Example Of Ethics Of Outsourcing Clinical Trials To Developing Countries Essay

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Clinical Trials to Developing Nations: Ethics Issues

In the last 20 years, a number of American drug enterprises such as Pzifer and Bayer have outsourced their clinical tests to Third World countries. This is due to the decreased costs and facilitated examination results. Emerging countries have embraced clinical tests outsourcing as a way for them to give their citizens what would have been prohibitive and expensive healthcare services.
Withal, by opting for this mechanism, criticisms regarding the ethicality of the practice have arisen. Among the issues that have arisen include failure to secure the needed consent from the patients, convey the threats regarding the experimental tests, and to pay the patients for their participation; in addition, the data collated from these tests can be used in the local of the outsourcing country (Anand, 2013, p. 1).
With a rising number of US companies electing to outsource many of their corporate functions abroad, it is not surprising that American drug companies would also send their testing needs abroad as well. However, reports published in the New England Journal of Medicine has raised apprehensions on the ethicality and the system of rising numbers of clinical trials being conducted abroad when the ultimate goal of these studies are designed to secure approval to be sold in the United States (Singer, 2009, p. 1).
Walthall (n.d.) states that brisk enlistment of patients and cost restriction are two of the considerations that industry leaders and even American government benefactors to extensively study “non-traditional regions” as favoured locations for drug testing research. Decreasing levels of patient recruitment among Western nations has given rise to two belief systems; one, the world must embrace globalization without any restriction or hesitation, and two, that researchers in the developing world cannot accomplish studies to the same level as in the West (Gaidos, 2013, p. 27).
Globalization is the sole method that US multinational drug companies to be able to get sufficient numbers of individual test beings to be able to conduct the trials. In general, modern day Americans are strongly resistant to being enrolled in clinical tests; even patients with the most deadly illnesses will traditionally refuse to take part in any experimentation of drugs for their cases. It has been noted that in the United States, a measly 1.7 percent of all patients diagnosed with cancer, whether these will be in the early or terminal stages, will be likely to enrol in clinical tests (National Collegiate Honours Council, 2015, p. 1).
However, the main motivator that fuels outsourcing of medical trials to developing nations is expense. The constricting and ever increasing number of regulations being developed and enforced in the West, rising research and development outlays, and time constraints in being able to recruit the needed number of patients are elements that significantly pressure on drug manufacturers to find alternatives for their testing requirements. If Western drug companies were to conduct their trials in their own countries, research and development costs for the introduction of new medical products in the market would be extremely prohibitive.
For one, it would be a given for these companies to wait 10-15 years and for every drug that the US Food and Drug Administration (FDA) will approve, these companies should expect to incur $800 million to $ 1 billion, inclusive of the costs attendant to the costs of the numerous failures associated with testing the drugs. Clinical testing is a major cost allocation for drug companies, and is about 60 percent of the costs related to the development and release of the drug to the market (Gaidos, 2013, p. 27).
The United States as well as the members of the European Union bloc is considered as the biggest pharmaceutical trading zones. With the two increasingly tightening the regulatory systems in their countries, drug companies began to “migrate” much of their testing activities that would have been delayed or even prohibited in the US and EU blocs. Though the two economic powerhouses have pushed the pharmaceutical industry players to pursue a policy of transparency; however, if there is no legal compunction to enforce the policy, it has been long believed that drug industry stakeholders will not disclose any information to regulators.
This type of concealment can be extremely deleterious that can destroy the trust for the industry among subjects and industry participants. In the case of German pharmaceutical multinational Bayer, where the drug company was accused of being the trigger of more than 100 patient deaths in India, company shareholders have called for more clearness from the company’s senior management. Lastly, the cache that the companies may have accumulated by consistently resorting to inexpensive outsourced clinical testing can be nullified several times over by the damage that can be incurred by the tainting of the company’s name and public perception owing to disclosures of illegal clinical tests overseas, exploitative treatment of patients overseas, drug recalls, and damaging lawsuits that the company will incur. If drug companies choose to ignore this scenario, the results can be devastating for the sector in the long term (Gaidos, 2013, p. 29).
