FAKE MEDICINES, A NEW WORLD PANDEMIC / MEDICINAS FALSAS, UNA NUEVA PANDEMIA MUNDIAL.

Las Medicinas Falsas, una nueva pandemia mundial. 

Fake medicines, a new world pandemic,

 

 

 

EDITORIAL ESPAÑOL
=================
Hola amigos DERMAGICOS, hoy les traigo un tema que es de interés para toda la HUMANIDAD, LAS MEDICINAS FALSAS UNA NUEVA PANDEMIA MUNDIAL. Se trata que en estos últimos años el NEGOCIO de las falsas medicinas ha ido aumentando progresivamente.

En un informe del instituto de seguridad farmacéutica entre el 2.011 y 2.015 la incidencia mundial de falsificación de medicamentos se ha incrementado en un 51%, entre 2.014 y 2.015 aumentó en un 38%. Para que tengan una idea de este nuevo macabro NEGOCIO miremos esta cifra: En África mueren 120.000 mil niños al año por medicamentos contra la malaria falsos.

La Organización Mundial de la Salud (OMS) clasifica las falsificaciones de medicamentos en seis categorías: 

1.) Fármacos sin ingredientes activos (32,1 por ciento)
2.) Fármacos con la cantidad equivocada del ingrediente activo (20,2 por ciento)
3.) Fármacos con ingredientes erróneos (21,4 por ciento)
4.) Fármacos con el ingrediente activo, pero con envases falsos (15,6 por ciento)
5.) Fármacos copias de medicamentos originales (1 por ciento)
6.) Fármacos con altos niveles de contaminantes e impurezas (8,5 por ciento).

Cualquier medicamento puede ser objeto de una falsificación, es decir se coloca en el mercado de una manera fraudulenta una medicina con una estas seis (6) características mencionadas, simplemente con la finalidad de GANAR DINERO, es decir un NEGOCIO, sin tomar en cuenta la calidad de vida de las personas, la vida y la salud. En el listado coloque 17 medicamentos que han sido objeto de falsificaciones, donde predominan los utilizados contra el cáncer; y hay muchos mas.

ALGUNAS MEDICINAS QUE HAN SIDO FALSIFICADAS:
==============================================
1.) CIALIS (TALADAFIL): tratamiento de la disfunción eréctil.
 
2.) TAMIFLU (OSELTAMIVIR): Tratamiento de la influenza A H1N1.
 
3. SIBUTRAMINA (DESMETHYLSIBUTRAMINE Y / O PHENOLPHTHALEIN): La sibutramina es un supresor del apetito que fue retirado del mercado de los EE.UU. en octubre de 2010.
 
4.) AVASTIN O ALTUZAN (BEVACIZUMAB): Tratamiento del cáncer. Altuzan no está aprobado por la FDA para su uso en los Estados Unidos (es un medicamento aprobado en Turquía). El 14 de febrero de 2.012 la FDA emitió una alerta sobre otro medicamento contra el cáncer  distribuido en Estados Unidos que fue comprado de una fuente extranjera y se encontró que era falsificación.
 
5.) BICNU (CARMUSTINA): tratamiento de cáncer cerebral, mieloma múltiple y linfoma (Hodgkin y no Hodgkin).
 
6.) PARACETAMOL ELIXIR (ANALGÉSICO): Tratamiento de la fiebre y el dolor. Etilenglicol que se encuentro en el elixir de paracetamol, responsable de insuficiencia renal y la muerte de más de 50 pacientes en Bangladesh (en su mayoría niños) 10, y representa un problema internacional de seguridad de los medicamentos.

7.) BOTOX (ONABOTULINUMTOXINA): Tratamiento de (problemas oculares, rigidez muscular / espasmos, migrañas, cosmética, vejiga hiperactiva). La toxina botulínica se utiliza para tratar el estrabismo, el blefaroespasmo, la distonía cervical, la tortícolis y reducir la apariencia estética de las arrugas. También para prevenir dolores de cabeza en personas con migrañas muy frecuentes. La toxina botulínica relaja el músculo bloqueando la liberación de una sustancia química llamada acetilcolina. La toxina botulínica también se usa para tratar la vejiga hiperactiva.

8. ADDERALL DE TEVA (SACARATO DE DEXTROANFETAMINA, ASPARTATO DE ANFETAMINA, SULFATO DE DEXTROANFETAMINA Y SULFATO DE ANFETAMINA): Tratamiento de trastornos de hiperactividad con déficit de atención (ADHD) y narcolepsia.

9.) VIAGRA (SILDENAFIL): tratamiento de la disfunción eréctil.

10.) SEROSTIM (SOMATROPINA (ORIGEN DEL ADNR) PARA INYECCIÓN): Tratamiento del fracaso del crecimiento en niños y adultos que necesitan la hormona de crecimiento natural. Esto incluye a las personas con insuficiencia renal crónica, síndrome de Noonan, síndrome de Turner, síndrome de Prader-Willi.

11.) NEUPOGEN (FILGRASTIM): Tratamiento del cáncer.

EPOGEN (EPOETINA ALFA): tratamiento: número de glóbulos rojos (anemia) inferior al normal causado por enfermedad renal crónica en pacientes en diálisis para reducir o evitar la necesidad de transfusiones de glóbulos rojos.

13.) COMBIVIR (LAMIVUDINA MÁS ZIDOVUDINA): Tratamiento del VIH.

14.) ZYPREXA (OLANZAPINA): Tratamiento de la esquizofrenia y la manía bipolar aguda.

15.) PROCRIT (EPOETINA ALFA): Tratamiento de ciertos tipos de anemia. Las personas con anemia tienen un número inferior a lo normal de glóbulos rojos (glóbulos rojos). PROCRIT® funciona como la proteína humana llamada eritropoyetina para ayudar a su cuerpo a producir más glóbulos rojos. PROCRIT® se utiliza para reducir o evitar la necesidad de transfusiones de glóbulos rojos.

16.) HERCEPTIN (TRASTUZUMAB): Tratamiento del cáncer; Medicamento que interfiere con el crecimiento y la propagación de las células cancerosas en el cuerpo.

17.) MAB THERA (RITUXIMAB): Tratamiento de Artritis Reumatoide, linfoma, no Hodgkin, Leucemia Linfocítica, Crónica, B-Cell.

Para darte una idea de lo peligroso de ingerir un medicamentos FALSO, revisa la referencia 9 donde el TAMIFLU (OSELTAMIVIR) utilizado para la gripe A H1N1 fue sustituido por CLOXACILINA un antibiótico de la misma clase que las penicilinas. Si eres alergico a la penicilina y lo usabas, severos efectos adversos ibas a padecer.


Revisa la referencia 17 (MEDICAMENTOS FALSIFICADOS) donde podrás observar que la medicina COMBIVIR (LAMIVUDINA mas ZIDOVUDINA) utilizada en el VIH, fue sustituida por ZIAGEN (SULFATO DE ABACAVIR), la cual puede ocasionar severas reacciones de hipersensibilidad.

Y lo peor, medicinas para el cáncer como el AVASTIN (BEVACIZUMAB) fue copiado fraudulentamente bajo el nombre de ALTUZAN, el cual NO TIENE EL PRINCIPIO ACTIVO, no funciona. y ASI ocurre con casi todas....

De modo que debes estar vigilante de las medicinas que utilizas !!!

PARA COMBATIR ESTE PROBLEMA (FLAGELO), DEBEMOS COMENZAR POR LO SIGUIENTE:

1.) Quien hace una medicina falsa? Un laboratorio falso.
 
2.) Quienes son los empleados de esa empresa ? Personas que saben que están haciendo medicinas falsas.
 
3.) Quién es el dueño de la compañía ? Un personaje que no tiene las credenciales para fabricar medicinas.
 
4.) Dónde está ubicada la compañía ? Por lo general el mejor sitio LA INTERNET, donde no podrás ver donde está ubicada la empresa.
 
5.) Cuánto vale la medicina falsa ? Por lo general, mucho menos que la verdadera.
 
6.) Como es el producto ? por lo general viene con defectos de manufactura, errores ortográficos, mala impresión, etc.

SI YA TIENES EL MEDICAMENTO EN TUS MANOS: DEBES HACER LO SIGUIENTE:

1.) Revisa el empaque, color de la caja, textura, nombre del medicamento, presentación, Farmaceuta patrocinante,fecha de salida al mercado, fecha de expiración, código de barra.
 
2.) Si tienes tiempo tomando el medicamento original y compraste uno falso, tu cuerpo inmediatamente te dirá que es falso porque sentirás que "algo raro" esta pasando.
 
3.) Si sientes efectos adversos, acude al médico inmediatamente.
 
4.) No debes suspender el tratamiento hasta que compruebes que es falso, a menos que tengas severos efectos en tu cuerpo que te obliguen a descontinuarlo. SUSTITUYE la medicina falsa por la original, pero no te quedes sin tratamiento.
 
5.) Si sospechas que es falso debes notificarlo inmediatamente a tu medico, la organización mundial de la salud (WHO) la FDA, autoridades sanitarias locales, hazlo publico a través de las redes sociales.
 
6.) Comprueba tu sospecha buscando "medicamentos falsos" en la internet, específicamente LA FDA (Administración de Alimentos y Medicinas) Y WHO (organización mundial para la salud). TODA LA INTERNET.
 
7.) Trata de llegar al origen, es decir, de donde viene la medicina, esa es la clave. Si lo compraste por internet debes averiguar si el Web Site es confiable.
 
8.) Si lo compraste en una farmacia, investiga quien le vendió esa medicina a la farmacia, donde esta ubicado el falso laboratorio.
 
9.) Denuncia al mercader de la salud, que con su NEGOCIO SUCIO esta acabando con la salud de la HUMANIDAD.

DEBES SABER QUE:

1.) TODO MEDICAMENTO tiene sus efectos secundarios.
 
2.) TODO MEDICAMENTO puede ocasionar efectos inesperados, aun fatales, los cuales por lo general vienen descritos en el empaque del producto.
 
3.) TU ORGANISMO puede no responder al medicamento aun siendo NO FALSO. Es por ello que el principal NEGOCIO DE los medicamentos falsos va dirigido a medicinas contra el cáncer, pues muchas veces no hay respuesta positiva ante el avance de la enfermedad, aun con medicinas originales, Pero indudablemente:
 
4.) CUALQUIER MEDICAMENTO, puede ser objeto de falsificación. 

DEBEMOS RECORDAR TAMBIEN QUE:

LOS LABORATORIOS, los verdaderos laboratorios fabrican las medicinas para brindar salud, mejorar, la calidad de vida de los habitantes del planeta, son científicos que dedican su vida a ello, y realmente hay que reconocer el esfuerzo que hacen dia a dia con sus descubrimientos e investigaciones.

A diferencia de los FALSOS LABORATORIOS que fabrican falsos medicamentos con el fin primario GANAR DINERO, y como fin ultimo, DIEZMAR LA POBLACION, pues no les importa que TU MUERAS porque consumiste un falso producto.

