transplantation tourism mohammed alsaghier, mbbs multiorgan transplant surgeon king fahed specialist...

Transplantation TourismTransplantation Tourism

Mohammed Alsaghier, MBBSMultiOrgan Transplant Surgeon King Fahed Specialist Hospital

Damamm , Saudi Arabia

Outline of PresentationOutline of Presentation

• Background

• Challenges for transplant on Saudi Arabia

• Transplant Tourism

• China

• Conclusions

Issues with Transplant Tourism

• Clinical / Medical

• Financial

• Ethical

• Legal

Introduction

No of Dialysis units on Saudi No of Dialysis units on Saudi ArabiaArabia

1971-20071971-2007

1993-20071993-2007 No of PatientsNo of Patients

20072007Age distribution byAge distribution by

The future patientsThe future patientsمم1995-20151995-2015

No of new patient per MillionNo of new patient per Million

الحدوث معدلمليون) لكل

نسمة (

دد الُج� مرضى عددم(2007)

السكان عددم(2006)

المنطقة

الُجنوبية1435443.810.102

الوسطى1429706.819.111

الشرقية1344663.470.525

الغربية13110017.625.261

الشمالية1212361.953.850

المُجموع1363217723.678.849

Transplant global historyTransplant global history

• Research for transplant: one hundred years ago– Alexis Carrel )Nobel Prize 1912(

• WW II, kidney transplants between identical twins

• immunosuppression– living donors

• First heart transplant )1967(– “Definition” of brain death– Growing no organs from deceased donors )DD(– Supply never meets the need )waiting lists(

• Transplantation becomes global practice• 1980s: organ trafficking and Tourism.

DECEASED DONATIONDECEASED DONATION

Deceased donorsDeceased donors

• Donor has been declared dead by two physicians independent of the transplant team

• Usually occurs only in cases of neurologically determined death

Live donorsLive donors

• to donate one or part of an organ to someone on a transplant waiting list.

DONATIONDONATION

Yearly Number of kidney transplant per million

population per year -

USA - 52 Predominantly Deceased Donors

Europe - 27 Predominantly Deceased Donors

Asia - 3 Predominantly Living Donors

WORLD STATUS OF RENAL WORLD STATUS OF RENAL TRANSPLANTSTRANSPLANTS

The deceased donors per million population per year

USA - 20.7 Europe - 15.9 Asia - 1.1 South America - 2.6

DECEASED DONOR RATESDECEASED DONOR RATES

1986-20071986-2007

1986-20071986-2007

The successful Donation from DDThe successful Donation from DD1986-20071986-2007

DD Reported 2008DD Reported 2008

االستئصال

الحاالت العائلهاالقرارالمثبته

الحاالت المبلغة

مستشفى

910252634RMC

االيمان78141023

االمير 79121317سلمان

الحرس 55131316الوطني

الُجامعة336711

العسكري00457

00235KFMC

الملك 00223فيصل

المملكة 789020825738969

الدول 1517282931األخرى

Reason for Donation Rejectionم1986-2007

• Incidence of End Stage Organ failure

• Community and professional Mind-set to Brain

Death and Donation

• Legal aspect

• Trained Donor Coordinators

COMMON PROBLEMS IN DD COMMON PROBLEMS IN DD TRANSPLANTTRANSPLANT

• Public awarness

• Reporting of Brain Death

• Hospitals Donation system .

• Religion , Society and Organ Donation

COMMON PROBLEMS IN DDCOMMON PROBLEMS IN DD

System Funding for Donor program

Hospitals work to identify & maintain “Brain Dead” donors

Community Awareness of “Brain- Death” Concept

For cadaveric donation,

‘ ‘ Society acceptance remains a crucial in a transplant program’Society acceptance remains a crucial in a transplant program’

PROBLEMS WITH DD TransplantPROBLEMS WITH DD Transplant

Transport of organs –between cities

Transport of organs –between cities

Adequate No. of Intensivists in ICUs

Adequate No. of Intensivists in ICUs

Well qualified Surgeons to undertake Retrieval & TX

Well qualified Surgeons to undertake Retrieval & TX

HLA Tissue typing and Cross-matchHLA Tissue typing and Cross-match

Trained transplant

Co-coordinators

Trained transplant

Co-coordinators

Support Organization to SCOT

Support Organization to SCOT

Hospitals Donation SystemHospitals Donation System

ا;حي;ا... نما ك;ا; ف; ا;حياها م;َن; وجميعا? ... الناس;

