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Combating Counterfeit with a Patient Perspective
- 1. Combating counterfeits with a patient perspective Sven Bergmann, The Partnership for Safe Medicines
- 2. The Partnership for Safe Medicines News and resources at safemedicines.org Print materials: editors@safemedicines.org
- 3. The United States has the safest drug supply in the world… …but as many as 19 million Americans buy medicines outside that supply chain, from foreign online pharmacies or other unlicensed sources.
- 4. Since 2012, smugglers caught selling fake drugs sold up to 63 medications to over 3,000 doctors, clinics and hospitals across the U.S. Physicians break the supply chain, too.
- 5. Counterfeit Avastin In 2012, the FDA discovered 2 lots of an imported counterfeit cancer drug (Avastin) with no active ingredient. The agency launched a massive recall and a lengthy investigation.
- 6. 932 doctors and clinics warned
- 7. • “Canadian Pharmacy” front • Transshipped across multiple countries • Lack of authentication • Distributed to doctor’s offices throughout the U.S. Path of counterfeit - Avastin Imported drugs lack safety of FDA regulation
- 8. Public health threat is real Late stage lung cancer patient Betty Hunter was treated with counterfeit Avastin in 2011 and died 3 months later. Source: Medicin der Dræber Source: FDA
- 9. Pills have been found in 43 states, with deaths reported in 22 – March 2019 Fentanyl-laced counterfeit Full report: “Forty States and Counting” at www.safemedicines.org
- 10. Fentanyl-laced counterfeits First reports of counterfeit Xanax and fake opioids laced with fentanyl and analogues in late 2015
- 11. Fentanyl-laced counterfeits Counterfeit Xanax Source: Yakima Police Department Counterfeit Oxycodone Source: Public Health Seattle & King County Counterfeit Percocet Source: Georgia Bureau of Investigations
- 12. All Fentanyl is imported Since 2015, counterfeit pills that are laced with deadly imported fentanyl have been killing Americans across the U.S.
- 13. Main source of Fentanyl - China October 2017: DOJ indicts 2 Chinese nationals in fentanyl trafficking case
- 14. Source: eBay Equipment for deadly trade readily available Pill presses readily available on the internet. As are counterfeit medicine die molds Source: eBay
- 15. Fentanyl Counterfeit Seizure: Utah 95,000 pills Source: www.deseretnews.com 6 charged with production and online distribution of thousands of fake prescription pills. In November 2016 the DEA seized $1.2 million and 95,000 pills worth as much as $2.2 million in sales. Raid also resulted in seizure of pill presses, dies, stamps and illegally imported fentanyl and alprazolam from China.
- 16. Fentanyl-laced counterfeit victim Tosh Ackerman, Aptos, CA The evening of October 27, 2015, 29- year-old Tosh Ackerman took a Benadryl and part of a Xanax pill to help him sleep. He never woke up, and his girlfriend found him dead the next day. Ackerman’s Xanax was counterfeit. It contained a fatal dose of fentanyl. His mother, Carrie, is speaks to schools and the media. You can reach her at ToshsStory@gmail.com
- 17. Fentanyl-laced counterfeit victim Betty Jean Collins, Macon, GA A 60-year-old Macon resident recovering from open-heart surgery took one of her husband’s Percocets and ended up in the hospital. The medication was counterfeit–made with fentanyl–and Collins was one of a series of poisoning cases across Georgia. Source: gbi.georgia.gov
- 18. Best industry practices against counterfeit • Product Security & Prevention: • Covert & overt authentication features • Market monitoring / Track complaints • Active Enforcement Posture: • Online / Offline • Investigation Intel • Law Enforcement Engagement & Support • Litigation
- 19. Best industry practices against counterfeit • Communications: • Consumer Alerts • Education on risk of counterfeits • How to avoid counterfeit • Government Affairs: • Proactive to improve enforcement policy & conditions • Educate on unintended consequences of policy
- 20. The Partnership for Safe Medicines Americans are largely unaware of this threat. PSM awareness tools: □ Comprehensive reporting on counterfeit incidents online □ Explaining the risks in a variety of mediums □ Telling the stories of people who have been hurt by fake medicine
- 21. New legislative threat: Drug Importation Imported drugs–whether they are sold by wholesalers or retail pharmacies–are not monitored by any regulatory agency. “Drug importation proposals would worsen the opioid crisis…” 2017 report from Louis Freeh, FBI Director 1993-2001 Health Canada “…does not assure that products being sold to U.S. citizens are safe…and does not intend to...” U.S. regulators cannot ensure the safety of drugs produced outside FDA- approved sources.
- 22. The dangers of importation IMF’s are overburdened and FDA cannot inspect enough shipments. USPS: handled ~ 621 million pieces of inbound international mail in 2016–54% more than 2012 Operation Pangea X (2017) □ 123 countries □ 400 arrests □ Stopped 3,584 websites and >3,000 fake pharmacy ads □ Seized >$51 million in medicinesPackages for inspection and suspected counterfeit tramadol, Source: GAO
- 23. Lack of prosecution Prosecuting foreign nationals for selling counterfeit drugs is hard, which makes a poor deterrent. 23 2014: DOJ indicted 5 CanadaDrugs.com executives for selling $78 million of fake cancer drugs 2017: Canada set extradition hearing for May 2018. 2018: Plea bargain pending - no jail time CanadaDrugs.com still has their Canadian wholesale license and continues to sell to Americans.