Esta publicación la hice para "CREAR" conciencia a nuestros médicos, colegas dermatólogos, personas, en fin toda la HUMANIDAD, con el fin único de alertar sobre este NUEVO Y FRAUDULENTO NEGOCIO de las medicinas falsas.

Lee y comparte con tus familiares, amigos, y médicos. LA sociedad te lo agradecerá ! y recuerda que:

"El mañana nunca muere, ni nunca morirá por causa de medicinas falsas, si tu reconoces al falso laboratorio y las personas que las fabricaron.."

En las referencias los hechos


Saludos a todos.

Dr José Lapenta.

Dr José M. Lapenta.

EDITORIAL ENGLISH
===================
Hi DERMAGIC friends, today I bring you a topic that is of interest to all HUMANITY, FAKE MEDICINES A NEW WORLD PANDEMIC. It is about that in recent years the business of false medicines has been increasing progressively.

In a report from the Institute of Pharmaceutical Safety between 2011 and 2015, the global incidence of drug falsification has increased by 51%, between 2,014 and 2,015 increases by 38%. To give you an idea of this new macabre BUSINESS, let's look at this figure: In Africa, 120.000. children die every year for false malaria drugs.

The World Health Organization (WHO) classifies drug counterfeits into six categories:

1.) Drugs without active ingredients (32.1 percent).
2.) Drugs with the wrong amount of the active ingredient (20.2 percent)
3.) Drugs with wrong ingredients (21.4 percent)
4.) Drugs with correct amount of active ingredient but with fake packaging (15.6 percent),
5.) Drugs copies of original drugs (1 percent)
6.) Drugs with high levels of contaminants and impurities (8.5 percent).
 

Any medication may be falsified, a medicine with a six (6) mentioned characteristics is placed on the market in a fraudulent way, simply for the purpose of MAKING MONEY, a BUSINESS, regardless of the quality of life of the people , Life and health. In the list put 17 drugs that have been falsified, where they predominate those used against cancer; And there are many more.
 

Some medicines that have been falsified:
========================================

 1.) Cialis (taladafil): treatment of erectile dysfunction.

 2.) Tamiflu (oseltamivir) : Treatment of influenza A H1N1.

3.) Sibutramine ( Desmethylsibutramine and/or Phenolphthalein): Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.

4.) Avastin or Altuzan (bevacizumab): Treatment of cancer. Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey). On February 14, 2.012 FDA issued an alert about another cancer drug in U.S. distribution that was purchased from a foreign source and found to be counterfeit.

5.) BiCNU (carmustine): treatment of brain cancer, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s).

6.) paracetamol elixir (analgesic) : Treatment of fever and pain. ethylene glycol found in paracetamol elixir, which were responsible for the renal failure and death of over 50 patients in Bangladesh (mostly children),10 and represents an international medicines safety issue.

7.) Botox (OnabotulinumtoxinA): Treatment of (eye problems, muscle stiffness/spasms, migraines, cosmetic, overactive bladder). Botulinum toxin is used to treat strabismus, blepharospasm, cervical dystonia, torticollis, and to reduce the cosmetic appearance of wrinkles. Also to prevent headaches in people with very frequent migraines. Botulinum toxin relaxes muscle by blocking the release of a chemical called acetylcholine.Botulinum toxin is also used to treat overactive bladder.

8.) Teva’s Adderall (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate ): Treatment of attention deficit hyperactivity disorders (ADHD) and narcolepsy.

9.) Viagra (sildenafil): treatment of erectile dysfunction.

10.) Serostim (somatropin (rDNA origin) for injection): The treatment of failure of growth in children and adults who need the natural growth hormone. This includes people with chronic kidney failure, Noonan syndrome, Turner syndrome, Prader-Willi syndrome.

11.) Neupogen (filgrastim): Treatment of cancer.

12.) Epogen (epoetin alfa): treatment: lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell ransfusions.

13.) Combivir (lamivudine plus zidovudine): Treatment of VIH.

14.) Zyprexa (olanzapine): the treatment of schizophrenia and acute bipolar mania.

15.) Procrit (epoetin alfa): treat certain types of anemia. People with anemia have a lower-than-normal number of red blood cells (RBCs). PROCRIT® works like the human protein called erythropoietin to help your body make more RBCs. PROCRIT® is used to reduce or avoid the need for RBC transfusions.

16.) HERCEPTIN (trastuzumab): Treatment of cancer; medication that interferes with the growth and spread of cancer cells in the body.

17.) Mab Thera (Rituximab): Treatment of Arthritis, Rheumatoid Lymphoma, Non-Hodgkin Leukemia, Lymphocytic, Chronic, B-Cell.

To give you an idea of how dangerous it is to take a FAKE medication, check reference 9 where TAMIFLU (OSELTAMIVIR) used for A H1N1 influenza was replaced by CLOXACILLIN an antibiotic of the same class as penicillins. If you are allergic to penicillin and you used severe adverse effects you were going to suffer.

Check the reference 17 (CONTERFEITS DRUGS) where you can see that the drug COMBIVIR (LAMIVUDINE plus ZIDOVUDINE) used in HIV was replaced by ZIAGEN (ABACAVIR SULFATE), which can cause severe hypersensitivity reactions.

And the worst, cancer drugs like AVASTIN (BEVACIZUMAB) were fraudulently copied under the name of ALTUZAN, which DOES NOT HAVE THE ACTIVE INGREDIENT, does not work. And I happen with almost all...

So you should always be vigilant of the medicines you are using !!!

To combat this problem(scourge), we must begin with the following:

  

1.) Who makes a fake medicine? A fake lab.

2.) Who are the employees of that company? People who know they are making fake medicines.

3.) Who owns the company? A  person who does not have the credentials to make medicines.

4.) Where is the company located? Usually the best site THE INTERNET, where you will not be able to see where The company is located 

5.) How much is false medicine worth? Usually, much less than the real one. 

6.) How is the product? Usually comes with manufacturing defects, spelling mistakes, bad printing, etc.

If you already have the medicine in your hands: you must do the following:

 
1.) Check the packaging, box color, texture, name of the medication, presentation, sponsoring pharmacist, Date of exit to the market, date of expiration, bar code.

2.) If you have time taking the original medication and bought a fake one, your body will immediately tell you that it is fake Because you will feel that "something strange" is happening.

3.) If you feel any adverse effects, go to the doctor immediately.

4.) You should not discontinue treatment until you prove it to be false, unless you have severe effects on your body Which oblige you to discontinue it. REPLACE fake medicine for the original, but do not run out of treatment.

5.) If you suspect it is false you should immediately notify your physician, the World Health Organization (WHO) the FDA, local health authorities, make it public through social networks.

6.) Check your suspicion for "fake drugs" on the internet, specifically the FDA (Food And Drug Administration) AND WHO (World Health Organization). ALL THE INTERNET.

7.) Try to get to the source, where the medicine comes from, that's the key. If you bought it online
You should find out if the Web Site is reliable.

8.) If you bought it at a pharmacy, investigate who sold that medicine to the pharmacy, where is the false laboratory.

9.) Denounces the health merchant, who with his DIRTY BUSINESS is putting an end to the health of HUMANITY.

You should know that: 

1.) ALL MEDICATION has its side effects.

2.) EVERY MEDICATION may cause unexpected, even fatal effects, which are usually described on the product packaging.

3.) YOUR ORGANISM may not respond to the medication even though it is NOT FAKE. That is why the main business of counterfeit drugs is directed at anti-cancer drugs, because there is often no positive response to the disease, even with original medicines, but undoubtedly:

4.) ANY MEDICATION, can be falsified. 

We must also remember that:

THE LABORATORIES, true laboratories manufacture medicines to provide health, improve, the quality of life of the inhabitants of the planet, are scientists who dedicate their life to it, and really must recognize the effort they make day by day with their discoveries and research.

Unlike the FALSE LABORATORIES that make false drugs with the primary purpose to WIN MONEY, and as the last end, DECREASING THE POPULATION, because they do not care that YOU DIE because you consumed a false product.

This publication was made to "CREATE" conscience to our doctors, dermatologist colleagues, people, in short all HUMANITY, with the sole purpose of alerting about this NEW AND FRAUDULENT BUSINESS of false medicines.

Read and share with family, friends, and doctors. Society will thank you! And remember that:

"Tomorrow never dies, nor will ever die
Because of fake medicines, if you recognize
the false lab and people which I manufacture  them "

In the references the facts

 

Greetings to all.

Dr Jose Lapenta.

Dr Jose M. Lapenta.

