This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.
slate.com
slate.com
At some point, this knowledge becomes a public good and the conflict of interest presented by those seeking to win approval also being the ones who stand to win a "get a monopoly free card" becomes too great a moral hazard to expect to overcome.
There just seems to be something fundamentally wrong with rent seeking someones pain, no matter what legal process led to that result. It feels like something we should have grown out of by now.
We've already did the private fire departments with medallions. Doesn't exactly work out when the non-medallioned house next door is on fire.
Or, we've read the articles about the for-profit prison systems. And they were even buying a judge to sentence juve offenders to the max.
Yes, private stuff does make sense. So does public.
This would be a disaster. It really is expensive to test drugs, and so pharma companies must carefully consider which ones are worth pursuing. If they no longer need to bear the cost, then they'll just throw everything at the agency. Then the agency will either fall behind, so that good new drugs never get approved, or it will tremendously balloon the costs of testing (and we're already complaining about those costs).
For new drugs hoping to win approval, which are inventions and are already granted monopolies via patents, things could still work the current way.
Interesting fact did you know that it used to be process patents only, now it's product patents?
I think anyone will agree that FDA's intentions are good. But sadly, what really matters are consequences, not intentions.
> In 2009, after winning FDA approval, URL Pharma won exclusive rights
Exclusive rights granted by who? Why blame pharmaceuticals for following the incentives they are provided with?
The truth is that FDA and other industry regulations increase costs in addition to destroying competition and innovation in the pharmaceutical industry.
Milton Friedman says it better than I can here: http://www.youtube.com/watch?v=dZL25NSLhEA
The various hurdles imposed by the FDA raise the cost of drugs. Various proponents of the current FDA regime tell us that this is necessary, and that the cost increase is worth it for the FDA guarantees of efficacy and safety.
Will those proponents now come out and defend the FDA in this instance? Will they declare that the new safety guarantees given to patients are worth $2.40/pill?
I don't entirely, though I'm not claiming malice either. The purpose of drug testing is to make drugs safe. The FDA has mistaken goals for means, and now they are testing drugs for the purposes of testing drugs.
If an untested drug has been used for decades by millions of people to treat a chronic condition that requires each of them to themselves consume the drug for decades at a time, that by itself puts such a sharp, strong bound on the maximum damage the drug may be doing that it is well in excess of what any study could possibly hope to establish. The improved methodology the study may have is simply swamped by the statistical power of a sample five or six orders of magnitude larger (measured in man-years) we have in the real world. In fact you just don't get any statistically more powerful than a "sample" of 100%.
Even if the study managed to produce some small negative side effect there is no chance in hell that it will exceed the positive value of a drug for gout.
I've actually seen this before. Several children's drugs have been "unrecommended" by the FDA for toddlers, not because they could produce a shred of evidence that they were dangerous but because the studies-for-the-sake-of-studies had not been done. Again, decades of use by millions of people dominates what any study could produce.
(By the way, when I say "dominates what a study would produce" I emphatically do not mean "is perfectly safe". I mean precisely that a study will not be able to find the small damage. Drugs have after all gotten all the way through our stringent approval process and then had to be pulled because it turns out they were still dangerous. If the process couldn't catch the several diet drugs that turn out to give you a heart attack, it isn't going to pick up on something that could escape hundreds of millions of man-years of usage. Studies do not have infinite resolution.)
It's a continuing degradation in the standards of science, as the disease of scientific form replacing scientific substance marches on. That's why I don't claim "malice" in my first paragraph. Malice is not required, merely the raising of form above substance. I do not call "intention to have good form even at the cost of substance" good intentions.
The $5-per-pill price URL Pharma set for Colcrys surprised the FDA
Find the people that were surprised and terminate them immediately. The "FDA" wasn't surprised, it was a few idiots left in charge.
What if they just do a compromise of $2.50 a pill, is that really going to help anyone when it was 10 cents previously? How about $2, or even $1 ? 1000% markup is okay when it comes to people's health? It's okay for the CEO to buy their 2nd or 3rd house with the profits while patients suffer? When as a society are we going to tell corporations they need to be responsible for all their actions and not just help a few charities to do penance afterwards.
