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Stanford Anthropologists Study Role That PGx, Race Play in Drug Discovery

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A small team of anthropologists at Stanford University has begun investigating whether pharmacogenomics technologies and the use of racial and ethnic data are creating health-care disparities among different racial groups.

The object of the study, which recently received a $500,000 grant from the National Human Genome Research Institute, is to learn how drug makers use pharmacogenomics technologies and racial categories to make drug-development decisions, according to lead author Sandra Lee, a senior research scholar in anthropology at Stanford.

Although the research will not focus on pharmacogenomics technology directly — a portion of the study will seek to define the technologies that exist within the discipline and how they are used in drug discovery — it will try to identify what some in the industry believe is an unfortunate tendency among many pharmaceutical companies of using racial categories to help them determine which drugs to pursue and which to abandon.

To be sure, the motive is neither nefarious nor illegal; Lee, as well as a number of bioethicists familiar with the issue, said that pharma companies make these kinds of decisions for economic, not racial, reasons. Nevertheless, the product of these decisions — in essence, drugs not chosen for development because the majority of patients they would likely target are statistically less likely to afford it — may lead to health-care disparities among various patient groups, Lee explained.

Unwittingly complicit in this, she said, are pharmacogenomics technologies and US Food and Drug Administration-recommended race and ethnicity categories that appear to aid drug makers in making these decisions. Lee, therefore, aims at investigating how the products of pharmacogenomics research — drugs and diagnostics — “may enhance or aggravate some of the existing health disparities among racially identified populations.”

“I think we are on a certain trajectory where we are going to have to confront these issues,” Lee told SNPtech Reporter this week. “Maybe what we need is a more critical thinking about what [racial] categories we use, what the impact is, and how it pans out in terms of the actual lives of different people in different populations.”

Lee, an anthropologist who studies race, ethnicity, and culture in science, technology and biomedicine, said she has spoken with a number of pharmaceutical officials who have been “very upfront in [saying] that a lot of the pressures that have been placed on them is to [develop drugs] for the populations that are actually going to be able to afford the drug. And [as] we talk about race, they’re really upfront in saying that that is mainly the white and Asian populations. This may mean that others lose out,” she said.

In the study, which began in August and will run for five years, Lee will be embedded in an undisclosed “small” pharmaceutical company in California’s Silicon Valley, and will observe the kinds of decisions the company makes from the standpoint of identifying race — whether through PGx tools or race data — as a variable in scientific research. Then, she will try to track the kinds of products that move down the pipeline, and what affect they have on different populations.

“If you look at the incredible amount of investment a drug company needs to make to bring a product from the bench to the bedside … certain decisions have to be made along the way,” she said. “And I guess one of the concerns is whether or not pharmaceutical companies will find enough incentive to work on a product that may only be beneficial for a very small fraction of the market share.”

Though past research has suggested that different racial groups respond differently to various diagnostic and therapeutic products — for example, it is widely held that blacks respond differently than whites to certain drugs for cardiovascular disease — Lee said she will not track the development of any specific drug candidate. Rather, she said she has a “wide net” at the company and will follow many different candidate compounds as they wend their way through the drug-development pipeline.

Lee said the study has several objectives: Initially, she would seek to learn why the issue of health disparities has “emerged as such an important health policy goal” in the United States. (The NIH, through its ELSI initiative — which funded Lee’s study — hopes to eradicate this disparity by 2010. Lee called this goal “ambitious.”) Another goal of her study would be to provide “some practical bioethical guidelines” for industry, scientists, and policy makers to help them “wrap their minds around what the ethical implications could be … and to develop guidelines that deal with any type of technology that deals with racial segmentation. ...”

Lee suggested the project to the NHGRI following a similar program in which she studied the way racial data are used by drug makers. This tied into an FDA guidance, issued in January, that recommends specific methods by which drug companies should submit race and ethnicity data in drug trials. Known as the OMB guidance, for the Office of Management and Budget, which issued it in 1997, the guidance defines race and ethnicity as “American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, and Hispanic or Latino.”

“Using standard categories will make it easy to compare FDA data with health statistics collected by other federal agencies,” an explanation of these groupings on the FDA website states. “Another goal of the guidance is to enhance consistency in sub-population characterization. This improves our ability to assess potential differences in the ways various racial and ethnic groups respond to drugs.” This directive, said Lee, may need to be updated in order to ensure that race doesn’t continue to play such a prominent role in drug-development decisions.

But the issue isn’t confined to pharmaceutical companies. “It’s also [evident among] researchers and the academic centers in this country,” said Lee. “There is something in the infrastructure right now that … makes us think about the population in terms of race.” At a recent pharmacogenomics conference that attracted many basic scientists, “race was a very interesting issue that emerged among the scientists,” she said. “There is an acknowledgement that it’s already embedded in the type of research they do.”

She said some scientists “are more interested” in this, while others are happy to use categories common in medicine — such as the new FDA guideline — and “not worry about it.” She suggested that “part of the … issue is that basic science may be thinking about race or human genetic variation in one way, [but] once it gets translated into health practices, and clinicians become involved, that’s where race becomes incredibly salient, because many decision-making processes are based on race.”

Indeed, this week in California voters were asked to consider a referendum that sought to prohibit the state from collecting and using most racial and ethnic data. Opponents of the bill, which included medical and public-health experts, argued that the measure “would undermine ... school reforms, make diseases tougher to track and treat, and hurt anti-discrimination efforts,” according to the Los Angeles Times. The referendum was defeated.

“This defeat represents the concerns of the public that this information is important to have when it relates to health care, public safety and the education of our children,” Elena Stern, a spokeswoman for the Coalition for an Informed California, comprising groups opposed to the measure, was quoted in the paper as saying. “The loss of that information would have impacted a broad spectrum of Californians across the state.”

Most insiders agree that pharmaceutical-based issues of pharmacogenomics and race will be difficult to pinpoint and remedy, primarily because most drug makers are unlikely to divulge data voluntarily from discontinued trials — whether or not they contain overt racial components. Additionally, because the subject of health-care disparity and race seldom appears on scientific conference agendas, it is not something that is debated. But Lee remained optimistic. “I think there is a consciousness in the industry that these ethical issues need to be addressed, and they have been very open to saying, ‘let’s think about the issues, what are the concerns,’ and ‘let’s have a transparent process.’ This is a field that is now coalescing, and they want to talk about ethics from the beginning. That’s the attitude of many representatives in the pharmaceutical industry.”

On the tool front, Lee said, “I don’t think this study is going to necessarily condemn [pharmacogenomics] technology. Technology can be a wonderful tool. But I do think that we have to take a step back and think about what the implications are so we can more usefully use [it].

“It’s going to be on the shoulders of particular [pharmaceutical] companies to make the first step out of the box,” she said. “But once one does, then others will follow suit.”

To some bioethicists, the issue is more fundamental. “The biggest question I have about race and pharmacogenomics is, ‘Who qualifies as what race?’” said Paul Lombardo, a bioethicist at the University of Virginia. “If I have a person whose parents are white and black ... what race would I assign them?”

To others, the issue is more of the same. “The color pharmaceutical companies care about most is green,” Art Caplan, a bioethicist at the University of Pennsylvania, told SNPtech Reporter. “Race and poverty and class do, to some extent, set the drug company agenda.” He said drugs that target diseases of the Third World, like malaria, or the inner-city poor, like drug or alcohol addiction, “are not going to be commanding top pharmaceutical company attention, because that’s not where the market is.”

Plus, the issue often reaches common diseases in which race does not play a role, or rare diseases in which wealth will not necessarily save a patient because drug companies do not have enough of a financial incentive.

— KL

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