Are pharmaceutical companies responsible for the opioid crisis?

Steve Phillips

Recently a major pharmaceutical company settled a lawsuit with the state of Oklahoma for $270 million. The state had alleged that the company’s marketing of OxyContin had helped to fuel the opioid epidemic in the state. Pharmaceutical companies in general do some things that are very good and have many times had some questionable practices. Some of their pricing and marketing practices are morally questionable, but it seems to me that it is the role of the FDA to evaluate those marketing practices and discipline pharmaceutical companies when they market inappropriately.

It does not seem to me that states suing pharmaceutical companies is an appropriate way to deal with the opioid crisis. The problem of what we used to call narcotic addiction has been around for centuries. It has been a problem long before any modern pharmaceutical companies existed. Whether the narcotic being abused was opium, morphine, heroin, or prescription pain pills the primary driver of narcotic addiction has always been hopelessness and despair. This is true whether it involved the opium dens in China or the slums of London, heroin addiction in the inner cities of the US or opioid abuse by the rural poor of states like Oklahoma or Indiana (where I practice). Supply plays a role in which narcotics are abused, but the underlying problem is a social and spiritual one.

There are many factors that go into the hopelessness and desire to escape that underlies narcotic addiction. One factor is economic. People who are unable to find work to support themselves and have no hope of being able to do so may turn to narcotics to escape. Those who are wounded by broken families and have no hope of being able to find the wholesome family relationships they desire frequently turn to alcohol and drug abuse. It would make as much sense to sue those who have contributed to these economic and social conditions as it would to sue pharmaceutical companies. Should states sue manufacturers who have yielded to economic pressures and have left empty factories scattered around our country while they profit from manufacturing goods overseas? Should they sue musicians who glorified drug abuse in their songs and modeled that in their behavior? Should they sue the entertainment industry that has promoted sexual immorality and the breakdown of families? Should they sue both state and federal legislators who have created a welfare system that promotes dependence and generational poverty?

I do not think that this is the answer. There are many things in our society that have helped to promote the increase in drug abuse that we are dealing with today. It will take all of us working together voluntarily to impact this crisis. Churches, businesses, physicians, hospitals, pharmaceutical companies, and government at the local, state, and federal level will all need to work together to help reduce the hopelessness and despair that underlies the current opioid epidemic. Research and treatment like what will be funded by the settlement of the Oklahoma lawsuit is needed, but working on the underlying problem of hopelessness and despair is essential. Local churches have the potential to impact that most effectively without needing to sue anyone.

Human germline gene editing is not a solution for genetic diseases

By Steve Phillips

I have said this before (see post on 12/5/18), but since otherwise intelligent people continue to say that we should pursue human germline gene editing because it can be used as a means of eliminating the transmission of genetic diseases to future generations, I need to say it one more time. There is no reason to expect that editing the genes of human embryos will ever be a practical and effective way to eliminate the transmission of genetic diseases to future generations.

There are several reasons for this. One is that the elimination of genetic diseases in future generations would require the widespread screening of all potential parents to identify everyone who would need to use this technique for it to actually eliminate a genetic disease. There is no reason to think that that will ever be practically possible and if it were possible it would require an extreme limitation on personal liberty (think Brave New World). If genetic diseases cannot be eliminated using this technique, then what those who take this position must be advocating using it as a means for a particular couple to avoid passing on a genetic disease when they know that they are carriers of that disease. There are additional reasons why gene editing will not be practical and effective for that.

If the couple’s sole priority is to eliminate the possibility of passing on the genetic disorder that they carry to a child, the simplest and most effective way to accomplish that is to choose not to conceive children. That means that their desire to have and raise children would need to be fulfilled through adoption, but it is the most effective way of achieving the goal of not passing on the genetic disorder that they carry. If this method is not chosen, the couple must recognize that they are trying to accomplish two goals, both having their own biological child and not transmitting the inherited disease.

For the large majority of couples trying to accomplish both of those goals the method with the least risk and highest likelihood of success would be creating a child through IVF and using preimplantation genetic diagnosis (PGD) to choose an unaffected embryo to be implanted in born. However, this method carries significant moral concerns related to the creation and elimination of embryos who have the genetic disorder. Some might think that this moral concern would be a reason to choose gene editing instead, but it is not that simple. The development of the technique of human embryonic gene editing will require using human embryos as research subjects who will be destroyed as an essential step in the research to establish the effectiveness of this technique. This means that it is not a morally superior technique for those who are concerned about the value of the life of a human embryo.

