Hawk 1

Carol Ann Hawk

06/26/2017

Tyler Barnum

Intro to writing (EN)-ENGL 1010-304

Literary Review on the Topic of Insulin Prices

In the community of Type 1 diabetics and insulin dependent Type 2 diabetics, insulin

prices have been a hot topic in the diabetic community. Insulin is expensive especially for Type

1 and Type 2 who rely on the drug as a life support. Diabetics with high deductible insurance

plans, and no insurance are hit the hardest when it comes to prices of insulin. To start the

discussion, some things about diabetes need to be explained.

What is diabetes? There are two basic kinds of diabetes. Type I is an autoimmune disease

where the immune system starts to destroy the insulin hormone producing beta cells inside of the

pancreas gland, and so the pancreas gland can no longer regulate blood sugar levels. Type 2 is

when a persons body becomes resistant to insulin. A little background on types of insulins, there

are three medications with two categories. Animal insulin, the first invented, saved lives but a lot

of people had reactions from it. Cloned human insulin, the next improvement, had way less

reactions. The most recent Analog insulin is a synthetic insulin of human insulin. Each type of

insulins have two subtypes, a fast-acting insulin that is to correct high blood sugars and used to

eat food and a long-lasting insulin used mostly to regulate blood sugars during the night. It is

worth noting that Type I diabetics have to use both fast-acting and long-acting. Blood sugar

meters are crucial to knowing how much insulin to give. Type Is blood sugar levels can go from

0 to 2000 but the goal is to be within the range of 70-180. While Type II diabetics can use oral
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pills and are recommended to use the long acting insulin. Diabetics experience hyper and

hypoglycemiahyper meaning high blood sugar, hypo meaning low. There are many side

effects for both; hyper is fixed by insulin, hypo fixed by sugar. So insulin to diabetics is a big

deal, consequently, how expensive they have become is a hot topic. The articles discuss the

prices of insulin and why it has risen so drastically in the past and present of the world. The first

three articles will be on the history and invention of insulin.

In the article of Frederick Grant Banting, Discoverer of Insulin by J. B. Collip that ran

in Scientific Monthly in May 1941, the author writes about his close friends accomplishment in

the discovery of insulin. Banting was born in Alliston, Ontario, Canada on Nov. 14, 1891 to his

parents William Thompson Banting and Margaret (Grant) Banting. After high school and

university education, Banting joined the Canadian Army Medical Corps. Collip shared that after

the war, Banting worked at the Sick Childrens Hospital of Toronto for one year as a resident

surgeon. He continued his work in London, Ontario, and the University of Western Ontario in

the department of Physiology as a part-time assistant. It was at the university when Banting

started his work on problems in the pancreas of internal secretion. In 1932, Banting and Macleod

were awarded a Nobel Prize for discovering insulin and life annuity in Canada. The author told

about personal experiences with Banting. Collip claimed that Banting was unselfish, mindful of

helping others and encouraged young researchers to investigate and research. In the authors

opinion, Bantings accomplishments are attributed to the discovery of insulin, developing the

department of medical research department of the University of Toronto, and carrying out

research for the war effort. (Collip, 473-474)

In The Discovery of Insulin: A Case Study of Scientific Methodology by William D.

Stansfield, a biology professor wanted to highlight the scientific discovery of insulin. The author
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writes about who and how insulin was invented. In 1923 four men were credited for the

discovery. Two were given the Nobel prize for medicine, namely Frederick G. Banting and John

James Rickard Macleod. The other two men were Charles Herbert Best and James Bertram

Collip. Banting led the experiments, surgeries, and treated early diabetics with pancreas extract.

Banting also shared his prize money with Best. Macleod provided guidance, advice, animals,

equipment for the experiments. Macleod shared his money with Collip. Best tested animal blood

and urine for sugar levels before, at random intervals and after treatment; Collip made

commercial amounts of purified insulin. (Stansfield, 11)

The author goes into detail of how they made insulin and biology of pancreas. The

pancreas is located in the abdominal cavity, there are two cell types that matter. Endocrine cells

make enzymes that help in production of the hormone insulin. The enzymes work with the bile

gland and help digest carbohydrates, proteins, lipids, and rennin. The endocrine cells form small

clusters throughout the pancreas; the formations are called islet cells. Islet cells make a hormone-

like substance called glucagon, termed alpha cells. Islets that make insulin are called beta cells.

