How Have American
Patients Been Impacted by
Unsafe Medicines?
Patient Risk, 2010 - 2013

#fakedrugs
#PSM2013
The Problem of
Misbranded Treatments
●

The United States has seen a rash of cases in
which medical professionals have pur...
The Problem of
Misbranded Treatments
● This

problem threatens a broad range of
patients who must rely on their healthcare...
Patients Buy
Counterfeits in Pursuit
of Savings or
Magical Solutions
Patients, too, break the supply chain
by buying from ...
Patients Buy Counterfeits in Pursuit of
Savings or Magical Solutions
These consumers don't realize that:
●

Drugs they buy...
Misbranded Treatments
“Mirena” IUDs
What is the impact?
●In

2010, 2,140,000 women in the US used IUDs.

●Non-FDA

approve...
Misbranded Treatments
Botox
Botox (onabotulinumtoxinA) -injected anti-wrinkle treatment, also for
repetitive neck spasms a...
Misbranded Treatments Botox
What’s the Impact?
•2.95 million Americans use Botox for a variety of reasons,
both cosmetic a...
Counterfeit Medicines
and Chronic Illness

#fakedrugs
#PSM2013

●

Patients are easily exploited while they are seeking be...
Misbranded Treatments
Osteoporosis Drugs
Aclasta (zoledronate) and Prolia (denosumab) -injected medicines to treat osteopo...
Diverted Treatments
HIV Drugs
MOMS Pharmacy, New York, 2012
●4

individuals allegedly resold black
market HIV and AIDS med...
Diverted Treatments
HIV Drugs
What’s the Impact?
●1.1

million people are living with AIDS
in the United States.
‣ (130,00...
Misbranded Drugs - Dialysis
American Inhalation Medication Specialists, Inc.,
Tennessee, May 2013
●Tennessee

pharmacist R...
Misbranded Drugs - Dialysis
What’s the Impact?
●At

the end of 2009, more than 871,000 Americans were
being treated for En...
Fake Drugs - Diabetes
● 2013: FDA warned diabetics to beware of illegal
“natural” remedies for the treatment of diabetes.
...
Fake Drugs - Diabetes
What’s the Impact?
●

As of 2011, 18.8 million Americans had been diagnosed
with diabetes.
●

Diabet...
Misbranded Treatments
Avastin
●

McCleod Blood and Cancer Center
○

Kincaid, and his business
manager purchased misbranded...
Misbranded Treatments
Avastin
Kincaid and the
manager conspired
to hide the illegal
purchases from
nursing staff who

reco...
Misbranded Treatments
Avastin
What’s the Impact?

It’s difficult to know because the drugs were
administered to gravely il...
Misbranded Treatments - Avastin

What’s the scope of this problem?

We don’t know.

#fakedrugs
#PSM2013
Panelists
Scott Williams, Director, American Cancer Society
Cancer Action Network
Suzanne Willard, President-Elect, Associ...
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Panel 1: Patient Safety Moderated by Scott Williams

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Panel 1: Patient Safety Moderated by Scott Williams

  1. 1. How Have American Patients Been Impacted by Unsafe Medicines? Patient Risk, 2010 - 2013 #fakedrugs #PSM2013
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 20. Misbranded Treatments - Avastin What’s the scope of this problem? We don’t know. #fakedrugs #PSM2013
  21. 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

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