Concise Minutes of the Karachi Bioethics Group (KBG) Meeting held in 2022
Date: Monday, February 7, 2022
Time: 8.30 am – 10.00 am
- Review of the DRAP Act: “The Ethical Marketing to Healthcare Professional Rules, 2021” – Dr. Nida Wahid Bashir
Dr. Nida opened the discussion on the Drug Regulatory Authority Pakistan (DRAP) Act 2012, amended as the Ethical Marketing to the healthcare professional rules 2021 and released on November 17, 2021. She shared the outline of the act, described the relevance, and asked the group to brainstorm on areas of concern.
She related the document under discussion with the KBG’s ethical guidelines for physician-pharmaceutical interactions, 2009. It was also mentioned that the National Bioethics Committee (NBC)’s national guidelines on the mentioned issue were also inspired by the KBG’s document.
It was brought to the notice of the group that the DRAP Act is not a set of guidelines but rules, which if not followed must have their own consequences. These rules bind the pharmaceutical companies, not the healthcare professionals.
Following is a brief description of the document shared in the meeting:
Introduction to the Document – The document has sixteen sections including title, commencement, and definitions (of terminologies used in the document), benefits of ethical interactions (specifically keeping the patient in mind; transparency, avoiding the conflict of interest), the interaction of healthcare industry professionals (defines primary rules of interaction) followed by eight prime areas of interaction, effective implementation and enforcement, contravention, and punishment, cognizance of the offense.
Prime Areas Addressed – The prime areas addressed in the document are very relevant. It clarifies about consulting arrangements with healthcare professionals, third-party educational conferences, company-sponsored training and educational meetings, business meetings, educational items, gifts and entertainment, grants and donations, demonstrations, and evaluation processes.
Areas of Concern – Dr. Nida, while sharing the areas of concern including transparency, conflict of interest, enforcement, and disclosure, brought about a detailed discussion. Even though a good attempt has been made in this document to take care of these areas, the issues regarding public disclosure, the specification of the authority and proper channel, the methods of enforcement lacked clarity in the document.
- Exploring Bioethics from the Lens of Humanities – Mr. Farid bin Masood
Mr. Masood shared a poster of the latest movie ‘Spider-Man: No Way Home’ which he translated to Urdu as Insani Makrra, Ghar ki koi rah nahi surrounded by a few words in Urdu and opened the floor for discussion with the members. The group members were asked what came to their mind upon seeing the image and they shared their views.
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Date: Tuesday, March 29, 2022
Time: 8.30 am – 10.00 am
- Contextualizing Genetic Counselling – Dr. Seema Hashmi
Dr. Seema Hashmi, Professor, Paediatric Nephrology, SIUT shared the case of a firstborn 2-year-old boy who was evaluated for recurrent passage of stones in the urine with no family history of renal failure. He was diagnosed with Nephrocalcinosis. Genetic testing for Primary hyperoxaluria (PH) was done after the due consenting process of the child and his parents which was positive. On asking, the father was informed that the disease was transmitted via genes from both parents. During a follow-up checkup after 6 weeks, the doctor was informed that the child’s mother was divorced the very next day of the first counseling. The physician was taken aback by this revelation and due to a sense of guilt stopped further counseling.
- Visual Society – Ms. Shaheen Jaffrani
Ms. Shaheen Jaffrani, Artist and Outreach Associate at CBEC-SIUT said that the beauty of art is that it is open to interpretation and the reading and meaning will be subjective to the viewer who is to perceive it; however, along with its perceptive subjective-ness art can be used as a tool to understand medicine at a humanistic level. She shared two different paintings by Robert Pope and asked the group to interpret them and share their views on them.
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Date: Tuesday, June 07, 2022
Time: 8.00 am – 09.30 am
- Ethics of Advertising
Dr. Nida briefed that there are various advertisements that need ethical consideration. Two TV advertisements were played for a thorough ethical discussion in the group.
- ‘Humara Azam, TB Khatum’ by Pfizer (https://www.youtube.com/watch?v=1xYyAO9vUXU)
The group brought up the ethical issues in the advertisement.
