Names have been removed to protect privacy. Identifying letters are assigned in alphabetical order and bear no relationship to the person’s actual name.

A Decision by the Health and Disability Commissioner

 

Introduction

Summary of events

Opinion: Dr B — breach

Opinion: Te Whatu Ora — no breach

Recommendations

Follow-up actions

Appendix A: Extract from COVID-19 document

Appendix B: MCNZ guidance statement released 28 April 2021

 

 

Introduction

1. This report is the opinion of Morag McDowell, Health and Disability Commissioner.
2. The report discusses the care provided to Ms A by general practitioner (GP) Dr B[1] in November 2021.
3. At the time of these events, Dr B was contracted to provide services to a virtual GP Managed Isolation and Quarantine Facilities team for a DHB/Te Whatu Ora. On 1 November 2021, Dr B rang Ms A, who was then positive for COVID-19. Following the call, Dr B sent Ms A a document titled ‘Guide to COVID early treatment’. Dr B specifically directed Ms A’s attention to a COVID-19 treatment protocol in the document. The document also included a section about ‘Experimental COVID Vaccines’. Ms A complained to HDC about having been sent the document, in particular that it contained ‘anti Vax information’.
4. The following issues were identified for investigation:

• Whether Dr B provided Ms A with a reasonable standard of care in November 2021.
• Whether Te Whatu Ora|Health New Zealand provided Ms A with a reasonable standard of care in November 2021.

Summary of events

5. On 1 November 2021, Ms A, her partner, and her children all had COVID-19. Ms A’s partner was isolating in a Managed Isolation and Quarantine (MIQ) facility. Ms A and her two children were isolating at home.
6. Ms A received a call from Dr B, who was at the time contracted via a separate organisation to provide services to the virtual GP Managed Isolation and Quarantine Facilities (MIQF) team. Dr B told HDC that it was her first day working for the MIQF team. The team was providing medical health services to returnees isolating in the MIQF. Dr B had been ringing to speak with Ms A’s partner but was advised during the call that Ms A and her children also had COVID-19.
7. Ms A told HDC that Dr B was kind when talking to her, and asked about her symptoms, and spoke to her about ‘getting zinc, Vitamin D and C plus some antibiotics’. Dr B also asked Ms A for her email address and said that she would send some further information on the extra medication and advised her to contact her GP.
8. Following the call, Dr B sent Ms A an email attaching a document called ‘Guide to COVID Early Treatment’ (the COVID document). Dr B wrote: ‘Please find attached a COVID treatment guideline p15. Please talk to your family doctor and see if they think it would be appropriate for you.’ (A copy of page 15 of the COVID document is included as Appendix A.) Dr B documented in the clinical notes that she ‘advised [Ms A] to arrange an [appointment] with her GP to discuss treatment options for COVID-19’.

The COVID document

9. The COVID document is published by the US-based Truth for Health Foundation as an ‘educational resource’. The organisation’s website — a link to which was included at the bottom of every page of the COVID document — sets out its vision as follows: ‘We envision a world where people choose their path to live fully as human beings according to the physical and spiritual laws of life as God designed us.’ The organisation has a particular focus on COVID-19 and the COVID-19 vaccines, with resources on vaccine injuries and COVID treatment guides, as well as information on the impacts of 5G wireless communication on human health.
10. Page 15 of the COVID document includes a flow chart entitled ‘New Uses of Older Medicines: COMBINATION THERAPY USED FOR COVID’. The flow chart sets out care pathways for people with COVID-19, and includes treatments and medications such as zinc sulfate, vitamin D, vitamin C, azithromycin (an antibiotic), hydroxychloroquine (a medication used to treat rheumatoid arthritis, lupus, and to treat or prevent malaria), ivermectin (a medication used to treat parasites), and doxycycline (an antibiotic). The flow chart was taken from a 2020 research article[2] published in the International Journal of Medical Science and Clinical Invention.
11. Page 3 of the COVID document is titled ‘Your “Road Map” for Using This Guide’. This page includes the following statement:

‘Before you decide to take an experimental genetic “Covid shots” [sic], our expert physicians and scientists suggest you read our Patient Guide FACT SHEETS 1–4 to make an informed decision. For updates on “the COVID shot”, go to FACT SHEET 5.’

