HIV/AIDs Medication: The Black Market and Safety

Jim Dahl, Board Member, PSMAugust 4, 2014

Today’s presentation

1. Meet the Partnership for Safe Medicines 2. Black market medicine in the US3. Why is the black market a problem?4. How the US regulates medicine5. How black market drugs enter the US6. How are HIV/AIDS patients being harmed?7. How can we protect patients?8. Where to learn more

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PSM MembersAcademy of Managed Care PharmacyAIDS Drug Assistance ProgramAlaska Pharmacists AssociationThe ALS AssociationAmerican Association for HomecareAmerican College Health AssociationAmerican Pharmacists AssociationAmerican Society of Health System PharmacistsArizona Pharmacy Alliance (AzPA)Association of Nurses in AIDS CareBioForwardBiotechnology Industry OrganizationCalifornia Healthcare InstituteCalifornia Pharmacists AssociationCalifornia Society of Health-System Pharmacists

(CSHP)Colorado Biotechnology AssociationCommunity Access National NetworkThe Council for Affordable Health InsuranceEuropean Federation of Pharmaceutical Industries

and Associations (EFPIA)Generic Pharmaceutical AssociationGlobal Medicines ProgramHealthcare Distribution Management AssociationHealthCare Institute of New JerseyHealthcare Leadership CouncilThe Hispanic InstituteIllinois Pharmacists AssociationInstitute of Health Law StudiesInstitute for Safe Medication Practices

Interamerican College of Physicians and SurgeonsInternational Anti-Counterfeiting CoalitionInternational Federation of Pharmaceutical

Manufacturers and AssociationsKidney Cancer AssociationThe Latino CoalitionThe Life Raft GroupMaryland Pharmacists AssociationMaine Pharmacists AssociationMaine Society of Health-System Pharmacists

(MSHP)Men’s Health NetworkMissouri Pharmacy AssociationNational Alliance for Hispanic HealthNational Alliance On Mental Illness National Association of Chain Drug StoresNational Association for Uniformed ServicesNational Association of Boards of PharmacyNational Association of Drug Diversion

InvestigatorsNational Association of ManufacturersNational Alliance of State Pharmacy AssociationsNational Biopharmaceutical Security CouncilNational Community Pharmacists Association National Grange of the Patrons of HusbandryNational Latina Health NetworkNeedyMedsNevada Board of PharmacyNew York State Council of Health-system

Pharmacists (NYSCHP)

North Carolina Association of PharmacistsOklahoma Pharmacists AssociationParenteral Drug AssociationPDMA AlliancePennsylvania Pharmacists AssociationPennsylvania Society of Health-system

PharmacistsPharmaceutical Industry Labor Management

Association (PILMA)Pharmaceutical Security InstitutePharmacists Planning Services, Inc.PhRMARetireSafeSpina Bifida Association of AmericaTexas Pharmacists AssociationTexas Society of Health-System PharmacistsUnited States Chamber of CommerceUniversity of New England College of PharmacyUniversity of Texas Pharmacy SchoolVietnam Veterans of AmericaVirginia Pharmacists AssociationVermont Pharmacists AssociationWest Virginia RxWomenHeart

International and Governmental Organizations

World Health OrganizationOrange County Healthcare Agency

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Black market drugs and HIV/AIDS Almost since there were

HIV/AIDS treatments, unlicensed distributors have been selling black market medications to American pharmacies and patients.

Since 2006 at least 86 individuals have been charged with distributing of black market meds prescribed to patients with HIV or AIDS in the US.

Advertising promoting the sale of cheap prescription medicines is ubiquitous in email and on the internet

97% of websites selling prescription drugs do not follow safe practices

1 in 6 Americans buys drugs on the internet without a prescription

How common is black market medicine?

How common is black market medicine?

Why is this a problem? Medication from unlicensed sellers is of

unknown quality.

