Final Essay A Case Study of Roche’s Drug Trials in China Introduction In business we must evaluate decisions along ethical lines and we must recognize that, for the long-term benefit of society, we cannot always make these decisions based simply upon a profit motive. The following case exemplifies the complexities inherent in business decisions. The case examined addresses whether it is worth doing something ethically questionable for the sake of a justified end. In 2010, the pharmaceutical company Roche came under fire from Traidos Bank, the Berne Declaration, Greenpeace, and other critics for its policy of testing an organ transplantation drug called CellCept in China. CellCept is a drug designed to “prevent the rejection of …show more content…
As Roche makes clear, “CellCept was a medicine which had saved and continued to save thousands of patients’ lives by preventing post-transplant organ rejection.” If CellCept can receive regulatory approval in China then it could improve the lives of many people, as well as save them from other costly or less effective alternatives. In order to properly conduct an ethical analysis of this case study, each relevant party must be distinctly identified. The primary decision maker, the pharmaceutical company Roche, holds an interest in the revenues it would receive from regulatory approval. While it is easy to assume that businesses are driven solely by the profit motive, the company spokesperson’s statement, “Withdrawing [CellCept] from the market in any country would be morally unthinkable”, indicates that Roche may be legitimately interested in the welfare of its end users. The party most impacted by Roche’s decision is medical patients waiting for organ transplants in China. This party is actually made up of two categories: those patients who will participate in Roche drug trials, and those who would receive the drug CellCept only in the event of Chinese regulatory approval. We can assume both of these groups belong to the same patient party for the following reasons. First, Roche has indicated that independent institutions conduct organ procurement, and we have been given no information to indicate that procurement procedures are different for test patients as
The demand for an organ transplant continues to grow and when an organ becomes available there are multiple precautions to take to make sure the body does not reject the organ. The certain anti-rejection (immunosuppressant) medication that needs to be taken before a transplant to decrease the body’s immune response from attacking a foreign object (the transplant organ). The medication also lowers the immune system. Therefore, the immune system does not cause the body to reject the organ. Statists have shown, that up twenty percent of patients that get an organ transplant, experience one out of the three organ rejections.
Today we are in great need of a solution to solve the problem of the shortage of human organs available for transplant. The website for Donate Life America estimates that in the United States over 100 people per day are added to the current list of over 100,000 men, women, and children that are waiting for life-saving transplants. Sadly enough, approximately 18 people a day on that list die just because they cannot outlive the wait for the organ that they so desperately need to survive. James Burdick, director of the Division of Transplantation for the U.S. Department of Health & Human Services confirms, “The need for organ transplants continues to grow and this demand continues to outpace the supply of transplantable organs”. The
There are numerous problems dealing with organ transplantation. A major issue concerning organ transplantation is that organ donors are deficient and scarce. Donors have been known to scarce because not everyone takes good care of his or her body. There are not enough people to donate organs, yet the amount of people in need of organs is increasing by the hour. “Another conflict is organ transplants can still lead to other medical problems. This is usually because of the medicine you need to suppress your immune system” (Nazario Brunilda , “Common”). After an organ transplants, it is a must that you continuously take your medication; a sudden stop will most likely cause the immune system to reject the organ. “The medications can also raise your blood pressure and can cause osteoporosis due to loss of calcium” (Etienne, Flueridor Wendy).
Cloning has been a hot topic for many in the medical field and regular people. One of the new ideas for cloning is organ. Organ cloning is a process many doctors and scientists are interested in. Organ cloning is a process that can many benefits for humans. The possibility of using that organ cloning can become enormous. The one thing it could make it is easier for people whose need transplants to get one. It could also make the chance that the body will reject the organ to zero. While the idea of organ cloning is a great and interest idea there still some ways to go before we can actually do it. The one chance for the success of organ cloning is therapeutic cloning. Therapeutic cloning is a process in which DNA is extracted from the people
After the transplant, both the patient and donor embark on long roads to recovery depending on the transplant performed. In general, if the surgery goes well, the patient still must face the possibility of rejection (where the body fights off the newly implanted organ). Rejection is harmful to transplant success because the body fights off the new organ by making proteins called antibodies that go to the new organ and try to kill it. In order to hold back the antibodies that threaten the new organ, transplant patients have to take power immunosuppressant drugs to keep the level of antibodies down low enough for the organ to integrate into the body and start working [22].
Cloning organs could save one 's life and lower the number of names on the transplant waiting list. Transplants are tricky since the body can reject the organ, which is known as an organ rejection. However, with therapeutic cloning, the stem cells can become another part of the cell and can be found inside an embryo or the umbilical cord of a baby. This could create an organ specifically made for a patient using the stem cells from their body and reduce the risk of organ rejection. (16)
By having the organ made from the patient’s cell reduces the chance of that patient’s body rejecting the organ. This will also eliminate the need of a donor. Though these are all great advantages of therapeutic cloning it has numerous disadvantages. Scientists cannot prove this method to be completely safe for a patient. Some patients have had these cells that were made from this process mutate into cancer cells. The cost for this is also extremely high so it is not available to a large group of the population. While reproductive cloning of a human has not been successful yet, there are some concerns surrounding that. As the Dalai Lama asked in his essay, “What would this practice do to the future gene pool? To the diversity that has been essential to revolution?” (Dalai Lama
Through this, doctors will be able to create more personalized medicine that attains to each individual and reduces the risk of complication. In addition, in his section on cloning for medical treatments, Highfield states, “One day doctors will be able to use cloning to grow a patient’s own cells and tissues and tissues to carry out repairs” (Highfield 163). No longer will patients have to wait in hope that a donor will become available for their damaged organ. Doctors will be able to grow the perfect organ matched for the individual, eliminating the chance of rejection, and alleviating the struggle many transplant patients face with rejection medication. While cloning organs and tissues to repair the body would be beneficial in the medical world, doctors must be careful not to let the power slip into the wrong hands.
