Biotech; Mad Or Bad?

By Glenn Dyer | More Articles by Glenn Dyer

Perhaps the first time the world realised that the stuff of science fiction had a human dimension with genuine possibilities was in January 1998 when a Chicago physicist, Dr Richard Seed announced that he would clone a human being.

Media furore followed with calls for government regulators to deal with this emergent possibility of a new ‘being'.

Seed never followed through with his intentions, after first claiming he would clone himself, and then changed his mind to cloning his wife Gloria.

This event gave the governments the task to deal with the emergence of cloning, gene modifications, and regulating the business behind these prodigious claims.

And just as controversial as the claims themselves, is the business behind it.

After all, we are dealing with people's lives.

Biotechnology, as defined by The United Nations Convention on Biological Diversity, is: any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use."

It is a tough business.

To follow through the prodigious claims, or even those mildly off-putting, awaits a Byzantine regulation nightmare. Even to create a new vaccine against influenza – the costs, the initiatives and the resources required are mind-boggling.

And why would any investor put their hard-earned money into aspirations that usually takes at least eight years to eventuate – and hope that in the meantime it doesn't get swallowed up in the black hole of unsuccessful drug trials!

But the bottom line is the benefit to human kind.

As Michael Moore, chairman and chief scientist of Greenspirit Strategies, an environmental consulting agency states: "The programs of genetic research and development now underway in labs and field stations around the world are entirely about benefiting society and the environment."

Take, for example, the case of the Golden Rice in China. Hundreds of millions of people in Asia and Africa suffer from Vitamin A deficiency which causes blindness.

Scientists have found that infusing rice with a gene that makes daffodils yellow, beta-carotene, and a precursor to Vitamin A could insure that 100 grams of Golden Rice could provide 50 per cent of the daily need.

Yet, Greenpeace activists are strongly against this – they have threatened to rip the GM rice out of the fields if scientists dare plant it.

Greenpeace activists are not the only hurdle to be fought in this industry.

Its relatively young age (approx 4 decades) is a factor as well as the perceived ‘unnaturalness' of the work done.

Firstly, the regulation can be restricting, and in Australia's case, it certainly is. In simple terms, any new drug has to undergo clinical trials, which are only a small part of the research that goes into developing a new treatment.

Potential drugs, for example, first have to be discovered, purified, characterized, and tested in labs (in cell and animal studies) before ever reaching clinical trials.

This is where Australia hits a wall. Our regulatory facilities only allow testing to be done up to this level, i.e. animal testing.

Once it passes this, it is then off to the actual ‘clinical trial' which consists of different so-called phases, and as no such facilities exist in Australia, then it is off to one of the big nationals to complete the process – and in turn pocket a large portion of any proceeds.

The nation's tradition of discovery was highlighted again in 2006 with the world's first cervical cancer vaccine, developed by 2006 Australian of the Year, Professor Ian Frazer.

It has now been government subsidised and is free for women ages 12-26 and it has also been approved in more than 60 countries.

Doctor Ian Frazer started researching the link between human papilloma viruses and cancer, and ways to reduce the incidence of cancers associated with these viruses more than 20 years ago. Almost 100 per cent of cervical cancer is caused by infection with the sexually transmitted human papilloma virus (HPV).

Consequently, Dr Frazer and his late research partner Dr Jian Zhou developed Gardasil at the University of Queensland, in collaboration with Australian pharma giant, CSL Ltd and US-based Merck & Co., Inc.

According to the World Health Organisation, cervical cancer kills about 250,000 women annually all around the world. The vaccine passed the regulatory authorities, Drug Administration (FDA) and Australia's Therapeutic Goods Administration (TGA).

That is definitely a show-stopper, enough to catapult Australia onto the international market.

The only injustice here is that most of the hard and well-earned money from these ventures end up in the accounts of huge international pharma companies. Dr Ian Frazer points this out in a recent TV interview:

"There's a gap in our industry here at the moment and it's quite a big one, and that is that we can't actually make the products here for testing clinically.

"We don't have the facilities that we need to get that done". So now instead of pocketing 30% of the billion-dollars-a-year sales we receive just a small return for intellectual property.

"We have all the talent here and we have the small biotech companies here. It may not be that we end up with one Merck or Roche in Australia but if we're producing the products through to the stage where they're of great value to American Roche, we'll get a lot more back into the country as a return for that".

On the international circuit, Australia is not faring badly, considering the performance of the biotech firms on the stock market.

According to Professor Michael Vitale from Australian Graduate School of Management who says that investors in the IPO of biotech companies

About Glenn Dyer

Glenn Dyer has been a finance journalist and TV producer for more than 40 years. He has worked at Maxwell Newton Publications, Queensland Newspapers, AAP, The Australian Financial Review, The Nine Network and Crikey.

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