If a couple would choose to pursue embryonic gene editing for the purpose of having a biological child who did not suffer from a genetic disorder that the couple carries, there are still other problems. If gene editing is being used to transform an embryo with a genetic disorder to an embryo without that genetic disorder, it would be necessary to be able to determine that the embryo actually has the disorder before doing the gene editing. Except for the case of two potential parents homozygous for a recessive disorder, some diagnostic test would be needed. We can currently diagnose many genetic disorders in a multi-cell embryo produced by IVF by using PGD. However, for embryonic gene editing to be effective in completely removing the genes for a genetic disorder and replacing them with normal genes the best time to do the gene editing is at the single cell stage. Even if it is established that gene editing can be done effectively and safely, it is hard to see how we would be able to establish that a single cell human zygote has the genetic disorder prior to treating that single cell.

For all of these reasons, the situations in which human embryonic gene editing would possibly be the preferred means of creating a child without a genetic disorder would be quite rare. It is much more likely that the technique would be used for enhancement.

Abortion and viability

By Steve Phillips

There has been considerable reaction to the recent passage of a New York State law a regarding abortion. It has been celebrated by those who support a woman’s choice to have an abortion at any time and for any reason and strongly opposed by those who believe that a human fetus has a life that should be greatly valued because he or she has been created in the image of God. The new law basically changes two things in the previous New York State abortion law which led the way in the legalization of abortion prior to Roe v. Wade. One is that it expanded those who can legally perform and abortion in the state to include nurse practitioners, physician assistants, and midwives in addition to physicians. I will not be discussing that here. The other changes have to do with the circumstances under which an abortion may legally be done after 24 weeks gestation.

The 1970 law stated that an abortion could be done legally for any reason prior to 24 weeks, but only to protect the life of the mother after 24 weeks. Why 24 weeks? 24 weeks gestation was considered to be the limit of viability for a fetus in 1970. Today it would probably be more like 22 weeks, but they didn’t change that. What has changed in the new law is that abortion is considered legal after 24 weeks if there is an absence of fetal viability after 24 weeks or to protect the life or health of the mother. This significantly expands the cases in which abortion after 24 weeks can be considered legal. Roe v. Wade already expanded it in the second way. In that decision the Supreme Court ruled that the state could have an interest in the life of the fetus later in the pregnancy that it did not have early in the pregnancy but limited that interest by saying that a state could not say that an abortion was legal if it was done to protect the life or health of the mother. A companion decision made at the same time stated that the health of the mother should be interpreted very broadly to include the emotional well-being of the mother. That left us with the current situation in which the United States has the broadest definition of a legal abortion in the world.

The thing that I find most interesting about the new law is that it keeps the distinction between abortions done before and after 24 weeks and that it adds the condition that an abortion after 24 weeks can be legal in the absence of fetal viability. If the law is going to say that an abortion can be legal at any time during the pregnancy based on the mother suffering emotional distress, why would those making the law be concerned about fetal viability? I think that what is being said by those who have written and passed this law is that until a fetus is capable of living independently of his or her mother the life of that fetus has absolutely no value other than the value conferred by his or her mother. They want that to be contained in the law even if it actually makes no practical difference regarding the legality of abortion. Why is that so important?

I think it is important because the fundamental underlying issue regarding the permissibility of abortion has to do with how we determine who is a person who we are obligated to treat as we would want to be treated ourselves. It is essential for those who support the moral permissibility of abortion and therefore its legality to say that a fetus is not such a person. The best way to do that is to say that an individual is only a person with full moral status when that individual has certain capabilities that are like ours. One of those capabilities which can be fairly clearly defined is viability. If people can be convinced that they should look at capabilities such as viability to determine who we are obligated to treat like ourselves it will distract them from the alternative way of determining that. The alternative is to say that every human being, or every member of the human family, no matter what their level of development or capabilities is a person that we should treat as we would want to be treated ourselves. That means that every human being who is weak, helpless, and marginalized has equal value with the strongest and most privileged of human beings. That is the position of those of us who believe that every human being is important because we have been made in the image of God. That includes everyone who is dependent including those who are dependent to the point of being unable to survive outside their mother’s womb.

The hope of Christmas

By Steve Phillips

Every year at this time I try to spend some time reflecting on the meaning of Christmas and for this blog I try to reflect on how the meaning of Christmas interacts with bioethics. This year the Christmas musical program presented by the choir that I sing in at our church was focused on the themes of hope, love, joy, and peace represented by the outer candles of the Advent wreath that we light each of the four Sundays of Advent. As I have been thinking about the meaning of Christmas I have been focusing on the hope of Christmas.

