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This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

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Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#61
post #52

The FDA has a somewhat scary recourse here: 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 a…

"You abuse it, you lose it" actually sounds like a pretty good rule of thumb for enforcement of patent law...

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#62

> One can't fault the FDA for the price increases for Makeda and Colcrys; the agency is doing what it's supposed to do, clearing out old drugs and improving the standards of the national Pharmacopoeia. (Disclosure: I worked as a speechwriter for FDA in early 2010 but had no involvement in the colchicine or 17OHP issues.) I think anyone will agree that FDA's intentions are good. But sadly, what really matters are cons…

Mary Ruwart (a doctor and also a leading candidate for the libertarian party's presidential nominee in 2008) has written on this subject: http://www.ruwart.com/Healing/chap6.html.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#63
post #22

Just had an epiphany. If it is these old drugs (since 6th century) that are getting monopolized.... It means they don't really need advanced technology to create! Just grind some herbs, measure carefully, sun dry, etc. If they're over-charging by 5000% you might actually save money producing the drugs yourself for self consumption! Who's up for creating a website to share recipes of these drugs?

http://www.fda.gov/food/dietarysupplements/default.htm

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.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#64
post #52

The FDA has a somewhat scary recourse here: 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 a…

"You abuse it, you lose it" actually sounds like a pretty good rule of thumb for enforcement of patent law...

define abuse a priori.

The whole IP system is a patch on top of hack on top of a compromise on top of a insiders club.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#65
post #52

The FDA has a somewhat scary recourse here: 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 a…

"You abuse it, you lose it" actually sounds like a pretty good rule of thumb for enforcement of patent law...

Where "abuse" is defined by fiat, rather than clear apriori regulations?

What happened to the rule of law?

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#66

Drugs are broken in the US. The FDA testing of a drug costs a huge pile of money (I was in Clinical Trials for a while). Most protocols don't work out so your success rate is somewhere around the success of rolling out software. The ones that do, take a long time and allow for a very limited monopoly period. So, you spend a lot of money on advertising to maximize. Plus, the FDA does weird crap and drug producers up t…

The way to deal with it is to allow legal consenting adults to take any drugs they want to - provided they sign a contract saying they understand the drug is not approved by the FDA.

But if a drug is approved by the FDA, then the drug company is inured against liability for that drug.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#67
post #55
post #36

Earlier quoted context omitted.

I don't think you understood what he was saying. 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 s…

It seemed pretty clear that in addition to the FDA he was attacking the company for behaving like a profit seeking entity (which it, of course, is). He questioned whether it is "ok" for them to charge the particular price they wanted and questioned how many homes the CEO should be able to own while there are still suffering people in the world. We can argue that this particular bit of regulation is wonderful or evil…

Relentless profit-seeking tendencies combined with monopolies are fundamentally toxic. Which is why we (generally) outlaw monopolies. The ones we do grant have (in theory) provisions that favor the public interest.

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.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#68
post #3

Based on previous "investigations", basically nothing will happen to the company and things will continue as usual. 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 cen…

"It's okay for the CEO to buy their 2nd or 3rd house with the profits while patients suffer?" 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

They all look alike to me, tart cherry juice and colchicine must work just the same! This struck a chord with me, it is like saying MySQL and Ruby are both used to make websites, why not replace one with the other?

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.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#69

Drugs are broken in the US. The FDA testing of a drug costs a huge pile of money (I was in Clinical Trials for a while). Most protocols don't work out so your success rate is somewhere around the success of rolling out software. The ones that do, take a long time and allow for a very limited monopoly period. So, you spend a lot of money on advertising to maximize. Plus, the FDA does weird crap and drug producers up t…

The way to deal with it is to allow legal consenting adults to take any drugs they want to - provided they sign a contract saying they understand the drug is not approved by the FDA. But if a drug is approved by the FDA, then the drug company is inured against liability for that drug.

The FDA already has rules to allow patients to take drugs being tested if they are on death's door (cannot remember the terminology or exact rule).

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.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#70

I think maybe its about time we set up something life the NSF to conduct these trial for the FDA (in the particular case of orphaned and old drugs) and generally does a much better job of dealing with the mess that drug trails have come to be. 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 monopo…

This is not a story of greed, it's a story of how product patents are effed up.

Interesting fact did you know that it used to be process patents only, now it's product patents?

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