No explanation as to the cause of the shortcoming. Do drug companies just hate money?
Madehow has a decent article on the history of insulin synthesis [1]. I don’t see any natural bottlenecks that would interfere with scaling the process.
Profits for generics are too low and there are no new market participants because outlays for initial investment and conformance testing is too high. Generics manufacturing is a strange beast, there are surprisingly few players involved, there is very little overcapacity, and that's not a good situation. When Hurricane Maria took out pharmaceutical plants in Puerto Rico there were severe drug shortages that were not easily fixed.
That's a strange argument. If there are few suppliers in the market, and inelastic demand, they should be able to pretty much set their own price, at least enough to be profitable. The only way that prices trend to zero profit are in commodity markets with a lot of competitors.
In most countries that aren't the US, the government is the biggest purchaser of medicines, and that is what keeps prices down. That's only a theory, though.
But the observable facts are that in the generics market there are only a few players, and profits in the generics market are low. If the economic theory can't explain that, it's the theory that is wrong.
The theory isn't wrong, it's what you'd expect. Outside the U.S., governments exercise monopsony power to keep prices artificially low, which results in a less-than-efficient amount of production of the generic: https://en.wikipedia.org/wiki/Monopsony. When you make prices artificially low you reduce the incentive to invest, and the result you're seeing is Econ 101.
What's happening inside the U.S. is harder to model. The patented versions of insulin are somewhat better than the generic ones. There might be insufficient incentives for people with health insurance to prefer the slightly inferior but much cheaper version. That leaves only those without insurance to pay for the generic, and that's not much of a market. As a biologic, insulin is expensive to make even the generic versions. And people who have no insurance probably have little ability to afford it.
What does "artificially low" even mean in this context? Valeant have demonstrated that you can drop research and raise prices on orphan drugs to stratospheric levels, and Valeant's owners are the only people that benefit. That can't be a desirable outcome for public health. When the government leans on manufacturers at least prices have some relationship with the costs of production.
The same reasons why hospitals don't produce their own medical supplies period? A hospital is a hospital and specialized in doing what hospitals do: Treating patients.
Manufacturing IV solutions is something that requires a clean room laboratory, with its own set of stringent requirements and doing it cost-efficient means doing it at scale.
They are only forming a purchasing consortium to get in front of the line of other buyers or force bulk discounts. If they don't want to build production capacity themselves they could purchase an existing facility, but they don't.
This is good fodder for a case that a public utility should produce these drugs. Of course that would freak various interests out so won't happen, at least in the US or EU.
A hybrid approach in the US has been fairly useful for orphan indications and, somewhat differently for vaccines, but of course jerks found ways to exploit that too. Still it points to a possibility.
But I favor a single utility making some small-molecule and biologic underserved drugs because of the economy of scale it could bring. A small NIH facility in some otherwise underserved part of the country could make a big difference at a relatively low cost.
Why are these drugs underserved though? If, as another commenter suggested, the core reason for the shortages is because the government is such a large purchaser and they're keeping prices too low to encourage investment in new supply, wouldn't it make more sense to just pay a bit more to create some oversupply to cope with shocks to the system and long-term growth?
If this was a viable model, I strongly suspect you would've already seen this happen in one of the many countries with socialized health care. I suspect you're assessment of the approach as "relatively low cost" is faulty. Biologic production is extremely difficult and expensive.
Biologic production is extremely difficult and expensive
It's not that bad. Brewers developed the knowledge how to work with microorganisms centuries ago. Most antibiotics are biologics, and they are dirt-cheap. Insulin isn't monoclonal antibodies, it's grown in bacteria, in the simplest expression system, and how to isolate it from the fermentation batch is well-understood and involves no problematic steps.
It's true that my work experience with manufacturing and approval is with small-molecule pharma, but as insulin was one of the very first biologic drugs and is one of the simpler ones to produce, I suspect this is reasonable.
