And what you can do about it – please sign the Parliamentary e-petition EN3364
On February 4th 2021, US pharmaceutical company Merck put out a very strange company statement.
It was an unusual statement for a pharmaceutical company because it was rubbishing its own drug, ivermectin, used for decades to treat the parasitic infection, scabies.
The statement went to Reuters, the international news agency, who wrote a story about it, and the story was run in newspapers, online and on TV all over the world.
Ivermectin did not work for COVID-19 and this tried and trusted drug – which has been used by millions worldwide for scabies and is on the World Health Organisation’s list of essential drugs – could be unsafe, we were told.
What Merck failed to disclose with their statement was that they had a potential conflict of interest.
They had been developing a drug to treat influenza and they wanted to repurpose it and sell it as an early treatment for COVID-19.
Furthermore, they would benefit if they could obtain emergency use authorisation for that new drug from the US Food and Drug Administration (the FDA) to speed up the process of getting their new drug to market – allowing them to skip some of the usual requirements.
But, if so, it would be awkward for Merck that the FDA’s rules for Emergency Use authorisation will only allow a drug to be authorised for such emergency use if “there are no adequate, approved, and available alternatives”.
So, it would be important to Merck, and indeed to any other pharmaceutical company wanting to get emergency approval for a new blockbuster drug to treat COVID-19, that ivermectin – or indeed any other existing drug – was NOT effective for COVID-19.
You see, new drugs are patented and expensive and bring in millions or billions of dollars for 20 years while they are “on-patent”.
Old drugs like ivermectin are “off-patent”, can be produced by any pharmaceutical company, and are as cheap as chips.
Just a month after their odd statement regarding ivermectin, Merck released a press release about encouraging phase 2 trials of their new COVID-19 treatment.
And on October 1st they released interim results of their phase 3 trial of this new drug -molnupiravir – which appears to be so successful that they decided to stop the trial early – with data reported on only 385 people with mild or moderate COVID-19 who took the new therapy.
Merck said they were applying for emergency use authorisation from the FDA “as soon as possible”.
On the strength of that, the Australian government has agreed to buy 300,000 doses of molnupiravir, subject to it getting approval as being effective and safe by our equivalent of the FDA – the Therapeutic Goods Administration (TGA).
One can imagine that it might be a little difficult for the TGA to reject molnupiravir!
Now, molnupiravir may turn out to be an effective drug and very useful indeed. The trial results do look encouraging.
The trouble is that phase three trials are quite good at determining how effective a drug is, but they are nowhere near as good at determining how safe they are.
If a drug is very unsafe, of course, that will show up in a trial.
But rarer side effects – say occurring in 1 in every 5,000 or 10,000 or 100,000 people simply will not show up in a trial where only 385 people have tried the drug.
Unfortunately, we live in a world where the FDA’s rules are very important.
The US is the world’s most lucrative drug market and so drug companies usually try first to get their drug approved by the FDA.
Once approved there, other regulators like our TGA often (but not always) follow like sheep.
Because of that FDA clause – quite sensibly saying that emergency use authorisation can only be given when existing safe drugs are of no help – we have the following situation:
An existing drug that has a very well-known safety profile after decades of use has been so-effectively rubbished that our TGA has banned GPs from prescribing it for COVID-19.
You see, ivermectin – despite the TGA’s announcement banning GPs from prescribing it – has an extremely good safety profile at the doses normally used for humans.
The question with ivermectin is not whether it is safe, but whether it works for COVID-19 at the established safe doses? And there are people like the BIRD group in the UK who think there is more than enough evidence to show that it does work.
Evidence from a meta-analysis on the topic (pooling data from 15 randomised controlled trials of using the medicine to treat COVID-19) shows ivermectin reduces the risk of death by 62%.
Instead, molnupiravir, a new drug which may work well, but is still experimental in that there is very little data on its immediate safety and possibly none on long term safety in humans, is likely to be unleashed on the Australian public.
Why? Perhaps because a pharmaceutical company is doing what all companies are supposed to do – putting shareholders first.
But regulators such as the TGA should be putting the safety of the Australian public first.
They should be aware of the incentive for pharmaceutical companies developing new drugs to rubbish evidence of existing off-patent drugs being effective for treating COVID-19 and be actively protecting the public from this.
Instead of banning ivermectin, the TGA should be recommending the use of ivermectin.
If the TGA baulks at recommending it, they could at least leave well alone, allowing Australian GPs to decide for themselves whether to use it in patients who have COVID-19, just as the TGA trusts GPs to make such decisions about almost all the other medicines in their armoury.
There’s something you can do about this.
An Australian doctor has written an e-petition to the Federal Parliament, demanding that your GP is once again given the right to prescribe ivermectin for you for COVID-19, should they think it appropriate.
We are all going to meet the virus. It’s only a matter of time. Although mild for most, we know it can be deadly for the vulnerable.
And the Australian statistics show that some
If you want your GP to have the option of prescribing ivermectin for you and for those you love when the virus reaches you, please sign this Parliamentary e-petition (EN3364) now.
The petition expires on 27th October so there’s no time to waste!
Please actively share this petition. Let’s make it the largest in Australia’s history!