Of all the concepts talked about in the readings that I did this week I was most interested in the recycling and dumping of pharmaceuticals that had failed their initial tests. Petryna talked about how a specific anti-depressant that failed in a different trial was being shipped down to Brazil to try to be salvaged. The drug was seen as useless and abandoned by the drug company. The Brazilian scientists knew the results of the failed antidepressant drug and its attributes. Once they had seen the previous results they wanted to test the drug in higher dosages and possibly pair it with a hypnotic drug. The researcher talked about how the drug was nothing more with the hypnotic drug. They were about to test this combination drug but a law enacted save this drug from going into a second stage. The doctor was happy about this new law because it saved her from doing something she considered unethical. Why would she do this unethical thing and it took a law to stop her?
When I was reading this part it really disturbed me. I wanted to dive into this idea of how tests are recycled and reused and retested to find out if the failed drug has any worth. I found this article online that showed how a drug company Lilly has seen many failures and survives on redesigning, coupling and repackaging there pharmaceuticals. “Many Lilly drugs have risen from failure. Evista, now a $1 billion- a-year drug for osteoporosis, was a failed contraceptive. Strattera, a hot-selling drug for attention deficit/hyperactivity disorder, bombed out as an antidepressant.” Some of the drugs that have seem failure and were recycled through the Lilly Company. These include some familiar names Strattera; Failed in depression studies, Evista; Failed for birth control, Alimta; Trial had been stopped, Cymbalta; Failed at lower dose, MEPM; Failed for psoriasis, Gemzar; Failed as antiviral agent, PPAR-alpha agonist; failed asthma trial, Ghrelin blocker; failed frailty study. All of these failed drugs were fixed, changed in some way, remarketed and put on the market. These reasons for failure were not as severe as the antidepressant in the case however the descriptions of why these drugs failed are to be interpreted. Did theses fail because of a lower dose of fail because the lower dose did not work and produced adverse side effects? Also what does frailty mean exactly in context of a medical trial. (Burton, 2004) The article put this company in good light because it turned its waste into a profit however I’m not fully convinced this drug company is as nice as it seems. “Lilly's chief scientific officer, initiated "failure parties" to commemorate excellent scientific work, done efficiently, that nevertheless resulted in failure.”(Burton 2004). This article was written in a business newspaper however it really showed how many of these recycled trials are changed into a successful product. No money is wasted.
The chapter started out with the concept of a global trials being registered. Petryna points out that although this would help the world immensely it has a lot of baggage. The issues that keep this from being well used and embraced are numerous. The resistance that the drug companies to give out this data, how in depth this data is going to be, who will fund this large endeavor and finally who enforce this compliance. Currently in the clinical trials industry there is a lot of secrecy and uncertainty. The FDA does not even know how many trials that are being done or the amount of trials that are being done per application. There is “no standardized format” (Petryna 91).
Poland was the next big trials market a few years ago. Petryna interviewed many people who were involved in different aspects of the polish clinical trials industry. The main person that helped her was a Dr. Mazur. He was one of the influential people in the polish trials industry. He was a cardiac doctor who specialized in finding patients and redesigning trials to be safer, quicker, and more specific. Dr Mazur set up interviews with his colleagues who were both good and bad. He mentioned that that bad ones weren’t bad they were just too opportunistic.
He gave Patryna the names of the good, ethical doctors. These doctors were concerned with getting the most quality patients, the safest possible environments, and the patients that actually had the specific diseases that were on trial. Some of the doctors that Dr. Mazur recommended Patryna speak with were not as ethical. These doctors were concerned with kickbacks that pay many times there public salary. They are also concerned with getting contacts. “Companies leave it up to their contractors to evaluate drug study protocols for their safety and to assess their own ability to execute the studies” (Petryna, 133). Because of this contractors can use ethics loosely to lower costs. This puts the trials industry in a grey area.
Insurance was a large issue talked about in this chapter. It was made clear that by off shoring and outsourcing to Poland and other countries made the large drug companies immune to the possible disaster of a drug incident. “Patients sign consent forms, but protection is a fiction” one Brazilian officer said. Piotr a lawyer for a large drug company saw 3 cases since 2003 which in his mind was a lot in comparison to the previous years. I found this very funny because of the hundreds of thousands of trials worldwide and the number of people in these trials is so great there were only 3 in the past few years. The main type of insurance is a claims based insurance that gives the patient the large task of making their own claims. This type of insurance does not give patients much power. Overall this section of the book went into “tracking trials, maintaining scientific integrity, and minimizing research related harm” (Petryna, 138). Poland was at its peak and now clinical trials are moving elsewhere. I only hope that the next frontier learned from there predecessors.
Adriana, Petryna. (2009). When Experiments travel. New Jersey: Princeton University Press.


