BiDil, A-HeFT, and the Future of Race in Pharmacogenetics/genomics

Last month the Federal Drug Administration approved BiDil, the first racially targeted drug: “BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self- identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status” (BiDil package insert). This approval, along with A-HeFT, the clinical trial that helped BiDil receive approval, added fire to the scientific debate over the role of race in pharmacology and pharmacogenetics. Is A-HeFT opening the door for racially-targeted clinical trials? Is BiDil opening the door for more racially-targeted drugs? Most generally and perhaps most importantly, with the first racially-targeted drug coinciding with the dawn of the so-called “Genomic Revolution,” how will race and genetics play out as factors in the future of medicine—especially since a genetic basis for race has been largely discredited? Should clinical trials continue to ask participants to self-identify as a particular race? Should this be used as a considerably less expensive alternative to the analysis of a participant’s individual genome?

When BiDil was approved last month, it made the headlines for a few days before fading back into obscurity. As a woman of color, the news left an impression on me that lasted even after the news headlines moved on to something else. Talking with colleagues and minority friends showed me that while most folks have an opinion on the drug itself, it’s hard to maintain a general discourse on the situation’s long-term, subtle effects on the body politic—precisely because those effects will be long-term and subtle. This is why I think it’s worth taking a look at this issue that will undoubtedly affect us all in years to come.

BiDil: What it is and how it was tested

Discovered in 1978 by University of Minnesota cardiologist Jay Cohn (Saul/New York Times), BiDil is a binary combination of two blood vessel dilators (vasodilators): isosorbide dinitrate, which affects both veins and arteries, and hydralazine hydrochloride, which affects mainly arteries (BiDil package insert). Both drugs are commonly used on heart patients, but not commonly used for heart failure. BiDil restores a patient’s nitric oxide levels—a naturally occurring compound found to be more highly deficient in blacks (Saul/NY Times)—but the exact mechanism for BiDil’s efficacy is not known (BiDil package insert).

From 1980-1990, Cohn headed two Vasodilator Heart Failure Trials (V-HeFT I and II) at veterans’ hospitals throughout the country (http://www.a-heft.org/history.asp). In the first trial, it was shown that there was no significant difference in mortality between those treated with BiDil and those treated with a placebo, though there was a trend favoring BiDil, “which in retrospective analysis, was attributable to an effect in blacks” (BiDil package insert). In V-HeFT II, BiDil was compared to the enzyme-enhibitor Enalapril (MedlinePlus:Enalapril). In whites, BiDil was found to have an inferior effect, but in blacks, there was no significant difference in the effect of BiDil and Enalapril (BiDil package insert). After these two trials, BiDil was submitted to the FDA for approval, but was rejected in 1997 on the grounds that its benefits were not statistically significant (Saul/NYTimes). At that time, BiDil was called ISDN-H and was submitted to the FDA by King Pharmaceuticals, then called Medco Research (http://www.a-heft.org/development.asp).

A-HeFT and NitroMed

In 2000, the company NitroMed “realized the potential of the combination drug for use in African Americans with heart failure” (http://www.a-heft.org/development.asp) and acquired the rights to BiDil. After applying for new FDA approval and receiving a request for more information, NitroMed designed the African American Heart Failure Trial (A-HeFT). It paid $200,000 to the Association of Black Cardiologists, Inc. (ABC) to organize A-HeFT’s clinical trials (Saul/NYTimes). A press release from ABC cites a Center for Disease Control study finding that black Americans between 45 and 64 are 2.5 times more likely to die from heart failure than white Americans in the same age range. This press release describes A-HeFT’s major results among blacks: 43% improvement in survival rates and 39% reduction in the rate of hospitalization. In July 2004, the Data Safety and Monitoring board and the A-HeFT steering committee voted to end the A-HeFT trial because the benefit rates were so high (Carter/ABC press release).

With the results of this new trial, a new FDA hearing was held on 15-16 June 2005. The hearing’s second day was opened for testimonials outside of NitroMed. Those who spoke in wholehearted favor of BiDil included Representative Donna Christensen, chair of the Congressional Black Caucus Health Braintrust, Charles Curry, president of the International Society on Hypertension in Blacks, and Lucille Norville Perez, the NAACP’s National Health Director (FDA BiDil printed statements, FDA BiDil Day 2 Transcript). Two of A-HeFT’s participants, Debra Lee and Dianna Wells, also spoke in favor of BiDil (FDA BiDil Day 2 Transcript). No speaker opposed BiDil’s effectiveness, and the drug was easily approved a few days later.