I agree that France or Brazil are better candidates for this approach.
You posted this comment using a network whose fundamental tech was developed in a government project. You posted it using a device descended from an original which was built as part of a government project, based on theories developed with no immediate profit motive.
Would you like to re-think whether it's possible to invent and develop important new things without immediate profit motive?
Government funding happens within an economy subject to market forces. DARPA, in particular, had an intimate cooperation with for-profit companies. BBN and RAND were instrumental to creation of the Internet. BBN won the contract to actually build ARPANet. Bob Kahn and Vint Cerf both went through the “revolving doors” between government and industry. Kahn was involved in the implementation of ARPANet at BBN, and then went to work for DARPA in 1973. Cerf was a program manager at DARPA then went to go work for MCI in 1972.
Government funding isn’t an alternative to the market; it’s a different kind of market partipant. Government funding competes with private investment, and government agencies compete with the private sector for talant, etc.
Type 2 diabetes can be reversed through diet. The evidence comes from medical practitioners and scientists, not from quacks making outlandish claims (although they exist too).
Some links:
The Diabetes Code by Jason Fung: This is a best-selling book by a Canadian Nephrologist (care and treatment of kidney disease) that explains type 2 diabetes in detail and recommends diabetics switch to a low-carb diet.
Counterweight Plus low-calorie diet plan: This diet was run as part of a scientific trial and showed promising results for obese patients with type 2 diabetes. Nearly half of the 300 patients in the trial reversed their diabetes. Note: the diet was run under the supervision of medical professionals and is not suitable for everyone:
https://www.nhs.uk/news/diabetes/radical-low-calorie-diet-ma...
The Truth about Carbs: this is a BBC documentary from earlier this year which is unfortunately no longer available to watch on the BBC website. It featured NHS doctors who ran a two-week low-carb diet plan with type 2 diabetic patients. All patients reported improvements to their health, but the most impressive result was a patient with type 2 diabetes for 17 years who was now in part-remission.
Something important that I think is worth noting is that you can reverse the symptoms of T2 Diabetes, but it does require a lifelong change of lifestyle. If you go back to your old lifestyle, those symptoms are just going to come right back. I know to some it may be obvious, but I think it's worth stressing this. When people say "reverse," they're talking "in remission." The symptoms are waiting to return if you start fucking up again. That being said, it is a much better approach than the alternatives.
I don’t have diabetes (yet). I do have another rather more complex neurological disease. As part of managing that over the past year I’ve switched to a low carb diet, and completely cut out anything with added sugar. Yet for some reason my blood sugar levels over that time have been creeping up and up and are now always above normal (ranging between ~105-145). So I’m thoroughly confused by the low carb thing and hope switching to low carb isn’t giving me diabetes.
> and completely cut out anything with added sugar.
Many products contain high amounts of "naturally" occurring sugar. The worst offenders here are various kinds of pressed fruit juice and other fruit products.
Even whole fruits such as apples, oranges, and bananas, have been cultivated over the past few centuries to be much sweeter than their natural counterparts used to be. If you ever eat a truly natural wild apple, it's quite sour.
This is true for type 2, one of my cousins was able to lose enough weight with a more proper diet and exercise, got his body functioning more normally without the need of insulin shots any longer. Obviously it takes effort, time and a lot of dedication to keep yourself in a good diet and exercise routine.
Quack here. I've been saying this, and backing it with scientific support, since at least 2003 and being dismissed. Got my mom to reduce her insulin by cutting out all the carbs (took several years), now she thanks me. I think we should be more open to more "outlandish" claims from people. There are some serious problems with modern medicine. SSRIs being out performed by pasebo or just turmeric, Potassium Bromide in bread causing cancer, Blood Thinners actually causing heart attacks, Titanium Dioxide, aluminum sulfate causing breast cancer and "race for the cure" not spending any money on actual research, no real antibiotic resistance with first responding antibiotics (simple amox, doxy, penn ) and reducing their use causes more harm, the need to ban glysophophate and do multi-generation claw back damages lawsuit. Anyway just thought I chime in. All of these are backed by research.