- ‘Rung Sub Key Liye’ by Nippon Paints (https://www.youtube.com/watch?v=RF9VIaztbC8)
- Bioethics Through the Lens of Humanities – Mr. Farid Bin Masood
Mr. Farid Bin Masood introduced the topic of narrative medicine stating that it focuses on the stories told by patients or doctors about illness and its sufferings for a holistic narrative of the experience. He added that poetry could be a better way to express emotions and feelings in the narratives. He shared an Urdu poem by Ibn-e-Insha, a Pakistani Urdu poet, on his deathbed. It depicted his feelings about the notion of time and the longing to live referring to a female fan’s wish to donate five years of her life to him.
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Date: Tuesday, August 2, 2022
Time: 8.00 am – 09.30 am
- Conflict of Interest in the Practice of Private General Practitioners (GPs): Preliminary Results of an Exploratory Study – Dr. Naveed Noor
Dr. Naveed presented a research study, a collaborative project between AKU, Karachi, Pakistan and the London School of Hygiene and Tropical Medicine (LSHTM), Bloomsbury, London. The principal investigators of the project included Dr. Rumina Hasan, Professor, and Dr. Sadia Shakoor, Associate Professor, Section of Microbiology, Department of Pathology and Laboratory Medicine, AKU in collaboration with Ms. Mishal Khan, Associate Professor, London School of Hygiene and Tropical Medicine, London.
Dr. Noor stated that the relationship between pharmaceutical representatives (PRs) and GPs can be very useful in giving the GPs updated information about medicines to treat and manage various ailments and therefore, help physicians to make clinically informed decisions so that they know the patient’s unique need and act accordingly. However, this relationship can turn into a hindrance in the performance of the broader system when particularly profit maximization takes priority over patients’ health and well-being. There is enough evidence that pharmaceutical companies, in many parts of the world, gave incentives to GPs such as money, items for clinics, home renovation, and sponsorship to attend academic conferences or leisure trips. This is unethical as it distorts physicians’ prescribing behavior which can lead to certain negative outcomes for patients. For example, GPs who are in an obligatory relationship with PRs can prescribe unnecessary medicines to their patients or may likely prescribe expensive medicines even when cheaper medicines are available in the market or unnecessary medicines.
The study consisted of three phases.
The formative phase included qualitative interviews with GPs and other stakeholders in the physician-pharma relationship, and a baseline survey on the knowledge, attitude and practice (KAP) of GPs. The results indicated that GPs have a limited understanding of COI in medical practice and seem to think they are unaffected by pharmaceutical promotion. There are some types of incentives that GPs find acceptable and have normalized as part of their interaction with pharmaceutical companies. They also ignore the existing guidelines on medical ethics; for example, taking financial incentives with linked prescription targets.
The intervention phase included randomized controlled multi-faceted intervention. This intervention was an interactive seminar on the ethics of dealing with pharmaceutical companies for the experimental group of GPs and a random seminar for the control group. The seminar included videos and talks by representatives from the Sindh Healthcare Commission (SHCC) and was inspired by various guidelines on ethics and emotive messages co-designed by communication experts. Later on, reminder messages were sent to the attendees regarding the same messages.
The third and last phase was evaluation and included an end-line survey and qualitative interviews. This was done by simulated medical representatives marketing imaginary companies to the GPs and trying to incentivize them. The initial analyses show a positive impact of the intervention.
- The Religion Card for Marketing – Dr. Tashfeen Ahmed
Dr. Tashfeen Ahmed presented a case encountered by an anonymous doctor. It created a discussion about whether GPs should receive religious gifts such as Qur’an, Tasbeeh, Ja-e-Namaaz, Aab-e-Zamzam, Itr and Madina dates. Such gifts that are of a religious nature are used as an incentive to influence, and refusing to receive such gifts may create discomfort and create a dilemma. The group argued that it is not a dilemma, but rather a discomfort in expressing refusal.