================================================================ REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES 
================================================================
1.) Public health interventions to protect against falsified medicines: a systematic review of international, national and local policies.
2.) Australians' use of fake tanning lotions: another piece of the puzzle.
3.) Meta-placebo: do doctors have to lie about giving a fake treatment?
4.) Quantitative bioassay to identify antimicrobial drugs through drug interaction fingerprint analysis.
5.) Poly(aryleneethynylene) Tongue That Identifies Nonsteroidal Anti-Inflammatory Drugs in
Water: A Test Case for Combating Counterfeit Drugs.
6.) Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study.
7.) Another counterfeit cancer medicine found in U.S. - Illegal practice puts patients at risk
8.) Counterfeit Version of Avastin in U.S. Distribution
9.) FDA Warns About Fraudulent Tamiflu
10.) June 3, 2011: Chinese National Sentenced to Federal Prison for Trafficking Counterfeit Pharmaceutical Weight Loss Drug
11.) Counterfeit Versions of Cialis tablets identified entering the United States
12.) FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries 05/12/2016
13.) Counterfeit Version of Botox Found in the United States
14.) FDA warns consumers about counterfeit version of Teva’s Adderall
15.) January 21, 2011: Internet Pharmacy Sold Counterfeit Viagra, Misbranded Drugs
16.) The Possible Dangers of Buying Medicines over the Internet
17.) COUNTERFEIT DRUGS
18.) Counterfeits of Herceptin found in EU supply chain.
19.) Mexican authorities find vials of fake anti-cancer drug
20.) Counterfeits Of Mab Thera Discovered In Germany
21.) Counterfeit drugs: 'People are dying every day'
22.) Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient
================================================================
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1.) Public health interventions to protect against falsified medicines: a systematic review of international, national and local policies.
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Hamilton WL1,2, Doyle C3, Halliwell-Ewen M3, Lambert G3.
Author information
1University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0SP, UK wlh26@cam.ac.uk.
2Wellcome Trust Sanger Institute, Wellcome Genome Campus, Hinxton, Cambridge, CB10 1SA, UK.
3University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0SP, UK.
Abstract
BACKGROUND:
Falsified medicines are deliberately fraudulent drugs that pose a direct risk to patient health and undermine healthcare systems, causing global morbidity and mortality.
OBJECTIVE:
To produce an overview of anti-falsifying public health interventions deployed at international, national and local scales in low and middle income countries (LMIC).
DATA SOURCES:
We conducted a systematic search of the PubMed, Web of Science, Embase and Cochrane Central Register of Controlled Trials databases for healthcare or pharmaceutical policies relevant to reducing the burden of falsified medicines in LMIC.
RESULTS:
Our initial search identified 660 unique studies, of which 203 met title/abstract inclusion criteria and were categorised according to their primary focus: international; national; local pharmacy; internet pharmacy; drug analysis tools. Eighty-four were included in the qualitative synthesis, along with 108 articles and website links retrieved through secondary searches.
DISCUSSION:
On the international stage, we discuss the need for accessible pharmacovigilance (PV) global reporting systems, international leadership and funding incorporating multiple stakeholders (healthcare, pharmaceutical, law enforcement) and multilateral trade agreements that emphasise public health. On the national level, we explore the importance of establishing adequate medicine regulatory authorities and PV capacity, with drug screening along the supply chain. This requires interdepartmental coordination, drug certification and criminal justice legislation and enforcement that recognise the severity of medicine falsification. Local healthcare professionals can receive training on medicine quality assessments, drug registration and pharmacological testing equipment. Finally, we discuss novel technologies for drug analysis which allow rapid identification of fake medicines in low-resource settings. Innovative point-of-purchase systems like mobile phone verification allow consumers to check the authenticity of their medicines.
CONCLUSIONS:
Combining anti-falsifying strategies targeting different levels of the pharmaceutical supply chain provides multiple barriers of protection from falsified medicines. This requires the political will to drive policy implementation; otherwise, people around the world remain at risk.
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2.) Australians' use of fake tanning lotions: another piece of the puzzle.
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Girgis A1, Tzelepis F, Paul CL, Walsh RA, McElduff P, McKenzie J.
Author information
1Centre for Health Research & Psycho-oncology, The Cancer Council New South Wales, Wallsend, New South Wales 2267. Afaf.Girgis@newcastle.edu.au
Abstract
OBJECTIVE:
To assess community attitudes and practices in relation to fake tanning lotions.
METHODS:
1,509 New South Wales residents aged 15 years and over, selected at random, completed a computer-assisted telephone survey.
RESULTS:
Thirty-three per cent of respondents thought fake tanning lotions were unsafe. In relation to The Cancer Council marketing fake tanning lotions, more than three-fifths thought The Cancer Council would be promoting tans, although 62% thought it would be a good thing as fake tans are safer than tanning in the sun. Nine per cent of respondents had used fake tanning lotions in the past 12 months. Almost half (48%) of female current users used fake tanning lotions occasionally or only for special occasions during the past summer. In particular settings, the sunscreen and hat-wearing practices of female users and non-users of fake tanning lotions differed significantly.
CONCLUSION:
There appears to be no consistent data to suggest that fake tanning lotions may be used as a safer alternative to sun tanning. However, there is a responsibility to at least disseminate accurate information on these products.
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3.) Meta-placebo: do doctors have to lie about giving a fake treatment?
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Med Hypotheses. 2008 Sep;71(3):335-9. doi: 10.1016/j.mehy.2008.03.040. Epub 2008 May 15.
van Deventer MO1.
Author information
1Hannie Schaftstraat 62, DL Leidschendam, Netherlands. m.o.vandeventer@planet.nl
Abstract
Fake treatments work. That is a well established medical fact. This is why the golden standard of evidence-based medicine requires double-blind testing. Both real and fake (also known as placebo) treatments are administered in order to be able to distinguish the effects of the treatment-under-test from the placebo effect. Given the medically proven fact that fake treatments work, doctors could include fake treatments in their medical repertoire. However, this poses an ethical dilemma. On the one hand the doctor does not want to lie to his patient. On the other hand, the effect of the fake treatment would diminish if the patient knows it is fake. For this reason, fake treatments are typically left to practitioners of so-called alternative medicine who are often not even aware of the ethical dilemma. The central hypothesis of this article is that the doctor does not have to lie, and that truthfully administering fake treatments would not render these ineffective. A proper term for this type of treatment "meta-placebo". The placebo effect is based on the healing belief of getting administered a real treatment. The meta-placebo effect is based on the healing belief that even fake/placebo treatments have positive effects. That is, if both the doctor and the patient believe in the healing powers of the fake treatment, it does not matter that both know the treatment is fake. If the meta-placebo effect exists, it would solve several of the doctor's dilemma's. First of all, he would not have to lie to the patient when applying a fake treatment. Secondly, by having fake treatments in his medical repertoire, the doctor could keep patients in the regular medical circuit and keep monitoring the patient's syndrome. Thirdly, the doctor could keep the patient away from the medical and financial risks associated with alternative medicine. Unlike the well-established placebo effect, the meta-placebo effect is still a medical hypothesis. The hypothesis shall have to be tested experimentally, before "meta-placebo" treatments can become evidence-based medicine. Such validation involves several medical philosophical complications. How can the hypothesis be tested following the golden double-blind standard? What syndrome would be suited for a meta-placebo-experiment? What would a treatment in a meta-placebo experiment look like? How can meta-placebo be distinguish from placebo? What ethical aspects do meta-placebo's have? This article discusses these questions in detail.
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4.) Quantitative bioassay to identify antimicrobial drugs through drug interaction fingerprint analysis.
=======================================================
Weinstein ZB1, Zaman MH2,3.
Author information
1Department of Pharmacology and Experimental Therapeutics, Boston University School of Medicine, Boston, MA 02118, USA.
2Howard Hughes Medical Institute, Boston University, Boston, MA 02215, USA.
3Department of Biomedical Engineering, Boston University, Boston, MA 02215, USA.
Abstract
Drug interaction analysis, which reports the extent to which the presence of one drug affects the efficacy of another, is a powerful tool to select potent combinatorial therapies and predict connectivity between cellular components. Combinatorial effects of drug pairs often vary even for drugs with similar mechanism of actions. Therefore, drug interaction fingerprinting may be harnessed to differentiate drug identities. We developed a method to analyze drug interactions for the application of identifying active pharmaceutical ingredients, an essential step to assess drug quality. We developed a novel approach towards the identification of active pharmaceutical ingredients by comparing drug interaction fingerprint similarity metrics such as correlation and Euclidean distance. To expedite this method, we used bioluminescent E. coli in a simplified checkerboard assay to generate unique drug interaction fingerprints of antimicrobial drugs. Of 30 antibiotics studied, 29 could be identified based on their drug interaction fingerprints. We present drug interaction fingerprint analysis as a cheap, sensitive and quantitative method towards substandard and counterfeit drug detection.
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5.) Poly(aryleneethynylene) Tongue That Identifies Nonsteroidal Anti-Inflammatory Drugs in
Water: A Test Case for Combating Counterfeit Drugs.
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ACS Appl Mater Interfaces. 2017 Jan 11;9(1):790-797. doi: 10.1021/acsami.6b11690. Epub 2016 Dec 22.
Han J1, Wang B1, Bender M1, Kushida S1, Seehafer K1, Bunz UH1,2.
Author information
1Organisch-Chemisches Institut, Ruprecht-Karls-Universität Heidelberg , Im Neuenheimer Feld 270, 69120 Heidelberg, Germany.
2CAM, Centre for Advanced Materials, Ruprecht-Karls-Universität Heidelberg , Im Neuenheimer Feld 225, 69120 Heidelberg, Germany.
Abstract
We report a sensor array composed of a highly fluorescent positively charged poly(para-phenyleneethynylene) P1 and its complex C with a negatively charged pyridine-containing poly(para-aryleneethynylene) P2 (quencher) at pH 10 and pH 13; a sensor field composed of four elements, P1 (pH 10), P1 (pH 13), C (pH 10), and C (pH 13), results. The elements of this small sensor field experience either fluorescence turn on or fluorescence quenching upon exposure toward nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, diclofenac, or naproxen. The combined responses of the sensor field are analyzed by linear discriminant analysis (LDA). All of the NSAIDs were identified and discriminated, and the sensing mechanism, hydrophobic versus electrostatic, was discussed.
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6.) Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study.
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BMJ Open. 2016 Dec 9;6(12):e013837. doi: 10.1136/bmjopen-2016-013837.
Naughton B1,2,3, Roberts L4, Dopson S2, Chapman S1,5, Brindley D2,5,6,7,8,9.
Author information
1Institute of Science and Technology in Medicine, Keele University, Stoke-on-Trent, UK.
2Said Business School, University of Oxford, Oxford, UK.
3Pharmacy Department, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
4Medicines Optimisation Clinical Network, Oxford Academic Health Science Network (AHSN), Oxford, UK.
5Department of Paediatrics, University of Oxford, Oxford, UK.
6The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK.
7Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, UK.
8Harvard Stem Cell Institute, Cambridge, Massachusetts, USA.
9USCF-Stanford Centre of Excellence in Regulatory Science and Innovation (CERSI), USA.
Abstract
OBJECTIVES:
To identify the authentication and detection rate of serialised medicines using medicines authentication technology.
DESIGN AND INTERVENTION:
4192 serialised medicines were entered into a hospital dispensary over two separate 8-week stages in 2015. Medicines were authenticated using secure external database cross-checking, triggered by the scanning of a two-dimensional data matrix with a unit specific 12-digit serial code. 4% of medicines included were preprogrammed with a message to identify the product as either expired, pack recalled, product recalled or counterfeit.
SETTING:
A site within a large UK National Health Service teaching hospital trust.
PARTICIPANTS:
Accredited checking staff, pharmacists and dispensers in a pharmacy department.
PRIMARY OUTCOME MEASURES:
Authentication and detection rate of counterfeit expired and recalled medicines.
RESULTS:
The operational detection rate of counterfeit, recalled and expired medicines scanned as a combined group was 81.4% (stage 1 (S1)) and 87% (stage 2 (S2)). The technology's technical detection rate (TDR) was 100%; however, not all medicines were scanned and of those that were scanned not all that generated a warning message were quarantined. Owing to an operational authentication rate (OAR) of 66.3% (over both stages), only 31.8% of counterfeit medicines, 58% of recalled drugs and 64% of expired medicines were detected as a proportion of those entered into the study. Response times (RTs) of 152 ms (S1) and 165 ms (S2) were recorded, meeting the falsified medicines directive-mandated 300 ms limit.
CONCLUSIONS:
TDRs and RTs were not a limiting factor in this study. The suboptimal OAR poses significant quality and safety issues with this detection approach. Authentication at the checking stage, however, demonstrated higher OARs. There is a need for further qualitative research to establish the reasons for less than absolute authentication and detection rates in the hospital environment to improve this technology in preparation for the incumbent European Union regulative deadline.
Introduction of the study
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" The terms counterfeit and falsified are often used interchangeably. According to the Food and Drug Administration (FDA), a counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose.1 According to the European Medicines Agency, falsified medicines are fake medicines that pass themselves off as real, authorised medicines.2 The pharmaceutical security institute report that between 2011 and 2015 the global incidence of drug counterfeiting has increased by 51%, with 2015 seeing the highest levels of counterfeiting to date, a 38% increase when compared with 2014.3 This upward trend can also be seen in the UK supply chain, where 11 cases of falsified medicines were detected over an 11-year period (2001–2011)4 The direct result of medicine counterfeiting includes deterioration of medicine quality and therefore patient health, unnecessary drug side effects and death in some of the most vulnerable patient groups.5–12 The indirect effects of drug counterfeiting include a loss in government tax revenue and the funding of illegal activity which may include terrorist organisations.13 High profile cases of counterfeit medicines include anticancer agents such as Avastin (Bevacizumab; USA),6 Herceptin (Trastuzumab; UK, Finland and Germany)8 and epidemic cases such as those seen in Bangladesh, where unsafe levels of ethylene glycol found in paracetamol elixir, which were responsible for the renal failure and death of over 50 patients (mostly children),10 and represents an international medicines safety issue.
The current methods for detecting counterfeit medicine are varied in nature and span from laboratory-based methods through to SMS texting. The detection of counterfeit medicines by customs officials usually occurs as a result of intelligence or random checks, suspect medicines are then sent away for laboratory-based analysis. Advancing technology has made a variety of techniques available which include spectroscopy, chromatography, SMS, handheld or portable laboratories, radiofrequency identification and serialisation.14 Serialisation is the process of identifying a medicine with a unique code printed onto the medicines pack and verification is the process for identifying and checking that code. In terms of the falsified medicines directive (FMD), the term ‘authentication’ relates to the final scanning of a medicine and the subsequent decommissioning of a product at the point of supply to the patient to ensure authenticity. The 2011 FMD15–18 and the 2013 Drug Quality and Security Act (DQSA)19 have adopted the serialisation and verification approach for counterfeit medicine detection. This is a low-cost, non-destructive and quick method for detecting counterfeit medicines. The FMD requires the systematic authentication of medicines at the point of supply to the patient while the DQSA requires verification at every point of sale and exchange throughout the drug distribution cycle, currently without authentication at the point of sale or administration to the patient. Although practices similar to those proposed by the FMD exist within the Italian, Greek and Belgian primary care markets, principally as a reimbursement method, FMD-legislated serialisation and authentication technologies are alien to many countries and have not been academically assessed and may prove difficult to implement, especially in the heterogeneous secondary care environment.20 "
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7.) Another counterfeit cancer medicine found in U.S. - Illegal practice puts patients at risk
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Source: FDA.
Statement Update Issued: July 10. 2012
FDA has issued letters to medical practices in the United States that purchased unapproved medications that may include the counterfeit versions of Avastin or Altuzan. The medical practices purchased unapproved medications from foreign distributors such as Clinical Care, Quality Specialty Products (QSP), Montana Health Care Solutions, and Bridgewater Medical.
Letters to Doctors about Risks of Purchasing Medications from Foreign or Unlicensed Suppliers

