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Have you ever come across anyone who refused treatment for a terminal disease and chose to die?
This answer may contain sensitive images. Click on an image to unblur it.A baby boy in Birmingham’s Children hospital who had a congenital heart disease required cardiac surgery and blood transfusions in order to live.Problem was, his parents happened to be Jehovah’s Witnesses. And Jehovah’s Witnesses are not allowed to have blood transfusions according to their religious beliefs.If you wonder why, here’s what their official website, jw.org, has to say about this:This is a religious issue rather than a medical one. Both the Old and New Testaments clearly command us to abstain from blood. (Genesis 9:4; Leviticus 17:10; Deuteronomy 12:23; Acts 15:28, 29) Also, God views blood as representing life. (Leviticus 17:14) So we avoid taking blood not only in obedience to God but also out of respect for him as the Giver of life.As a result, the boy’s parents refused to give consent for the blood transfusion, even though they were aware that this decision will cost their son’s life.Birmingham Children's Hospital then applied for an order to proceed with cardiac surgery and transfusions.High court judge Justice Keehan ruled that a baby boy can undergo blood transfusions as long as it is in the boy’s “best interest”, not withstanding his parent’s “understandable objections.”The child was thus saved.I was still in Med school when they narrated this incident to us in ethics class.The four pillars of medical ethicsare:Autonomy — respect for the patient's right to self-determination.Beneficence — “do good”Non-maleficence — “do no harm”Justice — to treat all people equally and equitably.Adult competent Jehovah’s Witnesses with capacity are allowed to refuse blood transfusions even if it may kill them. Forbidding their decision would be a direct violation for their autonomy. Straight-forward. No dilemma there.However, the line begins to blur when parents refuse treatment for their children.As we know, children do not have the mental capacity to be granted full autonomy. In most cases, parents will have to give legal consent for treatment procedures to proceed. And although a provider may believe that allowing a bleeding patient to die by not transfusing her with blood is clearly causing harm, devout Jehovah's Witness parents may perceive far more harm in the belief that eternal damnation will ensue from such a transfusion. The subsequent shunning and ostracism from their religious community that may result can add to the ordeal.Two commonly used arguments when parents refuse treatment are:parental rights to raise children as they see fitright to religious freedom.However, these rights are not absolute.Parental rights to raise children are qualified by a duty to ensure their health, safety, and wellbeing. Parents cannot make decisions that may permanently harm or otherwise impair their healthy development.Prince v Massachusettsset out the following reigning legal principle when parental religious beliefs collide with specific treatments:“Parents may be free to become martyrs themselves. But it does not follow that they are free, in identical circumstances, to make martyrs of their children…”A solid conclusion, in my opinion.But what about pregnant Jehovah's Witnesses?In 2015, a heavily pregnant Jehovah's Witness woman and her baby died in a Sydney hospital after she was diagnosed with leukemia but refused a blood transfusion that would probably have saved both of their lives.Her refusal to receive a blood transfusion meant that the treating doctors were unable to perform a caesarean section and to deliver the fetus.This was clearly a more complicated case. Instead of the child receiving the blood product, it’s now up to the Mother to receive it for the baby to be saved.Now before anyone starts condemning Jehovah’s Witnesses, it is important to realise that due to the push from them, research institutions have developed many forms of ‘bloodless’ medicine and surgery. Some of them may very well replace the mainstream counterparts as treatments of choice in the future if proven to be safer.However, as of now, many medical conditions still require blood transfusions and the dilemma persists.Feel free to voice your thoughts on this in the comments.Footnotes Ruling on Jehovah's Witness baby Why Don’t Jehovah’s Witnesses Accept Blood Transfusions? Essential learning- Law and ethics Children of Jehovah’s Witnesses and adolescent Jehovah’s Witnesses: what are their rights? Prince v. Massachusetts 321 U.S. 158 (1944) http://www.dailymail.co.uk/news/article-3027599/Jehovah-s-Witness-baby-die-refuses-blood-transfusion-seven-months-pregnant-cancer-80-chance-surviving-treatment.html#comments The Center for Bloodless Medicine and Surgery | Johns Hopkins Medicine in Baltimore, MD
How do clinical trials work?
