I accidentally discovered one of the most egregious pharma scams imaginable
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1. The pharma company selling Unisom+B6 for $800, with the FDA apparently not batting an eye. I mean, these are OTC substances, so it's probably safe for consumption, but still.
2. The doctor prescribing an $800 drug with two known, cheap, OTC ingredients. Probably receiving kickbacks.
3. The pharmacy accepting the prescription and billing insurance for a bullshit drug without informing the patient of an OTC alternative, when anyone who is licensed as a pharmacist knows the drug is Bullshit with a capital B and would save the customer $777.50 in needless expense.
4. The insurance company denying coverage, presumably with a form letter, without telling their customer about the OTC alternative.
What's to stop me from creating a pharma startup marketing a combination Vitamin D and acetaminophen as a treatment for back pain, selling it for $1000, and blasting doctors' offices with cold calls? Not our government(s), apparently.
You don't pay for the cost of the ingredients in pharmaceutical products (otherwise the cost of most drugs would be 1/10th of what they are or even less), but for the IP behind it. You need clinical trials to demonstrate that something works for a specific condition, and this is what gets an approved stamp by the FDA and integration with the reimbursement system, along with a negotiation on pricing.
If there were no such incentives, then nobody would do any kind of clinical trial for compounds that are already widely available in OTC form, and the only thing you would have is anecdotal evidence (i.e. noise) to know what works or not.
Whether this is the right way to incentivize research and development is a valid topic to discuss, however.
The government is the worst tool for this job, because they would need to hire external experts to assess which disease should be studied, and those experts would be already in bed with the industry for a long time. You would just be diverting tax-payer money in a different way.
There's no need to "hire external experts". They could have their own pool.
So it's not unsurmountable, just badly done...
Even so,
https://www.iam-media.com/article/switzerland-once-again-nam....
This is true to some extent (not all drugs approved require more than just superiority vs placebo), but that reads like throwing the baby out with the water. There's a ton of great drugs developed every year that are clearly very innovative in terms of mode of action, and by far and large those come from the US.
Innovation comes mostly from the public sector, not private sector. This applies equally to technology.
Private-led innovation is hyped by these industries PR departments. DARPA, NASA, NIH don't have a PR department.
References: 1/ Overall, NIH funding contributed to research associated with every new drug approved from 2010-2019, totaling $187 billion." (https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3731819) Search Mariana Mazzucato talks, books on innovation, example: https://www.noemamag.com/big-pharma-is-hurting-drug-innovati...
2/ "Apple Didn’t Build Your iPhone; Your Taxes Did": https://www.pbs.org/newshour/economy/the-entrepreneurial-sta...
3/ 97%-99% of Astrazenneca covid vaccine research was public+charity funded( ref https://pubmed.ncbi.nlm.nih.gov/34937701/ )
1. The price of drugs are regulated. There is no chance such a bullshit drug just combining OTC ingredients are allowed to be sold with such a high price.
2. Since there is no bullshit expensive drugs, doctors don't need to worry about it. Rebate is prohibited, but even if it exists, you can't prescribe the drugs you can't use.
3. I'm not sure about the quality of pharmacy in Japan but they regularly call doctor when they have concerns about the prescription and they switch to generic drugs on default unless patient strongly object not to.
4. Universal Health Care. The govt regulate the insurance so it's either all covered by insurance or nothing.
https://khn.org/news/article/medicare-ruling-aduhelm-controv...
https://hbr.org/2021/10/the-u-s-can-lower-drug-prices-withou...
(As testified before a congressional committee by an FDA official, his response to the question of "how many drugs receive government research funding?" was "all of them.")
Where is the "always" coming from? Check actual clinical trials registries and you will see that most clinical trials are not funded by the government.
No, it was not.
US Tax Dollars Funded Every New Pharmaceutical in the Last Decade:
https://www.ineteconomics.org/perspectives/blog/us-tax-dolla...
How many new drugs rely on government-funded science? All of them:
https://www.cbc.ca/news/health/drugs-government-funded-scien...
The industry works all the time with academics. Academics do the fundamental science labor, which means identifying new targets, new pathways, new proteins and so on. This kind of research is indeed usually funded by a combination of public and private grants. Most of that research leads to nothing in the end, by the way - not everything they produce is picked up by the pharma industry, because most of what they produce fails to give results - that's the inherent property of doing fundamental research.
