Defining Good in Abstraction

What good actually is might best be described as that which within oneself generates positive externalities outside oneself which has a greater tendency to promote the same form of positive externalities amongst those experiencing the initial externality than it would to promote negative externalities amongst the same individuals, as the initial externality ripples through both time and space. One draw back of this description is that it implies that good is dependent upon an intangible relation to and existence of others. A being thus cannot be good in and of it self but rather must be contrasted with that of another being in determinations of good. This unfortunately does not seem to be avoidable. The level of abstraction here is such that it may be easier to merely consider it, indefinable for brevity as G.E. Moore puts it, and it is certainly in and of itself, un-analyzable.

Doktor Kuckenmeister’s Gruesome Experiment

Herr Doktor Friedrich Kuckenmeister conducted a pioneering medical experiment on a prisoner awaiting execution. He persuaded the prison authorities to allow him to feed the unfortunate man a soup made from meat laced with cysts. Six weeks later the man was hanged, and when he was cut down, Kuckenmeister performed an autopsy. He found the man’s digestive tract riddled with tapeworms, confirming his suspicions that cysts in animal carcases formed part of the lifecycle of these parasites. Had the condemned man been allowed to live, the tapeworms would have grown and grown, feeding on his digested food, and might have reached a length of 30 m (100 ft).

Source: The Totally Useless History of the World by Ian Crofton pg. 229.

Research Bias

I’ve come across a TED Talk when searching for interesting video’s to watch on research ethics. I found this interesting talk by Garry Gray.

The talk is about the ethical dilemmas that professors face and whether they face an increased risk of bias for those who fund their research.

It’s an interesting short video for the weekend.

Here’s the link: https://www.youtube.com/watch?v=JSV4VZ8gdUQ

Have a great weekend,

Andrew

Comments on ‘Religion Within the Boundaries of Mere Reason’

In Religion Within The Boundaries of Mere Reason Kant puts forth the idea that for someone to be moral they must come to this decision on their own as totally free individuals and be moral for moralities sake alone. They cannot decide to be moral because they want to make other people happy, rather they must be moral because they understand it is the right thing to do and only for this reason. There is a problem that arises from this line of thought however which is if what Kant is arguing is true, it would seem that there is no need for the church, he even states that morality has no need for the church. Despite this, Kant involves himself throughout the book with the church. In this paper I will look at what role the church and other individuals could possibly have in relation to another person being moral, under Kantian thinking, and whether or not this is reasonable and consistent.

For Kant people are not innately evil, rather people are evil because they are not reasoning properly. People do not reason properly when they are among other people in a society. Kant believes community life encourages people to be immoral. “Envy, the lust for power, greed, and the malignant inclinations bound up with these, besiege his nature, contend within itself, as soon as he is among men.” (Kant pg. 85) Kant is saying that society attacks people in such a manner through, envy, greed, and the like, that people are pushed into immoral activity. For Kant, as I see it, for someone to be held morally accountable they must be able to act against their desires to be considered free and thus morally culpable. (Kant pg. 16) Someone whose nature is being besieged does not sound like someone who is free to me. Not only this but since it is in human nature to live in a society how can humans be expected to act in a moral manner if their natural instincts are taking them in the opposite direction. Not only do people have their own instincts pushing them to act immoral but also while in a society they have social factors pushing them to act immoral according to Kant. There are several problems I believe that arise from this. First of all if we are not acting in a free state then we should not be held morally accountable and secondly if society is causing people to be immoral how can we become moral while still living in a society and not resort to living solitary lives in the wild.

In response to the first problem Kant would say that we are in the end making these choices with our own free will, although through faulty reasoning, and as a result of being free while doing immoral acts people should be held morally responsible. Although it is true that in the end we are the ones to make the choice, immoral ones at times, it is an unreasonable burden. I take it to be equivalent to saying that if someone chooses to commit a robbery because they were being threatened, they are acting immoral. This is not right. The person acting immoral would be the one pushing the other into the act of robbery. If someone is unable to act against their desires and thus cannot be moral, as Kant asserts early in the book, it should follow that someone cannot be immoral under pressure. To be moral, whether good or bad, requires being in state of freedom. Kant is inconsistent when at one time he asserts that one needs to be able to act against their desires to be moral, and then now stating that regardless of the overwhelming desires from society, which our own instincts lead us to, we can be moral because in the end we are the ones making the final choice. Whether we are morally accountable under overwhelming pressure, Kant seems to waiver. Which ever is the case though there is still the problem that it does not seem like we would ever be able to be moral while living among men.