First I will describe the simplest possible clinical trial design using a hypothetical example, and then I’ll explain some of the things that create complications.In my hypothetical example, the goal of the study is to compare depression scores for a group of persons who receive a new antidepressant drug versus those who are given placebo. (An example of a much more difficult research problem: evaluation of an addiction treatment program.)In the simplest of all possible worlds, the researcher would recruit persons who meet the criterion for initial depression. (Baseline measures of depression would also be obtained). These people would be randomly assigned to either placebo or drug condition. Those in the placebo group receive capsules that are identical in appearance to the actual drug.Participants sign an informed consent form that tells them about potential benefits and risks; they know they might receive the placebo. They are informed about the duration of the study and what they will be required to do. The study procedures and informed consent statement must be reviewed and approved by an institutional review board (IRB). See more about this at: Obtaining Informed Consent From Patients: Brief Update ReviewTo minimize expectancy effects, both participants and the researchers who give out the drugs and assess depression should be “blind” to condition; in other words, they don’t know who does and does not get the actual drug. This can be done by putting code numbers on pill bottles, for example.If mean depression for the new drug group is significantly lower than mean depression for the placebo group, this is possible evidence that the new drug is effective.However, many problems can arise during this process that may limit generalizability of results or even make the study invalid.First, recruitment. This can be done in many ways; some studies recruit through this web site. Home - ClinicalTrials.gov or through other forms of advertisement. Typically participants need to live near the medical center where the study is conducted and they must meet many other eligibility requirements.People who are willing to sign up as participants in medical studies are different in many ways than people who are not willing, and this may limit generalizability of findings about possible drug effects. There are some people who make a living being guinea pigs in medical research The Life of a Professional Guinea Pig and Professional 'Guinea Pigs' Can Make A Living Testing Drugs Sometimes people lie about their medical history in order to be accepted as a participant.An ideal participant in a drug study would have a diagnosis of depression that is made in a standardized way (not just a self diagnosis) and would be free of other medical problems and substance abuse. The researchers may want the participants not to have other forms of ongoing treatment during the clinical trial (although sometimes they just include a ‘treatment as usual’ control group to try to account for this). Again, participants may not be entirely truthful about ongoing treatment, self medication, and so forth.Drugs (such as Prozac) that are studied in clinical trials mostly based on healthy young adults may later be given to children, frail elders, and even zoo animals (if the clinical trial only uses young adults it may not tell us about benefits and risks for other kinds of people).At all stages of clinical trials, attrition or dropout is a problem. People who drop out of a study for various reasons are usually systematically different from those who continue in the study. Reasons for drop out may include: person moved or refused to continue, perhaps because of side effects; or even, in studies of addiction treatment, person died. The consequence of attrition is that the final sample assessed at the end is biased towards some kinds of participants and systematically different from others. Researchers are required to document how participants are selected, qualified, and they what kinds of attrition occur using the CONSORT flowchart . Welcome to the CONSORT WebsiteAttrition (dropout) of participants makes data analysis extremely difficult: how much of the reduction in depression (if any) is due to the drug treatment, and how much of it is due to artifacts (for example, the most depressed persons might be the ones who drop out or commit suicide).Some clinical trials only follow up to assess treatment effects for a few weeks. In real life people often take antidepressants for many years, and the initial clinical trial provides no information about possible consequences of long term use.When clinical trials are funded by pharmaceutical companies (and they often are) there is a strong bias toward showing strong treatment effects and few/weak side effects. In past, drug companies have not submitted studies that failed to show an effect, or that yielded troubling side effects, to the Food and Drug Administration when they seek FDA approval for a new drug. In recent years, rules have emerged to require that the design for the study be registered ahead of time, and then, the results must be reported whether they show favorable results or not FDAAA 801 Requirements (and a study that was not properly registered ahead of time cannot be published or submitted to the FDA).Even with preregistration, there are still many ways that data analysts can fudge the results of studies The replication crisis (failure to replicate results when studies are run again by other researchers) is just as large a problem in medicine as in psychology. For