Should Malaysia spend hundreds of millions on Molnupiravir?

On October 7, the Health Minister KhairyJamaluddin announced that Malaysia had signed an agreement to procure 150,000 courses of the drug. However, he refused to reveal the costs involved saying that the government was bound by a confidentiality agreement with the company Merck.

If one uses Merck’s publicly announced retail price for Molnupiravir at RM293 per pill (10 pills per course of therapy) Malaysia will need to spend at least RM439,5000,000.

Why are we throwing good money (close to half a billion RM) at another experimental drug with a secret purchasing agreement (the second after Pfizer’s vaccines under KhairyJamaluddin’s watch), devoid of public scrutiny and oversight, which has no long-term safety data (just like the mRNA vaccines) whose ‘significant efficacy’ is under question but wildly profitable for Merck.

On 27 Oct, Merck & Co announced that it has signed a licensing agreement with the UN-backed Medicines Patent Pool (MPP) that will allow more companies to manufacture generic versions of its experimental oral antiviral Covid-19 treatment.

Merck said the royalty-free licence would apply to 105 low- and middle-income countries. It allows manufacturers selected by MPP to make generic versions of molnupiravir. According to the World Bank there are 137 low- and middle-income countries in the world.

32 of these countries are left out in this agreement. Is Malaysia among the countries excluded? And will anything change in Malaysia’s agreement to procure the drug since it was signed before the new licensing agreement to produce generic versions of the drug?

The experimental Covid-19 treatment pill has been hailed as a game changer, the silver bullet that can help ‘transform Covid-19 from a public health crisis into a manageable disease’.

Did we consider a cheaper alternative?

But is there something we are missing here? About one and half years ago clinicians, researchers and nations were touting a generic drug which was cheap, effective with a long safety record and long history of use to treat Covid-19. Many felt that this life-saving drug may indeed be a global solution to the Covid-19 pandemic.

However, national and international health agencies including the WHO were running down this therapeutic drug, despite the mounting and irrefutable medical evidence supporting it.

This drug Ivermectin was first manufactured by Merck until its patent rights expired in 1996. In 2020 Merck was asked to assist in Nigerian and Japanese trials on Ivermectin but the company has declined both overtures, meaning it had no intention of conducting clinical trials.

Merck had distributed Ivermectin free through the Mectizan Donation Programme (MDP) in cooperation with the WHO since 1987 to developing countries to prevent river blindness and lymphatic filariasis. Some 3.7 billion doses have been widely distributed over 30 years in 70 countries/regions for which the discoverers of the drug won a Nobel Prize in 2015. Merck itself had announced on its public relations page that there were very few serious adverse events in the MDP over a period of more than 30 years.

Conflict of interest

Merck entered an agreement with the US government to develop, manufacture and distribute a therapeutic drug for Covid-19 for which the government will pay Merck USD356 million upon approval or emergency use authorisation (EUA) from the USFDA.

It’s quite obvious that the media smear campaign against Ivermectin was timed to clear the market for Merck’s molnupiravir. Clearly there is a conflict of interest for Merck as the chances of Ivermectin which is cheap and patent-free, will successfully compete against Molnupiravir if Ivermectin is seen as an effective drug for Covid-19 treatment in the early stage of the disease.

In June 2021, FLCCC (Front Line COVID-19 Critical Care Alliance) President Dr. Pierre Kory in response to the announcement by the US government that it ‘was entering a contractual agreement with Merck where it will commit USD1.2 billion of taxpayer money in order to enrich Merck for a drug which has already been the source of a whistleblower complaint, and which has already failed in hospitalized patients, when we already have a drug which is low cost, safe, widely available which has been proven to work in many phases of disease – not only as outpatients but in in-patients’.

He drew attention to Merck’s statement which said there was no evidence to support the efficacy of ivermectin as well as ‘calling into question its safety one of the safest drugs known in history. That statement was a lie … They should instead be saddled with a colossal fine … If (the US government) fulfill this it will be a staggering waste of time and money, and it continues to ignore the widespread availability of Ivermectin… We already have another tool that we know can end it and that drug is Ivermectin’ he concluded.

40 times higher

Merck is selling its experimental Covid-19 pill to the US government for 40 times what it cost to make. According to a report by drug pricing experts from the Harvard TH Chan School of Public Health and King’s College Hospital London, a five-day course of the pill costs USD17.74 to make. But for the same amount, Merck is charging the US government USD712 which was revealed by The Intercept newsletter.

