Over­com­ing past mis­takes with pa­tients in med­i­cal re­search

Modern Healthcare - - NEWS - By Steven Ross John­son

The name Hen­ri­etta Lacks was never men­tioned around Veron­ica Robin­son’s house­hold when she was grow­ing up in Bal­ti­more.

Robin­son, the great-grand­daugh­ter of Lacks, said the name of the now-famous cell donor brought up too many painful mem­o­ries for her fam­ily.

“My grand­fa­ther had to watch his mom die an ex­cru­ci­at­ing death,” Robin­son said. Lacks un­der­went treat­ment for cer­vi­cal can­cer in 1951 at Johns Hop­kins Hospi­tal and died the same year from the dis­ease.

But un­be­known to Lacks or her fam­ily at the time, sam­ples of her cervix were taken for med­i­cal re­search. Her cells be­came known as the HeLa im­mor­tal cell line, the most com­monly used human cell line for bio­med­i­cal re­search and ar­guably the foun­da­tion of ev­ery med­i­cal science dis­cov­ery made over the past five decades. “She just im­pacted the world in such a grand way, and most peo­ple still don’t know who she is and why she’s im­por­tant,” Robin­son said.

But the con­tri­bu­tion Lacks made to medicine was largely unknown for years. Her own fam­ily was not in­formed of the

“All sorts of eth­i­cal re­search vi­o­la­tions as well as the preva­lence of health dis­par­i­ties that we have go­ing on in this coun­try give un­der­served and marginal­ized com­mu­ni­ties some sin­cere pause for trust­ing and work­ing with med­i­cal re­searchers.” Teri Browne As­sis­tant pro­fes­sor Univer­sity of South Carolina’s Col­lege of So­cial Work

HeLa line un­til the 1970s and have never been com­pen­sated for the cells that have been used for ev­ery­thing from can­cer and AIDS re­search to gene map­ping.

The way Lacks was treated is one of many ex­am­ples of ex­per­i­men­ta­tion that has led to ex­ploita­tion, in­jury and even death, which to­gether are at the root of decades of mis­trust of med­i­cal science among cer­tain com­mu­ni­ties.

“All sorts of eth­i­cal re­search vi­o­la­tions as well as the preva­lence of health dis­par­i­ties that we have go­ing on in this coun­try give un­der­served and marginal­ized com­mu­ni­ties some sin­cere pause for trust­ing and work­ing with med­i­cal re­searchers,” said Teri Browne, an as­sis­tant pro­fes­sor at the Univer­sity of South Carolina’s Col­lege of So­cial Work.

Re­cent changes to the Com­mon Rule, the fed­eral law pro­tect­ing human re­search sub­jects, up­set pa­tient ad­vo­cates who wor­ried the first up­date to the law since it was writ­ten in 1991 would threaten pa­tient pri­vacy and al­low for biospec­i­mens to be used with­out pa­tient con­sent.

But the re­la­tion­ship be­tween pa­tients and re­searcher may fi­nally be chang­ing, as the ad­vent of pre­ci­sion medicine is al­ter­ing the way in which clin­i­cal tri­als are con­ducted, with treat­ments be­ing tai­lored more to­ward a pa­tient’s ge­netic makeup rather than the type of dis­ease they have.

“The stan­dard can­cer trial was you took pa­tients with a cer­tain type of can­cer and ran­dom­ized them into treat­ment A ver­sus treat­ment B and looked at the ef­fects on sur­vival and other out­comes,” said Dr. Sun­deep Khosla, a Mayo Clinic en­docri­nol­o­gist and clini- cal re­searcher. “With pre­ci­sion medicine and the abil­ity to se­quence the tu­mors, you might have pa­tients with lung, ovar­ian or breast can­cer all part of a trial be­cause they hap­pen to have a com­mon mu­ta­tion that hap­pens to be tar­geted by a par­tic­u­lar drug.”