Statement Update Issued: April 25, 2012
FDA has issued letters to medical practices in the United States that purchased unapproved cancer medications from Quality Specialty Products (QSP) (also known as Montana Health Care Solutions), and distributed through Volunteer Distribution of Gainesboro, Tennessee that may include counterfeit versions of Altuzan.
Statement Update Issued: April 17, 2012
In a related action, FDA has issued letters to medical practices in the United States that purchased unapproved cancer medications that may include counterfeit versions of Altuzan.
Statement Issued: April 3, 2012
The U.S. Food and Drug Administration is alerting healthcare professionals that another cancer drug, originating from a foreign source and purchased by U.S. medical practices, has been determined to be counterfeit. Medical practices that purchase and administer illegal and unapproved foreign medications are putting patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous. Illegal drugs purchased from foreign sources may not be genuine or meet appropriate quality, safety, and efficacy standards, putting patients at risk and depriving them of proper treatment.
Patients receiving cancer drugs or other drugs not approved by the FDA for the U.S. market may not be receiving needed therapy. Patients are encouraged to discuss any concerns they may have about the source of their medications with their healthcare professional.
FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab), an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey). On February 14, FDA issued an alert about another cancer drug in U.S. distribution that was purchased from a foreign source and found to be counterfeit.
Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI). Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA. The agency cannot ensure that the manufacture and handling of these illegal products follows U.S. regulations, nor can FDA ensure that these drugs are safe and effective for their intended uses.
Any medical practice that has obtained unapproved products, in particular from Richards Pharma, Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI), should stop using them and contact the FDA. The products should be retained and securely stored until further notice by the FDA.
Healthcare professionals and patients should report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care professionals and consumers can either:
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
FDA is asking the public to report suspect counterfeit products and other suspect products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, Ban Dune Marketing Inc (BDMI), or other sources:
Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or
Email - DrugSupplyChainIntegrity@fda.hhs.gov
For more information about counterfeit medicine: Pictures of the counterfeit version of Altuzan are shown below:
Packaging or vials found in the U.S. that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit.
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8.) Counterfeit Version of Avastin in U.S. Distribution
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Source: FDA
Statement Update Issued: July 10. 2012
FDA has issued letters to medical practices in the United States that purchased unapproved medications that may include the counterfeit versions of Avastin or Altuzan. The medical practices purchased unapproved medications from foreign distributors such as Clinical Care, Quality Specialty Products (QSP), Montana Health Care Solutions, and Bridgewater Medical.

Statement Issued: Feb. 14, 2012
FDA sends letters to 19 medical practices about counterfeit product and other unapproved cancer medicines
The U.S. Food and Drug Administration (FDA) is warning health care professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.
In a related action, FDA has issued letters to 19 medical practices in the United States that purchased unapproved cancer medicines that may include the counterfeit Avastin. The counterfeit version is labeled as Avastin, manufactured by Roche. Roche is the company that manufactures Avastin approved for marketing outside of the United States.
Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:
are labeled with Roche as the manufacturer
display batch numbers that start with B6010, B6011 or B86017
The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. In addition, Genentech’s FDA-approved version of Avastin vials and packaging have a 6-digit numeric batch number and expiration dates in a 3-letter month and 4-digit year format (e.g., JAN 2014). Genentech’s Avastin products are safe and effective for their intended uses.
The 19 medical practices in the United States purchased unapproved cancer medicines and, potentially, the counterfeit Avastin, from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products. FDA has requested that the medical practices stop using any remaining products from these suppliers. FDA cannot ensure the safety or efficacy of any of these unapproved products.
Based on information to date, FDA has determined that none of the unapproved cancer medicines received by these medical practices from Volunteer Distribution are in shortage in the United States. FDA-approved versions of these medicines are available in adequate supply to meet current demand.
Medical practices that have obtained unapproved products from foreign sources, in particular from Volunteer Distribution and/or QSP, should stop using them and contact the FDA. These products should be retained and securely stored.
To report suspect counterfeit products and other suspect unapproved products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions or other sources:
Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or
Email - DrugSupplyChainIntegrity@fda.hhs.gov
Health care professionals and consumers are asked to report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care profssionals and consumers can either:
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
FDA continues to evaluate this counterfeit medicine situation and we will provide updates.
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9.) FDA Warns About Fraudulent Tamiflu
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FDA News Release
For Immediate Release: June 17, 2010
Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Fraudulent product is dangerous to patients allergic to penicillin
The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as “Generic Tamiflu” sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.
The agency reminds patients who are allergic to or may have experienced adverse reactions from penicillin products that they are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse. To date, the FDA is not aware of any reports of adverse reactions.
There is no FDA-approved generic drug for the prescription product Tamiflu.
The FDA bought the fraudulent “Generic Tamiflu” without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however.
“A rogue Internet website marketing drug products may look like a professional and legitimate website, but may actually be an illegal operation,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”
The FDA-purchased product arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder (see photos below). The foil backing is printed, and labeled in part, “Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules” and “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD.”
Although the FDA actively monitors the Internet and when appropriate purchases and analyzes drug products, consumers who purchase drugs using an online pharmacy can protect themselves by knowing how to recognize a legitimate Internet pharmacy and how to buy medicines safely online. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations.
Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at ww
w.vipps.infoThe FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by calling 800-551-3989
ttp://www.fda.gov/OCI).Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these fraudulent products to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
Food and Drug Administration
Office of Criminal Investigations
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10.) June 3, 2011: Chinese National Sentenced to Federal Prison for Trafficking Counterfeit Pharmaceutical Weight Loss Drug
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U.S. Department of Justice Press Release

