whitefeather
Thank the gods for Death
- Apr 23, 2020
- 506
June 4, 2020
Dear Governor Phil Murphy,
Hello, my name is Aileen Cui, and I am an employee at Bausch Health Pharmaceuticals, formerly known as Valeant Pharmaceuticals. I thank you for inviting me to the New Jersey Bioethics Panel and valuing my opinion. Based on my twenty years in the pharmaceutical company industry, I can safely say that despite international precedence, I have inherent hesitations about the implementation of New Jersey's "Aid in Dying for the Terminally Ill Act."
Bausch Health is a pharmaceutical company dedicated to improving people's lives and advancing global health by marketing products in the therapeutic areas of eye care, gastroenterology, and dermatology (About Us Who We Are). The company has a location in New Jersey, so the pass- ing of the bill has a direct impact on the company's running and allocation of resources. This is largely due to the fact that our company has sole ownership over the drug Seconal. Originally, Seconal was used as a sedative or treatment option for insomnia, but it has since become the standard drug that doctors prescribe to patients who are seeking Medical Aid in Dying (MAID) (Riley). Suddenly, the drug is prescribed for an "off-brand" purpose: death and essentially, its benign intent is completely changing. By intent, I mean the reasoning behind the determination to act in a certain way. As I previously mentioned, the well-minded intention of Bausch Health is to provide drugs that help alleviate pain, prevent infection, maintain health, and cure disease. In the case of MAID and the bill, the medication that our pharmaceutical company manufactures is being used for something that it was never designed for. Consequently, the drug and our company become inextricably linked to delivering death rather than good health. I do not want to obstruct the use of the drug, but I fear that the drug or the company's practices will be misconstrued. Fundamentally, pharmaceutical companies make medicines to save and improve patients' lives, so, the use of these products to end lives is counter to the industry's objectives.
The intent of the user and prescriber may be to eliminate pain. In reality, because of scientific limitations, sometimes the lethal drugs fail and patients suffer as a result. Standard MAID protocol in the USA involves the prescription of a lethal dose of a barbiturate, typically pentobarbital or secobarbital (commonly known as Seconal), to be consumed by the patient in liquid form (Ibid). The New Jersey law explicitly states that the patient must obtain the approval of an attending physician and consulting physician before self-administering the cocktail in order to retain autonomy and dignity (Aid in Dying for the Terminally Ill Act). I have two concerns.
The first involves the occurrence of "botched" MAID. Neurologically, the barbiturates put patients to sleep by slowing down the brain's electrical activity by stimulating the gamma amino butyric acid (GABA) receptors (Ibid). Stimulation of these receptors initiates an inhibitory response, reducing the firing of neurons (Ibid). Eventually, breathing slows down and ceases, leading to death. Barbiturates vary in how fast they act and how long they last, which creates major discrepancies concerning potential patient pain during death (Ibid). What is even more unsettling is that sometimes the drug fails at killing the patient. There are six reported instances where patients ingested lethal medications, went unconscious, and awoke sometimes days later (Ibid). Now, some may argue that this number is far too low to extrapolate any significant conclusions, but we cannot overlook the potential pain of a patient. The occurrence of such cases warrants a need for an investigation on drugs like Seconal, which now have a completely new purpose However, obtaining relevant clinical data on these drugs for lethal purposes remains an unsolved issue. Due to the ethical infeasibility of performing clinical trials, physicians can only rely on lethal dose indicators for mice or anecdotes of past instances, not monitored human patients (Ibid). All of this is to say that very little is known about the process of dying. Eventually, science could tell us more.