Closely related to DNA cloning is therapeutic cloning which, like DNA, is the cloning of cells; but the cloning is of embryos not in the hope to create human life but rather to harvest stem cells. The harvesting of these cells is important since these cells, unlike all of the others in the human body, are able to form into any type of cell in the body ranging from bone, tissue, blood, and brain cells. Once the human body progresses to a certain stage the stem cells change into specialized cells and from that they will only be able to form those specific cells from that point forward. The main hope from therapeutic cloning is to use these stem cells to serve as replacement cells to treat such diseases as cancer, heart disease, and even Alzheimer’s. However, one of the strongest arguments for therapeutic cloning is the use of these stem cells for organ donation (Cloning Fact Sheet, 2009). Because the cells do not require the use of immunosuppressant drugs, which is generally used when transplanting a foreign organ, with this and the fact that there is an extremely low risk of the body rejecting the organ cells since they are exact replica’s if the organ cells already existing inside the persons body (Cloning, 2011). According to one source, a long term solution to organ shortage is in fact an increased funding in therapeutic Cloning (Nelson, Rosenberg, Weiss, & Goodrich, 2009).
In the organ market, several allocation mechanisms come to mind. There is always the possibility that a particular patient has a family member or friend that is in the organ transplantation profession,
Healthcare workers and the ethics board make tough decisions that impact the patient’s future, specifically related to organ allocation. Organ transplantation is extremely important in order to save lives, prolong survival, and increase the quality of life (Beyar, 2017). Each year the number of people on the waiting list continues to rise at an alarming rate. According to the U.S. Department of Health and Human Services, organ donation statistics show that more than 116,000 people are awaiting organs. The number has risen significantly every year (Health Resources & Services Administration {HRSA}, 2016). In 2016, it was reported that approximately 41,335 organ donations were made,
Cloning shows a promising future in the medical field. Scientists have faith that stem cells show reassuring sources for advance remedies. With recent advances in research, scientists can possibly create cures for several diseases and create stand in tissues developed from a subject’s body cells (Follow-up). Stem cells are known for their wide variety of uses. Because of this characteristic, scientists can do almost anything with them making them beneficial to medical research. Eventually, scientists hope to manipulate cells into a wide variety of organs and tissues to help treat people with an assortment of illnesses. Once researchers can understand what causes these diseases, they will eventually be able to prevent them with genetic engineering. Recently, Israeli scientists announced that they have managed to grow embryonic cells to create specific organ cells like those from the heart and pancreas (Hope). President Obama reinforces the idea that “these tiny cells may have the potential to help us understand, and possibly cure, some of our most devastating diseases” (Follow-up).
Pharmaceutical companies are regulated by the FDA and immunosuppression has become a common therapy since the early 1960’s when the drug azathioprine was applied in anti-rejection therapies, cyclosporine was introduced in the 1980’s, mycophenolate mofetil and tacrolimus followed in 1994. These four drugs known by the brand names: Imuran, Neoral, CellCept, and Prograf are the backbone of immue suppressant drugs and have given a myriad of transplant patients a second chance at life. Organ transplant recipients have lived over 30+ years past their transplant due to these name brand anti-rejection drugs in combination with other various steroids, which is a remarkable thing (Pellegrino.2). Not so remarkable, are the serious complications that exsist with all anti-rejection
The European Commission approved a Communication of Organ donation and Transplantations: Policy Actions at the EU Level. The Communication spoke how important organ transplantation had become over the past fifty years or so and the process that it takes to properly remove an organ from a person’s body and how important organ transplants are to society. The Communication also spoke of areas that could be remedied by making improvements to various aspects organ donations and transplantation. These areas include: the prevention of the recipient receiving a disease from the donor through their transplanted organ. Increasing the donor pool to ease the donor shortage. Other improvements that could be made would be increase accessibility to transplant systems, ensure that the organs are safe for the recipient and making the transplant system more efficient and accessible (European Parliament). It also talks about how the need for transplants has increased with the number of organs that are being donated. Therefore, having an increase in donors does not help lessen the number of people who are waiting for a
There are many tragic stories told of someone being abducted, murdered, or sedated all just for his or her kidneys. These stories are not fictional but a shocking reality (Callahan.) Over 10,000 illegal organ transplants are taking place every year (Campbell.) As improvements in technology and medicine are made the number of organ transplants per year also increase, due to the escalating amount of sources (Hongda.) The Chinese government needs to constitute and enforce laws prohibiting the exploitation of organ harvesting.