Since the mid-1990s there has been a decline in the number of new drugs registered by the U.S Food and Drug Administration (FDA). 

This is despite the industry more than tripling its expenditure from US$15.2 billion in 1995 to US$51.1 billion in 2013.

Fighting and curing neurological diseases such as dementia, Parkinson’s disease, and schizophrenia has been a priority for pharmaceutical developers for decades, but to date there has been limited success.

According to Victoria University Professor Bart Ellenbroek, this trend is unlikely to improve unless there is a major shift within the industry.

The lack of research funding from pharmas is serious considering the high ratio of brain disorders happening around the world, he adds.

Ellenbroek, who specialises in neuroscience and behavioural pharmacology, says this is a serious problem, considering one in three people in the Western world suffer from a brain disorder at one stage during their lifetime.

Prof Ellenbroek, Victoria University

92 out of 100 fail

In the ontological field there is a less than 10% success rate in drug development, he says.

“If you start off with 100 drugs in phase one, only eight of those 100 will ultimately be registered for brain disorders – so 92 fail.

“It’s incredible.”

With the cost of developing one drug sitting at around US$1.5 billion, the loss incurred through unsuccessful trials is too much.

Because of this, big pharmaceutical players, such as GlaxoSmithKline, have withdrawn from research into brain disorders.

Ellenbroek says the underdevelopment of neurological drugs is a big cost on society and will continue to increase.

Each year €800 billion is spent on coping with brain disorders in Europe, he says.

“That is more than lung disorders, diabetes, heart disorders and cancer combined.

“[They] are about 75% of what brain disorders cost.”

This shift, he says, would have to involve a lot more investment in basic research on the brain, allowing for more accurate predictions on the success of different drugs.

A big proportion of the costs associated with brain disorders are indirect ones, such as early retirement or a loss of productivity.

So, he says, on the one hand there is a rising cost of brain disorders, and on the hand there is a lack of pharmaceutical investment in curing them.

“At some point in time that is going to be an enormous problem.

“As society is getting older and older, there is more dementia and there is more Parkinson’s disease.

“As that gets worse and worse, ultimately it’s society that’s going to pay the bill.”

Can New Zealand fill in the gap?

Although the majority of big pharmaceutical companies are in the United States and Europe, Ellenbroek says the climate for doing research in New Zealand, especially on brain disorders, is very good and needs to be further utilised.

Capitalising on current research and investing in more fundamental research into the brain is imperative, he says.

Investment on fundamental research would attract people in the industry from overseas and create a more attractive research climate in New Zealand.

Ellenbroek says this would ultimately help establish better models and more accurate predictive validity when developing drugs.

In turn this would make pharmaceutical companies would be more inclined to continue drug development.

Figuring out why drugs fail

The commercial viability for the unmatched market remains strong – especially in the hunt for a blockbuster drug – and with a higher chance of financial return, there will be a greater amount of productivity.

“The way we make it attractive for [drug companies] is we figure out why these drugs fail – and these drugs mainly fail in these phase two and three trials because they don’t do what we predicted that they would do.”

“If we can improve the chances that we have from about 8% as we now have to about 15% then a lot of companies will come back.”

To achieve this the government needs to play a greater role, he says.

“You can either wait until everything gets of control and then say, ‘Oh boy we have a lot more problems than we originally thought we’d have’ or you can invest now and hopefully reduce the burden in years to come.”

Pharmaceutical companies have been aware of the problem for a number of years, but he says the general public and governments do not fully understand the consequences of ignoring the issue.

He says the ultimate goal is to bring pharmaceutical companies back to developing drugs, especially ontological drugs, which society desperately needs.

Michael J Fox of Back to the Future fame talks about his Parkinson’s disease cause

Ellenbroek held an inaugural lecture at Victoria University this week (Sep 23, 2014) called “Crisis? What Crisis?” focussing on this issue.