pharmaceutical crime › documents › organized-crime › fm › roy... · 2013-02-19 ·...
TRANSCRIPT
![Page 1: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/1.jpg)
Pharmaceutical Crime
Federal Agency for Medicines and Health Products
Agence fédérale des médicaments et des produits de santé
Federaal agentschap voor geneesmiddelen en
gezondheidsproducten
UNODC Conference on Fraudulent Medicines, Vienna 14-15 february 2013
Roy Vancauwenberghe Head of Special Investigation Unit 0475/45.64.76
![Page 2: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/2.jpg)
![Page 3: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/3.jpg)
1) Narcotic & Psychotropic medicinal products
3) Veterinary related crime
5) (Adulterated) food supplements
7) Unlicensed Medicines
9) Doping (H & V)
11) Counterfeit & IPR related problems
13) Forgery (adulteration, tampering, falsification)
14) Theft
2) Internet
4) Diversion
6) Authorizations
8) Import, Export, Transit
10) Mailorder, Courier
12) GMP-GDP-GCP-GVP
Pharmaceutical Crime Crime phenomena Mechanisms
![Page 4: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/4.jpg)
Presented as
FOOD SUPPLEMENTS
which are
MEDICINES
(with labeled APIs)
Federal Agency for Medicines and Health Products
![Page 5: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/5.jpg)
Ebonosarm known as Ostarine
Investigational Selective Androgen Receptor Modulator (SARM)
![Page 6: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/6.jpg)
Bioactive GHRP-2 ester Z11(oral suspension)
![Page 7: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/7.jpg)
![Page 8: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/8.jpg)
Presented as veterinarian supplement for
humans containing prohormones
mimicing Zambon anabolics (winstrol)
Pharmaceutical Name
(cyclostanozol™ ) 360mg/capsule - 60 capsules/bottle
Effective Dose
( Orals: 2 - 8 tabs/day)
Price
( Orals:$79.95 - 60 tab bottle )
Cycle Info
Effectively Stacked with D-bol during bulking cycles to reduce water
retention and increase strength and energy levels. Also used
individually to help promote lean, hard, and ripped muscle mass.
![Page 9: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/9.jpg)
9
Anti-estrogen + DHEA
![Page 10: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/10.jpg)
FOOD SUPPLEMENTS
which are
MEDICINES
(with non labeled &
modified APIs)
Federal Agency for Medicines and Health Products
![Page 11: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/11.jpg)
Food Supplement
Phyto product
falsified with (acetildenafil)
www: therapeutic claims
![Page 12: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/12.jpg)
12
![Page 13: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/13.jpg)
13
Falsified with SIBUTRAMIN
![Page 14: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/14.jpg)
14
Adulterants found Problems caused
aminopyrine agranulocytosis
caffeine arrhythmia
chlorzoxazone coma
clobetasol proprionate Cushing's syndrome
diazepam diabetes
diclofenac increased INR
dexamethasone hypertension
ethoxybenzamide hypoglycaemia
fluoconolone acetonide gastrointestinal bleeding
glibenclamide septic shock
hydrochlorothiazide
hydrocortisone
indomethacin
mefenamic acid
methylsalicylate
paracetamol (acetaminophen)
phenacetin
phenytoin
prednisolone
sildenafil
Table 1: A list of adulterants found in Chinese herbal medicines, and problems caused by adulterants
(note that problems and adulterants are not linked in these lists)
http://www.medicine.ox.ac.uk/bandolier/band104/b104-8.html
![Page 15: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/15.jpg)
Counterfeit
Medical Products falsified
in relation to
identity, history or source
Federal Agency for Medicines and Health Products
![Page 16: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/16.jpg)
Falsified
Anti-malarial
AUTHENTIC FAKE
![Page 17: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/17.jpg)
Falsified veterinarian medicines
![Page 18: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/18.jpg)
18 Source: FDA
![Page 19: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/19.jpg)
19 Source: FDA
![Page 20: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/20.jpg)
![Page 21: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/21.jpg)
Destroying Nigerian pharma industry !!
530.000 Tablets
![Page 22: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/22.jpg)
![Page 23: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/23.jpg)
23
![Page 24: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/24.jpg)
24
![Page 25: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/25.jpg)
25
![Page 26: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/26.jpg)
Source: EDQM / OMCL / AGES
NO API !!