What role can the church help people to become moral, especially if, as Kant believes, society leads people to be evil and the church is a part of society? Kant would state something along the following. That society does not have to lead people to be evil that is merely the way it is now. There can be ethical communities in which people act in a universally ethical way bound through reason. The aim of the church Kant believes is to achieve such a society and it is the process of getting to this state which the church can help others. The church can act as a support group in a sense, by providing guidance to others on reasoning. This would be the extent of the churches ability; they could not tell people how to act for instance. The church for Kant is around to facilitate people to reason about their moral behavior through scripture and prayer so that they may come to their own realization that they should act morally for moralities sake. The church as a religious institute Kant does not care much about, and believes the only faith that matters is a moral one.

Kant divides faith into two types the Ecclesiastical faith which is visible in the institutions of churches, and a Pure Religious faith. The pure religious faith Kant deems as the real religion, an invisible one, inside of each person. One main reason for splitting the two apart is because Kant does not see anyway of knowing externally what God would want. So the only way of knowing what God would want is through something which every person has, and that is the ability to reason. Each person can reason what is right and wrong and each person can reason that they should be moral simply because being moral is good. According to Kant this is what God would want, for people to be moral, no more, no less. Ecclesiastical faith on the other hand goes along with the typical human thought that God wants more than merely doing what is moral, He would want things such as thanks for example. The problem with this as Kant sees it is that there is no way of knowing that God wants thanks or that good wants people to eat only certain things on certain days for example. In addition to not being able to know these, believing that God wants more than for people to just be moral to one another can easily lead the church to have the same problems which society in general has. Competing for example even if it is competing to be the most moral, it is morally wrong. Even though the Ecclesiastical faith has its problems Kant believes that each one has in it human moral reason which is simply buried by differing amounts of scripture and such, and the faith of Pure reason, the only true faith to Kant, can be cultivated in a sense from each of these other faiths. Kant believes we can deal Ecclesiastical faith to get to the real faith, the faith of pure reason. The reasoning behind this is that each of these faiths must have had at the base a desire or goal to be the religion of pure reason, each founder of these religions Kant assumes must have had it in their mind to aim for the faith of pure reason whether they knew it or not. This is a very bold statement on his part and he does not really support it.

The role of the church under Kantian thinking is hard to pin point. Most of the time he states that we do not need the church to be moral, religious, and do what God wants us to do. Other times though he asserts that we can use the church and through careful examination of scripture by people with strong moral fortitude we can come to the real religion of pure reason. The relationship between the Ecclesiastic faith and the faith of pure reason seems awkward at best. In one hand Kant is saying that we do not need Ecclesiastic faith, and in the other he is saying because a lot of people do not know to be moral on their owns Ecclesiastic faith will help them to reason, so that they can be moral. Although this is not an inconsistency it is certainly breeching on it. In addition if people in general do require the church to help support them to be moral it does not seem that they are doing it on their own, a requirement for Kant in order to be moral.

Bibliography

  1. Kant, Religion Within The Boundaries of Mere Reason (Cambridge University Press)

The Strange Fate of Eben Byers

Fall Guy

In November 1927, a wealthy industrialist named Eben Byers was returning from the annual Harvard-Yale football game aboard a special chartered train. Yale won the game 14-0, and Byers was a Yale alumnus. It’s not clear whether the celebratory atmosphere aboard the train (or Byers’s reputation as a ladies’ man) had anything to do with it, but sometime during the trip he fell out of his upper sleeping berth and injured his arm. The injury interfered with Byers’s golf game and his love life. He visited on doctor after another, but no one could ease his pain. Then a physician in Pittsburgh suggested he try Radithor, a patent medicine (which consisted of little more than the element radium in a distilled water solution).

