Authorise emergency 'off label' drug approval for Covid-19

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Instead of waiting for a new vaccine for Covid-19, what if we already had old drugs to improve survival of this killer disease?

My name is Jane McLelland, I am an international bestselling author, a survivor of stage 4 cancer and a former Chartered Physiotherapist. In 2003 I was given weeks to live when cancer returned as myelodysplasia, a blood cancer that was the result of large doses of chemotherapy and radiotherapy I had received years earlier. In desperation I hunted through endless research in medical journals and on Pubmed, discovering a cocktail of old drugs that saved me from certain death and put me in full remission. Some of the old forgotten drugs I discovered not only treat cancer but could reduce the severity and infection rates of Covid-19. Research into these drugs already show promise in the lab. As they have a long history of safety data and doctors can easily decide who could safely take them, why are we waiting to add them?

Like in cancer, there is an expectation that there will be a magic bullet, in this case a vaccine. However, as in cancer, the disease mutates and by the time it a vaccine is available it may not be effective.  There seem to be two variants of Covid-19 already.

One of the key drugs in my armamentarium was dipyridamole. Originally used as a metabolic drug to help prevent strokes before statins became widespread, it also had strong antiviral effects, so much so, that in the late 80’s it was used alongside AZT to treat HIV but then newer antiviral drug cocktails emerged. Dipyridamole became forgotten but it is once again being tested alongside the current cocktail of HIV drugs to improve outcomes in these patients.  

Dipyridamole has other effects besides being a cardiovascular and antiviral drug. I discovered reports of its powerful anticancer activity from an article in the Lancet that dated back to the mid 80's (Lancet: Mar 1985 EL Rhodes: Dipyridamole for the treatment of Melanoma). Seriously ill patients with stage 4 melanoma had no progression of their disease whilst on this drug. I explain why this is the case in my book, in brief- it is a growth inhibitor  (MMP-9 inhibitor), a cholesterol modifying drug (SREBP-2 inhibitor) and nucleoside transport inhibitor (it stops nucleosides such as adenosine entering cancer cells to make new DNA).  

I have long been aware of dipyridamole's potent antiviral effects and recent research from Dr Xi Liu, Wuhan Hospital University Feb 29th clearly shows potential against the Covid-19 virus. As well as being an antiviral, its has beneficial effects on the accompanying hypercoagulability that is a complication in severe cases of acute respiratory distress (ARDS). It also boosts the infection-killing white cells and it has known anti inflammatory effects.

Dr Liu at the Wuhan University Hospital writes:

'The human coronavirus HCoV-19 infection can cause acute respiratory distress syndrome (ARDS), hypercoagulability, hypertension, extrapulmonary multiorgan dysfunction. Effective antiviral and anti-coagulation agents with safe clinical profiles are urgently needed to improve the overall prognosis. We screened an FDA approved drug library and found that an anticoagulant agent dipyridamole (DIP) suppressed HCoV-19 replication at an EC50 of 100 nM in vitro. It also elicited potent type I interferon responses and ameliorated lung pathology in a viral pneumonia model. In analysis of twelve HCoV-19 infected patients with prophylactic anti-coagulation therapy, we found that DIP supplementation was associated with significantly increased platelet and lymphocyte counts and decreased D-dimer levels in comparison to control patients. Two weeks after initiation of DIP treatment, 3 of the 6 severe cases and all 4 of the mild cases were discharged from the hospital. One critically ill patient with extremely high levels of D-dimer and lymphopenia at the time of receiving DIP passed away. All other patients were in clinical remission. In summary, HCoV-19 infected patients could potentially benefit from DIP adjunctive therapy by reducing viral replication, suppressing hypercoagulability and enhancing immune recovery. Larger scale clinical trials of DIP are needed to validate these therapeutic effects.'

Dipyridamole is off patent and cheap and is available TODAY. It could be trialled IMMEDIATELY as part of a cocktail to treat Covid 19, reducing the time patients spend in intense care units. With all the focus on the disease affecting the lungs, you would expect people with respiratory diseases to be top of the list for severe complications. In fact it is those with cardiovascular disease, diabetes and hypertension that are most at risk. These are all metabolic diseases. This is critically important information that is being overlooked. Blood becomes thicker, oxygenation levels reduce, heart failure and sepsis are common sequelae in these severe cases. All of these problems are not being given the attention they deserve. Doctors mistakenly believe dipyridamole, which is called an 'anti-platelet drug', reduces platelets, but as is shown above and in the medical literature, this is not the case. Dipyridamole stops platelets sticking together and as mentioned above ‘significantly increased platelets and lymphocytes’. Not only will improved blood flow help oxygenation and reduce sepsis, dipyridamole will reduce the viral load and may improve the white cell count which is critical to our ability to fight the disease. 

Another drug that needs emergency 'off label' approval is chloroquine and its safer sister hydroxychloroquine. Both have shown potential to prevent, treat and reduce Covid-19 infection. This is an old drug that is used normally used to treat malaria, lupus and rheumatoid arthritis. The government seems to know of the potential of chloroquine, but I have spoken to many doctors who are still unaware of its potential against this virus. By approving it for emergency off label use, it can be prescribed by doctors to treat those most at risk. Both these drugs are off patent, cheap and with quick legislative approval, could be produced by every pharmaceutical company in the country.

Chloroquine works by modulating the immune response and altering a process called endocytosis. This is a ruffling of the cell membrane to ingest particles and nutrients from its surrounding environment. This is how Covid-19 enters a cell (after attaching to the ACE2 receptor) in a process that is similar to how some cancer cells grab extracellular nutrients to feed itself.  Blocking this process helps both 'starve' cancer and blocks the entry of Covid-19.

All the data suggests an exponential rise in infection rates over the next few weeks which will overwhelm our NHS. People are expected to die in their thousands. Doctors will have to make decisions about who to save and who they allow to die. They should not be  be put in this position. The health secretary has asked for urgent manufacture of extra ventilators. I demand the government also recognises the urgent need for these life-saving cheap drugs and Matt Hancock instructs our pharmaceutical industry to go into emergency production. 

NHS doctors are afraid to implement new strategies until there are phase 3 clinical trials to show a drug’s efficacy. This process can take many years. We simply don’t have time for that. Doctors on the front line need to realise they already have several tools in the cupboard to lessen the death rates that they simply haven't looked into before. We also need to welcome data coming from China and act on lessons they have learnt. Sadly I fear this opportunity to save many lives will pass us by in much the same way old off patent drugs are ignored in cancer. Randomised clinical trials are rarely done on cheap drugs with no future profitability for the pharmaceutical industry. We do not need to wait for large quantities of remdesivir,and other expensive antivirals, we can actively treat patients with more than just ventilators and palliative measures. 

This is an urgent plea to the Health Secretary, the Chief Medical Officer, the MHRA and NICE to approve dipyridamole, chloroquine and hydroxychloroquine for emergency 'off label' use for Covid-19, restricting use for severely ill patients in the first instance unless drug stocks are available to protect doctors and nurses on the front line. I also urge 'real world trials' to be undertaken immediately on the patients who need these drugs the most.