Here, a comparison of two states would be needed to make the point clearer. In the case of India and the United States, Americans earn an estimated $47,000 a year-this is 16 times the earnings of the average Indian. Tracking a test patient in India would cost $2,000, which is 10 times lower than what is being offered in the United States. Indians would have to be sent home; with tests being offered in India, these impoverished individuals would have a chance to avail of procedures that would otherwise be too costly for them (O’Reilly, 2009, p. 1).
Again citing the case of India, there is a brewing debate on the ethicality of clinical tests being conducted regarding “Letrozole,” an anti-cancer medication allegedly being experimented on for fertility. In one case, approximately 400 women were enlisted for the trials to experiment on the possibility whether the drug would induce ovulation in the women, even though the women were not informed of the trials and the company did not secure their consent to take part in the tests. Though it has been declared that the doctors and the parties who initiated the trials violated the law, not one of those responsible for the act has been indicted or even had charges filed against them in court (World Health Organization, 2004, p. 1).
Conducting clinical trials in impoverished nations can incur greater vulnerabilities than what has been established in prior research. Multinational drug companies outsource their trials to contractors, placing the credibility and veracity of the information of the tests, as well as incurring severe ethical damages for the pharmaceutical companies. These drug companies engage the services of “Contract Research Organizations (CROs) to conduct the trials in poverty stricken nations with large populations of marginalized, uneducated people, with little or no access to health care services.
The unethical large scale recruitment of sample patients in countries such as India and Brazil has been widely recognized in the industry; what has recently been discovered that these CROs, owing to pressures from their “clients,” are wont to “cut corners,” opting to lessen adherence to strict regulations and standards. Here, it can be said that the CROs sacrifice ethics and standards for the sake of facility and compensation (Centre for Research on Multinational Corporations, 2011, p. 1).
India is a case where the issue of being able to harness significant numbers of willing participants. Willing in the sense that the promise of free medication can fuel large numbers of indigent patients to try these new fangled drugs companies will offer. However, India offers what other countries cannot-a well trained staff of medical professionals who are proficient in English. Furthermore, these professionals and agencies are willing to conduct the trials for a small fraction of the costs normally being charged in the West; for example, drug trials in India only cost 40 percent of what costs to do the trials in the United States.
However, aside from this point, the general population is perfect for these companies to take advantage of; majority of the population is mired in poverty, have no access to even basic healthcare, and are too marginalized to avail of the expensive medicines these need to aid them with their illnesses. Owing to a “cocktail” of desolation and eagerness, the peoples of developing nations are exposed to a greater risk; clinical tests are their sole access to avail of health care services. For these people, as long as the study states remedies or therapies, the possibility of being treated will prove tempting. To these individuals, the issue of ethics is irrelevant as long as there is a possibility of availing of the benefits of the drug being tested. Aside from the drug, the trials will be accompanied by periodic check-ups, medical services that impoverished people will not be able to afford outside of these trials (National Collegiate Honours Council, 2015, p. 3).
Though these elements can prove to be staggeringly beneficial in enhancing the efficacy of the investments poured into research and speeding up the process of creating innovative treatments, there are a number of ethical controversies associated with this practice. The oversight regulatory functions that are prevalent in Western or developed nations and statutes that strictly enforce ethical standards in clinical trials may not be as sweeping or wide ranging in developing states. Here, the load is placed on the overseas investigators, where being able to deduce the ethicality of such testing can prove to be difficult. However, there are more serious ethics issues associated with this practice.
For instance, compensation for regulators and participants that would be conservative in developed countries would be extravagant sums in developing nations; hence, the payment of overseas researchers can generate the development of unethical means to be able to enrol the needed patient sample lot. In addition, the absence of comprehensive healthcare access for individuals in developing nations. It is common to discover that people who enrol in clinical tests cannot avail of health care services in their own countries, and these tests will provide the only medical care that these will be able to receive (Rubin, Becker, Siegler, 2014, p. 1).
