"The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo: How do these bad drugs get to our patients?" Congressional Briefing, March 7-8, 2016
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A presentation by Tom T. Kubic, President and CEO, Pharmaceutical Security Institute and Treasurer, Partnership for Safe Medicines about the threat of imported counterfeit prescription drugs.
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"The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo: How do these bad drugs get to our patients?" Congressional Briefing, March 7-8, 2016
- 1. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 2. The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo: How do these bad drugs get to our patients? Tom T. Kubic, President and CEO, Pharmaceutical Security Institute Treasurer, Partnership for Safe Medicines © 2016 Partnership for Safe Medicines, All Rights Reserved
- 3. Canada Drugs Indictment, July 2015 • DoJ indicted 8 individuals and 6 companies associated with Canada Drugs • Has been selling Americans illegally imported drugs since 2001 © 2016 Partnership for Safe Medicines, All Rights Reserved
- 4. Canada Drugs Indictment, July 2015 Indicted for selling $78 million in unapproved, mislabeled, counterfeit cancer drugs to American doctors, 2009 to 2012. Included 2 lots of counterfeit chemotherapy drugs (Avastin) with NO ACTIVE INGREDIENT, that led to a massive recall in 2012. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 5. According to DoJ a foreign drug distributor sold unsafe, ineffective medicine that was used to treat American patients. This isn’t a lone incident. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 6. JNS Impex (2006-2012) Pakistani business selling bulk counterfeit drugs via website to fake online pharmacies Claimed to be licensed to distribute and export drugs We know their products reached unlicensed online pharmacies in Florida, Arizona and Pennsylvania © 2016 Partnership for Safe Medicines, All Rights Reserved
- 7. JNS Impex (2006 – 2012) Sold counterfeit or unapproved versions of: • Viagra • Lorazepam and Diazepam (treat seizures and anxiety) • Alprazolam (treats anxiety) • Zolpidem (for insomnia) • Phentermine (for weight loss) Recently extradited proprietor Junaid Qadir faces 96 charges (potential sentence of 540 years in prison and $24m in fines). © 2016 Partnership for Safe Medicines, All Rights Reserved
- 8. Medical Device King (2009- 2013) Made $17m selling imported drugs as FDA-approved to ~1,000 medical practices in 46 states Sourced from unlicensed wholesalers in the UK, Turkey, the Cayman Islands, Canada, UAE, Switzerland, India In many cases, these drug providers weren't licensed to distribute prescription medications in their own countries. They are entirely unregulated. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 9. Medical Device King (2009-2013) The FDA intercepted and tested a drug which had been sold to an oncology practice in Iowa. They found that it had no active ingredient. How many patients were treated with fake cancer medications and lost their battles with cancer because of it? President convicted of 66 felony counts in 2015. (VP pleaded guilty to 2.) © 2016 Partnership for Safe Medicines, All Rights Reserved
- 10. Gallant Pharma (2009-2011) Gallant was a Northern Virginia-based company that pretended to be selling Canadian drugs. Sold $3.3m in misbranded drugs to at least 54 doctors, medical practices and hospitals Focus was injectable and infused drugs: cosmetic and plastic surgery, dermatology, pain management, neurology, anesthesiology, and oncology. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 11. Gallant Pharma (2009-2011) "Canadian" drugs were actually from other countries, including Turkey and India 2013 indictment has resulted in 12 convictions © 2016 Partnership for Safe Medicines, All Rights Reserved
- 12. Protecting the American Drug Supply Regulated, closed, secure supply chain covering pharmacists, pharmacies, nurses, physicians, wholesalers & manufacturers FDA testing of medications and pharmacovigilance programs Physician/Pharmacist supervision of medication choices and protocol © 2016 Partnership for Safe Medicines, All Rights Reserved
- 13. Protecting the American Drug Supply Any break in the hand to hand regulatory chain endangers patients. America is one of the few countries with a closed, secure, drug supply chain. Our medicine supply is the safest in the world. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 14. How does our safe supply chain get broken? Most Common: Patients break it • Buying online from a non-VIPPS pharmacy • Buying from an offline non-pharmacy (in the US or outside) © 2016 Partnership for Safe Medicines, All Rights Reserved
- 15. How does our safe supply chain get broken? Less common: • Physicians buying from unlicensed distributors • Pharmacists buying from unlicensed distributors © 2016 Partnership for Safe Medicines, All Rights Reserved
- 16. How does our safe supply chain get broken? Uncommon: Manufacturing supply chain producer © 2016 Partnership for Safe Medicines, All Rights Reserved
