The BFD | Remdesivir NZ: Not Approved for C-19

New Zealand Doctors Speaking Out With Science
nzdsos.com

Information

Opinion

More than convenient cherry-picking, see-sawing on the back of the Medicine’s Act seems to be the order of day when it came to provision of Remdesivir and the black-listing of Ivermectin.

Remdesivir NZ – A Unapproved Medicine Widely Used

In a recent Official Information Act (OIA) response, the Ministry of Health declined to provide the basis for Medsafe having not yet given approval or even provisional consent for Veklury (Remdesivir) in New Zealand. No information was provided from the sponsor (Gilead – the pharmaceutical company that produces Remdesivir) with regard to safety or effectiveness of this drug, nor was analysis provided on what constituted “success”. The excuse given, was that provision of this information would “unreasonably prejudice the commercial position of the person who supplied the information. I have considered the countervailing public interest in release in making this decision and consider that it does not outweigh the need to withhold at this time.”

Read that again: The commercial position of a non-descript person (presumably a highly-paid Gilead executive) was placed above that of the health of New Zealanders – by the Ministry of Health.

We thought we had seen it all, but yet again the NZ government and its regulatory bodies have once again flummoxed us with their tortuous attempts at placating their over-lords while keeping the public submissively thinking they had our best interests at heart.

By now, everyone is likely to be aware that doctors can prescribe approved medications for unapproved use and unapproved medication under sections 25 and 29 of the Medicines Act. The onus for informed consent, weighing and explaining the risks and benefits to the patient is on the prescriber.

Pharmac procured Remdesivir under section 25 and it was distributed to Auckland hospital and then to other hospitals in September 2020 for use in a hospitalised person with covid who needed oxygen at a cost of US$390/vial. By March of this year Pharmac had widened the access criteria to those with mild to moderate covid but who are at high risk of severe disease.

Interestingly as a New Zealand doctor looking for information on Remdesivir NZ, one finds a short write up in the NZ Formulary as below. However, there is no Medsafe datasheet.

So, doctors are being asked to prescribe this medication on the say-so of Pharmac.

How many emergency and ICU doctors have to time undertake a literature search on the appropriateness of Remdesivir in their particular patient? Usually, the Medsafe datasheet provides a comprehensive set of cautions and side effects that can be taken into account. Maybe the hospitals have their own information and protocols about Remdesivir but that means doctors are still relying on regulatory bodies who are concerned about commercial interests.

What is known, thanks to many doctors who are freely sharing information is that Remdesivir can cause significant side effects including liver, heart and kidney damage and the treatment may be worse than the disease. The science around Remdesivir is far from settled. The precautionary principle is not being applied in the use of this drug when successful protocols with far fewer questions and side effects are available. We wonder if the institution of these protocols would “prejudice the commercial position of the person”?

Ivermectin NZ – An Approved Medicine That Gets Doctors Investigated

Yes, Ivermectin is an approved medicine but not for covid. Going back to section 29 of the Medicine’s Act, doctors can prescribe an approved medication for an unapproved condition with the same informed consent safety-net that applies to unapproved medicines. Medsafe provides a full datasheet on Ivermectin. In a recent OIA, Medsafe stated that doctors could prescribe medication for unapproved conditions, while then hurriedly pointing to information from the WHO and the RNZCGP recommending against it. It is not often that government departments provide information in an OIA not asked for!

We have written extensively about Ivermectin, its safety record and its efficacy in covid. For a long read on what went on behind the scenes, this series from Dr Pierre Kory is worth your time.

A large number of the over twenty NZDSOS doctors being investigated by the Medical Council of New Zealand, have prescribed Ivermectin as one of their “charges” despite at no time was a patient complaint, nor evidence of harm submitted to the MCNZ.

These doctors did not benefit from their prescriptions, there was certainly no “prejudice of their commercial position” but they had looked at the literature and at the treatment of covid by those doctors on the front-line internationally who bore the brunt of the first waves of Covid with nothing but their experience, wisdom, willingness to look at all treatment options and a determination not to let their patients die.

Ivermectin vs Remdesivir

	Remdesivir	Ivermectin
Approved in NZ	No	Yes
Approved for treatment of covid	No	No
Long history of use	No	Yes
Known safety profile	No	Yes
Information easily available	No	Yes
Proven to work in covid	Maybe	Yes
Doctors persecuted for prescribing	No	Yes

Which Would You Rather Have?

While we fully admit we are comparing apples with pears in the above table, the argument remains that if the population had easy access to Ivermectin, the chances of individuals needing Remdesivir would decrease significantly. As we have argued, the protests, letters, OIA requests and the spreading of real information have been part of the dropping of the mandates.

We need to let the authorities know that their jobs are on the line if they do not act on information from those paying their salaries.