The price of $3k for 8 doses is so high compared to regular ketamine. I wonder if there is any real difference or if you’re really just paying for the comfort of doing it legally under the guidance of a doctor.
You're really paying for the cost of bringing a new drug to market for a specific label use. It wouldn't be worth the multi-million dollar expense for any for-profit company to do the FDA process to show that ordinary ketamine is effective for depression, because they couldn't privatize the profits to recoup their costs.
Instead they make an arbitrary but likely nonfunctional[0] chemical change[1], get it approved, and use their patent to demand high costs to recoup their FDA process fees (and if they're lucky, to make a profit).
[0]: Edit/clarification: Apparently some (meta)studies suggest the S-isomer is better than the racemic mixtures in some ways (waving my hands; I did not read or understand the details).
[1]: Edit/clarification: I don't know enough chemistry to be sure if describing the extraction of the S-isomer from the racemic mixture is a "chemical change," exactly, but you get the idea.
The trouble for anyone (citizens, government, and biotech companies) is sifting the wheat from the chaff as far as what drugs are likely to be safe and effective treatments. You could give away all of your money and not end up with one approved drug.
Edit: It's a common delusion that pharmaceuticals are sold for therapeutic uses. Actually, they're a mechanism to monetize intellectual property.
Edit: Oops. For having just the active isomer.
Edit: That comment about monetizing intellectual property comes from an expert economist :)
And just because it’s present in a plant doesn’t mean it can be drugged. It could have a short half life, high toxicity, etc., so derivatives are made to optimize it’s action.
Finally, even if a patent can’t be secured, the first version of a drug is given exclusivity by the FDA - they won’t approve another version up to 7 years (orphan drugs).
A cursory look at the top selling drugs of all time doesn't appear to show any plant derived drugs [0]. Obviously this does not disprove your statement but its the quickest heuristic i could think of
[0] https://en.wikipedia.org/wiki/List_of_largest_selling_pharma...
OP's statement was about sheer number of patented drugs. I don't know that OP's statement was accurate, but the wikipedia link doesn't really refute or confirm the idea.
[1] "pharmaceutical and biotechnology sales revenue increased from $534 billion to $775 billion between 2006 and 2015.... Drug industry spending for research and development increased from $82 billion in 2008 to $89 billion in 2014" (I assume there are other costs so one cannot simply divide to get gross profit but it seems illustrative)
In 2018 only like 12% of new FDA approved drugs were developed by big pharma. 63% were developed by small companies. A negligible amount were discovered by universities alone
Pharma acquired these drugs from startups through M&A which doesn't show up in profit and loss statements. It shows up on the balance sheet
That $84B r&d figure seems very low. The top 15 pharma companies spend something like $75B a year in r&d. VC backed startups spend like $10-15B. Then all the firms in between account for the majority of spending. Don't remember the source but I think total global pharma r&d is like $200B
https://www.nytimes.com/2014/11/19/upshot/calculating-the-re...
In 2018 only like 12% of new FDA approved drugs were developed by big pharma. 63% were developed by small companies. A negligible amount / zero were developed by universities
The $161M figure cited in that nytimes study is not at all representative because most early stage r&d is done outside of big pharma, and then big pharma buys the drugs and markets them
If drug research was profitable pharma would be doing more of it, not less
But maybe there's also a patent on the delivery mechansim. Or maybe it's a process patent.
Janssen obviously believes that it's valid. Or at least, they're confident that they can defend it. Maybe they know that it's not valid, but are confident that others won't figure out why.
In one case that I recall, the manufacturer bribed a chemist to retract a paper that had reported the synthesis of their drug.
Many years of budget cuts have rendered the Patent Office pretty clueless about drugs. And the FDA doesn't do any independent assessment of patent validity. I've seen testimony where FDA staff said that they lack expertise for that.
So basically, patents are valid if they survive litigation.
Anybody could perform a sufficiently capable of job this has way better career opportunities than earning $80k at the patent office. While this does support your notion of budgetary cuts being the primary problem, again I think that misses the core problem which is that the system has become so convoluted that actually having a meaningful holistic understanding requires immense skill and education. Systems that are supposed to be for public, and individual, use should not require a juris doctor to begin to parse.
The whole system needs a major overhaul, frankly like much of our formal structures. Isn't it a bizarre system that people are expected to completely obey laws which they are in no way expected to be able to completely understand?
> "A person shall be entitled to a patent unless . . . the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention."[0]
0) https://www.whitecase.com/publications/alert/supreme-court-s...
But if S(+) ketamine has been commercially available, even if only illegally, it's not patentable.
How could they recoup those costs without IP protection?
[1] https://clinicaltrials.gov/ct2/results?cond=&term=Esketamine...
So the next version will be monetizing the delivery system.
Clinical benefit -- making sick patients healthier -- creates value
You need patents because without patent protection, no one would invest the large sums of money and take on the huge risk to bring drugs to market
These days, investors and companies generally only fund development of drugs that provide a significant clinical benefit to really sick patients. This is because they deeply understand that value in pharma is determined by clinical benefit
The statement that pharmaceuticals are not sold for therapeutic uses is just wrong.
