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Skip to 0 minutes and 8 seconds (Fiona Morgan) In this discussion, we’ll be talking about what makes good evidence. And we’ll also be considering issues around risk and benefit and why it’s important that treatments are regulated. I’m joined for this discussion by Dr Andy Williams and Dr Mark Kelson. So what we’re going to focus on in this discussion is issues around self regulation and why it isn’t appropriate for companies who have a financial interest in a product to self regulate. We looked at thalidomide which was a truly shocking case study in which thousands of children were born severely deformed as a result of their mothers taking thalidomide during pregnancy on the clear understanding that this was, quotes unquotes, a safe product.

Skip to 1 minute and 22 seconds And we also look back at early issues around regulation of clinical research. Mark, you looked at that particularly. (Dr. Mark Kelson) Yeah, I mean I think it’s fair to say that over the course of medical research from concentration camp experiments through to the Tuskegee syphilis experiments to Porton Down in this country that there’s been a failure to self regulate in the medical research community. Awful things have been done, and that has led to add the necessity of creating regulatory bodies that control what researchers are allowed to do, very strict ethics committees. So I work in a clinical trials unit. We run clinical trials.

Skip to 2 minutes and 10 seconds And when you’re experimenting with people and you’re intervening with their care, you do have to have ethical review. And you have to be very careful. People must be told what’s going to happen. Informed consent is a huge part of medical research these days. The reasons are historical. That said, there are limitations to trials. You do need to have a very specific intervention. The classic teaching example is that if you want to find out whether pollution was causing asthma in a city, it’s very difficult to randomise cities to receive pollution or not. So you do have to rely on observational studies for that.

Skip to 2 minutes and 45 seconds And the classic smoking example that was mostly identified through the link between smoking and lung cancer was identified through observational studies. So RCT is really important. A constant criticism however is that they apply only and are done only in selected populations. And those types of populations in this country tend to be predominantly white. They tend to be younger. It’s very difficult to do work in children. So a lot of the time to find out dosing for children, it’s based on a crude weight correction because there isn’t so much work done in children. Pregnant women are very difficult to randomise for obvious reasons.

Skip to 3 minutes and 24 seconds And all this means that the best available evidence that you can get from a randomised control trial, you have to take it with a pinch of salt because the intervention effect that you might observe in the wider population could be different. (Fiona Morgan) So we’ve looked at severe hyperemesis gravidarum, very debilitating, perpetual vomiting and nausea during pregnancy. And we know this has been brought into much bigger prominence and attention because it’s something the Duchess of Cambridge suffered from.

Skip to 4 minutes and 0 seconds We also identified on a similar vein, the Instagram posted by Kim Kardashian– who I think more people have heard of unfortunately than many others– when she posted an Instagram promoting a drug and was then told, very reasonably by the FDA, that she had to remove that Instagram. And when you look at it, if you look at the side effects and the risk factors associated with this product, there are a number of instances where women who were suffering from morning sickness certainly should not be taking it. (Dr.Andy Williams) And again you see the power of the news media there, or media more generally in a few different ways don’t you.

Skip to 4 minutes and 54 seconds In the case of the Duchess of Cambridge, you’ve got the power of the mainstream news media to place an issue on the public agenda, to make it something that’s talked about more widely. This can be good and it can be bad. If it’s a very rare condition, then maybe it would be given undue prominence by the fact it’s associated with a celebrity. If it’s not, if it’s something that might affect lots more people and it could do with some exposure and public debate, than in these cases the news media plays quite a valuable role by putting them on the agenda. The case of Kim Kardashian is very differently isn’t it?

Skip to 5 minutes and 22 seconds Because the mainstream news media, which is so important to how we understand health and science in the news media, takes a backseat. It’s hardly an issue at all. Here you’ve got somebody– a celebrity– self publishing as their own media brand, and perhaps advertising a product to people inappropriately in a way which might lead them to maybe ignore or downplay the risks associated with that product. (Fiona Morgan) Mark, you were saying earlier on about the importance of the medical community taking a clear look at themselves and looking at issues around regulation and Hippocratic oath I think. (Dr.

Skip to 6 minutes and 6 seconds Mark Kelson) Yeah, I guess it’s particularly disappointing as a medical researcher that medicine hasn’t been able to keep the interests of patients at heart by itself. But this is the way it goes. I think people will always want to push boundaries. The best of intentions can lead to some horrendous things. That is what has happened, and regulation is tighter now than it has ever been. I think patients are protected in numerous ways. Patient and public involvement is a huge component of that.

Skip to 6 minutes and 39 seconds What that means is this when we’re putting together a study proposals or putting together steering committees to decide on research, that we have patient and public representatives on those boards and on those studies scrutinising the decisions that medical researchers make. And that provides a reality check to researchers and really keeps us grounded and makes sure that we are not only studying the right things, but not doing anything that could potentially harm patients. (Fiona Morgan) Excellent. Gentlemen, thank you very much.

Discussion: risk and regulation

This week’s discussion focuses on important issues raised in the course materials:

  • the reasons why self-regulation is inappropriate in the development of treatments;
  • how regulation shapes the kinds of trials that take place;
  • the power of the media in placing issues on the public agenda.

As Mark Kelson explains, it may be disappointing that medicine has not been able to always keep the interests of patients at heart in the course of its research but regulation, and scrutiny of the decisions that medical researchers make, is tighter now than it has ever been.

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This video is from the free online course:

Making Sense of Health Evidence: The Informed Consumer

Cardiff University