Basically alpha cells raise blood sugar, and beta cells lower it. (Stansfield, 10)

Now that the history and invention of insulin is explained. The discussion turns to how

and why prices for insulin are reaching the triple digits.

In the web article, Selling a Lifetime of Insulin for $3 by Craig Idlebrook on the site

Insulin Nation, the author writes about how expensive insulin has become and how insulin is a

cash cow for the pharmaceutical industry. The drug companies use insulin as a cash cow by

rising prices very fast and using legal battles to prevent long-lasting insulins from becoming

generic. The author stresses that the current trend of high prices for insulin wasnt always this
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way. That Frederick G. Banting, Charles Best, and James Collip sold the patent of insulin for just

$3 dollars to the board of governors for the University of Toronto in 1923.

Banting and Company reasoned that by patenting their formula of insulin, it would

prevent drug companies from rushing to patent their own version of the less potent or inferior

drug. The university turned around and gave the companies the right to make royalty-free insulin

and the ability to patent future improvements of the drug. The author reminds the readers that the

decision should be kept in historical context. The mass production of insulin was incredibly

difficult at the time of 1923. Because the drug was a life or death matter for children affected by

diabetes (now known as Type I), Banting and Company didn't want to lose the process to make

the drug. So to them, it was essential to put insulin into the hands of people how could mass

produce the drug, so patients could receive the treatment they needed.

Idlebrook explains that it worked for a while. But soon companies found a way to turn a

profit from insulin. In 1941, Eli Lilly and two other companies were indicted for a price fixing

scheme. The price once again rose in the 1970s when a human insulin was developed and the

prices has been increasing since then. As the legal battles over insulin patents have proven,

bringing insulin back to the altruistic ideals of Banting and Company will be a fight. (Idlebrook,

08/07/2015)

As mentioned in the articles above, the creators of insulin intended to make sure insulin

was mass produced so the life saving medication would be available to those who needed it

most. The next four articles touch on why and how prices have changed and how this affects the

diabetic community.

In the article How small changes led to big profits for insulin manufacturers by

Deborah Cohen and Philip Carter written for the British Medical journal in 2011, the authors
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write about how insulin manufacturers make their money. The market of diabetes therapeutic

class drugs is the fourth biggest market in the world. The authors show the monetary figures in

just Britain alone, costs the National Health Service (NHS) 10% of its budget to pay for Diabetic

therapeutic class drugs. The authors remind us that diabetes is one of the fastest increasing

markets in healthcare. The growth in part is due to the rising number of patients with type 2

diabetes and the aggressive push towards analog insulins. The recombinant insulin analogs are

more expensive to make and raise the unit cost of insulin. (Cohen and Carter,18)

In the UK analogs have been rushed in and now make up 80% of the prescriptions for

insulin while the cheaper insulin shares has fallen 41% in the 2005 market. In America, the

prescriptions make up 70% of prescribed medicine. The authors claim that for most patients with

Type II diabetes, the cost of the analog insulins do not bring any extra benefits therefore the

rising cost is not justified when cheaper insulins can do the same job. The authors suggest that

studies done by National Institute for Health and Clinical Excellence (NICE) and a Canada

Health technology both reach the same conclusion. The cost and clinical effectiveness of analog

insulins dont offer any advantages over older insulins in terms of controlling high and low

bloodsugars. Hence, why should there be a increase in cost for the newer insulins? But somehow

the companies are shrugging this off and continue to push their analog insulins (Cohen and

Carter, 18-19)

The authors question why the analog insulins are so popular when they are so expensive

and dont differ in effect of older insulins. They state that it is because of clever marketing by

insulin companies. Providers and medical professionals having been pushing and switch patients

to analog for a number of reasons: a once-a-day shot for type II; the new method of delivery

pens; illusion of choice of different types of insulin; hired nurses that provide a way to start on
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analog insulin but not human insulin; and training schemes for healthcare providers that

encouraged for life brands. Cohen and Carter point out that with diabetes shifted from

specialized secondary care to primary care, companies with their nurse programs are able to push

for more analog insulins to be used. They can compound this by taking older, less expensive

insulins off the market. (Cohen and Carter, 20-21)