- 17. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 18. In contrast, authentic Avastin comes from US manufacturing and is only distributed by five companies. It’s not hard to keep track of legitimate suppliers of safe, effective medication or their products. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 19. These criminals prey on Americans One of our board members received this mailing from Global Pharmacy Canada (Mississauga, Ontario, Canada). "Send us or fax a copy of the original prescription or you can send a copy/picture of the pill bottle label or send us your detailed pharmacy receipt/invoice.” As It turns out, they • Are NOT licensed in Ontario • Send prescription orders to a pharmacy in India for filling Property of Marv Shepherd © 2016 Partnership for Safe Medicines, All Rights Reserved
- 20. June 13, 2013 © 2016 Partnership for Safe Medicines, All Rights Reserved
- 21. Black Market Drugs Have Substandard Ingredients 3 Texans indicted in 2014 for reselling black market drugs from China were selling • “Xanax” either at 36% of the correct strength or containing an allergy medication called chlorpheniramine • “Valium” that only contained melatonin, rather than the correct active ingredient, diazepam © 2016 Partnership for Safe Medicines, All Rights Reserved
- 22. Counterfeit Medications Are Often Outright Poisonous © 2016 Partnership for Safe Medicines, All Rights Reserved
- 23. Since 2012, the FDA has sent more than 1000 letters across all therapeutic areas to professionals who may have bought medications from known counterfeit drug sellers. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 24. What kind of medicine? BLACK MARKET IUDS © 2016 Partnership for Safe Medicines, All Rights Reserved
- 25. What kind of medicine? UNSAFE OSTEOPOROSIS DRUGS © 2016 Partnership for Safe Medicines, All Rights Reserved
- 26. What kind of medicine? FAKE CANCER DRUGS © 2016 Partnership for Safe Medicines, All Rights Reserved
- 27. What kind of medicine? FAKE BOTOX © 2016 Partnership for Safe Medicines, All Rights Reserved
- 28. Counterfeits are the perfect undetectable crime • Often, the evidence is ingested and therefore destroyed. • If the drug lacked active pharmaceutical ingredients, the doctor and patient conclude the patient is not responding to treatment. • Cancer patients are particularly vulnerable because prognosis is grim anyway. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 29. Counterfeits are the perfect undetectable crime • Substandard medical devices (IUDs, counterfeit screws) may fail. • Or they may contain contaminants that compromise patients' health. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 30. Counterfeits are the perfect undetectable crime In 2011 the WHO attributed a world-wide surge in drug resistant malaria to substandard and counterfeit treatments. Resistant TB is also a problem. Resistant strains of MRSA, strep, TB and other illnesses are on the rise in the US. Protecting our safe medical supply can discourage drug resistant infections here. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 31. © 2016 Partnership for Safe Medicines, All Rights Reserved
- 32. QUESTIONS? © 2016 Partnership for Safe Medicines, All Rights Reserved
Editor's Notes
- In July 2015, the Department of Justice indicted 8 individuals and 6 companies associated with CanadaDrugs.com, alleging that they sold $78 million worth of unapproved, mislabeled and counterfeit cancer drugs to American doctors between 2009 and 2012. Canada Drug has been in the business of selling American citizens imported drugs that are not regulated by the FDA since 2001.
- These illegally imported medicines, which passed through the United Kingdom and were received by dropshippers at 3 locations in the United States, included 2 lots of counterfeit Avastin and Altuzan. The FDA's discovery of the counterfeit Avastin and Altuzan, which did not contain any active ingredient, led to a country-wide recall of Avastin in February 2012. In addition, the indictment provides evidence that the company knowingly sold unsafe medicines and deliberately covered up its role in the sale of counterfeit Avastin. Sources: Indictment "Charges dropped against U.S. man accused in cancer-drug smuggling conspiracy," The Star, October 20, 2015, http://www.thestar.com/news/canada/2015/10/20/charges-dropped-against-us-man-accused-in-cancer-drug-smuggling-conspiracy.html. "14 Execs Charged with Selling $78M in Counterfeit, Mislabled Drugs," Pharmaceutical Processing, August 18, 2015, http://www.pharmpro.com/news/2015/08/14-execs-charged-selling-78m-counterfeit-mislabled-drugs?et_cid=4750857&et_rid=866449022&type=headline. "Federal Justice Department part of CanadaDrugs.com raid," CBCNews, March 27, 2015, http://www.cbc.ca/news/canada/manitoba/federal-justice-department-part-of-canadadrugs-com-raid-1.3011421. "FDA Alert: Counterfeit Version Of Avastin In U.S. Distribution," Partnership for Safe Medicines, February 15, 2012, http://www.safemedicines.org/2012/02/fda-alert-counterfeit-version-of-avastin-in-us-distribution403.html.