My second objection lies with the prescription and administration of the drug. According to the New Jersey bill, a patient can obtain lethal medications if he or she "is capable and has been determined by the patient's attending physician and a consulting physician to be terminally ill and has voluntarily expressed a wish to receive a prescription" (Ibid). The bill defines capable as "having the capacity to make health care decisions Bioethics 16 17 and to communicate them to a health care provider" (Ibid). I find an issue with this definition because the medical community shares little consensus when it comes to diagnostic criteria for a patient to be considered mentally "capable (Ganzini). Moreover, suicidal tendencies and a desire to die with dignity and end suffering can become conflated, so psychiatrists may have a difficult time discerning the true mental state of the patient (Jones). Furthermore, an attending physician is defined as "a physician licensed who has primary responsibility for the treatment and care of a qualified terminally ill patient and treatment of the patient's illness, disease, or condition," while a consulting physician is "qualified by specialty or experience to make a professional diagnosis and prognosis regarding a patient's illness, disease, or condition" (Aid in Dying for the Terminally Ill Act). Australian pharmacists argue, and I agree, that a more interdisciplinary health team, including physicians, pharmacists, psychiatrists, and palliative care professionals need to be involved in such a complex decision with many nuances (Isaac). In an ideal medical team, decisions concerning the dosage of the drug are in the realm of a pharmacist's specialty, determining the patient's mental stability falls within the expertise of a psychiatrist, and a discussion of other treatment options happens with palliative care specialists. Through this approach, the patient receives a more comprehensive set of information. Moreover, the approach ensures that no health care professionals makes decisions about topics outside of their specialties. Once the patient obtains the prescription, I believe that a trained doctor, not the patient, should administer the drug. While this takes away patient autonomy, it also better ensures safety, efficacy, and monitoring.
What I have said should not scare you. The drug does do what it is supposed to do, but now the use is being diverted to a more uncertain purpose. I am worried about the value of the product, how it bounces back on the Bausch Health brand, and even how it could harm patients if the drug continues to be used in this way. If the drug were to fail, it damages our brand, a brand lauded for delivering quality medications for those in need. The last thing that we need as a company is for any potential controversy surrounding MAID to overshadow all of the other work that we do.
While I am on the point of controversy, I want to clarify something about the pricing practices of our company. Michael Pearson, the former CEO, had the business strategy of acquiring a drug and increasing its price (Thomas). This is what happened with Seconal: around 2015, a lethal prescription for the drug cost around $1500, but when Bausch Health gained sole ownership the price doubled (Dembosky). Now, states such as Oregon and Washington have adopted bills similar to New Jersey's, putting us in an interesting position because the bills promote the use of a drug that alienates a part of our customer base. People may see us as tacitly support- ing a policy that allows premature dying or a company trying to make a profit out of death. But, with so many moving parts in the production of a drug, including problems of mass production, expiration dates, and costs of keeping the drug on the market, pricing becomes a very complicated matter that gets oversimplified or written off as corporate greed. Currently, we are trying to navigate the ethical concerns surrounding the pricing points. I cannot deny the commercial imperative here. After all, the firm must make a profit to remain competitive in the market, but as more states adopt similar bills, the production of Seconal may prove more cost-effective. In the present, however, there are many obstacles that stand in the way of providing a more affordable Seconal. One of the most compelling counterarguments I have come across is the commonality of "off-label" prescriptions. According to the AMA Journal of Ethics, "off-label" drug use commonly refers to "prescribing currently available medication for an indication (disease or symptom) for which it has not received FDA approval" (Furey). Once a drug has been approved for the FDA, it can legally be used for any other indication. The practice is not uncommon. In fact, about 10-20% of all prescriptions written are "off-label" prescriptions (Ibid). For example, off-label use of antidepressants, anticonvulsants, and antipsychotics is high amongst patients' advancing in age to mitigate symptoms of agitation or paranoia. Some may say that since "off-label" prescriptions are not uncommon, the "off-label" use of Seconal should raise no concern either. To them, I'd ask for them to look at intent and scientific data.
In the case of drugs being prescribed to the elderly to treat their agitation, the intent of the user is to alleviate symptoms and increase their quality of life: there is no shift in intent. When a user ingests a lethal dose of Seconal, the intention is to kill. This is a shift from the "on-label" purpose of Seconal. Seconal was primarily prescribed as a viable treatment option to insomnia, but now, it is being used as a lethal medication. The drastic change differentiates the use for Seconal to other "off-label" prescriptions.
