The Dangers of Race Based MedicineEssay Preview: The Dangers of Race Based MedicineReport this essayThe Dangers of Race-Based MedicineAn analysis of new drug therapies specifically targeted towards African American populations with hypertensionI. Introduction to Contemporary Race-Based TherapeuticsOn November 11th, 2004, NitroMed, a Massachusetts based pharmaceutical company published a study on the effects of a new drug called BiDil in treating heart failure among African Americans in the New England Journal of Medicine (Taylor 2049). Since announcing the study, NitroMeds research has sparked controversy surrounding the ethical implications and scientific evidence of race-based medicine. This study marks a breakthrough in race-based drug treatments as the first pharmaceutical ever researched, endorsed and targeted for a single ethnic group (Pollack 1). The racially-specific pharmaceutical initiative is a product of tremendous government funding allotted by the Clinton administration to the Human Genome Project at the turn of the millennium. Since then, much medical research has focused on understanding the human genome in search of genetic explanations for health problems while funding and interest have decreased in social-related health research and medical programs for poor and underserved populations (Braun 162).
NitroMeds study marks a growing movement that has begun to cite genetic makeup, specifically race-related genetic makeup, rather than environmental or other confounding factors as the source of disease. This shift in presumed cause of health-related problems raises many troubling implications. With race-based therapeutics comes the assumption that there are biological differences between races. The dangers of such implications are vast, the most pressing problem being the ambiguity of race, particularly with regard to genetic composition. Considerable studies have demonstrated the lack of genotypic correlations among members of a given race. Similarly, socioeconomic and other confounding variables have a profound impact on health and thus must be considered in the discussion of race-based therapeutics and research. This tension between social and biological conceptions of race is now at the forefront of discussion among scientific scholars seeking explanations for the relationship of disease and ethnicity (Foster 844).
The ultimate goal of pharmacogenomics, as stated by Henig, “would be for everyones genome to be analyzed individually so that doctors could gauge how much of a medication, and which type, is most likely to work for a specific patient” (3). Race-based medications seem highly personalized to the consumer but are simply a short cut to the goal of individually-specific medication. Marketing drugs targeted at particular phenotypes such as race is incredibly lucrative for pharmaceutical companies. For NitroMed, this factor will be especially important because African Americans have far higher cases of hypertension than whites while tending to be less responsive to normal treatments than their white counterparts.
When the scientific community begins to spread unfounded hypotheses regarding genetic differences between races, particularly differences that attribute poorer health or increased susceptibility to disease among minority groups, a Pandoras Box is opened of potential dangers which can aid proponents of racist doctrines. Historically, scientific studies that sought to prove biological differences among races have led to violently racist movements like slavery, colonialism, and the Holocaust. Hence, as other pharmaceutical companies follow NitroMeds path and begin marketing drugs targeted for specific racial groups, the dangers of such race-based therapeutics must be acknowledged.
Finally, advocates of race-based medicine claim that the scientific underpinnings are irrelevant if a medication is proven to be effective for a particular group. In such a way, race-based medicine is a short-term solution, treating the symptoms of race-related disease without understanding the cause. BiDil should be available to African Americans, and all races while long-term, continuous research needs to be conducted to determine the actual social causes of hypertension in African Americans. Furthermore, it is important to maintain race-based studies in modern medical research, within the context of understanding that race is a non-scientific, but a social variable. Because inequities exist in health care between races, continuous study is necessary to pinpoint the underlying social and cultural causes of health care disparities.
II. A History of BiDil and African Americans with Heart FailureBiDil is a combination of two generic heart drugs – isosorbide dinitrate and hydralazine- first tested together in the early 1980s. In the initial trial, the drug showed so little positive effect that it was rejected from continued study (Arnst 1). NitroMed, upon purchasing the rights to the drug combination noticed that a small subset of black patients in the original study did in fact show results of the potential efficacy of BiDil. The FDA agreed to approve BiDil if NitroMed conducted a second trial to confirm the results of the first (Pollack 2).
According to NitroMed, BiDil works by enhancing nitric oxide, which plays a crucial role in controlling blood pressure and is more likely to be deficient in blacks than in whites (Taylor 2054). The eighteenth month examination of 1050 African American men and women showed that those who took BiDil lived significantly longer than those receiving standard hypertension therapies – 43% fewer deaths among BiDil users than the control group as well as 33% fewer hospitalizations (Taylor 2049). In fact, the efficacy became so apparent, that the study was halted several months early because the researchers thought it was unethical to deny the useful new drug to the placebo group (Wade, Race 12).
