Thursday, January 29, 2009

Compassion (and ethics) in clinical studies?

This morning's Straits Times carried a pretty insightful letter from Ms Sim Seng Ann. I reproduce it below for your reference.

Clinical scientific research tries to close the gap between the lab and the patient. The gap has always been there. This takes time to close. However commercial pressures have been driving very hard towards expediting the process. Ostensibly this is to benefit patients earlier, but we all know the pressures are mostly revenue related. Every day of delay in getting a new drug into the market costs the company developing it, millions of dollars.

Ms Sim is correct in pointing out that instead of taking "'discoveries from the laboratory to the patient'. It seems it is expanding the walls of the laboratory and taking the patient into the laboratory". The patient is very quickly becoming the guinea pig that serves the commercial interests of big pharma.

But surely new drugs benefit patients? Yeah...well, we can't deny that. But in reality, newer drugs benefit fewer and fewer patients, and become more and more costly to develop. Even where good drugs are developed, the incremental benefits are small. For example, it is not as if we do not have good anti-cancer drugs, we just want better ones. There are very good anti-diabetic drugs...though, apparently not good enough. In practice, most newer drugs often only produce marginal benefits.... and then often get hastily withdrawn from the market because of previously unrecognized toxicity.

The people pushing biomedical research in Singapore are usually those in support of trade and industry. Ministry of Health seems often to be dragged reluctantly into this as such activities tend to drive up health care costs with only marginal health benefits for the patients.

I have always been chary abut the ethics of many clinical studies. Most appear to benefit the investigators (fame, glory, and lots of money) much more than producing any real benefits for the patients (present or future).

'But aren't all these regulated by ethics committees?' You might ask.

Yes, they are. But without casting any aspersions of my colleagues who serve on ethics committees, it has always seemed to me odd that while the ethics committees are supposedly independent, they are all appointed by institutions who benefit from the research activities. Often, they end up been advocates of the research rather than being advocates of the people being experimented on. To be fair, they do look after interests of the 'experimented upon' but often when there is a conflict between who comes first, the balance can sometimes fall on the side of the 'experimenters' rather than the 'experimented upon'.

We certainly need more scrutiny of this process. But sadly I doubt we will get it.

Inject compassion into scientific studies

I REFER to the article, 'Immunity studies: From mice to men' (Jan 17).

The article is strong and logical on the need for immunity studies to shift from mouse-based research to human beings. However, it seems to be of scientific interest rather than medical or therapeutic interest.

The medical and scientific research industry has been given a lot of room and trust in internal regulation. It is not obvious to most people what the difference is between therapeutic research and scientific research, and sometimes the line is unclear, as in the case of writer Paola Castagnoli's proposition of human research in immunity studies.

A convincing hypothesis is still a hypothesis. While there are regulatory authorities and ethics review boards in place, their interest is in ensuring that the protocol and methodology comply with state laws and do not infringe on human rights.

I believe there is no one to question the necessity of the study in the first place, except the investigators themselves. Is it not possible that a patient who meets the inclusion criteria of a study, who may not need to go on a study because of the side effects it can have on the quality of his life, is recruited by the investigator anyway?

I am not too convinced when Ms Castagnoli said such research 'takes discoveries from the laboratory to the patient'. It seems it is expanding the walls of the laboratory and taking the patient into the laboratory.

It may take small sacrifices in order to find solutions for the greater good, but then, it is entirely a researcher's morals and value system that decide whether a study really comes from therapeutic interest or from scientific interest.

If people know exactly what is involved in them getting an answer to their rather innocent question, 'Is my immunity good or bad?', they may think twice about whether they want it answered. I hope that soon, scientists and researchers will be instrumental in instilling a culture of compassion and moral empathy in scientific studies.

Seng Ann Sim (Ms)


Anonymous said...

Market and commercial pressures should not be brought to bear on clinical studies
x-ray fluoresecence

gigamole said...

I fully agree. But I think it would be pretty naive to think that Singapore is charging so feverishly into clinical and translational research for altruistic reasons. The lures of fame, fortune and power are potent motivators.

To what extent is our ethics environment mature, sophisticated and objective enough to protect clinical research subjects? I am not so sure.

Looking at what's happening in the hospitals currently, I can't help feeling we are doing far more than is necessary to benefit the subjects/patients and the community.