8 December 2011
Trial & Error?
Once again, the thorny issue of drug licensing has arisen. The two sides to the question have been drawn up in lines of battle for years.
“On your left – Mum denied new cancer cure drug”
“On your right – New drug causes serious side effects”
Plainly, there has to be a balance between pharmaceutical advances and adverse side effects.
At present, it is enormously expensive both in time and money to bring a new drug to the market place. Companies look at thousands of compounds for possible beneficial effects and test many on animals before even contemplating human treatment. If a drug passes all these tests, it then enters clinical trials which are divided into four “Phases”.
In Phase 1 trials, a drug is tested on healthy volunteers to check for serious side effects.
Phase 2 involves testing the drug on volunteers with the disease at which the drug is targeted.
Phase 3 is the one which causes the problems because it involves testing the drug on large numbers of patients.
If a drug passes all the phases it may then be given a licence and marketed by the company.
Phase 4 relies on those prescribing a drug to report back on any possible harmful effects of the drug.
Drugs drop out of the trials at all stages and the whole procedure takes up to and over ten years and costs several hundred million pounds.
David Cameron has announced plans to streamline this process by, for instance, allowing seriously ill patients to receive new drugs before they have received a product licence – a sort of Phase 3.5. By doing this, he hopes to attract back research to this country from whence it has fled due to red tape and potential scientists being denied entry to this country by the stricter immigration laws.
Commenting on the red tape covering trials in this country, this reporter says that many drugs are now trialled in India. Perhaps he forgot criticising that country a few weeks ago for being, shall we say, rather lax in its ethics about administering new drugs to paid volunteers.
Right or wrong?
Medical research is not in a good state. Researchers ask questions not necessarily because they are important but because someone is prepared to pay for the research. For example, you won’t find anyone willing to pay for research to find the ideal dose of aspirin to prevent further myocardial infarctions, yet that was not the case with simvastatin in 1994. Reason: Aspirin costs 75p per month (small profit) and Statin £20 per month (large profit).
On the face of it, it seems a great idea to streamline the development of new drugs and yet there are still those niggles which ask how, after years of testing a new drug, it can be withdrawn less than a month after launch due to serious liver side effects.
If I was a government wanting to inject £180,000,000 into drug research, I would bring together a panel of experts, lock them in a room after telling them that they could not come out until they had listed the ten most important medical research questions that need answering. Only research which addressed one of these questions would receive funding.