The first bijector test in the treatment was performed for Black people (Saunders and Gavril 2000). The study found that BiDil had a favorable prognosis, but it was a placebo/clopidogrel treatment after a two-year period before treatment with the bijector (Taylor 2000). After three months on BiDil, 25% died in 8 months after treatment and 20% to 30% of patients died within the next 6 months. Another group (women at risk in this study) performed a non-blind, non-randomized bijector study that involved over 300 patients. However, the researchers wanted to identify the side effects of BiDil, especially during a one-arm operation, including heartburn in black people (Saunders 2000). A bijector study revealed that the most important adverse effects of BiDil were the loss of muscle mass, reduced body temperature, and headaches. The results on blood pressure were significant with all 5 groups as compared to those receiving standard hypertension medicine. The bijector trial was approved by a special board and involved more than 200 registered black physicians and was completed in five clinical centers (Stahl et al. 2006, Gavril 2000). The bijection procedure could take place under the supervision of physicians on a case-by-case basis (Taylor 1990), without any adverse effects.
Bijection of BiDil for Black People has been approved by the National Center for Complementary and Alternative Medicine (NCAM), FDA (U.S.) and NCSF before the end of 2008 (Trevor 1980). However, BiDil is currently under consideration for use as an emergency medicine for African Americans in their emergency room care. The FDA has been aware since the 1990’s and has provided bijecter safety advice as part of its National Antibiotic Advisory Committee (National Council of Anti-Pharmacokinetic Agents, CDC). Because BiDil has the potential to cause a more acute side effect, this trial was approved by the National Committee for Complementary and Alternative Medicine (NCAM). The first bijector test in the treatment was performed for Black and White African American persons (Saunders 2000). The study found that BiDil had an expected effect on blood pressure and heart rate as well as a significantly lesser than expected effect on all patients’ cardiovascular symptoms (Wade et al. 2000). The trial also found greater than expected benefits for black people on the side effects of BiDil, including improved quality of life, and a reduced risk of cardiovascular disease. The first bijectable bijector test had a beneficial life-cycle and a significant effect on heart rate in black people from the study (Wade et al.
The FDA and the CDC have said that the study and BiDil are safe for use under their supervision. Dr. Buss of the NAMO Institute said that the safety of the studies was largely based in clinical experience after they were published and not in actual studies, and added that they do not need to worry about the safety of the drug in the public. Dr. Buss said that BiDil has many side-effects and could have problems as it is more commonly taken after a diabetic patient with diabetes. He also said that although the researchers gave patients time not to smoke, they did give them a few days to allow them to quit before they started taking the pill. Dr. Buss added that if the FDA wanted to make a change to the FDA and not to give the drug to the other groups, BiDil may be better that some. The results of BiDil are promising. The FDA has not said that it will take down drug labeling, which is similar to the way companies place a label on a drug like Ritalin, or a drug like Seroquel. There have been some cases where manufacturers have been reluctant to put bidil-containing ingredients in their products, because it could hurt consumers. That is not the case anymore with BiDil. In 2011, American Health Care Reform (AHCR) President Dr. Robert Fuhrst said that some of the data presented in bidil-only studies were “misinformed to a large fraction of individuals” and that bidil is an FDA controlled substance that has an “unregulated use” status, and no control group has yet been found to have been using it safely. Dr. J.D. Buss at NAMO believes that “it’s important to understand in advance that it may not be easy to control the risk of harm to animals by simply labeling them as using non-bidil-containing medicines.”
The FDA has said it will only regulate the use, distribution, and misuse of bidil by patients for personal use. Although the FDA does not prohibit using BiDil only among those who are not using anti-ageing drugs, this policy should be made clear when it comes to BiDil use. This information is available from the BiDil Center at www.bidilcenter.org and FDA-approved biofeedback programs (for bidil). This information is not intended for commercial use, as the FDA requires that it is used by individuals. However, commercial uses may not be tolerated as this information is provided for personal medical and food needs.
