psm interchange 2014: tim mackey, after avastin: what have we learned, what can be done?

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After Avastin:What have we learned, what can be done?

Tim K. Mackey, MAS, PhDUC San Diego

PSM InterchangeSeptember 2014

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Counterfeit Avastin in the U.S. Drug Supply Chain

PRESENTATION AGENDA

PSM Interchange 2014

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GIS and FDA Safety Notices

Legal and Network Analysis

Questions and Future Directions…

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• Controlled Supply Chain: USA pharmaceutical 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

Counterfeit Avastin in the U.S. Drug Supply Chain

Sub headlineCounterfeit Avastin

IPSM Interchange 2014

After Avastin: A Multidisciplinary Examination

GISTop-line Data

Network Analysis

Funded by:

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TOP-LINE FINDINGS

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• 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)

Primary Findings

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U.S. CENSUS ZIP CODE ANALYSIS

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29,650 vs. 781?

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U.S. CENSUS ZIP CODE ANALYSIS

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I PSM Interchange 2014 Avastin Notice Waves Geocoded by Distinct Zip Codes

I PSM Interchange 2014 All Avastin Notices Combined Based on Zip Codes

I PSM Interchange 2014 All Avastin Notices Density Analysis

I PSM Interchange 2014 All Avastin Notices Hot Spot Analysis

I PSM Interchange 2014 Detail New York: USA Health Care Spending

I PSM Interchange 2014 Detailed Southern California: Over Age 65+ (Medicare)

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LEGAL PROSECUTIONS

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• 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

Primary Findings

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LEGAL PROSECUTIONS NETWORK ANALYSIS

McLeod Cancer and Blood Center (2 years)

Montana Healthcare Solutions (QSP)

Pharmacological (d/b/a Medical Device King)

Ozay Pharmaceuticals

Ban Dune Marketing

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RESEARCH LIMITATIONS

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Limitations Implications

Lack of Validated Data 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.

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REMAINING QUESTIONS

PSM Interchange 2014

3 years after Avastin, what have we learned?

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…

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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

Acknowledgments:

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Visit us at www.ghpolicy.org

Questions

tmackey@ucsd.edu

UC San Diego

@tkmackey

www.linkedin.com/in/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