Then the industry purchases/licenses (and patents) what is considered to have the largest commercial potential - then pre-clinical, phase 1 up to phase 3 are mostly funded by the pharma industry. This is also where the bulk of the cost is. A clinical trial in phase 3 can costs in the dozens of millions of dollars, and there's always a solid chance that it fails to meet its endpoints so the risk is far from nil.
Based on the NIH numbers, the funding for research (i.e. grants) is about 45 billions annually. At the same time, the pharma industry spends 87 billions per year on R&D, which is about twice more.
I dont have those stats handy, but given how unhealtht the American population is as a whole I dont expect that we'd end up on the better end of that comparison.
Japan actually has a bunch of fairly major pharma companies that develop a lot of new drugs. You just don't hear their names in the US because the drugs get licensed to other companies when they're sold in the US and you only hear the name of the company that licensed them, but there are plenty of drugs that are commonly described in the US that were developed by Japanese pharma companies.
Local drug price regulations actually don't necessarily affect drug companies in a given country that much for this reason (they don't just develop drugs for the domestic market, and licensing to other countries to sell internationally is pretty much the norm).
However, in the case of the US it seems like the US pays a disproportionate amount of the total costs so it's possible that US drug price controls would affect pharma companies worldwide more than other countries' drug price controls. I'm not sure whether or not this can really be described as the free market doing a good job or not since the location where drugs are developed doesn't really affect their availability in other countries.
Wrong, the drug pricing in Japan is not based on the ingredients itself, it's based on what you can prove as an indication for a specific disease. Does not matter if you can mix off the shelf drugs to get the same drug. For example there are painkillers with prescriptions that contain the same drug than the OTC versions but are sold at a more expensive price.
> Since there is no bullshit expensive drugs,
You seem to have no idea what you are talking about, sorry, There are drugs that cost more than 1000 dollars per injection in Japan as well, and that are reimbursed. Oncology is full of such drugs, look at the highest pharma revenues in Japan, they are all coming from companies focusing on oncology.
> Rebate is prohibited
Rebate is happening between wholesalers and hospitals, and it's not unusual, it's the de-facto mode of operation in Japan.
> they switch to generic drugs on default unless patient strongly object not to.
Depends, if the doctor has prescribe the drug with the commercial name the pharmacist can't switch you to a generic. And generics are not equivalent to the original drug - the formulation matters, not just the active ingredient.
> The govt regulate the insurance so it's either all covered by insurance or nothing
You still have to pay out of pocket in Japan, while it&'s a fraction of the total cost (30% for regular employees, 10% for elderly people). It can still get fairly expensive if you add hospital nights and all. That's why you also have additional private insurances in Japan to get higher levels of reimbursement.
In the best case scenario. The more likely, and actually worse scenario, is that they have no idea either.
Doctors get "free samples" all the time, and are so conditioned to receiving "freebies" by drug reps unquestionably that they aren't even aware of their biases after a while.
Pyridoxine/doxylamine is nothing new, and was released in the USA in the fifties, and withdrawn from the market in the early eighties due to numerous (baseless) lawsuit alleging it caused birth defects. This formulation is known as Diclectin in Canada, where there were no lawsuits (and thus, no withdrawal), and it costs pennies.
The medication was reintroduced in the USA about 10 years ago as Diclegis by another manufacturer, and Bonjesta is essentially Dicglesis with improved pharmacokinetics (whether this matters clinically is another question).
It is interesting to note that Bonjesta is produced by Duchesnay USA, which is owned by the Canadian company Duchesnay, which markets Diclectin here in Canada. I suspect that no American company is willing to risk a lawsuit *even* at the current seemingly absurdly high pricing. Duchesnay USA is essentially a mono-pill company, and I imagine that the strategy is that they're willing to go under in case of a class action.
But a __doctor__ enabling this kind of predatory behavior? Financial harm, rather than bodily harm, may not be against the text of the Hippocratic Oath and the various laws it has inspired, but I would argue it violates their spirit.
There are doctors who have done far worse things like assault young girls and prescribe chemo for patients who don’t need it, but they are in jail and (hopefully) will never practice Medicine again.
