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 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 price for legitimate treatments. #fakedrugs

#PSM2013#fakedrugs #PSM2013

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.

Patients, too, break the supply chain by buying from fake online pharmacies (often claiming to be Canadian) or other unapproved avenues.

Recent examples:● Weight loss pills ● Flu Treatments● Adderall

Patients Buy Counterfeits in Pursuit of Savings or

Magical Solutions

#fakedrugs #PSM2013#fakedrugs #PSM2013

Patients Buy Counterfeits in Pursuit of Savings or Magical SolutionsThese 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

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.

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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.

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Misbranded Treatments BotoxWhat’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.

Counterfeit Medicines and Chronic Illness● 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.

#fakedrugs #PSM2013

Misbranded Treatments Osteoporosis DrugsAclasta (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

Diverted TreatmentsHIV 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

Diverted TreatmentsHIV 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

Misbranded Drugs - DialysisAmerican 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

Misbranded Drugs - DialysisWhat’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

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

Fake Drugs - DiabetesWhat’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

Misbranded TreatmentsAvastin

● 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

Misbranded TreatmentsAvastin

Kincaid and the

manager conspired

to hide the illegal

purchases from

nursing staff who

recognized that the

treatments were

counterfeit.

#fakedrugs #PSM2013

Misbranded TreatmentsAvastinWhat’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

What’s the scope of this problem?

We don’t know.

Misbranded Treatments - Avastin

#fakedrugs #PSM2013

PanelistsScott 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