(Emphasis in original.)

12. Fact sheet 5 is titled ‘Experimental COVID Vaccines: Update on Safety’. This page states that women who are pregnant or of childbearing age, children under the age of 12, and nursing home patients, should not receive any type of COVID vaccine. The rationale given for this statement is that these people were excluded from the drug company studies for the vaccines, and therefore there was no data on the effectiveness or safety for those groups.
13. This page also includes sections about the benefits and risks, side effects, and complications of the COVID vaccines from the clinical trials. It states that the trials showed no evidence of reduced spread of COVID to others, and no evidence of reduced hospitalisations or deaths. The risks, side effects and complications listed include ‘abnormal bleeding, menstrual problems in girls, testicular pain/inflammation in boys, infertility’ and ‘[m]iscarriages; deaths of mothers, deaths of nursing babies after mother vaccinated’. None of these side effects are included in the Medsafe (New Zealand’s medicines safety authority) data sheet[3] for the main COVID-19 vaccine[4] used in Aotearoa New Zealand at the time of events (or the current version of the data sheet).
14. Fact sheet 5 also claims incorrectly that none of the vaccines had been approved by the FDA (the U.S. Food and Drugs Administration, the body responsible for controlling and supervising the use of medications and vaccines, among other things).[5] The sheet includes the following statement:

‘Evidence shows genetic material and spike proteins generated by the vaccine penetrate the ovaries, testes, brain, spinal cord, nervous system, heart, lungs, intestines, kidneys, and cross the placenta in pregnant women. Actual degree of distribution around our body has not been studied and is urgently needed.

NO ONE KNOWS ALL the risks and side effects, or how long the adverse effects may last. Increasing numbers of physicians and scientists report vaccinated patients exposed to the virus again are having worse illness than if they had never been vaccinated.’

(Emphasis in original.)

15. Page 18 of the COVID document includes a discussion about the COVID vaccine, and states:

‘Safety and effectiveness are urgently in serious question worldwide due to the alarming and rising numbers of vaccine-induced deaths and severe complications, including paralysis. The good news is there are safe and effective early treatments already available making vaccination unnecessary.’

(Emphasis in original).

16. Aside from the 2020 research article referred to on page 15 of the COVID document, no scientific evidence[6] is presented or cited to support the claims in the document.

Comment from Te Whatu Ora

17. Te Whatu Ora told HDC that information for managing COVID-19 positive cases isolating at home was not made available to Dr B at the time of events. However, it said that guidance regarding COVID-19 was, and is, accessible to GPs nationally on a number of websites,[7] and specific guidance was provided to GPs from a regional perspective through regular Medinz[8] and Regional HealthPathways.

Comment from Dr B

18. Dr B told HDC that the COVID document was sent to her by a more senior GP colleague who had prescribed treatment according to the flow chart on page 15 for COVID-19 positive patients. She said that she was not aware of the contents of the document beyond page 15, and that sending it to Ms A was the first and only time she shared the COVID document with anyone.
19. In response to my provisional opinion, Dr B said that the flowchart on page 15 that she thought was relevant to Ms A (<50 and healthy) did not include ivermectin and hydroxychloroquine as treatments. Dr B has not advised HDC who provided the COVID document to her.
20. Dr B also said that the patient management system (PMS) used for the MIQF team was different to that which she used in her clinical work as a GP, which limited the resources available to her. She stated that at the time, no other guidelines were provided to help GPs to assist patients in the community who were positive for COVID-19 and symptomatic. Dr B said that she was aware of the Regional Community HealthPathways for COVID-19 case management in adults but noted that the Pathways stated that they were ‘interim guidance’, as they were being updated regularly. Dr B described the guidance available to New Zealand GPs on the management of COVID-19 as being ‘in their infancy’.
21. Dr B also described herself as a ‘Champion of COVID vaccination for all people’. She said that she helped to educate people about the vaccine in her clinic and had been the clinical lead in community Q&A discussions about the vaccine in churches throughout the area. She told HDC that this complaint has taught her to thoroughly check any documents she shares.