COMMENTARY: "Catastrophic health expenditure" by John S Yudkin, the author

writes about the catastrophic health expenditure. A catastrophic health expenditure is defined as

out-of-pocket medical expenses make up a large portion of a household available budget. The

author demonstrates that the Novo Nordisk company has taken had some bad press from recent

years. In 2008, Novo Nordisk ranking in the Access to Medicine Index came in second with the

worrying score of 3.9 out of 5unacceptable. In 2010, the headlines were negative when the

Novo company threatened to take away all its products away from Greece after its government

ordered all drugs prices to be slashed by 25%. And the company was involved in a lawsuit in

South Africa that tried to block trade negotiations to use of generic drugs. In a 2010, an update of

the Access to Medicine Index the company was ranked down to eighth and a worse score of 2.1.

(Yudkin, 29)

The author shares suspicions that the companys recent studies are only for marketing

reasons. Studies are used to determine safety and potency. Novo Nordisks predictive study paid

doctors in 26 countries to enroll 47,565 people in the study for adverse effects while using

Levemir. While the study has generated some publications from the 11 European countries in the

study, the other 15 countries have no publications. Doctors were compensated by convincing

patients to switch from pills or from human insulin to analog insulin. Most patients would rather

stay on the analog then switch back uncompensated. Yudkin explains that Novo Nordisk did not
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provide the insulin for the study, rather the insulin was paid by health insurance, health care

system and the patients themselves; the U.S. was not included in the study. (Yudkin, 29)

Another study with 26 countries, European and U.S. countries were excluded. The study

ranged from the wealthy Luxembourg (GDP per capita $105,197) to India (GDP per capita

$1,410). The author claims that 3,435 patients were recruited in India. The retail price of

Detemir, a human insulin costs $17.77 for 3ml pen. If a patient is using 30 units a day of the

analog, it would cost $648.60 compared to the $74.32 for generic human insulin. The author

states that human insulin should be the first choice for treatment, especially when resources are

scarce. The strategy of Novo Nordisk of driving up prices may end up causing catastrophic

health expenditures for diabetics. (Yudkin, 29)

The top three insulin companies are taking away cheaper alternatives for insulin and

using analogs to raise the prices to exacerbate numbers that are burdening diabetics with prices

ranging from $500 to $1000 for insulins if they have high deductible plans, hit the donut hole or

no insurance. This is on top of what diabetics spend on doctor visits, health insurance, needles,

sharps containers, glucagon (kits, tablets, syrup), blood sugar meters and test strips, and ketone

strips. In the next article, the discussion turns to rising prices in the drug industry to highlight the

similarity of how insulin prices have risen.

In the article Continuing Rise in Drug Prices: Brand Leaders Show the Way by

Wishvas Rane was written in the year of 1999. The author discusses how major drug companies

claim a small rise in drug prices over the past year when a study of product-wise investigation

demonstrates that brand leaders drugs have risen greatly in price. The price of all top drugs have

increased the products of the two companies, Rhone Poulenc and Novartis which saw the highest
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price raise, therefore the author claims that the net earnings were because of drug earnings not a

change in how they calculated.

Rane insists that for the justification for the decontrol of drug prices, the report of

Operation Research Group - Marketing and Research Group (ORG-MARG) is cited to support

upping the prices of drugs. Rane argues that the report is misleading; he says if you ask any

customers or retail chemist they will report that drug prices are going up sharply. (Rane, 2057)

The authors study of the prices of leading brand drugs show how much drugs prices are

increasing. In his analyses tables of drugs and prices, it shows how prices rose: Human Insulin-L

Eli Lilly Ranbaxy cost $170 in 1998 and cost $206 in 1999; Human Insulin-N cost $170 in 1998

and cost $209.90 in 1999; Human Insulin-R in 1998 cost $170 and in 1999 cost $206; Human

Basal Hoechst cost in 1998 $174.40 and cost in 1999 $198.90; Insuman 25/75 Hoechst went

from $174.40 in 1998 to $198.90 in 1998; 50/50 insulin was $174.40 in 1998 and was $198.90 in

1999; and Insulin Soluble 40 IU Knoll went from $47 to $50.34 from 1998 to 1999. (Rane, 2059)

The author finishes by stating that looking at the data of prices of leader drugs which

should be nothing less than 30-40 percent of total sales. How can anyone believe that the claim

of a small raise in price by drug companies, when the facts show that once brand name drugs

raise their price, others follow suit. Rane ends by saying there is no justification of decontrol of

drug prices. (Rane, 2060)

In the article of Post-marketing studies of new insulins: science or sales? by Edwin

Gale writes about how post-marketing studies are more about making money than science.

