Why Does Insulin Cost More Than Ever? It's All In The Way It's Made

Dr. Frederick Banting courtesy of the New Tecumseth Public Library

| May 23, 2007

Banting Gives It Away - Insulin was discovered in 1921 by Fred Banting and Charles Best. In a generous gesture that unfortunately didn’t start a trend, they sold the patent for a dollar so that cheap insulin would quickly become available. It worked like a charm: within two years, Eli Lilly had sold 60 million units of its purified extract of pig and cow pancreas.

Patents Premiere

The first insulin did not last long in the body, forcing people with diabetes to inject themselves several times a day with the sword-like needles that were available at the time. In the 1950s, longer-acting insulin was developed to reduce the number of painful injections. Each improvement came with a patent, and each patent came with a price increase. Still, even with the new patents, insulin was fairly cheap. Many people recall paying less than a dollar a vial for insulin in the 1960s. Even in 1975, our editor-in-chief paid only $2.99 a bottle.

The Era of Biologics

In 1978, researchers at the biotech company Genentech did something that had never been done before: they manipulated bacteria into making human insulin. Insulin became the first pharmaceutical biologic; that is, a protein made biologically, by living organisms, instead of chemically. The making of insulin as the first biologic was the dawn of the biotech era.

Eventually, yeasts were also used as tiny insulin-making factories. Once the gene for human insulin was inserted into one yeast DNA, the yeast did what yeasts do: it multiplied ad infinitum, and each new yeast came with a little copy of human insulin. This breakthrough, naturally, carried with it a big, profit-making patent.

Advance of the Analogs

In 1996, the Food and Drug Administration approved the first insulin analog. Newer insulins are called analogs because they’re analogous to human insulin: like it, but not quite exactly. Before being put into the yeast, the human genetic material is slightly changed, to produce slower or quicker acting insulin, for instance. Each one of these improvements comes, of course, with a patent. And all these patented insulins cost - big time.

Where's the Generic?

Eventually, patents do expire. And when patents expire, generics generally leap into the market. Why not generic insulin? Because even though biologics have been on the market since the 1980s, the FDA has never told the generic companies how they can get generic biologics approved. There are no official guidelines for approval of generic insulin.

Generic Shortcuts

Insulin guidelines would need to answer one basic question: whether generic insulin manufacturers can use the usual generic shortcuts to approval. When generic manufacturers copy standard drugs, they aren’t forced to repeat the exhaustive clinical testing that the drugs went through to get approved in the first place. All they need to prove is that the generic version contains the same active ingredient as the name brand, in the same purity, quality, and strength. The generic maker isn’t forced to start from scratch and re-prove the drug’s safety and effectiveness. This shortcut is called “piggybacking” on the clinical studies originally done by the drug company that invented the drug.

FDA Guidelines are a No-Show

Because the FDA has not supplied guidelines to the generic companies on how to achieve approval of generic insulin, they don’t know what to do. Can they piggyback or not? The FDA said in 2001 that it was developing guidelines for approving generic insulin, but it never did. Now the FDA says that it no longer plans to issue guidelines for each biologic medicine, one by one. Instead, it’s announced that it will develop global guidelines applicable to all biologic generics, from simple insulin to the latest super proteins. This announcement has caused a lot of protest because such complex guidelines would take much longer to produce than a single set of guidelines targeted to insulin alone.

No Piggybacking for Biologics, Says the BIO

Some say the FDA’s foot-dragging has been influenced by lobbyists from the Biotechnology Industry Organization (BIO), which represents the biotech pharmaceutical companies. The BIO says that the shortcuts awarded to conventional generic drugs don’t apply to biologics, even simple ones like insulin. According to the BIO, the critical element in regular drugs is simply the active ingredient, but for biologics, it’s different: it’s all about the little creatures in the manufacturing process, and that’s much more complex.

Just Give Us A Guideline

For safety reasons, Novo Nordisk and Lilly both oppose the FDA allowing generic insulin to piggyback without repeating clinical studies. But generic drug makers note that biologic insulin has been around since the eighties. It’s relatively simple, they say, and costly clinical trials would only raise the price prohibitively high. They concede that the approval process for generic biologics should be more stringent than for conventional generic drugs. They just want some guidance from
the FDA so they can get started.

Patents Pending

In any case, some biotech companies are beating the generics to the punch by manufacturing cheap editions of their own expired patents. For instance, Novo Nordisk makes ReliOn/Novolin, which is simply its patent-expired biologic human insulin. It’s sold at Wal-Mart for $19.96 a vial.

