Sunday, February 28, 2010

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.