Companies making insulin are using switch campaigns and more post-marketing studies. The

switch campaigns encourage doctors to switch patients to new analog insulins, and they observe

the patients using the insulin patients have to buy themselves. The Office of Inspector General
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and the European Medicines Agency are concerned over the questionable legality of such studies

under U.S. laws and point out that these studies should not be conducted with the sole reason of

being to promote a medical product. The author claims that when it comes to safety of theses

drugs, few patients have been exposed to a new drug by the time it is licensed. Drug companies

seek to use post-market studies as way to add value to their product. (Gale, 24)

The author reminds readers that analog insulin now makes up 48.8% of the U.K. drug bill

for diabetic meds; and in 2010, the global drug sales for insulin made more than $12 billion by

phasing out older human insulins with analogs, pharmaceutical companies can charge two to four

times more the cost. The post-market studies Gale insists are lacking in well-defined hypotheses,

no control arm and a deficit of data. The makers of theses studies have admitted that increased

attentions and engagement contributed to outcomes unrelated to the use of analog insulins. The

studies ask no hard hitting scientific questions, address the same issues each time, no control

group, and the testing group populations are larger than necessary. Because theses types of

studies are not forbidden by any oversight, they will continue. The author deems it prudent to ask

whether the companies would invest in such studies if not for commercial gain. (Gale, 25-27)

THE PRICKLY PROBLEM OF ACCESS TO INSULIN by Deborah Cohen examines

the topic of the problem of accessing affordable insulin for diabetic patients. Cohen starts by

using an example of parents in Africa who feel relief when a child with diabetes dies, because

the parents no longer have to pay so much for insulin and can send their other children to school.

It is something medical professionals hear often in the poorer countries of Africa. The creators of

insulin intended for it to be seen as a giftnot a commercial opportunity for profit. But massive

numbers of people in poorer countries are unable to receive this gift because of such high costs

for it. In most high income countries, government or insurance can help offset the cost of the
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drug, but low or middle income countries citizens often have to pay out-of-pocket for the

medicine. For a child with Type I diabetes, the life expectancy in Sub Saharan African countries

differs from seven months to seven years. (Cohen, 562)

The obstacles that stand in the way for more affordable insulin are numerous. The author

lists why. Generics have no way to actually compete in a global market. The top three insulin

companies Novo Nordisk, Eli Lilly and Sanofi Aventis dominate the world insulin market by

90%. Because of the widespread belief of doctors who believe that human insulin is subpar

compared to analog, their reasons for this is that tighter control of insulin leads to less mistakes.

The author claims that in 2007 in the U.S., the two companies Eli Lilly and Novo Nordisk

objected when state governors urged Congress to pass bills that issue guidance for generic

insulin manufacturers; and as of now, Europe doesnt have any generic insulin available. (Cohen,

563)

Cohen advises that if insulin is going used to treat the diabetes epidemic, there should

more incentives to guarantee accessible insulin to diabetics. Unlike past drugs, the push for more

accessible insulin has been dampened. The main representation for global diabetics is the

International Diabetes Federation, while it does much good, the IDF is restrained from speaking

out against insulin prices because their funds come from the top three insulin companies. The

IDF does provide insulin and diabetic supplies at subsidised prices or in some cases free of

charge. The author insists that one critic says that this presents the companies with looking good

and installing brand loyalty once money does become available. Cohen ends by stating that once

governments signed up for the U.N. Declaration of medical rights, it's up to diabetics to hold

companies responsible. (Cohen, 564-565)

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In the next set of online articles, the companies touch on their reasons prices have risen

and the rebuttal of other articles on why prices have risen.

