Terminally ill patients and the right to try new untested drugs

In the United States nearly half of the states have passed a “right to try” law, which attempt to give terminally ill patients access to experimental drugs. Some scientists and health policy experts believe such laws can be harmful by causing false hopes and even suffering.  Rebecca Dresser argues that states should not implement such laws due to dashed hopes, misery, and lost opportunities which can follow from resorting to unproven measures, see  hastings centre report . For instance, someone might lose the opportunity to spend his last days with his family in a futile attempt to extend his life. In this posting I want to examine the right of terminally ill patients to try experimental drugs which have not been fully tested.My comments here will only apply to experimental drugs but I would suggest that they could equally apply to all experimental treatments such as the use of Crispr gene editing tools. In what follows experimental drugs will refer to new drugs which have not yet been fully tested. Of course pharmaceutical companies must be willing to supply these drugs. I am only examining the right of patients to try experimental drugs which pharmaceutical companies are willing to supply and not patient’s rights to demand these drugs. In practice pharmaceutical companies might be unwilling to supply such drugs because of a fear of litigation, I will return to this point at the end of my posting.

I fully accept Dresser is correct when she asserts that experimental drugs might cause dashed hopes, misery, and lost opportunities. Untested drugs can cause harm. It is this harm that forms the basis for not allowing terminally ill patients access to these drugs. I now want to examine in more detail the harm that access to experimental drugs might cause to the patients who take them. I will then examine how access to these drugs might harm future patients by distorting drug trials.

How might access to experimental drugs harm the patients who take them? Firstly they might further limit a patient’s already limited lifespan. Secondly they might cause a patient greater physical suffering. Lastly they might cause him psychological suffering by falsely raising hopes and then dashing these hopes if they fail. I will now examine each of these three possible harms in turn. Previously I have argued that terminally ill patients, those suffering from Alzheimer’s disease and other degenerative conditions should have a right to assisted suicide, see alzheimers and suicide  . If terminally ill patients have a right to end their lives it seems to follow that the fact that experimental drugs might possibly shorten someone’s life does not give us a reason to prohibit the taking of such drugs. It might be objected that someone taking a drug to end his life and someone taking an experimental drug to extend his life have diametrically opposed ends. However, even if this is true a patient taking a drug to try and extend his life should be aware that it might do the opposite. Provided a patient is reasonably competent and aware that such a drug might shorten his life it should be up to him to decide if he is prepared to accept the risk of shortening his life in order to have the possibility of extending it. It might now be objected that by providing experimental drugs to someone we are not acting in a caring way, we are not acting beneficently. In response I would argue the opposite holds and that if we prohibit the use of these drugs we are caring for patients rather than caring about them. Caring for differs from caring about. If I care for a dog I must care about what is in its best interests. If I care about a person I must care about what is in his best interests and what he thinks are in his best interests. Failure to do so is a failure to see him as the sort of creature who can decide about his own future and displays moral arrogance. I have argued elsewhere that If I care about someone in a truly empathic way I must care about what he cares about, rather than simply what I think might be in his best interests, see woolerscottus . It appears to follow that competent patients should not be prohibited from taking experimental drugs which might shorten their lives provided they are aware of this fact. After all smoking shortens many smokers’ lives but because we respect autonomy smoking is permissible.

It might be objected that the above argument is unsound as often terminally ill patients are not the sort of creatures who can really make decisions about their own future. The above objection as it stands is unsound as the terminally can make some decisions about their treatment. For instance, it is perfectly acceptable for a patient to choose forgoing some life extending treatment in order to have better quality of life with his family. The above argument can be modified. It might be argued that terminally ill patients are not good at making decisions about their future or lack of it. This might be caused by stress, a disposition for false or exaggerated optimism and an inability to understand probabilities. In response I would point it is not only the terminally ill but the public and some doctors who are not very good at understanding probability, see Helping doctors and patients make sense of health statistics . Nonetheless false optimism remains and this false optimism might distort a terminally ill patient’s decision making capacity. What exactly is meant by false optimism? Is it just a failure to understand probability or is it someone assigning different values, weights, to the things he finds to be important? No decisions are made without reference to these weights, our values, and it follows changing our values might change the decisions we make without any alteration to the probability of certain events occurring. What might appear to us as false optimism might be someone giving different weights to what he finds to be important. I would argue we must accept that the terminally ill have a right to determine their own values and assign their own weights to things they find pertinent to their decision-making for two reasons. Firstly, we should recognise that the terminally ill remain the sort of creatures who can and should make decisions about their own future. Secondly, most of us are in a state of epistemic ignorance about what it means to experience terminal illness and if we criticise the values of the terminally ill we are guilty of epistemic arrogance. It would appear if we accept that the terminally ill are the kind of creatures who can make decisions about their own future the fact that experimental drugs might shorten their lives does not give us reason to prohibit them from using such drugs.

