And your second point is excellent – great idea.

Congrat’s on posting, I m curious though, why should NZ lead the rest of the world in reducing the time to get clinical trials approved when the FDA in the US is going through serious questioning over issues like VOIXX. Surely the risk to what reputation we have for clinical research is worth more than any decision that could jeopardise that without strong overseas evidence that such a change works, certainly a $100m industry is not significant enough to damage NZ’s clean green image & I’d argue “clinical trials” gone wrong are not going to make us look good.

Lastly, is what is required not something more akin to a tiered system, adding honey to a dressing seems a particularly safe concept, so could be approved by something more akin to a district court hearing vs high court hearing, for lack of a better analogy. Then if the trail does need to progress to the next level the approval process could move up to the higher level, but initially trials deemed to have insignificant potential side effects could be “fast tracked”.

In the words of Kevin Bloody Wilson, they’re supposed it easy not to making it fuckin’ hard. As I understand it, the study won’t be appearing on the cover of Science or Nature tomorrow. Objections by the committee should only qualify the study, not rule it out. And as for child experiments, we’re throwing Ritalin down our kids’ throats and tinkering with their brain chemistry. A little honey on a scratch is a pretty low-risk bet in comparison.

1. They can not find the international guidelines that I referred to which state that you only need 5 members of an Ethics Committee. This is stunning: the guidelines I referred to, ICH-GCP are THE global guidelines for undertaking clinical trials (http://www.ich.org). It is hugely worrying that they did not know about them.

2. I did not say that private Ethics Committees should be the norm – I said that they should be allowed for those who want to use them, and those that do not want to can use the public system.

3. The primary reason that the study was not approved was because they said it was too small. Anyone who knows anything about research knows that the first time you are trying a treatment, based on anecdote and limited data, you start with a pilot study of 10-15 participants. Pilot studies will rarely give you a statistically significant result and they are not designed to – they tell you if it looks like you may be onto something. This was explained clearly to the Committee and they did not understand this, one of the most basic facts in research. It would in fact have been unethical to have started with a massive trial.

4. Yes, the NZ system takes around the same time as overseas systems (60 days, when it could be done in 5 days). The point I was making was that we need to make the system much quicker if we are to attract investment in clinical research in NZ, not be around the same as everyone else. This could easily and quickly create a $100 million industry, retain scientists provide an infrastructure to develop drugs in NZ and would not cost the Government any money. Someone previously asked why this was not raised at the jobs summit, as simple regulatory changes that could create jobs was one of the main goals. I asked to attend to raise this idea but was not invited.

5. Maori consultation. Since around 1998, it has been compulsory to consult with Maori before submitting a study to Ethics. Also, Ethics Committees must have at least 2 Maori members. The idea is to make sure that there are no cultural issues with the research, and in my experience, there very rarely are, and if there were, surely the Maori members of the Committee would pick them up. I consulted as usual for the honey study and attached the letter of support and you can see from the reply that I had to consult with more Maori Health providers. Whilst this was not given as the primary reason for rejection, there was no choice but to do this to get the study approved.

6. Apparently my article is not helpful – I disagree. I’ve had many emails in support from frustrated researchers and no one else is making a stand on this issue at the moment.

And to answer specific comments from above…

“It looks as if Dr Holt did not fill in his application correctly” – I was on an Ethics Committee for 3 years and have made probably 100 applications – I know how to fill the form in! The question re qualifications was particularly bizarre- I gave full contact details of the co-investigators and described their qualifications as General Practitioners. That’s all there was to say and it was I’ve done on every previous application. And the application stated exactly what questions we were asking….but they wanted to actually see the sheet with them written on.

“It seems from those points that this application didn’t explain how they would control for various potential problems.” – again this was bizarre. Molluscum generally lasts for 6-24 months and there are few treatments and those can be painful and scarring. The issue was that they thought that when the honey was cleaned off and every 2 days and more honey was applied, then this cleaning could be treating the condition!! This is beyond belief and could only be a factor if children with molluscum did not wash during the 6-24 months that they have the lesions.

“why use the ethics committee unless their approval carried some form of recognition or just plain credibility” – its a legal requirement that an Ethics Committee approves a clinical trial before it starts. I also think this is a good thing.

“beatup from a person who just didn’t get what he wanted.” – if you think that doctors who have potentially great, simple treatments that can help children, or anyone else, and they shouldn’t be allowed to test them, you’re as bad as they are. I think that’s unethical.

“poor quality of his submission” – see above, I’ve probably seen or submitted as many application as anyone. It was poor quality of the Committee who were not up to the job.

Thanks for the support and for discussing this issue.

Shaun Holt

So, for example, providing qualifications of co-investigators. Perhaps the form had a spot for co-investigators, and only the name of them was listed without any qualifications provided (i.e. form very poorly filled in). Or, perhaps the form had a section for co-investigators, Dr Holt had none, so he (reasonably) left it blank. The implication of those two is very different. I imagine that many of the points listed could equally go either way.

It sounds a little to me like someone from outside the system having difficulty in filling in the forms, where someone inside the system just knows what to fill in, and everything goes smoothly. Which is also often the case with councils – if you are experienced you know to write in “no co-investigators” in the co-investigators section, and thereby avoid that question.

If you’re on the committee and you’re doing 40 of these in a day, you’re probably saying to yourself “why can’t this guy get it right, everyone else figured it out.” And if you on the outside looking in, you’re probably saying “why the hell is this so damn hard.” There are many processes that work like this, and it takes someone quite smart and interested in customer service to be able to notice that there is a problem, and harder still, to make the forms work for both groups.

Read in context it looks as if the 40 objections to Dr Holt’s study had less to do with ‘political correctness gone mad!’ and more to do with the poor quality of his submission.

Sick and tired, sick and fucking tired of this Maori prima inter pares P.C. bullshit.

“Don’t build a motorway there! There’s a Taniwha that lives there!”

“Don’t implement private prisons, the Treaty of Waitangi enshrines Maori rights to plasma TVs!”

“Don’t restructure welfare! Lounging around doing fuck all is an integral aspect of Maori’s rich cultural heritage!”

STOP referencing every little thing that occurs in the public sector to Maori special interest. Maori are a small segment of the population and the rest of us don’t care what the beneficiaries and the criminals think.

The study sounds innocuous enough but the reality is that carrying out medical experiments on children is a big deal, and any ethics council is going to take such a study VERY seriously. It seems completely reasonable to turn down someone who fails to provide basic details about the nature of their experiment.

Aren’t these people supposed to be checking for safety of participants, not judging the design and effectiveness of the experiment?

I think ethics is supposed to extend a bit beyond safety, but yeah, presumably, unless approval implies some kind of funding.

Ryan, if so, then why the rubbish?

Beats me. I don’t know enough about the topic to make a judgement. It’s possible he could explain himself better with further discussion. I just felt compelled to say something nice about him – without saying anything about his letter. Just cos he’s such a decent sort.

Loving all of these opinions about it that are informed more by political ideology about red tape than by anything medical

No doubt “the feminazis” have a hand in all of this too…?