Final - Purdue Pharma - Group 8

Presented By:
The Role of Purdue Pharma Aakash Malpekar

in Opioid Crisis | 31.05.2021 Meet Hirani
Krishna Bhutani
© 2018 Risk Educators Pvt Ltd. Confidential, for limited circulation only.
INDEX
Introduction to the Company
What are Opioids ?
The Opioid crisis
What did Purdue do ?
Stakeholder Identification
Stakeholder Mapping
Impact on Purdue
Stakeholder Identification
Stakeholder Mapping
Root Cause Analysis
Strategical Recommendations
Ethical Company Analysis
© 2018 Risk Educators Pvt Ltd. Confidential, for limited circulation only. 2
The Purdue Pharmaceutical L. P.
Name – Purdue Pharma L. P.

Founded - 1892
Headquarters – Stanford,
Connecticut, United States
Est. Revenue – 3 Billion Dollars
Est. Employees – 5000
Famously known for its drug
“Oxycontin” launched in 1996
What are Opioids?
• Opioids can be prescription medications often referred to as
painkillers, or they can be so-called street drugs, such as heroin.
• They are used to block pain signals between the brain and the body
and are typically prescribed to treat moderate to severe pain.
• In addition to controlling pain, opioids can make some people feel

relaxed, happy or “high,” and can be addictive.
• Their side effects can include slowed breathing, constipation,

nausea, confusion and drowsiness.
The Opioid Crisis
• From 1999 to 2019, nearly 841,000 people died from a drug

overdose
• Over 70% of overdose deaths involved an opioid like

prescription opioids
• In last 20 years, 7 million Americans abused Oxycontin.
• A mass addiction that has killed over 450,000 people till date.
• In 2017, 27,000 babies born with Neonatal Abstinence Syndrome

(NAS)
The Opioid Crisis (Cont.)
• A forecast by STAT, a reputed health and medicine
media company, estimates that in next 10 years,
500,000 people could succumb to this epidemic It is
an equivalent to the population of Baltimore. City in
USA.
• Major worrying aspect of the crisis is that people

who become dependent on pain pills are likely to
switch to heroin because it’s cheaper than
prescription drugs. The National Institute on Drug
Abuse found that almost half of young people who
use heroin started doing so
after abusing prescription painkillers. Those addicted
to prescription opioids are
40 times more likely to become addicted to heroin.
What did Purdue do?
• Aggressive marketing – To change the whole narrative in the

country regarding the addiction, the use of opioids and pain care.
"It became almost a religious-like fervor, around expanding the
access to opioids." Said Dr. Adrew Kolodny, the co-director of
opioid policy research at Brandeis University.
• Paid doctors - to feature in the promotional videos. The most
impactful video "I got my life back', which featured, Johnny
Sullivan, later became the poster child of the drug, along
with six other patients of Dr. Alan Spanos, were sent to 15,000
doctors without FDA approval. Nine years later, one of the
patients featured in the video succumbed to the deadly
consequences of the drug.
What did Purdue do? (Cont.)
• False Claims - In one study conducted by Purdue

Pharma they stated that only about 1 percent of opioid
users become addicted but then shortly after they were
forced to come out and say that they used falsified
information and that the number was much higher.
• Massive sales force and a narrow target – Within 6 years

from the launch of Oxycontin, their sales force grew
more than 100%.
It’s not a drug, It’s a brand – They tried to create a brand
out of their drug
• The conspiracy also involved aiding and abetting

violations of the Food, Drug, and Cosmetic Act by
facilitating the dispensing of its opioid products,
including OxyContin, without a legitimate medical
purpose, and thus without lawful prescriptions.
• Purdue also admitted it conspired to violate the federal

Anti-Kickback Statute. Between June 2009 and March
2017, Purdue made payments to two doctors through
Purdue’s doctor speaker program to induce those doctors
to write more prescriptions of Purdue’s opioid products
Stakeholders
INTERNAL • Employees
STAKEHOLD
ERS
• Sackler Family
• Government
• Suppliers
• Distributors
• Prescribers
• Pharmacies
EXTERNAL • Patients
STAKEHOLD
ERS
• W.H.O (World Health Organization)
• D.E.A (Drug Enforcement Administration)
• F.D.A (Food and Drug Administration)
• Media
• Joint Commission on the Accreditation of
Healthcare Organization
Stakeholder Mapping
Circle of Control:
Employees
Suppliers
Circle of Influence:
Prescribers
Pharmacies
Patients
Circle of Concern:
Government
WHO
DEA
FDA
Media
JCAHO
Impact on Purdue
• In 2019, Co. had 2600 lawsuits from 49 states claiming $2.15
Trillion dollars.
• Financial Penalties: In 2007, $634.5 millions for misleading ads.

