Lack of transparency between the hospital and the medical research volunteers.
According to the health policies by the medical center, there should have been absolute transparency between the hospital and the medical research volunteers commencing the trials. Kathryn Hamilton would not have met her tragic death if all the facts regarding the treatment, inclusive of the lack of the intravenous medication, was told to her. Her estimated two years of survival would have been fulfilled had she not met her death after accepting the experimental medication. From the research and facts brought about by the Seattle Times, it’s clear that the doctors were neglectful of the patients, causing their deaths, due to the financially beneficial outcomes of the experiments. They lacked consideration for the patients and their families. It was also irresponsible of the facility, to hide the facts about the cause of deaths, by the protocol 168 of the cancer treatment. This was similar to Becky Wright’s death after the protocol 126 leukemia experiment. The fact that the center tried to have an out of court settlement with Kathryn Hamilton’s husband, shows that they well well aware of their negligence in her treatment and sought to avoid the greater issues heading their way from the case, and sought to pay out their negligence. This is a fault in the health center and their bid to evade justice for the victims of the wrongful deaths on the accounts of malpractice, mismanagement and breaking of oath. It goes to prove the need for stricter insight into the health facilities who seek to attempt such experimental medication on victims, in a bid to protect the victims from researchers such as the Fred Hutchinson Cancer Research Center researchers (Heath D. , Hutch settles consent case out of court, 2003).
They do hold fact that most patients were so desperate and would try any experimental drug availed to them if it provided hope for a better future. While it may hold truth, it goes against the health practioners oaths to serve and protect the patients, by using medication that is not only harmful to their health but also leads to a quick untimely death. Dr. John Pesando drew the alarm over the experiment, due to the health risks that it brought to the patients. From the court proceeding, this proved to be true from the 18 billion dollars used in starting private companies and millions of personal wealth gained by the doctors. He found the experiments as unhuman and unethical. More to that, they did in no way receive consent to go ahead with the treatment without availing such facts to them and their family members. Kathryn agreed to the medication, under the promise that she would receive the drugs intravenously to which the researchers knew wasn’t true as the IV drug wasn’t available at the center as the supplier had cut off the supply. They were fully informed of the details of the supplier’s termination of the IV drugs supply, after the internal memo sent out to all doctors by the director of clinical research. Dr. Bensinger acknowledged to not crossing the references of the IV drug, to which he claimed uncertainty. The facility didn’t agree to take up responsibility but yet were so quick to claim that they knew that the medication wouldn’t work and yet they let the patients participate. This is a direct affirmation of their guilt to the issue. It was a case of negligence as they didn’t fully comply to respecting transparency with the cases (Heath D. , Tougher laws urged for medical research, 2002).
Neglectful of the patients, causing their deaths, due to the financially beneficial outcomes of the experiments.
Jesse Gelsinger’s participation in the human gene therapy under the supervision of Dr. Wilson for his rare ornithine transcarbamylase deficiency (OTCD), raised issues of financial status that the likes of Dr. Wilson were looking for at the expense of human subject’s health. Having taken up a long-term working solution from co-principal Dr. Batshaw, he wasn’t off the radar trusting in Dr. Wilson, Batshaw’s partner for a cure for his condition. Jesse’s clinical trial expected to hopefully treat his condition failed after he received 17 folds less than what the animals received, ultimately causing his death. From the evidence provided, the high stakes that Wilson had acquired in the bio-technology company as shown by the documents at the University of Pennsylvania, showed that he abused his oath. He administered the virus despite being aware of Jesse’s high ammonia levels. Jesse also like Paul, never received his trial test results which would prove if he was a successful candidate for the clinical trial. After a series of hearings by the senate and house of representatives, it was clear that Wilson had a motive in the financial aspects of the trial. There was a series of protocol violations, misleading information disclosed amongst other errors (Wilson, 2010).
This was held true to the fact that Dr. Wilson held shares in a biotech company; Genovo, to which the Wallstreet Journal would later estimate at $13.5 million. This was proved to be more by twice the amount according to Penn documents obtained. The two sues for wrongful death and violation of civil false claims acts were filed by the family of Jesse alongside the federal government. The case was rather interesting, as the suits were settled without any apology or acceptance of the errors committed. The institute of medicine (IOM) also raised a voice for need of stricter policies to curb such issues. The lack of public information over the trial also raised questions. Regardless of the fact that all teams settled with the institution, the case defined medical history for not only Jesse’s death but also those of other participants as well. Availing the information would help in improving the direction that clinical trials would take for time to come. It would also raise awareness concerning the same. The institution also violated civil rights, as shown by the fact that they tried to cap Wilson, by restricting major decisions between the patients and him alongside the financial interests in Jesse’s trials. The question lies under why he wasn’t incarcerated by his crimes so far. More to that, it wasn’t just about money, it was also about fame and accolades from his fellow colleagues that would give him opportunity to gain grants and academic promotions and also lengthen his tenure in the institution (Wilson, 2010).
Dr. John Pesando drew the alarm over the experiment, due to the health risks that it brought to the patients.
With corporation of stricter health institution policies around experimental medication, not only can the measures save the lives of thousands of volunteering participants who take up such trials yearly, but it can improve on the patient’s trust in the institution alongside that of their families as well. This also caps unethical health practioners from engaging in health malpractices for financial gains or also for other gains; among them being promotions, fame and prestige. More to that, there needs to be transparency around such procedures and tests from the patients to the public. The documentation and procedures need to be put out to the public so that the patients and their families are able to make clear and concise decisions around their participation in the experimentation. There is need for other key stakeholders to participate fully into the experimentation from government (Ministry of Health and Family Welfare to evaluate the functioning of the Central Drug Standard Control Organization (CDSCO) and US-food and drug administration (FDA)) to private stake holders like human right associations (WHO (World Health Organizations)). This means getting the legal aspects of the procedures keenly followed on through use of legal firms to represent all stakeholders in the procedure before commencement of the procedures so as to ensure that all parties have their rights secured going forward. This means that there needs to be stricter hefty measures taken against defaulters to protect future participants.
Conclusion
Both cases present a lack of integrity from both research health institutions. It also shows the lack of health institutions to protect the patient’s health and safety despite being aware of errors that are committed by doctors and researchers in the institutions. It shows the lack of morals and ethics from the health practioners who take more importance to the financial aspects of the treatment than the patient’s health which risks future chances for successful experimental drugs and damages the trust of the public in health institutions and the doctors at large form the death that they seemed so unapologetic about.
References
Heath, D. (2002, August 9). Judge: Hutch didn’t reveal study’s risk to patient. Retrieved from The Seattle Times: https://community.seattletimes.nwsource.com/archive/?date=20020809&slug=hutch09m
Heath, D. (2002, October 4). Tougher laws urged for medical research. Retrieved from The Seattle News: https://community.seattletimes.nwsource.com/archive/?date=20021004&slug=hutch040
Heath, D. (2003, January 15). Hutch settles consent case out of court. Retrieved from The Seattle Times: https://community.seattletimes.nwsource.com/archive/?date=20030115&slug=hutch15
Wilson, F. R. (2010). The Death of Jesse Gelsinger: New Evidence of the Influence of Money and Prestige in Human Research. Retrieved from Washington and Lee University of Law: https://scholarlycommons.law.wlu.edu/wlufac
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