Pharmaceuticals and Marketing
Introduced to the “biotech industry” as small companies in the 1970s, Contract Research Organizations (CROs) “[expanded] from drug discovery and preclinical work to clinical trials, drug manufacturing, and even marketing.” According to The Scientist, “the CRO market grew to nearly $20 billion” in 2008 despite the economic recession. Although developing pharmaceutical drugs is crucial in order to fight disease, money and increased profits consistently and significantly increase and it raises questions about the motive behind the many developments of a myriad of drugs.
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Introducing a New Drug to the MarketPrior to introducing a pharmaceutical drug to the international market, it must first be tested. According to the Association of Clinical Research Organizations, the development of a drug takes about 15 years: during the first to three years, the drug is tested on animals until it is safe to begin testing the drug on humans. In the first phase of human testing, “20-80 healthy individuals” consume the drug. In the second phase, “100-200” individuals who are to be treated for the condition the drug was made for consume the drug. In the last phase, the drug is tested “with several hundred to several thousand participants at a variety of sites to verify efficacy and safety on a larger scale.”
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Clinical Trials in Developing Countries
Because the process of developing a drug requires the participation of many people, there are people who are in charge of getting as many participants as possible in order to test the drug. Rajesh Nadia, a recruiter of the international drug-testing industry says that many of his recruits in India are poor and “sometimes, people feel weak or get body ache. They don’t care about these little things because they need the money.” Often the money is an inducement. According to research done by NBC’s Chris Hansen, the attraction of money usually drives some people to participate in more than one study at a time which not only puts their lives in danger, but can skew the results of the pharmaceutical drugs being tested that would be used to determine the safety of the drug. When Nadia was asked if he was aware of this, he said it happens a lot but sometimes companies are desperate enough that they ignore it. Furthermore, “the Indian government reports that across the country more than 1,500 people have died in clinical trials since 2008, many participating in studies for Western pharmaceutical companies.”
In the Effective Drug Regulation, A Multi-country Study by the World Health Organization (WHO), ten countries were studied to “draw generic conclusions from the strengths and weaknesses of different systems and identify features affecting the performance of drug regulation.” The different systems implemented in the countries involve laws used to regulate; however, “all laws are meaningless unless they are enforced,” and, “policy-makers must also address regulatory efficiency, transparency and accountability when evaluating regulatory policies.” This means that policy-makers must enforce the laws, must revise the laws in accordance to relevance and how well they work, and must come up with a way that someone is held responsible when a law is violated. WHO was able to generalize the following about regulation in developing countries: “Generally, in most developing countries, drug regulation is very weak, and the safety, efficacy and quality of imported or locally manufactured drugs cannot, therefore, be assured. Studies carried out in some countries show that about 20% of tested drug products fail to meet quality standards. Reports have also shown that the prevalence of substandard and counterfeit drugs is higher in countries where drug regulation is ineffective.” However, conducting drug trials in foreign countries “is rapidly becoming an attractive alternative for U.S. pharmaceutical companies,” because millions of dollars can be saved in conducting research cheaply and with little to no regulations. WHO also found that of the ten countries studied, those with high Gross National Product (GNP) had low infant mortality, and those with low GNP had high infant mortality (with the exception of Cuba). This research allowed WHO to conclude that there is a correlation between wealth and health, and made it evident that “population size and GNP per capita will influence drug regulatory functions.” Current global context of ethical violations in clinical drug trials can be examined closely with the global context of poverty. Usually, the developing countries, such as India, fall victims to laws not being enforced to protect the people. The need for money also drives the citizens of the developing country to participate in clinical drug trials that can put their lives in danger for the sake of clinical research organizations that U.S. pharmaceutical companies are increasingly taking part in because it is more economically convenient. |
Visit NBCNews.com for breaking news, world news, and news about the economy “Generally, in most developing countries, drug regulation is very weak, and the safety, efficacy and quality of imported or locally manufactured drugs cannot, therefore, be assured. Studies carried out in some countries show that about 20% of tested drug products fail to meet quality standards. Reports have also shown that the prevalence of substandard and counterfeit drugs is higher in countries where drug regulation is ineffective.” |
Akst, J. (2009, August 5). Contract Research on the Rise. Retrieved March 25, 2015, from http://www.the-scientist.com/?articles.view/articleNo/27578/title/Contract-research-on-the-rise/
Drug Development Process. (n.d.). Retrieved March 26, 2015, from http://www.acrohealth.org/clinical-trials/about/drug-development-process/
Hansen, C. (2012, March 2). 'People keep falling sick': How poor Indians are recruited for clinical drug trials. Retrieved March 30, 2015, from http://investigations.nbcnews.com/_news/2012/03/02/10561824-people-keep-falling-sick-how-poor-indians-are-recruited-for-clinical-drug-trials
Ratanawijitrasin, S., & Wondemagegnehu, E. (2002). Effective drug regulation a multicountry study. Geneva: World Health Organization.
Drug Development Process. (n.d.). Retrieved March 26, 2015, from http://www.acrohealth.org/clinical-trials/about/drug-development-process/
Hansen, C. (2012, March 2). 'People keep falling sick': How poor Indians are recruited for clinical drug trials. Retrieved March 30, 2015, from http://investigations.nbcnews.com/_news/2012/03/02/10561824-people-keep-falling-sick-how-poor-indians-are-recruited-for-clinical-drug-trials
Ratanawijitrasin, S., & Wondemagegnehu, E. (2002). Effective drug regulation a multicountry study. Geneva: World Health Organization.