The millions invested by Malta in stockpiling antiviral drugs Tamiflu and Relenza to tame influenza outbreaks is money “down the drain”, according to the most comprehensive review of the two drugs.
The study, conducted by the influential Cochrane Collaboration and published in the British Medical Journal, found that the drugs are no more effective than paracetamol in relieving flu symptoms.
Companies behind the drugs held back information that would have shown the drugs were ineffective, the researchers say.
The news is being labelled as ‘one of the biggest scandals of the century’ as governments spent billions on the drugs during the avian flu and swine flu scares.
Malta has a stockpile of Tamiflu tablets that cost €672,000 and has spent millions of euros on the drugs over five years although government figures are conflicting.
The Health Ministry said it spent over €2.3 million on the antiviral drugs between 2005 and 2010. Yet the figure is actually half the amount the previous administration had said was spent on Tamiflu in one year.
Former Health Minister Louis Deguara had told Parliament in October 2005 that the country had ordered enough Tamiflu to cover 25 per cent of the population requiring an allocation of Lm2 million (€4.7 million) to prepare the country against the avian influenza pandemic.
In addition to government expenditure, private orders of Tamiflu from pharmacies was estimated at around Lm600,000 (€1.4 million), bringing the total estimated expenditure on Tamiflu in 2005 to €6.1 million.
Then in 2009, when fear of swine flu went viral, government announced an investment of €3.5 million to prepare the country. This investment included 10,000 courses of Relenza. At the time, it was estimated that the existing stock of Tamiflu was enough to cover 28 per cent of the population.
In July of the same year, the Parliamentary Secretary for the Elderly and Community Care, Mario Galea, announced that government supplies would be increased as two 26-year old male rugby players were confirmed as Malta’s first swine flu victims.
Throughout these years, when fears of flu pandemics were at their peak, Tamiflu and Relenza received widespread media coverage as the medicines that had the best effect on the virus. Tamiflu sales hit US$3.6 billion (€2.6 billion) in 2009 alone.
The government is following the advice of international expert bodies
International expert bodies like WHO (World Health Organisation), CDC (Centre for Disease Control) and ECDC (European Centre for Disease Prevention and Control) all recommend that every country has a stockpile available, the Health Ministry said.
Yet, the authors of the study found that regulatory agencies relied on summaries of studies. After a four-year effort to obtain the data, scientists found details buried in the 175,000 pages of clinical trials by the drug companies that show that the antiviral drugs are only effective in reducing the duration of flu symptoms by about half a day.
Researchers say there is no strong evidence to support the stockpiling of the drugs. Tamiflu does not reduce hospitalisations, stop the spread of the flu or minimise complications like pneumonia.
The study reveals a failure in the approval process of the drugs and points to a weak regulatory system where clinical trials are done by the manufacturer.
Roche Holding manufacturers of Tamiflu, and Glaxosmith-kline is the company behind Relenza. Both companies stood by their studies.
The European Parliament earlier this month passed a law requiring drug companies to publish all clinical trials for drugs, but it only applies to drugs approved since last January.
The Health Ministry said it “will be looking into the new information” but said government is following the advice of international expert bodies.