Since BiDil’s recent approval, a few complications have already arisen. A number of newpapers have reported that hydralazine hydrochloride, one of BiDil’s key vasodilators, has been known to cause lupus in some patients. Lupus is a disease that disproportionately affects black women—they are three times as likely to contract the disease as white women (Alonso-Zaldivar, LA Times).

Another complication is that of price: the financial analysts reacted in surprise to NitroMed setting the price of BiDil at $1.80 a pill, significantly higher than expected and twice the cost of some other heart medications. This comes out to $5-11 per day (depending on dosage). This price is part of a tiered system in which patients without prescription insurance can get the drug for $25, and low-income patients can get the drug for free. Nevertheless, financial analysts have raised revenue predictions for NitroMed, and one of NitroMed’s investment banks raised its own predicted revenue about $125 million higher (Saul/NYTimes -Bidil Price).

NitroMed as Stakeholder

NitroMed hardly has a history of blockbuster drugs, but BiDil could change that. A small twenty-two year old company with about 100 employees, NitroMed specializes in nitric oxide medications. Previous to BiDil, this company had never spent money on drug promotion and had, according to an Associated Press article, "relied on research collaborations with other companies for its revenue" (Associated Press). BiDil marks a sea change for NitroMed—195 contractors have been hired to market the drug, and revenues are expected to reach $192 million by 2007, a big change from a $29.7 million loss on $26.5 million in revenue in 2005 (Associated Press). NitroMed's stock value was a low $10 since its initial public offering in 2003, but it jumped to $27.99 last February, and currently trades around $22.50. According to Morningstar.com, NitroMed’s revenues have grown more than 300% in the past three years. Though NitroMed reported net losses for the second quarter just a few days ago (NitroMed, Inc.), this was due to high startup costs for BiDil and is expected to turn around within the next few years (Associated Press). BiDil seems to have reinvigorated NitroMed’s ambitions to become a leading drug company through the African American market, as stated on its web site:

“Our goal is to become a leading, multi-product pharmaceutical company by developing additional innovative nitric oxide products and by building on our BiDil development experience and commercialization infrastructure to identify and market additional products for cardiovascular and metabolic diseases for the African American population” (NitroMed: About NitroMed).

To this goal of targeting African Americans, Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, says: “If I were a drug company executive, in addition to finding out about what works, I might be albe to find out what causes problems, and save myself some liability” (Wadman, “Drug targeting,” 1009).

A Crude Marker?

Statements like that above worry many geneticists and genethicists who think that race is being used as a “crude marker” for genetic and environmental factors (Wadman, “Drug targeting,” 1008). Even science writers are making this mistake: In the 24 June 2005 issue of Science, an article called “Going From Genome to Pill” said “BiDil represents the latest example of the industry’s push to target drugs to subgroups of patients who, based largely on their genetic makeup, are most likely to benefit (Service 1858). As was explained earlier, genetic testing did not play any role in BiDil’s clinical trials.

Geneticists as Stakeholders

For geneticists, the shape of future research is the most at stake. Institutional support of clinical trials using race-based criteria may open the door to more funding for genetic research using race-based criteria. Geneticists are very divided over this particular stake—some, like Charles Rotimi, acting director of the National Human Genome Center at Howard University, say that “If this misconception is allowed to stand, researchers will feel justified to equate group membership, e.g., African American, Hispanic, European American, or Asian American, with disease mechanism of action in biomedical research” (Rotimi position paper). To avoid this misconception, studies are being made using genetic marker sequences as a criterion instead—like at the University College of London, where David Goldstein is leading a study of genetically diverse samples from various populations around the world. Using 40 marker sequences to divide the samples, they found that “the resulting subgroups showed differences in the genes for enzymes that metabolize drugs” (Aldhous 355).

