Covid-19: Is there a Priority Search for a Cheap Therapeutic?

My second question to the European Commission on Covid

To combat Covid-19, President Trump and other leaders have recommended use of anti-malaria drugs such as hydroxychloroquines, Azithromycin and Zinc sulphate. These are known and used for decades and are well tested products. The US Dept of Health (HSS) and is now recommending their use. Is the EU doing the same?

https://thehill.com/homenews/administration/490110-fda-issues-emergency-use-authorization-for-anti-malaria-drugs-amid

Commission Response

“We are aware that Chloroquine is traditionally used for malaria, rheumatoid arthritis and Lupus. We are also aware that chloroquine and hydroxychloroquine are used ‘off-label’. We also know that in the EU trials are underway regarding the use of chloroquine. The European Medicines Agency, EMA, state that the efficacy of chloroquine in relation to Covid-19 patients has not to date been proven. While the pandemic spreads with great speed, robust clinical trials should remain the gold standard here. They are most likely to generate conclusive evidence that is needed to enable rapid deployment and approval of potential treatments of the virus disease. Clinical trials are a national competence. However we continue to explore with the EMA .possible joint clinical trials at the EU level to scale up evidence of any promising therapeutics.”

Comment

‘Off-label‘ refers to drugs that have been produced and tested but doctors use them for different purposes than originally intended. Some were introduced long ago, like the use of malaria drugs against Covid-19, and are now very cheap. Doctors know how they should be used and what the side-effects are. American Medical Association vice president Roy Schwarz estimated that “off-label” uses of drugs account for up to 60 percent of all drugs prescribed.

So why aren’t anti-malaria drugs that have been used for decades and have proved to be effective in now thousands of cases being supplied to doctors for use to patients in dire need of relief from Coronavirus? One factor is the economics of drugs. Anti-malaria drugs cost cents rather than dollars or thousands of dollars. A second factor is that a vaccine has higher profits for the big Pharmaceutical firms. A vaccine is likely to take a year or two to develop with control tests.

The Chinese have done small-size control trials for anti-Covid-19 malaria drugs with very positive results and symptoms ‘significantly relieved.’

Why isn’t there more wide-spread use of these drugs especially for those in intensive care? Is the medical bureaucracy being too cautious when, for many patients, it is a matter of life and death? Over-regulation is a general problem of the American and European drug system. Is red tape strangling patients?

One commentator says:

Stanford University professor Dale Geringer observed, “In terms of lives, it’s quite possible that the FDA bureaucracy could be killing on the order of three to four times as many people as it saves.” One study estimated that 150,000 heart attack victims may have lost their lives as a result of the FDA’s delays in approving the emergency blood-clotting drug TPA. National Cancer Institute officials accused the FDA of being “mired in a 1960’s philosophy of drug development, viewing all new agents as…poisons.“

Follow-up question to the European Commission

On the use of anti-malaria drugs that some doctors have shown to be very effective for hundreds of patients with Covid-19, the EU says more robust control tests are needed. These tests are the competence of Member States. European control test may be initiated.

Which States are conducting trials?

When are results expected?

Have Europe-wide control trials been organised and what is the plan?

European Commission written response

I draw your attention to the fact that the European Medical Agency has issued a statement yesterday regarding chloroquine and hydroxochloroquine (link: https://www.ema.europa.eu/en/news/covid-19-chloroquine-hydroxychloroquine-only-be-used-clinical-trials-emergency-use-programmes). The Agency confirms that efficacy of these substances in treating corona is yet to be shown in studies.

We are aware that trials are ongoing at national level regarding the use of chloroquine in the context of the coronavirus, e.g. in Norway, Germany and France

When it comes to potential treatment for COVID-19, we need robust clinical trials to generate the conclusive evidence needed to enable rapid development and approval of potential treatments and to ensure safety and efficacy.

Clinical trials are a national competence. However, we continue to actively pursue with EMA possible joint clinical trials at EU level to scale up evidence on any promising therapeutics.