Roaccutane

Mike Thornton Excerpts

Tuesday 3rd December 2013 Westminster Hall

[Sir Nick Harvey]

I entirely agree that a great deal more research is needed. My point in raising the matter with Government through my hon. Friend the Minister is that I cannot see who other than a public authority could initiate or, indeed, fund such research. It is certainly not in the manufacturer’s interest; Roche clings to the notion that millions of people have been treated with the drug without side effects or mishap. That may be perfectly true, but it does not alter the fact that, for those who have suffered a serious side effect, the impact has been devastating. I ask again: where is the precautionary principle?

[Mike Thornton (Eastleigh) (LD)]

What is Roche’s answer to the fact that the drug is more or less banned in the United States—one must sign a separate declaration—and that it is banned in other countries? If the drug is totally safe, why do other countries not consider it so?

[Sir Nick Harvey]

What has happened in the United States is interesting. As we know, the United States has a much more litigious culture than we do in the UK, and the manufacturer there has paid out to a patient on quite a large scale. That patient suffered different side effects, but the manufacturer nevertheless had to pay out. That, combined with the fact that generic versions of the drug are now available on the US market, has caused the manufacturer to withdraw altogether from the US market.

While we are discussing the attitude of Roche, it is worth noting that the information in the drug’s packaging includes explicit warnings about the possible psychological side effects, including incidences of suicide. If Roche acknowledges that to the extent of being willing to put it on the information, it seems to be recognising that for all the millions who may have used it successfully, a cohort of the population has nevertheless suffered as a result of using the drug.

The logical continuum of that is the ultimate withdrawal of the drug altogether. Rationally, I do not think that we can ask the Government to move straight to that in one go, much as I would like them to. Were they to attempt to go down that path, in no time at all they would find themselves locked in some sort of litigation with Roche, which would certainly not stand by and watch a major market like the UK ban its product. The court would expect the Government to demonstrate overwhelming scientific evidence, which I do not believe is available as yet. That is why, as a first step, I am calling for such scientific research to take place.

--- Later in debate ---

[Sir Nick Harvey]

My hon. Friend makes an interesting point, and I am sure that he is absolutely right in his belief that if it were mentioned in the warning notes, the use of the drug would undoubtedly be greatly reduced, as we would want in the interim.

Let us look at the available scientific and anecdotal evidence that establishes a link between the drug and the effects that I have described. Roaccutane is a vitamin A-related compound that has long been known to cause psychiatric side effects. Reports of users experiencing depression have continually surfaced, so much so that in the USA the Food and Drug Administration forced Roche to produce safety warnings about Roaccutane as long ago as 1998. The following year, an Irish study found that users of the drug were 900 times more likely to suffer from depressive symptoms than patients being treated for acne with antibiotics.

Although many studies since that time have provided limited evidence, they have often been too small to be viewed as conclusive. However, I want to mention two that stand out. First, in 2005, Dr Doug Bremner from Atlanta university published a study using brain imaging before and after four months of treatment with Roaccutane. The images clearly showed an impact on brain function, associating the drug with a decrease in function of the frontal lobe—a part of the brain that regulates emotion. Secondly, Dr Sarah Bailey from Bath university undertook studies on young adult mice and rats. When the animals were put through a “forced swim” test, where they were placed in water, those on Roaccutane spent longer being immobile, without attempting to escape, than those on antibiotics—a change in behaviour consistent with depression-related behaviour in the animals. Of course, humans and mice are very different and therefore much more research is necessary. However, at the very least Dr Bailey’s findings should be seen as a caution to doctors prescribing the drug.

These studies simply are not enough. It is evident that not everyone who takes Roaccutane develops depression, but there is clearly a vulnerable population of patients who do. Investigations just have not gone far enough to find out why that group is vulnerable, but such research is vital. Surely, before we lose more young lives to the psychological impact of the drug, there is a clear case for further study on a larger scale.

Roche consistently says that it does not know the mechanism by which the drug actually works. Therefore, one might conclude that it is none the wiser about, or perhaps is not interested in, how these side effects work. However, one cannot ignore the fact that isotretinoin—I cannot pronounce it properly—is the only drug not designed to affect mental state that features in the USA’s top 10 list of drugs associated with depression. In response to the idea of a link between Roaccutane and depression, many people have suggested that the victims were already depressed because of their acne. While acne may indeed reduce self-esteem—many acne sufferers will know what I mean by that—it is an exaggeration to generally describe people who suffer from acne as being in the grip of depression.

[Mike Thornton]

That description just sounds ridiculous. Surely, if this drug is effective at curing acne, if someone took it and their acne was cured, they would not be depressed by having acne because their acne would have gone. There is no way acne could be described as being the cause of the depression.