For Immediate Release
June 3, 2011
United States Attorney
District of Colorado
Contact: Jeff Dorschner
Public Affairs Officer
(303) 454-0243
DENVER - Shengyang Zhou, aka "Tom", age 31, of Kunming, Yunnan, China, was sentenced yesterday to serve 87 months (over 7 years) in federal prison for trafficking and attempting to traffic in counterfeit goods, namely counterfeit versions of the pharmaceutical weight loss drug known as Alli. The sentence was pronounced by U.S. District Judge Philip B. Brimmer. In addition, Zhou, was ordered to pay restitution totaling $504,815.39 to the victims of his crime, including an emergency room doctor from Texas who suffered a mild stroke from ingesting the counterfeit medication. Following his prison sentence Zhou will be deported. He appeared at the sentencing hearing in custody, and was remanded immediately following the hearing.
Zhou was first charged by Criminal Complaint on March 5, 2010. He was arrested based on a Criminal Complaint on March 23, 2010 in Honolulu, Hawaii. Zhou was indicted by a federal grand jury in Denver on April 22, 2010. The government sought a superseding indictment on November 17, 2010. Zhou pled guilty on January 24, 2011, and was sentenced yesterday, June 2, 2011.
According to court documents, over the course of December 2008 through March of 2009, the FDA issued a series of alerts on its website concerning tainted weight loss pills and counterfeit drugs. Initial alerts focused on "Superslim," "2 Day Diet," and Meitzitang, among other purported weight loss products believed to having been imported from China and being marketed as dietary supplements or nutritional products. The FDA stated in these initial alerts that the items posed a very serious health risk to consumers, because, based on analysis, they were found to be drugs that contained undeclared active pharmaceutical ingredients, including Sibutramine (a non-narcotic controlled substance).
The ingredient Sibutramine can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. In later alerts, FDA warned the public about counterfeit versions of the brand name drug Alli, a popular over the counter weight loss drug manufactured by GlaxoSmithKlein. The alerts indicated that these counterfeit drugs were also being imported into the United States from China and did not contain the proper active pharmaceutical ingredient for the authentic product but instead contained dangerous levels of Sibutramine. The counterfeit versions of Alli were being sold in the United States, among other ways, through internet websites, including online auction websites such as eBay.
During the course of the investigation, law enforcement agents identified Zhou as the trafficker and importer into the United States of these counterfeit and unapproved purported weight loss related drugs. Zhou also identified himself as the manufacturer of the counterfeit Alli.
Zhou's website, "xxxxxxxx" indicated that his business operated a United States branch out of Plano, Texas. Agents determined through investigation that the branch was operated by Qing Ming Hu, a naturalized United States citizen born in China. Some of the unapproved product featured in FDA public alerts was shipped to Hu for re-distribution to United States customers. Hu was also prosecuted, and received a sentence of 3 years probation.
Agents acting in an undercover capacity placed numerous orders for the counterfeit and illegal diet pills. In turn, money was wired to bank accounts. At one point, two agents flew to a third country in an undercover capacity to meet with Zhou. At that meeting they discussed in depth Zhou's manufacturing capabilities. Zhou identified himself as the manufacturer of the counterfeit Alli and promised to fix defects in the counterfeit versions of the Alli he had previously shipped, defects that had been noted by the FDA in its public alerts. During that meeting the undercover agents told Zhou that they had access to a private customs broker who would be willing to import the counterfeit Alli into the United States through air cargo shipments that would be mis-described.
As the investigation continued undercover agents and Zhou agreed to meet in Hawaii to discuss increasing the order for counterfeit Alli. At that meeting Zhou provided proof that he was capable of producing large quantities of Alli, and that he had cured certain imperfections. At the end of the meeting agents handed Zhou cash to complete the Alli order transaction. At that point, Zhou was arrested.
A number of consumers reported feeling an assortment of adverse physical effects from taking the counterfeit Alli that they had purchased from the defendant's web page or through a re-distributor. One consumer, an emergency room doctor, suffered a mild stroke after ingesting the counterfeit Alli.
"Today's sentence demonstrates what can be accomplished when the FDA Office of Criminal Investigations, ICE Homeland Security Investigations, and U.S. Postal Inspection Service combine resources to investigate and apprehend an international criminal whose actions were harming Americans," said U.S. Attorney John Walsh. "Those who rely on the Internet to obtain their prescription medication must do due diligence to ensure they are dealing with a reputable company providing the actual medicine prescribed by a physician."
"FDA's Office of Criminal Investigations, working in concert with the United States Attorney's Office and other foreign and domestic government agencies, will protect the public health by aggressively targeting those responsible for counterfeiting pharmaceutical drugs," said Patrick J. Holland, Special Agent in Charge of the FDA Office of Criminal Investigations Kansas City Field Office. "This case highlights that even when complex criminal networks engage in such illegal activities on a global scale from a foreign-based location, without regard for risk to human life, they are still held accountable for their actions in the United States. We commend the United States Attorney's Office in Colorado and our law enforcement partners for their tireless efforts in connection with the investigation and subsequent prosecution of this case."
"After working closely with our law enforcement counterparts to secure a conviction following our extensive investigation, this prison sentence sends a strong message to current and potential pharmaceutical counterfeiters of the consequences that await them," said David M. Marwell, Special Agent in Charge of ICE HSI in Denver. "This case demonstrates how our agents pooled their experience, expertise, and law enforcement authorities to shut down this criminal enterprise, and help protect the public."
"Combating the shipment of counterfeit pharmaceuticals through the U.S. Mail continues to be a priority for the United States Postal Inspection Service," said Acting Denver U.S. Postal Inspector in Charge Andrew Balkin. "When the mails are used to ship counterfeit pharmaceuticals it is a violation of Federal Law, and United States Postal Inspectors take this offense seriously. Investigation of this crime displays another successful effort to dismantle criminal enterprises involved in this type of activity."
This case was investigated by the Food and Drug Administration's Office of Criminal Investigations (FDA OCI), U.S. Immigration and Customs Enforcement (ICE), and the U.S. Postal Inspection Service.
Zhou was prosecuted by Assistant U.S. Attorney Kenneth M. Harmon, with assistance from Assistant U.S. Attorney Ryan Bergsieker.
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11.) Counterfeit Versions of Cialis tablets identified entering the United States
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Source: FDA
FDA is alerting consumers and health care professionals that counterfeit versions of Cialis 20 mg tablets were found in the mail on its way to a U.S. consumer. While this shipment was stopped, FDA is concerned about other possible mail shipments to consumers. FDA laboratory analysis showed the counterfeit versions contain multiple active ingredients, which if used could result in adverse effects or harm. Consumers should only buy prescription medicines from state-licensed pharmacies located in the U.S.
FDA cannot confirm that the manufacturing, quality, storage, and handling of these products follow U.S. standards because these products are from an unknown source. Therefore, these products are considered unsafe and should not be used.
FDA also recommends consumers talk to their health care professional about their condition and options for treatment if they received a counterfeit product.
FDA-approved Cialis tablets made by Eli Lilly contain the active ingredient, tadalafil, and are used for the treatment of erectile dysfunction and other approved indications. Currently, Eli Lilly’s authentic product is considered safe and effective for its intended uses. There is no indication that the legitimate supply chain is at risk, therefore consumers can be confident that prescription medicines received through legitimate state-licensed pharmacies located in the U.S. are safe and effective.
Counterfeit versions of Cialis can be identified by the following differences on the label of the bottle when compared to the authentic product. The label:
lists “AUSTR81137” on the front of the bottle;
does not include an NDC number on the front of the bottle, such as “NDC 0002-4462-30” for the 20 mg tablets;
does not include the tablet strength in a colored box;
has different patterns and colors; it has yellow and darker green designs on the front label;
has misspellings; it lists, “CLALIS is a product of: Eli lilly Australia PTY Limited” on the side of the bottle;
lists the manufacturer location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle; and
lists “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle.
Pictures of the bottle of counterfeit version of Cialis 20 mg TabletsCounterfeit labe of Cialis front Counterfeit Cialis label 2 Counterfeit Cialis label 3
Consumers should not use products that match one or more of the descriptions above. If you have additional information about these products, you may contact FDA at DrugSupplyChainIntegrity@fda.hhs.gov.
To date, FDA is not aware of consumer adverse events related to the use of these counterfeit versions of Cialis. Health care professionals and consumers are encouraged to report adverse events related to the use of any suspect medications to FDA’s MedWatch Adverse Event Reporting program by:
Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
Downloading and completing the form (PDF - 1.22MB), then submitting it via fax at 1-800-FDA-0178
Consumers who buy prescription medicines online should be careful. Some websites sell medicine that may not be safe to use and may put their health at risk. Go to ww.fda/gov/BeSafeRx for more information about the risks, to learn the signs of websites that may sell counterfeit or otherwise unsafe medicines, and how to find legitimate licensed online pharmacies.
FDA is committed to protecting public health by working to secure the drug supply chain against counterfeit and unapproved medications that enter the United States through fraudulent sources.
Picture of authentic bottle of Eli Lilly’s Cialis 20 mg Tablets sold in the U.S.
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12.) FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries 05/12/2016
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Source: FDA.
Comparison of the authentic BiCNU product vial to the counterfeit product vial
Authentic BiCNU Vial Counterfeit Product Vial
Authentic BiCNU Vial Counterfeit Product Vial
The authentic product has a blue flip top; the counterfeit product has a gray flip top
The NDC number on the authentic product vial should end with -31, not -41.
[05/12/2016] The FDA is informing health care professionals that a counterfeit version of the FDA approved cancer drug, BiCNU (carmustine for injection) 100 mg, has been detected in some foreign countries. There is no indication at this time that counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received counterfeit BiCNU.
The authentic product is approved to treat different types of brain cancer, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s). BiCNU is manufactured by Emcure Pharmaceuticals Ltd. and distributed in the United States by Heritage Pharmaceuticals Inc.
The FDA is advising health care professionals to carefully inspect the BiCNU vial as an added precaution to ensure the product administered to patients is authentic.
BiCNU is available as a vial of BiCNU and dehydrated alcohol co-packaged together. While the NDC on the outer package of the authentic and counterfeit versions might match, the best way to distinguish a counterfeit is to look at the BiCNU vial inside the packaging.
The product may also be counterfeit if the vial displays the following lot numbers, batch numbers, manufacturing dates, and expiration dates. Following is identifying information for the counterfeit lots that have been reported to the FDA to date:
The FDA urges health care professionals to purchase drug products only from legitimate suppliers. Health care professionals are encouraged to report sales solicitation of suspect drug products by:
Calling the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989;
Reporting to OCI; or
Emailing DrugSupplyChainIntegrity@fda.hhs.gov.
Health care professionals and patients should report adverse events related to the use of any suspect medications to the FDA’s MedWatch Adverse Event Reporting program by:
Completing and submitting the report online atwww.fda.gov/medwatch/report.htm; or
Downloading and completing the form, then submit it via fax at 1-800-FDA-0178.
The FDA is committed to protecting public health by securing the drug supply chain against counterfeit and unapproved medications that enter the United States through fraudulent sources. Visit Know Your Source: Protecting Patients from Unsafe Drugs for information about how to safely purchase prescription drugs for your patients.
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13.) Counterfeit Version of Botox Found in the United States
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Source: FDA [4-16-2015]

FDA is alerting health care practitioners and the public that a counterfeit version of Botox was found in the United States and may have been sold to doctors’ offices and medical clinics nationwide. The product was sold by an unlicensed supplier who is not authorized to ship or distribute drug products in the United States.
The counterfeit products are considered unsafe and should not be used. FDA cannot confirm that the manufacture, quality, storage, and handling of these suspect products follow U.S. standards.
There are some similarities between the counterfeit Botox products and the FDA-approved Botox for injection (100 units/vial), manufactured by Allergan. The FDA-approved Botox displays the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial. Currently, there is no indication that Allergan’s FDA-approved version is at risk, and the genuine product should be considered safe and effective for its intended and approved uses.
Both the outer carton and vial on the suspect product are counterfeit. The counterfeit product can be identified by one or more of the following:
the vial is missing the lot number
the outer carton does not have any entries next to the LOT: MFG: EXP:
the outer carton and vial display the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”
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14.) FDA warns consumers about counterfeit version of Teva’s Adderall
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FDA NEWS RELEASE
For Immediate Release: May 29, 2012
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Tablets purchased on the Internet contain wrong active ingredients
The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – a class of drugs for which special controls are required for dispensing by pharmacists.
FDA’s preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.
Currently on the FDA’s drug shortage list, Adderall is in short supply due to active pharmaceutical ingredient supply issues. Teva continues to release product as it becomes available. Consumers should be extra cautious when buying their medicines from online sources. Rogue websites and distributors may especially target medicines in short supply for counterfeiting.
The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers. Any product that resembles the tablets or the packaging in the photos below and claims to be Teva’s Adderall 30 mg tablets should be considered counterfeit. The counterfeit versions of Adderall should be considered as unsafe, ineffective and potentially harmful.
Authentic Adderall 30 mg tablets produced by Teva are round, orange/peach, and scored tablets with “dp” embossed on one side and “30” on the other side of the tablet. Teva’s Adderall 30 mg tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02 listed.
Pictures of the counterfeit version of Teva’s Adderall 30 mg tablets and packaging
Pictures of the counterfeit version of Teva’s Adderall 30 mg tablets and packaging. The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers.
Counterfeit Adderall label. There are misspellings on the package as follows: "NDS” instead of “NDC”, “Aspartrte” instead of “Aspartate”, and “Singel” instead of “Single”
The Adderall 30 mg product may be counterfeit if:
1. The product comes in a blister package.
2. There are misspellings on the package.
“NDS” instead of “NDC”
“Aspartrte” instead of “Aspartate”
“Singel” instead of “Single”
3. The tablets are white in color, round in shape, and are smooth.
4. The tablets have no markings on them.
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15.) January 21, 2011: Internet Pharmacy Sold Counterfeit Viagra, Misbranded Drugs
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Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release