- In 2015 Pakistani citizen Junaid Qadir was indicted and then extradited from Germany to face charges that his company, JNS Impex, was a prescription drug wholesaler offering bulk counterfeit medications to U.S. fake drugs resellers. According to the indictment, the defendants operated between 2006 and 2012, receiving orders via the internet, primarily from individuals and entities operating internet pharmacy websites and other types of illicit pharmacy operations. These included fake onlne pharmacies in Florida, Arizona and Pennsylvania.
- JNS Impex’s products included counterfeit and misbranded anxiety and seizure medicines, Viagra, and anabolic steroids The case is a good illustration of the complexity of business processes in the counterfeit medicines trade. Sources: Press Release from DOJ: http://www.justice.gov/usao-co/pr/pakistani-man-makes-appearance-us-district-court-denver-following-indictment-and-arrest ICE Release: https://www.ice.gov/news/releases/pakistani-man-indicted-and-arrested-selling-and-distributing-new-misbranded-and
- On April 30, 2014, ihe Department of Justice unsealed a 73 count indictment against William "Liam" Scully and Shahrad Rodi Lameh, the president and vice-president of Pharmalogical, Inc, a Great Neck, New York-based company doing business as Medical Device King (MDK). (Scully was also the owner and operator of Taranis Medical Corporation (TMC) an unlicensed prescription drug wholesaler.) Between February 2009 and July 2013, MDK and TMC imported misbranded and counterfeit prescription drugs from unlicensed wholesalers in the United Kingdom, Turkey, the Cayman Islands, Canada, United Arab Emirates, Switzerland and India MDK misrepresented their products as FDA approved drugs to the approximately 1,000 medical practices that purchased them. In many cases, these drug providers weren't licensed to distribute prescription medications in their own countries. They were entirely unregulated. According to the indictment, Medical Device King's executives grossed $17 million in profits.
- The drugs included cancer drugs, contraceptives (unapproved IUDs, subdermal contraceptive implants) and drugs for patients with kidney failure, multiple sclerosis, Crohn's disease and other chronic conditions. Medical Device King was specifically responsible for selling counterfeit cancer drugs. In one case, the FDA was able to get a hold of the drug they sold before it was given to a patient and then lab tested it. It contained no active ingredient. In many other cases the medications were sold to clinics and administered before the FDA could capture and test them. How many patients received fake cancer medication and lost their battles with cancer because of it? Sharad Rodi Lameh pleaded guilty to 2 counts (conspiracy to commit wire fraud and conspiracy to distribute misbranded drugs) on October 16, 2014, forfeiting $500,000. Scully was convicted of 66 felony counts on November 12, 2015. The Medical Device King case has had tremendous reach across the country; on May 13, 2013, FDA sent more than 1,000 letters to medical practices in 46 states that may have received prescription drugs from Pharmalogical, Inc., d/b/a Medical Device King. Sources: Robert E. Kessler, "Federal jury convicts Commack man of distributing unapproved drugs, officials say," News Day, November 17, 2015. http://www.newsday.com/long-island/nassau/william-scully-of-commack-convicted-of-distributing-unapproved-drugs-officials-say-1.11135936 Timothy Bolger, "Great Neck Rx Execs Sold Counterfeit Drugs," Feds Say, Long Island Press, April 30, 2014, http://www.longislandpress.com/2014/04/30/great-neck-rx-execs-sold-counterfeit-drugs-feds-say/ Robert E. Kessler, "Pharmalogical Inc. officers indicted in cancer drug fraud," feds say, News Day, April 30, 2014 http://www.newsday.com/long-island/nassau/william-scully-and-shahrad-rodi-lameh-charged-in-17m-prescription-cancer-drug-fraud-feds-say-1.7871937 (paywalled, but with pictures of the defendants). "2 charged in $17M cancer drug fraud out of Great Neck-based pharmaceutical company Pharmalogical," Long Island News 12, http://longisland.news12.com/news/2-charged-in-17m-cancer-drug-fraud-out-of-great-neck-based-pharmaceutical-company-pharmalogical-1.7877453 Bill San Antonio, "Two indicted for selling fake meds" The Island Now, May 8, 2014, http://www.theislandnow.com/great_neck/news/two-indicted-for-selling-fake-meds/article_fcbd2382-d6c5-11e3-90f6-001a4bcf887a.html "Businessmen charged with selling counterfeit drugs," The Washington Times, April 30, 2014, http://www.washingtontimes.com/news/2014/apr/30/ny-businessmen-face-drug-counterfeiting-charges/ (AP story)