And he who saves a man’s life shall be considered as one who has saved the life of mankind as a

whole

Transplantation TourismTransplantation Tourism

IssuesIssuesA. Living donors

A. Autonomy vs. nonmaleficence B. Risks to Donor ( “benefit”)

B. Deceased donorsA. Brain death (accuracy; conflict of interests)B. Consent?

C. Waiting listsA. Allocation (medical vs. social)B. “Shortage”

D. CommercialismA. Autonomy vs. desperate “donors” )B. Transplant tourism ( “ deal” including donor, at “bargain”

)

Japan - 12,974

Taiwan - 7000

Saudi Arabia - 4248

Korea - 4000

Pakistan - 1650

Hong Kong - 1018

Singapore - 666

Bangladesh - 125

Waiting Time

Taiwan – 1.9 yrs

Korea – 2.2 yrs

Hong Kong – 4.3 yrs

Singapore – 5.8 yrs

No Waiting list in Iran for No Waiting list in Iran for

Kidney Tx.Kidney Tx.

KIDNEY TX WAITING LIST IN ASIA (2002)KIDNEY TX WAITING LIST IN ASIA (2002)

Waiting List #’s# of donors per population

AustraliaAustralia1,76410 per 1,000,000

CanadaCanada3,99013.5 per 1,000,000

United United StatesStates

75,00034.3 per 1,000,000

KIDNEY TX WAITING LIST IN THE KIDNEY TX WAITING LIST IN THE WORLD (2002)WORLD (2002)

Five organ trafficking hotpots identified by Five organ trafficking hotpots identified by the WHOthe WHO

CHINAPAKISTAN

EGYPTCOLOMBIA

PHILIPPINES

2007Sources: Reuters, World Health Organization

Clinical Outcomes for Saudi Patients Clinical Outcomes for Saudi Patients Receiving Deceased Donor Liver Receiving Deceased Donor Liver

Transplantation in ChinaTransplantation in China

2King Faisal Specialist Hospital & Research Center – Saudi Arabia

• consequent increase in the number of patients seeking transplant abroad especially in China.

• Attracting factors in China:• easy accessibility.

• relatively low cost,

• relatively short waiting time.

• lax transplantation indications.

Despite these attractive factors, the main Despite these attractive factors, the main growing concern with this choice is the growing concern with this choice is the

uncertaintyuncertainty regarding the outcomeregarding the outcome …… ……

• Seventy-four adult patients (60 males & 14 females).• Mean age: 54.7 years.• Nationality: Nationality: Forty-six Saudi nationals; 28 Egyptians.• Average MELD score: 17.• In 5 patients (6.8%) MELD score > 25.• Indications for liver transplantation:Indications for liver transplantation:

• hepatitis C related decompensated cirrhosis (n=29). • hepatocellular carcinoma (n=24).• hepatitis B (n=14). • cryptogenic cirrhosis (n=6).• primary biliary cirrhosis (n=1).

• Median period between contacting centre & travel: Median period between contacting centre & travel:

• 4 weeks (2-16w).

RESULTSRESULTS

• 41 patients (55%) had been denied live transplantation in KSA or in Egypt.

• Reasons for rejection of transplantation:

• unsuitable medical condition due to multiple co-morbidities (n=23), • age >65 (n=13), • advanced hepatocellular carcinoma (n=5). • three patients: tumor size > Milan and UCSF criteria; • one: invasion of the right branch of the portal vein; • one: invasion of the main portal vein.

Reports from ChinaReports from China

● In-China waiting period: In-China waiting period: 5-20 days (median14 days).

● Donors’ data: Donors’ data: Only the age of the donor (range 20-35 years, median 25 years) & the cause of death (severe brain injury in all cases) were provided.

● Operative details: Operative details: missing or incomplete.

● Early post-operative morbidity: Early post-operative morbidity: Complications were rarely described in detail.

● Mortality: Mortality: Two patients died in China, due to unknown cause.

Follow up after return from ChinaFollow up after return from China

● Follow up care for a median of 13 months (2-60 months).

ComplicationsComplications

Biliary complicationsBiliary complications

• Diffuse biliary stricture: Diffuse biliary stricture: 14 (18.9%)

• Six died.

• The rest required repeated interventions (ERCP, PTC).

• Two required surgery and one required retransplantation.