For Immediate Release
January 21, 2011
United States Attorney
District of Kansas
Contact: Jim Cross
Public Affairs
(316) 269-6481
Belgian citizen pleads guilty to federal charges in Kansas
KANSAS CITY, KAN. - Manuel Calvelo, 37, a citizen of Belgium, has pleaded guilty to charges filed in U.S. District Court in Kansas alleging he operated an Internet pharmacy that sold $1.4 million worth of misbranded and counterfeit drugs as well as controlled substances, U.S. Attorney Barry Grissom said today.
Calvelo, who was arrested in Costa Rica and extradited to Kansas, pleaded guilty to one count of conspiracy to defraud the United States and one count of conspiracy to commit drug trafficking. In his plea, he admitted that from 2005 to 2008 he and another man operated Web sites offering for sale without a prescription misbranded and counterfeit drugs to customers in the United States in violation of the Federal Food, Drug and Cosmetic Act.
Calvelo's Web sites offered for sale more than 40 prescription drugs including brand names Viagra, Depakote, Glucophage, Zoloft, Lipitor, Cialis, Xanax, Ativan and Klonopin. Controlled substances for sale from the Web site included Alprazolam (sold under the brand name Xanax), Lorazapam (Ativan) and Clonazepam (Klonopin). Under federal law, the crime of misbranding includes dispensing a prescription drug without a valid prescription from a licensed practitioner.
Calvelo's Web sites included cheapestviagraworldwide.com, allcheapdrugs.com, allcheappills.com, cheapdrugspharmacy.com, allmedspharmacy.net, allnaturalpharmacy.com, horizonpharmacy.net, and trustgeneric.com.
Calvelo's Web sites accepted orders from buyers in the United States and elsewhere. He operated a customer service call center in the Philippines and issued payments to employees through wire transfers via Western Union in the Philippines, Costa Rica and the United States. He also received payments from customers via credit card processors in the Netherlands.
From early in 2007 to early in 2008, Calvelo paid a company in Overland Park, Kan., for hosting his Web sites. In 2008, he transferred the hosting of some of the Web sites to a company in Columbus, Ohio.
In 2007, an undercover agent from the Food and Drug Administration's Office of Criminal Investigations made purchases from Calvelo's Web sites. The agent later contacted Calvelo through the Costa Rica Off-Shore Business Center posing as a pharmaceutical wholesaler in the United States seeking to establish an on-line pharmacy. In conversations with the agent via video conference calls on Skype, Calvelo admitted his role in the Internet pharmacy scheme and provided details of the operation.
"Americans must have confidence that drugs introduced into and distributed throughout the United States are genuine, FDA-compliant products," said Patrick J. Holland, Special Agent in Charge of the FDA Office of Criminal Investigations. "The FDA will aggressively pursue all foreign and domestic perpetrators of illegal drug distribution schemes."
Sentencing is set for May 3. He faces a maximum penalty of five years in federal prison and a fine up to $250,000 on the fraud charge and a maximum penalty of three years and a fine up to $250,000 on the conspiracy charge. In his plea agreement, Calvelo agreed to pay a money judgment of $1.4 million. Co-defendant Jeffrey Westmoreland, 35, a citizen of Canada, is a fugitive.
Grissom commended the Food and Drug Administration's Office of Criminal Investigation, John Claud of the Justice Department's Office of Consumer Litigation and Assistant U.S. Attorney Scott Rask for their work on the case.
In all cases, defendants are presumed innocent until and unless proven guilty. The indictments filed merely contain allegations of criminal conduct.
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16.) The Possible Dangers of Buying Medicines over the Internet
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Source: FDA Updated: January 26, 2011
The Food and Drug Administration wants to warn consumers about the possible dangers of buying medicines over the Internet. Some websites sell prescription and over-the-counter drugs that may not be safe to use and could put people's health at risk.
So how can you protect yourself? FDA says that consumers should know how to recognize a legal Internet pharmacy and how to buy medicines online safely.
Don't Be Deceived
Buying prescription and over-the-counter drugs on the Internet from a company you don't know means you may not know exactly what you're getting.
There are many websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines. But there are also many “rogue websites” that offer to sell potentially dangerous drugs that have not been checked for safety or effectiveness. Though a rogue site may look professional and legitimate, it could actually be an illegal operation.
These rogue sites often sell unapproved drugs, drugs that contain the wrong active ingredient, drugs that may contain too much or too little of the active ingredient, or drugs that contain dangerous ingredients.
For example, FDA purchased and analyzed several products that were represented online as Tamiflu (oseltamivir). One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets. When analyzed by FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir.
FDA also became aware of a number of people who placed orders over the Internet for one of the following products:
Ambien (zolpidem tartrate)
Xanax (alprazolam)
Lexapro (escitalopram oxalate)
Ativan (lorazepam)
Instead of receiving the drug they ordered, several customers received products containing what was identified as foreign versions of Haldol (haloperidol), a powerful anti-psychotic drug. As a result, these customers needed emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms, and muscle stiffness—all problems that can occur with haloperidol.
Other websites sell counterfeit drugs that may look exactly like real FDA-approved medicines, but their quality and safety are unknown.
Signs of a trustworthy website
It's located in the United States.
It's licensed by the state board of pharmacy where the website is operating. A list of these boards is available at the website of the National Association of Boards of Pharmacy.
It has a licensed pharmacist available to answer your questions.
It requires a prescription for prescription medicines from your doctor or another health care professional who is licensed to prescribe medicines.
It provides contact information and allows you to talk to a person if you have problems or questions.
Another way to check on a website is to look for the National Association of Boards of Pharmacy's (NABP) Verified Internet Pharmacy Practice Sites™ Seal, also known as the VIPPS® Seal.
This seal means that the Internet pharmacy is safe to use because it has met state licensure requirements, as well as other NABP criteria. Visit the VIPPS website to find legitimate pharmacies that carry the VIPPS® seal.
Signs of an unsafe website
It sends you drugs with unknown quality or origin.
It gives you the wrong drug or another dangerous product for your illness.
It doesn't provide a way to contact the website by phone.
It offers prices that are dramatically lower than the competition.
It may offer to sell prescription drugs without a prescription—this is against the law!
It may not protect your personal information.
Know Your Medicines
Before you get any new medicine for the first time, talk to a health care professional such as your doctor or pharmacist about any special steps you need to take to fill your prescription.
Any time you get a prescription refilled
check the physical appearance of the medicine (color, texture, shape, and packaging)
check to see if it smells and tastes the same when you use it
alert your pharmacist or whoever is providing treatment to anything that is different
Be aware that some drugs sold online are too old, too strong, or too weak
aren't FDA-approved
aren't made using safe standards
aren't safe to use with other medicines or products
aren't labeled, stored, or shipped correctly may be counterfeit
Counterfeit Drugs
Counterfeit drugs are fake or copycat products that can be difficult to identify.
The deliberate and fraudulent practice of counterfeiting can apply to both brand name and generic products, where the identity of the source is often mislabeled in a way that suggests it is the authentic approved product.
Counterfeit drugs may
be contaminated
not help the condition or disease the medicine is intended to treat
lead to dangerous side effects
contain the wrong active ingredient
be made with the wrong amounts of ingredients
contain no active ingredients at all or contain too much of an active ingredient
be packaged in phony packaging that looks legitimate
For example, counterfeit versions of the FDA-approved weight loss drug Xenical, which contains the active ingredient orlistat, recently were obtained by three consumers from two different websites.
Laboratory analysis showed that the capsules that the consumers received contained the wrong active ingredient, sibutramine.
Sibutramine is the active ingredient of a different medicine called Meridia, a prescription drug also approved by FDA to help obese people lose weight and maintain weight loss. In addition, sibutramine is classified as a controlled substance by the Drug Enforcement Administration because of its potential for abuse and misuse.
Using medicine that contains an active ingredient that wasn't prescribed by your licensed health care provider may be harmful.
FDA continues to proactively protect consumers from counterfeit drugs. The agency is working with drug manufacturers, wholesalers, and retailers to identify and prevent counterfeit drugs. FDA also is exploring the use of modern technologies and other measures that will make it more difficult for counterfeit drugs to get mixed up with, or deliberately substituted for, safe and effective medicines.
For more information on this topic, visit FDA's Web page on Counterfeit Medicine.
How to Protect Yourself
Only buy from state-licensed pharmacy websites located in the U.S.
Don't buy from websites that sell prescription drugs without a prescription.
Don't buy from websites that offer to prescribe a drug for the first time without a physical exam by your doctor or by answering an online questionnaire.
Check with your state board of pharmacy or the National Association of Boards of Pharmacy to see if an online pharmacy has a valid pharmacy license and meets state quality standards.
Look for privacy and security policies that are easy to find and easy to understand.
Don't give any personal information—such as a social security number, credit card information, or medical or health history—unless you are sure the website will keep your information safe and private.
Use legitimate websites that have a licensed pharmacist to answer your question.
Make sure that the website will not sell your personal information, unless you agree.
For information on protecting yourself against a whole range of bogus health products that includes counterfeit drugs, see FDA's Consumer Update, "FDA 101: Health Fraud Awareness."
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Updated: January 26, 2011
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17.) COUNTERFEIT DRUGS
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Source: FDA
FDA continues to believe that the quality of drugs in this country is high, and that the public can continue to have confidence that the drugs sold in the U.S. market are authentic. The Agency, however, takes very seriously any allegations or information regarding the counterfeiting or adulteration of drug products. As the drug manufacturing and distribution system has become more global in nature, the challenge of protecting against counterfeit, adulterated or substandard drugs has become more difficult. We are concerned about a spate of drug counterfeiting and tampering cases that have occurred in recent months, and we believe these incidents caution against any weakening of the current regulatory system.
The manner in which FDA handles these types of counterfeit and tampering incidents are driven by two primary goals that are often, but not always, complementary. First and foremost, FDA works with consumers, manufacturers, wholesalers, distributors, state agencies and others in order to determine the composition of the unsuitable product and the extent to which it has been introduced into the distribution chain, and we use this information do whatever is necessary to protect the public health. Second, OCI, with the support and cooperation of other FDA components and other law enforcement agencies, attempts to bring the perpetrators of criminal acts to justice. It must be noted, however, that the need to publicize the existence of a counterfeit or adulterated product in order to alert professionals and the public to potential dangers may compromise the successful conduct of criminal investigations.
Regular FDA district field investigators often work closely with OCI special agents in these cases. They follow up at specific wholesalers, distributors, hospitals or pharmacies identified as having received counterfeit product to conduct tracebacks on particular lots and to determine sources, quantities involved and the distribution of product to retail outlets. The FDA's Forensic Chemistry Center (FCC) and/or the drug and biologic review divisions provide field personnel with the labeling and packaging of authentic product for comparison with counterfeit product. FDA also posts information to its MedWatch site to inform consumers and health care professionals about safety concerns related to counterfeited or tampered products.
OCI opened 55 counterfeit drug cases from October 1998 through June 2002. During that time we have made 26 arrests with 20 convictions. We have seen a gradual increase in the incidence of finished dosage form counterfeit activity over the last few years. So far this year we have 16 cases opened, 12 arrests, and seven convictions. Eight of these arrests and five convictions are attributable to the latest eight counterfeit drug appearances.
The current focus on drug counterfeiting and the public perception of a more dramatic increase in counterfeit drug activity is due to the fact that the latest several counterfeits have appeared in the wholesale market and received wider distribution than has been the case historically. This is due to the existence of an illicit wholesale drug diversion network that has grown up around tiered pricing and economic fraud.
This system consists of criminal middlemen who knowingly solicit closed door pharmacies, such as a hospital or nursing home supplier, to over-order certain drugs based on fraudulent demand. The drugs are then sold into the wholesale drug diversion network. The diverter typically offers a 25 percent kickback to the closed door pharmacy and diverts the excess drugs into the illicit wholesale diversion system. This system depends on the diverter maintaining confidentiality for the closed door pharmacy since the pharmacy would lose its preferred pricing should the manufacturer discover the fraudulent arrangement. False pedigrees are the hallmark of the system as each wholesaler passing the drugs on to the next faces being "cut out" if the subsequent buyer knows the identity of his supplier's source. It is easy to see how this system of "willful blindness" facilitates the entry of counterfeit and otherwise unsafe drugs into the marketplace. Unfortunately these illegal schemes net huge profits. From October 1998 to June 2002, OCI opened 255 Prescription Drug Marketing Act diversion cases, executing 464 arrests and resulting in 337 convictions, with fines and forfeitures totaling approximately $32 million.
The following examples of counterfeit drug products and tampering incidents may help to illustrate the types of activity we have recently encountered.
Serostim (somatropin (rDNA origin) for injection), Serono Laboratories
In late 2000 and early 2001, FDA became aware of consumer complaints about adverse effects and a recall at the distributor level of Serostim. FDA enforcement personnel and criminal investigators became involved and engaged FDA field offices nationwide, which included investigative follow-up at other distributors and the manufacturer. In January 2001, Serono issued a press release regarding the apparent counterfeiting of one particular lot. An additional press release and Dear Health Care Professional letter were issued by the company in May 2001, regarding a second lot.
In May 2002, Serono became aware that counterfeit Serostim displaying a fake lot number had been distributed. Preliminary information indicates that the counterfeit product may have been distributed via the Internet. Laboratory analysis by FDA shows that the product contains no active ingredient, and it has been determined that the product did not originate from Serono. On May 16, Serono issued a letter advising Serostim handlers to be aware of the counterfeit lot even though it has not shown up in normal distribution channels.
Neupogen (filgrastim), Amgen, Inc.
In the spring of 2001, based on observations by a distributor about product appearance, Amgen analyzed a suspect lot and determined that the vials contained only saline solution. Investigation by the company and FDA revealed that the lot did not display a legitimate Neupogen lot number, but one that had been assigned to a lot of Epogen, another Amgen product. The FCC performed additional analysis. In May 2001, Amgen issued 17,000 Dear Health Care Professional letters nationwide informing patients, physicians, pharmacies and wholesalers about the counterfeiting of Neupogen. Later that month, Amgen reported to FDA on product with four lot additional numbers having wrong expiration dates, indicating either counterfeit lot numbers or that expiration dates were changed to make them more saleable by extending dates. In June, Amgen updated its Dear Health Care Professional letter with information on additional confirmed and suspected counterfeit lots.
Epogen (epoetin alfa), Amgen, Inc.
In May 2002, FDA, state regulators and Amgen became aware that potential counterfeit Epogen may be in commerce. Amgen analysis indicated that a counterfeit product labeled as Epogen 40,000 U/ml vials with a particular lot number contained a clear liquid having active ingredient approximately 20 times lower than expected. Samples of the authentic product as well as the counterfeit product were sent to FCC for analysis. On May 8, Amgen issued a letter advising health care professionals about the counterfeit Epogen and describing the differences between authentic and counterfeit packaging so that physicians can identify the authentic product. Further investigation revealed that a major wholesale distributor was holding approximately 1,600 cartons of counterfeit product. The majority of this counterfeit product was tracked back to a wholesaler located in the western U.S. On May 24, Amgen issued a second advisory letter to warn health care professionals that two additional counterfeit lots of Epogen were discovered.
Combivir (lamivudine plus zidovudine), GlaxoSmithKline
In the spring of 2002, GlaxoSmithKline (GSK) received four complaints that bottles containing 60 tablets of Combivir were being replaced with Ziagen tablets. In addition, the firm determined that counterfeit Combivir labels were placed on authentic bottles of Ziagen tablets. Both medicines are used as part of a combination regimen to treat HIV infection. A GSK health hazard evaluation of this situation determined that if an individual takes the wrong tablet and is sensitive to abacavir sulfate (Ziagen), a potentially life threatening hypersensitivity reaction could occur. GSK has stated that the incidents appear to be isolated and limited in scope, and no injuries or adverse reactions have been reported. However, in May, distributors were advised to initiate recall to their customers. GSK also issued a press release to alert patients, pharmacists and physicians to watch for third party tampering that incorrectly labels Ziagen as Combivir.
Zyprexa (olanzapine), Eli Lilly & Co.
In the winter and spring of 2002, Eli Lilly received complaints from four pharmacies in four states that the product Zyprexa had been removed and replaced with white tablets labeled as aspirin. Zypreza is indicated for the treatment of schizophrenia and acute bipolar mania. The tampering situations occurred in two strengths and in three different lots. The company determined that the tablets from two of the complainants were non-Lilly tablets and looked the same in both complaints. FDA has determined the manufacturing source of the white tablet marked as aspirin and is continuing to investigate. On May 4, Lilly issued a press release and Dear Health Care Professional letter concerning the tampering situation. The company stated in their press release that these incidents appeared to be isolated and limited in scope.
Procrit (epoetin alfa), Amgen/Ortho Biotech
In May 2002, based on requests from state health authorities, Amgen obtained and analyzed samples of 40K vials of Procrit from a certain wholesale distributor. The analysis indicated that a counterfeit drug product labeled as Procrit 40,000 U/ml vials with a certain lot number contains a clear liquid having active ingredients approximately 20 times lower than expected. Samples of the authentic product as well as the counterfeit product were sent to FCC for further analysis. Investigators are continuing following up at wholesalers and distributors identified as receiving the counterfeit product. One major wholesale distributor was found to be holding approximately 339 cartons of counterfeit product. In June, Ortho Biotech issued a Dear Health Care Professional letter and press release which details the differences between authentic and counterfeit packaging so that physicians can be certain they have the authentic product.
In addition to the above cases, OCI has made a number of recent arrests relating to counterfeit AIDS and cancer drugs, as described below.
Serostim, (somatropin (rDNA origin) for injection), Serono Laboratories
In November 2000, Nicholas Hanson was arrested by a task force of OCI, U.S. Postal Inspection Service, and Iowa State Police on charges of conducting an ongoing criminal enterprise. Hanson was the leader of a small group that counterfeited Serostim. He imported the human growth hormone through the Internet from China, via Express Mail. At the same time, Jeremy Gansen was arrested by the same task force and charged with conducting an ongoing criminal enterprise related to the misbranding and distribution of human growth hormone and steroids. Gansen assisted Nicholas Hanson in the counterfeiting of Serostim.
Nutropin AQ (somatropin (rDNA origin) for injection), Genentech
In July 2001, an individual was arrested in Texas by OCI and subsequently indicted in August 2001 by a Federal Grand Jury. He was charged with counterfeiting Nutropin, trafficking in counterfeit goods and controlled substances violations. He subsequently plead guilty to counterfeiting Nutropin and distributing controlled substances. In December 2001, a second individual was indicted by a Federal Grand Jury in Texas for counterfeiting the above Nutropin, conspiracy to defraud the FDA, aiding and abetting and controlled substances violations. He is a fugitive and a provisional international arrest warrant is being sought for his arrest. He will be extradited to the U.S. In April 2002, two additional individuals involved in the distribution of counterfeit Nutropin were arrested by OCI and DEA for selling heroin to an undercover agent. Finally, in May 2002, a fifth individual was arrested by OCI for selling counterfeit Nutropin, and he subsequently plead guilty to the charge.
FDA remains strongly concerned about any possibility that counterfeit or otherwise unsafe drugs may find their way into the American drug supply. We will remain vigilant as we refine and improve the programs and procedures that we use to ensure the availability of safe medications for consumers. We also believe that proposals that have been put forth in Congress to allow either the reimportation of drugs by persons other than the original manufacturer, or to allow consumers to import drugs for their own personal use, will provide additional avenues for unscrupulous individuals to place counterfeit, substandard or otherwise dangerous drug products into U.S. commerce and into citizens' medicine cabinets, as discussed below.
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18.) Counterfeits of Roche's Herceptin found in EU supply chain
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Source: fiercepharma.com/
by Eric Palmer | Apr 17, 2014 7:52am