I guess the absence of laws against the behavior highlighted in OP means the doctor did nothing illegal, but the failure to prevent it is a systemic one. This doctor unambiguously betrayed the patient’s trust, and we need laws to prevent such things from happening. The Medical-Industrial Complex must be broken up.
Systems that reward, encourage and enforce sociopathy eventually end up promoting sociopaths to all levels of power and authority at the top.
> Commentary: There have been no efficacy and safety trials conducted with Bonjesta. A double-blind, randomized, multicenter, placebo-controlled study was conducted to support the safety and efficacy of 10-mg doxylamine succinate and 10-mg pyridoxine hydrochloride tablets (a different formulation and dosage strength) in the treatment of nausea and vomiting during pregnancy. Women 18 years of age or older at seven to 14 weeks gestation (median, nine weeks) with nausea and vomiting were randomized to 14 days of 10-mg doxylamine succinate and 10-mg pyridoxine hydrochloride tablets or placebo. The primary efficacy endpoint was the change from baseline at day 15 in the Pregnancy Unique-Quantification of Emesis (PUQE) score. The PUQE score incorporates the number of daily vomiting episodes, number of daily heaves, and length of daily nausea in hours for an overall score of symptoms rated from 3 (no symptoms) to 15 (most severe). At baseline, the mean PUQE score was 9.0 in the 10-mg doxylamine succinate and 10-mg pyridoxine hydrochloride tablets arm and 8.8 in the placebo arm. There was a 0.7-point mean decrease in nausea and vomiting symptoms from baseline in PUQE score at day 15 with 10-mg doxylamine succinate and 10-mg pyridoxine hydrochloride tablets (95% confidence interval, 0.2–1.2; P = 0.006) compared with placebo.
according to this paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215271/
Maybe the manufacturer has realized this and is apparently now conducting an actual clinical trial, focusing on adolescents, probably for an expansion of its indication:
"A Multicenter Trial of the Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents"
https://clinicaltrials.gov/ct2/show/NCT05289557
the FDA is a running joke at this stage. Why would anyone trust that agency is beyond me.
Would you expect this? Not every drug on the market goes through safety and efficacy tests of their exact formulation do they? The point of safety and efficacy testing is to establish that it’s safe and effective, and this can be done in general for a drug, and then múltiple different formularios might enter the market.
You don’t redo crash tests of cars because you change the interior lining.
you are supposed to test the actual formulation in clinical trials, not "some mix that is kind of similar". In safety studies (Phase 1) you can get away with testing something different (i.e. much higher doses) because you want to prove that the drug is safe for use. But Phase 2 is usually where you decide on the final formulation by having several options, and Phase 3 is the final drug tested "as is" before it reaches the market.
The formulation is not some kind of cosmetic property, it impacts dissolution speed, bio-availability and many other parameters that can change how the drug works. Some minor adjustments can be made to the formulation between Phase 3 and commercialization but there are strict guidelines on how to justify such changes. In any case, Bonjesta has apparently done no such trials based on the publication referenced.
> You don’t redo crash tests of cars because you change the interior lining.
Bad analogies are bad analogies.
Also both arguing that the drug is overpriced because it’s just a combination of two other available drugs that you could just buy separately and take together, and then also arguing that they should have conducted a separate tox and efficacy study on the exact formulation they are using is crazy.
And you state it yourself in your argument, you are allowed to make changes to the formulation, and not suprimo no Ku they where allowed. And they are not illegally marketing this, so what on earth is your argument?
Here is a link to the archive.org copy of the original thread: https://web.archive.org/web/20220728040832/https://twitter.c...
The Hippocratic oath does not, apparently, apply to pharmacists, or to patient's wallets.
Interesting...
The first is a YC company CostPlusDrugs which has now received backing from Mark Cuban. Started by a physician they're manufacturing 100 common drugs and selling them for a 15% markup over cost. They've also said that they will never go public.
The second is CapitalRx which is a middleman (known as a PBM) that is working for a flat fee and passing on their cost on drugs.
Just like the Jeff Bezos famous quote your margin is their opportunity!
mmmh I don't know, for the rest of the planet (except for a handful of backward African and Middle Eastern countries), however, it works...
so here we're almost at the classic title of the onion: 'No Way To Prevent This,' Says Only Nation Where This Regularly Happens
[1] https://slatestarcodex.com/2014/06/15/fish-now-by-prescripti...