From the structural analysis, a number of themes emerged, and these themes are explored in details below.
The health of the patient in focus
Molecular biologists employed in a private biopharmaceutical company have the patient in focus when they plan research projects. They describe their research aims as gaining knowledge about cell, protein and gene functions in order to develop biopharmaceuticals to help patients. This means they have a specific effort of beneficence in mind. This is seen in MBP, Q7, below.
... We are employed here to produce drugs for the benefit of the patients, so we have to see things in a broader perspective ... of course, that is not where your focus is when you are about to clone something and considering what restriction sites to apply. At that moment, the overall perspective is not the focus of your attention, but you have to keep it in the back of your mind as part of your daily activities in order for things to make sense in the end.
But although the individual researcher in the biopharmaceutical company has the beneficence of the patient in focus when planning new projects, the choice of the management of the company to start up a new project has to do with economics. This is seen in MBP, Q8, below.
It requires a willingness to accept that you are not always able to finish your job completely, because sometimes you reach a conclusion where you have to admit that this part was not so good anyway – we may lack some answers, but we never get around to ... we cannot defend the continuation of the work, and therefore we close this activity now. You need to accept that you cannot complete all your work in detail, but the positive side is the fact that there are always exciting new projects to address and take further ... but, of course, you always have to weigh the financial aspects ... There needs to be an indication that this could potentially become a drug before it is even recognised as a project.
In contrast to molecular biologists employed in a private biotechnology company, molecular biologists employed at a public university do not have any specific effort of beneficence in mind; their research goal is to provide answers to interesting basic research questions so as to accumulate knowledge. They describe their research aims as gaining knowledge about fundamental cell, protein and gene functions. This is seen in MBU, Q9, below.
... our overall goal is to understand how interferon works ... it is pure basic research.
Oncology physicians working in a clinic at a public hospital describe their research aims in a similar way to molecular biologists employed in a private biopharmaceutical company; they have a specific effort of beneficence in mind. Oncology physicians regard the goal of clinical trials as developing better treatment for patients. Their motivation is to help sick people. This is seen in quotation OPC, Q1, table 4. When deciding the inclusion criteria for a clinical trial, physicians firstly have the present patient in focus and consider how this experiment can benefit this patient. Secondly, the physician considers how this experiment can benefit future patients. This is seen in OPC, Q10, below.
We have to give consideration to the patients first and foremost. If you are about to make an experiment, consideration for the patient comes first, but there are also all the future patients to consider. You have to constantly try to gain more insight, and perhaps you can kill two birds with one stone by offering a patient the chance to participate in an experiment.
Oncology physicians find that patients suffering from terminal illnesses want to participate in trials to benefit other patients. This is seen in OPC, Q11, below.
The more ill you are, and the more hopeless your own situation is, the more ... So you try to attach some meaning to your situation, so that it can at least be to some use for others. Then I think you make a ... You try to find some sense in it and some ... Something positive is bound to come out of all this misery. If nothing else, greater knowledge on a collective basis.
Risks and dangers
Molecular biologists employed in a private biopharmaceutical company or at a public university face minimal environmental and health risks regarding radioactivity and chemicals when conducting basic research. This is seen in quotation MBU, Q12, below. With regard to experiments in cell cultures, they believe that mammalian cells have a built-in safety margin against spreading to nature, since cells are sensitive and need to be treated well if they are not to die. Furthermore, molecular biologists experience very strict safety guidelines. This is seen in quotation MBP, Q13, below.
It is minimal, but we do work with radioactivity, so that is one risk factor. But we use very small amounts ... a few chemicals that you should not eat directly ...
The cells we use ... mammalian cells are generally very sensitive. If you do not treat them really, really well, they die ... So this is a margin of safety in itself ... I mean, against spreading to nature for instance ... and we also have systems to kill them before anything spreads to nature. As a precaution, we have very strict rules against pouring it down the sink. Everything needs to be ... sterilised. Everything is either autoclaved or we ... add something to the cell media and cell cultures that we use to kill the cells.
Molecular biologists employed in a private biopharmaceutical company carry out animal testing to investigate whether biopharmaceuticals may produce cardiac problems or cancer. This is seen in MBP, Q2, table 4 and in MBP, Q14, below.
Clinical development is about finding out if whether or not this is an effective and safe treatment ... if it is not safe, then it is no use ... You cannot accept a treatment that makes people ill.