Burton, Thomas. (2004, April 21). Flop factor: by learning from failures, lilly keeps drug pipeline full;. Wall Street Journal, A1.

http://www.southparkstudios.com/episodes/103576


When we were in class we began to talk about how kids are being over prescribed and causing many problems. It reminded me of this South Park episode, that played about 10 years ago. Please, if you have time, watch this episode. The overall theme is that we prescribe too many drugs for all the wrong reasons. It’s about a boy, Timmy, who is diagnosed with ADD (attention deficit disorder) and eventually all the kids in the city are diagnosed with ADD. Everyone is on Ritalin and completely whacked out.

This episode just illustrates the idea that Americans are over prescribed. We are over prescribed because of the kickbacks that drug companies get, overprescribed because doctors depend of pills to cure all and if one pill doesn’t work then the doctor will try another pill, and because Americans are trained from birth to take the medicine and it will make everything better. This is why Americans also abuse prescription drugs. How does this tie in to the book When Experiments Travel by Adriana Petryna? The point I am trying to explain with this example is that Americans are very dependent on drugs. Petryna said that Americans are not ideal candidates for drug testing because our bodies are so intoxicated with drugs, hormones, and many other bad things that make our results skewed and or wrong during drug trials. This can also cause reactions that drug companies do not want such as mixing drugs or canceling out desired results.

My second example is not a specific example. I am going to explain how statistical materials can be easily skewed and how the wording of statistical results can be changed into desirable results. Correlation can show that two variables are related. The results can be manipulated using size comparables and graphs to show how well they correlate whereby the correlation might be insignificantly small and unimportant. This result would be statistically significant, however the difference is small enough to be utterly unimportant. “Many researchers urge that tests of significance should always be accompanied by effect-size statistics, which approximate the size and thus the practical importance of the difference.” (Wiki)
Other few of words that are thrown around that many people don’t understand are correlation and causation. "Correlation does not imply causation." It is a phrase used in science and statistics to emphasize that correlation between two variables does not automatically imply that one causes the other. The opposite belief, correlation proves causation, is a logical fallacy by which two events that occur together are claimed to have a cause-and-effect relationship.”(Wiki) Many companies including drug companies use this language and techniques to hide results or give false hope to customers. Technically, they are not lying about their product, however they know that most people don’t know the difference in the meanings so they use it to their advantage.
As you can see in the graph the results are exactly the same. When you see the first graph you would see a clear winner but if you saw the second graph you would think that all products were created equal. This is one technique used today to convince people that their product is better.
In the first chapter of the book, Petryna provides a light overview of many of the problems that clinical trials cause and face in the United States and the world. Problems Petryna wrote about were the ethical aspects of giving care in the form of clinical trials to patients that have life threatening illnesses and most likely poverty. There are many reasons why these patients should not be used. For one they are faced with the option of trying experimental drugs that could hurt them or potential death or the inevitable death that would come from their disease. Another reason why these people are not good candidates is because they use these trials for medical care when their own government has no way of helping. People should not have to be put into these situations.

Saturation of human subjects was another thing that clinical trials face. Trials need a large pool of people to test on; also there are a large number of trials being done all over the United States. The competition to grab these people with the symptoms of the desired disease is always being fought over because the pressure to innovate is extremely high. “Regardless of how many Americas are ready to become trial subjects, the pool will never be large enough to satisfy the current level of demand in pharmaceutical research (Petryna, 22).” Petryna later introduces the CRO’s, contracted business organizations, whose sole purpose is to research, that is outsourced by the trial companies, in order to save money. She also introduced the FDA and their numerous rules and regulations to help protect patients and citizens.