One of the reasons that I have been thinking about hope is that I see so much hopelessness in the small rural community where I live and practice. Many of the patients that I care for feel hopeless. It can be seen in how the community is impacted by substance abuse and suicide as I wrote about last year. Many would relate the hopelessness to the poor economic climate of the community, and that does have a significant impact on people’s lives. But being poor does not necessarily entail hopelessness. There are many examples of those who are economically poor but rich in hope and joy. Hopelessness comes from a poverty of the soul that is more than just economic. It comes from a lack of positive relationships and positive social interaction. It comes from a lack of anyone or anything in which people can put their trust. Hopelessness comes from seeing that this world is far from what it ought to be and having no reason to think that will ever change.

The message of Christmas is that, even though we live in a broken world that is not what it ought to be, there is a remedy for the brokenness of this world. The way by which our brokenness can be healed came to earth as a baby born in Bethlehem. Jesus became one of us to be God’s clearest revelation of himself to us. His death provided the answer to our brokenness. His resurrection provided assurance of the hope that we can have in him. That is the hope of Christmas. Jesus is the answer to our own hopelessness, the hopelessness of those in our communities, and the hopelessness of the world.

Gene editing for genetic enhancement

By Steve Phillips

I appreciate the prior posts by Jon Holmlund and Mark McQuain regarding the recent announcement of the birth of genetically modified twins in China. Much has been written about why this should not have been done, but something very significant has been left out of most of those responses. They have failed to mention that the scientist who created the genetically altered twins was doing a form of genetic enhancement. As I have noted before, the only real reason for anyone to do research on the genetic modification of human embryos is to enable the possibility of human genetic enhancement. The scientist involved in this situation has recognized that and directly pursued it. I suspect that his open pursuit of enhancement is one of the reasons why he has received such a negative response from those who otherwise support the permissibility of using human embryos for experimentation on germline genetic modification.

The primary argument presented for why this was wrong is that he has subjected two healthy human infants to the unknown risks of genetic modification without any corresponding medical benefit to the infants. The modification was disabling the gene that codes for a cell membrane receptor that the HIV virus commonly uses to gain entry into cells it infects. The hope was that these infants would have enhanced resistance to HIV infection, although not complete immunity to such infection. The infants themselves would not have been at increased risk for HIV without the modification, but the parents had a desire to have children with increased resistance because their father has HIV and is aware of the difficulty of living with the disease. Thus, the modification was being done to provide an enhancement desired by the parents and was not being done to infants would have otherwise suffered from a genetic disorder.

Most who support current research to develop effective techniques for human germline genetic modification take the position that the safety of doing this has not been established well enough to use the technique to create infants and that when the research does reach the point that genetically modified human infants are created it should only be in situations in which those infants would otherwise have had serious genetic disorders. They are correct that this technique is currently unsafe but fail to realize that we will probably never be able to establish the safety of this type of genetic modification, because that would require safety data from multiple generations of these infants’ offspring. The idea of restricting this technique to infants who would have been born with serious genetic disorders and the idea that this technique could be used to rid the world of these genetic disorders does not make sense. If a couple desires to have children and know that they are at risk to have a child with a serious genetic disorder and have no moral concerns about the destruction of human embryos involved in such things as genetic modification, they can pursue selection of an unaffected embryo using PGD and have no need to take on the additional risks of genetic modification. Using genetic modification to eliminate genetic diseases would require a Brave New World scenario in which all human beings are artificially conceived and natural conception is prohibited. Therefore, the only reason to pursue the genetic modification of human embryos is for the purpose of human enhancement.

Let me be clear that I agree that what the scientist has done is wrong because he has subjected these two infants to significant risk without any significant medical benefit. That is always wrong. However, the strength of the negative response from those who generally support research to develop human germline genetic modification is likely due to the fact that he has opened up to public scrutiny the real purpose of such research. He has also shown that it is not true that we can ignore ethical concerns about enhancement because we could regulate the use of genetic modification so that would not occur. Enhancement was the goal of the very first use of this technique to produce human infants.

Thanksgiving and ethics

By Steve Phillips

It is good at times for us to stop and think about why we do the things that we do and what they mean. Tomorrow is Thanksgiving Day, a holiday that our society enthusiastically celebrates with lots of food, the gathering of families, and sporting events, followed by intense shopping. Historically Thanksgiving in America began with a group of Christians expressing their gratitude to God for what he had done for them. Christians continue to see this holiday as one during which we pause to remember what God has done for us and take time to express our thanks to him.