But Stanford University geneticist Neil Risch says that this kind of study is over-complicated, and just recreates self-identified race labels. Being an advocate for the use of self-identified race in medical and genetic trials, Risch argues that using genetic markers in a study can lead to the misinterpretation that results are based on genetics when they might be actually based on socio-economic factors (Alhous 366). In an article in Genome Biology, Risch and colleagues write that “Ignoring our differences, even with the best intentions, will ultimately lead to the disservice of those who are in the minority” (Risch).

Francis Collins, director of the NIH National Human Genome Research Institute (NHGRI), agrees that these differences are important, but he argues that “'race' and 'ethnicity' are poorly defined terms that serve as flawed surrogates for multiple environmental and genetic factors in disease causation, including ancestral geographic origins, socioeconomic status, education and access to health care” (Collins). He contrasts BiDil with Iressa, lung tumor drug that is effective in only 10% of the patients taking it—but Japanese patients are three times as likely as whites to fall into that 10%. Unlike in the BiDil trials, where genetic response was not tracked, it was found that the patients who responded well to the drug have specific mutations in the receptor for epidermal growth factor. To this, Collins says: “Wouldn’t it be unfortunate if at this point all we knew is that there is a better chance of responding if you are Japanese?” (Wadman, “Drug Targeting,” 1008).

Collins cites projects like the International Haplotype Mapping Project (http://www.hapmap.org/), a consortium of scientists from Canada, China, Japan, Nigeria, the U.K., and the U.S.A., as moving beyond the terms of ‘race’ and, with its diverse samples of DNA, towards a closer examination of geographical ancestry as it pertains to genotype.

Collins’s article was part of a Department of Energy- sponsored Nature Genetics supplement called “Genetics for the Human Race.” This supplement was proposed by scientists at a NHGRI conference at Howard University, a historically-black school in Washington, D.C. With the high stakes of research, funding, and human perception in mind, the DOE, NHGRI, Howard University’s own Human Genome Center, and many other research groups are carrying out their own studies—on they way they should study race and/or genetic variation.

Heart Patients and Doctors as Stakeholders

Patients have their own health at stake, and their doctors must deal with the hundreds of heart drugs on the market—Medline Plus/NIH lists 489 drugs in its directory (Medline Plus Heart Drug List). But pre-existing health problems aren’t the only issue: 100,000 patients die each year of adverse reactions to prescription drugs, and 10% of European hospital visits are due to these adverse reactions. Even in patients who don’t die, many are taking drugs that don’t help. One-third of heart patients taking beta-blockers are not helped by this drug, and one-half of antidepressant patients are not helped by their drugs (Abbott 760). This has led to the speculation that genetically tailored drugs, or ‘designer drugs,’ would help physicians narrow down the long list of available drugs (all with potentially undesirable side effects) and help match patients to drugs that are actually effective—and safe. Jeffery Drazen of Harvard Medical School believes that within a decade, physicians will send off a patient’s blood sample for genetic analysis and receive a ranked list of best options for that patient. “For patients subjected to the current prescribing lottery, that day can’t come soon enough” (Abbot 762).

The need for better drugs is urgent, but it’s also expensive: GeneticHealth.com, a web site of volunteer health educators, lists a number of genetic tests, from the ‘breast cancer gene’ to Ashkenazi mutations, with costs ranging from $190 to $3000. When it comes to advising patients to use insurance to pay for the costs of genetic testing, GeneticHealth notes that while using insurance saves a lot of money, the insurance company will likely note the genetic test as part of a patient’s file. At this early point, it is hard to tell how this might create the potential for genetic discrimination.

Health, cost, and discrimination—patients, and doctors as advisers, face many stakes with the introduction of BiDil and the rise of pharmacogenetics.