- Gallant Pharma International was an illegal drug importation business headquartered in Crystal City, Virginia that presented itself to U.S. medical facilities as a Canadian pharmaceutical company. They sold low-cost drugs that were purported to be from Canada. The 2013 indictment of Gallant Pharma charged 10 co-conspirators and the corporation itself with a series of charges that included introduction of misbranded drugs into interstate commerce, unlicensed medical wholesaling, wire fraud, importation contrary to law, and monetary transactions with criminally derived proceeds. Between August 2009 and November 2011, the defendants generated at least $3.3 million from the sale of misbranded drugs to at least 54 doctors, medical practices, and hospitals in the United States. Gallant Pharma specialized in wholesale distribution of “Brand Name and Generic products” for cosmetic surgery, plastic surgery, dermatology, pain management, neurology, anesthesiology, and oncology.”
- The reality is that Gallant Pharma purchased their non-FDA approved drugs in bulk from foreign countries such as Turkey and India. In May 2014, Gallant Pharma co-founder Syed “Farhan” Huda was sentenced to 3 years in prison and required to pay $3.4 million in restitution after pleading guilty to illegal importation, introducing misbranded drugs, unlicensed medical wholesaling and wire fraud, the Department of Justice (DOJ) reports. According to the DOJ, to date, 12 individuals associated with Gallant Pharma have been convicted for their role in the illegal importation of prescription medication. Source: DOJ Press release: http://www.justice.gov/usao-edva/pr/illegal-drug-company-gallant-pharma-and-co-founder-sentenced
- The well publicized counterfeit Avastin case (2012) is a good example of how difficult it is to assure the safety drugs imported outside FDA regulations, and to prosecute criminals selling substandard and counterfeit products. Investigations showed that counterfeit Avastin moved from country to country with no authentication between sources. The medication that ended up doctors’ offices from California to Illinois came from unauthorized distributors in the US. Those people in turn purchased the medication from other unauthorized distributors from overseas where the medication wasn’t required to be inspected because it was “for export only.” Back from the UK, to Denmark, to Switzerland, to Egypt, the original signatory for the medication came from an illiterate supplier who signed his name with an “X” before traveling across three countries and through six countries. What jurisdiction did this crime occur in? Are the countries that passed the medication “for export only” through responsible? How do we protect patient safety when it’s so easy to pass the hot potato on to another party in another country?
- In contrast, authentic Avastin comes from US manufacturing and is only distributed by five companies. It’s not hard to keep track of legitimate suppliers of safe, effective medication or their products.
- One of our board members received this mailing from Global Pharmacy Canada (Mississauga, Ontario, Canada). It’s the kind of advertising that reaches thousands of Americans every day As It turns out, this company is NOT licensed to dispense medications in Canada. They possess no valid pharmacy license anywhere. And even though they’re called Global Pharmacy Canada they send prescription orders to a pharmacy in India for filling.