Patients taking substandard medicines risk higher viral loads, poor health, and drug resistance, even if they are carefully following their drug regimen. The CDC reports that HIV surveillance sites in

2007 found that 1 in 6 newly diagnosed infections were drug-resistant.

Black market medicines are a serious threat to the health of current and future HIV/AIDS patients.

Why is this a problem? Testing kits imported from countries with little

or no regulation of the pharmaceutical market may not work.

False negatives delay treatment for people who are HIV positive and could lead to higher transmission rates.

Why is this a problem? Drugs on the black market are not being

manufactured by companies accountable to the FDA, to state licensing boards or anyone.

Counterfeiters claim to be selling Truvada, Sustiva, Ziagen, and Serostim online, even without a prescription. But it’s impossible to know whether you’re receiving safe FDA-approved medicines or drugs that are expired, contaminated or diluted.

Why is this a problem? Counterfeiters substitute cheap ingredients,

offer medicines in unfamiliar doses, omit instructions and safety warnings. Sometimes the medicine a patient receives contains harmful chemicals or contaminants. Sometimes “medicine” contains no active ingredients at all.

Why is this a problem? Diverters often adulterate medicine in the

process of reselling it.

In 2010, three men in New Jersey were caught relabeling expired medication with forged labels. They removed the old labels with lighter fluid, potentially contaminating the expired contents.

Why is this a problem? Addicts who resell their

medication often take a dose of an IV drug and replace the missing contents with water using the same syringe. As result, diverted medicines may be diluted and contaminated.

Patients have contracted hepatitis C as a result of diverted IV drugs. Since 2004, as many as 30,000 have been exposed to the virus as a result of

diversion in hospital settings.

Why is this a problem?

Many drugs become

ineffective without temperature control and careful handling. Norvir capsules should

be refrigerated. Procrit, prescribed to

HIV patients with anemia, may be damaged if the vials it comes in are shaken.

Who knows how black market medication has been stored or handled?

Why is this a problem?

Undocumented

Unregulated

Unsafe

Illegal

This is not victimless crime Patients risk their own health buying

medication from unknown sources Buying non-FDA approved medicine supports

criminals who take advantage of people with chronic illnesses to line their own pockets

Cut-rate diverted drugs usually come from patients who are selling their medicines at the cost of their own health

Buying discounted prescriptions from illicit sellers creates drug resistant strains of HIV, which makes treatment more difficult for others

How does the US regulate medicine distribution to keep patients safe?

The FDA regulates manufacturers of medicines where ever the production facilities are, in the US and beyond.

Wholesalers are regulated by the US states, each with different rules. A voluntary cross-state licensing program (VAWD) helps ease license verification.

Doctors, pharmacists and pharmacies purchase from wholesalers, and are themselves regulated by each state.

Patients are protected by the closed, secure supply chain. Every entity in the chain is answerable to a regulator.

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How a closed supply chain gets broken

Patients purchase directly from unlicensed sources, i.e. flea markets, swap meets, non-pharmacy stores, individuals or the Internet.

Wholesalers forge documentation of legitimacy for counterfeit drugs and pass off as authentic.

Doctors and pharmacists purchase from counterfeit drug distributors.

Stolen and partially used medications are re-sold as unused, untampered drugs through clearinghouses back to into the legitimate supply chain.

Counterfeiters send mass quantities through customs packed in disguised packages, i.e. speakers full of fake aspirin, that are then packaged and distributed to pharmacies and stores looking for discounted products.

An example: Ozay Pharmaceuticals CoIn May 2011, 2 cancer patients in Arizona had immediate bad reactions to chemotherapy medication administered to them in their oncologist’s office.

They’d been treated with Altuzan, the Turkish version of a cancer drug

sold as Avastin in the U.S.The “Altuzan” they received contained water and mold, but none of the active ingredient that makes Avastin effective.

An example: Ozay Pharmaceuticals Co

Those drugs were falsely labeled as gifts

Some of them had counterfeit packaging and vial labeling

They were shipped at temperatures too high to maintain their quality

One source of that counterfeit medicine was Ozkan Semizoglu, the foreign trade director of a Turkish company called Ozay Pharmaceuticals. He sold the medicine to a British wholesaler, who sold it to American doctors.

