A Government Guide to Keeping Insulin Unaffordable

https://fee.org/articles/a-government-guide-to-keeping-insulin-unaffordable-3-easy-steps-on-how-to-hogtie-a-market/

by henvic • 7 years ago

130 63 7 years ago

It's unaffordable because there is a monopoly on Insulin. Why is there a monopoly? Because it takes decades of work and close to a billion dollars to get a new drug through FDA approval.

We need to work on bringing these costs down, so more companies can actually compete. Government regulation schemes will only reduce the amount of companies willing to go through the process and give us less choice in the end.

hjk055• 7 years ago

There isn’t a monopoly. It doesn’t take decades to get a generic on the market. Insulin is available in wallmart for 25$ per vial.

There is a definite problem in the US with drug pricing, and middlemen gauging the market, but it’s a straw man to claim new insulin products don’t bring any change. If you ask the patients there’s a world of difference between the cheap genetics and the main brand products, which is why they want the newer products and not the generics. But of cause patients also want the newer products at the same price as the generics which will never happen, even if the government fixes the drug pricing market.

lostmymind662• 7 years ago

If the generics are $25, then I don't see a problem. It's cheaply available and this article is wrong.

ng122• 7 years ago

If you ask the patients there’s a world of difference between the cheap genetics and the main brand products

The main problem is the $25 insulin is R and not fast-acting. It's not the difference between generic and name-brand, it's about using an insulin that takes over twice as long to be absorbed by your body.

deogeo• 7 years ago

Even though insulin treatment itself can’t be patented, improvements in delivery mechanisms can be. These incremental improvements, no matter how small, can be used to extend the 20-year patent on a drug, a process called “patent evergreening.”

I'm confused - wouldn't the new patent only cover the improved method, and the patent on the original, un-improved version would still expire?

DarkStar851• 7 years ago

Yes, the old drug patent will expire, and when this happens the company typically pulls an "oh our old version is now magically unsafe!" to wrestle away competition.

Plus developing a product from the old patent still requires extensive FDA approval. Very expensive stuff.

hjk055• 7 years ago

Do you have references for that claim? If a company goes out with a claim their old product is unsafe it’s not like it’s rocket science to test the claim. And if their lying and you could literally corner a billion dollar industry by testing the claim I’d expect every producer of generics to do so. On the other hand if the product is actually unsafe that opens up liability claims from costumers.

postpawl• 7 years ago

It is possible to get a generic of the un-improved version from Walmart for $25: https://www.vox.com/science-and-health/2019/4/10/18302238/in...

The article says some people need up to 6 of those vials per month. So, it can still end up being $1,800 per year.

Other non-US countries are able to provide a yearly supply of the newer biosimilar insulin for just $72-133 per year: https://gh.bmj.com/content/3/5/e000850

Scoundreller3• 7 years ago

Your 2nd reference talks about the theoretical lowest price that a hypothetical manufacturer could manufacture longer-acting insulins at. It doesn't identify any manufacturer actually producing at those prices.

adamzk• 7 years ago

As mentioned in the article they are very effective at preventing smaller companies from producing generic versions based on expired patents. Then they just stop manufacturing the old drugs so there is no supply.

mirimir3• 7 years ago

That's not the issue. As long as a brand drug is listed by the FDA -- whether or not it's actually being manufactured -- physicians can write prescriptions for generic equivalents.

However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common.

However, there is a workaround: compounding pharmacies. To my knowledge, accredited compounding pharmacies can make, on a customer-by-customer basis, any product that the FDA has ever approved. And many of them are mail-order pharmacies. In my experience, prices are comparable to mass-market generics, or lower.

rayiner5• 7 years ago

“Evergreening” is a term made up by journalists that has no basis in patent law, and is also actively misleading.

The real issue is that nobody has an incentive to prescribe the older, less good but still acceptable drug. (In the case of insulin, note, it’s not only the delivery mechanisms that have improved, but the insulin itself.) the insurance company, in particular, under the ACA, have no incentive to cut costs to improve profits.

pessimizer• 7 years ago

Or, in the case of albuterol inhalers, the companies can actively lobby to prevent the older version from being distributed anymore.

Evergreening is absolutely a thing, and absolutely planned and executed by the companies that profit from it.

jablongo23• 7 years ago

There may be some confusion about "delivery mechanism" here. In this context the only relevant definition would be referring to chemical components in updated formulas for the injectable solution. Delivery _devices_ would have no relevance to the patent of the injectable solution.

drunkpotato• 7 years ago

I fail to see how the term "evergreening" is misleading. It seems to me to be an accurate term that precisely describes an industry practice responding to market and regulatory incentives. I think journalists are spot on for this one, "evergreening" is an accurate and completely truthful assessment of the situation, and perhaps you are thinking too narrowly within the scope of legal terms in patent law and not enough about real world effects.

rhino369• 7 years ago

Yes, the new patent can only cover the new improvement.

The issue is that doctors keep proscribing the newer, slightly improved methods.

Trying to evergreen on purpose is also dangerous since your competitor can patent an improvement on your invention. I somewhat doubt it is a purposeful strategy. But rather it just reflects the iterative nature of invention.

henvic2• 7 years ago

By the way, you can do business without IP...

