In the United Kingdom cancer patients who are terminal have the opportunity to take experimental drugs long before they would be allowed to in the United States.
The UK Department of Health has authorized a network of 19 hospitals where patients who have no other hope of a cure can agree to take drugs which might be years away from being approved. The first of these Centers for Experimental Cancer Medicine is now open at Bart’s Hospital in London. Additional centers are scheduled in England, Scotland, Wales and Northern Ireland.
The experience in the UK is that patients are desperate to participate in the program. The patients don’t seem to care that the drugs being offered are at a very early stage of development. This raises many complex moral and ethical issues.
The stated goal is to cut in half the current ten year time period it takes to obtain approval of a drug. The basic goal of the program is to simply find out if the experimental drug has an effect on the targeted disease.
Each of the 19 sites will receive around £2million a year. Funding is provided by Cancer Research UK and the Department of Health.
The Health Department has given ethical approval because the patients involved are no longer responding to conventional medicines and have no other hope of recovery.
Initially patients are only given a very small dose of the experimental drug. When the drug is shown to be tolerated the dosage will then be increased only if it seems to provide an improvement.
The UK’s Medicines and Healthcare products Regulatory Agency will have first approved all drugs for clinical trials. All the drugs used will also have been successfully tested on animals. The local hospitals will closely monitors all patients who are participating in any trial.
Clearly, this sort of program puts enormous additional risk on the participants, but with complete informed consent, if the goal of halving the time to approval can be accomplished, the program would eventually save tens of thousands of people.
One concern remains, can terminal patients with no other options be too easily convinced to participate. These patients are most vulnerable and are deserving of extra government protection. If this increased level of protection can be provided to them then programs like this should be encouraged and expanded.
Joel T Nowak MA, MSW