HIV/AIDs Medication: The Black Market and Safety

1. HIV/AIDs Medication: The Black Market and Safety Jim Dahl, Board Member, PSM August 4, 2014

2. Today’s presentation • Meet the Partnership for Safe Medicines • Black market medicine in the US • Why is the black market a problem? • How the US regulates medicine • How black market drugs enter the US • How are HIV/AIDS patients being harmed? • How can we protect patients? • Where to learn more Register for Interchange 2014: http://safedr.ug/NADDI14

3. PSM Members Academy of Managed Care Pharmacy AIDS Drug Assistance Program Alaska Pharmacists Association The ALS Association American Association for Homecare American College Health Association American Pharmacists Association American Society of Health System Pharmacists Arizona Pharmacy Alliance (AzPA) Association of Nurses in AIDS Care BioForward Biotechnology Industry Organization California Healthcare Institute California Pharmacists Association California Society of Health-System Pharmacists (CSHP) Colorado Biotechnology Association Community Access National Network The Council for Affordable Health Insurance European Federation of Pharmaceutical Industries and Associations (EFPIA) Generic Pharmaceutical Association Global Medicines Program Healthcare Distribution Management Association HealthCare Institute of New Jersey Healthcare Leadership Council The Hispanic Institute Illinois Pharmacists Association Institute of Health Law Studies Institute for Safe Medication Practices Interamerican College of Physicians and Surgeons International Anti-Counterfeiting Coalition International Federation of Pharmaceutical Manufacturers and Associations Kidney Cancer Association The Latino Coalition The Life Raft Group Maryland Pharmacists Association Maine Pharmacists Association Maine Society of Health-System Pharmacists (MSHP) Men’s Health Network Missouri Pharmacy Association National Alliance for Hispanic Health National Alliance On Mental Illness National Association of Chain Drug Stores National Association for Uniformed Services National Association of Boards of Pharmacy National Association of Drug Diversion Investigators National Association of Manufacturers National Alliance of State Pharmacy Associations National Biopharmaceutical Security Council National Community Pharmacists Association National Grange of the Patrons of Husbandry National Latina Health Network NeedyMeds Nevada Board of Pharmacy New York State Council of Health-system Pharmacists (NYSCHP) North Carolina Association of Pharmacists Oklahoma Pharmacists Association Parenteral Drug Association PDMA Alliance Pennsylvania Pharmacists Association Pennsylvania Society of Health-system Pharmacists Pharmaceutical Industry Labor Management Association (PILMA) Pharmaceutical Security Institute Pharmacists Planning Services, Inc. PhRMA RetireSafe Spina Bifida Association of America Texas Pharmacists Association Texas Society of Health-System Pharmacists United States Chamber of Commerce University of New England College of Pharmacy University of Texas Pharmacy School Vietnam Veterans of America Virginia Pharmacists Association Vermont Pharmacists Association West Virginia Rx WomenHeart International and Governmental Organizations World Health Organization Orange County Healthcare Agency Register for Interchange 2014: http://safedr.ug/NADDI14 2

4. 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.

5. How common is black market medicine? • 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

6. How common is black market medicine?

7. 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.

8. 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.

9. 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, contaminatedor diluted.

10. 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.

11. 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.

12. Why is this a problem? • Addicts who resell their medication often take a dose of an IV drugand 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.

13. 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?

14. Why is this a problem? • Undocumented • Unregulated • Unsafe • Illegal

15. 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

16. 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. Register for Interchange 2014: http://safedr.ug/NADDI14

17. 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.

18. An example: Ozay Pharmaceuticals Co In 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.

19. 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 OzkanSemizoglu, the foreign trade director of a Turkish company called OzayPharmaceuticals. 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.

20. The Path of Fake Avastin

21. How are these products marketed?

22. How are these products marketed?

23. 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.

24. 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.

25. 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.

26. 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.”)

27. 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.

28. 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.”

29. 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.

30. “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

31. 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

32. Strategies for saving money safely • Use discount cards. The NeedyMeds DrugDiscount 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.

33. 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.

34. How patient advocates can help Educate 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.

35. How patient advocates can help Teach 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

36. How patient advocates can help Teach 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 descriptionand appearance.

37. How patient advocates can help Teach 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 aprescription. 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.

38. How patient advocates can help Teach 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.

39. 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 Register for Interchange 2014: http://safedr.ug/CANN2014

40. Register and Attend our Annual Conference - September 18 in DC Buy 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 Justice The Institute of Medicine The Pharmaceutical Security Institute The Office of Criminal Investigations, FDA National Association of Drug Diversion Investigators The Alliance for Safe Online Pharmacies The Federal Bureau of Investigation The Maine Pharmacy Association Register for Interchange 2014: http://safedr.ug/CANN2014

41. Register and Attend our Annual Conference - September 18 in DC September 18, 2014 Knight Conference CenterThe Newseum555 Pennsylvania Av., NWWashington, DC Buy tickets and use discount code “CANN2014” to save $100 on registration. Use this link: http://safedr.ug/CANN2014 Keynote speakers: Mississippi Attorney General Jim Hood and FDA Deputy Commissioner Howard Sklamberg Register for Interchange 2014: http://safedr.ug/CANN2014