To put things into perspective, Covid-19 real-time analysis of 64 studies on Ivermectin as at October 11, 2021, show that Ivermectin use in Covid-19 demonstrated 66% and 86% improvement for early treatment and prophylaxis respectively. Statistically significant improvements are seen for mortality, ventilation, ICU admission, hospitalisation, recovery cases and viral clearance.

The Uttar Pradesh experience

Ivermectin does not need an EUA as it passed trials in 1986. It just needs to be recommended to treat Covid-19. But it is unlikely to happen despite the instrumental role it played in crushing the epidemic in Utter Pradesh (UP). On September 10th, the state government of Uttar Pradesh declared all the 33 districts in the state were now free from Covid-19 while the recovery rate had increased up to 98.7%. The state has a population of 241 million people – the highest population in India, which is almost eight times Malaysia’s population.

As of September 20, 2021, tests over the previous two weeks on over two and half million samples (2,524,162) revealed 201 cases tested positive or 0.007% with 24 deaths over the same period. UP was the first state in India to introduce large scale prophylactic and therapeutic use of Ivermectin despite having only a low vaccination rate of 5.8% fully vaccinated compared to Malaysia that has 93.8% fully vaccinated. Uttar Pradesh’s accomplishment in stopping the spread of Covid-19 with Ivermectin puts paid the raging controversy over the drug.

Apart from aggressive contact tracing and surveillance, the UP state government distributed medical home kits with each kit comprising multivitamins, zinc tablets, paracetamol, a thermometer, a pulse oximeter, doxycycline and Ivermectin. Phone calls were made twice daily to affected households to ask for their temperature and oxygen saturation readings as well as reminders to take the doxycycline and Ivermectin.

Conveniently this feat by the UP government and the astounding results was not reported by the global media houses (not in Malaysia too). WHO lauded UP’s success story but did not mention what was in the medical home kits which cost USD 2.65 per kit. Without doubt there are valuable lessons that the world and Malaysia can learn from UP’s experience in tackling the Covid-19 epidemic.

Incidentally on 8 October, Reuters quoting a source with the Drug Controller General of India reported that Merck’s experimental antiviral Molnupiravir has not shown ‘significant efficacy against moderate Covid and the effective efficacy is towards wild cases’ according to the source. This will put a dampener on the media hype around the novel drug were it found to be true.

Tess Lawrie in the UK, (whose peer-reviewed meta-analysis of Ivermectin use for Covid-19 scored eight place out of some 18 million publications – one of the most cited of medical references of all time), in her written evidence to MPs, the UK Cabinet and the WHO states: ‘The evidence, in support of using Ivermectin for Covid-19 treatment is far stronger than the evidence on any other medicine given EUA to treat Covid-19. In addition, Ivermectin can be used in asymptomatic, mild, moderate and severe Covid-19 infection – no other treatment has been shown to do this. In addition, Ivermectin is very safe – currently used by millions of people the world over for Covid-19 and other infections’.

Instead of another EUA drug, without a proven long-term safety record like the mRNA vaccines, MOH could have added Ivermectin to its arsenal of Covid-19 treatment protocols, which would have given ‘doctors another option where they can choose to use it on those who have been vaccinated or otherwise and those with certain medical conditions or are suffering from severe symptoms’ to quote the Health Minister.

Vaccines alone not the solution

Malaysia has the dubious distinction of having the highest rate of Covid-19 cases in Asia at 2,481,267 infections (Nov 4). The total deaths numbered 29,091. This was despite the breakneck speed of the vaccination programme that exceeded the peak rate of other countries including the US and the UK. On a per capita basis the country continues to record high Covid-19 infections and fatalities daily. Clearly vaccines alone are not the solution to deal with the disease.

The MOH should have allowed early treatment protocols with Ivermectin since it is safer, more effective and cheaper than vaccines or novel drugs. Instead MOH has completely ignored and avoided discussion about the issue and refused all reasonable attempts to discuss what the science actually shows. We need to seriously rethink our public health policies instead of slavishly complying with WHO’s directives. Too many lives have been lost, too much time has been wasted and too much money has been frittered away.

If the MOH had repurposed and rolled out Ivermectin instead, its 12 mg Ivermectin pill which it currently prescribes for scabies should cost around USD0.029 or RM0.12 per tablet (using WHO’s cost of Ivermectin for scabies which is USD2.90 for 100 12 mg tablets at 2018 price). Ivermectin is given for Covid-19 treatment for five days (one 12 mg tablet a day). Thus for the equivalent 150,000 courses of Molnupiravir procured, Malaysian tax payers will only need to pay some RM21,750 for ivermectin instead.

Press Statement, 5 November 2021