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 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.
I think maybe its about time we set up something life the NSF to conduct these trial for the FDA
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).
I read the comment as proposing only that the NSF (or someone) run the trials for old drugs that are already widely used, in lieu of the current odd system of re-monopolizing drugs that had previously been widely available as generics.
For new drugs hoping to win approval, which are inventions and are already granted monopolies via patents, things could still work the current way.
Oh sure another taxpayer funded job-killing GOVERNMENT agency. Don't you understand that the private sector, in combination with absurd patent/monopoly incentivization, is the ideal solution to all human need?
I can imagine privately owned roads. Toll booths every few miles sound far fetched? Try looking at midevil europe, and that would be the US you would have.
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.
> 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 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.
"I think anyone will agree that FDA's intentions are good."
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 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?
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.
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 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.
This is just unbelievably incorrect, absurd, and just shows complete ignorance of the healthcare industry. Profits for healthcare companies are the same as those in any other industry. A quick check on Yahoo Finance will let you compare their respective financial statements. The culprit is in the endless rules and regulations that drive up costs to make the pills, preventing competitors from coming in to drive down the costs.
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.)
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 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.
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.
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 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.
"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.
I'm still optimistic. For some reason, while the general exclusive is for 3 years, for my condition(Familial Mediterranean Fever) it is 7 years. Yikes.
Yes. The FDA regulates (among other things) "indications" for drugs. For example, you can't represent that a drug is effective at treating something without FDA approval. So, currently, only one company can make this pill, and even then they can only sell it for a specific list of diseases. After some time, other companies will be able to make the pill and sell it for the same list of diseases, except this one. The FDA has the power to regulate the claims made by various companies, so this was probably a compromise that was part of a larger deal.
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.
This is a situation where inconsistent enforcement of law actually works to the consumer's advantage in reducing the number of edge cases where companies make speculative bets on exploiting weaknesses in the formal certification process. Especially with the FDA carefully trying to avoid setting any precendent.
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.
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 the price. It is a very weird cycle. Including, spending a lot of time on stuff that is more lifestyle than cures. Never mind the liability laws, since almost every drug made will react badly with someone.
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.
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.
If you've got a chronic/debilitating/painful illness, as long as you're not about to drop dead, no soup for you? I can't see how that is a compassionate, just, or rational policy.
With the current court system, it is about as good as it gets. Contracts absolving other parties of responsibility don't hold up in court. Heck, take a look at all the problems around Accutane. If you take it, you are told and sign forms stating it can cause depression. Well, it looks like that won't be good enough. People's love of punishing the big even companies have doomed those that suffer more than the revenge has ever been worth.
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?
"Don't be based out of the U.S." would seem to be a simple solution. The problem being that most other jurisdictions where you can actually make money have similar problems.
There are ways around that, but (I hope) the "cheap drug spammer" market is saturated.
I dont know of a business model, but a TCM practitioner would fit the rest of the criterion.
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.
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.
The counterpoint to that is if they don't grant the exclusivity, the cos won't be willing to invest money and resources to do the testing because the returns wouldn't be as strong.
In these cases though, the counter-argument to that is the price jump is unjustified relative to the $ invested in doing the testing.
At first I was puzzled by the upvotes because pro-monopoly arguments are usually unpopular here, but then I realized that I didn't really express myself clearly and that probably my argument was misunderstood :) So I'm not against drug monopolies, or patents, (or copyright, for that matter) - in fact I'm staunchly pro those things; the problem in this case is the strictness of the FDA, setting an arbitrarily high bar, causing all but one manufacturers to not be able to produce the drug any more.
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).
You do not seem to understand orphan drugs or this article. Basically every word of your second paragraph is incorrect.
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.
It was my understanding from the article that originally there were several versions of the drug, then something changed (the author seemed to blame the FDA) after which there was only 1 left, and then there was a price hike.
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?
Whatever the prior sources (IIRC, pharmacists could just whip up a batch), making it was cheap, legal, and unrestricted due to grandfathering. FDA wanted to regulate it, and granted someone exclusive rights to achieve it.