In chapter two Petryna tries to give us a history of how clinical trials have evolved and some reasons why these trials are moving oversees. She starts out the chapter with an interview with Dr. Besselaar. Dr. Besselaar, a doctor who has been around the pharmaceuticals industry forever, gave accounts of specific instances and milestones in the clinical research that shaped how it is today. It started out with the thalidomide experiments. This drug was supposed to treat morning sickness in pregnant women and help them sleep. This drug however had horrible side effects that caused deformation in the babies of these pregnant women. “That was really the situation that set the regulators on their course to make the whole process of drug approval and therefore the regulatory affairs business much more rigid than it was before” (Besselaar 55). A little later, Petryna describes techniques of how to show results that are desirable. Such as engineering out harm, meaning choosing only patients that will show good effects and hide bad effects. She also touches on the use of statistics, and how some organizations ignore bad results and hide them. In the past, the pharmaceutical companies have enjoyed phenomenal success. Recently in the US there has been a decline in the profitability. “The intense amount of litigation the industry faces in the United States also reflects, “the fundamental abandonment of the scientific method as it is not being tailored to prioritize safety, it’s a lottery game” (Petryna 87).

In the first two chapters of this book Petryna sets the groundwork of the rest of the book. She sets up the history and reasoning why clinical trials are moving and what that will do to the pharmaceuticals industry.

Parker, Trey. (Photographer). (2001). Timmy 2000. [Web]. Retrieved from http://www.southparkstudios.com/episodes/103576

Misleading. (2008). [Web]. Retrieved from http://www.k12science.org/ciesemath/misleading1.jpg

Correlation and dependence. (n.d.). Retrieved from http://en.wikipedia.org/wiki/Correlation

Adriana, Petryna. (2009). When Experiments travel. New Jersey: Princeton University Press.

Military

The Life sciences, as Melinda Cooper and many other authors we have read have said, are the future of the world in the aspects of bioeconomy. Life is the new frontier replacing the industrial world. Recently the life sciences had found its way into the military.

The National Guard is the mostly volunteer military branch that is basically our reserve troops. These people are trained to fight but it seems that in an emergency they are the first to respond. This means that the National Guard can be mobilized any time natural disasters or other emergencies occur within America’s borders, and also serve alongside U.S. combat forces in other parts of the world (national guard, 2010). This is strait from there website. To assist in natural disasters and emergencies is mostly what they do. Today’s military is controlling these situations with military precision. Should the military be involved on these matters of health and safety? “Skeptics of the military mission at home question whether this signals a "creeping militarism" into our civilian culture (Morrisey).” Recently the National Guard was deployed to Hati to help with the emergency relief. This is normal to Americans to see the National Guard and other military forces helping the needy. Another recent story of the military “helping out” was the H1N1virus scare. The military had made a plan to coincide with FEMA to help with “anything civilian authorities could not”(Starr). I found a clip of this to summarize this possible action. However it is very opinionated keep that in mind.

Melinda Cooper defines a Complex emergency is a breakdown of water, sanitation, and public infrastructure. The idea of biological warfare, infectious diseases and natural disaster are now considered military issues and will be carried out in a militaristic way. Cooper describes the militarization of these issues and the complications with militarization. In the height of the aids crisis it was made clear that it was a problem and that the military would be utilized.

In the recent two decades the aids epidemic in Africa has been profound. The Aids fight went from a disease into a political war, with the large powerful drug companies fighting against the Mbeki. The war was over the rights to distribute cheap drugs to the infected people and basically it all boiled down to patent law, the WTO and the Trips agreement.
Patents are exclusive property rights in intangible creations of the human mind. They
exist only as provided in the laws of sovereign states, and can be enforced only to the
extent that application has been made and a patent granted covering the territory of an
individual state. The TRIPS Agreement permits such compulsory licenses in health emergencies, even in cases where the compulsory license is for an imported product. However, to date, no compulsory licenses actually have been issued. This was the basis for the courts case of the Mbeki v the drug companies. The drug companies tried as hard as they could and got the American people behind them to fight against the possibility of the emergency act happening (Lehman). In the case the Mbeki people did win however they did not act on that win.