Only a limited number of drug manufacturers implement strong measures to guarantee that outsourced medical trials in emerging countries are secure and humane. The majority, however, offered no evidence of actively taking part in the regulation and administration of the trials done by their contractors. In the report of the Netherlands-based “Access to Medicine Index,” more than one billion individuals are unable to afford even basic health care services and the medications that can mitigate their medical conditions. However, though there is a recognized and pressing need to provide safe, affordable, and accessible medicines in these countries, the instability of the regulatory structures in developing countries is one of the main stumbling blocks in this regard (Dreaper, 2012, p. 1).
There are global standards that regulate and monitor clinical testing. Among the most notable is the “Declaration of Helsinki” of the World Medical Association. Implemented in 1964, the statute declares that possible study participants should be sufficiently informed of the vulnerabilities as well as the benefits of participation. In addition, the statute mandates that the participants be informed of their rights to reject and even quit from the study (O’Reilly, 2009, p. 1).
There is little by way of documentation to buttress preliminary concerns associated with the veracity and credibility of the data drawn by researchers enlisting participants in impoverished nations. However, there is a significant amount of literature that proffers those regional alterations in socioeconomic status and health care access can result in a major effect on patient results and the possibility of identifying life ending illnesses. Endeavours to conduct clinical trials in developing countries on a long term basis may prove deceptive, particularly if the policy makers will continue to negate the results (Walthall, n.d., p. 21).

Bibliography

Anand, N., 2013. The ethics of pharmaceutical testing in the developing world. Yale Journal of Medicine and Law [e-journal] Available through: Yale Medicine and Law website<http://www.yalemedlaw.com/the-ethics-of-pharmaceutical-testing-in-the-developing-world/> (Accessed 6 February 2015)
Centre for Research on Multinational Corporations, 2011. Ethics and quality of drug testing in low income countries subject to additional pressure through outsourcing [online] Available at:<http://somo.nl/news-en/ethics-and-quality-of-drug-testing-in-low-income-countries-subject-to-additional-pressure-through-outsourcing (Accessed 6 February 2015)
Dreaper, J., 2012. Concern at outsourced clinical trials in developing world [online] Available at :<http://www.bbc.com/news/health-20468396> (Accessed 6 February 2015)
Gaidos, A., 2013. CSR boundaries in the pharmaceutical industry: is outsourcing of clinical trials to developing countries really unethical? Journal of European Management and Public Affairs Studies 1(1) 27-32
< https://opus4.kobv.de/opus4-th-wildau/frontdoor/index/index/docId/290
National Collegiate Honours Council, 2015. Doing anything for care: exploitation through the globalization of clinical trials [online] Available at:<http://nchchonors.org/wp-content/uploads/2012/04/Bedera-Nicole-Westminster-College-Paper.pdf> (Accessed 6 February 2015)
O’Reilly, K.B., 2009. Outsourcing clinical trials: Is it ethical to take drug studies abroad? [online] Available through<http://www.amednews.com/article/20090907/profession/309079969/4/
(Accessed 6 February 2015)
Rubin, D.T., Becker, S., Siegler, M., 2014. Ethical considerations for clinical trials in inflammatory bowel disease. Gastroenterology and Hepatology 10(1) 37-41
Singer, N., 2009. Outsourcing of drug trials is faulted. The New York Times 18 February
Walthall, P., Outsourcing clinical trials 18-22, Marketplace and Business (n.d.)
< http://www.icr-global.org/EasysiteWeb/getresource.axd?AssetID=2401&type=full&servicetype=attachment
World Health Organization, n.d. Clinical trials without ethical review under the spotlight [online] Available at:<http://www.who.int/bulletin/volumes/82/4/ethics0404/en/print.html (Accessed 6 February 2015)