examples, seehttp://pss.sagepub.com/content/22/11/1359.full.pdfThe Extent and Consequences of P-Hacking in ScienceMany medical studies report results only in terms of “statistical significance” (a result that is statistically significant does not necessarily imply a treatment impact that is large enough to be of clinical or practical importance. Odds ratios are also frequently reported in research about medical treatment outcomes (without information about base rates). Many clinical trials leave people under the false impression that a new drug is “highly effective” when in fact the new drug might have performed only slightly better than placebo.In psychology, there is a movement toward the “New Statistics” The New Statistics with a focus on effect size reporting and meta analysis to summarize effect sizes across studies. Depending upon the type of effect size reported, it is possible to give both clinicians and patients a more accurate sense of actual treatment benefit than is provided in most clinical trials as typically reported.It is not very useful to report that a treatment such as drug shows “statistically significant” improvement (p < .05).It is useful to tell people the following things. This information is often not included in journal article reports of clinical trials (and your physician probably won’t know these things).How many points did people’s scores go down on specific depression measures (including a confidence interval to indicate sampling error)? Were depression scores lowered from a range that indicates moderate / severe depression, to a range that indicates mild to no depression?At multiple follow up points in time, did this benefit continue to exist?What were the side effects of treatment, and how many people dropped out because they could not tolerate side effects?For drugs such as cancer chemotherapy: how many weeks or months longer did patient who received the new treatment live compared to control group, and what was their quality of life (e.g. vomiting, weight loss, and other issues).What was the effect of a drug (such as statin) on mortality (e.g. did fewer people die during the duration of the study in the group that received statins)? What was the effect of the drug on mortality from cardiovascular disease? On all-cause mortality? And was the duration of the study long enough to really assess this well?To phrase this another way, what was the mean difference in life expectancy for those who did/ did not receive a treatment (or who were/were not exposed to a risk factor)?How many people would need to receive treatment for just one patient to receive benefit (Number Needed to Treat, NNT). This number is sometimes suprisingly large; for examples see theNNTThere have been “miracle drugs” (such as penicillin, when it was first introduced) where use of the drug often made the difference between life and death.However, many recently released drugs (remember, they are released because the drug companies can make a lot of money from them, not necessarily because they are highly effective!) perform only a little bit better than placebo. Most clinical trials also do not examine whether the new drug performs better than existing drugs for the same diagnosis (they don’t have to have this information for FDA approval). A new drug only has to outperform placebo well enough to pass the test of “statistically significant”)A high price for a drug is not related to its effectiveness (or its safety), but to whether the patent has expired.Amazon.com: The Truth About the Drug Companies: How They Deceive Us and What to Do About It (9780375760945): Marcia Angell: BooksSo there’s my rant about clinical trials for drugs in medicine.
Did the Indian Supreme Court rule correctly on Section 377 on September 6, 2018?
I skimmed through the 495 page judgment of the Supreme Court. Some key insights (in summary form) are presented in this answer.The statements in quotes in this answer are copied from the judgment. Everything else is my comments/summary.#1] IntroductionThe court begins by laying the emphasis on a person’s individuality, and says that a person cannot escape their own individuality and says that ‘one defines oneself’ and that this entire decision intends to explore the meaning of it.The overarching ideals of individual autonomy and liberty, equality for all sans discrimination of any kind, recognition of identity with dignity and privacy of human beings constitute the cardinal four corners of our monumental ConstitutionFurther, the court noted that the time has come to bid adieu to perceptions, prejudices, and stereotypes deeply ingrained in the societal mindset and empower everyone.More importantly, the court noted that an individual’s identity is given by nature, and not accepting it would be an assault on a person’s dignity and infringe his fundamental rights.The court deliberated on gender identity, as below:Gender identity refers to each person‘s deeply felt internal and individual experience of gender, which may or may not correspond with the sex assigned at birth#2] Submissions in favour of LGBTQ+ communityHomosexuality, bisexuality and other sexual orientations are natural. The court agreed that the American Psychological Association has opined that sexual orientation is a natural condition and attraction towards the same sex or opposite sex are both naturally equal, the only difference being that the same sex attraction arises in far lesser numbers.The petitioners pleaded that a person’s sexuality affects not only their sense of individualism, but also affects their