I recommend the following book: Against Intellectual Property by Stephan Kinsella.

https://mises.org/library/against-intellectual-property-0

jablongo23• 7 years ago

As a type-1 diabetic and user of Lilly and Novo Nordisk insulins, this article is spot on. People are literally dying in some cases due to this dysfunction.

One thing that is not mentioned is that the dynamics of prescription-writing in the first place is anti-competitive in terms of price. Fiasp and Humalog are equivalent fast acting insulins from Novo-Nordisk and Lilly - competition will only happen when patients can decide which one to take instead of their doctors, who are not sensitive to small price differences (and in most cases are not themselves taking the drug).

rayiner5• 7 years ago

s a type-1 diabetic and user of Lilly and Novo Nordisk insulins, this article is spot on. People are literally dying in some cases due to this dysfunction

How many people would be dying if there wasn’t the same level of incentives to research these drugs in the first place?

Diabetes is a common health problem around the world. Nothing stopped say a non-profit or government from beating Lilly and Novo Nordisk to the punch developing these drugs. But profit seeking corporations are simply better at innovation than governments and non-profits.

markbnj2• 7 years ago

The whole point of the article is that the manufacturers aren't developing new drugs. The drugs haven't changed in decades. They're making small changes to delivery systems and other ancillary aspects and then patenting these new variations, as well as engaging in the usual quid pro quo wink wink old boy network anti-competitive manipulation of regulatory regimes.

pasquinelli• 7 years ago

The basic science behind insulin-the-drug wasn't innovated by profit seeking corporations. Applying that basic science to make a usable drug wasn't innovated by profit seeking corporations either. A cursory glance at the wikipedia page for insulin tells me the innovation was done be german, american, and canadian scientists at public universities, starting in the 1880s and not developing into a usable drug until the 1920s.

I don't think a profit seeking corporation would've done that.

Nasrudith• 7 years ago

None in that case - insulin is perhaps the worst specific case to cite. https://en.m.wikipedia.org/wiki/Insulin#History_of_study

disabled2• 7 years ago

Agreed 100%. I have T1D myself, in addition to 2 rare autoimmune neurological diseases that affect my peripheral nervous system.

Last time I checked (in March 2019), you could buy 13.5 [10 mL] vials of Novorapid/Novolog in Canada for 1 [10 mL] vial of Novorapid/Novolog in the United States. I am actually going to buy insulin in Canada on a trip in a couple of weeks due to formulary restrictions imposed by my insurance company (cannot obtain this type of insulin via insurance--not due to cost...).

It makes me absolutely sick to my stomach that people with T1D ration insulin. You cannot safely or effectively ration insulin with T1D, ever.

Anyways, I am one of the most stubborn people you will ever meet, but honestly, I do not see a future in this country (the United States). I expect the Affordable Care Act to be either partially or completely overturned next year (June-July 2020), based on the rare cases where the Solicitor General did not defend a case at the Supreme Court. Based on those cases, the likelihood of a partial or complete overturn of the ACA is staggeringly high.

I am trying to warn you that things may get really bad, and to be prepared. Consider other countries, with universal healthcare, in fact, even actually any country in the European Union. They will accept you regardless of the cost of your medical care, as long as you can get a visa. Same goes for citizenship, in the long run. No medical inadmissability restrictions whatsoever.

The Anglo-Saxon countries (US, UK, Canada, Australia) are largely closed to immigration, and the latter 2 have medical inadmissability criteria. Remember that.

BurningFrog• 7 years ago

Obligatory link to essay explaining the issues in pedagogical detail. Section II is on insulin:

https://slatestarcodex.com/2019/04/30/buspirone-shortage-in-...

TomMckenny• 7 years ago

If campaign contributions are called free speech and legislators are happy making laws blatantly favoring contributors, you're going to have a pretty tight loop.

IG_Semmelweiss2• 7 years ago

Most of thw misunderstanding on this topic has to do on people from outside the patent field trying to figure out what is going on in it, and specifically, how drug companies are gaming it.

Here is a great podcast on the matter. If you want to know about drug patents and how they are gamed, this is your bible.

http://www.econtalk.org/robin-feldman-on-drugs-money-and-sec...

mnm1• 7 years ago

How big is the insulin market? It sounds fairly big considering how many people have diabetes. So where are the Mexican cartels or similar black market organizations when you need them? If we're going to wait for the government, or worse, the industry itself to fix this problem it'll never be fixed. What we need is a proper black market. Is insulin available on the dark web drug markets? If not someone should make it available and cash in while still providing massive savings. That's how you solve a problem like this when your fucking government has stopped working like the US government has.

henvic2• 7 years ago

Proper black market is exactly a part of the industry that the state fights.

One of the things I always wanted was to create a black market for electronics in my home country (Brazil) because taxation here is really high.

You should also know that the government with its patents system is the root cause of this price spike.

I wish black market organizations doing legit and good stuff (like selling medicine that is pricey due to state granted monopolies) was the norm and I hope someday it will be. However, we are not there yet.

A Government Guide to Keeping Insulin Unaffordable

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