1. How Have American
Patients Been Impacted by
Unsafe Medicines?
Patient Risk, 2010 - 2013
#fakedrugs
#PSM2013

2. The Problem of
Misbranded Treatments
●
The United States has seen a rash of cases in
which medical professionals have purchased
non-FDA approved medicines and other
medical devices.
●
Illegal distributors make a profit selling drugs
from sources that aren’t trustworthy -- illegally
imported, expired, stolen, damaged by bad
handling.
●
Doctors and pharmacist generate profit by
billing insurance, Medicare and patients the full
#fakedrugs
price for legitimate treatments.
#PSM2013

3. The Problem of
Misbranded Treatments
● This
problem threatens a broad range of
patients who must rely on their healthcare
providers for safe treatments.
● Infused,
injected and inhaled drugs are
particularly easy to counterfeit; the main
challenge is packaging.

4. Patients Buy
Counterfeits in Pursuit
of Savings or
Magical Solutions
Patients, too, break the supply chain
by buying from fake online pharmacies
(often claiming to be Canadian) or
other unapproved avenues.
Recent examples:
●Weight
●Flu
loss pills
Treatments
●Adderall
#fakedrugs
#PSM2013

5. Patients Buy Counterfeits in Pursuit of
Savings or Magical Solutions
These consumers don't realize that:
●
Drugs they buy from Canadian online pharmacies are
not from Canada's legitimate drug supply.
●
Despite the assurances of drug exporters about "Tier
One" countries the FDA has never designated any
country from which it is universally safe to import
medicine.
If it’s not FDA-approved, you can’t be assured that the
contents are safe, or what they’re supposed to be.
●
#fakedrugs
#PSM2013

6. Misbranded Treatments
“Mirena” IUDs
What is the impact?
●In
2010, 2,140,000 women in the US used IUDs.
●Non-FDA
approved IUDs may cause unintended
pregnancy or infections.
#fakedrugs
#PSM2013

7. Misbranded Treatments
Botox
Botox (onabotulinumtoxinA) -injected anti-wrinkle treatment, also for
repetitive neck spasms and chronic
migraines
●Multiple
cases. One false distributor sold
almost 6,000 doses of unapproved, imported
Botox and Juviderm.
●FDA
warnings to over 350 medical
offices, including a Dallas area hospital, since
2012.
#fakedrugs
#PSM2013

8. Misbranded Treatments Botox
What’s the Impact?
•2.95 million Americans use Botox for a variety of reasons,
both cosmetic and medical.
•Since 2005, fake Botox has been found in investigations in
Los Angeles, Miami, and Kentucky.
•Patients have been disfigured and suffered
respiratory paralysis from counterfeit Botox.

9. Counterfeit Medicines
and Chronic Illness
#fakedrugs
#PSM2013
●
Patients are easily exploited while they are seeking better
or less expensive treatments.
●
Patients taking ongoing medications are at high risk
because they have longer exposure to more medicines.
●
Poor response to counterfeit or substandard medicines
may be misdiagnosed as treatment failure.

10. Misbranded Treatments
Osteoporosis Drugs
Aclasta (zoledronate) and Prolia (denosumab) -injected medicines to treat osteoporosis.
●Since
September 2012, the FDA has warned 23
US medical practices that they may have
purchased unapproved versions of these
treatments.
What’s the Impact?
●40
million Americans suffer from osteoporosis or
are at high risk.
#fakedrugs
#PSM2013

11. Diverted Treatments
HIV Drugs
MOMS Pharmacy, New York, 2012
●4
individuals allegedly resold black
market HIV and AIDS medications that
included drugs previously dispensed to
individuals, as well as stolen and expired
medications.
●MOMS
Pharmacy and its parent
company, Allion Healthcare sought
reimbursement from Medicaid.
●The
alleged scheme was a multi-state
operation that netted millions of dollars.
#fakedrugs
#PSM2013

12. Diverted Treatments
HIV Drugs
What’s the Impact?
●1.1
million people are living with AIDS
in the United States.
‣ (130,000 in New York State)
●Expired
or poorly handled treatments
are less effective (or ineffective).
HIV/AIDS patients rely on these
medicines to control their illness.
Ineffective treatments lead to decline
and death.
#fakedrugs
#PSM2013

13. Misbranded Drugs - Dialysis
American Inhalation Medication Specialists, Inc.,
Tennessee, May 2013
●Tennessee
pharmacist Robert Harshbarger, Jr.
substituted a cheap Chinese import for the iron sucrose
used to treat anemia kidney dialysis patients.
●Benefit
programs paid more than $848,000 for the
misbranded iron sucrose between 2004 and 2008.
●Several
patients of Kansas Dialysis Services, L.C were
treated with the misbranded dialysis drugs.
#fakedrugs
#PSM2013

14. Misbranded Drugs - Dialysis
What’s the Impact?
●At
the end of 2009, more than 871,000 Americans were
being treated for End Stage Renal Disease.
●Untreated
(or ineffectively treated) iron deficiency anemia
causes fatigue, shortness of breath, chest pain. Severe
cases can cause heart problems, infections and other
complications.
●Adulterated
iron sucrose could cause
severe illness and death.
#fakedrugs
#PSM2013

15. Fake Drugs - Diabetes
● 2013: FDA warned diabetics to beware of illegal
“natural” remedies for the treatment of diabetes.
● Other cases around the world:
○
2011 - Fake test strips in India
○
2009 - Counterfeit insulin needles in the UK
○
2006 - Counterfeit test strips in the US
#fakedrugs
#PSM2013

16. Fake Drugs - Diabetes
What’s the Impact?
●
As of 2011, 18.8 million Americans had been diagnosed
with diabetes.
●
Diabetes contributes to 231,404 deaths each year.
●
Ineffective treatment and poor blood sugar control
cause heart disease, stroke, blindness, kidney
disease, amputations, and poor immunity to other
diseases.
#fakedrugs
#PSM2013

17. Misbranded Treatments
Avastin
●
McCleod Blood and Cancer Center
○
Kincaid, and his business
manager purchased misbranded
drugs, and administered them to
patients.
○
Kincaid made at least $500,000 by
seeking reimbursement through
the Medicare and Medicaid/
TennCare programs as well as
other health benefits programs.
#fakedrugs
#PSM2013

18. Misbranded Treatments
Avastin
Kincaid and the
manager conspired
to hide the illegal
purchases from
nursing staff who
recognized that the
treatments were
counterfeit.
#fakedrugs
#PSM2013

19. Misbranded Treatments
Avastin
What’s the Impact?
It’s difficult to know because the drugs were
administered to gravely ill patients who might have died
anyway.
"People who receive a fake medication instead of
Avastin could have lost several months of their lives.” –
Dr. Nimesh Nagarsheth, oncologist
#fakedrugs
#PSM2013

20. Misbranded Treatments - Avastin
What’s the scope of this problem?
We don’t know.
#fakedrugs
#PSM2013

21. Panelists
Scott Williams, Director, American Cancer Society
Cancer Action Network
Suzanne Willard, President-Elect, Association of
Nurses in Aids Care (PSM member)
William E. Arnold, CEO and Vice-Chair, Community
Access National Network (PSM member)
Christopher Weaver, Health & Science Reporter, The
Wall Street Journal
#fakedrugs
#PSM2013