In effect the FDA set a ~1 billion dollar bounty from doing 2 study's on this drug. What was not said is there are limited resources in the industry so while this company went after this fairly safe and profitable drug plenty of other companies went after other drugs and there is no incentive to research the same drug as another company. This is a land grab plain and simple and only an idiot would think a company would act any differently.
PS: And when you realize the only thing patents gained from this was higher prices you need to conciser it poor regulation. (1 study of 200 people says next to nothing about a drug regularly taken but 10's of thousands of people for hundreds of years.)
We can argue that this particular bit of regulation is wonderful or evil all we want, but to think that any for-profit organization is going to act in your best interest rather than it's own, or that it's even possible to regulate a company or person into doing so, is just plain naive.
In other words, if your business operates a monopoly granted by the state, you DO have a special set of legal, moral, and ethical obligations that don't apply to less privileged organizations. If a protected company DOES start to behave in an anti-social fashion, opting for pure profit-maximization and short-term shareholder gains, then it's the JOB of the government to attack them, rescind their monopoly, and generally punish the hell out of them for violating the basic contract that accompanied the initial grant.
If they don't like that possibility - or realize that they're just not up to the (admittedly challenging) task of administering an public trust along side a commercial business - then they can retreat to the less complicated, less ethically demanding, and more mercenary ranks of those operating in the free market - which has it's own set of mechanisms from weeding out the truly dishonest and abusive.
If there were such obligations, they would be made specific in the regulation. It's pointless to set the rules for the game and then get upset when they are followed. I personally find the price gouging distasteful as well, but those are my ethical beliefs and they in no way compel the behavior of others.
Hence my claim that the regulations should be the subject of the discussion, not whether some particular company is acting in accordance with our personal views.
To be fair, patients can continue to take the drug in it's herbal supplement form the same way people have been taking it forever. Or they can take tart cherry juice, which also works; a one month subscription for home delivery of tart cherry juice is only $60 on cheribundi.com
The few times I have had to take colchicine, I had to titrate my dose up, taking two 0.6mg pills to start and then 1 every hour, at least until the diarrhea and abdominal pain sets in. My gut has continued to hurt for months after the fact. The risk of organ damage, especially the kidneys, is serious. So it is important to watch exactly how much your taking so that you take the absolute minimum needed, usually around 3mg total for me. I don't think controlled upping of dosages is even possible with the herbal supplement version.
The relief it brings within 24 hours, after being 2 weeks into a devastating gout attack, is unbelievable. It is the difference between laying frozen in severe pain, unable to so much as twitch for fear of pain that is not unlike being stabbed. Try not moving the "stabbed" appendage under penalty of being stabbed harder additional times the moment you do. Severe, quivering pain is the result of this feedback loop, as you struggle to stay calm and limit movement. It is torture and rates very high on the official pain scale.
I have also drank lots of tart cherry juice, which may work as prophylactic but doesn't seem to bring attacks under control. It has anti-inflammatory properties similar ibuprofen (it is a COX inhibitor), and may help alkalize the body a bit, but this is not the mechanism colchicine works by, and the effect is not the same. This is common knowledge for anyone having to deal with gout. I don't drink cherry juice anymore, but I do make fresh lemonade to help alkalize my blood and take regular inexpensive COX inhibitors to control inflammation when needed.
I'm not saying cherry juice is bad, just expensive and not comparable to colchicine. I would not buy from cheribundi and just get 100% tart cherry concentrate in syrup form. The concentrate does not have added sugar, which has a significant acid forming effect that can scuttle the benefit.
The bottom line is Colchicine, which is now sold exclusively under the name Colcrys, has been written about since 1500BC. Ben Franklin brought it over here from France to deal with his own ailments. There is a long history behind the stuff and the studies required to monopolize the drug haven't changed the way it is used or made it any safer. Suggesting alternative treatments is a red herring, nothing else works quite like it.
This reminds me of Wikipedia of all things. I recently read somewhere about how Wikipedia had put all the door to door encyclopedia salesmen out of business. Families would often buy just a couple volumes because they were hard to afford, but now we have Wikipedia which is more expansive and comprehensive than what was offered then. Sure fewer $ are being made and that is a hit to the economy, but this shows that using $ earned as the the only measure of value is sketchy, particularly when competition is diminished through regulatory or other means.