The problem is, most people favor the newer insulin analogs over the older varieties of insulin. That’s one reason the big pharmaceutical companies aren’t too worried. Even if FDA guidelines are created and generics do make it to market by 2008 or 2009, the major companies don’t expect to lose many patients to generics. Insulin analogs themselves could become targets for generics in 2014, when their patents begin to expire. But by then, the major drug companies are confident that they will have newly patented next generation insulins on the market.

Power to the Diabetic People

In spite of everything, consumers do have influence when it comes to generic insulin, if they choose to wield it. As well-known diabetes blogger Scott Strumello states, “Regardless of which insulin we use personally, we should not tolerate regulatory inaction regarding generic insulin. All people with diabetes should urge their legislators to support legislation that removes barriers to price competition in the insulin market.”

ADDENDUM: On February 14, 2007, Rep. Henry Waxman, Rep. Jo Ann Emerson, and Rep. Frank Pallone, Jr., along with Senators Charles Schumer and Hillary Rodham Clinton, introduced H.R. 1038, the “Access to Life-Saving Medicine Act,” which will establish a process through which the FDA will be able to approve lower-cost copies of biopharmaceuticals. See  Henry Waxman's website for details, and send your support.

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Categories: Diabetes, Diabetes, Food, Insulin, Novo Nordisk, Type 1 Issues

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Posted by Anonymous on 12 November 2007

It is not only insulin that is costly, but other aids such as the pen needles as well.. My next door neighbour in India told me that she uses just two pen needles a month for sixty injections (2 a day ). I gave her some pen needles before I left to come back to Canada. We all can do a lot more for any of the less fortunate people any where in the world. Roger M. Natarajan, District Chair, Diabetes Awareness for Nova Scotia Lions.

Posted by Anonymous on 19 November 2007

Anyone in the USA paying over $40/vial of Humulin/Humalog needs to search the canadian pharmacies online.I buy 3 vials of Humalog for $100 shipped to my door. The USA prescription drug market is owned by the corporate profiteers.
"For safety reasons, Novo Nordisk and Lilly both oppose the FDA allowing generic insulin"
No, it is for profit reasons. Novolog was approved by the FDA a year before it became available at US pharmacies because NovoNordisk was working out a deal with EliLilly so that they could both overcharge.
The Metrika company came out with a cheap home A1C test and was immediately purchased by the Bayer Corp and removed from stores. Bayer owns most of the labs that charge $100/A1C test. They killed a great company/product for their profit.
I will know we have turned the corner on this problem when pharmaceutical executives start going to jail.

Posted by Anonymous on 27 December 2007

I'm a type 1 diabetic (12yrs) my average is 7.4 but I just lost my RX coverage and am looking for discount NPH insulin online. I wish that there was generic insulin available. I cannot get individual health insurance in Oregon...you know why. Isn't that discrimination? How can that be legal?
Anyway, do you have a link to cheap insulin?

Posted by Anonymous on 5 January 2008

My 26 year old daughter has type 1. Since late in 1989 she has been dependent on daily insulin doses. She now has a pump which works so well for her but the steep increase in the cost of Humalog has her so frustrated that she just wants to give up.
It is hard enough for all of us to make ends meet and young people are having such a hard time trying to live on their own as it is. How are any of us expected to keep up. It is like the phamaceutical companies are penalizing diabetics for being sick!
It's all upside down!
A mom.

Posted by Anonymous on 27 January 2008

I have been diabetic for over 47 years now. In that time I have heard of countless pie in the sky promises in regards to a cure, and/or improvements in treatment IE. non blood letting testing etc... . I guess my basic comment is that I really don't believe that anyone is working for a cure, when there is as much profit made keeping us on the needle. Pharmaceutical companies are only interested in profit and should be treated like what they are. Extortionists of the worst kind! I am now getting older and have many health problems due to my long term diabetes, if it had not been for the fact that my father worked himself into the grave trying to take care of me, I would have perished years ago. Why doesn't anybody seem to care about diabetics? I believe it's because we can live normal lives if we take care of ourselves. That's right, it's normal to have to test your blood 10 times a day and take on an average of 5 insulin injections a day. If everybody had a normal life like that, how long do you suppose that would stay the standard for normal?