In the website article on Novo Nordisks Our position on Pricing and Affordability, it

starts by the company stating that they many Americans are having trouble affording their

products. That as a company, its focus is on improving the lives of diabetics and it is

unacceptable that people cant afford to pay for their medication. Novo Nordisk claims that

making sure insulin is available is a matter they share with all of the healthcare system and that

the challenges diabetics face are due to our complex evolving healthcare. They advise the best

way to deal with this problem is to work together with insurances, pharmaceutical companies,

pharmacy benefit managers, insurance companies, employers, policy makers, patient

organizations and payers.

They present three solutions to deal with the problem of insulin costing so much. The

first is fixing the complex pricing system. The company insists that the current system is

complicated by deductibles, co-pays, administrative fees, rebates, and discounts. The system

needs to be simplified and transformed. The second is creating more price stability, by limiting

their price increases to single digits in the future. The third is to reduce out of pocket costs to

their customers by using company co-pay assistance programs, patient assistance programs, and

making sure human insulin stays on the market and future discussions about the issue. (Novo

Nordisk, 2017)

In the Eli Lilly companys address on Insulin prices in Our Next Step in Addressing

Insulin Affordability, Eli Lilly starts by claiming to have engaged the diabetes community,

business community, and advocacy organizations on the subject of insulin prices. They

acknowledge that many diabetics are being burdened with rising insulin prices and the company
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is committed to seeking more solutions that help patients have access to insulin. The company

Eli Lilly has joined with Expressed Scripts in a drug discount program Inside Rx which help

Lilly Insulins to be discounted at 40%. The company states they will continue to look for ways to

help with options for people who pay full price at pharmacies. (Eli Lilly, 2017)

The only information to be found on the cost to make insulin was Hagens Berman law

firm that is filing a class action suit against the top three insulin companies and even then it's

only a passing mention.

D. Climbing Insulin Prices Unrelated to Any Rise in Production Costs 172.

Despite the availability of a number of highly effective insulin drugs, too many people

living with diabetes go without proper treatment for an all too familiar reason: cost 42.

173. Sanofis benchmark price (AWP) for Lantus, the top-selling analog insulin, now sits

at $310.64 for a package of Lantus 100 units/mL Solution for Injection and $465.95 for a

package of Lantus SoloStar 100 units/ml Pre-Filled Pens for Injection. Sanofis

benchmark price (AWP) for Apidra is $318.89 for a package of Apidra 100 unit/ml

Solution for Injection and $616.04 for a package of Apidra SoloStar 100 units/ml Pre-

Filled Pen Solution for Injection. Most diabetes patients need at least one package of

insulin per month. Many patients need more than one. Therefore, Lantus patients spend

roughly $300 to $460 or more per month on Lantus if they buy based on the benchmark

price; Apidra users spend roughly $320 to $616 or more per month on Apidra if they buy

based on the benchmark price. Figures 8 and 9 demonstrate Sanofis price increases from

2006 to 2016 for Lantus and Apidra vial and pen packages.

42 Even the real costs for Novo Nordisk, Eli Lilly, and Sanofis insulin products

are high. These companies drugs are all branded pharmaceutical products. Because
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there are not yet any generic equivalentsversions of the drugs that are bioequivalent to,

but lower in price than, the Defendants productsin the market, the Defendants can

command supra-competitive, monopoly prices for their product. But if the real cost is

high, the benchmark price is off the charts. Quoted from the amended complaint

(HBSSLAW 2017)

The insulin companies keep the actual cost of what it costs to make insulin close to the

chest and little to nothing can be found on the subject. The next online article goes into an in

depth look at all the factors that rise insulin prices.

The Rising Cost of Insulin: Why the price of this lifesaving drug is reaching new

heights was written by Allison Tsai in March 2016. Tsai explains the Prescription Drug

Gamethe price of insulin starts with the insulin company setting the list price. The companies

claim because they are a for-profit business and they have to take into account: clinical benefits

that reduce diabetic complications; more costs from health care system; and if sales are lower, if

a drug patent is expiring, they must price match a competitor. Insulin companies say that the

wholesale price is more practical to be negotiated. Tsai insists that middlemen such as pharmacy

benefit managers, health plans retail pharmacy chains, drug wholesalers and distributors all

negotiate price discounts from the wholesale price set by insulin companies, and middlemen take

a cut of profit. Tsai argues that it becomes more confusing because discounts are not given from

the beginning. It is hard to determine discounts and prices when they are confidential.