Radithor was a product of the Bailey Radium Laboratory of East Orange, New Jersey, found by one “Dr.” William Bailey, a Harvard dropout who falsely claimed to have a medical degree from the University of Vienna. In 1915 he had served time in jail for mail fraud. A few years later, after a stint peddling strychnine, the active ingredient in rat poison, as an aphrodisiac under the brand name Las-I-Go For Superb Manhood, he began selling Radithor as “Pure Sunshine in a Bottle.” He claimed it would cure more than 150 different ailments.

Hot Stuff

Drinking radioactive water to improve health may sound crazy today, but in the 1920s, when much less was known about radiation, it seemed to make sense. People had long wondered what gave natural hot springs their supposed healing properties. When the waters were found to be mildly radioactive due to the presence of dissolved radon gas in t he water (an hour’s soak in a hot spring exposed the soaker to as much radiation as an hour in the sunshine), the radon appeared to be the explanation.

It wasn’t just quacks like Bailey who thought radiation was good for you. In an article in the American Journal of Clinical Medicine, a Dr. C. G. Davis claimed that “radioactivity prevents insanity, rouses noble emotions, retards old age, and creates a splendid youthful joyous life.” Other experts credited radiation with stimulating the body to throw off waste products.

Drink to your health

Water from natural hot springs was bottled and sold as a health tonic, but devotees claimed that the bottled stuff lost most of its healing properties after just a few days. This, too, appeared to be explained by the radon, which has a radioactive half-life of just 3.8 days. That means that half of the radon will decay into other substances in that time. At that rate, less then 1 percent of the radon would remain in the water after just one month.

If the radioactivity in spring water was what made it so beneficial, the thinking went, then water that had gone “flat” could be recharged by reirradiating it. There were numerous products on the market in the 1920s that enabled you do just that: You could buy a Zimmer Radium Emanator that, when dunked in a Revigator water crock, made from radioactive core.

All better now

Why stop with water? Companies sold radioactive hair tonic, face cream, toothpaste (for a glowing smile), blankets, soap, candy, chocolate bars, earplugs, hearing aids, laxatives, contraceptives, and countless other products that were credited with curing everything from pimples to high blood pressure to arthritis, gout, constipation, and chronic diarrhea.

In addition to Radithor radium water, William Bailey also sold radioactive flue and cough medicines, and an athletic supporter called a “radioendocrinator” that he claimed would cure impotence. Wearers were instructed to position the radium “under the scrotum as it should be. Wear at night. Radiate as directed…” Eben Byers took his doctor’s advice and began drinking Radithor. A lot of it. He found the water so “invigorating” that he continued drinking it long after his arm stopped hurting. Byer’s cure was more likely due simple passage of time than to any purported healing effects and radium, but he didn’t know that. In addition to downing as many as three bottles of Radithor a day for nearly three years, he sent cases of the stuff to associates and lady friends and urged them to drink it. He even instructed his stable boys to feed Radithor to his racehorses.

Too much of a “good” thing

Byers kept right on drinking Radithor into the early 1930s, when he began losing weight and suffering aches and pains all over his body. These symptoms were soon followed by blinding headaches and terrible pain in his jaw, but it wasn’t until his bones began breaking and his teeth started falling out that he realized he was suffering from something much more serious than “inflamed sinuses,” as his doctors had diagnosed.

Precisely what was wrong with him didn’t become clear until X-rays of his deteriorating jaw were sent to a radiologist in New York. The radiologist was familiar with the case of the “Radium Girls” – factory workers who had died after ingesting the radium in glow-in-the-dark paint while painting watch dials during World War I. The lesions on Byer’s jawbone were similar to the ones the Radium Girls had suffered. When the radiologist learned that Byers had consumed as many as 1,500 of Radithor since 1927, his diagnosis, like Byers’s fate, was sealed.