As for my point on scientific data, "off-label" prescribing is legally permissible and justified when "scientific evidence suggests the efficacy and safety of a medication for an indication for which it does not have FDA approval (Ibid). In the case of Seconal, however, I've already mentioned that there is a lack of clinical data when it comes to Seconal being used as a lethal medication because of the nature of the trial. Doctors and pharmacists must then rely on anecdotal offerings or evidence from mice when making their decision about the dosage. The drug is being used in a way that is not consistent with the original testing of the company. Without any credible or published scientific data that supports the use of Seconal as a lethal medication, we cannot justify the use of Seconal for MAID.
In conclusion, I believe that the "Aid in Dying for the Terminally Ill Act" should not have been passed in New Jersey. As an employee for a pharmaceutical company, I have always believed that medicines should be used to heal patients and alleviate their symptoms, not to kill them. Furthermore, I cannot support the use of the drug being used this way because I know of its limitations. There are, in fact, cases where a lethal dose of the drug fails to kill the patient and subjects them to potential suffering. To minimize these risks, I believe that a trained doctor should be the person who administers the drug and monitors the whole process. In general, I worry about how the new use of this drug will reflect back on Bausch Health brand. The company has faced scrutiny following the increase in the price of Seconal, and I do not believe that further inquiry will do anything good for the respectable brand. Once again, I thank you for the invite to join the New Jersey Bioethics Panel and I hope you consider what I have to say.
Sincerely,
Aileen Cui
Works Cited
"About Us Who We Are." Bausch and Health, Bausch Health Companies Inc, www.bauschhealth.com/about-us/who-we-are. Accessed 12 Feb. 2020.
Dembosky, April. "Pharmaceutical Companies Hiked Price on Aid in Dying Drug." KQED Science, KQED, 22 Mar. 2016, www.kqed.org/stateofhealth/163375/pharmaceutical-companies-hiked-price- on-aid-in-dying-drug. Accessed 9 Feb. 2020.
Furey, Katrina, and Kirsten Wilkens. "Prescribing 'Off-Label': What Should a Physician Disclose?" AMA Journal of Ethics, June 2016, pp. 587-93, https://10.1001/journalofethics.2016.18.6.ecas3-1606. org. Accessed 12 Feb. 2020.
Gawande, Atul. Being Mortal. New York, Metropolitan Books, 2014.
Isaac, Sami, et al. "Australian pharmacists' perspectives on physician-as- sisted suicide (PAS): thematic analysis of semistructured interviews." BMJ Journals, vol. 9, no. 10, 30 Oct. 2019, https://10.1136/bmjo- pen-2018-028868.prg. Accessed 10 Feb. 2020.
Jones, Roland M., and Alexander I.F. Simpson. "Medical Assistance in Dying: Challenges for Psychiatry." Front Psychiatry, vol. 9, no. 678, 10 Dec. 2018, https://10.3389/fpsyt.2018.00678.org. Accessed 10 Feb. 2020.
McCormick, Thomas R. "Principles of Bioethics." UW Medicine, University of Washington, depts.washington.edu/bhdept/ethics-medicine/ bioethics-topics/articles/principles-bioethics. Accessed 10 Feb. 2020.
New Jersey State, Legislature, Assembly. "Aid in Dying for the Terminally Ill Act". Aug. 2019. 1504th Legislature, Assembly Bill 218 (enacted).
Riley, Sean. "Navigating the new era of assisted suicide and execution drugs." Journal of Law and the Biosciences, vol. 4, no. 2, 28 Sept. 2017, pp. 424-34, doi:10.1093/jlb/lsx028. Accessed 10 Feb. 2020.
Thomas, Katie. "Valeant Pharmaceuticals Picks Joseph Papa, Perrigo- Chief, as C.E.O." The New York Times [New York City], 25 Apr. 2016, www.nytimes.com/2016/04/26/business/valeant-pharmaceuti- cals-chief-executive-joseph-papa-michael-pearson.html. Accessed 12 Feb. 2020.