The inverse has happened here with colchicine, introducing scarcity so $ can be generated. All the while providing diminished value due to the drug being financially out of reach for many, without any additional benefit to those able to afford it.
Makena (aka 17P), a compound used to control preterm labor got similar treatment. KV Pharmaceutical announced plans to multiply the price by x100 and set off a storm.[1]
The FDA has simply decided not to enforce the monopoly that KV legally acquired.
Beth Martino, a spokeswoman for the FDA, called the Makena controversy a "unique situation." Martino stressed that the drug agency's enforcement actions are discretionary, and that it has chosen at this time not to take action against other suppliers in order to "support access to this important drug." [2]
[1] It appears they spent something between $250,000 and $1m acquiring rights and commissioning studies for the FDA approval or existing practices. They appear to be set to reap 18 times that in monopoly rent.
[2] http://www.stltoday.com/business/local/article_26f67c9a-5ae9...
The whole IP system is a patch on top of hack on top of a compromise on top of a insiders club.
What happened to the rule of law?
It would be difficult to draft a definition of "abuse" that didn't encompass raising cost of a drug a hundredfold above the market rate in order to recoup costs invested not in research, but in acquiring the company that achieved FDA certification (mostly using existing NIH funded research) for an already widely-available treatment.
It is a damn mess, that should have been the first thing addressed in health care legislation, because it is an input cost to health care. I sometimes wonder if separating the research from the producer and guaranteeing royalty for a number of years after approval would have been a good way to go. Much like not allowing film companies to control the theaters back in the day.
But if a drug is approved by the FDA, then the drug company is inured against liability for that drug.
Drug companies should not have to worry about lawsuits unless they knowing let a dangerous drug on the market, but people and doctors ignore warnings and nothing is totally safe for everyone.
Who's up for creating a website to share recipes of these drugs?
No, seriously, somebody please figure a pharmaceutics delivery business model that does not depend on FDA for legality & operations.
Many of the plants used in traditional chinese medicine are extremely dangerous to use otherwise. One I know, if injected, causes death. If you breathe the smoke of the same burning material, you cannot speak. But just like all drugs, they have their intended purpose if used wisely.
Now, how about would they get around the FDA? It's simple: It's the chemical application of the Tao Te Ching. It's cheap, but pull the "spiritual and religious" card.
There are ways around that, but (I hope) the "cheap drug spammer" market is saturated.
These could fall under a dietary supplement, which would have been the easy route for the drug companies to take. However, if they had done that, they may not have been able to over-charge.
Makes one wonder if the FDA isn't so focused on their 'rules' that they ignore the opportunities around them. They had to have recognized that this 'drug' which has been around for centuries is likely mostly herbal, and therefore fit the FDA regulations for dietary supplements.
In these cases though, the counter-argument to that is the price jump is unjustified relative to the $ invested in doing the testing.
If the FDA can't do its job properly, then it should stay the hell out of the way.
The point of the article was that the FDA used to approve other manufacturers, but then required higher standards which only one manufacturer can meet. So now there's a de facto monopoly - not because of a patent, but because of the requirements the FDA set (retro-actively). The FDA needs to restrict itself to more basic testing (rather, testing requirements) so that the market can take over in the price setting of the drug through competition.
(I'm not an expert on the chemistry and medical aspects of pharma; actually I don't know anything about it. I don't know if, in the specific case of the article, the additional requirements set by the FDA are really required, or just paranoia. I think the FDA, and similar bodies in general, need to relax on their 'err on the side of caution' principle. To put it extremely - yes it sucks to be harmed by a thus far unknown side effect of a drug or food, but requiring near-100% safety on everything on the market hampers progress, and we can't know if the positive effect outweigh the negative ones. I hypothesize they don't, but until we know, let's lay off the state nannying, and replace it with a clearer mechanism to let consumers know how far something has been tested, so that they can make their own choices on whether or not they want to take/eat the drug/food).
These are drugs that have never been approved by the FDA. No manufacturers were previously approved and no standards have been changed.
The FDA wanted clinical trials on the drugs. There are incentives in place to encourage companies to develop drugs for rare conditions where there are not enough patients to warrant investing in for economic rewards (and yet you envision companies in competition over them). These include grants for the required trials, tax credits for half of the cost of developing the drug, and a seven year monopoly on the drug.