• Anastomotic stricture: Anastomotic stricture: 6 (8.1%)

• BileBile leakage:leakage: 4 (5.4%)

Biliary ComplicationsBiliary Complications

MortalityMortality

● Two patients died in China very early after surgery.

● Sixteen died during follow up:Sixteen died during follow up:

• biliary complications resulting in either sepsis or poor graft function (10 patients).

• recurrent metastatic HCC (3 patients).

• poor graft function due to portal vein thrombosis (1 patient).

• GVHD (1 patient).

• fibrosing cholestatic hepatitis (1 patient).

• Age above sixty-five: Age above sixty-five: reviserevise• Eight died in the first year post-transplant, • Two had portal vein thrombosis, one had biliary

stricture, five required repeated admissions to the hospital during the first year, and three suffered from severe infections.

1)1) Rejected due to advanced HCCRejected due to advanced HCC • Four died in the 1st year post transplant, three of

whom suffered from brain or lung metastasis. • One died after two months of severe pneumonia

and sepsis.

Outcome of patients rejected for Tx Outcome of patients rejected for Tx in KSAin KSA

Comparison of Outcome with patients at Comparison of Outcome with patients at KFSHKFSH

China

)n=74(

KFSH & RC

)n=120(

P-value

Age54.7 )10.0( 42.1)14.4( <0.01

MELD score 17 )13- 23( 19)15-26( >0.01

HCC > Milan criteria

5 )6.76%( 0)0( <0.001

Patient Survival ratePatient Survival rateSurvival Functions

Survival ( Days )

Country

Saudi ArabiaChina

1.00 - Censored

2.00 - Censored

Cu

m S

urvi

val

0 500 1000 1500 2000

1.0

0.8

0.6

0.4

0.2

0.0

Graft Survival rateGraft Survival rate

1 - Censored2 - Censored

1.0

0.8

0.6

0.4

0.2

0.0

Cu

m S

urvi

val

Survival Functions

0 500 1000 1500 20000 500 1000 1500 2000

Survival ( Days )

12

Country

Incidence of ComplicationsIncidence of Complications

ChinaChinaKFSH & RCKFSH & RCP-value

Biliary complications20 (27%)13(10.8%)<0.01

Vascular complications

3 (4.1%) 5(4.2%) >0.05

Sepsis7 (9.5%)1(1.0%)<0.01

Acquired HBV infection

4 (5.4%) 0 (0) <0.05

Metastasis3(4.0%) 0 (0) <0.05

Requirement for surgery

16 (21.6%) 12 (10%) <0.05

Medical CareMedical Care

• Postoperative interventions.

• Frequent hospital admissions.

• Frequent Visits to day medical unit.

• Frequent Visits to the ER.

• Frequent Laboratory investigations.

Burden on the Hospital resources.

• The results in this study may not represent the actual survival data of the Chinese centers.

• Indeed, the presented data from China are only of the patients who are followed up in our center, and do not include those who may have had early death or complications, those who are followed elsewhere, and all other non-Saudi & non-Egyptian patients not known to us.

Renal Transplant – Favorable OutcomesRenal Transplant – Favorable Outcomes

• Sever MS et al 1997 540 Saudi patients transplanted in India

• 96% graft survival• 89% patient survival • Similar results to those transplanted in Saudi Arabia

Pediatr Nephrol. 2006

• Morad et al 2000 515 Malaysian patients transplanted in China or India

• >90% graft and patient survival» Transplant Proc. 2000 Nov

Renal Transplant - Inferior OutcomesRenal Transplant - Inferior Outcomes

• Kennedy et al 2005 16 Australian patients

• 66% graft survival • 85% patient survival

• Sever et al 2001 Turkish patients

• 84% graft survival• patient survival similar to locally

transplanted patients

Compared to Canadian TransplantsCompared to Canadian Transplants.….…

• Inferior graft survival at 3 years 98% biologically related donors 86% emotionally related donors 62% transplanted abroad

• Patient survival at 3 years 100% for those transplanted in Canada 82% for transplant tourists

Iran factsIran facts::

One, and five survival rate is reported to be 92.8%,

83.7% respectively.

Iran is the only country with no waiting list for

kidney transplant and patients can receive the

necessary organ in less than 2 months.