Posted by Anonymous on 28 February 2008

humalog thru canada 29 dollars a vial...with no prescrition needed...here in USA 98 dollars = 1 vial why..do we as a people put up with outright theft from medical industry

Posted by Anonymous on 16 March 2008

Ive been diabetic for nine years and recently lost my medical coverage!! even haveing the medical i had, was a nightmare because i was constantly fighting to get the basic diabetic needs covered.. and it is a real shame that i am 23 years old and i am now fighting for my life.. i live in san diego near the mexican border and am now forced to live in mexico because i bearly can afford cost of living here with the coverage i had!! along withe the two insulins i need the strips and syringes, im looking at a min. of 5-600 a month!! with no med. coverage if anything goes wrong!!

Posted by Andrew Olson on 26 May 2008

I have been buying insulin since I was 19 years old and this past weekend, using a prescription, I was astonishsed at the price for a vial of Regular or 70/30: $128.97!?

Can this be possible? The insurance covered the firrst 68.97 and left me with a $60 per vial bill to pay. I thought a vial of insulin was still in the high $40's range ... is there a possibility of a scam between Walgreen's and the insurers to artificially boost the price? What is a regular retail national price, does anyone know?

Posted by Anonymous on 12 September 2008

have been diabetic for 2yrs you know by now that the goverment has a cure ,they want us to stay on insulin cause we have to buy insulin and that gives them money to play with for there own pleaures and it would put the pharm. co out of buisness, look who makes the profit government,the pharm co. why does everyone tell it like it is. the government runs everything and us too. the government isn't going to do anything caus it would cost them to loose money.

Posted by Anonymous on 14 September 2008

Just like oil prices this is just another cash cow for the goverment. The good OL USA has run a muck and is all about how much they can bend you over for now.Dont be fooled this is greed ,and until we get leaders willing to help the people and not themselves we will continue to be screwed over. They just dont care.

Posted by Anonymous on 18 September 2008

I have been on insulin for nearly 52 years. Why now, does my pharmacy/insurance company want to charge me $75 for one vial and tell me I have to use it for 2 months after it's potency has diminished? If they only want to give me a one month supply then where is the 330 unit bottle I need for one month? Bottles currently contain 1000 units. It's time to look elsewhere for all my medical supplies. And I don't mean looking to the government for Universal Stealth Care.

Posted by Anonymous on 19 September 2008

Of course they don't care, and this may help you understand why.

I worked at a place that empowered women and various ethnic groups traditionally left out of the good ol' boys network.

We thought that when they saw how much was being made by corruption, greed, and back-scratching, that they would want to change the system.

Nothing could have been farther from the truth. They didn't want to change the system, they wanted their turn to profit from it!

We don't have a prayer when it comes to humans running the show.

Posted by Anonymous on 7 November 2008

I noticed a 100$ increase in my Humalog Pens which with everything else I take come to a total of 236$ yesterday. Is someone trying to kill us?

Posted by Anonymous on 25 November 2008

Pharmaceutical companies profit from this disease. If left up to them, there will be no cure, only small, incremental steps consisting of endless, repetitive procedures that require more long-term care (implantable glucose monitors, for example), and therefore continued dependence on said companies. To believe otherwise is the height of irrationality, and those who do so are clearly suffering from a unique variant of Stockholm Syndrome. Solution: support independent researchers who cannot be bought, e.g. government researchers. Where is the new Manhattan Project?

Posted by Anonymous on 6 December 2008

WOW, what a bunch of whiners!!!

Must be all liberals, expecting major drug companies to GIVE AWAY their hard-earned research products.

What about all those families who invested in them during the dry years? You want them to suffer just so you can have for FREE what they worked hard for?

Do your research! Many of those drug companies give away major blocks of INSULIN to those who qualify. I got two 4Month batches from ELI LILLY a couple of years ago.

Though now they no longer help those in the Medicare system and we have to go elsewheres, but there is an elsewheres. And, even the FDA understands so that they are NOT seizing the cross border shipments of pharmaceuticals.

Ive used CANPHARMA with good results. But, even they are violating their contract obligations with LILY by taking the excess production out of TURKEY and shipping them to US users via UK and Canada. Its in the legal system to stop them and others, but until then...

Another avenue is to really look into what your PPD pays. I was shocked at what Humalog cost, compared to Novolog and Novolin. Now its just a matter of adapting to what is cheapest for me and will work as well as Humalog.

Last year I survived on gifts from my MD and a friendly drug rep. This coming year it will be worse, as Humana increased rates and copays by 50%. I see CONSPIRACY, so that they can appease Congress later this year by rolling back the rates and then claiming they did their share. So, you can see I am not without sympathy for many of you.