Radioactive Man

Had Radithor been made with radon gas dissolved in water, like the waters in natural hot springs, Byers probably would have escaped serious injury. But Radithor wasn’t made with radon, it was made with radium, a different radioactive element altogether. Radium’s half-life isn’t 3.8 days like radon’s – it’s 1,600 years. Even worse, because radium is chemically similar to calcium, instead of passing through the body in a day of two, which would have limited the amount of harm it caused, it accumulates in the bones, where the radiation if gives off destroys the surrounding bone marrow, blood cells, and other tissue. This was why Byer’s bone s were breaking and his teeth were falling out – they’d been destroyed by radiation and were no disintegrating. By the time he began to experience the first signs of radium poisoning, he had already consumed more than three times the lethal dose. He was doomed.

A Government Investigation

Even if the Food and Drug Administration had understood just how deadly radium was, in those days its powers to act were very limited. Radium was neither a food nor a drug, after all – it was a naturally occurring element, placing it outside the agency’s jurisdiction. The only government agency capable of acting was the Federal Trade Commission, which was empowered to protect consumers against misleading trade practices, including false advertising claims. Ironically, the FTC had used this power to take action against companies selling products that claimed to contain radioactive materials but didn’t.

By the time Byers fell ill, evidence of the dangers of radioactive products had begun to mount. The FTC opened an investigation into Radithor, which had been advertised as being “harmless in every respect.” Clearly it wasn’t and in 1931 a legal team was dispatched to Byer’s estate to record his testimony. By then he was too sick to appear in court. “A more gruesome experience in a more gorgeous setting would be hard to imaging,” attorney Robert H. Winn remembered:

We went to Southampton where Byers had a magnificent home. There we discovered him in a condition which beggars description. Young in years and mentally alert, he could hardly speak. His head was swathed in bandages. He had undergone two successful jaw operations and his whole upper jaw, excepting two front teeth, and most of his lower jaw had been removed. All the remaining bone tissue of his body was slowly disintegrating, and holes were actually forming in his skull.

The Fallout

Thanks in large part to Byer’s testimony, Radithor was pulled from the market in December 1931. Byers died three months later, at age 51. Any doubts that the radium killed him were resolved at the autopsy, when some of his teeth and a portion of his jawbone were set on a plate of unexposed photographic film: The radiation in the bone expose the file just as if it had been used in an X-ray machine. To prevent the radiation in Byer’s body from leaking out, he was buried in a coffin lined with lead.

No one knows how many people died from drinking Radithor. At least one female friend of Byers died from radium poisoning after he introduced her to the product. In all, dozens or possibly even hundreds of people may have been killed. Considering that William Bailey is estimated to have sold more than 400,000 bottles of Radithor over the years, it’s a wonder that more didn’t die. Many were probably saved by the price: Even when it was sold by the case, Radithor cost $1.25 a bottle (around $15 in today’s money). Few people would have been able to afford to consume as much as Byers had.

Lights Out

Byer’s death received a lot more press than those of the Radium Girls. (“The Radium Water Worked Fine Until His Jaw Came Off” read a Wall Street Journal headline.) Reason: Byers was a millionaire socialite; the Radium Girls were working-class nobodies employed by a paint factory. Very few people worked in such a place, so their story wasn’t as scary to readers as Byers’s, who’d died because he drank a health tonic sold to the public.

The scandal surrounding Byers’s death prompted the government to grant FDA much broader powers to regulate patent medicines and protect the public from other dangerous products. Another result: Today the sale of “radiopharmaceuticals” – radioactive materials used in medicine – is restricted to authorized members of the medical profession.

Caveat Emptor

If you collect antiques, you may know that some shops and dealers specialize in medical objects. From time to time an empty bottle of Radithor pops up, but think twice before you buy one – even though the bottles have likely been empty since their original purchasers consumed the product more than 70 years ago, the bottles themselves remain dangerously radioactive. Just like Eben Byers, still at rest in his lead-lined coffin in a cemetery in Pennsylvania, they will be radioactive for thousands of years to come.

 

SOURCE: Uncle John’s fully loaded 25th anniversary bathroom reader. (2012). Ashland, Or.: Bathroom Readers’ Press. p. 407 – 411

With ICH GCP E6 (R2) the emphasis is on Quality Management

For 19 years ICH GCP E6 has not changed. Now, nearly two decades after its initial release, change is coming. Perhaps the biggest difference is the focus and preeminence of Quality Management.