In 2020, co. also agreed on $8 billions settlement. Also, agreed
for future payment of additional $10 billion dollars.
• Loss of Market share.
Impact on Purdue (Cont.)
• Negative International Media coverage
Impact on Purdue (Cont.)
• All this led to massive Reputational Loss
• Purdue will be dissolved as part of the settlement, and its

assets will be used to create a new "public benefit company"
controlled by a trust or similar entity designed for the benefit
of the American public. The new company will ultimately be
owned by a new National Opioid Abatement Trust established
for the benefit of the American people. State and local
governments will neither own, nor operate the new company.
Root Cause Analysis
• Ineffective Whistleblowing Mechanism
• Too much emphasis on Profits
• Myopic view of Stakeholders
• Lack of Transparency
• Tone from the Top
• Regulatory Failures of F.D.A

- Failure to properly enforce marketing regulations
- Failure to obtain evidence of long-term safety and effectiveness
- Failure to manage conflicts of interest
Strategical Recommendations
Effective Whistleblowing mechanism

Transparency
Tone from the Top
Due Diligence of prescribers and Pharmacies
An independent Audit Committee
Training and monitoring systems
Overhaul of the FDA Regulations
EXAMPLE OF ETHICAL
COMPANY
–
LONZA PHARMA
About Lonza
Name – Lonza Pharma and Biotech
Founded in 1897 in the Swiss Alps
Headquarters : Basel, Switzerland
Lonza operates across five continents.
Approximately 14,000 full-time

employees
In 2020, Lonza generated sales of CHF
4.5 billion
Ethics & Compliance Policies
• Trade Sanctions and Export Controls

Lonza supports international efforts to prevent trade in technology,
substances, and materials that can be misused for warfare or warlike
activities, for the manufacture of illicit drugs or for other
internationally prohibited activities.
• EHS
Lonza is committed to operations and practices which prevent harm or
damage to people, the environment, or property. Our vision is zero
injuries, zero process incidents, zero distribution incidents and zero
environmental incidents.

• Conflicts of Interest
Situations that create, or appear to create, a conflict between a Lonza
employee’s personal benefit and Lonza’s interests should be avoided,
or else be disclosed to management and resolved.

• Business Gifts
Offering, soliciting or accepting gifts and donations related to our
business is prohibited. However, entertainment and gifts of
insignificant monetary value arising out of ordinary corporate .

• Accuracy of Records
Lonza expects its employees to report any unrecorded funds or assets
or false or artificial entries in Lonza’s books and records to the Legal
Department. In addition, Lonza expects employees to comply with
its travel and expense reporting policies

• Fair Competition
Lonza is committed to the principles of fair competition and respects
the laws restricting the operation of cartels and other monopolistic
practices. Lonza employees must be aware of antitrust and competition
laws and their implications in their business area.
• Anti-Corruption and Anti-Bribery

No Lonza employee shall offer any payment or improper financial
advantage to any government official (including any employee of a
government-controlled agency, state-owned enterprise, or public
international organization) or any other third party (including
customers and suppliers) for the purpose of obtaining or retaining a
commercial advantage of any kind.
What makes Lonza stand out?
• The foundation of our ethics and compliance commitment
is openness, accessibility, and discussion within the Lonza
community. Most issues can be resolved at the local level
before they become problems for employees, Lonza or the
public.
• The Lonza Open Door and Non-Retaliation policy

encourages employees to present ideas, ask questions, or
voice concerns about any subject, especially those related to
company policies and procedures, GMP guidelines, correct
data and recordkeeping, and ethical or legal questions.
What makes Lonza Stand out?
(Cont.)
• In addition to the Open Door and Non-Retaliation policy,
Lonza provides several confidential ways to report issues
or concerns.
• Lonza managers have leadership responsibilities for

setting a good example, encouraging an environment of
open and honest communication without fear of
retaliation, and taking prompt action when ethical or
compliance issues are brought to their attention
References
• https://www.gao.gov/assets/gao-04-110.pdf
• https://www.abc.net.au/news/2019-03-19/the-small-town-doctor-taking-on-
the-sackler-family/10910916
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2622774/
• https://www.sciencetimes.com/articles/26934/20200818/purdue-pharma-2-
15-trillion-opioid-lawsuit-49-states.htm -
• https://www.lonza.com/sustainability/ethics-and-compliance
• https://www.worldsmostethicalcompanies.com/honorees/
• https://www.cdc.gov/injury/features/prescription-drug-overdose/index.html
• https://www.latimes.com/projects/la-me-oxycontin-full-coverage/
Campus Address :
88, Sector 44,

Gurgaon – 122002
CONTACT US
www.grm.institute Thank you!
Email :
admissions@grm.institute
© 2017
2018 Risk Educators Pvt Ltd. Confidential, for limited circulation only. 28

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Presented By:

The Role of Purdue Pharma Aakash Malpekar

Name – Purdue Pharma L. P.

• In addition to controlling pain, opioids can make some people feel

• Their side effects can include slowed breathing, constipation,

• From 1999 to 2019, nearly 841,000 people died from a drug

• Over 70% of overdose deaths involved an opioid like

• In last 20 years, 7 million Americans abused Oxycontin.

• In 2017, 27,000 babies born with Neonatal Abstinence Syndrome

• Major worrying aspect of the crisis is that people

• Aggressive marketing – To change the whole narrative in the

• False Claims - In one study conducted by Purdue

• Massive sales force and a narrow target – Within 6 years

• The conspiracy also involved aiding and abetting

• Purdue also admitted it conspired to violate the federal

• Financial Penalties: In 2007, $634.5 millions for misleading ads.

• Loss of Market share.

• Negative International Media coverage

• All this led to massive Reputational Loss

• Purdue will be dissolved as part of the settlement, and its

• Ineffective Whistleblowing Mechanism

• Too much emphasis on Profits

• Myopic view of Stakeholders

• Tone from the Top

• Regulatory Failures of F.D.A

Effective Whistleblowing mechanism

Name – Lonza Pharma and Biotech

Founded in 1897 in the Swiss Alps

Headquarters : Basel, Switzerland

Lonza operates across five continents.

Approximately 14,000 full-time

• Trade Sanctions and Export Controls

• Anti-Corruption and Anti-Bribery

• The Lonza Open Door and Non-Retaliation policy

• Lonza managers have leadership responsibilities for

88, Sector 44,

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