Tim Mackey, Assistant Professor, University of California, San Diego - Department of Anesthesiology, speaks about the effect counterfeit Avastin has had on efforts to protect the American public from counterfeit medications.

1. After Avastin:
What I
have we learned, what can be done?
Tim K. Mackey, MAS, PhD
UC San Diego
PSM Interchange
September 2014

2. I
PRESENTATION AGENDA
Counterfeit Avastin in the U.S. Drug Supply Chain
1
GIS and FDA Safety Notices
Legal and Network Analysis
Questions and Future Directions…
2
3
4
PSM Interchange 2014

3. Counterfeit Avastin
Sub headline
Counterfeit Avastin in the U.S. Drug Supply Chain
• Controlled Supply Chain: USA pharmaceutical
I
supply chain one of highest controlled and
regulated markets.
• Counterfeit: Contained cornstarch, acetone
and other chemicals but no API
• Global Trade: Counterfeit Avastin traveled from
Turkey – Switzerland – Denmark – UK - USA
• Gray Market: Purchased from little-known drug
wholesaler, Montana Healthcare Solution
connected to Canadadrugs.com
• Drug Regulatory Authority: FDA contacted
hundreds of clinics in numerous states in the
USA that purchased counterfeit Avastin

4. After Avastin: A Multidisciplinary Examination
PISM Interchange 2014
Top-line GIS
Data
Network
Analysis
Funded by:

5. I
TOP-LINE FINDINGS
PSM Interchange 2014
Primary Findings
• FDA Warning Notices: 932 FDA safety notices in 791
distinct zip codes from 2012-2013. Included 48 different
states and 2 U.S. territories.
• Highest Impacted States: California (17.7%, n=168),
Texas (9.2%, n=87), Florida (8.5%, n=81), and New York
(8.2%, n=78).
• Legal Prosecutions: 10 published closed or ongoing
prosecutions identified (i.e. criminal
complaints/indictments, plea agreements, sentencing,
civil settlements)

6. I
U.S. CENSUS ZIP CODE
ANALYSIS
29,650 vs. 781?
PSM Interchange 2014

7. I
U.S. CENSUS ZIP CODE
ANALYSIS
PSM Interchange 2014

8. PISM Interchange 2014 Avastin Notice Waves Geocoded by Distinct Zip Codes

9. PISM Interchange 2014 All Avastin Notices Combined Based on Zip Codes

10. PISM Interchange 2014 All Avastin Notices Density Analysis

11. PISM Interchange 2014 All Avastin Notices Hot Spot Analysis

12. PISM Interchange 2014 Detail New York: USA Health Care Spending

13. PISM Interchange 2014 Detailed Southern California: Over Age 65+ (Medicare)

14. I
LEGAL PROSECUTIONS
PSM Interchange 2014
Primary Findings
• Criminal Prosecutions: Filed by federal prosecutors in
multiple jurisdictions mostly in cooperation with OCI in CA,
MD, MO, MT, TN, NY.
• Defendants: Of 18 named defendants assessed, 10(56%)
owners/staff; 5(28%) physicians-owners; 2(11%)
pharmacy/pharmacist. Longest sentence: 24 months
• Warning Signs: Shipping to multiple states; aware of
improper shipping/storage; some with direct knowledge of
adverse events; concealment from staff; profit driven
• Other Cancer Drugs?: Legal prosecutions reveal
possibility of other counterfeit cancer drugs: Rituximab,
Eloxatin, Zometa, Gemzar, Neulasta, and others

15. Ban Dune Marketing
PISM Interchange 2014
LEGAL PROSECUTIONS
NETWORK ANALYSIS
McLeod Cancer and
Blood Center (2 years)
Montana Healthcare
Solutions (QSP)
Pharmacological (d/b/a Medical Device King)
Ozay Pharmaceuticals

16. I
RESEARCH LIMITATIONS
Limitations Implications
Lack of Validated Data
PSM Interchange 2014
Inability to determine where counterfeit versions were
sent and how many patients impacted
Incomplete Information
Legal analysis limited to cases in public domain, may
not include ongoing investigations/prosecutions
Patient Awareness?
Vast majority of cases were criminal prosecutions
with few settlements for patients harmed
FDA Warning Letters
Warning letters are poor proxy for assessing impact,
but is the best data we currently have
The perfect crime: Buy and administer fake cancer medications to
unsuspecting patients who already have high mortality rate and remain
undetected due to lack of surveillance.

17. 3 years after Avastin, what have we learned?
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REMAINING QUESTIONS
Lack of validated data on Avastin incidents
Clinicians remain unaware and lack knowledge
No idea of how many patients impacted
Are we better prepared for the next Avastin?
More robust counterfeit drug surveillance
Education, physician engagement in surveillance
Will track and trace help, and when?
No, and future cancer patients depend on us…
PSM Interchange 2014

18. Acknowledgments:
Financial Support: Special thanks to the UCSD Moores Cancer Center and the
American Cancer Society for their funding of this multidisciplinary project on the drug
supply chain and patient safety (ACS IRG 70-002).
GHPI Research Associate: Raphael Cuomo, MPH, CPHFunded by ACS and
provided GIS data analysis support
MAS Student: Camille Guerra, JDProvided legal support and analysis
GHPI Special Advisor: Bryan Liang, MD, JD, PhDProvided drafting support and
advice for research
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19. I
Questions
tmackey@ucsd.edu
www.linkedin.com/in/tkmacke
y
Visit us at www.ghpolicy.org
UC San Diego
@tkmackey
Thank you for listening and we welcome any questions/commentsSpecial thanks to the Partnership for
Safe Medicines for advocating for fights against counterfeit medicines