Lack of Diversity in Medical Research Is Bad for Your Health

Low participation of minority populations in clinical trials can lead to development of medicines that are dangerous for the people using them.

BALTIMORE - APRIL 5: Nurse Coordinator Lisa Chrisley (R) injects an experimental flu vaccine into the arm of volunteer Kwisa Kang of Mt. Washington, Maryland, a medical school researcher, during a clinical trial to test the effectiveness of the vaccine to combat avian influenza April 5, 2005 at University of Maryland School of Medicine in Baltimore, Maryland. The trial aims to find out if the vaccine can protect people from a lethal avian flu strain, also known as H5N1, which was first detected in chickens and other birds in Hong Kong in 1997, claiming the life of a three-year old boy. There have been at least 69 more confirmed cases with 46 deaths since then, mostly in Vietnam and Thailand. University of Maryland School of Medicine was one of three U.S. sites that took part in the trial funded by the National Institutes of Health. (Photo by Alex Wong/Getty Images)
National Journal
Sophie Novack
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Sophie Novack
March 13, 2014, 8:51 a.m.

Minor­ity groups are severely un­der­rep­res­en­ted in clin­ic­al tri­als, and the dis­crep­ancy poses ser­i­ous risks for drug safety and pa­tient health.

Afric­an-Amer­ic­ans make up 12 per­cent of the United States pop­u­la­tion, but they ac­count for only 5 per­cent of par­ti­cipants in clin­ic­al tri­als, ac­cord­ing to a 2011 Food and Drug Ad­min­is­tra­tion study. His­pan­ics make up 16 per­cent of the pop­u­la­tion and a mere 1 per­cent of tri­al par­ti­cipants.

A new cam­paign, led by the Phar­ma­ceut­ic­al Re­search and Man­u­fac­tur­ers of Amer­ica, and the Na­tion­al Minor­ity Qual­ity For­um, launches this week to try to nar­row this chasm. It will be the first large-scale na­tion­al ef­fort fo­cused on in­creas­ing par­ti­cip­a­tion and di­versity in clin­ic­al tri­als, and it will fo­cus on fur­ther­ing con­nec­tions between phys­i­cians, in­vest­ig­at­ors, and pa­tients, par­tic­u­larly in minor­ity pop­u­la­tions.

PhRMA Pres­id­ent and CEO John Cas­tel­lani blames “in­sti­tu­tion­al in­er­tia” for why a sim­il­ar large-scale re­sponse to minor­ity un­der­rep­res­ent­a­tion hasn’t happened earli­er.

“We’re good at do­ing what we’ve al­ways done the same way we’ve al­ways done it,” he says. “But the im­per­at­ive is, sci­ence is chan­ging. The fu­ture of medi­cine is in medi­cines aimed more and more at ge­net­ic­ally ho­mo­gen­ous pop­u­la­tions, and those pop­u­la­tions need to be par­ti­cip­at­ing in the dis­cov­ery pro­cess.”

Demo­graph­ic dis­crep­an­cies are wor­ri­some be­cause clin­ic­al tri­als play a ma­jor role in the way drugs and med­ic­al treat­ments are de­veloped, yet ge­net­ic dif­fer­ences mean that med­ic­a­tions af­fect dif­fer­ent pop­u­la­tions in dif­fer­ent ways.

Cer­tain dis­eases — in­clud­ing type 2 dia­betes, car­di­ovas­cu­lar dis­ease, HIV/AIDS, some types of can­cer, and neuro­psy­chi­at­ric ill­nesses such as schizo­phrenia and de­pres­sion — dis­pro­por­tion­ately af­fect minor­ity pop­u­la­tions, yet the demo­graph­ics of clin­ic­al-tri­al par­ti­cipants don’t re­flect the in­cid­ences. Thirty-sev­en per­cent of new dia­betes pa­tients each year are black, com­pared with 10 per­cent of dia­betes tri­als par­ti­cipants; 36 per­cent of pa­tients are His­pan­ic, com­pared with 4 per­cent of par­ti­cipants, ac­cord­ing to data from the FDA and the Na­tion­al In­sti­tutes of Health.