Patients who take experimental drugs might cause themselves physical harm. The first principle in medical ethics is to do no harm, non-maleficence, so it might be argued that the prescription of such drugs by medical practitioners should be prohibited. The above argument is unsound. Chemotherapy harms patients but this harm is offset by its benefits. Let us accept that an experimental drug might harm a patient but that it might also benefit him. Indeed, such drugs are only tested because it is believed that they might benefit patients. The above argument might be modified. It might now be argued that that the prescription of experimental drugs by medical practitioners should be prohibited until such a time as the benefits of taking these drugs can be shown to offset any harm they cause. However, the above argument is also unsound. Chemotherapy does not always benefit patients and so does not always offset any harm it causes. If we accept the above argument then we should prohibit chemotherapy, such a suggestion is nonsensical. However, the modified argument might be still further modified. It might now be argued that that the prescription of experimental drugs by medical practitioners should be prohibited until such a time as the benefits of taking such drugs can be shown to offset any harm they cause in the majority of cases. This further modified argument is about how much risk patients should be exposed to.

The reason we don’t want to expose patients to excessive risk is because we care about them. However we don’t prohibit paragliding because we care about those who participate. Who should determine what risks are acceptable? I can use the same argument I employed above, showing that patients have the right to risk shortening their lives if there is some limited chance of life extension provided they understand the risk involved, to deal with the risk of patients harming themselves. I would suggest that if we prohibit the use of experimental drugs which might harm patients but also might benefit them that once again we are caring for patients rather than caring about them. I argued above that we should care about people in a different way to the way we care for dogs. Failure to do so is a failure to see patients as the sort of creature who can make decisions about their own future and displays moral arrogance. If patients understand the risks involved it should be up to patients to decide if they are prepared to accept these risks. The last way the use experimental by patients might harm them is by causing psychological suffering by raising false hopes and dashing these hopes if these drugs fail. I believe in this context the above argument can once again be applied and I will not repeat it. To summarise it would seem that possible harm to actual patients is not a reason to prohibit access to experimental drugs provided patients are aware of this possible harm.

Even if we accept the above somewhat tentative conclusion it doesn’t follow that we don’t still have a reason to prohibit access of experimental drugs to terminally ill patients. Future patients might be harmed because the effectiveness of drugs might not be fully tested in the future. Drug trials are expensive and if pharmaceutical companies can rely on data obtained by using a drug on terminally ill patients then they might be reluctant to finance fully fledged trials. Doing so might lead to two problems. Firstly, some drugs which appear not to harm terminally ill patients might harm other patients. The long term effects of a drug, which extends a patient’s life in the short term, might not become apparent. Secondly some drugs which do not appear to have any effect on terminally ill patients might be effective on less seriously ill patients. Such drugs might not become available to future patients. Can these two problems be solved?

Regulation might solve the first problem. Experimental drugs might be used on terminally ill patients if they desire them but their use should not be permitted on other patients until after undergoing a full clinical trial. It might appear that because there are less terminally ill patients compared to other patients that pharmaceutical companies would continue to conduct full clinical trials on experimental drugs. However this appearance might be unsound. Pharmaceutical companies might try to extend the definition of a terminally patient so as to continue using some drugs without them ever having to undergo a full trial. This problem might be overcome by regulatory authorities insisting that experimental drugs are only used on those who are terminally ill. Applied philosophers might aid them in this task by better defining what is meant by terminal illness. The well-known physicist Stephen Hawking has motor neurone disease and it is probable that this disease will kill him but at the present he would not be classed as terminally ill. Terminal illness should be defined by how long someone will probably live rather than the probability that his illness will kill him. Perhaps someone should not be considered to have a terminal illness unless it is probable that he has less than six months to live. Let us consider the second problem. Might some pharmaceutical companies be tempted not to fully trial some drugs which might benefit some patients on the basis of incomplete evidence gathered from their use on terminally ill patients? Once again regulation might solve this problem. I would suggest that provided that terminal illness is defined tightly enough that this problem shouldn’t arise. A tight definition of terminal illness means fewer terminally ill patients for pharmaceutical companies to test drugs on forcing them to conduct full clinical trials. To summarise once again it appears harm to future patients does not give us reason to prohibit access to experimental drugs for the terminally ill provided that terminal illness is tightly defined.