That ap­proach re­quires a col­lec­tion of pa­tient per­sonal data on a scale that has never been seen be­fore, which could mean that get­ting com­plete

While African-Amer­i­cans and His­pan­ics com­bined make up nearly 30% of the pop­u­la­tion, they ac­count for roughly 6% of clin­i­cal trial par­tic­i­pants, ac­cord­ing to the U.S. Food and Drug Ad­min­is­tra­tion.

data sets within those dis­en­fran­chised groups could be dif­fi­cult, given their past. “Med­i­cal re­searchers in our coun­try have a pretty bad his­tory of re­search ethics when it comes to vul­ner­a­ble and un­der­served com­mu­ni­ties,” Browne said.

Per­haps the most egre­gious ex­am­ple oc­curred from 1932 to 1972 through the U.S. Pub­lic Health Ser­vice. Known as the Tuskegee syphilis ex­per­i­ment, re­searchers ob­served the pro­gres­sion of syphilis in 600 poor, African-Amer­i­can farm­ers in Alabama with­out ever telling them they were in­fected with the dis­ease, or pro­vid­ing them with treat­ment de­spite the avail­abil­ity of peni­cillin as early as 1947.

A boost from PCORI

The move­ment to broaden the pool of pa­tients in clin­i­cal tri­als was bol­stered by the cre­ation of the Pa­tient-Cen­tered Out­comes Re­search In­sti­tute in 2010 un­der the Af­ford­able Care Act. PCORI’s mis­sion to in­ves­ti­gate the rel­a­tive out­comes and ef­fec­tive­ness of var­i­ous med­i­cal treat­ments has pushed re­searchers to de­sign more pa­tient-cen­tered med­i­cal re­search stud­ies and look upon pa­tients as col­lab­o­ra­tors.

Some­times, re­searchers asked for pa­tients’ help with the de­sign of the stud­ies them­selves. “It’s very dif­fer­ent from the very pa­ter­nal­is­tic type of model we had with re­search,” said Dr. W.H. Wil­son Tang, a car­di­ol­o­gist at the Cleveland Clinic and di­rec­tor of its Cen­ter for Clin­i­cal Ge­nomics.

“I think there’s a grow­ing em­pha­sis on mak­ing sure that the re­search that we do mat­ters,” Browne said. “And it’s hard to do that and con­nect our re­sults with ac­tu­ally im­prov­ing peo­ple’s lives with­out mak­ing sure that the re­search that we do is pa­tient-cen­tered.”

Browne cited her own work as ev­i­dence of the in­creas­ing role pa­tients play in clin­i­cal re­search. Browne is part of a fiveyear, PCORI-funded study that be­gan in 2016 in part­ner­ship with re­searchers from Duke Univer­sity and Geisinger Health Sys­tem to ex­am­ine how to im­prove qual­ity of care and health out­comes in kid­ney dis­ease pa­tients as they tran­si­tion from early stages to end-stage re­nal fail­ure.

Eight pa­tients and their fam­i­lies have worked as part­ners with the re­search team since the be­gin­ning of the project. They have helped form re­search ques­tions from a pa­tient’s per­spec­tive and have been in­volved in the writ­ing of the grant ap­pli­ca­tion for fed­eral fund­ing. “They are true co-in­ves­ti­ga­tors,” Browne said. “They add so much to mak­ing sure that this re­search project is re­ally go­ing to help pa­tients.”

De­spite such ef­forts to­ward more pa­tient-cen­tered re­search, in­creas­ing clin­i­cal trial par­tic­i­pa­tion re­mains a big chal­lenge for cer­tain pop­u­la­tions. While African-Amer­i­cans and His­pan­ics com­bined make up nearly 30% of the pop­u­la­tion, they ac­count for roughly 6% of clin­i­cal trial par­tic­i­pants, ac­cord­ing to the U.S. Food and Drug Ad­min­is­tra­tion.

