FROM TUSKEGEE TO HELA

TO EBOLA: ISSUES FACING

SMU
HEALTH PROVIDERS & Community

CONSUMERS Reads
2014-15

DECEMBER 3, 2014
RICHARD ROCCO, PHD
MARJORIE HAMMER, MSN, FNP
 AGENDA

ETHICS: The 4 Principles

 Autonomy
 Non Maleficence
 Beneficence
 Justice
HISTORICAL BACKGROUND: The 4 Principles
 1947 Nuremberg Code
 1930-1970 Tuskegee & Guatamala Studies
 1951 HeLa Cells, Johns Hopkins
 1990s Lead Study, Johns Hopkins
 2013 Human Genome
 2014 Ebola
 D I S C U S S I O N : Issues facing health providers & consumers: What
would YOU do?
 ETHICS: THE 4 PRINCIPLES

Autonomy
Non Maleficence
Beneficence
Justice
 HISTORICAL BACKGROUND:
1947 NUREMBERG TRIBUNAL

TEN POINT CODE OF ETHICS = THE

NUREMBERG CODE
Ethical standards to govern human
experimentation worldwide
Recommendations; not a law!
Emerged as result of Nazi experiments
7 Nazi doctors sentenced to death for
research on Jews without consent
 NUREMBERG CODE

Requires patient consent

But in early 1950’s:

 Not formally taught in medical schools
 No formal research oversight in U.S.

U.S. physicians & researchers resisted proposed laws to regulate

human experimentation:
 interfere with scientific progress.
 @ one trial, lawyer’s argument: “If the whole profession is doing it, how can you
call it ‘unprofessional behavior’?”

S k l o o t , R . ( 2 0 1 0 ) . I m m o r t a l C e l l s o f H e n r i et t a L a c k s , C h a p . 1 7
 TUSKEGEE STUDY:
PHOTO BY U.S. PUBLIC HEALTH SERVICE
 HISTORICAL BACKGROUND:
1930-70 TUSKEGEE SYPHILIS STUDY
 Tuskegee Syphilis Study re: natural history of syphilis
 Tuskegee Institute & US Public Health Service
 Study was proposed to last 6 months; lasted 40 years
 399 African American men infected w syphilis; 200 not infected (most
AA’s did not have health insurance @ that time)
 Provided free health exams, food & transportation
 Investigated the course of untreated syphilis
 Is the natural history of syphilis different in AA?
 None who had syphilis were told they had it
 None who had syphilis were given sufficient treatment
 They were told they were being treated for “bad blood”.
 1933 Spinal taps to diagnose neurological syphilis
 1943: Public Health Service treats patients w syphilis w
penicillin; Tuskegee patients NOT treated.
 TUSKEGEE

1960’s: Cash payments $1-$2 to encourage ongoing participat ion


1961: 12 th r ep or t on t h e st udy issu ed: T he Tuskeg e e Stud y of

Untreated Syphilis: The 30 th Year of Obser vation.
1969: CDC convenes p anel to review eth ics of t he study. Panel vo tes t o

co ntinue.
1972: Ended wh en Pub lic H ealt h Service employee told repo rt er

By 1972:

128 men had died of syphilis or its complications
40 wives contracted syphilis; 19 children were born with it.
1974: Settlement

Each living syphilis subject receives $37,500;
heirs of each deceased subject with syphilis awarded $15,000;
each living control is granted $16,000, and
each deceased control is rewarded $5,000: 6,000 people will receive some compensation.
1997 President Clint on makes public apology

http://www.examiningtuskegee.com/
Reverby, S. (2010). Invoking "Tuskegee": Problems in Health Disparities, Genetic Assumptions, and History
Journal of Health Care for the Poor and Underserved, Vol. 21 (Supplement 2010): 26-34.
 U.S. PUBLIC HEALTH SERVICE IN
GUATAMALA
 1940s: Study of Penicillin r/t sexually transmitted diseases:
 696 Guatemalans (prisoners, military, mental patients) were infected
w STI’s (772 exposed to gonorrhea)
 Study exposed by Susan Reverby, 2010
 "The doctors used prostitutes with the disease to pass it to
the prisoners (sexual visits were allowed by law in
Guatemalan prisons) and then did direct inoculations made
from syphilis bacteria poured onto the men's penises or on
forearms and faces that were slightly abraded when the
'normal exposure' produced little disease, or in a few cases
through spinal punctures," Reverby wrote.
http://www.cnn.com/2010/HEALTH/10/01/guatemala.syphilis
.tuskegee/
 JOHNS HOPKINS: HELA & LEAD