Lastly at the beginning of this post I suggested that in practice pharmaceutical companies might be unwilling to supply experimental drugs due to a fear of litigation. It should be possible to overcome this fear if patients are required to sign a comprehensive consent form making it clear not only that there are risks involved but also that these risks include as yet unknown risks.

The above discussion leads to the rather tentative conclusion that the terminally ill should not be prohibited from trying experimental drugs subject to certain safeguards. These are,

1. Terminal illness must be clearly and tightly defined. Philosophy can play an important part in doing this.
2. No drugs which have not been fully tested should be used on non-terminally ill patients except for the purpose of testing
3. Any terminally ill patient taking an experimental drug must sign a comprehensive consent form in the same way patients taking part in trials do. This form must make it clear that they are prepared to accept as yet unknown risks.

Driverless Cars and Applied Philosophy

Google has developed an autonomous car and major car makers such as Ford and VW are showing an interest in doing the same. It is reported that up to ten million such cars might be on the road by 2020, see businessinsider . I am somewhat doubtful about such a figure but nonetheless autonomous cars are coming and their coming raises some ethical issues. According to Eric Schwitzgebel

“determining how a car will steer in a risky situation is a moral decision, programming the collision-avoiding software of an autonomous vehicle is an act of applied ethics. We should bring the programming choices into the open, for passengers and the public to see and assess”,

see autonomous cars . Clearly autonomous cars needs collision-avoiding software. Intuitively Schwitzgebel seems to be correct when he argues that an ability to address moral concerns should built into this software. For instance autonomous cars might be programmed to not to protect their passengers if by so doing a large number of pedestrians would be harmed. In this posting I want examine three questions. Firstly is Schwitzgebel correct when he argues that an ability to address moral concerns should be built into the software. Secondly is such software actually possible. Lastly if it isn’t possible to design software which can make moral decisions should we nonetheless permit autonomous cars on our roads?

What does Schwitzgebel mean when he says that the software of an autonomous car should be able to address moral concerns? In this posting I will assume he means some rules should be built into a car’s software about what to do in situations which involves some moral considerations. Does a autonomous car need such software? It is by no means certain it does. Consider a driver whose car will collide with either a young pregnant mother or an old man due to unforeseen circumstances. Does she make a decision about what to do based partly on philosophy? I suggest she does not. Of course her emotions might kick in causing her to avoid the pregnant mother. It might then be concluded if drivers don’t, or can’t, make a decision based on philosophy, that there is no reason why autonomous cars should do so. Of course that autonomous cars should be safe as possible for its passengers, other road users and pedestrians. The above leads to two tentative conclusions. Firstly, provided autonomous card are as safe as drivers then there it would seem that there are no ethical reason against their introduction. Provided autonomous cars are as safe as drivers then autonomous cars do no more harm than drivers. Secondly, provided autonomous cars are only slightly safer than drivers then it would appear that there is an ethical reason for their introduction. Autonomous cars do less harm than drivers. Of course issues concerning responsibility remain.

What objections can be raised about accepting the above conclusion? Firstly it might be objected that my example is chosen to mislead and that in other situations, when the circumstances are much clearer, people do in fact make decisions roughly based on applied philosophy. For instance a driver might be faced with the choice of hitting a concrete stanchion and killing himself or running into a queue of schoolchildren waiting at a bus stop might choose to hit the stanchion for moral reasons. I accept that in some extreme circumstances drivers might make a moral decisions. However such a decision might be based on the driver’s emotions rather than the application of applied philosophy. Applying philosophy takes time and time and may not be a viable option in a collision situation. Moreover I would suggest in real life situations this second example is just as misleading as the first. A car crashing into a queue might kill one or two people but it is unlikely to kill a very large number. It seems to me that only a large number of victims might enable a driver to make a clear moral decision quickly. I have argued drivers don’t usually make moral decisions when making collision decisions and rarely if ever do so by applying philosophy. Does this mean autonomous cars do not need a controlling system that takes account of moral considerations? The above seems to suggest that they don’t. However let us assume drivers should take into account moral considerations in collision situations provided this is possible. It follows autonomous cars should have a controlling system that takes account of moral considerations in collision situations provided this is possible. However if this isn't possible and autonomous cars are at least as safe as drivers the inability to make moral decisions shouldn't prevent the introduction of autonomous cars.