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Date: Tuesday, October 4, 2022
Time: 8.00 am – 09.50 am
- KBG Website and Donations
Donations for the Website – The group was requested to donate for the payment of the hosting service of the KBG website. Its annual fee is PKR 10,000. Dr. Nida informed the group that there was PKR 3000 cash in hand. During the meeting, some members contributed their share.
Suggestions for future donations:
- Those who wish to contribute may email Dr. Nida at KBG’s email address.
- The online participants may transfer their contributions online to the coordinator’s bank account or use the Jazz transfer facility in the future if all agree.
Updating KBG Website – The KBG website was created in 2004, and last updated in 2017. Following Mr. Farid bin Masood’s presentation, the group discussed suggestions and possibilities for updating the website and making it alive, interactive and updated. There was also a discussion on making someone responsible for its maintenance.
- “Terminal Sedation vs. Intentional Killing – Misinterpretation of the Doctrine of Double Effect” – Dr. Muhammad Atif Waqar
Dr. Waqar after introducing himself explained the term ‘the doctrine of double effect’. Dr. Waqar defined it as a situation where a single act of intervention could have two foreseeable effects, the beneficial effect and the detrimental effect, to the patient. It is not always morally prohibited and that the intention is to benefit the patient and not to harm them in any way. Two common examples he shared included the surgical resection of conjoined twins and the use of opioids, a medication used in terminal patients for relief although they do cause respiratory depression which eventually hastens the dying process. In palliative care, the patient is allowed to proceed a natural course with reduced suffering and eventually face death, without the intention of hastening it. This is a situation of “terminal sedation”.
Dr. Waqar also explained the terms Euthanasia, Medical Aid in Dying (MAID), Physician-assisted death/suicide or Mercy Killing. However, these are different terms with different meanings, he said. Referring to Rabindranath Tagore’s explanation of death ‘“Death is not extinguishing the light; it is putting out the lamp because the dawn has come” Dr. Waqar posed a question as a preamble to a case which he presented next. “Do the physicians sometimes put off the lamp before it is even dawn?”
Case – Dr. William Husel, an intensivist working the ICU night shifts at Mount Carmel Health System in Columbus, Ohio, was being investigated in connection with the deaths, all linked to overdoses of fentanyl, a powerful opioid. In 2018, Mount Carmel Health System removed Dr. Husel from patient care following complaints about excessive medication use.
Dr. Husel would tell families who were agonizing over removing a loved one from a ventilator that he would ease the patient’s suffering with pain medication, but he didn’t tell the families he was prescribing a potentially lethal dose of the opioid.
The Ohio State Medical Board suspended Dr. Husel’s license and Mount Carmel fired him. Lawsuits were filed by relatives of the deceased patients, but Dr. Husel had pleaded not guilty. He was indicted in June 2019 and charged with 25 counts of murder. A judge later reduced these to 14.
In May 2022, Dr. Husel was found not guilty on all 14 counts of murder. The Jury after review of all the evidence was not convinced beyond a reasonable doubt that William Husel was guilty of any charges submitted to them. At the trial, there was no doubt that Dr. Husel had administered very large doses of fentanyl. The patients had received excessive and potentially fatal doses of the medication that went beyond the therapeutic range required for providing comfort at the end of life. Most of the 14 patients were given 10 times the amount of fentanyl that would normally be given in a nonsurgical hospital setting. One patient received a dose 20 times higher.
The prosecution contended that his intention was to hasten the patient’s death. “Even though they were very critically ill, and perhaps some of them were on a trajectory to die very soon anyways, you cannot hasten their death, you cannot quickly, painlessly cause the death of a dying person — not in the state of Ohio.” But the defense lawyers argued that the doctor’s intent was simply to relieve his patients’ suffering, not to kill them. They told the jury that the amount of the dose was up to the doctor’s discretion.
“The prosecution’s case on intent hinged on the circumstantial evidence that the amount of fentanyl administered was so high that the only possible explanation was that Husel intended to kill the patients.” But the jury was persuaded otherwise.