- 24. Law Enforcement Risk: Officer Exposure Minuscule (2mg) exposure can cause injury and death New procedures for law enforcement Suspension of field tests Source: KEPRTV.com
- 25. What companies can do Share PSM patient resources: www.safemedicines.org/patient-resources www.safemedicines.org/safe-savings-tip Share PSMs Fentanyl resources: http://safedr.ug/fentanyl101 http://safedr.ug/40statesandcounting Contact Members of Congress on the dangers of importation http://safedr.ug/NoPoisonInUSA
Editor's Notes
- 19 million comes from Kaiser Health News, December 2016: https://khn.org/news/faced-with-unaffordable-drug-prices-tens-of-millions-buy-medicine-outside-u-s/ Based on a “ nationally representative sample of 1,202 adults”
- https://www.npr.org/2017/10/17/558330881/justice-department-indicts-2-chinese-nationals-in-synthetic-opioid-case Xiaobing Yan and Jian Zhang, face a raft of charges, including conspiracy to distribute large quantities of fentanyl and drugs with a similar chemical makeup in the U.S. through the mail or international delivery services. The case against Yan, 40, began in 2013 in Mississippi when investigators traced the drugs back to Yan, who allegedly operated two chemical plants in China and websites selling fentanyl to Americans, The case against Zhang, 38, began in North Dakota in 2015 after the overdose of a local 18-year-old. Investigators mapped the distribution network through Oregon, Canada and eventually to Zhang in China. Zhang's organization would send fentanyl as well as pill presses, stamps and dyes to U.S. customers through the mail. Yan faces up to 20 years in prison and a $1 million fine, if convicted. Zhang faces up to life in prison and a $12.5 million fine, if convicted. The Justice Department says 21 people have been indicted on federal drug charges in North Dakota and Oregon as part of the investigation.
- 30mg Oxycodone
- DoJ release: https://www.justice.gov/usao-ut/pr/drug-trafficking-organization-faces-indictment-involvment-manufacturing-fake News piece on Shamo: https://www.deseretnews.com/article/900000059/from-mormon-kid-to-alleged-drug-kingpin-inside-the-rise-and-fall-of-aaron-shamo.html
- Health Canada, which licenses drug wholesalers across Canada, has no interest in regulating trade outside its own borders. In 2004, Diane C. Gorman, then Assistant Deputy Minister of Health Canada, explicitly warned Americans “Health Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future.” American regulators are already overburdened and will not be able to examine the flood of newly imported drugs. Many of this year’s bills in state legislatures openly acknowledge that Track and Trace won’t be implemented until imported medicines reach the U.S. Those drugs could come from anywhere. Proposals in Congress which would open the floodgates to the importation of unlicensed foreign medicines will increase the volume of unidentified packages containing pharmaceuticals, and make the problem even worse. The Freeh Report: Key Findings: Drug importation would increase the threat of illegitimate products entering the United States, fueling criminal organizations’ activities and profits. Drug importation proposals would worsen the opioid crisis – a crisis that has already grown substantially worse due to the powerful opioid fentanyl and fentanyl analogue-laced counterfeit pills being produced by illegal drug trafficking organizations, including in China, and reaching the United States through Canada and Mexico. Already overburdened law enforcement and regulatory capacity would be unable to ensure a safe prescription drug supply under importation.
- The Freeh Report (40): “A former FDA official reported that IMF’s are inundated with thousands of packages containing pharmaceuticals, and while many shipments may in fact be legitimate drugs, there is no assurance because they are not approved for the U.S. and have never been subject to FDA inspections or requirements. In addition, the FDA cannot and will not inspect most shipments because the agency can only examine a small fraction of imports before they are passed onward to place like clinics, nursing homes or U.S. distributors.” Express consignment operators are required to provide “electronic advance data” (EAD)—such as the shipper’s and recipient’s name and address—for all inbound express cargo which U.S. Customs and Border Protection (CBP) uses to target inspections. USPS is not required to provide this information to CBP––advance data are unavailable for roughly half of inbound international mail… USPS officials reported in November of 2016 that they planned to expand one of the pilots, CBP officials stated that the pilot was not ready for expansion because of USPS’s inability to provide 100 percent of targeted mail to CBP for inspection. USPS stated that it is working to address challenges related to identifying targeted mail within sacks containing hundreds of individual pieces of mail The challenges are substantial: In FY2016: USPS handled ~ 621 million pieces of inbound international mail–about 54 percent more than in 2012. Operation Pangea X, (20170 197 agencies from 123 countries: Made 400 arrests worldwide Took 3,584 websites offline, took down > 3,000 online fake pharmacy ads Seized more than $51 million in potentially dangerous medicines: dietary supplements, pain reduction pills, epilepsy medication, erectile dysfunction pills, anti-psychotic medication and nutritional products
- Hard to regulate foreign nationals on foreign soil (Canada Drugs extradition). (The judge holding extradition hearing in Canada decides whether to surrender the 5 CanadaDrugs.com employees who are under indictment to the US for trial.) http://www.safemedicines.org/2017/10/five-canadadrugs-com-defendants-have-extradition-hearing-dates-set-for-may-2018.html