In 2013, Semizoglu also smuggled drugs into the U.S. directly.

The Path of Fake Avastin

How are these products marketed?

How are these products marketed?

Rick Roberts’ health was threatened by counterfeit medicine In 2000, university professor Rick Roberts

began taking Serostim, a human growth hormone, to treat weight loss and fatigue related to HIV wasting syndrome.

Over time, he noticed stinging at the injection site and inconsistencies in the quantities in the vials.

He learned from his pharmacist that he had been taking fake drugs.

A distributer in Nevada had purchased unapproved Serostim that included doses of a women’s fertility drug and contaminated, diluted Serostim.

Counterfeits caused Rick 6 months of anxiety and denied him several months of treatment. Unchecked, they could have caused permanent damage.

Black market Serostim, Nutropin AQ Between 2000 and 2003, at least 3 different

counterfeit operations sold hundreds of boxes of diverted human growth hormone to pharmacies who dispensed them to HIV/AIDS patients and children.

Patients who unknowingly purchased these secondhand drugs could not rely on their medicine to help with wasting syndrome, andthey may have been harmed by contaminants,too.

One child—a brain cancer survivor—suffered developmental and growth delays after he was treatedwith counterfeit Nutropin AQ, another growth hormone.

Black market Serostim, Nutropin AQ The black market drugs ultimately came from illegal sources

—often from patients re-selling their medicine or doctors selling supplies meant for patients.

Licensed wholesalers bought questionable medicine from networks of unlicensed distributors who covered their tracks with forged paperwork.

One group laundered more than $2.1 million in funds from the transactions over just 2 years.

In the meantime, patients who were very ill paidfull price—more than $1,700 a week—for drugs that were expired, diluted, damaged, contaminated, or outright counterfeit.

Black market HIV & Hep-C testing kits HIV and Hepatitis-C test kits help people stay healthy

and protect their partners. False positives cause tremendous stress. False negatives mean delays in treatment and accidental transmission.

Between 2006 and 2008, residents of Louisiana, New Jersey, Ohio and Florida unwittingly bought unapproved HIV and Hepatitis C testing kits.

Florida resident Jonathan Barash had illegally imported the kits from China, repackaged them and sold them as FDA approved devices.(This is still a problem. In 2011, Canadian and British authorities warned citizens that “illegal HIV test kits imported from China for sale online could give an incorrect diagnosis.”)

Drug diversion of antiretrovirals Since 2012, investigations have shown that

diversion of HIV/AIDS medicines is happening on a massive scale.

Patients have been sold secondhand, stolen and expired medicines that have been stored in uncontrolled conditions. There is no guarantee that these medicines are safe or effective.

Drug diversion of antiretrovirals Between 2008 and 2012,

customers of New York branches of MOMS Pharmacy were prescribed $274 million in second hand, stolen or expired HIV treatments.

In 2012 in New York, the FBI seized more than 33,000 bottles of second-hand AIDS, asthma and schizophrenia drugs and 250,000 loose pills from drug diverters. They were bound for local pharmacies.

Between 2006 and 2009 a Tennessee based company called Cumberland Distribution sold $58 million in HIV/AIDS, antipsychotics and diabetes treatments to pharmacies. Their sources had acquired the drugs from “street level drug diverters.”

Selling American patients unsafe medicine is big business Pharmacists in the MOMS case were paid more

than $27 million to sell patients unsafe drugs. Cumberland Distribution made over $14 million in

profit. Defendants in the New York diversion case sold

more that $62 million worth of second-hand prescription drugs over a 12-month period.

“The ringleaders of this complex scheme not only cheated the state Medicaid program out of millions of dollars, but preyed on some of New York’s most vulnerable patients just to make a quick buck.”

~ New York Attorney General Eric Schneiderman

Strategies for saving money safely Adopt FDA

approved generics if possible.

