DRUGS & VACCINES: Testing Pool Has Uneven Ethnic Make-Up
Pharmaceutical companies continue to exclude minorities from their testing pools, despite mounting evidence that shows varying reactions to drug medications in different populations. A year-long investigation by the San Jose Mercury News found that by failing to increase testing on minorities, companies are disregarding federal guidelines and placing these groups at greater risk for ineffective dosages or adverse side effects. All but one of the 41 drugs investigated were tested on a "significantly greater" percentage of Caucasians, compared to the number affected by the disease. LaVera Crawley of Stanford University's Center for Biomedical Ethics said, "It's as if medical research is still stuck in the pre-civil rights era."
Rx Companies at Fault?
Although academic centers are spending millions of dollars researching this "revolution in medical thinking," the drug industry -- accounting for roughly 99% of the estimated $24 billion spent on drug development each year -- has yet to fund substantial studies examining the relationship between drugs and race. In 1994, the NIH began requiring all government-funded research to include minorities. The FDA has been pushing for more diversification in drug trials since 1988, but only recently began monitoring company efforts. Last year it announced that all companies provide the "breakdown and analysis of the racial demographics of its trial populations." Those who fail to abide by these rules risk having their applications tabled until the information is supplied. Despite the lack of definitive research on the topic, some medical experts argue that companies should at least "raise a warning flag," noting race effects on product labels. In addition to health concerns, bioethicists are worried about the fairness in having one ethnic group -- in this case Caucasians -- "shouldering the risk of testing for the good of everyone who will use the therapy."
But drug companies contend that the "emphasis on drugs and race is misplaced." Bert Spilker of the Pharmaceutical Research and Manufacturers of America, said, "Our first priority is to get the drug on the market to help those who are sick. That is our purpose, that is why the pharmaceutical industry exists." Others argue that such research may lay the foundation for legitimizing prejudices because the definition of race is "murky," and hard to identify. Also, minorities might hesitate to join studies. For example, African Americans are often still suspicious of research in light of the infamous Tuskegee syphilis study. Susan Shinagawa, co-chair of the Intercultural Cancer Council, an umbrella organization for other health and minority groups, said the low numbers of minorities in research is not "because of racism and not in any way meant to discriminate, but unconsciously, because people don't think about race" (Cha, San Jose Mercury News, 12/19).
Opposite for Vaccines
Ethical concerns also surface in the vaccine testing arena. Eight of the 14 childhood vaccines approved since 1990 have been tested "disproportionately in lower-income minority communities." Analysis of six of these trials shows that the procedure and potential dangers "weren't properly described to parents," in part because of a language barriers. Kaiser Permanente's Northern California district, the nation's most popular vaccine- testing site, has a testing pool that is more than 60% African American, Latino, Asian, Native American or multiracial, compared to a 28% minority population nationally. Unlike the case of drug trials, the government has "largely stayed out of the ethical debate," but expressed interest in "specific concerns ... about specific studies." One industry spokesperson said the "ethnic and racial imbalance in vaccine testing is 'meaningless,'" adding "It's only a problem if they were victims ... if there were some conspiracy to use them as guinea pigs. But there is not. Our trials are mutually beneficial." But University of Washington- Seattle professor Douglas Diekema warned that if the trial results in serious side effects, "you have just taken advantage of a population." He said, "It's always easier to justify the decision if the vaccine works." Some minority communities, however, claim they are "comfortable harboring the burden," as "the potential benefits ... outweigh the risks." Ethicists counter by saying that once approved, vaccines protect the entire population, thus testing should mirror national demographics (Cha, San Jose Mercury News, 12/20).