The risks of clinical trials

By AnthonyLast updated: Wednesday, March 15, 2006 • Save & Share2 Comments

The outcome of participating in a clinical trial of TGN1412 has been utterly dreadful for the six men at Northwick Park Hospital. It is not at all clear they will survive this experience unscathed, and one can only hope that they will respond to treatment. While we do not yet know why this has occurred, and hence any comments are speculative, there are a few issues that have been raised which are more general in nature.

The anti-vivisection argument

At the BBC’s Have you Say website, the incident has led to claims that this proves vivisection is useless. This claim does not stand up to much scrutiny. Events like this are extremely rare; all the patients taking active treatment had severe reactions. However animal testing does find toxicity of drugs, which prevents them being taken into human trials. Without such tests, severe adverse effects in human test subjects would be more common.

The anti-human testing argument

Some are arguing that such testing is unsafe, and therefore should not be allowed. However without initial dosing studies in humans, there would be no way progress the drug to studies in human subjects with disease processes. It would effectively end the ability of pharmaceutical companies to produce new drugs. There are some commentators at the BBC site suggesting that both human and animal testing should stop. What can you say?

Concerns about consent

These individuals will have given consent to the procedures being carried out on them. There is an extremely rigourous system of ethical review studies, run by ethics committees, who assess the patient information (including the risks involved in taking part in the study). Having steered three non-drug studies through ethics committees, I can tell you they are extremely focused on the rights of participants in studies. However, at some point individuals do give consent.

One might argue that a student with plenty of loans being money for being involved in a trial is being coerced. I’m not so sure. Would you participate for nothing? I personally would not. The motivations behind why people participate in clinical trials are also not are not always financial. One of the men involved in the TGN1412 trial cited helping to increase scientific knowledge, as well as money. The key issue, is were the participants as fully informed about the risks involved. If that is the case, then one has to respect the individual’s decision to give consent (assuming they had the ability to judge the risks). Afterall, this is still a world were we expect grown adults to be able to make their own decisions.

The involvement of a private company

The presenter on Radio 5 Live this morning, who interviewed the head of the Medicines and Healthcare Products Regulatory Agency about this case, did appear to be somewhat shocked that a private company was performing clinical trials within an NHS establishment. I got impression that she thought this made it more likely that problems would have occurred.

The NHS is not in the extremely expensive business of developing new drugs. It has neither the skills or the ability to risk huge sums of capital on such development. For that reason virtually all drug research involves private companies – otherwise new drugs would never reach the market. The list of Soviet pharmaceutical innovations is very small.

In any case, even if this was a publically funded trial run by a University, it would have had to jump through exactly the same hoops as a private company. It is far from clear what additional safety benefit the lack of a private company would have brought. One supposes that the profit motive is being put forward as an intrinsic “evil”. I’m not sure how the desire to make a profit is meant to provide motivation to see your drug’s reputation destroyed in one day.

UPDATE:

There is some debate about the status of animal testing in this case:

A solicitor representing one man said it was not clear if successful animal tests had been previously held.

Ann Alexander, whose 29-year-old client is on a life support machine, said: “There is confusion about whether the drug had actually been tested successfully and safely on animals before the tests on these volunteers.”

She said the “problem” needed to be “investigated urgently”.

2 Responses to “The risks of clinical trials”

Comment from Paul
Time 17/3/2006 at 4:11 pm

A pharmacist colleague raised the intriguing point that what he found unusual was that the drug had been simultaneously given to the six. It was his understanding that in Phase I trials, it would usual to give the drug sequentially, after a reasonable interval to the volunteers, in case there was a reaction such as that seen in these six unfortunate men.

Comment from DrugDrDon
Time 21/3/2006 at 1:49 am

I have run Phase 1 trials for almost 20 years, both with Pharma companies and while running Phase 1 research clinics. From all of the public press available, it appears that both the sponsor and the unit used the standards required for these types of trials. I would find it highly unusual that all 8 subjects received their dose simulataneously. Typically we do these with a 2-5 minute gap in between each subject to enable the study site to keep up with all of the procedures.