Put your skeletal outline on this document:

1. Introduction

a. Real life example of how the price of insulin harms someone.

b. Preliminary information

c. Thesis

2. History

a. What is insulin? + What happened to people with diabetes before insulin

b. What is a biologic drug, and how is it different from standard drugs?

c. Monopoly on market by the three major companies (Yes, it is historical. The

same companies have had an monopoly on the market since the creation of

insulin due to the patents.)

i. Eli Lilly

ii. Novo Nordisk

iii. Sanofi

3. Cost of insulin

a. Why are inflation rates so high?

b. Darby Herkert of Yale University in the article “Cost-Related Insulin Underuse Among

Patients With Diabetes” describes the correlation of high insulin cost to insulin's under

use among diabetic patients. Insulin is a medication people with Type 1 and Type 2

diabetes need to live. The World Health Organization put it on the Model List of Essential

Medicines. This means it should be available at all times an affordable price. However, in

the United States over the past few decades, insulin prices continue to inflate. In 1996, Eli

Lilly first came out with the supply of Humalog for $21 a month. In 2001, that price
 increased to $35, and in 2019, the price of Humalog was $275. From 2001 to 2019 there

was a 1200% increase in the price of Humalog. It is not just Eli Lilly, one of the world's

largest manufacturers of insulin, that is increasing it's prices. Novo Nordisk and Sanofi,

the other two manufacturers of insulin, had also raised the price of insulin over 50% from

2014 to 2019. Even though diabetics need insulin to live, they are under-using it or not

using it at all because they cannot afford it. In the survey conducted in the article, the

team of Yale and Harvard students gave a survey to patients with Type 1 or Type 2

diabetes at the Yale Diabetes Center between June and August of 2017. The Yale

Diabetes Center serves a diverse population from New Haven, Connecticut, and other

counties. The questions in the article asked whether or not patients used less insulin than

prescribed, stretched out their supplies of insulin, took smaller doses of insulin, stopped

using insulin, not filled insulin, or not started because of cost. The survey found that 25%

of patients at the center reported cost related insulin underuse and as a result, they had

poor glucose levels. They found that patients who were economically disadvantaged were

more likely to report cost-related underuse. Two-thirds of these patients also experienced

difficulties of affording diabetic equipment.

i. Behind the scene negotiations

4. United States Healthcare

a. Insured

i. Public (Medicare and Medicaid)

ii. Private

b. Uninsured

5. What do people who are insulin dependent do if they cannot afford insulin in the U.S?

a. Travel to other countries

 b. Blackmarket

c. Ration/Not take recommended amount

i. What are the effects of not taking the prescribed amount of insulin?

6. Other countries insulin cost/healthcare compared to the United States

a. Similar Nations

i. Canada

ii. United Kingdom

b. Other countries

i. Mexico

ii. Japan

7. How come the government hasn’t done anything about insulin’s price tag, and what are

the effects of there not being enough regulation?

a. Politics

b. Federal governments limitations

i. Ban on negotiation with drug companies

ii. FDA cannot regulate the price of drugs, so companies have been able to

mark up prices over 100% due to the free pricing system.

1. What have some states (California, Maryland, Nevada and

Vermont) done to combat this?

2. Virginia: In April of 2020, Governor Ralph Northam signed House

Bill 66 which is a bill that will limit cost- sharing to $50 for a 30-day

supply of insulin for those who have state-regulated commercial

insurance. Cost-sharing is the share of cost covered by your

insurance that you pay out of your own pocket. The American
 Diabetes Association believes this bill will help bring economic

relief to the 870,000 Virginians who live with diabetes. Although

the ADA supports Governor Ralph Northam decision to sign the

bill, the organization believes that cost-sharing should be

eliminated and revert to a $50 co-pay cap.

iii. Lack of transparency (Private insurers and benefit managers can

negotiate prices with drug companies and don’t have to inform the public

about the deals.)

iv. What do experts believe the government should do to combat the issue?

8. Legal

a. United States Laws

b. International laws/agreements

c. Proposed bills

d. Current court cases/case law

i. Issue: Did the three major companies that produce insulin Sanofi, Novo
Nordisk, and Eli Lilly conspiring to high insulin prices, are they concealing
the arrangements they've made to hike up the price of insulin, and are
they working with pharmacy benefit managers to set the price of insulin?

Rule/Legal Principle: Racketeer Influenced and Corrupt Organizations

(RICO) Law is the federal law that allows for the prosecution of all
individuals in a corrupt organization. A RICO enterprise is a corporation
(or multiple corporations) that conduct corrupt activity. In Avandia
Marketing, Sales Practices & Product Liability Litigation, a RICO claim
requires proximate causation. That means the RICO predicate offense
was “not only the cause of the injury, but the proximate cause as well.”
The reason it applies to the current case is because people have been
hospitalized, gone into diabetic ketoacidosis, and died because they could
not afford insulin, the only medication that can save their lives. The
reason they cannot afford it allegedly is because the companies they are
suing are not competing with one another to make the price of insulin
more affordable and they are exploiting the United States drug-pricing
system to benefit themselves and pharmacy benefit managers by
gradually increasing the price of insulin. Therefore, Sanofi, Novo Nordisk,
and Eli Lilly created a problem which is leading to the plaintiffs physical
injuries.

Facts: There are three major companies that control and manufacture
90% of the world's insulin. These three companies are Sanofi, Novo
Nordisk, and Eli Lilly. The reason that there are not more companies to
“me too” drug versions of insulin is because insulin is a biologic drug. This
means that they are more complex to produce than regular drugs. To
produce an off brand Advil the company would just need to copy the
chemical component of the drug. However biologic drugs are a lot more
complicated to produce than just copying the chemicals. It also cost a lot
more to produce a biologic drug. Because it's hard to recreate a biologic
drug without seeing the original designs, many companies that have
attempted to produce an off-brand version fail. Many don't even attempt
because the three major companies have patents that protect them from
another brand of insulin coming out. Therefore, the three major insulin
companies have a monopoly on the world's insulin supplies. Because of
this, they get to set the price. The issue is that they continued to inflate
the price of insulin to the point where many died because they can't afford
to pay for it. According to the American Diabetes Association and the
University of Southern California Center for Health Policies, between
2007 and 2016, major brand insulin list prices have increased by 252%.
For some, three bottles of insulin can cost $900 a month because they
are uninsured, or they have not met their health insurance companies
required ductable. Pharmaceutical benefit managers are lower-cost than
what is offered to the public from these companies. However, these
pharmaceutical benefit managers are also enticed to keep the price up
because they make a large profit from insulin. When people have a
problem with how something is priced or the ethics of a company, they
can boycott the company or choose to support another brand that is
similar to the one they were supporting. However, insulin is a drug that
people need to live. Many people have to take it hourly, and it's not like
they can choose to support another brand over the one they are buying
from because these brands have a monopoly on the market, and some
people have to have a certain brand of insulin.

Decision: Court ruled that the plaintiffs had adequately shown proximate
causation because the plaintiffs asserted that the cost that was passed
down from the pharmacy benefit managers would not have occurred if
not for the drug manufacturers inflation on insulin. (This wasn't the official
 case but the case to allow the plaintiff to file a class action lawsuit in the
United States, so we're still waiting for the actual decision.)
9. Conclusion

a. Overview

b. Thesis

c. Final argument