family, social and professional life in multiple ways.That, such people need to live without fear in the hope that the court shall protect them from an oppressive majority, that can affect them in various ways - including employment, medical treatments, insurance, live-in etc.The law should have treated them as natural victims and sensitized the society towards their plight and laid stress on such victimisation, however, the reverse is being done due to which a sense of estrangement and alienation has developed and continues to prevail amongst the members belonging to the LGBT groupSection 377 was a violation of the Constitution:Article 21: right to life and liberty - because a person’s gender identity and sexuality is a part of his individuality and must be protected just as his life and liberty.Article 15: which states that the law must treat all citizens as equal, regardless of their sex. The court observed that section 377 violated this article.Article 19: which talks about an individual’s freedom of speech. The court observed that a person’s sexuality is one of the ways that they express themselves, and restricting it is a violation of this basic tenet of the Constitution.Section 377 was also vague, because ‘unnatural’ sex is not defined anywhere either in that section itself or elsewhere in the law. Such a broad provision leaves too much to interpret.The previous decision was also erroneous in that it assumed that only a very minuscule proportion of the population was affected by it, when in reality almost 7–8% of the population is affected.#3] Submissions opposing the said petitionThe Union of India simply stated that they leave the matter to the court’s wisdom, but that this decision should not be extended to any other sections without first giving them a right to be heard. However, other people intervening the court had a few things to say, in support of Section 377, which are discussed below:Firstly, they contended that acts mentioned in Section 377 are done by abusing a person’s body organs, which is undignified and derogatory, and cannot be sanctioned by the court.That, enough liberty was granted to transgenders by way of previous various judgments and no further liberty is necessary, and that they are only doing it to abuse public morality.It was also submitted that sometimes we have to make some things punishable in order to stop it from happening, especially if the society considers that it is wrong.They contended that homosexuals are more likely to be affected by HIV/AIDS and therefore Section 377 is important to prevent people from being affected by such diseases.Some other contentions in favour of Section 377 were made by the intervening NGOs:Removing it would place the family system in shambles and our society may become corrupted. Many homosexual activities would start for money, and it would tempt and corrupt the youth of the country.That, just because other countries have de-criminalised it does not mean we should do it too. Our country is different.That removing it would hurt various religious groups, and is thus against Article 25 (right to religion)Homosexuality is against the order of nature. It is the duty of the court to protect the society from such individuals who attempt to affect others by their unnatural conduct.#4] Court’s deliberation about the ethos of our ConstitutionThe court reiterated the principles of a previous judgment wherein it was held that the Constitution is organic in nature. Like a living organ, it must change with the passage of time.Common sense has always served in the court's ceaseless striving as a voice of reason to maintain the blend of change and continuity of order which are sine qua non for stability in the process of change in a parliamentary democracyFurther, the court noted that treating the Constitution as a ‘living document’ also finds merit in various other countries that have also upheld this principle in order to evolve with time:Supreme Court of Canada: stated that the Constitution is like a living tree that must accommodate the modern realities by way of progressive interpretation, rather than regressive.Supreme Court of USA: creators of the Constitution could not have thought about everything, and they only hoped to create an organism that was capable of change.The concept of transformative constitutionalism has at its kernel a pledge, promise and thirst to transform the Indian society so as to embrace therein, in letter and spirit, the ideals of justice, liberty, equality and fraternity as set out in the Preamble to our Constitution.#4] Constitutional morality and LGBT not being a ‘choice’.The concept of Constitutional morality cannot have been fixed by the founders of the nation who were only emerging from centuries of colonial era. It is the duty of today’s State organs to keep it flowing, based on the principles laid down earlier.Supreme Court further held that the Constitutional morality must prevail over social morality, regardless of how popular it might be.In the garb of social morality, the members of the LGBT community must not be outlawed or given a step-motherly treatment of malefactor by the society. If this happens or if such a treatment to the LGBT community is allowed to persist, then the constitutional courts, which are under the obligation to protect the fundamental rights, would be failing in the discharge of their dutyThe court then deliberated upon the meanings of various sexual orientations and gender identities. It held that various experts have opined that this is not a person’s choice, and