Many in those com­mu­ni­ties can ei­ther di­rectly or in­di­rectly tie their re­luc­tance to­ward par­tic­i­pat­ing in med­i­cal re­search to past cases of ex­ploita­tion like those of Lacks or Tuskegee. “I think when it comes to our com­mu­ni­ties, our very, very young peo­ple may not ex­actly know Hen­ri­etta Lacks or Tuskegee, but they have in­her­ited, un­for­tu­nately, a mis­trust of the health sys­tem,” said Dr. Robert Winn, as­so­ciate vice chan­cel­lor for com­mu­nity-based prac­tice and di­rec­tor of the Univer­sity of Illi­nois Hospi­tal & Health Sciences Sys­tem Can­cer Cen­ter in Chicago.

‘All of Us’

In 2015, UI Health along with North­west­ern Medicine and Univer­sity of Chicago Medicine part­nered to ap­ply for a grant to be part of the Na­tional In­sti­tutes of Health-spon­sored All of Us Re­search Pro­gram. The pro­gram aims to col­lect health in­for­ma­tion from 1 mil­lion vol­un­teers, with the goal of gath­er­ing data from such a large scope of the pop­u­la­tion that it en­ables re­search on a va­ri­ety of dis­eases and pro­vides more in­di­vid­u­al­ized treat­ment ap­proaches. The NIH is ex­pected to fund up to $5 mil­lion in grants over the next three years to sup­port com­mu­nity-led outreach ini­tia­tives such as the one at UI Health.

“The stan­dard of care doesn’t al­ways mean that peo­ple get the ap­pro­pri­ate care,” Winn said. With the move to­ward pre­ci­sion medicine, Winn ex­pressed con­cern that pop­u­la­tions that don’t par­tic­i­pate in med­i­cal re­search could miss out on the op­por­tu­ni­ties to find bet­ter treat­ments that are more per­son­al­ized.

“If we’re not care­ful, we’ll have the All of Us pro­gram gen­er­ate what I be­lieve will be new in­for­ma­tion that will lead to even bet­ter drugs and ther­a­pies, but that might only ben­e­fit a small num­ber of peo­ple,” Winn said.

Ac­cord­ing to the NIH, more than 1,000 peo­ple have en­rolled in the All of Us pro­gram in the past two months.

For their part, the Lacks fam­ily un­der­stands how dis­trust for the health sys­tem can lead some to­ward avoid­ing par­tic­i­pa­tion in med­i­cal re­search. But Robin­son said the fam­ily uses its own ex­pe­ri­ences not to dis­cour­age oth­ers from par­tic­i­pat­ing in stud­ies, but rather to cre­ate a di­a­logue be­tween the med­i­cal and pa­tient com­mu­ni­ties.

“We are the fam­ily of re­search and medicine,” said Veron­ica Robin­son, who is cur­rently train­ing to be­come a reg­is­tered nurse. “Our role in the com­mu­nity is to help bridge that gap be­tween science re­search and medicine.”

Last month, Robin­son along with mem­bers of her fam­ily at­tended a fo­rum in Chicago held by UI Health in which the sub­ject of es­tab­lish­ing pub­lic trust in re­search was dis­cussed. She said trust starts with pa­tients ask­ing ques­tions and re­searchers tak­ing the time to lis­ten and ad­dress pa­tient con­cerns.

“If the com­mu­nity is afraid to an­swer ques­tions and share things about them­selves, how can they be cared for bet­ter?” Robin­son said. “But re­searchers have to re­mem­ber when they talk to peo­ple they have to talk to them in ways they un­der­stand, be­cause if they don’t they’re steal­ing some­thing from them.”


At right, Veron­ica Robin­son (Hen­ri­etta Lacks’ great-grand­daugh­ter) was among the fam­ily mem­bers who spoke at the Univer­sity of Illi­nois at Chicago about Lacks’ legacy in med­i­cal re­search.

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