“Volunteering for medical tests” topic by Tatiana
Essay by Lawrence
The methodology and protocols for selecting volunteers for clinical trials is a well established procedure in medical science. It is also well documented and information about the subject is plentiful which is easily available through an internet search*. Healthcare services, government websites, medical research centres and drug administration authorities would most probably also have a section on their websites for this subject.
There are also many companies who pay volunteers for participating in clinical trials. And patient organisations and disease theme charities would also have some form of recruiting volunteers for clinical trials. Finding volunteers is important for drug development, but as I will argue later on there are side issues with everything.
In principle volunteers can be people who are suffering from a disease or ailment and healthy people. In reality it is very difficult to recruit volunteers for clinical trials. One of the key reasons is that we just don’t know that there are clinical trials going on that require volunteers. An equally important obstacle is that there aren’t enough people who are suffering from a disease to participate in a specific trial. And to complicate the situation patients are usually distributed in a number of hospitals that cannot be recruited for a study at the same time.
There is also the language aspect to contend with the problem. For example there is no such thing as cancer research is an umbrella term not a subject of study. Scientific research and drug research is usually for a specific aspect of a disease and type of disease. Thus some diseases are more common and, therefore, more effort is put into them because they have a strategic number of patients that maybe enrolled into a clinical trial. Even still, for example lymphoma related cancers are a group of cancers and not a single variant or type of cancer. “There are over 60 different types, broadly grouped into Hodgkin lymphomas and non-Hodgkin lymphomas.” according to the Lymphoma Action Organisation (0). Other diseases that are equally important but because of their nature they are labelled as “rare diseases” such as lupus. Thus our conception of a disease and the development of research might not coincide with medical reality. And volunteers might be motivated by their public understanding of the disease and not necessarily the medical understanding of the reality.
Healthy people are also a key part of clinical trials, since they can act as part of the control groups in a study, participate in testing for side effects which wouldn’t be ethical to test on patients who are weak, and of course volunteers can offer their blood for example as a control group. But as I will argue and demonstrate below researchers still need to screen volunteers who might not even be suitable for the research never mind exposing volunteers with pre conditions to possible toxins that might have an adverse effect on the people.
The bottom line is that medical science cannot advance today without thousands of people volunteering every year to participate in clinical trials. There is no doubt that society ought to be grateful to these people for their bravery and sacrifice. So what are the philosophical issues of the subject? I will not discuss animal testing since it is not relevant for our subject. I will also not comment on the liability should something go wrong during a trial; this issue is also well settled in jurisprudence. But the starting point for this subject is the Hippocratic Oath or The Physician’s Pledge as the World Medical Association refers to the oath in the WMA Declaration of Geneva (1)
A key issue for us is the meaning and use of “volunteering”. How should we understand the meaning of this term? When we need to go to hospital we do not hesitate to give our doctor a signed informed consent form. This process also applies to volunteers of clinical trials. But in our country we assume that our doctor has explained any possible issues, we trust the doctor won’t expose us to unnecessary risks and so on. But this is our country.
Consider this short abstract by Sandhya Srinivasan in “Patient Protection in Clinical Trials in India: Some Concerns” (2): Clinical trial participants should not be influenced by undue inducement. Clinical trial investigators should be guided by ethical principles, and patient protection should be a top priority. This does not seem to be the case in India. (2010). Even still, there is the philosophical case of what do people understand when they give an informed consent? And what are the necessary conditions for a consent being informed? I would say that these questions are beyond the scope of my essay.
Is coercion a justified strategy even if only used for urgent situations? Indeed there are provisions in the informed consent ideology not to ask for consent, but usually these exclusions are based on the immediate interests of the patient. And even then the law courts could decide what is to happen. Alternatively would a pandemic be the equivalent to say a war situation when people are conscripted to build a fighting army? Fortunately in the present Covid pandemic there were enough and there are enough volunteers to participate in the clinical trials and subsequent tests for a vaccine.
Consider this Feature report in the BMJ by Elisabeth Mahase: Covid-19: Vaccine trials need more transparency to enable scrutiny and earn public trust, say experts (3). One of the issues is that what is transparency in clinical trials of this kind? There is a balance between doing high level risky science and informing the public on what is happening. We can even use warfare as a reference point. Under war conditions we don’t want to give too much away to the enemy and yet we want to keep people informed if only to assure them that something is being done.
But a key dilemma about transparency is balancing giving bad news about adverse effects during the clinical trial stage and discovering the side effects when the vaccine is being administered to people (see the Feature). It is argued that the latter would create a larger backlash to the vaccine, but then again a problem during the clinical trial stage might easily be solved (e.g. the so called the Oxford vaccine). A leg of the dilemma is asking thousands of volunteers to risk life and limb, and yet when the trial is successful many people would refuse to be vaccinated.
But this is a very similar situation about bad news in warfare. The difference between searching for vaccine for Covid-19 and warfare is that the answer to defeat Covid-19 is established by nature and we just have to find a way to arrive at the answer. In warfare we cannot know what will defeat our enemy, and hence we have to discover our own way to do it. Thus different research groups for a vaccine might still end up with the same or similar solution in warfare the best we can do is to form alliances. In other words, the doctrine for volunteers is very much subject to the nature and science of the disease in question. And even in modern warfare armies do not accept everyone who wants to volunteer; as many American discovered after 9/11.
One reason why we shouldn’t be too keen on sharing too much information amongst scientists is because we might be also be unwittingly sharing errors and false results. This disaster would be more serious than just some companies making more profits than other companies. Also sharing the same vaccine would not clear us from our ethical obligations, simply because it would take too much time to arrive at a 100% level of confidence that one vaccine is better than all the rest. In the long run maybe there will be a single type of vaccine but not yet. The other issue is that the technology needs to evolve and improved, we cannot just stop at yesterday’s technology, hence why a large number of people are always required for testing even for proven technologies. Once again maybe the language should not be “find a vaccine” but rather “find an evolving vaccine”.