Minorities as Stakeholders

Like geneticists, minorities stand on both sides of the issue, some saying that using race as an early marker for genetic difference—and then eventually using that genetic difference itself—will lead to greater discrimination and stigmatization than what already exists. Others argue that tailoring drugs to individual racial populations will help those populations, just as tailoring a drug to two individuals will help each individual more than the current pharmacological ‘one-size-fits-all’ policy. When it comes to BiDil, there are black leaders on both sides: advocates the previously mentioned Representative Donna Christensen, Charles Curry (International Society on Hypertension in Blacks, and Lucille Norville Perez (NAACP), as well as the Association of Black Cardiologists and a number of black advisors to the A-HeFT trial. Gary Puckrein, director of the National Minority Health Month Foundation, says that he supports BiDil but asserts “no absolute or implied correlation between ‘social race’ or genotype, and the efficacy of BiDil” (Puckrein). Charles Rotimi and Charmaine Royal of Howard University’s National Genome Center and Troy Duster, director of the Institute of History and Production of Knowledge at New York University, are strongly against racial targeting—at least the non-specific way it was carried out with the A-HeFT trial. In Rotimi’s position paper, he state that “untold numbers of African Americans have lost their lives because of inadequate treatment” in trials that show that vasodilators tend to work in African Americans while beta-blockers tend to work in whites. Rotimi also adds that racial targeting may make minorities suffer at the expense of each other: “Members of other ethic groups are likely to benefit from this drug [BiDil] as well… and because of ethic binning, a drug like BiDil, which may help other ethic groups. Could never achieve its full potential” (Rotimi).

As for South Asian Indians, who also have a high and increasing general risk to heart failure, Constance Holden reports in Science magazine that Indians “believe that Indian vulnerability to heart disease is striking enough” to warrant some kind of racial separation. Enas Enas, cardiologist and director of the Coronary Artery Disease in Indians Foundation in Illinois, stated that blood pressure and obesity goals should be 10% lower, and cholesterol 20% lower, in Indians than in Caucasians (Holden 596). Prakash Deedwania of the Univeristy of California, San Francisco, cites an upcoming clinical trial, sponsored by the drug company AstraZeneca, comparing the drugs Crestor and atorvastatin in South Asian Americans. He says it will be the largest prospective trial ever done on Indian-Americans, with about 800 subjects from 150 centers around the country (Holden 596).

A Three-Prong Resolution

I. Labeling/Package Insert

In the scientific community, there seems to be a general agreement that while race is a poor substitute for genetic polymorphism, truly genomic drugs are at least decades away, so race seems like the decent interim solution to provide more specific (and hopefully more effective) drug prescriptions to patients.

Troy Duster at NYU says that with race being such a loaded concept, even its use as only an interim solution “can leave its own indelible mark once given even the temporary imprimatur of scientific legitimacy by molecular genetics” (Duster 1050). He says that if the BiDil is approved (his article was published before the approval), a warning label should be added to the package insert (Duster 1051). Charles Rotimi and Charmaine Royal both testified at BiDil’s approval hearing that race should not be a part of the drug’s labeling at all. If previous drugs, the vast majority of which were approved on the basis of clinical trials with a vast majority of white participants, are “good enough for all races,” than BiDil should be too (FDA BiDil Approval Hearing, Day 2 Transcript). I agree with Drs. Rotimi and Royal that this drug should not be filed in the ‘African American Interest’ section of the drugstore. But there’s no honest way to not mention race—a good portion of BiDil’s package insert is devoted to explaining the A-HeFT trial. It is a subtle mention, though, which I think warrants Troy Duster’s warning: “allelic frequencies vary between any selected human groups—to assume that those variation reflect ‘racial categories’ is unwarranted.” Dr. Rotimi also has an additional note to non-African races: “Although it was tested only in African Americans, it may indeed be an effective treatment for heart patients who may not self identify (or be identified) as African Americans.” Both these messages are pretty subtle and, if added to the insert, would help to explain the context of A-HeFT; anything more overt, more simplified, might lead to a stronger racial perception in the minds of doctors and patients.

II. Uniform Clinical Trials

But the racial targeting behind A-HeFT has been perceived as exploitative by journalists like Robin Henig of the New York Times and bloggers on BlackInformant.com. I agree that even with the results from V-HeFT I and II, it was a mistake to target only blacks in all stages of A-HeFT—it has echoes of the euphemism “separate but equal,” one of the catchphrases of the Jim Crow laws that divided this country until only the 1960’s. In the future, the FDA should require that trials statistically significant samples of diverse populations. A trial like A-HeFT should have been more diverse in and of itself or it should have been the first of a series of trials testing many populations. Rather having study to test blacks and this study to test whites (which the vast majority of studies already do) and to test study testing Asians, Hispanics, Arabs, etc—there should be an FDA requirement that studies be more uniformly diverse across the board. This would amount to a sort of equal opportunity policy, which can then be narrowed (for instance, if drug shows higher effectiveness in some subpopulation) in a later phase of the trial. The process of self-identifying should also be more uniform, and the FDA has already made recommendations to this end. In a 2003 paper entitled “Guidance For Industry: Collection of Race and Ethnicity Data in Clinical Trials,” the FDA suggests that clinical trials use the same categories of the U.S. Census. It also suggests that “study participants self-report race and ethnicity information whenever feasible, and individuals be permitted to designate a multiracial identity.” This is also a technique that was used in the last census (“Racial and Ethnic Classifications Used in Census 2000 and Beyond”).