In order to have people cure something though diet, you have to convince them that they can control their own fate. The powers that be don't want that, they'd rather scare people with talk of insulin shortages.
Wonder why they picked 2030. I _might_ have read a 3-year forecast since they are sometimes correct. But any forecast involving social processes that is beyond 5 years is almost always wrong.
Virta Health is a sf startup with meaningful results reversing T2 diabetes. If you’re interested in this topic they are a compelling counterpoint to this study.
Type 2 diabetes can be reversed. Many people aren't seriously suggested this option by their medical professional or are unwilling to change their lifestyle.
I don't think it's a counterpoint to the study, but rather to the ways the data will drive policy changes.
It is phenomenal to see such a movement sprout up, as if a chunk of society decided to just give up. I couldn't imagine a serious, equivalent movement on the same scale for alcoholism and cigarette smoking, to cite a few examples. Yet the abuse of food is going to (or is already) cost us far more.
I've never come across the Fat Acceptance Movement before, but it is something I've thought about.
The issue seems to be equated with race and gender equality, rather than addiction, which I'm not entirely convinced by either. I don't think obesity 'denormalisation' is the answer, but I don't think we should close the door on saying a certain weight isn't healthy.
We pretty much have that with regards to marijuana. I'm not sure why it's treated so differently from tobacco. In both cases you are inhaling the smoke from burning leaves.
Because you can vaporize it, turn it into oil and again vaporize it, bake it into food and eat it, etc. too. Even if you do smoke, a regular marijuana smoker consumes a lot less tar than a regular tobacco smoker since they need less plant product to get the desired effects. Plus, nicotine promotes cancer growth (but does not directly cause it) while THC may mildly inhibit cancer growth
Tobacco is unusually nasty, just look at throat cancer from chewing tobacco. Incense, woodsmoke, and Pot do cause problems, but the risks are significantly lower.
Type-II diabetes isn't caused just from being fat anyone can develop it. I have active, skinny, vegetable eating relatives with type-II diabetes. I avoided diabetes so far but I have hypothyroidism, you could say it's a related cousin disease in the endocrine family.
Endocrine system diseases need to be researched more and the general public needs more education on it. Sugar doesn't cause Type-I or Type-II diabetes as it seems many on the Internet believe. And being fat isn't the only way to develop Type II diabetes.
And as my mother says, "I'm not a diabetic, I'm a person who has a disease called diabetes."
I will absolutely believe that diet and obesity are not the only causes of Type II diabetes. And no, not all obese people are diabetic. But it is a primary factor in many cases. And if people who are obese would change their diet and lose weight, the rate of diabetes would likely plummet. I don't think anybody is suggesting that changing diet and reducing obesity is the only answer, but rather that it would make a huge difference.
I remember as a kid our family doctor straight up telling my parents that they were too fat and they needed to exercise and lose weight. I assume doctors still do this, as it's good health advice, but with "fat shaming" being a thing now, I'm sure that some are more hesitant.
>It has been over 10 years since the resolution of type 2 diabetes was observed as an additional outcome of surgical treatment of morbid obesity. Moreover, it has been shown unequivocally that diabetes-related morbidity and mortality have declined significantly postoperatively, and this improvement in diabetes control is long lasting.
How about we stop masking the problem of insulin resistance by pumping type 2 diabetics with insulin?
Why don’t we start telling diabetics the truth — your diet is broken and needs to be fixed; avoid most carbs, do strength training.
We don’t need more insulin to shove the massive onslaught of blood sugar from your crappy diet into your cells (which are telling you they’ve had enough, AKA insulin resistance), we need more honesty.