Generic versions of Ziagen, Combivir, Viramune, Retrovir, Videx and Zerit currently exist

More key patents are expiring between now and 2017

Strategies for saving money safely Use discount cards. The NeedyMeds Drug

Discount Card can save you as much as 80% on your prescriptions

Comparison shop using online tools Pharmahelper.com compares prices at

VIPPS-accredited online pharmacies to find you the best price.

WeRx.com, LowestMeds.com and GoodRX.com canfind you the lowest prices in your own neighborhood.

Strategies for saving money safely

The Partnership for Prescription Assistance (PPA) matches patients who cannot afford medication to prescription assistance programs. Find the program that’s right for you for free at www.pparx.org.

How patient advocates can helpEducate people—patients and medical professionals— about the risks of buying medication from unlicensed distributors Black market medicines are being sold outside the

regulated drug supply. They are often counterfeit, contaminated, diluted, improperly stored and transported or expired.

Substandard medicines may not stop the progress of a patient’s disease and may foster drug resistant HIV.

Since 2005, doctors and pharmacists have paid more than $13.4 million in fines in connection with buying black market drugs. Some have also been sentenced to prison.

How patient advocates can helpTeach patients to identify illegitimatemedication at the doctor’s office:

Ask to see the packaging the drugs came in.

Look for accurate labeling, packaging that is in good condition, and product descriptions in English.

Keep a record of the lot number of the medicine

How patient advocates can helpTeach patients to identify illegitimate medication at home Check that the packaging is clean and correctly sealed,

with instructions in English. Compare it to past packaging. Look for differences in

paper, printing, color, and fonts. If you notice changes, do not take the drugs, and show the packaging to your doctor.

Examine the appearance of the medicine. If it looks chipped or cracked, or different from earlier prescriptions, it may be fake.

If unsure whether the prescription is genuine, visit WebMD online to look up the drug's description and appearance.

How patient advocates can helpTeach them to recognize symptoms of ineffective medicine Pay attention to changes in the way medicine

tastes. Do not ignore side effects from a new dose of a

prescription. New reactions like a stomach ache or a head ache could signal changes to the drug.

Note adverse effects or failure of treatment.

If you work with medical professionals, make sure that they are alert to the possibility that patients may be using compromised medication.

How patient advocates can helpTeach patients and medical professionals what to do if they suspect that there is something wrong with a drug

Patients should contact the pharmacy where you purchased the medicine

Patients and medical professionals should contact the FDA and the manufacturer of the medication to report your concerns. The FDA can be contacted by calling toll-free 1-

800-FDA-1088 (800-332-1088), or on the Web at www.fda.gov/medwatch.

Where can you learn more?Pick up your copy of our report at the conference today.

www.safemedicines.org

Thank you for the opportunity to speak to you today.

Jim DahlThe Partnership for Safe Medicines

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Register and Attend our Annual Conference - September 18 in DCBuy tickets and use discount code “CANN2014” to save $100 on registration. http://safedr.ug/CANN2014Sessions include:

New research about counterfeit drugs by Dr. Marv Shepherd, University of Texas, Austin and Dr. Tim Mackey, University of San Diego

New international developments in the fight against counterfeit medicines

Recent prosecutions of counterfeit drug criminals in the United States

Impacts on patient safety from counterfeit, unapproved and diverted drugs

The real dangers and fake drugs found at fake online pharmacies

Hear representatives of:

The Department of JusticeThe Institute of MedicineThe Pharmaceutical Security InstituteThe Office of Criminal Investigations, FDANational Association of Drug Diversion InvestigatorsThe Alliance for Safe Online PharmaciesThe Federal Bureau of InvestigationThe Maine Pharmacy Association

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Buy tickets and use discount code “CANN2014” to save $100 on registration.Use this link: http://safedr.ug/CANN2014Keynote speakers:Mississippi Attorney General Jim Hood and FDA Deputy Commissioner Howard Sklamberg

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