It seems that the inclusion of genetic testing will soon be an increasing part of clinical trials, which will help take the burden off the monikers ‘race’ and ‘ethnicity’ for distinguishing differences between populations—and provide a more accurate picture of the subjects represented. Joanna Mountain, an anthropological geneticist at Stanford, says that while “race and ethnicity are explanatory, even it is unclear what they are surrogates for,” nearly all researchers agree that they need to be discarded as the explanatory power of genetic testing becomes more efficient (Wadman, “Geneticists struggle,” 1026). In 2001, the NIH established a Pharmacogenetics Research Network (PRN) to work on the cutting edge of this front, and I hope that the soon FDA establishes a first round of guidelines based on the PRN’s findings. This would encourage drug companies, most of which are currently more reluctant to use genetic testing in their clinical trials, to be more forward-thinking. Most companies have planned ahead and take blood samples just in case retrospective genetic analysis is needed or required, but they want to pharmacogenetic methods become more reliably predictive before including them in trials (Abbot 762). Companies like GlaxoSmithKline, which has a genetics division that actively advocates pharmacogenetic testing (Abbot 762), is in the minority so far. It’s clear that with so much money and legal liability at stake, companies will continue to be conservative—all the more reason for the FDA to take a more active role in guiding the issue of clinical trials.

III. Joint Consortiums and Better Linkage

It’s clear that the promise of the Human Genome Project (HGP) will increasingly come into play in the way that drugs are studied, targeted, and taken. But this is hardly made clear when seeking information from the HGP, FDA, or NIH—in the maze of government web sites, these agencies’ web sites do not link very closely together. (The only link is from the FDA to the NIH web site.) Each agency has made its own important individual initiatives like the Nature Genetics sponsored supplement and the Pharmacogenetics Research Network, but it would be more prudential to link together, both in the terms of the internet and the intellect, to examine the future of gene-targeted drugs from the pharmacological (FDA), genetic (NIH), and genomic (HGP) perspectives. Perhaps medical and scientific representatives from each agency could form a consortium (call it a ‘Pharmacogenentic/genomic Research Network’). This consortium could initiate joint research projects and issue joint reports to the public, in widely circulating journals like Nature, but also in periodicals more targeted at laypeople like daily newspapers or general news magazines.

The hope is that each agency would balance the others, sharing information and providing a more rigorous environment of standard-setting. As Charles Rotimi points out in his position paper, this rigorous environment was not a part of A-HeFT, and the standard-setting government agencies should held accountable for it: “We also advocate for greater accountability for substantiating and conveying truths about what the BiDil clinical trials has and has not demonstrated, especially on the part of an institution such as the FDA, established to protect the general US public interests.”

Not only would a joint consortium help these agencies respond to the call for greater accountability, it would help set an example for drug companies and the inevitably more multidisciplinary clinical trials they will hold as genetic technology becomes more affordable and reliable.

Reservations/Weaknesses

I. Labeling/Package Insert

A resolution for an issue as complicated and as far-reaching as that of how to deal with race in pharmacogenetics/genomics—of course it will have its detractions. The part of this resolution most vulnerable to argument and controversy is that of labeling, since they are the frontline of consumer connection—the thing that most immediately influences doctors’ and patients’ understanding of a drug. Some might argue that my proposal adding Duster’s and Rotimi’s caveats to the package insert is too subtle—why not add a large label to the package, like with European cigarette boxes? Others might argue that there should be no label at all, for this would bring attention to the racial controversy surrounding drugs like BiDil. I gave the first argument long thought, since I originally meant to use it. But the large label on a cigarette box reflects that all health professionals agree that smoking is bad for a person’s health. The same can not be said of race in clinical trials—as we have seen, stakeholders on this issue hold their stakes all over the map. Using a large, simplistic label would overstate the issue of race in one direction or the other: either ‘the use of race is good’ or ‘the use of race is bad.’ As for the second argument, which basically supports BiDil’s current insert—a careful reading of the insert shows that not enough is done to place A-HeFT, a trial based on socially-defined criteria, in a proper social context. Not to balance the explanation of A-HeFT with a subtle social explanation might leave BiDil to languish in a sort of conceptual ethnic bin.

