I found three very similar articles featuring the same topic but in a different way. The first remarks on the lack of standards and regulations for drug trials in Latin America and how the area has become a growing favorite for drug companies because of its "treatment naive" patients. The second describes a mother's personal experience in dealing with such a trial, and how she was taken advantage of by the drug company. Finally, the third goes on to question the medical ethics of studies conducted in the developing world.
Drug testing is a necessary aspect of medical technology. While the US has numerous stringent requirements on domestic studies, international studies are less controlled. As the third article demonstrates, testing standards have lately been compromised by the reversal of adherence to the Declaration of Helsinki. Drug companies in these three articles have favored economically and fiscally advantageous methods versus ethical treatments: in the first article companies take advantage of Latin America's relatively inaccessible health care by seeking uninsured, untreated, accessible patients; in the second informed consent is neglected and a mother's emotions are manipulated in order to assure her participation in a pediatric experimental transgenic rice solution study; and in the final article placebo control groups versus actual treatment controls are favored in order to avoid cost.
Why should other countries be held to lesser standards than those of the developed world? While there certainly is an economic benefit to the countries where the majority of studies are conducted, are the potential costs and neglect of rights worth it? What constitutes informed consent? Are companies responsible for providing treatment as a control to patients who would otherwise have no access to it? I think these are all good, appropriate questions to be raised.
I found the "treatment naive" aspect quite interesting as it was something I'd never really given thought. As Professor Rozier mentioned in class regarding the TVs, despite high poverty rates much of the Asian world, namely India, still has access to certain luxuries--apparently pharmaceutical drugs included. I wonder why this is, as opposed to say Central and South America? What makes them so readily available in India?
Another thing, when toys have lead, meat becomes contaminated, a restaurant chain has unsanitary conditions (or non-beef "beef" tacos...), or a drug has unforeseen negative health effects the news is all over television or online. However, when a US run clinical trial has health implications for another country, the milk trial in Peru, it's not even a blip on the radar. I can find front page news stories on Yahoo for Super Bowl ads, "Is your love meant to be?", and Gaga's Vogue cover. What is happening to our media? Yes, public health has difficulty getting coverage for success--but even it's failures are neglected. I would never have heard of the FDA's reversal of the Declaration of Helsinki in 2008 if I hadn't read that article. There is something wrong here, a fundamental disconnect between real information/news and the media. If education is one of the key components of public health, America ought to take a hard look at how we are using our media to educate our populace on what is important and current news.
In the second article, the woman sought out help through the media network covering the story. Nothing was mentioned as to whether she ever brought a lawsuit against the company. Here in the US we certainly have a very healthy medical law industry and high rates of medical malpractice suits. I think it is just so hard to find the correct balance between regulation and all of the number of things it affects. With regulation comes bureaucracy, with bureaucracy comes time and money, with money comes lack of access, and with time comes a decrease in effectiveness. How do we simplify the process while ensuring its safety?
Like the first article said, we must find a balance between regulation and innovation. With ever more competitive markets, increased drug resistance, and dwindling resources for miracle antibiotics and drugs, drug and treatment research is of the utmost importance. The question is, at what cost?
http://pulitzercenter.org/blog/peru-pharma-companies-outsource-clinical-trials
http://pulitzercenter.org/blog/peru-diana-canessa-informed-consent-clinical-trials-medical-ethics
http://pulitzercenter.org/articles/national-institutes-health-compromising-medical-ethics
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