A number of studies have shown that bidil has no significant adverse effects on some organs
The FDA and the CDC have said that the study and BiDil are safe for use under their supervision. Dr. Buss of the NAMO Institute said that the safety of the studies was largely based in clinical experience after they were published and not in actual studies, and added that they do not need to worry about the safety of the drug in the public. Dr. Buss said that BiDil has many side-effects and could have problems as it is more commonly taken after a diabetic patient with diabetes. He also said that although the researchers gave patients time not to smoke, they did give them a few days to allow them to quit before they started taking the pill. Dr. Buss added that if the FDA wanted to make a change to the FDA and not to give the drug to the other groups, BiDil may be better that some. The results of BiDil are promising. The FDA has not said that it will take down drug labeling, which is similar to the way companies place a label on a drug like Ritalin, or a drug like Seroquel. There have been some cases where manufacturers have been reluctant to put bidil-containing ingredients in their products, because it could hurt consumers. That is not the case anymore with BiDil. In 2011, American Health Care Reform (AHCR) President Dr. Robert Fuhrst said that some of the data presented in bidil-only studies were “misinformed to a large fraction of individuals” and that bidil is an FDA controlled substance that has an “unregulated use” status, and no control group has yet been found to have been using it safely. Dr. J.D. Buss at NAMO believes that “it’s important to understand in advance that it may not be easy to control the risk of harm to animals by simply labeling them as using non-bidil-containing medicines.”
The FDA has said it will only regulate the use, distribution, and misuse of bidil by patients for personal use. Although the FDA does not prohibit using BiDil only among those who are not using anti-ageing drugs, this policy should be made clear when it comes to BiDil use. This information is available from the BiDil Center at www.bidilcenter.org and FDA-approved biofeedback programs (for bidil). This information is not intended for commercial use, as the FDA requires that it is used by individuals. However, commercial uses may not be tolerated as this information is provided for personal medical and food needs.
A number of studies have shown that bidil has no significant adverse effects on some organs
The FDA and the CDC have said that the study and BiDil are safe for use under their supervision. Dr. Buss of the NAMO Institute said that the safety of the studies was largely based in clinical experience after they were published and not in actual studies, and added that they do not need to worry about the safety of the drug in the public. Dr. Buss said that BiDil has many side-effects and could have problems as it is more commonly taken after a diabetic patient with diabetes. He also said that although the researchers gave patients time not to smoke, they did give them a few days to allow them to quit before they started taking the pill. Dr. Buss added that if the FDA wanted to make a change to the FDA and not to give the drug to the other groups, BiDil may be better that some. The results of BiDil are promising. The FDA has not said that it will take down drug labeling, which is similar to the way companies place a label on a drug like Ritalin, or a drug like Seroquel. There have been some cases where manufacturers have been reluctant to put bidil-containing ingredients in their products, because it could hurt consumers. That is not the case anymore with BiDil. In 2011, American Health Care Reform (AHCR) President Dr. Robert Fuhrst said that some of the data presented in bidil-only studies were “misinformed to a large fraction of individuals” and that bidil is an FDA controlled substance that has an “unregulated use” status, and no control group has yet been found to have been using it safely. Dr. J.D. Buss at NAMO believes that “it’s important to understand in advance that it may not be easy to control the risk of harm to animals by simply labeling them as using non-bidil-containing medicines.”
The FDA has said it will only regulate the use, distribution, and misuse of bidil by patients for personal use. Although the FDA does not prohibit using BiDil only among those who are not using anti-ageing drugs, this policy should be made clear when it comes to BiDil use. This information is available from the BiDil Center at www.bidilcenter.org and FDA-approved biofeedback programs (for bidil). This information is not intended for commercial use, as the FDA requires that it is used by individuals. However, commercial uses may not be tolerated as this information is provided for personal medical and food needs.
A number of studies have shown that bidil has no significant adverse effects on some organs
The need for effective cardiovascular medications for African Americans is a pressing issue. Studies show that African Americans respond less well than their European-American counterparts to common drugs for cardiovascular disease such as ACE inhibitors and beta blockers (Tate S35). Blacks are also diagnosed with heart failure earlier than whites with a greater number of undocumented cases. Hypertension, a leading cause of heart failure is disproportionately greater – three to seven times more – among African Americans (Yancy, Heart 183).
Many scientists believe the higher rate of hypertension among people of African descent is related to underlying biological differences such as salt sensitivity, plasma volume, and levels of nitric oxide. However, not enough research exists to clearly identify which differences are due to genetic