Counterfeiters and middlemen have targeted some of Roche's best selling cancer drugs in the U.S., selling fakes and unapproved foreign versions at deep discounts while still reaping substantial payoffs. Now Europe is facing the problem, with the authorities warning that vials of Roche's cancer med Herceptin that were stolen in Italy are now showing up across the continent with little or none of its active ingredient.
On Wednesday, the European Medicines Agency (EMA) issued an alert to healthcare professionals to be on the lookout for the vials, which may show signs of tampering. Herceptin maker Roche ($RHHBY) decided to recall all of the batches from which the stolen drugs came even though only a small number were thought to be affected. The EMA said none of the stolen vials have been found in hospitals, and there have been no reports that any patients have been harmed. It said some of the vials were stolen from hospitals in Italy and that authorities there are investigating. It did not indicate how much of the drug was stolen, but 9 batch numbers were listed by the agency.
So far, counterfeit Herceptin has been discovered in Britain, Finland and Germany, Roche told Reuters. The company said testing found that some of the vials, which come with falsified records, did not contain the injectable cancer drugs' active ingredient. Others had it but showed signs of tampering or dilution. "Such tampering could compromise the sterility or efficacy of the product putting the health and well-being of patients at risk," Roche said in a statement.
The faked vials are labeled as Italian Herceptin® 150 mg, according to the EMA, but batch numbers and expiry dates on most vials do not match those on the outer package. Some of the packages of powder have liquid in them, and "evidence of tampering with the rubber stoppers, crimping caps or lids" was apparent on some.
Counterfeit and unapproved drugs have become an increasing problem in the U.S. and Europe as counterfeiters begin to target higher priced and sometimes lifesaving drugs. A counterfeit version of Allergan's ($AGN) cosmetic drug Botox was found in the U.S. last year, and in 2012, the FDA found that fraudulent versions of Roche's cancer treatment Avastin had been sold to physician practices throughout the U.S. The FDA and Department of Justice have also been prosecuting a number of cases in which versions of drugs manufactured for foreign markets but unapproved in the U.S. have been sold to American physician practices--including some of Roche's cancer meds. In some cases doctors knowingly bought the unapproved products because of the deep discounts offered on them, and the feds have charged some of them.
In an effort to better protect the U.S. supply chain, Congress approved a new law last year that over time requires the creation of a national track-and-trace system. Under the new law, drugmakers are required to begin tracking prescription drug lots in 2015. Two years later, industry players must begin assigning serial numbers to individual "saleable units" of every prescription product sold in the U.S., government deadlines mandate. The EU is working on similar requirements, and drugmakers are responding. Eli Lilly ($LLY), for example, is investing $110 million into stamping unique codes and serial numbers on every drug package it sells worldwide to help protect against fakes.
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19.) Mexican authorities find vials of fake anti-cancer drug
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Source: Globalnews.ca February 2.016
By Staff The Associated Press