Comment from Ms A

22. Ms A was particularly concerned that Dr B was contacting members of the Pacific community. Ms A told HDC: ‘This is scary to think this information has been sent out to some of the most vulnerable people who SHOULD be getting vaccinated to fight off this virus.’

Subsequent events: Ms A’s complaint and Dr B’s response

23. On 1 November 2021, the same day on which Dr B spoke with Ms A and sent her the COVID document, Ms A complained to a number of organisations (including HDC, the Ministry of Health, and a media outlet). In response, Dr B sent a letter to Ms A on 4 November 2021. In the letter, Dr B apologised for ‘any unintended distress’ that Ms A experienced. Dr B also wrote:

‘I … have been involved in talking to the Pacific community about encouraging vaccination and addressing their concerns about it (after-hours in my personal time). I have never discouraged anyone from getting the covid-19 vaccination. I am fully vaccinated. I believe you are not aware of the consequences of your complaint as I regard it as highly defamatory … Your complaint suggests that I am spreading the anti-vaccination message. This is completely FALSE. Without confirming your false beliefs about me, you have sent your complaint to the media, New Zealand Medical Council, Covid-19 response team, Dr Ashley Bloomfield and my managers which has serious consequences. I will need to advise all the recipients that the information provided is false. Your complaint not only affects me but my immediate and wider family.’

24. At the end of her letter, Dr B also wrote: ‘This email is “private and confidential” and not for dissemination.’
25. In response to the provisional opinion, Dr B told HDC her initial response had been ‘out of shock at being labelled as an antivaccination misinformation spreader, having given so much effort towards educating the vulnerable communities to get the vaccine, which was done in [her] own private time’. She said that the response was also screened by her legal representative, who believed it was ‘appropriate’.
26. Ms A told HDC that she felt bullied and intimidated by Dr B’s response to her complaint.

Status of COVID-19 vaccine and other medications in New Zealand

27. As noted above, the main COVID-19 vaccine used in Aotearoa New Zealand at the time of events was made by Pfizer-BioNTech (Pfizer).
28. Medsafe checks applications for all new medicines, including vaccines, to make sure they meet international standards and local requirements. It will recommend that a medicine is approved for use in New Zealand only if it meets these standards.
29. Medsafe formally made the decision to provisionally approve the Pfizer vaccine in New Zealand on 3 February 2021, and the provisional approval was renewed on 28 October 2021. Pfizer must give Medsafe ongoing data and reporting to show that it meets international standards. Medsafe monitors the safety and efficacy of the vaccine as it is used. It reviews data from ongoing clinical trials around the world, and reports from healthcare professionals and people who have been vaccinated.
30. On 9 July 2021, the Ministry of Health issued a document called ‘COVID-19 Science Updates’. It noted that neither ivermectin[9] nor hydroxychloroquine[10] nor vitamins D and C were supported by current evidence at the time as treatments for COVID-19. None of these were recommended as treatments for COVID-19 in New Zealand at the time of events or currently.

Responses to provisional opinion

31. Ms A, Dr B and Te Whatu Ora were all given the opportunity to respond to relevant sections of the provisional opinion. Where appropriate, their comments have been incorporated into the report above.
32. Te Whatu Ora told HDC that it had no further comment to make.
33. Ms A acknowledged that Dr B was in a difficult position and reliant on Te Whatu Ora providing GPs with sufficient information and support. Ms A told HDC that she stands by her view that the document should never have been sent out.
34. In response to the provisional opinion, Dr B told HDC that it was her first day working as a virtual GP to the MIQ facility, and she was working remotely from home and was not feeling well. Dr B said that at the time, the regional pathway guidelines stated, ‘[N]o specific treatments are currently recommended in primary care,’ and that as a medical doctor she found that to be unethical. Dr B stated:

‘It is unethical that there were no options other than monitoring for symptoms until it was severe enough to go to the hospital. It is unethical to overlook the treatment options that were successfully used overseas who at the time had a significantly higher number of people positive with COVID-19. I had only shared this document once, and it was to [Ms A] with the intention that she share it with her family doctor to see if it was appropriate for her.  New Zealand was behind the rest of the world in terms of the number of COVID-19 positive cases and treatment options were based upon international data. Similar to the Pfizer vaccine being recommended here in New Zealand based upon the millions that had received it in the United States of America and Israel prior to the vaccine rollout.’

35. Dr B felt that the Ministry of Health could have done better to provide early treatment to patients with COVID-19 to prevent deterioration of their health, hospitalisation, and death. She stated: ‘Upon reflection, all our hope was put into a single Pfizer vaccine that has now been proven to have not stopped transmission.’
36. Dr B disagreed with the proposed findings.

Opinion: Dr B — breach

Introduction

37. Under Right 4(2) of the Code of Health and Disability Services Consumers’ Rights (the Code), a consumer has the right to have services provided that comply with professional, legal, and ethical standards. This opinion will consider whether Dr B complied with applicable standards when providing services to Ms A.

The COVID document

38. When Dr B sent Ms A the COVID document, Dr B specifically directed Ms A’s attention to page 15, which set out COVID treatment care pathways. Dr B also advised Ms A to discuss the care pathway with her GP.
39. Elsewhere in the COVID document are statements explicitly discouraging vaccination for particular groups such as pregnant women or women of childbearing age, children under the age of 12, and care home residents. In my view, other statements in the COVID document could also reasonably be interpreted as discouraging anyone from getting the COVID vaccine. These include:
40. References to the vaccine as ‘experimental genetic “Covid shots”’;
41. The claim that vaccination is unnecessary because of the availability of alternative treatments;
42. Statements that vaccine clinical trials show no evidence of reducing the spread of COVID, hospitalisations or death; and
43. Lists of very serious side effects, including miscarriages, and deaths of mothers and nursing babies after the mother has been vaccinated (none of which were confirmed by official sources in New Zealand such as the Medsafe datasheet at the time).
44. No evidence is presented in the COVID document to support the vast majority of these statements, and at least one statement is patently incorrect.[11]
45. On 28 April 2021, the Medical Council of New Zealand (MCNZ) issued a guidance statement, ‘COVID-19 vaccine and your professional responsibility’ (the MCNZ guidance statement) (see Appendix B). The MCNZ guidance statement includes the following:

‘As a health practitioner, you have a role in providing evidence-based advice and information about the COVID-19 vaccination to others. You should be prepared to discuss evidence-based information about vaccination and its benefits to assist informed decision making. There is information on the Ministry of Health (MOH) website to support engagement with staff or colleagues and the public who may be hesitant about getting a vaccine. As regulators we respect an individual’s right to have their own opinions, but it is our view that there is no place for anti-vaccination messages in professional health practice, nor any promotion of anti-vaccination claims including on social media and advertising by health practitioners.’