A more nefarious aspect of clinical trials is when the developers of a drug or a medicine intentionally introduce a bias in the data to achieve a certain outcome. A more innocuous situation is when a bias is unwittingly introduced in the data (e.g. the Oxford vaccine). For example, biased trials would be not including a sufficient sample set of the type of patient the drug is meant for. Imagine searching for a Coronavirus virus vaccine but including insufficient people from the 80-100 age group; this surely will introduce a bias in the results.
But even if there were enough volunteers within such an age group, scientists and ethics committees are still bound by the Hippocratic Oath. In effect there is always scope for manipulation of data to achieve the desired results, but there still remain the ethical issues of the “do no harm” doctrine and the nature of the study itself. Just because companies do not cheat it does not mean that we are free of ethical dilemmas. Nature itself might compromise our intentions by making us avoid certain risks. For example we don’t ask volunteers to be infected with a cancer or operated on to explore a surgical procedure.
Although I have no big issues with paying volunteers to participate in clinical trials assuming that they are reasonably and equitably compensated for should something go wrong, this is not without its down side. The donation (4) of blood (paid or unpaid) in the 1980s introduced the danger of HIV/AIDS infected people passing on these disease in the blood they donated. Indeed the Covid-19 situation today is very similar to the HIV/AIDS case, both diseases do not always manifest into symptoms and, therefore, the volunteer is not aware they have HIV/AIDS or Covid-19. Luckily today we have tests to detect the Coronavirus, although we also know that these tests are not always reliable even if low in numbers.
As I argued above volunteers might themselves introduce a bias in a study even if they are innocent and without malice. In the HIV/AIDS case we now know that because people are paid for blood donation this attracted a high proportion of people who are likely to have the disease, for example drug users sharing needles.
Today we don’t have too much public domain information about the volunteers involved in the clinical trials for the Covid vaccine. We can assume that the right protocols were followed, the data will be made available and that volunteers were sufficiently informed about the Coronavirus. I would suppose that so many people volunteered for these trials was because they knew exactly what was involved and the risks. Perhaps this would partially explain why the scientists were able to introduce a functioning vaccine so soon. And even still a few days after mass inoculation two nurses in the UK had a reaction to the vaccine except that they had a history of adverse reactions to vaccines. This suggests to me that people who had adverse reactions to vaccines were not included in the clinical trials.
Another controversial issue is the inclusion of children in clinical trials. The issue here is the reluctance of parents to expose their children to the risks of a clinical trial. Sure parents might be willing to enrol a child who is seriously sick, but it would be reasonable for parents not to put their children at risk or distress. The problem is when healthy children are needed for aspects of the trial for example should they be inoculated with the test drug in a blind study? Whatever it is, the experience is surely stressful for the child.
But the dilemma is as an article by the American Academy of Pediatrics (5) points out: “It's important to study new treatments in children because children are not little adults.” The dilemma for the health carers and medical science in general is foregoing specific trials on children because of the surrounding issues and then guess a therapy regime and dosage for children. From what I understand guessing a dosage for children is equally risky for the child as much as participating in a clinical trial. Surely this dilemma is the ultimate ethical issue in medicine. The status quo is exposing children to possible risks post approval of a drug, or simply apply more pressure on parents to the point of coercion to have their children enrolled in clinical trials.
A relatively old issue is whether we should be using people to test out drugs and medicines in the first place. I personally don’t see the idea of not using people and volunteers happening any time soon. However, I do imagine that unnecessary trials would probably be limited or the use of humans reduced. Maybe more progress can be made in banning clinical trials that just duplicate existing successful drugs. I also imagine more computer and mathematical modelling would be involved in the future in the process of drug making. But certainly not excluding humans from the process.
In effect medical science is now one of the most important disciples that has to deal and find solutions for philosophical issues in an every day context. I would even go so far as to say that the Coronavirus pandemic has upstaged nuclear energy as a world threat to humanity. What is sure is that these are not the times to rely on ideology or dogma and certainly no one should be excluded from scrutiny and accountability.
Best Lawrence
(*) I will include some reference links here:
Mayo Clinic - Clinical Trials
Volunteering
https://www.mayo.edu/research/clinical-trials/deciding-to-volunteer
AND
Clinical trials – NHS Health A-Z
https://www.nhs.uk/conditions/clinical-trials/
(0)
What is lymphoma?
Lymphoma Action Charity UK
https://lymphoma-action.org.uk/about-lymphoma-what-lymphoma/causes-lymphoma
(1)
WMA Declaration of Geneva
The World Medical Association, Inc.
https://www.wma.net/policies-post/wma-declaration-of-geneva/
(2) Patient Protection in Clinical Trials in India: Some Concerns
Sandhya Srinivasan
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146073/
(3) The BMJemahase@bmj.comCite this as:BMJ2020;371:m4042http://dx.doi.org/10.1136/bmj.m4042
Published: 22 October 2020
Elisabeth Mahase: Covid-19: Vaccine trials need more transparency to enable scrutiny and earn public trust, say experts.
(4) Paid plasma donation and risk of blood-borne diseases in blood-product recipients
The Lancet Journal
Published:December 08, 2001DOI:https://doi.org/10.1016/S0140-6736(01)06996-3
AND
Blood, plasma donation policies reflect fears born in an earlier epidemic: HIV in the 1980s
ByZoë ReadAugust 25, 2020v published in WHYY
(5) Should My Child Join a Clinical Trial?
American Academy of Pediatrics
telephone/WhatsApp: 606081813
Email: philomadrid@gmail.com
http://www.philomadrid.com
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