Panel for congressional briefings hosted by The Partnership for Safe Medicines and partner organizations, September 24, 2019.

1. Cartels and Counterfeits: International
Organized Crime And Counterfeit Drugs
Charlie Cichon, Executive Director NADDI
Andrea Thomas, Counterfeit victim family advocate, Voices for
Awareness Foundation
Armando Rivera, Security Lead at Bristol-Myers Squibb, DEA veteran
Mark Baughman, Retired DEA and Florida Sheriff’s Office

2. Report Findings
● Pill presses are broadly available
for sale on the Internet and they
are virtually untracked.
● Novice criminals make millions of
nearly perfect-looking counterfeits,
with deadly consequences.
● Possession of a pill press without molds is at most a violation of a
DEA registration requirement carrying no jail time.
● Disrupting the availability of pill presses will be a challenging
process.
Released March 2019

3. Resources for learning more

4. Andrea co-founded, with D’Ann Hopkins,
the Voices for Awareness Foundation, a
Grand Junction, Colorado-based non-
profit which raises awareness about
substance abuse, addiction prevention,
recovery, and counterfeit drugs, as well as
bringing awareness to mental health
issues relating to self-harm.
Andrea Thomas

5. Ashley Romero
Andrea’s daughter, Ashley Romero,
died on June 11, 2018 after taking a
counterfeit prescription Oxycodone to
alleviate the pain of her pancreatitis.
The pill was fentanyl laced and killed
her almost instantly.

6. R. Armando Rivera is the Illegal
Trade Americas and NACC Security
Lead for Bristol-Myers Squibb, as
well as an 18-year veteran of the
Drug Enforcement Administration.
R. Armando Rivera

7. Dangers of counterfeit and adulterated
medications
Case Examples

8. English Pack Opdivo
Counterfeit Case
● Mexico 2019 - Counterfeit Opdivo®
(prescribed for multiple types of cancer)
● Two patients in remission provided
counterfeit units
● NGO used to legitimize counterfeit units
● Forged letter using Canadian cancer institute
to justify use of English packs
● Lab results indicate cancer has returned in
one of the patients
● Investigations led to the raid of a pharmacy
but no arrests so far

9. Drug for Respiratory
Distress Syndrome
● Colombia 2018
● Survanta®: prescribed for prevention &
treatment of RDS in premature babies
● Product diverted in Venezuela; sold to
clinics & government sanctioned health
care providers in Colombia
● At least 16 premature babies died at one
clinic
● 20 individuals arrested

10. Counterfeit Sprycel Case
● Mexico 2018-2019
● Patient in his 60s and adolescent received counterfeit Sprycel® (indicated for chronic
myeloid leukemia)
● Counterfeit product sourced from a registered distributor that sourced it from an
unregistered source
● Payment made through an insurance company that paid 1/3 of the market price set
by BMS . No red flags by procurement
● Family of adolescent filed a complaint since his cancer, which was in remission had
returned
● Sources identified and case referred to authorities
● No action as of yet

11. BMS Orencia involved
with TC Medical case
2 complaints from
Jacksonville,
Florida
T.C. Medical Group, Ontario
Unauthorized distributor
Orencia Order
Sourcing Point
in Turkey
Orencia Dispensed
from Turkey
Ordered
US FDA-OCI &
Key BMS
Business Units
Part of a $15M
conspiracy
scheme
Intelligence passed
to
Mutilated cartons
hide pedigree & put
patients at risk
Cold-chain
Orencia sent
direct to US

12. TC Medical (aka Clinic Care Direct)
• Texas infusion center receives blast fax from Clinic Care Direct offering Orencia, a cold-chain infusion medicine
• Test purchase initiated but unable to obtain product; federal indictment soon followed
Email sent direct to Texas Infusion CenterMisuse of BMS Glyph logo on website to feign legitimacy and drive sales

13. Mark Baughman
Mark Baughman is a 35-year law
enforcement veteran, who is retired from
the Drug Enforcement Administration
(DEA) and retired Captain from the
Pinellas County (FL) Sheriff’s Office
Narcotics Division.

14. Operation “Top Dog Hot Dog”

15. Operation “Top Dog Hot Dog”
Total Seizures:
• 21 Subjects Arrested
• 5 Pill Presses capable of producing thousands of pills hourly
• 5,479.4 g Fentanyl & Fentanyl Derivatives
• 3,101 g N-Ethylpentylone (Molly)
• 999 Fentanyl pills (Represented by dealers as Oxycodone/Percocet)
• 97.1 g Marijuana
• 49.4 g Cocaine
• 14.2 g Alprazolam
• $1,552,750 in US Currency/ $458,000 in Real Estate/ $68,520 in Jewelry
• $309,060 in Luxury Vehicles (Audi R8, Aston Martin DB9, Maserati Quattroporte, Porsche Panamera)
• 10 Firearms including high capacity magazines and ammunition