42. In my opinion, the COVID document contains misinformation that amounts to anti-vaccination messaging. I acknowledge that Dr B directed Ms A’s attention to page 15 and did not suggest that she read the entire COVID document. I also note that Dr B has stated that she was not aware of the information in the COVID document beyond page 15. That may be true; however, Dr B remains responsible for the information she sends to consumers, and it could reasonably be expected that Ms A would read beyond page 15, and accordingly would be exposed to the anti-vaccination misinformation. Dr B’s failure to read the information in full does not lessen that responsibility. In any event, I consider it irresponsible for providers to send documents to consumers without being completely aware of their contents.
43. I also acknowledge that Dr B told Ms A to discuss the information with her GP. This demonstrates that Dr B intended for Ms A to obtain input from other medical professionals when planning her COVID-19 treatment, which is appropriate. However, in my opinion that does not mitigate Dr B’s responsibility to provide accurate information, to share information from public health approved channels, and to verify the appropriateness of the resource being provided.
44. I also note Dr B’s submission that no other guidelines were provided to help GPs to assist patients in the community who were positive for COVID-19 and symptomatic. She was aware of the relevant HealthPathways but noted that it was ‘interim’ guidance. She also described New Zealand COVID-19 guidance available to GPs as being ‘in their infancy’. I accept that the HealthPathways guidance was subject to change as new processes developed and as a national COVID-19 care framework was being developed.[12] I also accept that it was Dr B’s first day working for MIQF, and the MIQF PMS was different to that she used in her clinical work as a GP, which may have limited the resources available to her. However, I do not accept that any of these factors justify Dr B sharing the COVID document, especially in the absence of providing evidence-based information from the Ministry of Health relevant to the New Zealand context and when Ms A had not actually asked to be provided with written information about COVID-19 treatment options.
45. Dr B’s response to my provisional opinion — that she disagreed with the HealthPathways guidance — reinforces my criticism that Dr B had awareness of the Ministry of Health guidance but instead provided alternative information.
46. Ultimately, I consider that Dr B irresponsibly shared anti-vaccination misinformation when she sent Ms A the COVID-19 document. In my view, this amounts to a failure to comply with the MCNZ guidance statement.

Ivermectin, hydroxychloroquine, and vitamins C and D

47. The treatment pathways on page 15 of the COVID document, to which Dr B directed Ms A’s attention, recommend treatments including hydroxychloroquine, ivermectin, and vitamins C and D. Dr B also mentioned vitamins C and D as treatment options, among other things, when she spoke to Ms A initially. None of these medications were recommended at the time, or currently, as treatments for COVID-19 in New Zealand.
48. The MCNZ standard ‘Doctors and complementary and alternative medicine (CAM)’ (November 2017) (the CAM standard) refers to therapies and treatments that are not commonly accepted in conventional medical practice. Complementary therapies are healthcare and medical practices that are used alongside conventional medical treatments but are not an integral part of conventional medicine, while alternative therapies are used instead of standard medical treatments. In this context, vaccination is a standard medical treatment, and this Office has previously found[13] that hydroxychloroquine, ivermectin and vitamin D amount to alternative treatment for COVID-19. The CAM standard refers to a 2003 decision by the Medical Practitioners Disciplinary Tribunal, which stated:

‘There is an onus on the practitioner to inform the patient not only of the nature of the alternative treatment offered but also the extent to which that is consistent with conventional theories of medicine and has, or does not have, the support of the majority of practitioners …’

49. In the context of COVID-19 treatments, I expect practitioners to explain to consumers that vaccination is the standard medical treatment, and that medications such as ivermectin, hydroxychloroquine, and vitamins C and D are not recommended for treating COVID-19 in New Zealand. I am critical that Dr B did not do so. However, again I note that Dr B recommended that Ms A discuss the COVID treatment pathway with her GP, and I consider that to be a mitigating factor.