is totally natural.The society cannot remain unmindful to the theory which several researches, conducted both in the field of biological and psychological science, have proven and reaffirmed time and again. To compel a person having a certain sexual orientation to proselytize to another is like asking a body part to perform a function it was never designed to perform in the first place.Whether one's sexual orientation is determined by genetic, hormonal, developmental, social and/or cultural influences (or a combination thereof), most people experience little or no sense of choice about their sexual orientationThe court reiterated this with further scientific backing.Research suggests that the homosexual orientation is in place very early in the life cycle, possibly even before birth. It is found in about ten percent of the population, a figure which is surprisingly constant across cultures, irrespective of the different moral values and standards of a particular culture. Contrary to what some imply, the incidence of homosexuality in a population does not appear to change with new moral codes or social mores. Research findings suggest that efforts to repair homosexuals are nothing more than social prejudice garbed in psychological accouterments.Wonderful!The court then talked about why dignity is enshrined as a fundamental right of all citizens, and treating LGBT community with dignity is of utmost importance.It is not only the duty of the State and the Judiciary to protect this basic right to dignity, but the collective at large also owes a responsibility to respect one another's dignity, for showing respect for the dignity of another is a constitutional duty. It is an expression of the component of constitutional fraternity#5] Right to privacyRight to privacy is not only a fundamental right, it is also a human rights issue. The court noted Article 12 of International Declaration of Human Rights, which states that ‘no one shall be subjected to arbitrary interference with his privacy, family, home or correspondence nor to attacks upon his honour and reputation.’We all have a right to a sphere of private intimacy and autonomy which allows us to establish and nurture human relationships without interference from the outside community. The way in which we give expression to our sexuality is at the core of this area of private intimacy.The court observed that it’s important to recognise some rights as fundamental rights so that we can avoid it being unfairly influenced by the majoritarian view.Following this, the court saw the practices in various other countries around the world for a perspective, including reading various cases in USA, Canada, South Africa, United Kingdom, Philippines etc.#6] Whether homosexuality is ‘unnatural’?The court observed that Section 377 only criminalises ‘unnatural’ behaviour, and question arises if LGBT community really falls under the definition of ‘unnatural’?Interestingly, the court said that, with the evolution of time, even sex these days is not only about making babies.With the passage of time and evolution of the society, procreation is not the only reason for which people choose to come together, have live-in relationships, perform coitus or even marry. They do so for a whole lot of reasons including emotional companionshipIn the contemporary world where even marriage is now not equated to procreation of children, the question that would arise is whether homosexuality and carnal intercourse between consenting adults of opposite sex can be tagged as “against the order of nature”. It is the freedom of choice of two consenting adults to perform sex for procreation or otherwise and if their choice is that of the latter, it cannot be said to be against the order of nature.Section 377 can in fact be used to harass LGBT community, and must not be sustained. Also, ‘unnatural’ is not at all defined, so should we also cover heterosexual couples if they are not having a vaginal intercourse? The court said that there seems to be no purpose of keeping this section.#7] Conclusions of the courtSexual orientation and gender identity is a part of a person’s identity. It is inseparable and cannot be treated differently.Saying that LGBT community is a minority is no excuse to continue keeping this provision in the law.Our Constitution is a living document and must change with time, especially when it comes to protecting the minorities.Dynamic Constitution also helps to bring change in the society and ‘guide the nation towards a resplendent future’.Social morality is different from Constitutional morality and we cannot allow social morality to dictate laws.Right to live with dignity is a fundamental right and a human right. Section 377 was against such a basic principle.Sexual orientation is a natural phenomenon, inherent in an individual which is determined by neurological and biological factors.Right to privacy is a fundamental right, and Section 377 was infringing upon a fundamental right.Even if there is a scope for interpretation, the court must adopt the principle of progressive realisation of rights.A person has autonomy over their intimacy and sexuality, and they can do whatever they please to do with it. It’s their choice.That consent is the determining factor. Even in Section 375, consent is what distinguishes between rape and sexual intercourse. Consent is not enshrined in Section 377, which makes it wrong.Neither IPC nor any other law have defined what is ‘unnatural’, hence including LGBT community here is entirely arbitrary.Section 377 is a violation of