As a feminist working on bioethics, I often turn to the reality of material singularity as a way to argue for more specificity in our dealings with the matter of living bodies. What do I mean by “material singularity?” This term attempts to sum up the way that matter, and especially living matter, is the source of irreducible difference (as feminists like Irigaray and Grosz, along with other thinkers like Deleuze and Guattari, argue). Because matter itself is the source of difference, each body is singular and unique. No body is universal and no body is exactly like another. The inherent singularity of living bodies is often overlooked in Western medicine, but it cannot be effectively ignored. We see this singularity, for example, in the ways that each individual body reacts differently to medications and treatment. Clinical research in various fields, such as toxicology and nutrition, makes use of statistical aggregates and averages to attempt to overcome these singularities, but the fact that these methods are necessary shows that the singularity of living bodies is in fact irreducible. Sexual difference is a major (but not the only) example of an irreducible difference in living bodies. The fact that there is now a push to pay attention to sexual difference in clinical trials, an issue discussed in several IJFAB blog posts last week, is a huge step towards recognizing the importance of material singularity for providing just and adequate health care.
This commonly overlooked aspect of bodily life that I am calling “material singularity” has also taken a surprisingly central role in an intense political debate that has unfolded over the last year between the U.S. and Colombia regarding healthcare access, costs, and social justice. Like many other Latin American countries, Colombia has been developing policies to regulate the development and use of biotechnological drugs. Biotech drugs are produced using living human cell lines and are used to treat a variety of conditions, from wrinkles to Leukemia and rare blood conditions. Since 2013, Colombia’s ministry of health has been working on legislation that would regulate the use of these medicines while also enabling Colombia to begin to develop its own biotech industry, with the goals of making these medicines more available to its citizens while lowering their costs. As in other places in the world, increasing access and lowering costs happens through the development of generics. This is where things get complicated, because, as it turns, out, living cell lines cannot be precisely reproduced, especially when the original cell lines are protected by patents.
Material singularity actually makes developing any kind of generic version of a biotechnological medicine in principle impossible, a fact widely recognized in the medical research community. The cell lines used in biotech medicines are patented, so generics are made using different cell lines, which has huge consequences for both the biological structure and the clinical impact of the resulting drugs. The closest we can get to a generic biotech drug is something called a biosimilar, which must be proven to have a similar biological development and effect as the brand name drug. In the past 10 years or so, the U.S. F.D.A. and the European EDQM have created guidelines for the development of biosimilar medicines (in 2009 and 2006, respectively). In many ways these guidelines are just a preliminary attempt to balance the economic and social benefits of biosimilars against the risks of playing around with the unpredictable effects of living matter’s singularities. Because these risks are so high, current FDA and EDQM guidelines currently specify that each biosimilar must go through rigorous clinical testing; the clinical tests of the brand name cannot be relied upon to demonstrate the safety of biosimilars.
This is in itself a sticky issue, since if there were other ways to prove biosimilarity, those animal and human tests would be unnecessary and thus ethically problematic. For this and other ethical and economic reasons, in both the U.S. and Europe the possibility of an “abbreviated pathway” to approval of biosimilars is being explored. This pathway would use publicly available data and other kinds of non-clinical testing to determine whether the molecules and medicines in question are sufficiently comparable to the original. This abbreviated pathway faces many challenges, including the elevated risks for humans that come along with a lack of clinical testing, and the fact that much of the information available about biotechnology is strictly protected by patent and intellectual property rights.
In drafts of legislation creating similar guidelines for Colombia, the Colombian ministry of health also includes the possibility of an abbreviated path into their guidelines. Organizations representing the multinational pharmaceutical industries in both countries as well as the U.S. government have come forth publicly to state their concern for the health and welfare of the Colombian people who might be exposed to unsafe drugs approved through this “third pathway.” Vice President Biden even wrote a letter to President of Colombia, Juan Manuel Santos, in which he mentions the questionable safety of Colombia’s proposed regulations.
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This perspective might seem benevolent if it weren’t for the fact that such an abbreviated pathway is a topic of global discussion already, especially in the global North where biosimilars are already being approved for use. One of the arguments the biotech industries have made is that biosimilars need to be approved based on comparability to reference drugs (patented drugs) that have done clinical on trials on the Colombian population, rather than on foreign reference drugs (see this letter from the Bioetechnology Industry Organization [BIO]). This means that Colombian companies developing biosimilars would only be able to use research done by companies with patents in Colombia, a policy that appears benign but in reality would allow multinationals to retain control of the pharmaceutical industry in Colombia for at least a few more years.
All of the biotech drugs sold in Colombia are made by multinational pharmaceutical companies, many of them from the U.S. (hence the pressure on Colombia from Vice President Biden). The cost of these products in Colombia is far higher than in Northern (wealthier) nations. In some cases, they cost up to ten times as much in Colombia as they do in the U.S. or Europe. Although their use in Colombia is quite limited, Colombia still spends a billion dollars per year on biotech medications. In a country with many other important economic and social fish to fry, this is an appalling sum. Facilitating the development of biosimilars would lower costs and increase access in Colombia. Yet multinational and U.S. pharmaceutical lobbies have put intense pressure on the Colombian ministry of health to constrain the possibility of development by not allowing Colombian biosimilars to use foreign-approved drugs as referents when establishing bio comparability.
Somehow, the singularity of bodies becomes a matter of pharmaceutical concern just at the moment when it can help to protect the interests and the territory of multinational pharmaceutical industries in Colombia. The Colombian people, however, aren’t convinced that their bodies are somehow intrinsically different from those of the Europeans and northern Americans that provide the basis for clinical trials of foreign reference drugs.
What do you think?
(Note: despite intensive lobbying and international pressure, on September 18, 2014, the Colombian government finalized its guidelines for the regulation of biosimilars, including the possibility of an abbreviated pathway. See this article [in Spanish] for a summary of this story from the Colombian perspective.)