However, many in our society no longer believe in a personal God to whom gratitude is due. What does it mean to celebrate Thanksgiving if a person believes that those things that they are pleased to have are theirs due to a combination of chance and their own effort? Or if in our entitlement culture they believe that all that they have are things that they deserve. If that is the case, there is no reason for giving thanks and no one to whom thanks can be given. Instead of being a time of actually giving thanks to the one who has graciously given good gifts to us, the holiday has become a celebration of affluence and good fortune. Sporting events and shopping fit that very well.

How does this relate to ethics? The two different meanings of Thanksgiving correspond with two different ways of thinking about how we ought to live. For those of us who see Thanksgiving as a time to remember that the good things that we have come from God, it also reminds us that we are created beings who are made by and dependent on the God who has given us the things that we are thankful for. Remembering this helps us realize that God is the source of all that is good and that our understanding of what is right and how we ought to live comes from him as well. The alternative meaning of the Thanksgiving celebration is self-focused. If there is no God to be thankful to, the celebration is about the fulfillment of personal desires. That correlates with the ethics of moral individualism in which moral values are based on how a person feels and focused on fulfillment of personal desires.

Whether we see Thanksgiving Day is a time to actually give thanks to the God who is the giver of all good things or not makes a big difference in how we think about ethics.

Abortion by mail, part 2

By Steve Phillips

Last week I wrote about a European organization that has begun providing the medicines used for medical abortions by mail to women seeking abortions in the US following an online consultation. This violates the current restrictions that the FDA has on the prescribing of mifepristone, the primary medicine used for medical abortion. The restrictions exist due to safety concerns with the use of the drug. Those who think that those restrictions should be ended cite FDA statistics that show that serious harm to women who take the drug are quite rare. I concluded that the data indicate that it is hard to support the restrictions based on the risk of harm to a woman who chooses to use mifepristone.

I mentioned that there is another, somewhat perverse, risk that is usually not discussed which enters into the decision about whether the prescribing of should be limited to a certified prescriber dispensing the medicine in a clinical setting. That is the risk to the embryo/fetus. Those who support the use of mifepristone cite an effectiveness rate of 95-97%. That means that over 95% of the time the use of mifepristone in early pregnancy causes the death of the embryo/fetus and along with the use of misoprostol the pregnancy is ended with a medically induced abortion. In the 3 to 5% of cases in which this does not occur, some result in the death of the embryo/fetus, but the products of conception are retained within the uterus and may present some risk to the mother. As noted above, the observed risk to the mother turns out to be quite low. Sometimes when the process of medical abortion fails the embryo/fetus may survive. Mifepristone is an anti-progesterone. We know that medicines which alter the hormonal environment of an embryo can cause congenital anomalies. Therefore, there is a risk that if an embryo does not die and a subsequent surgical abortion is not done an infant may be born who suffers from congenital anomalies due to exposure to the medicines which were intended to cause a medical abortion. To prevent this, it is recommended that women who take the medicines for medical abortion who do not abort within the usual period of time have a surgical abortion. That would be the primary reason to support the FDA’s requirement that these medicines only be dispensed in a clinical setting by a certified prescriber. The role of the certified prescriber is to make sure that no embryo who is exposed to mifepristone survives to be born with the possible congenital anomalies.

Thus, we have a situation in which our society, as represented by the FDA, has decided that it is permissible to give a pregnant woman a medicine that will kill the embryo/fetus living inside her, but only if the medicine is dispensed in such a way that it can be assured that the embryo/fetus will be killed and not survive with an abnormality caused by the medicine. I said this was perverse. It is what we get when we have a society that puts a higher value on avoiding suffering than the value placed on human life.

Abortion by mail

By Steve Phillips

A recent article on the CNN website reports on a European organization called Aid Access which has recently made the medicines used for medical abortion available to women in the US by mail. The organization utilizes telemedicine in the form of online consultations to prescribe the abortion drugs from a pharmacy in India to be mailed to the woman desiring an abortion in the US. It is clear that this violates FDA regulations. To ensure the safe use of mifepristone the FDA currently requires that the drug, which has no medical indication other than induction of abortion, is only available to be dispensed in clinics, medical offices and hospitals, by or under the supervision of a certified prescriber. At issue is whether those restrictions should be lifted to allow more open prescribing of mifepristone.

The appropriate reason for the FDA to have additional restrictions on certain drugs is safety. Those who advocate lifting the restrictions on mifepristone argue that the safety of this drug has been established and cite FDA statistics that the risk of death from using the drug to induce medical abortion is only one in 155,000. This makes its use much safer than either surgical abortion or continuing a pregnancy to term. Those who oppose lifting the restrictions counter with concerns that the unsupervised use of the drug may also lead to failure to diagnose ectopic pregnancy and can result in situations that require surgical intervention, which may have increased risk in an unsupervised patient.