You should also be grateful that the generics are lowering their prices even more for those $4-$12 programs at pharmacies. Thats also helping.

But, for those who use INSULIN PUMPS, there is a program that the GOVT pays all costs. Just keep in mind there are ISSUES with the point of entry; ie infection-related problems.

Im still annoyed that I get charged, by HUMANA, so much for the needles and testing supplies. I thought that was supposed to be FREE under the govt programs???
But, ACCU-CHEK has been great, in that they have given me free meters and lots of free strips over the years; even when I forgot to rotate a batch that is now a year expired.

So, dont complain and moan, do research and dialogue with others.


Posted by Anonymous on 18 January 2009

I have recently been offered a job opportunity that requires me to relocate from Australia to the USA. I have been a type 1 diabetic for almost twenty years now and have been researching the cost of living in the USA and the cost of diabetic treatment. I have insurance provided by my employer but it interesting to note the expense associated with a condition that needs ongoing treatment, as this is not covered. In Australia we have insulin subsidised by the government. As such I purchase, for example, Lantis 5ml vials that are packaged in 6 packets each containing 5 vials. This will cost me approximately 30 Australian dollars (30 vials). As I use two different insulin products my total bill is at 60 Australian Dollars and can last anywhere up to 4 months. Along with this I can approach my local Diabetes Australia office and obtain such items as a nova pen absolutely free. Other products, such as test stripes and needles are all subsidised. With the diabetes epidemic growing every year this may not last forever but I feel for the plight of the ordinary America citizen afflicted with the disorder and then having further stress placed on them by weighing up whether they can afford to live. This is a concern I will need to evaluate before any move can take place. I wish you all the best and good health.

Posted by Anonymous on 6 March 2009

It is so sad that there are a few who are over-charging the suffering many simply because there is no end in sight. But that is about to change. I would like to announce that in a few weeks a huge change will improve the diabetic sufferers. Berean Development, Inc. has patented two of its products for international usage as well as obtained FDA endorsement. 100% natural and effective to abate and remediate diabetes. All insulin-dependent people will slowly disgard the old standard. This will be the new standard. Product name: Glybalance & Mirac. A GlyBa1ance pill of 3mg will reduce anyone's BGL an of avg. 31% within 30 mins. This is not a joke. If you're looking to reduce your insulin expense, consider this new product. It may take 6 to 12 month. Anyone reading this is welcome to prove me wrong. Ask your doctor about it.

Posted by tkeplington on 16 March 2009

In the last 30 days I personally witnessed positive results emerging from the "soon to be the new standard" for the world. Doctors are not absolutely needed to obtain these products. At best, merely advising on how much insulin is needed. A very small number of doctors in the entire USA are currently using GlyBalance & Mirac to deal with a well-known problem called Autoimmune Disease. I can tell you that if you are suffering from Fibromyalgia, MS, Arthritis, and Lupus besides Diabetes these 100% natural products is what you should embrace. I would like to simply state that my statements are not intended to convince anyone. I suffered from Fibromyalgia for several years and since taking Mirac I have not received any awful pain and headaches. Regarding Diabetes, I've made presentations to several friends and neighbors regarding the efficacy of Glybalance. I administered one 3mg pill to each individual and all were impressed in the reduction of both the BGL & HbA1c within 30 mins. So, here's my challenge to you. Find the worse Diabetic person, and administer this one free pill (which I know you want) and check BGL results with 30mins

Posted by Anonymous on 15 May 2009

Bottom line appears to be get right with God and don't expect to have any material things because we're gonna have to live on welfare to afford meds. I am new to diabetic world at 39 years old; recognized high blood sugar levels at annual company physical. Still haven't been to doctor for official diagnosis and training- still overcoming denial. But my views on my future are changing; it's okay to die if you're right with God, spend your money/401k now as later it will be used for meds.

Posted by Anonymous on 27 June 2009

I find it interesting that with so many US citizens unemployed that we are still paying for the worlds prescriptions. We have laws designed to protect the Pharmaceutical companies profit, so they can "recoup" the cost of drug research, yet we allow the same drug company to sell the same exact product all over the world at significantly lower prices because of competition and other government laws that force lower prices! Here is an idea - Change US law that makes it illegal for a pharmaceutical company doing business in the U.S. to sell any drug at a higher price than what they sell it for any where else! If Eli Lilly sells it for $10 in canada, they can't charge more than that here!

