I've always been very, very skeptical of this claim.
If there's an actual natural, identified substance with huge benefits to people, it's going to go gangbusters and you're going to make a lot, LOT of money selling it, even if you're doing it via roadside lemonade stand.
It feels like this claim is usually used to promote cures and treatments with extremely low quality RCTs backing their use as a sort of panacea.
I used to believe the "just do shrooms to cure depression" claims on principle until I looked into the quality of those studies, which is very low. At that point, you're just making stuff up.
Caffeine is grandfathered in as a Generally Recognized as Safe food additive. If energy drink companies had to go through clinical trials with no patent protection for each drink formula, they wouldn't make them.
I think the current regulatory regime in many US states allows companies to make a killing off of selling naturally occurring bioactive substances as dietary supplements with few regulatory hurdles.
Kratom, CBD, and delta-8 THC are naturally occurring bioactive substances that are newer to the US market. Both have carved out a pretty nice economic niche with a bunch of claimed health benefits.
A couple of years back, I saw a sign outside a fancy legal highs shop in Fishtown, Philadelphia touting the benefits of kratom as a pre-workout supplement. The insanity that a business was advertising an addictive opioid to healthy, opioid-naive people for better gains in the gym almost makes me want more regulation in this area.
Your point is a bit undermined by the fact that two out of your three examples are cannabis extracts, where cannabis proper - literally a leaf - is still very much illegal and has to be "laundered" through chemical processes to make it less fun and therefore "medicine" instead of "recreational drugs".
I think your point and mine can both be true at the same time. Cannabis is the subject of a past regulatory regime that restricted nearly all psychoactive substances popular at the time (natural or synthetic). The actions of that regime do not go away when the zeitgeist changes. The current regulatory regime is much more dovish, and that is visible in the difference between the controlled status of chemicals that became popular recently versus similar ones that were popular 50 years ago.
Isn't it relatively easy to sell anything "naturally occurring" as a supplement? I think there is very little regulation (of course if you want to claim it's a drug and presumably charge much more for it it's another matter).
Even synthetic research chemicals are generally legal as long as you add a "not for human consumption" label (and they aren't explicitly banned or analogous to other illegal/regulated drugs).
The global coffee market is worth $138 billion, the soft drink industry is $556 billion (and growing). The vast majority of which being caffeinated. Starbucks the company is #116 on the Fortune 500 and #1 in food services. There's sufficient economic activity to warrant continued research in the area.
Lithium is a good counter. It is by far the best treatment for bipolar 1, and its cheap and easy to source. Prices for lithium carbonate and other lithium medicament's are not at all cheap, and there are not a lot of medical companies producing it. There has even been shortages. Instead antipsychotics have been pushed as a preferred treatment, even though the outcomes are worse than with lithium.
Lithium in dosages effective in treating a mood disorder is quite toxic (e.g., to the kidneys) so most of the price is probably to offset the risk of lawsuit awards.
With regular blood checks its not an issue. You can catch it before the kidneys take damage. Antipsychotics are literally neurotoxic (first gen atleast).
I'm skeptical of your claim because if there's any additional margin to be made doing it artificially, at big-pharma scale history shows that they plenty willing to squeeze every penny out that they can even if it's less effective/natural.
Right, but there is a free rider problem. Why should a company spend $100 million doing clinical trials to get FDA approval if once it is approved, all other companies can sell it, even though they didn't pay anything? Even if every actor in the market thinks there will be a good return on investment if they get FDA approval, there is a strong incentive to instead wait for someone else to do it and free ride on them. The result is no one acts.
Clinical trials are a significant expense in developing a drug. Kind of makes me think we should award patents not for coming up with some molecule, but instead award them for showing a molecule is safe and effective.
CBD, which doesn't appear to have a fraction of the therapeutic efficacy of something like Ozempic, is a multi-hundred billion dollar industry now with a lot of active research.
Do you have a source for that? Everything I can find online puts global CBD industry revenue at less than $10 billion. And that's everything. The only FDA approved use of CBD (treating seizures), I'm sure is only a tiny fraction of that.
In any case, none of that refutes that there is a strong economic incentive for market actors to not fund FDA approval trials since any benefit will be shared by the entire market.
Nitrous Oxide (laughing gas) is both significantly cheaper, and less risky than epidurals for reducing pain during childbirth. Yet, in the US, most hospitals don't even offer it as an option, and I think a major part of that is that patented epidurals have much higher margins, so that is what the medical suppliers push.