Response to Ms A’s complaint

50. Dr B responded to Ms A’s complaint in November 2021. In her response, Dr B described Ms A’s complaint as ‘highly defamatory’.
51. The MCNZ standard ‘Unprofessional behaviour’ (August 2020) (the Unprofessional Behaviour standard) provides that unprofessional behaviour includes repeated inappropriate behaviour, as well as one-off incidents that may be disruptive. The inappropriate behaviour or incident may apply to interactions with patients, other healthcare professionals and colleagues, or outside of work. Whether a doctor’s behaviour is unprofessional often depends on the context, and how that behaviour is perceived.
52. The Unprofessional Behaviour standard also states that unprofessional behaviour does not necessarily occur only within the healthcare setting; it can also extend to behaviours outside the healthcare team that may damage the trust and confidence that patients have in their doctor. Unprofessional behaviour includes bullying and intimidation, and inappropriate communication. The Unprofessional Behaviour standard requires doctors to be respectful, professional and considerate, even in stressful and difficult situations.
53. I acknowledge that it can be stressful and upsetting to be the subject of a complaint. It appears that part of Dr B’s concern related to the dissemination of the complaint to others, and the impact on her family. However, under Right 10 of the Code, Ms A had a right to complain about the services provided to her, and her complaint had legitimacy, noting the anti-vaccination messaging that Dr B had, in fact, sent to her. In my view, it was inappropriate and unprofessional for Dr B to describe Ms A’s complaint as ‘highly defamatory’ in her response, even if she did not agree with Ms A’s account of events. I also consider that such a comment, and the general tone of the final paragraph, undermined the authenticity of Dr B’s apology, and I accept Ms A’s comment that she felt bullied and intimidated. In my view, Dr B failed to comply with the requirements of the Unprofessional Behaviour standard, and her response fell short of that to be expected when responding to a complaint as required by Right 10. In the event that a provider disagrees with a complaint, this can and should be done respectfully and professionally.

Conclusion

54. I have a number of concerns about the services provided by Dr B to Ms A. Specifically, Dr B:

• Irresponsibly shared anti-vaccination misinformation with Ms A;
• Did not explain to Ms A that ivermectin, hydroxychloroquine, and vitamins C and D are not recommended for treating COVID-19 in New Zealand; and
• Initially responded to Ms A’s complaint in an inappropriate and unprofessional manner.

55. In my view, these issues represent failures to comply with MCNZ standards.[14] Accordingly, I find that Dr B breached Right 4(2) of the Code.

Opinion: Te Whatu Ora — no breach

56. At the time of events, Dr B was contracted to provide services to Te Whatu Ora as part of what was a virtual GP MIQF team. She had been a vocationally registered GP for several years at the time.
57. In my opinion, given her experience as a vocationally registered GP, it was reasonable for Te Whatu Ora to rely on Dr B to comply with professional standards, including those around professional behaviour and providing consumers with evidence-based information from accurate sources. I also consider it reasonable for Te Whatu Ora to expect that Dr B would share information from official sources such as the Ministry of Health.
58. I note Te Whatu Ora’s acknowledgement that it did not at the time make available to Dr B guidance for providing care to COVID-19 positive consumers isolating at home. However, there was information available to GPs nationally, and regional information via the HealthPathways, to help guide GPs caring for adults with COVID-19. Accordingly, I do not find that the lack of guidance from Te Whatu Ora constituted a breach of the Code.
59. In addition, I do not consider that this materially mitigated Dr B’s responsibility for complying with relevant standards in respect of sharing appropriate information with consumers and responding to consumer complaints.

Recommendations

60. I recommend that Dr B:

• Provide a further apology to Ms A for the issues identified in this report. The apology is to be sent to HDC, for forwarding to Ms A, within three weeks of the date of this report.
• Complete HDC’s online training on the Code, and report back to HDC on her learnings within three months of the date of this report.
• Attend training on communication and professional standards, and report back to HDC on her learnings within six months of the date of this report.

Follow-up actions

61. A copy of this report with details identifying the parties removed will be sent to the Medical Council of New Zealand and the Royal New Zealand College of General Practitioners, and they will be advised of Dr B’s name.
62. A copy of this report with details identifying the parties removed will be placed on the Health and Disability Commissioner website, hdc.org.nz, for educational purposes.

 

 

Appendix A: Extract from COVID-19 document

New Uses of Older Medicines: COMBINATION THERAPY USED FOR COVID

*FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial, citing risk of heart rhythm problems based on hospitalized patients. Please consult with your physician before use.

For more information on safety of HCQ and other medicines in the algorithm, check the c19study.com website that summarizes more than 154 studies of HCQ-based treatment, which are particularly favorable when HCQ is used in the first few days of COVID-19 symptoms as recommended in the above algorithm. For further information, see AAPS compendium of articles and studies on COVID-19.