While there are risks to the use of mifepristone, it is hard to make the case that the risk of harm to the mother is high enough to warrant the additional restrictions that currently are required for this drug. That makes it hard to justify limiting access due to true concern about the risk to the woman whom uses it. This is not the case for another regulation regarding abortion. Laws that require abortion clinics to meet the same standards as outpatient surgery centers have a clear justification. Surgical abortion has similar risks to other outpatient surgeries, so it is reasonable to require the same safety measures for an abortion clinic and an outpatient surgery center.

There is one risk related to the use of mifepristone, which is not usually discussed, which does support the additional restrictions on its distribution, but in a somewhat perverse way. That will be the focus of my next post.

Starting with moral conclusions vs. foundational principles

By Steve Phillips

Last week I wrote about how Jeremy Williams’ moral position on sex-selection abortion was influenced by his position on abortion itself. Reflecting a little more on what he wrote raises the question of what comes first in our reasoning about a moral issue. Do we start with fundamental principles or with previously held moral conclusions? It is not a simple question.

Abortion is such a significant issue that it tends to dominate bioethics at times. Ethicists who defended the permissibility of a woman choosing abortion in the 1970s seemed to begin with the idea that abortion was permissible and then work back to reasons to support that position. Those reasons included an analogy of a violinist being attached to a person without her permission and the idea that some human beings were not actually persons. However, this process of starting with a conclusion is not exclusive to those who support abortion. Many of my students begin with a strongly ingrained belief that abortion is wrong without a good understand of why they believe that. They then address other issues according to how that would affect their belief that abortion is wrong.

My first reaction is that proper moral reasoning should begin with foundational moral principles, but those who take the casuist approach to ethics say that rigidly following principles can lead us astray. They say we should we should begin with a paradigm case in which the moral conclusion is clear and then determine how much the situation we are considering is like and unlike the paradigm case. Even Beauchamp and Childress who have helped to define the principles of biomedical ethics say that those principles are in a significant way influenced by our considered moral judgments and not just based on ethical theories.

So why do I think we should start with foundational principles? That goes back to why I think there is such a thing as moral right and wrong. I believe that morality itself exists because we were created by and live in a world created by a moral being who is by nature good. God’s innate goodness causes ethics to exist. If we were the result of chance and unguided evolution, we would have no reason to believe that such things as right and wrong exist. If ethics exists due to the moral character of God, then God’s moral qualities are the foundation of ethics. His expression of those qualities in scripture and through his incarnate Son form the foundational principles for ethics. That is where we need to start.

Noninvasive prenatal testing and sex-selection abortion

By Steve Phillips

The National Health Service in Great Britain has decided to implement the use of noninvasive prenatal testing (NIPT) and that has raised some concerns. It would seem natural for there to be concern about this test used to detect prenatal genetic conditions such as Down syndrome, which commonly leads to the choice to abort the fetuses with those conditions. However, according to a recent article in The Conversation by Jeremy Williams one of the major concerns is the use of this technique to facilitate sex-selection abortion. Williams states that one of the major political parties has proposed a policy of banning the use of NIPT for sex determination and has described sex-selective abortion as “incredibly unethical”.

Williams concedes that the idea that sex-selection abortion is morally wrong and ought to be prevented is widely held even by those who otherwise have no moral objection to abortion but suggests that taking that position is problematic for those who believe that a woman has a right to choose to have an abortion. Williams lists several reason that people give for why the sex-selection abortion is wrong. These include idea that sex selection abortions are done due to a trivial preference, concern that sex selection abortion constitutes unjust discrimination against female fetuses, concern about women being coerced into this type of abortion, and that it teaches that the lives of girls are not as important as boys. He is concerned that if these reasons are accepted they would apply more broadly than to just this one type of abortion, and he is right. Many abortions are done for reasons that seem trivial compared to the value of the life of the fetus. Any abortion that is done because of the characteristics of the fetus, including having a genetic disorder such as Down syndrome, are both unjust discrimination against those who have such a disorder and express a message that people who have such a disorder do not have the same value as those who do not. Many women are pressured into having abortions, and do not actually freely choose them.

The problem with what Williams has written is that sex-selection abortion is just clearly wrong. It is wrong to kill a fetus because that fetus is female and end the life of the girl and woman who that fetus would have become just because she is female. That is a clear violation of women’s rights. The fact that this helps us see that abortions in other situations are also clear violations of more universal human rights should make people question whether those abortions are also wrong. It does not mean that sex selection abortion is permissible.