A few ethical questions raised by Dr. Waqar included, was this really a murder or palliative care? Did the pharmacist (dispensing the medication) and the nurse (administering the medication) have an obligation to question an order? Would it be incorrect to say that they were complicit or an accomplice in this morally wrong act? Abuse of the disabled and elderly is a vile crime. The terminally ill are a special population that is just as vulnerable. And yet this was not considered a crime? How do we access the intention of the doctor?
- Case Discussion “Is it futile?” by Dr. Wardah Maqsood
Dr. Wardah Maqsood, surgical resident, SIUT presented a pediatric case with the query, is it futile?
Case – A four-and-a-half-year-old boy was evaluated for hematuria and diagnosed with a mass in the kidney. He required removal of the kidney (May 2021). The final diagnosis was Wilms tumor with a ruptured capsule. He developed a recurrent mass 7 months later which was treated with chemotherapy followed by a second surgery to remove the residual mass in December 2021. Two months later, he presented with a spread of disease (metastasis) in the abdomen and lung for which chemotherapy was started. The patient developed diarrhea and was re-admitted in March 2022 with high-grade fever with deranged biochemical markers that were addressed with supportive measures along with intravenous nutrition. Later, he was diagnosed to have a blockage in the intestine – which required resection and rejoining (anastomosis) of the intestine in May 2022. The biopsy at that time did not show malignancy. Further, he developed leakage from the anastomosis and started deteriorating clinically with feculent discharge from the wound and poor skin condition because of the leakage. Different sets of tubes were placed for feeding, antibiotics and necessary medications. The patient was already in the hospital for more than 65 days. Dr. Maqsood asked the group about their decision as a physician, for this child. Would they support continued supportive measures, more invasive techniques, doing nothing, or changing the goals of care?
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Date: Tuesday, December 6, 2022
Time: 8.00 am – 09.50 am
- KBG Website and Donations
Donations for the Website – Dr. Nida requested the group to share ideas regarding an active fund generation system to sustain KBG activities. She informed the group that the annual fee was PKR 10,000 whereas, PKR 7000 has been collected and PKR 3000 are still required. FM said that in the past KBG did not require recurrent requests for “funding”. The amount was covered with members’ keen interest in contributing. Some members contributed their share instantly. Dr. Farkhanda Ghafoor from Lahore Bioethics Group (LBG) is interested in contributing an amount and requested for a bank account number. This act of the LBG member was appreciated by KBG members.
Updating KBG Website –The purpose of upgrading and maintenance of the website is not only revamping, making it interactive and updating its data such as previous years’ minutes but also making it a hub for bioethics activities for people to get relative information.
Dr. Nida and Mr. Farid bin Masood in the process of discovering multiple options to upgrade the KBG website, met an individual in November last week, who managed a group of web designers. They shared their requirement with him. The estimated cost of an interactive website was PKR 80-90,000/- whereas for a static PKR 60-70,000/-. As the cost was too high to be paid by the group, Mr. Farid spoke to another group of web designers. Their estimated cost was PKR 30-40,000/- Dr. Nida would be meeting this group on December 7 for initial discussions. This discussion will be shared with the group for their views and agreement via email or in the next KBG meeting.
- Humanities and Bioethics – Mr. Farid bin Masood and Dr. Faisal Rashid Khan
Humanities and bioethics have been discussed in the 2022 KBG meetings in different forms such as advertisements, poetry, pictures and videos. In this meeting the theme was transgender. Dr. Faisal Rashid Khan, CBEC PGD alumnus, and psychiatrist practicing in Islamabad, read a piece from Leena Hashir’s fiction article, ‘Marnaey kaey baad, khuwaja Sara ko apni maa ko khat’
(https://www.pakistan.web.pk/threads/marnay-k-baad-khwaja-sara-ka-apni-maa-ko-khat.69594/) which depicted a transgender’s family life, social life and its impact on his upbringing. It was written in the real life of Alisha, a female transgender, who was shot on the road and succumbed to her wounds.