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Medical Aid in Dying: A Letter to Governor Murphy
Dear Governor Phil Murphy,
Hello, my name is Aileen Cui, and I am an employee at Bausch Health Pharmaceuticals, formerly known as Valeant Pharmaceuticals. I thank you for inviting me to the New Jersey Bioethics Panel and valuing my opinion. Based on my twenty years in the pharmaceutical company industry, I can safely say that despite international precedence, I have inherent hesitations about the implementation of New Jersey's "Aid in Dying for the Terminally Ill Act."
Bausch Health is a pharmaceutical company dedicated to improving people's lives and advancing global health by marketing products in the therapeutic areas of eye care, gastroenterology, and dermatology (About Us Who We Are). The company has a location in New Jersey, so the pass- ing of the bill has a direct impact on the company's running and allocation of resources. This is largely due to the fact that our company has sole ownership over the drug Seconal. Originally, Seconal was used as a sedative or treatment option for insomnia, but it has since become the standard drug that doctors prescribe to patients who are seeking Medical Aid in Dying (MAID) (Riley). Suddenly, the drug is prescribed for an "off-brand" purpose: death and essentially, its benign intent is completely changing. By intent, I mean the reasoning behind the determination to act in a certain way. As I previously mentioned, the well-minded intention of Bausch Health is to provide drugs that help alleviate pain, prevent infection, maintain health, and cure disease. In the case of MAID and the bill, the medication that our pharmaceutical company manufactures is being used for something that it was never designed for. Consequently, the drug and our company become inextricably linked to delivering death rather than good health. I do not want to obstruct the use of the drug, but I fear that the drug or the company's practices will be misconstrued. Fundamentally, pharmaceutical companies make medicines to save and improve patients' lives, so, the use of these products to end lives is counter to the industry's objectives.
The intent of the user and prescriber may be to eliminate pain. In reality, because of scientific limitations, sometimes the lethal drugs fail and patients suffer as a result. Standard MAID protocol in the USA involves the prescription of a lethal dose of a barbiturate, typically pentobarbital or secobarbital (commonly known as Seconal), to be consumed by the patient in liquid form (Ibid). The New Jersey law explicitly states that the patient must obtain the approval of an attending physician and consulting physician before self-administering the cocktail in order to retain autonomy and dignity (Aid in Dying for the Terminally Ill Act). I have two concerns.
The first involves the occurrence of "botched" MAID. Neurologically, the barbiturates put patients to sleep by slowing down the brain's electrical activity by stimulating the gamma amino butyric acid (GABA) receptors (Ibid). Stimulation of these receptors initiates an inhibitory response, reducing the firing of neurons (Ibid). Eventually, breathing slows down and ceases, leading to death. Barbiturates vary in how fast they act and how long they last, which creates major discrepancies concerning potential patient pain during death (Ibid). What is even more unsettling is that sometimes the drug fails at killing the patient. There are six reported instances where patients ingested lethal medications, went unconscious, and awoke sometimes days later (Ibid). Now, some may argue that this number is far too low to extrapolate any significant conclusions, but we cannot overlook the potential pain of a patient. The occurrence of such cases warrants a need for an investigation on drugs like Seconal, which now have a completely new purpose However, obtaining relevant clinical data on these drugs for lethal purposes remains an unsolved issue. Due to the ethical infeasibility of performing clinical trials, physicians can only rely on lethal dose indicators for mice or anecdotes of past instances, not monitored human patients (Ibid). All of this is to say that very little is known about the process of dying. Eventually, science could tell us more.
