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Leukemia is one of the most life-threatening diseases and has undergone a significant change in its treatment methods. In 1940s and 1950s treatment was based on single-agent chemotherapy. Multi-agent chemotherapy was introduced in the early 1960s which dramatically increased the survival rate of patients. However, resistance to chemotherapy was developed when a patient relapsed. In early 1970s, more intensive treatment was introduced which involved chemotherapy and full-body irradiation followed by bone marrow transplantation. Bone marrow replaces the immune cells which are destroyed during chemotherapy.
Unfortunately, sometimes the transplanted cells (Graft) may produce an immune response against healthy or normal tissues (Host) which may affect the organ functions or cause it to fail all together also known as Graft Versus Host Disease (GVHD) or Condition.
Fred Hutchinson Cancer Research Center, one of the largest and most successful cancer research centers in the world conducted a series of trials in the 1980s using T-Cell depletion in order to prevent GVHD. The experiment involved injecting antibodies in the patient’s body that were supposed to kill white blood T-Cells in the donated marrow in order to eliminate GVHD.
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Instead, it lead to a dramatic increase in rejection of donated marrow and cancer relapse. 82 patients were recruited irrespective of their age or life expectancy out of which 80 died and the death of 20 patients is attributed as a result of the treatment. Only 2 of 82 patients are still alive. The patients complained that they were not informed about the risks associated with the treatment and alternatives or about the financial interest of the staff and filed a class-action lawsuit against the center.
The case was filed in Kitsap County Superior Court in Port Orchard on behalf of the families of 82 patients.
Genetic Systems Corporation and its successor company were named as defendants in the trial as they were known to sign an agreement for commercial rights for 3 of the 8 drugs being tested in the trial. Also they gave stock and position to Drs. E. Donnall Thomas, a 1990 Nobel laureate and former head of the center's clinical division, John A. Hansen and Paul J. Martin (Principal Investigator) which were named as individual defendants in the trial.
This trial is a classic example of Conflict of Interest (COI) which occurs when financial or other considerations can bias or affect professional judgment apparently or potentially. Every single scientific study or clinical trial has conflicts of interest, and most of them are related to financial benefit of investigators, institutions, sponsors, and other relevant individuals or organizations. It is important to note that conflicts of interest cannot be eliminated completely whether decisions are influenced by a person or a group.
Money is a potent motivation for pharmaceutical companies and researchers. Financial conflicts, therefore, are the most visible conflicts in each decision of a clinical trial. As a top bone marrow transplant center in the world, the institution gets huge funding from NIH per year. The Conflict of Interest Policy published by the Fred Hutchinson Research Center claims that “a representative shall not receive payments from any source conditioned upon a particular research result.” However, according to the lawsuit, the investigators received a consulting fee for conducting clinical trials, and the institution was a long-term contractor who had the commercial rights to study products provided by the sponsor. Although there was no definite evidence to prove that some of the investigators gain more profit from this trial, they still had the opportunity to obtain personal benefit, and that would impact their decisions when designing medical alternatives or enrolling eligible participants. For example, if an investigator is responsible for emergency treatment of adverse events, he/she would consider drugs which may not have effectiveness but are owned by the sponsor in order to get rewards from the sponsor.
There are no federal rules that require disclosure of the extent or relationship of relevant people, but it is ethical to explain that to all subjects. Dr. John Hansen and Dr. E.D. Thomas hold founder stock in the sponsor company when starting the trial, and Dr. Hansen was Medical director in the Fred Hutchinson Research Center. Even though the Conflict of Interest Policy sets limitations on participation which says a representative who has a significant financial interest or a business entity, the fact was that a director and some officers participated in this clinical trial, and they could not prove themselves having any conflict of interest. Once the victim families discovered these relationships, they would suspect whether there is any benefit transaction or not. Lack of transparency may cause serious ethical issues, such as loss of public trust and force of public opinion.
It is essential to note that Dr. E.D. Thomas is not only a Nobel Prize owner but also an advisory committee member. When an individual’s position could make significant effects to decisions for a clinical trial, some harm related to the sponsor, the institution, or the participants would be caused if review process existed some problems. Dr. E.D. Thomas had very strong power to interfere every step in this study with personal interest, which may lead to high mortality rate. Additionally, the lawsuit claims that the investigators failed to act in accordance with the Institutional Review Board (IRB). It is hard for the public not to connect this result with the special position of Dr. Thomas. Except financial interest, there are several interests that may have effects to this trial, for instance, publishing new knowledge, receiving political benefit, and obtaining future research funding.
If the investigator consults for a company or companies then his or her essential responsibility is to the institute and his/her counseling agreement should not strife with that commitment or struggle with some other institute guidelines or directions. The investigator has to guarantee that his/her counseling agreement does not allow the organization to access any thoughts that don't emerge because of his/her counseling exercises or would be esteemed as an augmentation of the institute exercises. Also the investigator should not give the organization early or selective access to results of the research, except if those outcomes originate from a supported research venture with the organization. The investigator counseling exercises should be as isolated from his/her examination as could be expected under the circumstances, with the goal that these exercises are not seen as an augmentation of his/her supported research at the institute and the counseling understanding must not defer or forbid distributions coming about because of sponsor research at the institute. The extent of your counseling duties should be quite certain so it doesn't allow the organization access to work not done under the counseling agreement or meddle with licensed innovation revelation, or distributions coming about because of his/her scholastic work. The investigator should keep in mind that his/her counseling agreement is a lawful understanding drawn up by the organization's legal advisors. It may be useful for the investigator to furnish the organization with a duplicate of the Patent and Copyright agreement.
The investigator is allowed to sit on advisory board in light of the fact that such positions don't convey, nor are they seen to convey, administration duty. In any case, his/her essential duty is to the institute and administration on a advisory board should not struggle with that commitment or strife with some other institute guidelines or directions. Frequently benefit on an advisory board is remunerated with stock or investment opportunities - such value can raise the issue of such motivating forces bargaining objectivity, especially where human subjects are associated with investigations of the organization's items. The investigator should not give the organization early or selective access to the result of the results, except if those outcomes originate from a supported research venture with the organization. The investigator should keep his/her money related premiums emerging from administration on advisory board sheets separate from the examination and institute commitments with the end goal to secure the patient’s rights, preserve the integrity of the research, cause no damage to human subjects utilized in the examination, see that any manifestations or disclosures that emerge over the span of his/her examination or academic exercises at institute are not pipelined to the organization, and are uncovered in an auspicious manner to the Workplace of Innovation authorizing and deny publication emerging from the institute exercises. The investigator should reveal this association with the organization in productions and open discourses of any of his/her research that is supported by the organization or identified with the organization.
If the investigator serve on a board of directors:
When a Conflict of Interest Occurs. (2021, Dec 23). Retrieved from https://studymoose.com/when-a-conflict-of-interest-occurs-essay
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