Another argument is that the real trouble is not with BiDil’s package insert, but with NitroMed’s marketing. Though some news articles say that BiDil’s makers ‘warn against ignoring genetics’ (Jewell), a look at NitroMed’s BiDil web site, http://www.bidil.com, shows that NitroMed is ignoring its own warning—the home page of this web site has a slide show of black people embracing each other and highlights the phrase “solely on African Americans with heart failure.” To that, I say that while its marketing strategy feels a little exploitative, to try to police NitroMed’s marketing too closely would start to infringe on the its right to freedom of speech. Ultimately, I also don’t think it’s a generally profitable business practice—it might make sense for a small company like NitroMed, looking to resuscitate itself, but it doesn’t make much sense for a more powerful company to limit itself to a niche market.

II. Uniform Clinical Trials

At first, I thought it was inappropriate to use race at all in clinical trials, and some might still argue this point: why use race at all in clinical trials? After coming to the understanding that race is helpful geneticists in a limited, temporary, complicated way, it seems that what was inappropriate about A-HeFT was that it accentuated race without acknowledging its limitations. The same can be said of BiDil’s marketing now. To make clinical trials more uniform—where many races are tested, and in that testing, race is always a factor, but just one of many factors—would help to de-accentuate race in light of its limitations. Matching the use of race to the U.S. Census seems very useful—in the census, race is considered but it is not the only thing considered.

A larger concern is that using many factors in clinical trials will be possibly unreliable, expensive, and lead to greater liability on the part of companies. This concern does not apply as much to factors that subjects will identify themselves, like race, age, etc, but it does apply to the genetic analysis of blood that subjects will be more likely to supply in future clinical trials. These are all major concerns, which is why progress will have to be slow and careful, and another reason why an interagency consortium of the FDA, NIH, and HGP would be so helpful. There are some additional developments that do address these concerns. In that genetic testing is unreliable, it seems that the reduction of this is the major goal of genetic technologists, and like with most technology, that which is unreliable usually becomes more dependable in a short few years’ time. In that this testing is expensive, with the current knowledge that a key group of drug-metabolizing enzymes is the P450 family, some genomics companies are starting to manufacture DNA microarrays that focus on nucleotide polymorphisms that influence this family (Abbot 762). This is much less expensive and more relevant (as far as drugs are concerned) than sequencing a person’s entire genome. And that sequencing may become exponentially faster sooner rather than later. A new DNA sequencing machine just released by 454 Life Sciences of Branford, Connecticut, can sequence DNA in 0.1% of the time it took to just ten years ago and at 25% of the current cost. It uses the chemistry of fireflies to generate a flash of light every time a unit of DNA is correctly analyzed. This light is detected by the same chips used by telescopes to detect faint light from faraway galaxies (Wade).

Finally, when it comes to liability, genetic testing in clinical trials may help reduce adverse reactions in earlier stages of drug testing—helping companies to avoid Vioxx-style lawsuits. Right now, adverse and even lethal reaction don’t tend to a drug are less likely to be noticed in clinical trials than after a drug is widely released to the market. If common genetic polymorphisms can be identified among patients who have adverse reactions, this can be noted as a warning on the drug’s label and help doctors to eliminate these drugs from the regimes of patients with the polymorphism. The FDA is already starting to add genetic knowledge to the labels of drugs approved long ago, like the innately toxic cancer drug Mercaptopurine, first approved in the 1950’s. In the mid-1990s, William Evans and a tem at the St. Jude Children’s Research Hospital in Memphis identified three nucleotide polymorphisms common to patients with a life-threatening reaction to the drug. A note of these polymorphisms has since been added to the Mercaptopurine’s label.

III. Joint Consortiums and Better Linkage

The common complaint on bureaucratic agencies is that they are overly complex and inefficient. Might this apply triply to three agencies (or rather, two agencies and an agency-level project) if they were to form a consortium? Will the initiatives made by this kind of consortium just lead to more esoteric jibberish?

