Craig Kelly (Hughes, Independent) Share this | Hansard source

I rise this evening to speak on the National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021. It was a pleasure to listen to the member for Macarthur, who spoke before me, outline some of the significant breakthroughs that are coming down the track that can improve the quality of Australians lives, but we must remember that to list drugs on the Pharmaceutical Benefits Scheme, to make them available to Australians at an affordable cost, costs money. We have first to create wealth out in the community.

There was a period in the time that I've been a parliamentarian when this parliament, in the three years from 2010 to 2013, then under a Labor government, decided that, because of the budgetary situation, the listing of some drugs on the PBS had to be delayed. The member for Ryan was correct when he spoke about that. However, there is no point in continuing to list drugs on the PBS if it's all done by running up our debt. Back when the listing of new drugs on the PBS was suspended the debt was something around the $100 billion mark. Today, national debt stands at something like $1,000 billion—a trillion dollars' worth of debt. This debt is going to greatly compromise this parliament's ability to continue to list on the PBS new life-saving drugs and drugs that will improve the quality of life of many Australians.

I have a second reading amendment that I am proposing, which has six separate points. I will quickly go through some of those. The first one is:

"whilst" … "not declining to give the bill a second reading, the House notes:

(1) that the price of the drug Ivermectin in Australia under the Pharmaceutical Benefits Scheme (PBS) is significantly higher than reported elsewhere in the world;

I had a quick look on the PBS schedule, and it has the price for a pack of four three-milligram tablets of ivermectin at the maximum safety net price of $41.30. Yet anyone who looks on the internet can see that same drug available out of India costing something like 20c Australian per tablet, so a pack of four, which you can buy online from India, would be less than a dollar, yet it is $41 even under the Pharmaceutical Benefits Scheme. Something is going very wrong if a drug that costs less than a dollar to make is being sold to Australians, even under the Pharmaceutical Benefits Scheme, for $41.30.

The second point in the amendment that I am moving is:

(2) that on 10 September 2021, the TGA placed new restrictions on prescribing Ivermectin through the PBS for COVID-19, denying sick Australians access to a medicine that many medical experts believe could save lives, and this denial of Australians' access to a medicine through their doctor was described by experts—

including no less an authority than Emeritus Professor Robert Clancy—

as 'a sad and shameful day for Australian medicine';

I'll quote from the article. Again, these are not my words; these are the words of Emeritus Professor Robert Clancy, which he published an article in Quadrant on 13 September. He said:

September 10, 2021, was a black day, the day a group of faceless bureaucrats known as the "Advisory Committee for Medicines Scheduling", through its effector arm, the Therapeutic Goods Administration (TGA), compromised medical practise and the health of their fellow Australians. The TGA used its regulatory muscle to prevent doctors at the COVID-19 pandemic's coalface from prescribing ivermectin (IVM), the one therapy available that is safe, cheap and which reduces mortality in the order of 60 per cent.

These are not Craig Kelly's words; these are the words of Emeritus Professor Robert Clancy. I will continue to read from his article:

This poorly conceived action threatens the high standards of medical practise we have achieved in Australia, and the credibility of the administrative structure within which medicine operates.

The immediate consequence of the TGA Notice means patients contracting COVID-19 are left to hear, "Sorry, no treatment for COVID-19 is legally available. Just go to hospital when you get very sick." In the longer term it means that bureaucrats can change the way medicine is practised for whatever reason without review by, or discussion with, the medical community. It is important for Australians to consider two issues that follow the TGA's decision: first, it adds risk to those exposed to COVID-19, putting additional pressures on health-care facilities; second, it drives a wedge into the fault lines that have appeared in medical practise during the course of the COVID-19 saga.

Looking at the first issue, the decision by the TGA to prevent general practitioners from prescribing IVM to manage COVID-19, the Notice is flawed and misleading, although giving clues to its political motivation.

Again, I am quoting directly from Emeritus Professor Robert Clancy. He writes:

The evidence that IVM is safe and effective in both preventing and treating early (pre-hospital) COVID-19 is overwhelming, as has been  laid out in four Quadrant articles published through 2021. Despite this evidence, every artifice has been used to quash IVM's use and to do so in unprecedented fashion. The causes for the suppression include political agendas, pressures from pharmaceutical companies, ideology and breakdown in medical communication. This latest blow by the TGA follows its previous form in shutting down use of hydroxychloroquine, another safe, effective and cheap COVID-19 therapy. Every experienced doctor prescribes drugs for 'off-label' indications. It is anathema and dangerous that the doctor-patient relationship can now be over-ridden by government agendas.