Tsai points out that insulin companies, together have increased prices by 160% in the past

five years and because more high deductible insurance plans patients are having to pay full

wholesale prices for insulins. Out-of-pocket costs by high deductible plans are have increased by

89% from 2000 to 2010. For many patients, it has come down to bills or insulin. The Donut hole
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is when there is a coverage gap in insurance, when patients have paid a certain amount of money

and hit their deductible, they have to start paying a larger percentage of their drugs until they can

get out of the donut hole.

Tsai puts forth a way for a long term solutions. Government should step in with

regulations, such as a limit on how much they can charge for insulin. Insulin is unique in the fact

there are no other therapies for diabeticslifesaving medication should never be inaccessible for

those who need it most. (Tsai, 2017)

In summary, both types of diabetes are serious illnesses; insulin manufacturers are price

gouging simply because they can; and Type I diabetics die without their supply. No one wants to

put the companies out of business. But the question among diabetic communities is why are their

lives being made into profit? Why are companies charging more without justified cause? What

needs to be studied and discussed more is how much profit is too much. How is it ethical to make

chronically ill patients pay so much money just to stay alive? For a medication that has been

around for 94 years, why have productions costs stayed the same? How is it ethical for less

developed countries diabetics to die, from lack of insulin? It would be encouraging to see more

literature, studies, and research to why insulin costs so much. It is important to examine these

questions and seek solutions, because the current situation cost lives, money, and peoples

health.
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Works cited

Cohen, Deborah. THE PRICKLY PROBLEM OF ACCESS TO INSULIN. BMJ: British

Medical Journal, vol. 343, no. 7823, 2011, pp. 562565. JSTOR,
www.jstor.org/stable/23051381.

Cohen, Deborah, and Philip Carter. How Small Changes Led to Big Profits for Insulin
Manufacturers. BMJ: British Medical Journal, vol. 342, no. 7787, 2011, pp. 1821.
JSTOR, www.jstor.org/stable/25766607.

Collip, J. B. Frederick Grant Banting, Discoverer of Insulin. The Scientific Monthly, vol. 52,
no. 5, 1941, pp. 472474. JSTOR, www.jstor.org/stable/17312.

Gale, Edwin. Post-Marketing Studies of New Insulins: Science or Sales? BMJ: British Medical
Journal, vol. 344, no. 7862, 2012, pp. 2427. JSTOR, www.jstor.org/stable/23235730.

Stansfield, William D. The Discovery of Insulin: A Case Study of Scientific Methodology

The American Biology Teacher Vol. 74, No. 1 (January 2012), pp. 10-14. JSTOR,
http://www.jstor.org.libprox1.slcc.edu/stable/10.1525/abt.2012.74.1.4

Wishvas Rane. Continuing Rise in Drug Prices: Brand Leaders Show the Way. Economic and
Political Weekly, vol. 34, no. 30, 1999, pp. 20572060. JSTOR,
www.jstor.org/stable/4408225.

Yudkin, John S. COMMENTARY: Catastrophic Health Expenditure. BMJ: British Medical

Journal, vol. 344, no. 7862, 2012, pp. 2929. JSTOR, www.jstor.org/stable/23235732.

External works cited

Idlebrook Craig. (http://insulinnation.com/treatment/medicine-drugs/selling-lifetime-insulin/

Accessed 07/28/2017, published August 7th 2015)

Eli Lilly (https://www.lilly.com/our-next-step-in-addressing-insulin-affordability) 2017 accessed
on
08/03/2017
Novo Nordisk (http://www.novonordisk-us.com/whoweare/about-novo-nordisk/our-position-on-
pricing-and-affordability.html) 2017 accessed on 08/03/2017
HBSSLAW 2017(Amended Complaint 03/03/17 pg 250 accessed on 08/03/2017)
Tsai, Allison 03/2016 accessed on 08/03/2017 (http://www.diabetesforecast.org/2016/mar-
apr/rising-costs-insulin.html?referrer=https://www.gogle.com/)
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