That's just semantic hand waiving.
Patents create value. With no patent, as with generic drugs, price approaches marginal cost of production. With a patent, price is limited only by competition with other therapies. And sometimes by regulatory intervention.
> These days, investors and companies generally only fund development of drugs that provide a significant clinical benefit to really sick patients. This is because they deeply understand that value in pharma is determined by clinical benefit
That's because "really sick patients" are desperate.
Right. But the thing is, bringing a drug to market is extremely expensive. So without patents, there isn't a financial incentive to bring a drug to market. Biotech companies aren't charities.
> That's because "really sick patients" are desperate.
Not sure what you're driving at. The alternative to offering an extremely expensive patented drug to really sick patients is no drug at all (or whatever the previous standard of care was). Yeah, drugs are expensive until the patent runs out, but the patent does eventually run out.
Without this system, we wouldn't have new drugs brought to market by for-profit companies. With this system, sure, new drugs are really expensive the first 17-20 years. But then they're really inexpensive, and exist. In the other timeline, they simply did not exist.
However, I am arguing against patent protection for de minimis structural changes that have no substantial therapeutic benefit. Or bullshit delivery systems.
For example, I use testosterone creme. Androgel costs a bloody fortune, because their formulation (basically hair gel) has patent protection. So I use a compounded cream that costs ~90% less.
> The alternative to offering an extremely expensive patented drug to really sick patients is no drug at all (or whatever the previous standard of care was).
That's not the only alternative. Drug development ought to be publicly funded. As it is, the drug industry tends to leech off publicly-funded research. And drug manufacturers ought to be paid only for the manufacturing.
Potato, potato. If they don't do the work to get FDA approval, even with the bullshit de minimis change, the alternative isn't a patent-free generic — it's nothing, for any price.
> Androgel costs a bloody fortune, because their formulation (basically hair gel) has patent protection. So I use a compounded cream that costs ~90% less.
So what is the problem with androgel's patent? How does it make your life worse? If they didn't have the patent, you'd still be using the same previous standard-of-care.
> Drug development ought to be publicly funded.
Well, good luck with that.
> And drug manufacturers ought to be paid only for the manufacturing.
Like, at-cost? I think you'd see drug manufacturing die out under that proposed policy.
No, the alternative is some old generic drug, which is just as effective as the new one. But the manufacturer bribes doctors to prescribe the new one, which has no generic equivalents.
> So what is the problem with androgel's patent? How does it make your life worse?
Because for years there was no commercial alternative. It was only by chance that I found a compounding pharmacy that sold an old-school version.
> Like, at-cost? I think you'd see drug manufacturing die out under that proposed policy.
That's how it works for generics. And there are lots of generics.
This is a little simplistic. The FDA strongly prefers evidence that new drugs are more effective than existing treatments. They look at the target condition and available treatments, including existing generics, to weigh the benefits and risks of a new drug being approved.
And the only reason that "old generic" drug exists at all is because the patent process paid for its R&D more than 20 years ago.
> But the manufacturer bribes doctors to prescribe the new one, which has no generic equivalents.
This is illegal, for obvious reasons. I suspect it is less wide-spread than you think.
> Because for years there was no commercial alternative. It was only by chance that I found a compounding pharmacy that sold an old-school version.
So you're saying there wasn't an alternative treatment available and androgel brought an effective treatment to market and was rewarded for it? And they shouldn't be, because?
> That's how it works for generics. And there are lots of generics.
Generics manufacturers first, absolutely do not sell at-cost; they're for-profit companies trying to make money, not charities. And most importantly, they don't develop novel drugs.
I've seen many thousands of internal documents from pharmaceutical firms. It's ~all about the money.
Except the government.
They already fund virtually all basic research in the US (and the world). I don't understand why they couldn't start funding pharmaceutical R&D.
Plus 30% or so of NIH money goes to universities for "overhead" and not to research
The odds of a promising academic finding becoming a drug are incredibly low. and there is not enough NIH funding to support drug discovery and development
I also think that if drug research was publicly funded t would be a nightmare. You'd probably end up with drugs costing more than they do now (in terms of added taxes you'd have to pay to bolster NIH budget) and getting fewer drugs approved. Pharma r&d is actually held to a much higher standard in terms of robustness than academic science. The incentives are just messed up in academia -- people want to publish first and foremost, not make medicines. And you can get crappy / irreproducble science published fairly readily
One of the first things pharma companies do when considering licensing academic tech is try to replicate the findings independently. Often they can't
At least in pharma, the incentives are to make drugs that get FDA approval, that docs prescribe to patients and that insurance companies pay for. For all that to happen the drugs have to work and work very well. And even with the profit motive as an incentive there is still poor decision making and incentive alignment
some people are studying ketamine + some sort of therapy, but it isnt clear whether this actually works, who it may work for or what the ideal regimen is. the idea is that ketamine treatment provides a very rapid antidepressive effect, but that effect isnt durable after treatment stops. some forms of psychotherapy are more effective when people are only mildly depressed, so ketamine can "prime" people for psychotherapy