Transplant outcomesTransplant outcomes• Outcomes of United States Residents who Undergo

Kidney Transplantation Overseas: Canales et al, Transplant Tourism 10 kidney transplant patients (Sept 02 – July 06)

• Transplanted in Pakistan (8), China (1), Iran (1)• Mean age: 36.8 years• Follow-up period: 0.4-3.7 years (mean 2.0)• 6 serious post op (in 3 months) infections in 4 patients• 1 death• 1 graft failure due to acute rejection• Graft survival and function – generally good• High incidence of post transplant infection• Inadequate communication of information – immunosuppressive

regimens and perioperative information

Kidney Transplants - IndiaKidney Transplants - India

• 150,000 Indians need transplants annually Only 3,500 actually performed

• Sale of organs illegal -

• Criminal act for foreigners to go to India to obtain transplants

SurgeryUSA USDIndia USD

BMTx400,00030,000

Liver Tx500,00040,000

CABG50,0005,000

Neuro-surgery29,0008,000

Knee surgery16,0004,500

Stem Cell Transplants - ChinaStem Cell Transplants - China

• Parkinsons: Human retinal epithelial cells from adults No immunosuppression required Cells injected stereotactically into putamen Daily cocktail of drugs to ‘fertilize the area’

• Stem cell activation and proliferation treatment (to enhance the body’s own neural stem cells)

~20 patients treated No published RCTs

Stem Cell Transplants - ChinaStem Cell Transplants - China

• Stroke ‘self stem cell activation and proliferation’ 50 patients treated Minor to significant improvements

• Cerebral plasy, Degenerative neurologic disorders, Epilepsy, Brain infections Neural (fetal) stem cells Bone marrow stem cells (autologous) Both types of cells delivered by lumbar puncture – cells are

said to flow through the CSF into the brain

Ethical issues – transplant tourismEthical issues – transplant tourism

• Source of transplanted organs Potential for coerced organ ‘donation’ Involuntary donations – executed prisoners,

kidnapping ??

• Transplant flow…. South to north Female to male Inter ethnic Poor to financially secure

• Association with organized crime India, Brazil and other areas

WHOWHO• World Health Organization• 1987: concern over commercial trade (WHA)

reports about brokers Benefits???

• 1989: Initiative for standards needed (WHA) International interest

• 1991: WHO Principles (WHA)

• 2004: Assemble more data (WHA) 2003: worldwide discussion on transplantation (Madrid) 2004-2006: meetings on cells, tissues, organs 2006: comprehensive awareness on Transplantation 2007: overall Observations (Spanish Ministry of Health) 2007: Second worldwide conference (Geneva)

WHOWHO• 1991: Principles

• International standards Deceased donors preferred Related donors preferred No commercial transactions in human body ,prohibition on

advertising. Fair access to donated organs ( economic)

• 2008: In revising Principles? Preference for deceased tempered by practice changes wider door for unrelated Commercial ban maintained, “incentives” acceptable? (real vs. subtle) Actions translucent & scrutinize; confidentiality secured. Quality for donors & Tx recipient.

Policies

• 50+ countries adopted laws giving effect to norms in 1991 Guiding Principles

• China: law adopted in 2006 sets standards license of transplant facilities (many closed) Bans profitable dealings. Establish criterions for deceased donor and allocation

of organs End using organs from executed prisoners

• Pakistan: law adopted in 2007 ban “transplant tourism”

Organ Shortage is a CrisisIn the gulf we need to Network and start thinking of sharing resources, expertise and organs • Set up Collaborative project• Use Media for advertising• Get Islamic scholars to contribute on Organ promotion.• Set up regional Transplant coordinators Forums

Cadaver Transplant - ConclusionCadaver Transplant - Conclusion

• Our data clearly show that Saudi patients who received transplants in China exhibited high mortality and morbidity rates.

• This result could be attributed to poor selection criteria, long warm ischemia time, and a question of suboptimal post-transplant care.

• Patients and clinicians need be aware of the outcome and its implications.

• Furthermore, patients should be enlightened about these risks as well.

CHINA CONCLUSIONCHINA CONCLUSION

In Gulf countries we need successful donor programs that look at all the options

On a straightforward steps and changes we can make all the distinction for our patients

DD Transplant - ConclusionDD Transplant - Conclusion

Bottom lineBottom line

• Transplant tourism is a reality… and a growth is expected

• Both risks and benefits exist

• Difficult to determine the extent of risks

• Quality of care is variable Gulf countries be aware

• Many ethical issues

THANK YOUTHANK YOU