One small part of the act that I found interesting was that Drugs exported under such a regime may (must) be packaged or colored differently to prevent them from prejudicing markets in the developed world. The creation of this invisible separation of the people who are rich and poor illustrate the power of the people. Is this because the drug companies want their products that are sold in the US to be seen as better or is it to combat the idea of collusion.

Back to the Case the idea of Debt imperialism comes into play. What does debt imperialism mean? Imperialism is a concept that has been around for centuries. It is the act of putting influence over another country. Debt is defined as owing someone. In the case of the Aids epidemic and the African people it allowed America to have significance influence over the developing world because of its power in patents, and power of lobbying for international law. The very juncture that enabled the United States to reconfigure its imperial power on the basis of perpetually renewed debt at the same time brought impossible debt burdens to many countries of the developing world (Cooper, 53). These debt burdens force people in these countries to prostitute, deal drugs, and sell there bodies keeping the cycle going. Why in the intro did I talk about militarizing? Well in the history of the United States we have had many wars. Revolutionary, civil World wars and so on. Today the wars fought are as Cooper put it “the most immediate threats to security are no longer those of a formal military nature. Rather, we are confronted with a plethora of everyday dangers (Cooper, 64). She is saying that biological, life sciences and biowarfare are the wars of today and the future. Aids were one of the first things to be named a military issue that was not of the traditional sense.

Another idea that Cooper talked about was the hype of the possible future, not only the future but the possibility of catastrophe. What to do and if we have already started the slow descent toward a catastrophe of biological nature. The fear of the future and the possible catastrophe has made us do strange things. There are CAT bonds for sale that basically insure the uninsurable. We are trying to predict things that have no real basis of fact. “think the unthinkable and quantify the unquantifiable” (SwissRe 1998). People are trading, prying and profiting on the fear of the future, fear that is only based on the scariest thought that our minds can come up with. Because of this mass hysteria people have decided to do things defined as preemption. Preemption transforms our generalized alertness into real mobilized force, compelling us to become the uncertain future we are most in thrall to.(Cooper, 89) The uncertainness of the future and the expectedness of the future makes us become crazy and putting the military in as a mobilized force might not be as good of an idea as it seems.“Microbial life will overcome our defenses, and yet we can never be sure when and how it will happen: “At some unpredictable time and in some unforeseeable manner nature will strike back (Ibid., 267)”

The First picture I choose was the one of the National Guard member in front of the plane on an air strip in Hati. This picture just represents the militarization of complex emergencies.

Works Cited

Krenke, Ellen. "National Guard ready to help Hati." (2010): Web. 21 Feb 2010. .

Morrisey, Siobhen. "Should the Military Be Called in for Natural Disasters?." Time Magazine (2010): Web. 21 Feb 2010. .

Starr, Barbra. “Military planning for possible h1n1 outbreak.” Time Magazine, Retrieved from http://www.cnn.com/2009/US/07/28/military.swine.flu/index.html


Lehman, Bruce. "Should the Military Be Called in for Natural Disasters?." Pharmaceutical Industry and the Patent System (2010): Web. 21 Feb 2010. .

