|
Pharmaceuticals, Genomics and Race (Politics)
By minerboy Tue Oct 25th, 2005 at 08:29:57 AM EST
|
|
|
The science of genomics is the study of genes and their function. Recent advances in genomics are bringing about a revolution in our understanding of the molecular mechanisms of disease, and are providing new ways for scientists to develop pharmaceuticals by targeting the specific genes, or the corresponding proteins responsible for the disease. The details of the process are summarized at Decision Resources. They write "Genomics-based drug discovery now offers the improved ability to identify greater numbers of drug targets. Genomics is based on the concept that a gene's function is to generate a certain effect or group of effects in the body. Genes achieve this functionality through the proteins they produce. Although the genes themselves might become therapeutic targets, the pivotal rationale behind this approach is that, by linking public genomic data with proprietary genomic sequence information, pharmaceutical companies can then launch a focused search for proteins expressed from these genes, providing additional therapeutic targets."
The new genomic approach to drug design may have a significant impact on the quality and scope of pharmaceuticals available, it also raises some important questions with regard to social justice, that is, how can you insure that certain groups of people are not disadvantaged with regard to drug development? It is conceivable that the pharmaceutical industry, driven either by profit or prejudice, will avoid developing drugs that will be vital to a minority population.
|
|
|
|
|
|
There are well documented differences in how different racial and ethnic groups react to certain pharmaceuticals. - Because African-American patients retain more salt and have a higher incidence of salt-sensitive high blood pressure, the use of diuretics may be more
effective in treating high blood pressure among black patients than among white patients.
- Many East Asians metabolize codeine differently than Caucasians, and the pain relieving effect is often lower.
- Ashkenazi Jews are significantly more susceptible to a potentially life-threatening blood disorder that can develop as a result of therapy with a particular drug used to treat schizophrenia.
- Asians and Hispanics with schizophrenia may require lower doses of antipsychotic medications than non- Hispanic whites to achieve the same level of the drug in the bloodstream.
An interesting example of the impact of race on the pharmaceutical industry, is the case of NitoMed, of Lexington, MA. The company specifically targeted efficacy within a racial group to get their drug, BiDil, to market. Previous studies of BiDil in the 1980s failed to show any significant benefit in a general population of heart failure patients, consequently it was not approved for use by the FDA. The results of NitroMed's most recent Phase III African American Heart Failure Trial (A-HeFT) of 1,000 African Americans, which was announced Monday, showed a 43% improvement in survival over standard heart failure therapy. In fact, BiDil is a combination of two generic drugs, isosorbide dinitrate and hydralazine, and is patented to treat heart failure. The targeting of the drug to African Americans has allowed the patent to be extended until 2020, 13 years more than otherwise and has been called the "first African American drug." NitoMed has the support of the Association of Black Cardiologists Committee on Heart Failure, while others are convinced that social inequities, not genetics, account for the differences in response to heart failure drugs between whites and African Americans.
A notable
opponent of the use of race in drug development, Jay Kaufman, an associate professor of epidemiology at the University of North Carolina School of Public Health, says "Undoubtedly, certain alleles are associated with responsiveness to certain drugs; and some of these alleles will be unevenly distributed amongst people of different ancestries. But this implies that drug treatments ought to be based on a person's allele, not on his or her "race." Using "race" as a substitute for "allele" in this case is tantamount to malpractice." Malpractice ? A perhaps more reasonable view from Borroughs et. al. (PDF) "race is an imprecise substitute measure of genetic differences among populations. However, the possibility of these differences should alert physicians that an alternate medication or dosage may be warranted for an individual patient."
Regardless of how specific genetic groups are classified, it is clear that the genetics of specific human groups are not evenly distributed. This may provide additional markets for the industry. For example, China is an emerging market, that has a unique genetic distribution. " The Chinese drug market is expected to be the world's fifth-largest by 2010, with $24 billion in annual sales, according to another report by Burrill & Company, which provides strategic analysis to life science companies interested in expanding into China." Given the size of the market, it is likely that drug companies will target drugs with greatest efficacy in the Chinese market.
At the same time, the pharmaceutical industry is becoming a globalized oligopoly. One of the main goals of the pharmaceutical industry is to standardize drug registration, or as the international conference on harmonization says "achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines." But, what if your country or region has a particularly unique genome ? Faced with this uncertainty, it is reasonable for small, isolated populations to look out for its own genetic interests. The Japanese, for instance, have begun their own Japanese genome project. Its objectives are "to determine where SNPs exist in genes influencing pharmacokinetics and how often they occur per 1,000 population in Japan. The expression and function of mutant proteins will also be studied. It is hoped that this will yield the basic data necessary to conduct research on drug responsiveness in the Japanese population."
Faced with global standardization on one hand, and market pressures on the other, it seems almost inevitable that those groups of people with a unique genetic makeup will not be well served by the pharmaceutical industry. The future utopian vision is of individualized medicine, where pharmaceutical teatments will be individualized based on ones' DNA sequence. But that dream belies the current realities of development, testing, and government regulation. Given the desire to standardize approval and patent regulations, it seems unlikely that personalized treatment will be practical for some time, if ever. A more likely scenario is that prevention, through prenatal selection for specific genotypes will be the prefered way to treat disease, with the possibility that individuals will be purposely selected that will have the most positive reaction with the set of pharmaceutical treatments currently available. For example, it is likely that parents will select children that are not allergic to penicillin. The current array of pharmaceuticals might act as a kind of template for the genome of future generations. This raises some interesting questions about the value of genetic distinctiveness among humans. We value genetically distinct animals, amd find it worthwhile to save species from extinction. Will this ethic translate to groups within the human genome? In the near term, it is conceivable that groups with a common genome will band together economically and politically to insure their inclusion in the development of new medicines. Can we count on organizations like the WHO to provide ethical guidelines that serve human genetic diversity ?
|
|
|