My second objection lies with the prescription and administration of the drug. According to the New Jersey bill, a patient can obtain lethal medications if he or she "is capable and has been determined by the patient's attending physician and a consulting physician to be terminally ill and has voluntarily expressed a wish to receive a prescription" (Ibid). The bill defines capable as "having the capacity to make health care decisions Bioethics 16 17 and to communicate them to a health care provider" (Ibid). I find an issue with this definition because the medical community shares little consensus when it comes to diagnostic criteria for a patient to be considered mentally "capable (Ganzini). Moreover, suicidal tendencies and a desire to die with dignity and end suffering can become conflated, so psychiatrists may have a difficult time discerning the true mental state of the patient (Jones). Furthermore, an attending physician is defined as "a physician licensed who has primary responsibility for the treatment and care of a qualified terminally ill patient and treatment of the patient's illness, disease, or condition," while a consulting physician is "qualified by specialty or experience to make a professional diagnosis and prognosis regarding a patient's illness, disease, or condition" (Aid in Dying for the Terminally Ill Act). Australian pharmacists argue, and I agree, that a more interdisciplinary health team, including physicians, pharmacists, psychiatrists, and palliative care professionals need to be involved in such a complex decision with many nuances (Isaac). In an ideal medical team, decisions concerning the dosage of the drug are in the realm of a pharmacist's specialty, determining the patient's mental stability falls within the expertise of a psychiatrist, and a discussion of other treatment options happens with palliative care specialists. Through this approach, the patient receives a more comprehensive set of information. Moreover, the approach ensures that no health care professionals makes decisions about topics outside of their specialties. Once the patient obtains the prescription, I believe that a trained doctor, not the patient, should administer the drug. While this takes away patient autonomy, it also better ensures safety, efficacy, and monitoring.
What I have said should not scare you. The drug does do what it is supposed to do, but now the use is being diverted to a more uncertain purpose. I am worried about the value of the product, how it bounces back on the Bausch Health brand, and even how it could harm patients if the drug continues to be used in this way. If the drug were to fail, it damages our brand, a brand lauded for delivering quality medications for those in need. The last thing that we need as a company is for any potential controversy surrounding MAID to overshadow all of the other work that we do.
While I am on the point of controversy, I want to clarify something about the pricing practices of our company. Michael Pearson, the former CEO, had the business strategy of acquiring a drug and increasing its price (Thomas). This is what happened with Seconal: around 2015, a lethal prescription for the drug cost around $1500, but when Bausch Health gained sole ownership the price doubled (Dembosky). Now, states such as Oregon and Washington have adopted bills similar to New Jersey's, putting us in an interesting position because the bills promote the use of a drug that alienates a part of our customer base. People may see us as tacitly support- ing a policy that allows premature dying or a company trying to make a profit out of death. But, with so many moving parts in the production of a drug, including problems of mass production, expiration dates, and costs of keeping the drug on the market, pricing becomes a very complicated matter that gets oversimplified or written off as corporate greed. Currently, we are trying to navigate the ethical concerns surrounding the pricing points. I cannot deny the commercial imperative here. After all, the firm must make a profit to remain competitive in the market, but as more states adopt similar bills, the production of Seconal may prove more cost-effective. In the present, however, there are many obstacles that stand in the way of providing a more affordable Seconal. One of the most compelling counterarguments I have come across is the commonality of "off-label" prescriptions. According to the AMA Journal of Ethics, "off-label" drug use commonly refers to "prescribing currently available medication for an indication (disease or symptom) for which it has not received FDA approval" (Furey). Once a drug has been approved for the FDA, it can legally be used for any other indication. The practice is not uncommon. In fact, about 10-20% of all prescriptions written are "off-label" prescriptions (Ibid). For example, off-label use of antidepressants, anticonvulsants, and antipsychotics is high amongst patients' advancing in age to mitigate symptoms of agitation or paranoia. Some may say that since "off-label" prescriptions are not uncommon, the "off-label" use of Seconal should raise no concern either. To them, I'd ask for them to look at intent and scientific data.
In the case of drugs being prescribed to the elderly to treat their agitation, the intent of the user is to alleviate symptoms and increase their quality of life: there is no shift in intent. When a user ingests a lethal dose of Seconal, the intention is to kill. This is a shift from the "on-label" purpose of Seconal. Seconal was primarily prescribed as a viable treatment option to insomnia, but now, it is being used as a lethal medication. The drastic change differentiates the use for Seconal to other "off-label" prescriptions.