- In June 2013, this specific fake online pharmacy, which was based in Belize, was forced by the Ontario Court of Appeal to shut down offices in Toronto for violating Ontario’s professional pharmacy rules. According to the ruling, Global Pharmacy Canada’s sales, purchases and orders were all processed through the Canadian call center, but the drugs were actually fulfilled by an unidentified “Indian pharmacist.” The Justice who made the ruling noted that there was “no named pharmacist in India. There is no indication in any of the documentation sent to the client who the supplier of the drugs may be, and whether or not these drugs in fact come from an Indian pharmacist as represented, or from a supplier of drugs.” Health Canada has warned that so-called “Canadian pharmacies” may not be in Canada at all. “Consumers should also be aware that there is no assurance that all claims made on the internet that a particular site is Canadian and / or a pharmacy, are reliable. Some internet sites may falsely claim to be a Canadian pharmacy and dispense foreign drugs that are unauthorized for sale in Canada.” Source: (http://www.safemedicines.org/2013/06/canadian-appeals-court-shuts-down-ontario-operations-of-global-pharmacy-canada539.html)
- We have documentation that these unlicensed businesses are selling substandard medicines. Texan residents Catherine Nix, Thomas Giddens and Wanda Hollis, for example, rented post office boxes under assumed names to receive at least 32 bulk shipments of prescription drugs from unlicensed sources in China, and broke them up into individual packages for resale. Drugs included Xanax, phentermine, Cialis and Viagra, Valium and Stilnox (and more). The confiscated pills were tested and confirmed to be counterfeit and substandard. Pills marketed as "name brand" Xanax, for example, were only 36% as strong as they should have been; the generic of Xanax, alprazolam, actually contained chlorpheniramine, diazepam and pIlls purporting to be Valium and Stilnox only contained melatonin.
- In truth, consumers are lucky if their illegally imported medication is just expired or substandard. Investigators have found counterfeit drugs: Contaminated with heavy metals Adulterated with rat poison, boric acid, antifreeze, PCBs and benzopyren Filled with floor wax, brick dust, sheet rock, house paint, road paint, or paint thinner Sold with substitute drugs that haven’t been approved by the FDA and may cause dangerous side effects These kinds of substitutions can literally kill consumers.
- Since 2009, 39 individuals in 7 states have been prosecuted for the purchase or sale of non-FDA approved intrauterine devices (IUDs). In 2010 the FDA issued a letter to healthcare providers warning that the effectiveness of black market IUDs could not be guaranteed, that they may have been manufactured or shipped in unsafe conditions and that billing for unapproved medical products could result in prosecution for insurance fraud. In 2012, researchers found that illicit online pharmacies were selling IUDs and teaching self-insertion with cartoons on YouTube.
- In September 2012, the FDA issued letters warning 23 US. medical practices in 11 states that they may have purchased unapproved versions of the osteoporosis treatments Prolia and Aclasta from unlicensed wholesalers.
- Since 2007, more than 16 physicians and drug distributors have been prosecuted for the purchase or sale of non-FDA approved cancer treatments. The FDA continues to conduct investigations. Since 2011, the FDA has notified more than 100 medical practices in 29 states that they may have purchased counterfeit cancer medications which were distributed by a fake online Canadian pharmacy. Some of the tested counterfeit cancer medication contained no active ingredients--only saline and acetone. Illegal distributors make a profit selling drugs that are illegally imported, expired, stolen, damaged by bad handling or outright counterfeits.
- Since 2005, at least 46 individuals in 16 states have been investigated for the purchase or sale of non-FDA approved cosmetic drugs—a variety of substances being passed off as Botox, collagen or other injected cosmetic treatments. Among those charged, 37 have pleaded guilty or beenconvicted in court, while the rest are still under investigation. During the same time period, 1 patient died and at least 11 others sought medical treatment for disfigurement or serious illness brought on by these black market injections. In 2012, the FDA notified 350 medical practices in 43 states that they may have purchased counterfeit Botox and since then more than 700 doctors across all therapeutic areas have received letters warning them that they may have purchased non-FDA approved drugs.
- Substandard medical devices could fail for reasons that are entirely unclear if there's no evidence they were counterfeit. Or they could contain heavy metals or contaminants that compromise patients' health.
- Finally, substandard therapies breed resistant strains of infection. The WHO has noted that interrupted treatment and substandard counterfeit drugs have caused a worldwide surge in drug resistant malaria. Drug resistant TB is also on the rise. The CDC has identified many life threatening drug resistant strains of common illnesses, among them MRSA, strep, TB, gonorrhea and Bacterial Meningitis. Counterfeits have caused needless suffering and death overseas. Protecting our safe medical supply can discourage drug resistant infections here. WHO, Global report on antimalarial drug efficacy and drug resistance: 2000–2010, http://apps.who.int/iris/bitstream/10665/44449/1/9789241500470_eng.pdf
- In 2012 and 2013 alone, the FDA warned at least 1000 medical practices in 46 states that they had been buying imported prescription medicine from illegal distributors who had been selling counterfeit and substandard products. In addition to that trade, countless Americans are importing unregulated drugs from unlicensed online pharmacies. This is a significant threat to Americans, and it’s affecting people in your state.