Designing systems that enable autonomous cars to make decisions which include moral considerations will be difficult. Perhaps then rather than designing such systems it might be better to make autonomous cars avoid the circumstances in which the need to make moral decisions arises. Cars and pedestrians don’t mix so perhaps it might be safer to limit autonomous cars to motorways and other major roads. Doing so might have the additional benefit that it might prove easier to design autonomous cars to avoid dangerous circumstances in which they might need to make moral decisions rather make moral decisions. Unfortunately such a course of action whilst desirable would seem to be impractical unless the way people use cars changes radically. People want cars to take them home, to work, to go shopping and their children to school. Satisfying these wants means mixing cars and pedestrians. Cars that don’t satisfy these wants would be unwanted. It would appear that even if it is very hard to do that an attempt to program the collision-avoiding software of a autonomous cars to enable them to take in to account moral considerations should be made provided this is possible.

I have argued that Schwitzgebel is correct in his assertion that the collision-avoiding software of a autonomous car should include moral considerations provided this is possible. Let us turn to the second question I posed, is such software possible? I have argued that in an emergency situation in which people have to make moral judgements that they do so quickly based on their emotions. Cars don’t have emotions so it follows the basis of any software system for making moral decisions in autonomous cars will be different from that used by drivers and based on set of rules. What sort of rules? Schwitzgebel argues that the rule of protecting a autonomous car’s occupants at all costs is too simplistic. I would question whether such a rule is indeed a moral rule at all. Might a strictly utilitarian rule of maximising the lives saved in a crash situation be adopted? Schwitzgebel points out such a rule would unfairly disregard personal accountability. For instance what if a drunken pedestrian steps in front of a car? Isn’t he accountable for his actions? If so shouldn’t his accountability be taken into account when assessing the consequences of any decision about the oncoming collision? Could a driver spot that a pedestrian was drunk in an emergency situation? I would suggest he couldn’t. At present a autonomous car’s software certainly couldn’t. It follows any rules used by autonomous cars must be primitive rules which don’t fully represent our own understanding of moral rules. It seems possible that if we are prepared to accept some primitive rules built into a autonomous cars software then it might be possible for such a car’s software to make some primitive moral decisions.

Let us consider my last question. If the rules involving moral decisions which are built into autonomous car’s software must, at least for the present, be rather primitive rules should we permit the use of such cars? I will now argue we should. Firstly I have argued that drivers don’t, or very rarely, make moral decisions in collisions situations. There is no legal requirement that drivers should make such decisions and I see can no reasons as to why a higher standard should be applied to autonomous cars. Indeed autonomous cars might be safer. Drivers can get drunk, tired and speed. Autonomous cars can’t get drunk or tired and their software can control their speed. Let us accept than any moral rules built into the software of a autonomous car must be concerned with its safe use. Let us also accept that being safe involves avoiding harm. Now let us consider a autonomous car with the primitive rule of protecting its occupants at all costs. This car safe for its occupants and avoids harming them. I would suggest we should not permit the use of autonomous cars using such a simple rule. It’s only safe for some. It might appear that the introduction of autonomous cars would only be acceptable if their software makes them safe for the public at large and avoids harming them. Achieving the above would be difficult. However the above might be amended. The introduction of autonomous cars would only be acceptable if their software makes them as safe to the public as driven cars.  I have argued above that drivers only have the time to make very limited moral decisions. It should be possible to create software for autonomous cars which can make the same sorts of moral decisions as drivers do. Indeed it might be harder to create software which recognises roadside features such as pedestrians than moral concerns.

What conclusions can be drawn from the above? Firstly provided autonomous cars are as safe as drivers then autonomous should be permissible. Secondly provided autonomous cars are only slightly safer than drivers then it would appear that there is an ethical reason for their introduction. However problems with accountability and insurance remain but these problems don’t seem insurmountable.