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Gleevec contract in Australia

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Hey folks,

I am posting an article here that some might find political because it deals

with government rationalization of dealing with drug importation's.

However, it is not my intent to cause any upset over this article. The

article states that patients in Australia must sign a contract with the

Government to go " off " Gleevec when the Government says so. Can our friends

from Australia on this list shed some light on this matter. Is there a

contract? What does it say? Can you tell us the criteria for which the

Government would like you to stop taking the drug?

I really would like some input on this.

Happy reading,

Cheryl

The 'European disease'

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By Goldberg

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Someone once asked Nobel laureate physicist Riccardo Giacconi, who conceived

the Hubble telescope, why so many great European scientists moved to

America. " A scientist is like a painter, " Mr. Giacconi said. " Michelangelo

became a great artist, because he had been given a wall to paint. My wall

was given to me by the United States. "

Today, we stand at the dawn of an age of personalized medicine, when

screening for genetic variations will allow us to provide the right drug, to

the right person, at the right time, for the right outcome, as a matter of

course. Yet even as we are on the verge of this triumph, what Mr. Giacconi

called our great wall of innovation is being painstakingly disassembled,

brick by brick, and shipped to Asia and India, where policy-makers are more

appreciative of the alchemy of entrepreneurship that sustains scientific

progress.

Last week, Congress held hearings on the Pharmaceutical Market Access and

Drug Safety Act of 2005. This bill forces companies to sell, make and import

their products from Canada and elsewhere, where government sets prices and

access to medicines. (Incredibly, it would also let versions of drugs that

haven't gone through the Food and Drug Administration testing process into

the United States. But that's for another article.)

Forcing companies to basically ship their medicines overseas so they can

be discounted and re-sold into America would destroy the global market for

new medicines, as it has already done in Europe. Thanks to Europe's version

of drug importation, it's biotech companies have no cash, their drug

companies launch fewer new products than 10 years ago compared to America

and biomedical research dollars have flowed to the United States.

Now, some of the European companies that moved here to escape price

controls are already preparing to move again, to Asia, if Congress passes

the act.

Five years ago, for instance, Sir McKillop moved research

operations of his pharmaceutical firm, Astra Zeneca, to America to escape

the European regime of price controls and rationing. Recently his company

developed two cancer drugs at considerable cost and risk. On April 15,

however, Sir Tom announced that, with passage of the Pharmaceutical Market

Access Act, he would likely relocate Astra Zeneca to China or India.

" There is real danger for the United States to catch the European

disease, " Sir Tom told the Telegraph of London. " Europe lost its prominent

position in pharmaceutical research because of policies that favored

parallel trading of drugs between states. "

Parallel trading is the sleazy international underbelly of national

price controls. Middlemen buy drugs in countries with the lowest

government-set prices, like Spain, and resell them in countries with higher

reimbursement rates, such as Germany. The parallel importers who bought

these same medicines from across the European Union made profits of $800

million at the expense of pharmaceutical firms. When these middlemen are

allowed to make profits that the drug companies aren't, the frustration of

the drug companies becomes easy to understand.

Importation is only part of the problem. People wonder why companies

don't charge Canada and Europe more. Even when faced with data that

different drugs provide important benefits to specific groups of patients,

governments in Europe or Canada or Australia use rationing and the threat of

not paying for the drug altogether to keep prices low. In Australia, one of

the countries that Congress wants to import from, patients taking Gleevec

have to sign a contract promising they will go off the drug when the

government wants them to. In England and Canada, some drugs that are

standard therapy for treating Alzheimer's or lung cancer here are

unavailable even after years of delay and price controls.

The coalition that has rallied around price controls likes to say, " A

drug that is unaffordable is neither safe nor effective. " But as the

" European disease " has shown, price controls will not merely make medicines

more " affordable. " They will make them unavailable and undiscoverable.

Meanwhile, India and China are eager for Congress to impose price

controls on our biotech and drug firms. They see them as a competitive

advantage. India has 80 firms engaged in modern biotechnology, including

protein engineering, molecular design and monoclonal antibodies. Investment

in drug research has increased by 400 percent over the past five years

because the Indian government has been strengthening patent protection,

lifting price controls and allowing nascent drug companies to keep their

profits without capital-gains taxes. Drug and biotech executives are hailed

as heroes, not public enemies. India, along with Singapore, Korea and China,

are giving this generation of " molecular angos, " as we might call

them, the wall that our own politicians are destroying.

" If you look at the history of industry, where it is not welcome and

does not have a receptive market, there will be a loss of competitiveness, "

Sir Tom said. He was talking about Europe. But he might as well have been

talking - from New Delhi headquarters about the American Disease, five years

from now, after Congress imposes forced importation and price controls.

Goldberg is director of the Manhattan Institute's Center for

Medical Progress.

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