Prescription insulin

Something I've always wondered about; why do some insulin require a prescription to buy and some others do not?

Humalog, novolog, lantus and levemire require prescription.
Regular and NPH do not require prescription.

Patents expired?

If that's the case, when does the patent expire on Lantus? It has been around a long time. And, what does the patent have to do with making a drug prescription only?

Doing a quick Google search, it appears that the Lantus patent expires this month, February 2015. It's more complicate that that, though. There is a flurry of lawsuit activity initiated by Lantus maker Sanofi against an Eli Lilly "bio-similar" Lantus insulin. It appears that the legal action will delay the Eli Lilly product from its introduction until at least 2016.

I don't undestand the relationship of a prescription to insulin availability. Perhaps prescriptions are a key feature for insurance reimbursement. I'll be interested if someone else can answer this question.

So pharmaceutical companies can recoup their investment in developing insulin make lots of money

After searching the web for the answer, I believe what Topcat37 says in this post from another forum: "I hesitate to comment on my "conspiracy theory" regarding this subject, but I cant resist. I think that the medical establishment in this country does everything that it can to "self perpetuate". In other words, the medical community has a vested interest in creating a system in which it has a much control as is possible on how dollars are spent. If I MUST go to my doctor before I am granted the opportunity to purchase a medicine that I cant live without, it insures that I will stay firmly rooted in a broken, and dare I say criminal, system that will allow the medical establishment to bill my insurance company inflated costs for my treatment. A tax on the sick. To take it even further, it is certainly not in the best interest of the medical community to find a cure for my affliction, only more expensive and controllable ways of treating it. If they can keep me alive for as long as possible, but insure that I stay on the "treatment tether", it guarantees a long and prosperous relationship. Chew on that for awhile, before you dismiss it out of hand."

Does anyone think he is wrong or have a better answer?

Oldspook, I think that the only reason that the last 10 years has seen advances towards a cure or near-cure treatment is due to independent companies and independent thinkers outside the mainstream medical and tech systems. Same with pumps and glucose meters.

There is no reason that type 1 diabetes should not have readily available and long term islet cell transplants at this date. And probably the same for type 2s although I don't read much in that area.
Chronic diseases are the mainstay of the medico-industrial complex. And no, I hardly ever use such a term in daily talk!
If we could get the faster acting insulin on the pharm shelf, it would help a large number of us - while we still wait, and wait, for a cure for everyone, not just a select few.

The history of prescriptions and insulin is complex. What happened is that it in the 1950s a series of federal laws created prescription control but exempted insulin. This discussion notes that "When the prescription legend was codified by the 1951 Durham-Humphrey Amendment to the 1938 Food, Drug, and Cosmetic Act, medications that required administration by injection, or were of such toxicity that a patient could not self-treat, were made prescription only.4 Inexplicably, insulin was exempted from these laws in the U.S. despite its clearly meeting both of those." There are speculations on the reasoning behind this, but ever since the 1920s insulin had been available over the counter without prescription even though industry would only sell insulin through pharmacy outlets. When insulin analogs were developed they became protected by patents and due to a law that was passed in 1997 were only available through prescription. The law as put in place with lobbying by pharmaceutical companies so that they could make a lot of money on patent protected and prescription only drugs.

Is there a consumer group that fights drug costs or drugs plus medical equipment? Seems there is for everything else. Some pay over $200 for one small bottle of insulin. I recall paying just a few dollars in the late 1970s.
Also, no rhyme nor reason for one inhaler to cost $300. Or more.

With the RX my insurance covers my insulin and other meds so that helps me and they negotiate the costs. My doctor likes to know how much insulin I need and use to follow my progress and does not mind giving me the RX(s) I need to stay alive. These are necessary for the durables I need as well. I don't believe in the "conspiracy theories". When the products are available over the counter, I do hope it decreases the cost but I'm not sure that will happen. I will never go back to NPH and R having had some experience with them, no matter how cheap they are ;)

Yes, he's not only wrong, he's full of...

This old saw, a long with the "golfing doctors" meme is old, stale, and idiotic.

The reason insulin analogs are prescription is because they're easier to kill yourself with than the R an N. Fast-acting, at least.

Personally, I'm against the entire idea of prescriptions, and government nannyism in this respect. I say if someone wants to take a powerful drug without the advice of expert people, go for it. We're adults. I'm opposed to prescription requirements entirely.

However, not because of some tinfoil-hat conspiracy theory. I've known many many doctors all my life, growing up in a medical family. I never ran across anyone that wasn't sincerely devoted to their practice to help and heal. It's not about financial enrichment for most.

It’s super easy to kill yourself with R and NPH. Not as fast but I found the irregular delivery to be much more dangerous than pumping Novolog.

What should they do, lose money?

Can someone show me where Big Pharma is making shockingly excessive profit?

I just tire so much of the demonization of various industries, and as a diabetic, the pharmaceutical industry. I'm fine with the profit margins of the IT industry, and computers and software are arguably as life-critical as medications these days (have a traffic signal control computer go whacko and see how many fatal accidents there are).

As such, I'm certainly not bothered by the substantially tinier profit margins in the pharm industry.

Developing these miracles is expensive -- VERY expensive. Manufacture is trivially cheap for most substances.

The R&D costs have to be paid for by someone. Under the current model, those costs are amortized over the expected viability of the drug, usually more or less the patent period. Seems to me the users of the drugs should pay those costs, no?

Now if the rest of the world would carry their fair share of the development costs, we here in the US would pay about half what we do now for insulin. I've seen the actual numbers. Our foreign brethren are getting a free ride.

Yes, and they'd probably be prescription today if not explicitly exempted back in the 50's.

The human R/NPHs only date back to the 1980s, they were the new thing when I was dxed in 1984…

I'd say pharma's doing alright for itself:

Yep. And instead of saying thank you, those foreign brethren then malign the pharma companies for ripping us off, evidence being the low prices in their countries. Average cost vs marginal cost is confusing to many people.

Developing these miracles is expensive -- VERY expensive. Manufacture is trivially cheap for most substances.


Compare the profit margin for pharma in the table above with the tech sector:

"The average margin for the tech sector, which on an annual basis is consistently among the most profitable U.S. industries, is expected to come in between 15% and 16% in 2014."

Looks like pharma is outpacing tech.

Sadly we passed the law with the intent that providing for a return on investment would encourage industry to innovate. Lilly produces Humulin and Humalog. It has been going on thirty years. Have we seen any new insulins from Lilly? If companies and industries like pharma are given "exemptions" like extending patents and prescription control they have an obligation to follow through with their side of the bargain.