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Model for Drug Development

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Many reports are coming out about how much (surprise) the pharmaceutical

industry has lied about drug development costs while raping the crap out

of us all and destroying our healthcare system for increasing

profits.

Here is a model that further underscores the need to bring new models to

the approach of drug development. This is also true for many infectious

diseases, largely ignored. But it can also include cheaper and more

effective, less toxic medications for Hepatitis C and HIV.

It's time to end the industry's hostage hold on our lives to their lies

and genocidal profiteering. Of course, this must be coupled with, in the

US, the development of a single payer healthcare system along with price

controls. Spending 16% or more of GDP on healthcare but getting outcomes

no better than the Czech Republic--along with 47 million of us

uninsured--is an utterly broken system that is only deteriorating more

rapidly. How bad does it have to get?

M.

***

http://www.guardian.co.uk/medicine/story/0,,1981199,00.html

Scientists find way to slash cost of

drugsIndian-backed approach could aid

poor nations and cut NHS bills

Boseley, health editor

Tuesday January 2, 2007

The Guardian

Two UK-based academics have devised a way to invent

new medicines and get them to market at a fraction of the cost charged by

big drug companies, enabling millions in poor countries to be cured of

infectious diseases and potentially slashing the NHS drugs bill.

Sunil Shaunak, professor of infectious diseases at Imperial College,

based at Hammersmith hospital, calls their revolutionary new model

" ethical pharmaceuticals " .

Improvements they devise to the molecular structure of an existing,

expensive drug turn it technically into a new medicine which is no longer

under a 20-year patent to a multinational drug company and can be made

and sold cheaply.

The process has the potential to undermine

the monopoly of the big drug companies and bring cheaper drugs not only

to poor countries but back to the UK.

Professor Shaunak and his colleague from the London School of Pharmacy,

Steve Brocchini, have linked up with an Indian biotech company which will

manufacture the first drug - for hepatitis C - if clinical trials in

India, sponsored by the Indian government, are successful. Hepatitis C

affects 170 million people worldwide and at least 200,000 in the

UK.

Multinational drug companies put the cost of the research and

development of a new drug at $800m (£408m). Professors Shaunak and

Brocchini say the cost of theirs will be only a few million

pounds.

Imperial College will hold the patent on the hepatitis C drug to

prevent anybody attempting to block its development. The college employs

top patent lawyers who also work for some of the big pharmaceutical

companies.

Once the drugs have passed through clinical trials and have been licensed

in India, the same data could be used to obtain a European licence so

that they could be sold to the NHS as well.

Professor Shaunak says it is time that the monopoly on drug invention and

production by multinational corporations - which charge high prices

because they need to make big profits for their shareholders - was

broken.

" The pharmaceutical industry has convinced us that we have to spend

billions of pounds to invent each drug, " he said. " We have

spent a few millions. Yes, it will be a threat to the monopoly that there

is.

" I'm not only an inventor of medicines - I'm an end user. We have

become so completely dependent on the big pharmaceutical industry to

provide all the medicines we use.

" Why should we be completely dependent on them when we do all the

creative stuff in the universities? Maybe the time has come to say why

can't somebody else do it? What we have been struck by is that once we

have started to do it, it is not so difficult. "

The team's work on the hepatitis C drug has impeccable establishment

credentials, supported by a grant from the Wellcome Trust and help and

advice from the Department for Trade and Industry and the Foreign and

Commonwealth Office.

But the professors' ethical pharmaceutical model is unlikely to find much

favour with the multinational pharmaceutical companies, which already

employ large teams of lawyers to defend the patents which they describe

as the lifeblood of the industry.

One industry insider envisaged legal challenges if the new drugs were not

genuinely innovative. It could become " a huge intellectual property

issue " , he said.

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