"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

© 2016 Partnership for Safe Medicines, All Rights Reserved

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


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


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.


According to DoJ a foreign drug distributor sold unsafe, ineffective medicine that was used to treat American patients. This isn’t a lone incident.


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


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).


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.


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.)


Shabbir Safdar

Usually these drugs are given to patients before law enforcement can get their hands on them, but in one incident in this case, the FDA intercepted...

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.


Gallant Pharma (2009-2011)

"Canadian" drugs were actually from other countries, including Turkey and India

2013 indictment has resulted in 12 convictions


Protecting the American Drug SupplyRegulated, 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


Protecting the American Drug SupplyAny 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.


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)


How does our safe supply chain get broken? Less common:

• Physicians buying from unlicensed distributors

• Pharmacists buying from unlicensed distributors


How does our safe supply chain get broken?

Uncommon:Manufacturing supply chain producer



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.


These criminals prey on AmericansOne 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


June 13, 2013


Black Market Drugs Have Substandard Ingredients3 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


Counterfeit Medications Are Often Outright Poisonous


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.


What kind of medicine? BLACK MARKET IUDS


Eva Reffell

Tyler, we didn't do a straight map for IUDs, did we? I'm not sure how legible this is in this context. Am deferring to you...

What kind of medicine? UNSAFE OSTEOPOROSIS DRUGS


What kind of medicine? FAKE CANCER DRUGS


What kind of medicine? FAKE BOTOX


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.


Counterfeits are the perfect undetectable crime

• Substandard medical devices (IUDs, counterfeit screws) may fail.

• Or they may contain contaminants that compromise patients' health.


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.



QUESTIONS?


"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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