 Fears in U.S. Black community re: medical research

 1873: Johns Hopkins, wealthy businessman and banker,
donated $7 million to start a medical school & charity
hospital to serve “the indigent sick of this city… without
regard to sex, age or color…, without charge.” (Skloot, 166-7)
 1908: Johns Hopkins founded in poor Black neighborhood of
Baltimore:
 to serve the poor? or
 to have ready access to research subjects?
 1952 Henrietta Lacks
 1969 Lead study
 HISTORICAL BACKGROUND:
THE HELA CELLS
 1951 George Gay cultures first immortal human cell line from Henrietta
Lacks’ cervix: Named HeLa.
 1951 Henrietta Lacks dies of aggressive cervical cancer.
 1951 HeLa cells: first living cells shipped by postal service.
 1952 Tuskegee Institute opens the first “HeLa Factory”: Nonprofit; supplies
cells to researchers
 ~1952 Microbiological Associates: sells HeLa cells for a profit.
 1952 HeLa cells: used to help develop polio vaccine.
 1953 HeLa cells: first cells ever cloned.
 1954 Chester Southam, Sloan-Kettering Institute cancer researcher & chief
of virology, injects HeLa cells in Ohio prisoners without patient consent to
see if injection causes cancer.
 1957 First appearance of legal term “informed consent”.
 1960 HeLa cells: launched into space to see effect of zero gravity on
human cancer vs noncancerous cells.
 HELA CELLS

 1965 First animal-human hybrid: HeLa cells fused w mouse

cells. (precurser to human genome map)
 1965 Board of Regents SUNY finds Southam guilty of
unprofessional conduct and calls for stricter guidelines re:
human research subjects & informed consent. (Southam then
elected president American Assoc for Cancer Research.)
1966 NIH requires approval by IRBs for any research NIH
f u n d s ; 1971 Detailed definition of informed consent.
 1970 George Gay dies; 1971 As tribute to Gay, Henrietta
Lacks ID’d as source of HeLa cells.
 1973 Lacks family learns that HeLa cells are alive.
 1973 Johns Hopkins takes blood samples from Lacks’
children without informed consent to further HeLa research
 HELA CELLS

1974 The Federal Policy for the Protection of Human Subjects

requires informed consent for any human subject research.
 1975 Rolling Stone article re: HeLa. The Lacks family learns that the
cells have been commercialized.
1978 California Protection of Human Subjects in Medical
Experimentation Act
 1985 Portions of Henrietta Lacks’ medical records are published
without family’s knowledge or consent.
 1984- 1991 John Moore sues UC for property rights re: his tissues,
and loses, then wins, then loses: California Supreme Court says once
tissues leave the body, with or without consent, a person no longer
owns these tissues.
 1984 HeLa cells help discover that HPV causes cancer.
 1986 HeLa cells infected w HIV for HIV research.
 1993 HeLa cells used for study of TB.
HELA’S JOURNEY CONTINUES
 HISTORICAL BACKGROUND:
1990S LEAD STUDY, JOHNS HOPKINS
 1969 Hopkins’ researcher uses blood samples from >7,000 neighborhood children
from mostly Black poor families to look for a genetic predisposition to criminal
behavior – without consent.
 1 9 9 0 s Ken n e d y & K r i e g e r S t u d y of lead abatement methods:
 All families involved were Black.
 Treated homes differently for lead abatement.
 Encouraged landlords to rent to families with children so could monitor lead levels.
 Moms sued: children exposed to lead without informed consent; & not informed when
blood test revealed elevated lead levels.
 “ W h e n M a x wa s t e st e d s ix m o n t h s l a t e r , h i s b l o o d l ea d h a d n e a r l y q u a d r u p l e d ,
t o a l e v el k no wn t o c a u s e p e r m a n e n t b r a i n d a m a g e . ”
 “ B y t h e fo llo win g S e p t e m b e r , D e n i sa ’ s b l o o d l e a d l e v el h a d m o r e th a n t r i p l e d
a n d w a s no w six t im e s hig h e r t h a n t h a t c u r r e n t l y c o n si d e r e d sa f e b y t h e C e n te r s
f o r D i se a se C o nt ro l .

F r o m M a r k o w i t z & R o s n e r ( 2 0 1 3 ) . L e a d War s : T h e P o l i t i c s o f S c i e n c e & t h e F a t e o f

America’s Children.University of Califonia Press. http
://www.nybooks.com/articles/archives/2013/mar/21/lead-poisoning-ignored-scandal/
 POSITION PAPER ON
KENNEDY KRIEGER LEAD STUDY
This required, that the participants and their families maintain or obtain housing with
l e a d b a s e d p a i n t i n t h e h o m e w i t h t h e a s s u m p t i o n a s s t a te d , t h a t t h e c h i l d r e n wo u l d b e
e xp o s e d t o l e a d d u r i n g t h e s t u d y.

T h e s t u d y i t s e l f by d e s i g n p u r p o s e l y r e c r u i te d o r a l l o we d t h e p a r t i c i p a n t s to c o n t i n u e
to b e e xp o s e d to toxi n s w i t h o u t p r o vi d i n g a m e a n s f o r t h e m to s e e k c a r e to r e ve r s e t h e
damages.