They certainly could, but it will all depend on how they are run. The Taiwanese law professors Wenmay Rei and Jiunn-Rong Yeh address this concern in their examination of the bioethics committee model for nations to deal with their individual bioethical debates:

“This paper argues that, to the foregoing concern, national ethics committees are both a problem and an answer, depending on what kind of committee it is. As a problem, it is similar to administrative agencies in that it has no democratic legitimacy. When they are set up under the penumbra of the administrative agency it is to advise, these committees in fact carry a lot of weight in the "advisory" opinion they make. How can we justify such further "delegation" in facto? What are these committees' relationships with medical professions and other stakeholders that have a strong interest in the policy-making of these issues? How can we better justify the legitimacy of ethics committee in a democratic society?

On the other hand, as an answer, when properly structured, these ethics committee could serve as an institution for dialogue and deliberation, to promote public consensus in a democratic society. It is this possibility that this article wishes to address.”

A problem or an anwer—a joint consortium could be both, but with careful structuring and a sure sense of purpose, a ‘Pharmacogenetic /genomic Research Network’ could be very much of an answer. Even if race were to become an obsolete testing factor with the advent of faster and cheaper DNA sequencing machines and analysis processes, a joint consortium will help to navigate the unknown territory of a dawning pharmacogenetic/genomic era.

The Real Stakeholders

This essay deals with several of the stakeholders in the debate over race in pharmacology, genetics, and genomics: companies, geneticists, physicians, and patients. But in that almost all of us will take some kind of medicine over the course of our lifetimes, and in that all of us have genes, genomes, and a racial and ethnic identity—we are all stakeholders, and it will do us all good to pay attention to this debate as it unfolds nationally and internationally. This essay has examined the American stakeholders and has proposed a uniquely American resolution, but it can be argued that with innovations in therapeutic cloning taking place in nations other than the U.S., like South Korea, Japan, China, Singapore, India, and the United Kingdom, the real pharmacogenetic/genomic revolution might take place outside of the U.S. Most of these countries are populated by those who are considered ‘minorities’ in the U.S., which could possibly render obsolute the uniquely American debate over race in pharmacogenomics and the way it couched in terms of ‘black African’ and ‘white European.’ Though western countries, currently the wealthiest on the planet, may be the first to benefit from any kind of genetically tested drug, those who are considered minorities in the U.S. actually make up the majority of the planet—clearly this debate will affect not only all races but all nations, perhaps not equally, but nevertheless irrevocably.

Works Cited

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Nature, Vol 425, 23 October 2003: 760-762.

Aldhous, Peter. “Geneticists Fears ‘race-neutral’ Studies Will Fail Ethnic

Groups.” Nature, Vol 418, 25 July 2002: 355-356.

Alonso-Zaldivar, Ricardo. “Heart Drug Targeted at African Americans Carries Lupus Risk.” http://www.latimes.com/features/health/medicine/la-na-drug2jul02,1,1552513.story?coll=la-health-medicine

Associated Press. "Race-based drug reflects importance of genes." 15 July 005.

http://www.msnbc.msn.com/id/8573015/

BiDil Package Insert:

http://www.fda.gov/cder/foi/label/2005/020727lbl.pdf

Black Informant Blog: Why I Am Opposed to BiDil.

http://blackinformant.com/2005/07/01/why-i-am-opposed-to-bidil/

Carter, Meredith. “Association of Black Cardiologists: BiDil Press Release.” http://www.abcardio.org/article_jun24.html

Collins, Francis S. “What we do and don't know about 'race', 'ethnicity', genetics and health at the dawn of the genome era.” Nature Genetics, November 2004. http://www.nature.com/ng/journal/v36/n11s/full/ng1436.html

Duster, Troy. “Race and Reification in Science.” Science, Vol 307, 18 February 2005: 1050-1051.

FDA Cardiovascular and Renal Drug Advisory Committee, BiDil Open Public Hearing, Day 2 Transcript, 16 June 2005 http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4145T2.pdf

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FDA publishes a Notice of Availability announcing the availability of a draft

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FDA Regulated Products"

http://www.fda.gov/OHRMS/DOCKETS/98fr/03-2162.htm

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