As for my point on scientific data, "off-label" prescribing is legally permissible and justified when "scientific evidence suggests the efficacy and safety of a medication for an indication for which it does not have FDA approval (Ibid). In the case of Seconal, however, I've already mentioned that there is a lack of clinical data when it comes to Seconal being used as a lethal medication because of the nature of the trial. Doctors and pharmacists must then rely on anecdotal offerings or evidence from mice when making their decision about the dosage. The drug is being used in a way that is not consistent with the original testing of the company. Without any credible or published scientific data that supports the use of Seconal as a lethal medication, we cannot justify the use of Seconal for MAID.
In conclusion, I believe that the "Aid in Dying for the Terminally Ill Act" should not have been passed in New Jersey. As an employee for a pharmaceutical company, I have always believed that medicines should be used to heal patients and alleviate their symptoms, not to kill them. Furthermore, I cannot support the use of the drug being used this way because I know of its limitations. There are, in fact, cases where a lethal dose of the drug fails to kill the patient and subjects them to potential suffering. To minimize these risks, I believe that a trained doctor should be the person who administers the drug and monitors the whole process. In general, I worry about how the new use of this drug will reflect back on Bausch Health brand. The company has faced scrutiny following the increase in the price of Seconal, and I do not believe that further inquiry will do anything good for the respectable brand. Once again, I thank you for the invite to join the New Jersey Bioethics Panel and I hope you consider what I have to say.
Sincerely,
Aileen Cui
Works Cited
"About Us Who We Are." Bausch and Health, Bausch Health Companies Inc, www.bauschhealth.com/about-us/who-we-are. Accessed 12 Feb. 2020.
Dembosky, April. "Pharmaceutical Companies Hiked Price on Aid in Dying Drug." KQED Science, KQED, 22 Mar. 2016, www.kqed.org/stateofhealth/163375/pharmaceutical-companies-hiked-price- on-aid-in-dying-drug. Accessed 9 Feb. 2020.
Furey, Katrina, and Kirsten Wilkens. "Prescribing 'Off-Label': What Should a Physician Disclose?" AMA Journal of Ethics, June 2016, pp. 587-93, https://10.1001/journalofethics.2016.18.6.ecas3-1606. org. Accessed 12 Feb. 2020.
Gawande, Atul. Being Mortal. New York, Metropolitan Books, 2014.
Isaac, Sami, et al. "Australian pharmacists' perspectives on physician-as- sisted suicide (PAS): thematic analysis of semistructured interviews." BMJ Journals, vol. 9, no. 10, 30 Oct. 2019, https://10.1136/bmjo- pen-2018-028868.prg. Accessed 10 Feb. 2020.
Jones, Roland M., and Alexander I.F. Simpson. "Medical Assistance in Dying: Challenges for Psychiatry." Front Psychiatry, vol. 9, no. 678, 10 Dec. 2018, https://10.3389/fpsyt.2018.00678.org. Accessed 10 Feb. 2020.
McCormick, Thomas R. "Principles of Bioethics." UW Medicine, University of Washington, depts.washington.edu/bhdept/ethics-medicine/ bioethics-topics/articles/principles-bioethics. Accessed 10 Feb. 2020.
New Jersey State, Legislature, Assembly. "Aid in Dying for the Terminally Ill Act". Aug. 2019. 1504th Legislature, Assembly Bill 218 (enacted).
Riley, Sean. "Navigating the new era of assisted suicide and execution drugs." Journal of Law and the Biosciences, vol. 4, no. 2, 28 Sept. 2017, pp. 424-34, doi:10.1093/jlb/lsx028. Accessed 10 Feb. 2020.
Thomas, Katie. "Valeant Pharmaceuticals Picks Joseph Papa, Perrigo- Chief, as C.E.O." The New York Times [New York City], 25 Apr. 2016, www.nytimes.com/2016/04/26/business/valeant-pharmaceuti- cals-chief-executive-joseph-papa-michael-pearson.html. Accessed 12 Feb. 2020.
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