MEXICO CITY – Health authorities in Mexico have found five vials of a fake anti-cancer drug, supporting claims that a state government bought fake medications that contained inert substances.
The federal Health Department said the fake medication was found in the Gulf coast state of Veracruz, where the current governor has accused his predecessor in the medical scandal.
The department said Avastin had been administered to 119 patients in Veracruz between 2010 and 2016, but is unclear whether they got fake doses.
READ MORE: Justin Trudeau recognizes NB teen fighting cancer because #BeccaToldMeTo
Investigators said Friday they also found 23 tons of expired medications at state government warehouses. They also found that several firms that supplied the state government did not have offices at the addresses listed on procurement forms.
Current Gov. Miguel Angel Yunes said the scandal occurred under his predecessor, Javier Duarte.
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20.) Counterfeits Of MabThera Discovered In Germany
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Source: outsourcedpharma.com/ September 16, 2014
By Estel Grace Masangkay
Last week, counterfeit vials of Roche’s MabThera were discovered in Germany. This is the second time this year that Roche’s drugs have been targeted by counterfeiters, Reuters reports.
MabThera is an injectable biotech drug indicated as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with the drug plus chemotherapy. Also known as Rituxan, the drug is used to treat rheumatoid arthritis as well. MabThera was Roche’s highest seller last year, bringing in $7.45 billion in sales.
The company reported that the suspect drug batch was originally distributed to wholesalers in Romania. One vial was shown to have a reduced amount of MabThera’s active ingredient, while others had missing or tampered caps, missing information material, or inconsistent batch numbers. Roche stated that it was not aware of any existing link between the compromised vials found in Germany and the reported compromised and counterfeited products with Italian packaging.
It isn’t a surprise that counterfeiters would target this drug in particular, as they stand to make a solid chunk of change off of the counterfeits. According to the Wall Street Journal, a 50-milliliter vial of the drug costs roughly $1,416 in the U.K., making theft of the cancer drug a sizable moneymaking venture.
“Roche was alerted that counterfeit MabThera was detected in Germany by a German parallel importer… Once the product in question reached the wholesaler network, Roche has neither further control nor knowledge of the events that may have transpired,” Roche explained in an emailed statement.
Earlier this year, the company also reported the counterfeiting of its product Herceptin in several European countries after some drug vials were stolen in Italy.
The World Health Organization (WHO) classifies drug counterfeits in six categories: drugs without active ingredients (32.1 percent), drugs with the wrong amount of the active ingredient (20.2 percent), drugs with wrong ingredients (21.4 percent), drugs with correct amount of active ingredient but with fake packaging (15.6 percent), copies of original drugs (1 percent), and drugs with high levels of contaminants and impurities (8.5 percent). According to the Centers for Disease Control and Prevention (CDC), drug counterfeiting often takes place in countries where the rules governing drug development and production are few or sketchy. Around 10 to 30 percent of drugs sold in developing countries are considered to be counterfeit.
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21.) Counterfeit drugs: 'People are dying every day'
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Source: bbc.com
By Matthew Wall
Technology of Business editor
27 September 2016
Can a 'superpower force field' protect us from hackers?
Imagine seeing your child suffering from malaria, one of the biggest killers of children across the world. Symptoms include high fever, sweating, vomiting and convulsions.
But it's OK, you think, because you bought medicine to combat the disease from a local drugs market.
Now imagine what it must be like to see your child die nonetheless because the drugs you
bought were fake.
That is the brutal reality of the multi-billion dollar a year global trade in counterfeit drugs.
More than 120,000 people a year die in Africa as a result of fake anti-malarial drugs alone, says the World Health Organization, either because the drugs were substandard or simply contained no active ingredients at all.
Even medicines that are substandard - containing an insufficient dosage of active ingredients, say - can be deadly, leading to drug resistance, a particular issue for infectious diseases like malaria and tuberculosis.
Fake and stolen drugs are often sold openly in street markets
By some estimates, about a third of all anti-malarial drugs in sub-Saharan Africa are fake. And these fakes can find their way into pharmacies, clinics and street vendor stalls, or be sold online via thousands of unregulated websites.
But a handful of start-ups have been trying to tackle the issue using technology.
'Simple and cheap'
One tech firm, Sproxil, offers a beguilingly simply solution.
Participating drugs companies apply for scratch-panel stickers that can be attached to their packets of drugs. Customers scratch off the panel to reveal a code which they text to Sproxil. The company checks the code against its database of genuine drugs and texts back a confirmation of authenticity.
Consumers scratch off a panel to reveal a unique code, then text this to Sproxil
Buyers can also scan the barcode or simply ring a call centre staffed 24 hours a day, seven days a week to verify that the drugs are genuine. And Sproxil has introduced incentives for consumers to use the service, such as mobile phone air time rewards.
More than 70 drugs companies have signed up to the service, including multinationals such as GlaxoSmitKline and Novartis, says Sproxil spokesman Tolulope Gbamolayun, and about 28 million verifications have taken place globally since the scheme was launched in 2009.
Dr Ashifi Gogo, Sproxil CEOImage copyrightSPROXIL
Image caption
Sproxil boss Dr Ashifi Gogo believes his firm's system is saving lives
"It's a security measure that is simple and cheap," says Mr Gbamolayun.
In Africa, the scheme operates in Kenya, Ghana, Nigeria, South Africa, Tanzania, and most recently, Mali.
"But we're trying to spread our tentacles across all the countries of Africa," he says.
Catching the fraudsters
Social entrepreneur Bright Simons set up a similar "verify-by-mobile" system called mPedigree Network nearly 10 years ago.
Printed barcodes and scratch-off stickers, developed in partnership with US tech giant Hewlett-Packard, help consumers check authenticity against a central database.
"But you need to be able to track the product at each stage of its journey from the factory to the consumer," Mr Simons tells the BBC. "The consumer app was easy to develop, but the back-end was much more difficult."
Someone holding phone and packet of drugsImage copyrightMPEDIGREE
Image caption
Consumers can text a unique code to mPedigree and find out if the product is genuine
He says mPedigree's Goldkeys product helps manufacturers and regulators "monitor the entire supply chain. In Nigeria, our technology has helped regulators pinpoint where fraud is happening and catch the fraudsters."
Bespoke software helps drugs manufacturers register each packet of medicine in the factory and incorporate this data into mPedigree's database, which has now registered more than 2,000 products.
Mr Simons estimates 75 million people have benefited as a result of fake drugs being intercepted in Africa, and mPedigree now operates in 12 countries across Asia and Africa.
'Invisible printing'
The pharmaceutical industry has applied a number of other technologies to the issue, including the use of Radio Frequency Identification (RFID) tags.
"Our industry helps to prevent and detect fakes in the supply chain, namely through implementation of overt and covert technologies, including invisible printing to be applied on the actual packages, and forensic techniques such as hi-tech solutions that require laboratory testing or dedicated field test kits," says Mario Ottiglio, director of public affairs at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Big seizures of fake drugs only scratch the surface of the illegal trade
The United States Pharmacopeial Convention (USP), a body dedicated to setting drug quality standards, set up the Centre for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana.
CePAT aims to train African professionals how to screen for substandard and fake drugs, and since 2013, has helped train 190 professionals from 32 African countries, says USP chief executive Ronald Piervincenzi.
'People are dying'
But if such tech solutions are working, why are so many people still dying and suffering as a result of fake medicines?
"Most of the fake drugs are made in Asia and then imported into Africa," says Mr Simons. "The scale of the trade is huge and what we're doing is tiny compared to the size of the problem.
"And the very big multinational pharmaceutical companies have been very conservative - they've taken a long time to get on board," he says. "Tech start-ups can't solve the problem by themselves."
Bright Simons says corruption is a big problem in the fight against counterfeit drugs
Sproxil's Mr Gbamolayun agrees, saying: "We're trying to raise awareness and spread the good news to brand owners and customers around the world, but we need to educate a lot more people.
"Counterfeit drugs are still a big problem - people are dying every day."
Corruption is also to blame, says Mr Simons, with government ministers often purloining subsidised medicines and selling them privately at inflated prices, and inspectors accepting bribes to turn a blind eye to fake shipments.
"There's a black hole of accountability; we need far more transparency throughout the whole system," he says.
Some involved in the fight against counterfeit drugs have also complained about the comparatively light sentences for those prosecuted compared to the sentences given to criminals peddling narcotics.
"In countries with weak drug regulatory bodies that are poorly funded and poorly staffed, and where enforcement by the customs services and policy agencies is also weak, counterfeiters will continue to flourish and operate," warns IFPMA's Mr Ottiglio.
Technology can only do so much.
=====================================================
22.) Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient
====================================================
Source: FDA
SSUE: FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey).

BACKGROUND: Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI). Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA. Pictures of the counterfeit version of Altuzan are shown in the FDA statement. Packaging or vials found in the U.S. that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit.

RECOMMENDATION: Any medical practice that has obtained unapproved products, in particular from Richards Pharma, Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI), should stop using them and contact the FDA. The products should be retained and securely stored until further notice by the FDA.

FDA is asking the public to report suspect counterfeit products and other suspect products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, Ban Dune Marketing Inc (BDMI), or other sources:
Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or
Visit OCI’s Web site ww.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
Email - DrugSupplyChainIntegrity@fda.hhs.gov

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


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