If that makes the pharmaceutical companies nervous, it should. If the government still wants to help the pharmaceutical companies, make it illegal for new drugs protected by U.S. Patents to be sold anywhere that does not honor those U.S. Patents, so that they get the same protection everywhere else in the world. If Canada, India, China wants a new US developed drug, they will have to protect the drug company rights.

One last thought - US government... Create a website, with a law if needed, that posts the retail prices of all of the drugs sold in the US. Make ALL pharmacies post their prices. This would allow true competition for price. i.e. I am considering switching from Lantus in a standard vial to Lantus in the LantusĀ® SoloSTARĀ® pen, but I have no idea of the actual costs. As a consultant I go on and off of insurance and I would love to have some kind of idea of the real costs. Even my primary pharmacy (Walgreens) won't show me the prices online. In any other area of consumer goods, this would be called price fixing, or a monopoly!

Posted by Anonymous on 15 July 2009

As for the jerks in this world who start off calling people liberals turning this country once again into a liberal/conservative cesspool I would like to say the following. It is not the liberals whining but more the conservatives whining that their rich or ignorant lifestyles are going to be a little less opulent. I really think if rich people had to pay a little more for healthcare to help the less fortunate then so be it, that does more for people than some of their charity fundraising will ever do! It would also do well for some to read and read well the hippocratic oath because that means WE HELP PEOPLE HEAL not
overcharge them so we can make our mazarati or porsche payments on time and eat steak every night!
There has been price fixing in the medical community for years and personally I think our government SHOULD raise our taxes for a better health care system, pay for some of our copays and
definitely pay for any medication necessary for human life to be sustained such as insulin for type one diabetics. But I'm just one voice.
We all have to be willing to make this sacrifice together. So it means that we might not be wearing as much Prada, their boots hurt my feet anyway. It's not that much of a loss from a practical point of view. It comes down to this. People can afford either the medical doctors visits or the medications but usually trying to pay for both is stressful beyond belief! And some agenda promoting idiots like to come online and start calling people liberals? How asanine is that?! I'm tired of excuse toting conservatives wanting to sling mud, hide their mistakes, and then have the audacity to blame everything on liberals when its not a liberal or conservative thing in the first place! It is WHAT is right for the people that we
need to be focusing on. We need a better health care system in this country PERIOD, end of discussion! And I will not no longer listen to conservative excuses on it and attacks. I'm going to focus on what needs to be done and lobby to have it done! I recommend everyone take a risk and do the same. Support healthcare reform. If it doesn't work out, people can always change it later! Thats why we have elections in this country.

Posted by Anonymous on 30 July 2009

Eli Lilly stopped a Korean Dr from selling his islet cells wrapped with a seaweed extract (which I used at LANL for coating plastic veins for the Army), and his permanent, no problem cure sold for $2,000. You can get a derivative surgery for this in the UK for free, and it's a permanent cure. It's Eli Lilly that is killing people with prices, just like a terrorist. They need to be stopped like the Taliban. They kill more people thru impoverishment and bad treatment that all terror attacks have done so far, but they do it every year.

Posted by Anonymous on 24 January 2012

Eli Lilly "Cares", Yeah right, what they care about is money. I just purchased a 10ml vial of Humalog in Mexico for 39.40 today. 1/2012 I pay 128.40 in my home walmart pharmacy! It's the same bottle, made by Lilly in the USA but only with Spanish instruction sheet, well gee, how many time have i read that! No wonder diabetics are dying, loosing fingers, kidneys, eye, feet and damaging nerves. It's really tough to pay for the over priced drugs when you don't qualify for any hand out programs, or when you stuck in the donut hole or the deductable. So many times I've had to scrimp on insulin because I just can't afford the treatment...even with insurance and medicare! Now I find out Lilly and Walmart are bilking me for over 300.00 every month for my meds! This realllly makes me very very angry! Why is Lilly allowed to operate with Fraud like this! There's no other word for it! I'm really sorry for Diabetics who get this diabetic monkey on your back....diabetis really is a Multi Billion dollar disease and now I'm helping John C. Lechleiter CEO of Lilly get his 16.5 million dollar salary package at my expense! I hope his damn Yacht sinks!
What we need a great big Class Action law suit to make lilly give the money back to us!

Posted by Anonymous on 15 September 2012

The cost of insulin in our area has tripled over the past 3 months. I buy insulin for a diabetic dog, so there is no insurance relief. I'm sure that a vast group of uninsured diabetic people are also up against the wall with this. Can't our government / FDA / Congress do something about this? Drug manufacturers are exploiting a captive market.

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