I n c o n c l u s i o n , A B Ps i a g r e e s w i t h Ju d g e C a t h e l l o f t h e C o u r t o f A p p e a l s o f M a r y l a n d ,
t h a t t h i s w a s a n a t r o c i o u s a c t a g a i n s t t h e A f r i ca n A m e r i c a n p a r t i c i p a n t s o f t h i s s t u d y.
T h e v e r y r i g h t to p re s e r v e a n d p r o te c t o n e ’ s o w n l i f e a n d h e a l t h w a s c o m p r o m i s e d
a g a i n s t t h e w i l l a n d k n o wl e d g e o f t h e p a r t i c i p a n t s o f t h i s e x p e r i m e n t , w h i c h i s n o t j u s t
a crime against American citizens, but in a much greater sense according to the
N u r e m b e r g C o d e , a c r i m e a g a i n s t H u m a n i t y.

From Do No Harm: Association of Black Psychologists’ Commentary on Kennedy Krieger’s R & M Research Study
h t t p : / / w w w . a b p s i . o r g / p d f / 2 0 1 1 t h e r m s t u d y . p d f
 HISTORICAL BACKGROUND:
HELA & GENE MAPPING

 1973 First International Workshop on Human Gene Mapping (Yale)

 Addressed issue re: cell lines used for research were contaminated w HeLa
cells.
 Wanted Lacks’ family DNA samples to create a map of Henrietta’s genes.
 Scientist present at the meeting stated the family were still patients at
Hopkins and he had access to their records/contacts. (Skloot, Ch 23).
 Family members contacted to obtain DNA samples:
 Family member: “Part of your mother is alive!”
 Researchers: “”We never gave a consent form because you just go to draw
blood. We are not doing some kind of medical research, you know…. All we
wanted is a few tubes of blood and to do genetic marker test. It’s not
involved in a human research committee or things like that.” (183).
 & INTO THE 21 S T CENTURY…

1 9 9 6 H I P P A : H e a l t h I n s u r a n c e P o r t a b i l i t y a n d A c c e s s i b i l i t y A c t : i l l e g al to
m ak e pe r s o n al m e di ca l i n fo p ub l i c
19 99 R AN D Co r p o r at i o n r e p o r t : > 3 0 7 m i l l i o n t i s s u e s am p l e s s t o r e d i n U . S . ; t h e
m aj o r i t y w i t h o ut pa t i e n t c o n s e n t .
20 05 N at i v e A m e r i ca n H av a s up ai t r i b e m e m b e r s s u e Un i v e r s i t y o f A r i zo n a f o r us e
o f t i s s ue s do n at e d f or di ab e t e s r e s e ar ch t o r e s e ar c h r e : s c h i zo p h r e n i a &
i n br e e di n g.
20 06 N I H r e s e ar c h e r ch ar g e d w s e l l i n g t h o us an d s o f t i s s ue s am p l e s t o
ph ar m a ce ut i cal c o m pa n i e s fo r $ 0 . 5 m i l l i o n
2 0 0 8 G e n e t i c I n f o r m a t i o n N o n D i s c r i m i n a t i o n A c t
20 09 N I H f or m s fe t a l bl o o d b an k ( $ 1 3 m i l l i o n ) . Fam i l i e s s ue as f e t al t i s s ue s
t ake n w i t h o ut i n fo r m e d c o n s e n t & c an b e t r ac e d t o t h e i n fa n t .
2 0 1 3 H u m a n G e n o m e M a p

https://prezi.com/skbmxfnepwav/helahenrietta-lacks-medical-and-science-timeline/

http://rebeccaskloot.com/wp-content/uploads/2011/03/HenriettaLacks_RGG_timeline.pdf
 HISTORICAL BACKGROUND:
EBOLA
Ebola Drug Testing Sparks Ethical Debate
-Headline, Des Moines Register , November 2014

Ebola infection: 50-80% of those infected die

 FDA & NIH position:
 must have randomized controlled trials (control subjects) when evaluating
experimental drugs
 Must determine safety & efficacy
 Doctors Without Boar ders , O xford Univ, & the French NIH position:
 call for all study participants to receive the drug, even tho it is experimental
(safety/efficacy not known)

http://www.desmoinesregister.com/story/money/business/2014/11/15/ebola-drug-te
sting-sparks-ethics-debate/19110865/
 TODAY: THE 4 PRINCIPLES

DISCUSSION

THE FOUR PRINCIPLES OF CLINICAL ETHICS:

 Autonomy
 Non-maleficence
 Beneficence
 Justice

How might the four principles be applied to the analysis

of issues encountered in class or in clinic?
 NO DAY LIKE TODAY:
THE 4 PRINCIPLES

You are an agent of change.

You are a leader.
Where do you stand?
After graduation: What would YOU do?
 NO DAY LIKE TODAY:
THE 4 PRINCIPLES

“We must not see any person as an abstraction.

Instead, we must see in every person a universe
with its own secrets, with its own treasures,
with its own sources of anguish, and with some
measure of triumph.”

 Elie Wiesel, The Nazi Doctors and the Nuremberg Code