obstetrician at Albert Einstein Medical Center in Philadelphia.

"I'm breathless," said Dr. Joanne Armstrong, the head of women's health for Aetna, the Hartford-based national health insurer.>>

There better be a forthcoming investigation into this…

Anonymous

http://www.pharmalot.com/2010/04/the-big-disaster-at-kv-pharmaceuticals/

A list of problems (only six paragraphs, but jam-packed with corruption and incompetence goodness).

Anonymous

According the the Ayn Rand purists, nothing to discuss here, it’s how the market works.
The key thing to remember is that, in the US Health Case system, you’re not the customer, you’re the product. The system exists to support the firms providing goods and services.

There *is* a sort of creepy logic to this. Analogy: the Autobahns in Germany, by and large, have no speed limits. This allows Germans to drive at insane speeds … thus supporting a local industry generating high-performance cars, … that the world buys. Yes, they have horrific car accidents that wouldn’t occur at slower speeds but, on the other hand, BMWs!

Nor is this just the view of a proudly-left-of-center polemicist. 1/ I run a business, and it costs us $25,000 per year to insure our US employees and nearly nothing for our non-US employees. 2/ This viewpoint was expressed precisely and cogently by the head-of-Asia for a US pharma house.

Just remember: you’re not the customer, you’re the product. And, should GOP reforms in other areas take hold, the same will be true for other areas – education, for example.

salparadise23

“According the the Ayn Rand purists, nothing to discuss here, it’s how the market works.”

For the 100th time, government-created monopolies are not a “free market”. Are you that thick?
zyodei

What? No man, I don’t want government. I don’t want corporations. I don’t want state charters. I don’t want any of that shit.

I want people, trading peacefully, with some sort of mechanism to punish people who harm others and prevent that sort of behavior. That’s it.

Don’t get stuck in the democratic-republican divide, where the argument is over which aspect of government to empower.

It is a useful question, of course, what exactly ‘capitalism’ is. Sadly, in our current world, it is often seen as state-empowered corporations screwing everyone and suffering no personal liability.

Call it what you will. I call it economic fascism. I believe in truly free markets, where every actor is 100% responsible for the fruits or thorns of their individual actions.

gsilas

This is not corruption! I don’t understand where you people are getting off thinking that medicine should be as cheap as possible. If there is no exclusivity, then the competition will be between chemical companies and who can produce the drug cheaper. This sounds good at first, but producing drugs and developing them are different issues, and developing new drugs is far, FAR more expensive.

If no one is paying medicinal chemists and biologists paychecks, then no new medicines will get developed. MRSA and other superbugs can start running rampant, and we won’t have the tools or technology to combat them.

Read more on drug discovery before you start crying out to overthrow the industry.

And reread this post:
http://www.boingboing.net/2011/03/15/an-expert-in-one-fie.html

wn

Ummm, think about about ‘IP rights’ and the illogical nature of stimulating markets with monopolies before you parrot the big-pharma group-think.

The pharmaceutical companies only exist, as their protected and pampered niche, because our government hands out sweetheart deals like this and patents. But the researchers would still be there, and without defectors siphoning off all the money for lobbying we could afford to fund the research directly.

Without the drug-pushers trying to out-advertise and out-lobby the competition we’d have a sane government subsidized system that served the people.

We only appear to need patents because we’ve twisted the system into a firsts-past-the-post winner-take-all nightmare. Take patents away and you’ll no longer need strong legal protection against – get this, patents.
- gsilas
  
  So the problem you identify is that people (usually via intermediary insurance companies) are being charged high premiums to fund drug development. And presumably, taxpayers should instead, be the ones funding drug development. Hmmm… (see: Obama health care plan)
  
  Then, you’re problem is drug advertising and lobbying. Sounds like you don’t want a government subsidized system, in which neither of these would go away because competition breeds advertising and lobbying, but you want a state-run drug development system. That sounds like a terrible idea to me. Instead of patents protecting IP, we’ll just get rid of all competition to breed innovation!
  
  Read up on the NIH Translational program, and then I’ll tell you that everyone I know in (remember, I’m an academic) thinks it is a terrible idea.
  
  http://pipeline.corante.com/archives/2011/02/14/new_cures_faster_faster.php
  
  http://pipeline.corante.com/archives/2011/02/01/the_nihs_new_drug_discovery_center_heading_into_the_swamp.php
  
  I don’t really have more to say on the matter, so I’ll probably go back to spending taxpayers money in my lab.
  - wn
    
    You imply that the money we’re spending now is more efficient (on a drug for drug basis), despite the insane exec salaries the fortunes wasted on dishonest advertising, the bribes to doctors, etc?
    
    We’d still have competition in “my” system, but it’d be a merit-based competition. Publish a better proposal, get funding. Produce better results, keep that funding. Waste the funding, don’t get more. Because we weren’t being dicked around by giant welfare-dependent companies we’d be getting the medicines we needed. We’d allocate funding based on deadliness and harm caused, not on what sells well.
    
    The thing about your argument (patents, MOAR patents!) is that you never need to provide any proof. The government and industry all loudly claim patents are essential, that all failures are aberrations, and yet never produce any evidence. And, of course, they are helpful – to a lucky few. But they’re tremendously expensive to society as a whole (tax, chilling effects, slower development) so if only a tiny portion of that is unreasonably given to some company they’ve still made out like bandits.
    
    It’s funny how in patent discussions the pro-patent side are always sure we’ve found the solution. Some monarch started handing out monopolies hundreds of years ago because it didn’t cost them anything and this is suddenly the pinnacle of modern development encouragement.
    
    And this despite how not only is there a ton of evidence against the helpfulness of patents and other arbitrary government restrictions and monopoly rights being given to incumbents that you’d have to be daft to suggest it anywhere else. Imagine giving gas-station monopolies to some company – to help the industry. It’d certainly help that company to record profits but ruin everyone else. And almost undoubtedly, everyone would pay more for gas.
    
    But no, despite a story crazier than a pasta-based creator and a wealth of contradictory evidence we’re just supposed to accept that the antiquated and flawed system we have is the best.
    
    Perhaps you’ve become so accustomed to corporate welfare you’re just afraid it’s going to go away?

grimc

I think Big Pharma’s astroturfers are the most dedicated.

KV DID NOT FUND ANYTHING. THE NATIONAL INSTITUTES OF HEALTH FUNDED THE CLINICAL TRIALS.

Geez.

Anonymous

Some people have to take this shot or otherwise administer it daily.
At $1500/time for 8.5 months =~ $400K, it’s simply impossible.

$10 drug now $1500 after FDA grants monopoly

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