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.
It was not legal to make these drugs. However, the FDA did not want to suddenly get rid of drugs people were already taking so focused their efforts on drugs that they thought were harmful first.
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.
OK thanks, that's indeed a different chains of events than I initially thought, but the derived reasoning still holds - the FDA should've stayed out to begin with.
Perversely, these monopolies are often granted on the basis of 'natural monopoly theory'. If it's a natural monopoly, why does it need to be further enforced (preserved?) by a law?
Eh, what? What monopolies are granted by law on the basis of natural monopoly theory? As you state, there is no reason to put them into law; natural monopolies are usually the ones who are broken up by regulators, to enforce competition (e.g. telecoms, energy manufacturing/distribution, public transport, ...)
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.
Hopefully they will do the same for colchicine! So far, no cigar though and we(colchicine consumers) have a pretty active community that's been trying for years now to prevent this from happening with little luck.
It's not the same. The previous "drug" was really just mixing two existing drugs together. The company hoped they could legally prevent people from mixing those drugs. But the individual unmixed drugs are widely available. The FDA said they would not prevent people from mixing (compounding) drugs.
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.
The problem doesn't end there. Once these drugs' exclusive rights expire and "generic brand" prescriptions are allowed to compete, most insured patients will still prefer the "name brand" as they are only charged co-pay. Some insurance providers may place restrictions on which drugs are eligible for treatment but this is not the case with traditional U.S. sponsored Medicare/Medicaid (patients are free to choose between "name brand" and "generic brand"). Medicare/Medicaid patients may also be eligible for limited co-pay exemption. ("Why wouldn't I take the 'name brand'? I'm not paying for it./I'm paying the same price anyways.") This further drives up the price of "name brand" medication, simply because the "name brand" can get away with it. "Name brand" suppliers will also cut discounted deals with various insurance companies...no such luck for the uninsured though.
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...
In Australia, most people have to pay for drugs. There are subsidies available. If a drug company wants the subsidy, it has to offer a fair price. If they don't offer a fair price, then they don't get subsidized, and nobody buys it.
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.
> 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.
Surely the problem is the insurance industry? If the insurance industry wasn't able to foot the bill, no one would buy the product and market forces would be able to set a reasonable (affordable) price.
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.
There is some large cost of doing this drug research, with benefits that will accrue to all the people taking colchicine for decades into the future. The problem here is that congress has decided, through the Orphan Drug Act, to place that cost just on the patients who take the drug in the next 3 years (the length of URL Pharma's monopoly).
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.
I would agree with some of the other comments. The burden of testing this historical drugs should not be placed in the industries hands. The FDA should run the testing, either with its own money in the common interest or allow the collection of manufacturers of a certain drug class to divide the total bill. The practice of back dated invention seems archaic.
Gout may be another disease of civilization which might be preventable with diet. Gary Taubes had a chapter about this that he didn't have room for in his book, Good Calories, Bad Calories, but you can read it online: http://www.fourhourworkweek.com/blog/2009/10/05/gout/
I get saddened everytime I see this old story of greed and indifference. I've had a personal run-in with it myself: for years, we Scandinavians with sleeping disorders could enjoy Melatonin from several different producers to a very low price. About two years ago a company called Nycomed managed, with lies and deception, to get a monopoly on selling Melatonin in Scandinavia by convincing our governmental medical products agencies that Melatonin was harmful and had severe side-effects - of course, all Melatonin but their own magic kind, marketed under the name Circadin. Before their "coup", I could purchase 30 tablets á 2mg Melatonin for €5. Nycomed wants €22 for 21 of their 2mg tablets. We're close to a million people here in Scandinavia who rely on Melatonin daily to get our sleep. Why did you let this happen to us, Scandinavian MPAs?
As a 'budding' herbalist (sorry bad pun), I'd almost be willing to make my own tincture of this drug. Websites out there are doom and gloom only because you need to talk with a real herbalist about the proper mixture and technique in which to extract the chemicals.
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://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.
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.