Molecular biologists employed at the university stress that toxicology tests are always performed in animal models and not in humans the first time. This is seen in MBU, Q15, below:
Toxicology tests, for instance. You do not perform them on humans the first time. You always use some kind of test animal the first time.
To develop the most efficient cancer therapies with the fewest side effects, oncology physicians carry out clinical trials. They always consider how toxic the treatment is. When physicians decide whether or not to ask a patient to participate in a trial, the physician takes the situation of the patient into account. They consider whether the patient is suffering from a serious disease, whether the disease is curable or whether palliative care is needed. This is seen in quotations OPC, Q16–17, below.
... how to offer a cancer treatment that would be both effective and cause as few side-effects as possible. That is the balance we need to strike. The balance between our effective remedies – that include surgery, radiation and chemotherapy – and the whole person who has be able to function afterwards.
And of course, it must be viewed in the light of the seriousness of the situation. Are we dealing with potentially healthy patients or terminal ones? ... But in both cases you have to consider – even in the case of terminal patients: is it a real possibility? – and what kind of cost considerations are involved if they participate – how toxic is this?
According to molecular biologists employed at the university, ethical boards have to evaluate potential experiments or clinical trials in order to minimise the harm done to human subjects and patients. This is seen in quotation MBU, Q18, below:
But somebody has to check that the professional skills and expertise are satisfactory before you ...otherwise, some smart Alec who makes an unconsidered choice ...
Informed consent, external constraints, vulnerability and role reversal
In the study, we see examples of how molecular biologists find that informed consent can be influenced by external constraints. For instance, in MBU, Q3, table 4, a molecular biologist employed at the university says that patients must be informed of their options regarding treatment or trials and that their decision regarding these issues should be respected. This quotation indicates that informed consent should be respected without external constraints. However, in MBP, Q19, below, a molecular biologist employed in a private biopharmaceutical company stresses that very ill patients will accept any treatment, they will accept the risks involved, they are vulnerable and constrained by the circumstances to make a certain choice. MBU, Q20, presented below, illuminates the same issues and says that patients and human subjects should decide themselves, but that very ill patients are constrained by the circumstances to make a certain choice.
... if you were a seriously ill or terminally ill patient, I think I would accept just about any treatment, because you would accept the risk involved.
... people make their own choices; if you inform people of the risks, they must make the decision themselves. The problem is if they feel they are forced into it. Some may feel this way; it depends on the person.
Molecular biologists employed in a private biopharmaceutical company or at the university believe that if they were patients suffering from serious cancer, they would accept any treatment independent of side effects. They imagine themselves being in the situation of the patient (role reversal). This is seen in quotation MBU, Q21 and MBP, Q22, below.
... often you try to put yourself in that person's shoes; if it was your child or if you were the patient, would you run that risk ...
...if you tell a cancer patient: Do you want this treatment? – it will prolong your life by three months on average. If you were in that situation yourself, you would say: yes, give me this treatment. You could decide to live with various side-effects ...
Respect for autonomy based on the patient's wishes and ideas, information and understanding
Oncology physicians believe that informed consent or refusal is based on the patient's wishes and ideas, information and understanding. For instance OPC, Q4, table 4, says that in dialogue with the patient, the physician performs a medical prognosis or risk-benefit analysis based on the patient's wishes and ideas, mutual understanding and respect. Furthermore, OPC, Q23, below, stresses that the physician has a positive obligation to adjust to the level of the patient when disclosing information to make sure that the patient understands. OPC, Q24, below, emphasises that the tasks of the physician are 1) to disclose information so that the patient can make informed consent, and 2) to respect this informed consent.
... patients are very different and you must adjust to their level as best you can and try to work out what kind of language to speak and sense whether they have understood what you have told them, and maybe repeat it...
My task is to ensure as well as possible that they know ... receive information on what we can offer and what options are available to them in their situation. And that the information is communicated in such a way that it forms the basis of their decision-making. If they then decide something else, then that is that.
The principle of respect for autonomy does not apply
Oncology physicians think that there are situations, where the principle of respect for autonomy does not apply. OPC, Q25, below, describes such a situation.