The healthcare industry is morally and intellectually bankrupt. All the honest people who got into it trying to make a real difference don’t stand a chance, the truth doesn’t survive for an instant in this corrupt industry more focused on how much they can get out of insurance companies than treating patients.
First of all, diabetics take insulin because it keeps them from dying, not because it cures diabetes. Prior to getting on insulin, type 2 diabetics have likely already been on a drug which does not exacerbate insulin resistance (e.g. metformin). As the disease progresses, the pancreas starts to crap out and you eventually end up on insulin since your body can't produce enough insulin on it's own.
> Why don’t we start telling diabetics the truth — your diet is broken and needs to be fixed; avoid most carbs, do strength training.
Yes, since no diabetic person has ever heard this advice before... as someone who is not diabetic but knows many people who are, every single person who is diabetic knows that diet and exercise will help them, yet they can't seem to get it sorted out. To me, this says knowledge and willpower are not the problem. Also, if someone has made it to the point where they are on insulin, their body is already pretty screwed up at that point and making these drastic lifestyle changes is going to be very very difficult (though not impossible). Regardless, we should have some more compassion for these folks - it is a very difficult disease to deal with and shitting on people for being sick is just mean, regardless of how they got there.
It seems to be that these organizations are in the business of SICKcare, not HEALTHcare. It is much more profitable to keep people just a little sick (and dependent) than to cure them (which most diabetics are not even told is even a possibility).
I'm not saying the ADA and CDA are right or that your advice on diet and exercise is wrong, I'm saying the issue is more complicated than you are making it out to be. Your average diabetic knows what causes the disease and what is making it worse, yet they have a very difficult time making the lifestyle changes required to improve their outcome. If you're familiar with Jason Fung's work, you'll know that he himself raises this point, and this is why he is such an advocate of intermittent fasting - this lifestyle change seems to be easier to make for someone who is diabetic than improving diet and exercising more.
I’m not trying to make it a black and white issue, and there is definitely tons of variance in terms of what people respond to, my only claim is that when you have an absolutely massive portion of the population with diabetes, there is something seriously and fundamentally broken, it’s not just about coming up with some better ways to help patients make small behavioral changes (even if that is also important).
If telling people in America that "improving diet and exercise help manage your diabetes" doesn't get rid of our diabetes epidemic why would it get rid of Africa and Asia's?
Everyone wants to blame the government or big pharma, but I think the fact of the matter is, human beings are evolved for a world that is very different from the one we currently live in. At least my perspective, this explains the situation much better.
Humans evolved in an environment where there were no highly processed sugars or highly processed carbohydrates and where our long ago ancestors got daily exercise looking for food, building shelters, running or fighting predators and so on. The human body is optimized for a certain type of diet and a certain level of exercise. In addition to this, human beings evolved to crave sweet food and eating sweet food is an enjoyable experience. We know that eating highly processed carbohydrates or sweets leads insulin to rise more than eating other things and doing this repeatedly over time leads to fat accumulation, insulin resistance and diabetes.
Contrast with the world we live in today: sugary drinks and foods and processed carbs are everywhere. Many of us are required to sit all day (or at least be stationary, if not sitting) for our jobs. To get food today most of us either drive to the grocery store, drive to a restaurant, or have food delivered to our home. We don't build our own homes. We don't hunt. We don't fight off predators. There is very little that many of us have to do in modern life that requires exercise. Almost all exercise is optional.
Another thing to consider, is that the amount of stress we encounter in daily life has not gone down. If anything, at least in the developed world, we have ramped up the amount of stress that people experience on a daily basis in the past few decades. Stressful commutes, office politics, fighting the crowds while out shopping, constantly being prodded to compare yourself to everyone around you (i.e. social media) and poor sleep (and then overindulging in caffeine the next morning) are all parts of modern life. Consider that the stress response evolved in living things in order to get that living thing in to action, to flee or fight for its life. As it turns out, the physical activity that follows a stress response usually turns off the stress response.. but the times we find ourselves in stressful situations often do not offer a physical outlet for our stress. Thus, cortisol remains elevated in many of us, and it turns out that consistently high cortisol leads to insulin resistance.
