Business Ethics in the Pharmaceutical Industry in the Global Business Environment

The different Phases that a Drug Company goes through in order to bring a New Drug to Market in the U.S. and Europe

Torjesen (2015) informs that the first stage of developing a new drug involves understanding the disease intended to be treated in terms of its processes in order to determine how the processes can be interfered with. The effort involves conducting research studies to find which compounds are effective in weakening the disease processes. The compounds can be sourced from animals, plants, or fungi and those that are found to work, are used as the foundation of developing the drug that would be a candidate for treating the disease. After that stage, the compounds identified are then passed through the testing phase to establish how safe they are for use and animals or computerized structures are used as specimen before the experiment is conducted on humans. Once the safeness of the compounds has been established, the researchers seek approval from the concerned authorities for testing the compounds on humans. What the approving authorities look for in this stage is whether the initial testing has been sufficiently done before humans are used in the study. If the authorities are convinced, they approve the application and the researchers use a sample of healthy people to test the compounds. In this phase, the compounds are administered on the participants in small doses and the researchers observe the participants very closely. The sample size of participants used in this case is around 20 to 100 of them. In the following phase, new participants that have the targeted disease are used and here, very few of them are considered for the study (at most 500). The purpose of this phase is said to be one that determines the dosage, the best way to administer the drug, at what intervals, and to confirm its safeness. The third testing phase involves a larger population of participants (between 1,000 and 5,000) affected with the disease and these participants are located in different countries across the globe. The purposes of this phase are- to confirm the findings of the previous phase, to establish the best way to give the dosages, and to identify possible risks and mitigating them. The findings of this phase are used to make an application for licensing the drug to the authorities that regulate drugs. Once license is given, the pharmaceutical company can market the drug following the permission given by the authorizing bodies and the national government of every country approached. In the United States for example, the Food and Drug Administration is approached. At this stage, these bodies may demand another testing phase before giving a go ahead. After marketing, the company needs to patent its drugs. Those procedures used in the United States are similar to those employed in Europe says Torjesen (2015).

Analyzing whether or not Pfizer behaved unethically by rushing to take advantage of an epidemic in Nigeria to test Experimental Drugs on Children

Comparing the event described by Charles (2007) and what is informed by Torjesen (2015), the following is established about the Pfizer’s drug-testing. Trovan, the new drug developed aimed at treating numerous diseases caused by bacterial infection did not pass through all the stages required to test its safeness on humans. Pfizer is suggested to have skipped the initial stages mainly to save costs and tested it directly on humans to assess its effectiveness and forward it for approval and licensing. Thus, the company took advantage the desperation that was there in Nigeria of treating the meningitis disease that was spreading among children. The company was sure it would get an approval by the country’s government and use the untested drug to treat the children. Thus, the government and the parents of the children were not informed that the company was conducting a test on the children and suddenly the drug was harmful to the children. Ethically, any experiment conducted on human participants needs an informed consent from the participants or their guardians and therefore, Pfizer behaved unethically regardless of whether it obtained permission from the Nigerian government or not. More so, the company failed by using 198 children to test the new drug instead of using fewer of them at most 100 (Milkowski, 2007).

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Analyzing whether or not corners were cut with regard to Patient Consent in the rush to establish a Trial

Pfizer Company cut corners with regard to patient consent in the rush to establish the trial because, the company had realized that the people were desperate for treatment and were not well educated to assess the treatment processes and question them. According to Milkowski (2007), Pfizer had two different treatments/experiments, one that used a low dosage of a competitor proven drug and an addition of Trovan and the other one was use of Trovan only. These divisions were enough to question the treatments given to the children. More so, since it was a new drug, the parents would have questioned how the drug is to the children.

Determining if Pfizer should have been less opportunistic and proceeded more carefully

Pfizer Company can be said to have focused more on making profits and not on saving lives and if it were, it would have appreciated and respected the purpose of every phase that drug developers are supposed to pass through before having their drugs licensed for use. According to Milkowski (2007), the harm that Trovan had caused to the children included deafness, blindness, and paralysis and this would have been noted at the initial testing phase where an animal is used. More so, respecting the goals of each testing phase, would have made the company establish how the drug is delivered because, those children that were administered a mixture of Trovan and another drug, died (Milkowski, 2007).

Examining whether Doctors kept Patients on Trovan too long or if they should have switched them to another Medication and additional strategies they would have used

Charles (2007) notes that Pfizer took weeks to conduct its experiments on 198 children where these participants were divided into two halves for the two experiments the company was conducting. The main question raised from the outcomes of the experiments/treatments is why the company did not use at most 10 children to test its new drug and immediately switch it with a better one after Trovan proved to be ineffective. What the company was needed to do at first was to understand the disease that was affecting the children first, test how Trovan acted on the Meningitis, and establish any improvements it needed. From this test, it would have guided the researchers in understanding the responses of the patient to the treatment given and act accordingly. Otherwise, in the experiments, the researchers were just guessing and not understanding the patients’ reactions to the drugs given (Torjesen, 2015).

The Ethical Nature of testing Experimental Drugs on Children in a Crisis in the Developing World

Any new drug developed for children need to pass through the same phases and using a sample of healthy and sick adults in the testing stages before it is tested on children (Cheah, Parker & Dondorp, 2016). Due to the need to cut down costs of developing new drugs, SciDev Net (2011) claims that developing nations have become attractive places for pharmaceutical firms to test new drugs at reduced costs. Developing countries believe in advanced healthcare and thus, prefer the latest forms of treatment. In this regard, drug developers from developed countries are sure to get many people willing to get the new treatment. To be ethical, drug developers need to be considerate of the health needs of their participants and not to focus on how they themselves are to benefit from the drug trials. Thus, the developers need to have tested their drugs as required in order to inform their participants what they know about the drug mainly in terms of its side effects. The developers are not supposed to take advantage of the participants’ culture, which fears to turn down their participation, or question what is being done to them. Instead, they need to use suitable means to ensure they understand the process including what it is all about, and are not forced to participate in it.

References

Charles, H. (2007). International Business: competing in the global marketplace 6th ed. New York: McGraw-Hill/Irwin.

Cheah, P. Y., Parker, M. & Dondorp, A. M. (2016). Development of drugs for severe malaria in children. International Health, 8(5), 313-316.

Milkowski, R. (2007). Nigeria brings criminal charges against Pfizer over 1996 drug test. Retrieved< https://www.wsws.org/en/articles/2007/06/pfiz-j04.html>.

SciDev Net (2011). Ethics left behind as drug trials soar in developing countries. Retrieved< https://www.theguardian.com/global-development/2011/jul/04/ethics-left-behing-drug-trials-developing>.Torjesen, I. (2015). Drug development: the journey of a medicine from lab to shelf. Retrieved< https://www.pharmaceutical-journal.com/publications/tomorrows-pharmacist/drug-develo

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