The danger is that the the pop­u­la­tion be­ing stud­ied is not the pop­u­la­tion likely to re­ceive the med­ic­a­tion.

“Not hav­ing this in­form­a­tion, you don’t know what you don’t know,” says Dr. Jonca Bull, dir­ect­or of FDA’s Of­fice of Minor­ity Health. “So you would be faced with an in­ad­equate char­ac­ter­iz­a­tion of the product’s safety and ef­fic­acy pro­file. Every­one loses when you don’t have this in­form­a­tion, be­cause the pop­u­la­tion char­ac­ter­ist­ics are ab­so­lutely crit­ic­al to en­sur­ing that the health care pro­vider has the in­form­a­tion they need to make a well-guided de­cision as to wheth­er a par­tic­u­lar med­ic­al product is ap­pro­pri­ate for their in­di­vidu­al pa­tient.”

Ap­pro­pri­ate med­ic­a­tions and dosages can vary by pop­u­la­tion. Re­cent re­search in­dic­ates that cer­tain can­cer treat­ments may have sig­ni­fic­antly high­er tox­icity in Asi­an pa­tients than Caucasi­an pa­tients. Evid­ence has also found eth­nic vari­ations in drug meta­bol­ism and tox­icity of im­mun­osup­press­ant drugs, car­di­ovas­cu­lar med­ic­a­tions, and oth­ers.

Ad­voc­ates of in­creased di­versity cite his­tor­ic dis­trust in clin­ic­al tri­als and lack of aware­ness as the ma­jor cause of the dis­crep­ancy. Par­ti­cip­a­tion in clin­ic­al tri­als over­all is quite low, with only about 10 per­cent of Amer­ic­ans hav­ing par­ti­cip­ated in one, yet the demo­graph­ic dis­crep­ancy is of par­tic­u­lar con­cern.

“In most cases with­in com­munit­ies, there’s not aware­ness of clin­ic­al tri­als or un­der­stand­ing of why they take place,” says Dr. Sal­vatore Alesci, vice pres­id­ent of Sci­entif­ic and Reg­u­lat­ory Af­fairs at PhRMA, who is in­volved in the cam­paign. “This is as much an is­sue among pa­tients as among phys­i­cians.”

A Re­search!Amer­ica sur­vey in 2013 asked wheth­er groups would be will­ing to share per­son­al health in­form­a­tion to fur­ther med­ic­al re­search, and 78 per­cent of Asi­ans said yes, as did 76 per­cent of His­pan­ics, 75 per­cent of non-His­pan­ic whites, and 72 per­cent of Afric­an-Amer­ic­ans. On how im­port­ant the op­por­tun­ity to im­prove the health of oth­ers would be in de­cid­ing wheth­er to par­ti­cip­ate in a clin­ic­al tri­al, 62 per­cent of Afric­an-Amer­ic­ans said very, along with 57 per­cent of His­pan­ics, 50 per­cent of Asi­ans, and 49 per­cent of non-His­pan­ic whites.

Yet the per­cent­age that said they or a fam­ily mem­ber had par­ti­cip­ated in a tri­al was be­low 20 per­cent across all groups.

PhRMA and NM­QF take these find­ings to in­dic­ate a will­ing­ness on the part of these groups to par­ti­cip­ate, with the bar­ri­er be­ing lack of com­mu­nic­a­tion and ac­cess. Their “I’m In” cam­paign in­volves edu­ca­tion­al out­reach and events with both pa­tients and pro­viders, as well as an on­line data­base where in­di­vidu­als can re­gister to be con­nec­ted with rel­ev­ant clin­ic­al tri­als in their area.

Ac­cord­ing to Alesci, the fo­cus of more in-depth ini­tial pi­lot pro­grams will be in south­ern Texas and Flor­ida, with a par­tic­u­lar em­phas­is on the His­pan­ic pop­u­la­tion; At­lanta for Afric­an-Amer­ic­ans; and San Fran­cisco for Asi­an Amer­ic­ans.

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