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New company hopes to offer drugs trial to 100,000 New Zealanders

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Tue, 17 Jun 2008 12:00a.m.

New Zealanders may soon gain access to cutting edge medicines free of charge, as long as they do not mind acting as the proverbial guinea pig.

Dr Shaun Holt has launched science management organisation (SMO) Clinicanz in an effort to attract a slice of the multi-billion dollar pharmaceutical trials industry.

Globally pharmaceutical clinical trials are a $100 billion-plus industry, of which New Zealand's share is $20 million.

Dr Holt believes this is a "crazy" situation for an English-speaking country that has a medical profession with access to state-of-the-art patient databases and an educated yet "under-treated" population.

Talk of drug trials often conjures images of medical disasters, such as New Zealander David Oakley who gained fame as the "Elephant Man" due to the violent reaction he had during a drug trial he was part of in Britain.

But the trials Clinicanz hopes to attract will not be for drugs at the beginning of their development tests, where participants are paid to test the safety of drugs.

Rather they will be what are known as phase three and four trials, involving drugs which have already passed safety testing. It will also include drugs widely available overseas but are awaiting registration in New Zealand.

Patients stand to benefit from free access to the latest medicines, free doctors' visits and even free transport to their appointments.

"The risks are absolutely minimal at this stage of drug trials. They've been well researched, probably for around 10 years already," Dr Holt told NZPA.

"But with any medication, whether it is in a trial or not, there is always a slight risk and patients are fully informed of what those are."

Doctors gain access to a new and often lucrative source of income as well as the chance to up-skill themselves and their staff through being involved in the latest research.

Dr Holt planned to recruit about 40 doctors in Auckland, Wellington, Tauranga and Rotorua, which he said would provide access to around 100,000 patients.

"That will give us the critical mass to attract companies. They're not going to come here to put five or 10 patients on a trial, but with those numbers we will be able to put 300-500 on a trial and suddenly New Zealand is a very attractive place.

"And patients enjoy trials, they enjoy contributing to medical research and they feel very looked after."

Clinicanz will be open to any drugs which would be administered by a GP - covering most ailments outside of cancer.

Researched Medicines Industry Association (RMI) chief executive Ken Shirley said New Zealand enjoyed a vibrant clinical trials industry as recently as a decade ago.

"We had a $100 million investment in pharmaceutical (research and development) mostly in clinical trials. Today that's less than $20 million so we're a fifth of what we were 10 years ago, and still shrinking."

Last month the Australian Government established a Pharmaceuticals Industry Strategy Group, aimed at increasing investment in research and development and manufacturing in Australia.

Mr Shirley applauded the action and lamented that the industry in New Zealand had been heading in the opposite direction.

"A narrow, short sighted emphasis on cost containment in pharmaceutical investments has turned New Zealand into an unwelcoming, state-controlled market."

He said the lack of research happening in New Zealand made the country less attractive to many medical professionals.

"When you are looking at things like clinical trials you're looking out for the benefits, the multiplier effects of retaining the clinicians and the scientists and the researchers.

"It enhances the GPs' business, it enhances their professional interest. It means some New Zealand patients will have access to cutting edge, innovative medicines that otherwise they wouldn't have access to. Huge benefits. And most economies recognise this, this is what Australia has just done."

Rotorua GP Dr Mike Williams was one of the first to sign on with Clinicanz and agreed that practices which offered staff the chance to be involved in research would be seen as more desirable by medical professionals.

"From a GP's point of view it's using some of your skills in a slightly different way. It's something that's new and a bit more exciting that sparks your brain cells a little bit."

If Clinicanz succeeded in attracting clinical trials Dr Holt did not expect the extra business for GPs and laboratories would mean delays for patients.

"We're totally under-used in New Zealand and we should be doing a heck of a lot more."

Dr Williams was less convinced there would be no strain, but said it was something the industry needed.

"It's a lot more work, but nobody will mind working hard when we're getting paid to do it.

"I think if you want general practice to be sustainable for the long-term future then GPs have to look at other sources of income."

While most big pharmaceutical companies were based in Europe and America, Dr Holt said they had no qualms about conducting trials around the globe.

While India, Eastern Europe and South America were growing in popularity as trials hosts, he believed New Zealand could be a more attractive option.

"We're English-speaking, we've got a good sized population, GPs have very good electronic databases of their patients.

"We have, in some ways it's a shame to say, an under-treated population in things like asthma and emphysema and diabetes."

Another advantage New Zealand had was its position in the southern hemisphere, which enabled companies to test medications for seasonal ailments such as allergies, asthma and flu all year round.

Historically, Dr Holt said, GPs had struggled to get involved in trials.

"They know there are pharmaceutical trials, they just don't know how to get into it - who to approach, how to get trained, how to do ethics, budgets etc.

"So this is what the SMO does, we do all that for them. Then I'll be bidding in the international marketplace for international studies to come to New Zealand."

The industry is governed by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and a Ministry of Health Ethics Committee.

Mr Shirley said those bodies offered strong protection against unsafe drugs reaching the public.

Paul Flanagan, Northern Region ethics committee chairman and head of the national chairperson's group, offered insight on how the system worked.

Committees are made up from health professionals as well as people with consumer, legal and ethics backgrounds. The chair of each committee is always chosen from the non-health professional group.

"Generally, committees will ask themselves when they approve a study, whether they would be willing participants themselves in the research," Mr Flanagan said.

"If not, is there sufficient information made known (to the committee) and in the process of informing potential participants of the potential risks so that the public have information from which to choose to enter or decline participation?"

In addition each study must prove scientific validity, minimisation of harm, respect for persons and so on.

The committee also considered the level of compensation which would be made available to anyone who suffered as a result of a trial.

While they acted as the industry watchmen, Mr Flanagan said all committee members saw the value in research, "where the aim is to benefit the health and wellbeing of the public".

Dr Holt said the first big push to attract drug companies was due in October, when he headed to major medical conferences in Las Vegas and Berlin .

NZPA

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