![Page 27: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/27.jpg)
Falsified Novo Nordisk Norditropin SimpleXx
Illegal market
Sterility test: Paenibacillus messiliensis
source: AEMPS Spain
![Page 28: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/28.jpg)
MELANOTAN II
"Barbie drug" : Tanning & Aphrodisiac
MSH (Melanocyte Stimulating
Hormone) 1000 x more potent than
natural alpha-MSH.
May cause skin cancer and
damage immune and
cardiovascular systems
![Page 29: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/29.jpg)
Shipped from China as MT2 (Melanotan)
contains
porcine insulin (2012).
![Page 30: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/30.jpg)
Tβ4, a unique polypeptide of 43 amino acids
most potent Drug Free performance substance to the animal racing world
![Page 31: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/31.jpg)
TB-500 is a synthetic version of the naturally occurring peptide present in virtually all
human and animal cells, Thymosin Beta 4 (TB500). It is a first-in-class drug candidate
that promotes the following:
Endothelial (blood vessels) cell differentiation
Angiogenesis (growth of new blood cells from pre-existing vessels) in dermal tissues
Keratinocyte migration
Collagen deposition; and
Decreases inflammation.
![Page 32: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/32.jpg)
illegal medicines
(without Marketing
Authorization)
Federal Agency for Medicines and Health Products
![Page 33: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/33.jpg)
GRF (1-29) or sermorelin CJC1295 =
Research peptides
Canadian ConjuChem clinical trials mid 2000s
Treatment of obesitas in AIDS patients
Myocard infarct cases
![Page 34: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/34.jpg)
34
![Page 35: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/35.jpg)
35
![Page 36: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/36.jpg)
10.000 vials anabolic steroids from Egypt March 2009
![Page 37: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/37.jpg)
37
![Page 38: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/38.jpg)
Flaraxin is effective in 90% of oncologic diseases, it is a non-toxic anti-tumoral phytopreparation, Interferonogene, stimulating
tumoral necrosis factor, destroys tumoral tissue. Immunmodulator and antioxidant. Prevents metastatic spreading and relapse.
Flaraxin has no side effects unless the patient has a allergy on Iodine.
Clinical Research of the preparation “Flaraxin” was carried out in oncology department of Kiev medical institute in the period from
September 1990 to January 1991 and In Kiev Oncology SRI under oncologic process in the stage of neglect desolation in
patients with melanoblastoma in the period from December 1992 to October 1993 by the surgical oncologists Kulik Ivan
Anisimovich.
FLARAXIN
![Page 39: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/39.jpg)
39
![Page 40: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/40.jpg)
Falsified
Medical Devices
![Page 41: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/41.jpg)
![Page 42: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/42.jpg)
![Page 43: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/43.jpg)
UN Convention against Transnational
Organized Crime
Organized criminal group (3 or > persons)
Serious crime (>4 years of prison)
Structured group (not randomly formed..)
=>The Medicrime Convention of the CoE
Federal Agency for Medicines and Health Products
![Page 44: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/44.jpg)
Definitions (confusion)
Counterfeit Medicines (WHO & CoE)
Falsified Medicines (EU)
Fraudulent Medicines (UNODC)
Federal Agency for Medicines and Health Products
![Page 45: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/45.jpg)
Key messages:
1) involve the regulatory
2) laboratory analysis (OMCLs!)
3) sensibilisation campaigns
4) multidisciplinary & multisectoral (transborder) collaboration
(DRA-Police-Customs)
5) legislation (definitions) & enforcement
MEDICRIME CONVENTION
(Council of Europe)
![Page 46: Pharmaceutical Crime › documents › organized-crime › FM › Roy... · 2013-02-19 · Effective Dose ( Orals: 2 - 8 tabs/day) Price ( Orals:$79.95 - 60 tab bottle ) Cycle Info](https://reader030.vdocuments.us/reader030/viewer/2022041115/5f26b2846228e07fd86be356/html5/thumbnails/46.jpg)
THANK YOU
Roy Vancauwenberghe Senior Pharmacist Inspector
Head of Special Investigation Unit
e-mail: [email protected]
mobile: +32 (0) 475 45 64 76
office: +32 (0) 2 524 82 81
fax: +32 (0) 2 524 80 01
Federal Agency for Medicines and Health Products