... when we have a protocol like that – there is the inclusion criteria ... the patient may meet all the criteria, but when I sit in front of the patient, I think to myself: this just will not work. This patient is in some sort of crisis or situation in which it is not fair to ask them to make this kind of decision. And then I can choose to say to myself that it is not fair. Then we give them the standard treatment ... once in a while I decide that they are not capable of making these decisions themselves. It is not fair to place the strain and stress of having to make such a decision on them – because it
OPC, Q25 stresses that the physician's decision about treatment depends on the physical and psychological condition of the patient. Furthermore, the quotation tells us that the physician avoids asking the patient to make a decision if the patient is in a difficult situation, since it is not fair or just under these circumstances to place stress on the patient.
Clinical trials in developing countries, fairness, limited resources, public funding and waiting lists
Molecular biologists employed in a private biopharmaceutical company have interdisciplinary working groups that discuss the ethical and legal issues of the use of human material and animal models. One reason the company prioritises ethical evaluation is because of the investors: if the company behaves unethically, they will be punished by the consumers and by the investors in the long run. This means it is important for the company to have an ethical profile, since it pays off. This is seen in MBP, Q5, table 4. The private biopharmaceutical company performs clinical trials in developing countries. To benefit the research subjects, they are assigned a lifetime of treatment. The company's motive in helping developing countries has to do with economics. This is seen in MBP, Q26, below.
Generic drugs and placing drugs at the disposal of countries that cannot afford them. These are issues that management deals with, and there are guidelines ... on how to behave, if you make clinical experiments in a country that would not normally offer this kind of treatment. Then you should – well, not just should, but must – offer life-long treatment to the individuals involved, if it turns out that this clinical test is related to an effective treatment ... we have departments that are responsible for clinical experiments, and these are the kinds of things they deal with: Where can you carry out your clinical experiments, in which countries? And a number of things may speak in favour of the richest countries because then you will not be accused of ... exploitation. But there can also be good reasons for choosing less rich countries, because it gives them the opportunity to be included in treatment. And XX does it to some degree ... there are clinics established by XX in Africa, India and ... that are simply ... at XX's expense, and – you may say – compared to marketing budgets it is not a whole lot of money ... obviously, if you realise that it pays off. But at the same time it is a good thing.
Oncology physicians working in a clinic at a public hospital are dissatisfied with the management demands for efficiency. They think that budgets and demands for efficiency do not fit together and that the waiting lists are too long. The oncology physicians believe that they have to treat too many patients per day in the out-patients' clinic, since there is a limit to how many patients they can treat per day with empathy. This is seen in quotations OPC Q27–Q29, below.
It is a demand from the management who ... it has been decided ... Budgets are decided and followed by demands and expectations of a specific number of patients to be attended to within the framework of the budget, and these ends do not meet. We quite often have waiting lists, and that is very unsatisfactory ...
... You know there are already ten people in the waiting room and if you fall behind schedule, they will push you and ask you if it is not their turn? They are also nervous, because they are going to be tested. So it is all a race against time.
... it is dissatisfactory if the outpatient department programme is too tight ... if the production demand is too great. There is a limit to how many patients you can contain in your head in one day; to how much negative news you can give patients without becoming a tape recorder ... sort of a factory where things are weighed and measured that way.
Oncology physicians find that resources are limited, they have too few instruments and too little equipment compared to the number of patients suffering from cancer, and they want to treat as many patients as possible in the best way. This is seen in OPC, Q6, table 4. However, the physician does not consider that resources are limited when deciding treatment for the individual patient. This is seen in OPC, Q30, below.
I do not take into consideration that it will cost us 100.000 if we have to use Tascol again. I have not taken into consideration that it is too expensive. Not in relation to the individual patient, but of course, when we hold a meeting and the administrator informs us of the size of the current drugs budget, and that the expected payments deficit will be such and such if we initiate the new treatment, and we do not have the capacity or the staff to do it, and we do not have the means – or whatever – then you think about the financial aspects. But when you are facing the individual patient, you do not think too much about it.
Molecular biologists employed at a public university also find that resources are limited. They are stressed since they are under a constant pressure to apply for funding for research and the competition is hard. This is seen in MBU, Q31, below.
...difficult to raise enough money to make ends meet. You are quite isolated, doing your own thing and raising money for it ... so basically we are competing for the same money ...publication is a prerequisite for being able to raise funds – so that is where the shoe pinches: to get your work financed to be able to continue...and if you need material for your test tubes, or equipment or the like, you have to find a way of getting it ... that is what puts me under the most stress, I would say ... excellent researchers do not work alone ...