Again, these are not my words but the words of one of the most senior, respected and highly qualified immunologists in this country. He concluded:

The authoritarian and poorly conceived interference by the TGA in the effective running of clinical medicine, and its broader implications, is a further splintering event. This is a time when everyone needs to be on message to counter a devastating pandemic. The use of blunt legal tools to threaten and bully doctors with de-registration, legal action for "advertising" and even with jail terms for striving for the transparency and common sense that has served medicine so well compromises the rules of science and the doctor-patient relationship upon which our profession is built. The answer is transparency and communication around agreed goals based on science. We should again involve all levels of health care and the public we serve. The decision-making process should include clinicians familiar with the problem to ensure the pragmatic and common-sense approach needed to get us through this pandemic with minimum damage.

This is his final paragraph:

Rather than create the chaos and loss of respect for an important institution that will follow continued enforcement of the current Notice, the TGA should initiate a working party that includes frontline doctors to establish an agreed treatment protocol that includes dosage, with monitoring of the outcomes. We live in dangerous times that call for new ideas able to address a real world crisis that is out of control and will only get worse without a different way of thinking.

They are the words of Emeritus Professor Clancy, written in an article on 13 September.

The third point in the amendment that I would like to move is that the recently published Australian data evidence is that ivermectin prescribed under the PBS in Australia prior to the TGA's ban combined as part of a triple therapy including zinc and doxycycline has been highly successful in reducing hospitalisations and deaths. We actually have some data to show how effective this has been; this is not just some theoretical argument or theoretical conclusion put forward by Emeritus Professor Clancy. There is a paper that has been published with the lead authors Thomas Borody and Professor Clancy. In this study, they took 600 Australian residents with positive PCR symptomatic COVID and treated them with ivermectin, doxycycline and zinc for 10 days. The treatment period was from June to September 2021. It involved two states, New South Wales and Victoria, and over 30 frontline doctors. The result of those studies were that only two people visited hospital, for 24 hours, and went home. A total of five people in that study were admitted to hospital, 0.83 per cent, and there were no deaths.

In an equivalent control group, so if we took another 600 Australians with similar characteristics who weren't in general society and weren't given Dr Borody's triple therapy, what were the results? On average, 70 were admitted to hospital: 11.5 per cent. So we have those who took Dr Borody's triple therapy, with 0.83 per cent admitted to hospital; and those who didn't, with 11.5 per cent. The number of deaths in that equivalent group: six. In Dr Borody's group: 0.

When we have such results in an Australian based study, how is it possible that we are denying Australians access to these treatments? This is what the TGA have done. I do not know whether this drug is effective, but I do know that Australians should not be denied access to this treatment when we have published studies showing such results. Surely when we have people dying every day of COVID we have the right to try in this country. Surely doctors must have the right to practice medicine. Those rights are being taken away by a bad decision of the TGA that is criticised by some of our most senior immunologists in this country.

As I'm short of time on the clock, I will quickly also note that the TGA said there had been a threefold to fourfold increase in dispensing ivermectin prescriptions in recent months. They were concerned about the safety of this. We can go to the TGA's DAEN database and see whether this led to more reports of adverse events. We can see throughout the entire length of the pandemic, from 1 January 2020 to 14 November, the latest data of 2021, that there were only two cases of adverse events reported by people taking ivermectin as a single suspect medicine, and one of those took it not through the prescription. In comparison, the number of reports from the COVID vaccines on the same database for the same period is 80,669 cases.

I move:

That all words after "whilst" be omitted with a view to substituting the following words:

"not declining to give the bill a second reading, the House notes:

(1) that the price of the drug Ivermectin in Australia under the Pharmaceutical Benefits Scheme (PBS) is significantly higher than reported elsewhere in the world;

(2) that on 10 September 2021, the TGA placed new restrictions on prescribing Ivermectin through the PBS for COVID-19, denying sick Australians access to a medicine that many medical experts believe could save lives, and this denial of Australians' access to a medicine through their doctor was described by experts as 'a sad and shameful day for Australian medicine';

(3) recently published Australian data provides evidence that Ivermectin prescribed under the PBS in Australia (prior to the TGA's ban) combined as part of a 'triple therapy' including Zinc and Doxycycline (also prescribed under the PBS) has been highly successful in reducing hospitalisations and death;

(4) that the TGA noted on 10 September 2021 there had been a 3 to 4-fold increase in dispensing of Ivermectin prescriptions through the PBS in recent months, however the TGA Database of Adverse Events records no increase in adverse events;

(5) that a reason for denying Australians' access to Ivermectin through their doctor and the PBS to treat COVID-19 included the reason of 'national and local shortages for those who need the medicine for scabies and parasite infections', however medical regulators failed to take steps to overcome this shortage; and

(6) that this denial of Australians' access to this medicine through their doctor and the policies of other nations to adopt widespread use of Ivermectin to tackle COVID-19, have created a black-market for the drug undermining Australia's PBS".

I commend this amendment to the House.

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