So two hormones being persistently elevated lead to insulin resistance: insulin and cortisol. These hormones are persistently elevated in the average human in the developed world. Exercise improves insulin sensitivity but most humans in the developed world have no reason to exercise, aside from attracting mates and staying healthy.
Lastly, one's ability to forego pleasure or leisure now for a return later (or, for the promise of not getting sick later) varies a lot throughout the population. Some people are very good at this, some are not. Obviously the amount of education and knowledge one has also varies from person to person in the developed world. Since most of us crave sweets and processed carbs, they are readily available and nothing in our lives requires us to exercise, those who are not good at forgoing pleasure now or those who do not know that eating this way is bad for you, will sit and eat like garbage right now because it feels great right now.
It is not a simple explanation, but to me, this set of facts explains why it is becoming more of a problem as time goes on. As much as big pharma may want people to get sick and buy their drugs, big pharma didn't make people crave sweet food, nor did they make processed food ubiquitous, nor did they come up with office jobs that keep us sedentary, nor are they keeping us stressed out. These are all byproducts of evolution and our own technological successes.
I agree with most everything you’re saying, but it doesn’t change the fact that the healthcare industry is giving specifically harmful advice to people rather than drawing a hard line and saying it’s urgent and imperative that you make behavioral changes to fix diabetes. They’re told it’s terminal and all they can do is manage it, the reality is that many people could rid themselves of diabetes, which few doctors tell their patients.
People rely on doctors and doctor’s rely on research, and then when articles like this come out no one thinks there’s something fundamentally wrong with the industry?
> Why don’t we start telling diabetics the truth — your diet is broken and needs to be fixed; avoid most carbs, do strength training.
We already tell diabetics the "truth". In medical school, we're taught how to properly inform the patient in an unbiased, nonjudgmental way. It isn't up to the physician to force them to change their lifestyle, but instead for a mutual agreement to be made. Most people aren't able to change their lifestyle for a variety of reasons from being economically disadvantaged to lacking the knowledge of proper nutrition. It is not as simple "your diet is broken and needs to be fixed; avoid most carbs, do strength training.". I really wish it was.
It seems to be that these organizations are in the business of SICKcare, not HEALTHcare. It is much more profitable to keep people just a little sick (and dependent) than to cure them (which most diabetics are not even told is even a possibility).
I love that you’re completely ignoring that I’m making a broad, philosophical recommendation that people need to fundamentally focus on improving their diets and engaging in a specific type of exercise proven to improve glucose disposal and your only response is to be snarky.
Diabetes is an incredibly scary disease and we need more focus on the underlying causes and permanent solutions instead of pumping all this money and effort into stop gap measures that perpetuate the problem.
> ...you need to manage your diet and drink kefir to consume the intake sugar...
For others wondering, drinking kefir does not "consume the intake sugar" as in consuming all the extraneous blood sugar, though there is a statistically significant but still smallish effect upon Type 2 diabetics. What is actually happening is not precisely known yet, but the conjectured mechanism is beneficial alteration of the gut microbiome [1]. Like general fitness, the "manage your diet" part is the key. Fix satiation issues (physiological and psychological) surrounding that intake of calories, and then it does become "as easy as" CICO. As an aside, this study came out of Iran, which is good to see in our over-polarized world geopolitical situation.
Type 1 diabetic and ultra marathon runner here. I’ll admit keeping me alive is a waste of money (I don’t contribute much to the world) but if nothing else I am in pretty good physical shape. Aside from the diabetes, of course.
Madehow has a decent article on the history of insulin synthesis [1]. I don’t see any natural bottlenecks that would interfere with scaling the process.
1. http://www.madehow.com/Volume-7/Insulin.html