Major changes to the way clinical trials are conducted may be imperative to avoid unacceptable delays in getting new cancer treatments on to the market. Moreover, European countries will need to switch more of their gross domestic product towards healthcare and be prepared to spend more on pharmaceuticals if people are to benefit fully from new designer preventives, diagnostics and treatments.
These decisions will have to be faced in the very near future due to the quantum leap in biological technology, according to Dr Edison Liu, Director of the Division of Clinical Sciences at the National Cancer Institute in the USA.
He told a news briefing today (Thursday 28 September) at the European Breast Cancer Conference in Brussels that expression profiling using DNA microarrays was just one example in his own field of the new technology that was moving cancer research forward at an unprecedented pace and had, potentially, an enormous impact for future prevention, diagnosis, prognosis and treatment.
" It's one of the hottest things in cancer research - the biological equivalent of a spy satellite that allows you first to see a continent, then home in on one country, one city, one street and then a house in that street. The only difference is that the continent in this case is the cell and we can home in on groups of genes, single genes, even tiny tags of proteins and see how they 'live' together, how they interact and what role they may be playing in a disease.
'What is equally important is that we can do it fast. This technology permits us to interrogate thousands to tens of thousands of genes simultaneously so that we can get a comprehensive view of gene expression."
Expression profiling using microarrays in breast cancer has already allowed Dr Liu and his research team to, for example:
* define the control mechanisms of the breast cancer gene BRCA1 and another gene called myc which is mutated in many breast cancers
* define the DNA repair genes involved in normal breast development - vital knowledge contributing to understanding the causes of breast cancer
Dr Liu said expression profiling opened up a new spectrum of research because, for the first time, it provided a biological multi-dimensional picture that allows scientists to trace the intricate genetic pathway from the normal cell to the cancerous cell as well as providing a better view of how drugs work.
Molecular biology and technology are bringing to the scientific community entirely new concepts in drug design. When coupled with the efficiency of high-throughput processes, the results are stunning.
"The difficulty we will face is how to test all these new compounds. Clinical trials can take a long time and it may be five to 15 years before a drug is accepted on to the market. That's OK if you only have a few compounds. But what if you have 100 or 500 potentially effective new drugs? It's a daunting problem of testing.
"We need to look at study design, regulations and protocols and ask ourselves what endpoints we will accept. Do we need to show survival advantage? Do we need complete response? What about partial response? What about molecular endpoints? What about controlling cancer rather than curing? Of course we want to cure cancer, but if we can't, then stopping the cancer from progressing is an honourable stalemate."
Dr Liu said he sees many of the challenges to be social and political. He also thinks the new therapeutics should be affordable. However, there needs to be a shift in economic emphasis.
He said countries used to spend most of their resources and energy on food production. Then the industrial revolution shifted agrarian economies to economies based on manufacturing. More recently, there has been a shift to service and IT industries and countries always adapted.
"Maybe the next phase is to shift toward pharmaceuticals to help us live longer, stronger, smarter lives. The debate should be less on drug costs and more on our national priorities.
There is every reason why we should rethink our priorities and spend more of our GDP on health and pharmaceutics," he said.
Note: after 30 September Mary and Kay are available at 32-2-775 0203