Pharmaceuticals+-+Industry+&+Drugs

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“The United States is currently the largest market for pharmaceuticals in the world, with combined sales of OTC and prescription pharmaceuticals exceeding US$200 billion in 2007 .” //** Disposal Practices]


 * The pharmaceutical industry and the prescription drugs they create have increasingly become a source of concern for both developed and developing countries. When pharmaceuticals made it to the **** number 1 spot **** in profits on the list of **** Fortune 500 global companies ****, the concern only strengthened **[Carbone]. **Yet, pharmaceuticals are not simply a problem in the healthcare industry. From a sustainability standpoint, they create an entire matrix of problems across the board. The pharmaceutical industry and their drugs need to be carefully examined as we move forward toward a “greener” world.**
 * PHARMACEUTICAL INDUSTRY **** | **
 * Economic & Political Problems **


 * The economic and political concerns of the pharmaceutical industry are often so entangled that it is hard to separate these problems from one another, a problem that is further exacerbated by the introduction of the responsibilities of ethics. For example, the dramatic 70% decrease in US deaths from AIDS between 1996 and 1998 was due to the pharmaceutical industry’s development of antiretroviral drugs. Yet these life-saving drugs were **** priced between $10,000 and $15,000 **** per year – **** 10x their manufacturing cost! **** Is this a political problem within the governing structure of the company, or an economic problem due to the world’s concern with profit? Perhaps the problem is actually both, but the other side also claims that “the profits must meet ‘the cost of developing not only the drugs that work, but also the ones that do not.” In the US, the average pharmaceutical makes it to the market only after a decade and several hundred million dollars, and only 22% of drugs entering clinical trials make it to FDA approval **[Carbone].
 * How did we get to this point? The answer lies in **** Patent Protection **** . This concept has been essential to the growth of the pharmaceutical and biotech industry, as it is a high risk/high profit world. The United Kingdom suggested that in the absence of patent protection, UK pharmaceutical expenditures would be reduced by 64%, as opposed to an 8% reduction across all industries combined. An excellent example of the matrix of problems in patent law can be seen in the company Myriad Genetics. Due to patent protection, they basically enjoy a **** monopoly on diagnostic tests for breast cancer ****, not only in the USA but in much of Europe as well. No new diagnostic tests have been developed since they claimed their patent, nor could one be without Myriad’s approval. Not only does the pharmaceutical company claim their patents, but they are one of the fiercest industries in enforcing their patent rights as well. Once a lawsuit was even brought against South African attempts to distribute AIDS drugs that was in violation of patent law **[Carbone]. **It was eventually revoked after a large public outcry, but the fact remains the same: the industry is willing to go to great length to protect its investments and profits.**
 * Economically, there is a matrix of concerns as well. With spiraling costs, continual price pressure, import from low cost countries, and growing competition from generics, the pharmaceutical industry is constantly trying to maintain profit **[Federsel]. **Often this profit, however, comes at a much greater cost to those in need.** ** “Only 20% of global pharmaceutical products are sold in the developing world at all, and even those are typically purchased by the top 10% of the population. Moreover, these drugs, at least when made available on the commercial market, are often at higher prices than in developed countries.” Wide distribution of these drugs at a lower cost causes concern in the industry that a gray-market may develop for resale into other countries, undercutting profit ** [Carbone]. **. With uneven insurance benefits even in the developed world, the pricing power of these drugs is astronomical. In 2000, even the** ** Chinese biopharmaceutical industry **** was valued at **** US$870 million ** [China]. **Yet as long as “time to market” remains one of the highest priorities of the pharmaceutical companies, it seems unlikely we will see any change** [Federsel].


 * PHARMACEUTICAL DRUGS **** | **
 * Ecological Problems **


 * A large environmental footprint of pharmaceuticals are APIs, active pharmaceutical ingredients, in medications. There are two main types of ecological exposures to APIs: “long-term, low-level exposures of the aquatic environment to the on-going release of APIs via sewage and trash” and “acute poisonings made possible by unique, unforeseen circumstances, such as improper disposal of highly medicated animal carcasses or of unsecured medications in trash.” These types of exposures are caused by API exposure to the environment through two major routes: “consumers dispose of unwanted leftover stock, especially in sewers” and “as a result of their intended use – as a result of excretion of APIs not fully metabolized and as a result of washing away topically applied medications during bathing **[Daughton]. **” These two major routes show the extents of the problem; even those medications used as intended can still have unintentional environmental impacts. Both groundwater and agricultural food crops can absorb APIs, further exacerbating the problem for both humans and animals** [Daughton].
 * “Ecological exposure is considered adverse only when the effects are expressed at the level of an entire population; for humans, in contrast, any type of effect on an individual could be considered adverse if the exposure were unwarranted and not welcome.” These exposures are not even entirely understood, as there are thousands of APIs in use. Of these, only a small fraction have actually been looked for in environmental samples. This means that the actual effects on aquatic life as well as human life are unknown **[Daughton]. **Additionally, many catalysts used today to produce pharmaceuticals incorporate a heavy metal component such as osmium, palladium, and iron** [Federsel]. **This results in the issue of defining tolerable levels of residual amounts, and who is responsible for defining these levels.**


 * POSSIBLE SOLUTIONS? **** | **
 * The first federal guidance for consumer disposal of unwanted drugs was not enacted until February of 2007 by the White House Office of National Drug Control Policy **[Daughton]. **Increasing public education about pharmaceutical dangers is an important step toward protecting the environment. A more large scale move is necessary, however, in the education of physicians. They are currently taught how to treat ailments through the use of pharmaceuticals, often in schools that are partially sponsored by the pharmaceutical industry itself. By changing the way we teach our doctors, we can work toward a more sustainable medicinal practice of proper dosages and proper diagnoses. In terms of the industry, they have quickly seen that people will not stand for some of the unethical practices they work under. Patent protection may need to be loosened to ensure proper competition and allow the proper research to be conducted.**
 * MORE INFORMATION? **** | **** If you’d like more information on this topic, please visit the links below. There are many academic research articles available with a lot of good information. **

Pharma Planning to Dump Experimental and Controversial Vaccines in Public Schools [] The Pharmaceutical Industry Toasts to Your Health [] Lauderdale, J.W. "What Is the Pharmaceutical Industry Doing, and What Does the Pharmaceutical Industry Want from.." //Journal of Animal Science// 77.2 (1999): 367. []

Plant, Jane A., et al. "Chemicals in the environment: implications for global sustainability." //Applied Earth Science: Transactions of the Institution of Mining & Metallurgy, Section B// 114.2 (2005): 65-97. []

Sharma, Virender. Sustainability and Water. Associate Professor, Department of Chemistry, Florida Institute of Technology, 150 West University Blvd, Melbourne, FL 32901, (321) 674-7310, fax (321) 674-8951, vsharma@fit.edu, []

COMPLETE BIBLIOGRAPHY

** Sarah Barnard | Spring 2010 **