A modernized quality standard for clinical study processes is being espoused which is driving the adoption of Quality-by-Design and Quality Risk Management principles and methodologies by their full embrace throughout the guideline. Quality Management is expected to be risk-based, being applied to both the monitoring and auditing aspects of the clinical study process.

Going hand-in-hand with Quality Management is compliance. The draft addendum expands upon what is already written, by further stating that when there is significant non-compliance, it is the sponsors responsibility to perform a root cause analysis, implement corrective and preventive measures, and when needed, inform regulators. This facet of the Quality Management preeminence boosts the already existing quality-by-design and adaptive risk-based approach, with continuous improvement of the Quality Management processes themselves.

The changes being made to ICH GCP E6 (R1) reflect what is happening in the industry and are areas that have been highlighted by inspectors for several years. Some of these changes reflect guidance documents issued by regulatory authorities. These changes are expected to go into effect by November 2016. So mark your calendars.

For a consolidated list of the changes you can visit my blog, Ethics Nut, and scroll down to the post “Just the Additions – Consolidated Changes to ICH GCP E6 (R2).

For the full ICH GCP E6 (R2) you can access it here.

Review of Jennifer Hawkins Exploitation and Developing Countries

Jennifer Hawkins in her paper on exploitation and research ethics recognizes two principles of research which are being violated in many developing countries. She refers to the first principle as the principle of standard care, and the second principle the principle of clinical equipoise. Although these two principles seem to be logically inextricable, Hawkins notices that the two principles are not logically connected and that this can be seen when the two background assumptions usually associated with them are missing as can often be the case in developing countries.

The first principle requires research subjects to receive whatever the current standard of care is for the illness. If there is no treatment currently available then the use of placebos is allowed. The second principle the principle of clinical equipoise states that only under the condition that there is genuine disagreement within the medical community about which treatment is more beneficial for the subject are Randomized Control Trials (RCT) allowed to be used. Adhering to these rules provides researchers with the expectation that no one will be made worse off than prior to the research.

These two principles in the context of the developed world seem to be logically inseparable with the presence of two common background assumptions. The first assumption is that in the developed world there would never be any need to seek out new treatments which would be less effective than existing treatments. The second assumption is that in developed countries the treatments which are available are always the best existing treatments available and so there is no incentive to participate in research which may lead to someone getting inferior or dangerous untested treatment. When the assumptions which are present in the more developed countries are no longer applicable, such as the case in the less developed countries Hawkins thinks it is easier to see that satisfaction of one principle is neither necessary nor sufficient for satisfaction of the other.

The case in which standard of care is understood in terms of the standard which is locally available is an example under which one of the two principles can be satisfied without the other. To illustrate this, the example of a small imaginary tribe in Africa is useful. It is easy to envision such a tribe in a remote African area in which due to the remote location of the tribe the existing treatments are a fraction of the available options to those in more developed countries. Furthermore, because of economic restraints a vaccine with a slightly less effective than a full strength one may be of value because of the possibility of it being provided at a cheaper rate. Under these conditions both background assumptions are no longer present, and it can be seen how the first principle may be fulfilled without the second, supposing that the local remedies are wholly inadequate at fighting the disease when compared to western methods. In this scenario it would mean that the principle of standard care would be provided, the research subjects would be at least receiving the basic care normally provided and yet there would not be clinical equipoise. It would seem reasonable that within the medical community the majority would prefer the weaker version of the western vaccine than the local remedy. This shows that the two principles are logically independent of one another because the first principle would be fulfilled but not the second.

Thoughts on Peter Singer’s “Famine, Affluence, and Morality”

In the article Famine, Affluence, and Morality Singer argues for the position that the entire way we look at moral issues needs to be altered. The most crucial premise in Singers argument is this: “if it is in our power to prevent something bad from happening, without thereby sacrificing anything of comparable moral importance, we ought, morally, to do it.”[1]

I disagree with this premise. It does not incorporate enough factors in determining moral obligation. Merely, what is in our power, and without sacrificing anything of comparable moral importance are far too basic grounds to adequately determine what a moral obligation is. At least two other factors need to be considered those being, the relation between the person to that which needs help, and the distance between the two. Additionally it relies on an impossible calculation of what is of moral importance and presumes it is possible to compare two future paths in determining whether there is a moral obligation to help.