 

Appendix B: MCNZ guidance statement released 28 April 2021

‘Guidance statement

COVID-19 vaccine and your professional responsibility

Vaccination is a crucial part of the New Zealand public health response to the COVID-19 pandemic.

Health practitioners can help to protect themselves, their patients, and the wider community by getting their COVID-19 vaccination.

The Dental and Medical Councils have an expectation that all dental and medical practitioners will take up the opportunity to be vaccinated — unless medically contraindicated.

You have an ethical and professional obligation to protect and promote the health of patients and the public, and to participate in broader based community health efforts. Vaccination will play a critical role in protecting the health of the New Zealand public by reducing the community risk of acquiring and further transmitting COVID-19.

Patients are entitled to information that a reasonable consumer, in that consumer’s circumstances, would expect to receive (Right 6, Code of Health and Disability Services Consumers’ Rights).

As a health practitioner, you have a role in providing evidence-based advice and information about the COVID-19 vaccination to others. You should be prepared to discuss evidence-based information about vaccination and its benefits to assist informed decision making. There is information on the Ministry of Health (MOH) website to support engagement with staff or colleagues and the public who may be hesitant about getting a vaccine.

As regulators we respect an individual’s right to have their own opinions, but it is our view that there is no place for anti-vaccination messages in professional health practice, nor any promotion of antivaccination claims including on social media and advertising by health practitioners.

More information:

The latest government information on the COVID-19 vaccination programme can be found on the MOH website.

The Ministry for Business, Innovation and Employment (MBIE) has guidance for employers and workers about the employment law implications for the COVID-19 vaccination programme.’

 

[1] Dr B is a vocationally registered GP.

[2] McCullough et al, ‘Innovative Early Sequenced Multidrug Therapy for Sars-Cov-2 (Covid-19) Infection to Reduce Hospitalization and Death’, International Journal of Medical Science and Clinical Invention (2020), 7(12): 5139–5150

[3] A data sheet informs healthcare professionals about aspects of the relevant medicine they should know about, including known side effects, and is a legal requirement for all medicines.

[4] A vaccine made by Pfizer-BioNTech (also known by its brand name, Comirnaty). AstraZeneca and Novavax COVID-19 vaccines were also approved (although AstraZeneca is no longer available in New Zealand).

[5] On 23 August 2021, the FDA announced the first approval of a COVID-19 vaccine (the Comirnaty vaccine).

[6] The COVID document does include a link to a privately run website that compiles information from the Vaccine Adverse Events Reporting System (VAERS), a program managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. FDA to monitor the safety of all vaccines licensed in the United States. VAERS collects and reviews reports of adverse events that occur after vaccination. VAERS cannot determine whether a vaccine caused an adverse event but can determine whether further investigation is needed.

[7] Ministry of Health website https://www.health.govt.nz/covid-19-novel-coronavirus; Unite Against COVID-19 website https://covid19.govt.nz/; and Immunisation Advisory Centre website https://www.immune.org.nz/.

[8] Medinz is the process and platform for clinical messaging to GPs and other health providers regarding COVID-19 and other significant health matters.

[9] Medsafe published a website communication on 6 September 2021 stating: ‘Ivermectin is NOT APPROVED to prevent or treat COVID-19, which means that Medsafe has not assessed the safety and efficacy for this use.’ (Emphasis in original.) https://www.medsafe.govt.nz/safety/Alerts/ivermectin-covid19.htm.

[10] Pharmac’s website (updated 24 November 2021) states: ‘Hydroxychloroquine has not demonstrated an overall benefit in the treatment of COVID-19, as indicated by the World Health Organization.’ https://pharmac.govt.nz/news-and-resources/covid19/covid-19-hydroxychloroquine/.

[11] The claim that the FDA had not approved any COVID-19 vaccines.

[12] The first COVID-19 Care in the Community Framework was published in December 2021.

[13] 21HDC01972, available at www.hdc.org.nz.

[14] Specifically, as discussed in more detail above, the COVID-19 guidance statement, the CAM standard, and the Unprofessional Behaviour standard.