I doubt it. It's very commonly offered in the UK and while it's cheap and safe, based on what I've seen it's also not effective at all. Forget the same league, it's not even playing the same game as an epidural. An epidural is a drip of opioids right to your spine. Proper hardcore.
If the molecule itself is not patentable, the process of efficient extraction or synthesis may be. So, if somebody can come up with it, they may have a thriving business.
The substance in question is a peptide. It's not something you simply extract from a plant using a solvent. OTOH, being a peptide, it's likely easy enough to produce in a genetically engineered bacterium or yeast. Efficient extraction may remain a problem though, because you'll need to select a particular protein fragment (the peptide) from reams of other protein fragments of the bacterial / fungal cells you process.
The extraction problem has been solved for a long time to make recombinant insuline. Before that it had to be extracted from an animals pancreas. These days peptides are often improved using non-natural amino acids to make them more stable and thus longer acting. Semaglutide is a good example. These are synthesized using solid-phase synthesis.
Other mentioned extraction and such, but semaglutide had been known for some time, the other half of the problem is delivery. You’ll notice the article says the calorie intake was decreased an hour later. You need to make it stable, long lasting, and via a delivery method that people can tolerate.
Giving yourself an injection an hour before you eat or an hour before you are hungry isn’t going to work.
That’s not exactly true. Cannabidiol (CBD) is naturally occurring and there’s a commercial FDA approved drug for epileptic seizures in children called Epidiolex. If I remember correctly, the patent is for “Oral cannabinoid formulations”.
Even without a patent, companies can get FDA exclusivity but for not as long as a patent grants them so unless the addressable market is huge, it’s a financially riskier bet.
I'm late to the party and this is not my forte so I'd differ to many people, but if you patent the natural compound for a disease you can do that. In addition to that patenting it for certain formulations. A case in point is https://en.wikipedia.org/wiki/Dimethyl_fumarate Tecfidera (the drug name for the drug used for MS made Biogen Idec billions of dollars.
The history from wikipedia
The first medical use of fumaric acid was described in 1959 by Walter Schweckendiek, a German chemist, and was a topical formulation for psoriasis. The Swiss company Fumapharm eventually brought Fumaderm, an oral formulation of dimethyl fumarate (along with some monoesters) to market for psoriasis in Germany in 1994.
Based on the efficacy and safety of this formulation, and evidence that dimethyl fumarate was the main active component, an oral formulation of dimethyl fumarate was developed by Almirall. This oral formulation, under the brand name Skilarence, was approved by the European Medicines Agency (EMA) in June 2017, for the treatment of moderate-to-severe plaque psoriasis in adults.
Initial clinical research on the use of dimethyl fumarate for the treatment of multiple sclerosis was conducted by Fumapharm in collaboration with Biogen Idec; Fumapharm was subsequently acquired by Biogen Idec in 2006. Aditech Pharma in Sweden had also been researching oral formulations of dimethyl fumarate for MS and in 2010, the Danish company Forward Pharma acquired Aditech's patents.
this is 1000% not true, plenty of naturally occurring substances are turned into profitable medicine, aspirin and insulin are examples off the top of my head.
I feel like the natural occurring property makes it more likely a supplement company will bring it to market without FDA requirements. The path to market should be simpler from my understanding of this space, please correct me if that’s incorrect
Pretty sure this would help save health insurance companies and Medicare billions if it’s a relatively safe defense against obesity and related mortality. There could be a push to get it to market from Medicare? Anyone want to comment with more knowledge of how it could be funded by the government? Note: The current administration is gutting the NIH so those programs and grants are shrinking
I'm sorry, your hypothesis is that people will be less likely to try and build products around a naturally occurring weight-loss drug?
Like, less likely than they would be to pay Ozempic to use their patent? I mean, I could believe that if there weren't like Billions of dollars being funneled into weight-loss programs and foods that don't have any demonstrative weight-loss capabilities.
If this actually works and is naturally occurring, I'd be surprised if there weren't like enterprising startups and food companies adding this to existing products within a year or 2.
If only there was a way for the people to pool their collective resources, maybe each contributing a fraction of their annual income (with a greater contribution proportion at higher incomes), and put those resources towards development of thins that benefit the common good but lack a direct profit incentive. Hmm...
Why pay to get FDA approval, if you don't get a government granted monopoly on it afterwards?
This is one problem with using patents as the mechanism to incentivise development of medicine.