The relation that exists between the person, who is determining if they are morally obligated to help, and the person or object in danger, is a factor of importance. It is reasonable to place a higher moral obligation to someone who is closely tied to that which is in danger than a total stranger. For example, it makes more sense to say that a parent has a greater moral responsibility to save their child if it is drowning and they are capable of rescuing it, than a stranger standing next to them who has the same ability to save the child. Thus it is clear that the manner in which the two involved parties are interconnected must be of some importance.

Another factor which is important is the distance of which the person is from the bad occurrence. The further away the person is from the occurrence the greater the chance that someone closer can do the same task. The moral responsibility should thus fall upon them, or at least lessen the moral obligation of those further away from helping. For instance if someone requires help crossing a street and both a person standing fifty meters away and someone standing next to individual have it within their powers to help the person, it seems reasonable that the person closer has a greater obligation to help than the person further away. This does not show that distance completely negates moral obligations but it does make it reasonable to think that distance does to some extent play a factor in determining moral obligations. Moral obligations to provide aid rest upon the person closest to the incidence, not merely everyone who is capable of helping.

The final reason why I disagree with Singer’s premise is because it relies on an impossible calculation, namely the attempt to weigh what is of moral importance. I do not believe such a comparison is possible to the degree in which would be needed for this premise to be acceptable. Not only is it difficult to weigh what is and is not of moral importance, but it is even more difficult if not impossible to know if whether through certain actions something of possible greater moral importance will not be sacrificed. For instance assume a student wishes to go to a third world country for a year and volunteer to try and save some children’s lives. Although the student has done the calculations in their head and cannot see any downside to going away, they cannot know for a fact that they are not giving up something of possible greater moral importance had they chosen to stay. It could very easily be the case that while away the person misses the chance of meeting someone that they would have spent an amazing life with and could have with that person to help the children a few years later together.

[1] Singer, Peter. “Famine, Affluence, and Morality”. Philosophy and Public Affairs, Vol. 1, No.3 (Spring, 1972), 231

Science and the Swastika: The Deadly Experiment

If you are interested in the history of research ethics that goes beyond the typical one paragraph mention that normally accompanies the line about the Nuremburg Code this video is for you.

It discusses the experiments conducted in the concentration camps in a way I have not seen before and is a fascinating, humbling, and poignant reminder of how far we have come.

At just under 50 min this is a perfect video to watch on a lazy Sunday if you are interested in learning more about the origins of research ethics.

Link: https://www.youtube.com/watch?v=FZquBH0CH24

Disclosure in a Disaster Situation: Protecting Patient Privacy Rights with Public Safety

First and foremost it should be noted that the protection of a patient’s privacy is a right held by all patients regardless of ethnicity, religion, or other. It is a right which is to be respected in all situations, including that of a disaster. Patients always retain the right to determine through consent what information is disclosed, to who it is disclosed to, and for what purposes.

Consent to disclose information should be sought as early as possible either in writing or orally. This does not change in the event of a disaster but may prove more difficult. If consent is not provided the professional judgement of health care providers is to be used when disclosing information. Typically, in a disaster situation information on the patient’s whereabouts and current condition is shared at the first available opportunity to family members or friends involved in the care of the patient.

Despite the right of a patient to retain privacy and keep some information free from disclosure, the right to refuse disclosure is not always granted. A disaster situation may provide good reason for increased sharing of medical information.

If consent to disclose is provided, or if it is being done in the best interests of the patient, it is typically done only when a request for information is done under the condition that the name of the patient is given first. The patient has been referred to by name.

All of the above can be superseded if through disclosure of information the safety of public health is put into further jeopardy i.e. through disclosure the disaster spreads perhaps through alarmist irrational behaviour. Often however, when speaking of public safety in this context, it is an element which as a general principle is used to argue for increased information sharing so that hospitals can effectively coordinate their efforts.

In summary, basic health information can be disclosed in a disaster situation if consent is given, is in the best interests of the patient, or if there is a need for public health and safety. Information can likewise be withheld if disclosure would enhance the disaster, consent is not given, or if it is not in the best interests of the patient.