Now it's quite possible that I'm wrong - what was the cheap version that the author was taking before then? Wasn't it a product of a competitor? And if so, why isn't it available any more?
It's not available now because the FDA wanted certain tests done which hadn't been. No company did the tests because it wasn't worth their time/money to do so. The FDA _made_ it worth someone's time and money by offering them exclusive rights for 3 years if they did the tests. One company ran the tests, got approved, and was granted exclusivity as a reward. Supply plummeted (manufacturing went from many sources down to one), demand remained high, and prices increased 50x as a natural consequence.
The Law of Supply and Demand rules. It always does. Screw with it and you'll get hurt. The FDA screwed with it, and people got hurt.
Drug testing is designed to prevent actually harm. With the manufacturer's plan it seems that the only people that will have to pay significantly more make over $100k/yr and probably have it covered under their health insurance anyways.
http://nielsenhayden.com/makinglight/archives/007140.html
EDIT: Which is to say that the problem is the FDA jerking people around in general.
The drug maker K-V Pharmaceutical obtained exclusive
rights to produce an injection for women at high risk of
delivering prematurely. But the FDA is opening up the
market to specialty pharmacies after the company raised
the dosage price from $20 to $1,500.
In this case it's drug on it's own. I.e. manufactured. And for this they do actually have the legal right to be the only ones making it.
One particularly frustrating example I heard from my sister was about a mother on Medicaid who refused to switch her 19-month old infant from formula to solid food (infants usually make the transition around 7 months), complaining that the child had digestion problems when she tried. (Digestion problems are normal and temporary during the transition.) Formula is more calorie rich than seal milk and nearly as expensive as printer ink, however the patient had to pay for food but didn't have to pay for formula. As a result the infant became obese and developed diabetes - the treatment for which, is also covered by Medicaid.
Meanwhile uninsured/ineligible patients are forced to go for the "generic brand" pills due to a huge price disparity. This wouldn't be so bad as generic brands are generally just as effective, except that suppliers of generic brands can sometimes change who they source their pills from, subtly changing the dosages with them so users must constantly stay on alert to see if their pill changes color or shape as this could be an indication of a shift in supplier and depending on how sensitive the drug is, have mild to severe repercussions.
The Obama health-care reform was seeking to fix this issue by providing a third party government insurance plan which would promote a more transparent market in this arena amongst other things...
So, patients pay (a bit), so they avoid unnecessary treatment. But they don't have to pay to much. And if the drug companies try to play funny-buggers, they get shut out.
Also, the subsidy process is completely hands-off (it's run by an untouchable board of experts), so while it's a little inefficient (untouchable experts are always inefficient) it's incorruptible.
If they're actually incorruptible, that process can not be used in the US.
Disagree? Then produce a couple of incorruptible groups of experts with comparable powers in related areas.
Hope is not a plan.
As far as the US is concerned, it doesn't matter what works elsewhere, what matters is what will work here.
As a non-US citizen (I'm from the UK) I can't believe that such an obscene set of symbiotic relationships have been able to be formed between the medical establishment, medical insurance industry and pharmaceutics.
There are some things that benefit all - and some issues that every human holds close to their heart. Medicine and the ability to recover from ill health is too important to let companies hold individuals to ransom.
I'm shocked the situation was ever allowed to get this bad.
This is stupid. It's not the fault of the FDA (they're following the law) and it's certainly not the fault of the manufacturer. It's congress.
http://pipeline.corante.com/archives/2011/03/11/makenas_pric...
http://pipeline.corante.com/archives/2011/03/24/more_on_kv_a...
http://pipeline.corante.com/archives/2011/03/30/kv_pharmaceu...
This Google Books link seems to give the appropriate amount of drops per hour, which passes my BS detector. But like I said, you need a real herbalist for guidelines for making the tincture, or buy it from them.
http://books.google.com/books?id=gDLIrCv26hkC&pg=PA272&#...
http://www.aminaherbs.com/product.php?id_product=91 Also sells the seed, as do other sites. I just found this one due to the bulk nature that they sell in. I have no clue if this company is good, but just wanted to show that it is easy to buy.
Lastly, I thought this was some sort of sick "April Fools". Come to find out that this is normal FDA business with corporate profit extraction.