What is the Guard. (n.d.). Retrieved from http://www.nationalguard.com/life/what-is-the-guard

Military planning for h1n1. (2009). [Web]. Retrieved from http://www.youtube.com/watch?v=InX-0qvc2ww

In the past we had the industrial revolution. This was an era based on production, oil, commodities, hard labor. The era moving in is the quest for biological solutions. “ The 1980’s was a period in which the U.S petrochemical and pharmaceutical industries embarked on a dramatic self-imposed makeover, reinventing themselves - at least prospectively – as purveyors of the new, clean life science technologies ” (Cooper: 22). The shift into the future will not be industrially led it will be led by information, and science. The life sciences or the biological sciences will lead the future. “ Profits will depend on the accumulation of biological futures rather than on the extraction of non renewable resources and mass production of tangible commodities ” (Cooper: 24).Cooper talks about how the neoliberalsism is alive and well in the US and it is not only the result of politics it is a result of many things. Such as the change in the way our economy operates the type of work that is now being done, and the future promises of sustainability. The result of this thinking is a future that looks like this. “ This is a strategy that looks to the future to recuperate the costs of ecological depletion, while accelerating the actual production of wastes in the present ” (Cooper 49). Cooper points out that we are creating a cycle of new products to clean up our messes. We are promising the masses of a better world and going about everyday life recklessly, hoping that in a few years there will be a biotechnological solution to our problems. We are not solving problems we just changing them.

The definition of Neoliberalism is “ a program for destroying collective structures which may impede the pure market logic,” as put buy Pierre Bourdieu. In other words it is a movement toward the slow deregulation of rules and laws so that the market can operate freely have pure competition. This deregulation is almost always pushed for by the large companies that want free reign, through lobbying, and supporting certain people who have power to change the rules. This is also very common with large powerful companies globalizing and going overseas. There the company has power and reputation, then the company uses its clout to sway politicians to deregulate. You can easily find out if you know this concept and participate in this debate if you ask yourself what political party you are a part of. We face this battle every four years in the elections. One political group wants pure markets, and the other wants some form of government rules. This is why neoliberalism is now being talked about. We can see the effects of neoliberalism in everyday life and it has become more and more prevalent in the recent years. There has been deregulation of banks, energy, airlines, home mortgages, and many more.

In the past the government in the United States had some power over banks and the amount of lending and interest rates that were given out to people who had certain credit ratings, income levels and ages. Recently we have seen a very bad turn in the economy. It is not entirely because of the housing crash but it is defiantly related. The reason of the housing crash was the deregulating of banks. This led to many bankers lending to very risky people and only in the mindset of profifts. I very bad situation came out of this. People lost jobs, homes, the ecomony suffered. This is an example of the concept of neoliberalsim and Coopers ideas about how deregulation causes problems and creates waste. In this example it is peoples talent and lives at waste.

It was Adam Smith who introduced the idea of the invisible hand. I have heard this concept in so many of my business classes. The idea that economies should be left alone and not have governmental interference or regulation, because in a perfect competitive market every industry will eventually even out and produce the best situation for everyone, eliminating the weak and the strong are thriving. The thought is that increased competition will lower prices and make a better product improving for everyone. The problem is that no market is perfectly competitive. This is because one company has a property right, certain assets that are rare or there is some collusion. To many people who don’t understand the whole picture it sounds like a good idea. However like I said before no market is perfect. Because of this there will be a market leader who will own the business. This company will them have power. With this power it will use all of its power to deregulate.

How does this creep its way back into the biotech industry? Promises are being made for the future on the basis of the life sciences making organisms that can eat pollution, eat garbage, and create new forms of fuel. The biotech industry is our solution to all our wasteful problems. Is it really? What are these hybrids, cloned, test tube made things doing to our world? We have no idea. Our idea is that we can make these things that change the environment and if it satisfies us for now it is great. They will make something new if this thing produces a bad side effect.

The images I choose I thought represented the idea of neoliberalsim. The first is just a representation of what it means more of the definition. The second image I choose was the consequences of neoliberalism in a comedic way. The final image I wanted to show is the globalization effect. It has a hold over all of us and is unstoppable. The global companies push for pure competition and in turn creating waste.


"Scientist." Business Line. Web. 15 Feb 2010. .

"Break Freeeeeee." Web. 15 Feb 2010. .

Cooper, Melinda. Life as Surplus Biotechnology & Capitalism in the Neoliberal Era. Seattle/London: University of Washington Press, 2008. Print.

Bourdieu, Pierre. Web. 15 Feb 2010. .

"Globalization." Illuminati-News. Web. 15 Feb 2010. .