right to privacy and dignity.The intent behind punishing such acts (in case of consenting adults) is not clear because nobody is harmed in such case.Being entirely arbitrary, Section 377 does not even distinguish between consenting and non-consenting adults. This cannot be sustained.Public decency or morality cannot be applied here, because any such acts done in private do not concern the public at all.If Section 377 is applied, it would mean that any ‘unnatural’ sexual inter-course even between a man and a woman can be punished.The previous decision of the Court is overruled.As an aside, it is extremely important to note the conclusions of the court. Because not only has the Supreme Court invalidated Section 377, it has also laid down a number of other conclusions for the society to follow and emulate.After this, judgments of the five judges were discussed in detail. All of them, unanimously, said that Section 377 is liable to be struck down. Observations from the individual judgments are being shared below. I am not including the portions that are already covered above (there is repetition in each judge’s decision, so we shall ignore that portion).Judgment of Justice NarimanHe started with a history of Section 377 (right from 1533), and noted how initially any action intended to gratify ‘unnatural lust’ was covered and how the law changed with times, and how various questions were addressed with time:There is no evidence that this needs any psychiatric treatment, and no evidence that any such illness can be caused in the society due to non conformist sexuality.It cannot be said that men having sex with other men will then turn their attention to children. There is no merit to that assertion and no evidence to support it.The judge further noted that homosexuality is not a mental disorder, and it has been established after looking at sufficient evidence from experts in this field.Regarding religious issues, the judge said this:Morality and criminality are not co-extensive - sin is not punishable on earth by Courts set up by the State but elsewhere; crime alone is punishable on earth. To confuse the one with the other is what causes the death knell of Section 377, insofar as it applies to consenting homosexual adults.If you think homosexuality is a sin, take it up with your God, not with the Court. Ha, well said, judge!Judgment of Justice ChandrachudSpeaking quite harshly about Section 377, the judge said that we should have done this long time back.It is difficult to right the wrongs of history. But we can certainly set the course for the future. That we can do by saying, as I propose to say in this case, that lesbians, gays, bisexuals and transgenders have a constitutional right to equal citizenship in all its manifestations. Sexual orientation is recognised and protected by the Constitution. Section 377 of the Penal Code is unconstitutional.The Union government said that they leave the matter to ‘wisdom of the court’. But, the Judge said, we would have appreciated that they too, categorically agreed with the petitioners.Even the society is to blame for this, by promoting gender stereotypes about what men or women should do. This has to go away, as the Judge remarked.If individuals as well as society hold strong beliefs about gender roles – that men (to be characteristically reductive) are unemotional, socially dominant, breadwinners that are attracted to women and women are emotional, socially submissive, caretakers that are attracted to men – it is unlikely that such persons or society at large will accept that the idea that two men or two women could maintain a relationship.Quite an important observation, considering our society today!The Judge also dismissed claims that sexual orientation is a mental health issue, or that we should continue to control it so as to prevent HIV/AIDS. He said that there is no merit in such assertion.Judgment of Justice MalhotraSexual orientation is an innate attribute of one’s identity, and cannot be altered. Sexual orientation is not a matter of choice. It manifests in early adolescence. Homosexuality is a natural variant of human sexuality.She noted that homosexuality is not an aberration, but only a variation in nature, as far as sexuality is concerned.The Judge noted that in earlier times, it was a common perception that homosexuality was an illness which resulted due to an arrested development of the child. There is no truth in the statement.History owes an apology to the members of this community and their families, for the delay in providing redressal for the ignominy and ostracism that they have suffered through the centuries. The members of this community were compelled to live a life full of fear of reprisal and persecution. This was on account of the ignorance of the majority to recognise that homosexuality is a completely natural condition, part of a range of human sexuality.So, did the Supreme Court take the right decision?Well, they considered almost all the aspects that you could have imagined. If you are against this judgment, you must have your reasons, but believe me when I say this: your reasons have already been considered. The court exercised a lot of wisdom in considering all the aspects behind taking this decision. You only need to take the trouble to read.The court’s order is commendable.I intend to go through it in much greater detail later. But I must say, I am proud of our Supreme Court for coming up with such an exceptional deliberation behind this order. It’s beautiful!
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