Roaccutane

Caroline Nokes Excerpts

Tuesday 3rd December 2013 Westminster Hall

[Sir Nick Harvey]

My hon. Friend tempts me beyond my limited medical expertise, but the logic of what he is describing sounds convincing. The other point to be made about the delay in some cases is that the numbers on the incidence of suicide and psychotic disorder that I quoted a few minutes ago are highly likely to be gross underestimates. For example, just this morning, I had a telephone call from someone in Cornwall who had heard a morning bulletin on his local BBC radio station referring to this debate. He said that for the first time, the penny dropped with him. He had attempted suicide and been forced out of the Royal Navy, but he had never before put the two things together. With the benefit of many years’ hindsight, he realised that it happened just months after he had used Roaccutane to deal with acne. I therefore think that it is fair to say that we are looking at numbers far greater than we first thought.

[Caroline Nokes (Romsey and Southampton North) (Con)]

I congratulate my hon. Friend on this important debate. Given that he has said that the number of people affected may have been grossly underestimated, does he agree that what is desperately needed is robust scientific investigation and analysis of the numbers and possible causes, especially as many of the studies are not very up to date?

[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?

[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.

[Caroline Nokes]

On my hon. Friend’s point about calling for the drug to be withdrawn, does he agree with the dermatologist in my constituency who sent me an e-mail today saying that it would be a sad day for many thousands of acne sufferers if the drug were withdrawn completely? We desperately need this debate and the future to hinge on accurate scientific information.

[Sir Nick Harvey]

I am not entirely sure that I agree. Other treatments for acne are available. I readily acknowledge that they may not be as effective, but they include antibiotics and a variety of other treatments. Unless and until we have some way to predict which people are most likely to suffer catastrophic side effects, I would prefer on the precautionary principle that no one at all took the drug. If we could predict with some certainty—whether by means of genetics or whatever—who might be predisposed to such side effects, then and only then might it be safe to argue that anyone without such a predisposition could safely use the drug, but we are nowhere near that yet. I suffered from acne and was prescribed antibiotics for 11 years or so to deal with it. It is a miserable business—no one would make any bones about that—but there are other treatments, and the catastrophic consequences for some people of using the drug suggest that we would be better off without it.

--- Later in debate ---

[Sir Nick Harvey]

My hon. Friend undoubtedly raises a logical loop, but there is the question of time scales, because even a very brief usage of the drug could have—as other hon. Members have suggested—quite a lasting impact. I simply do not accept that the horribly sudden onset of mood swings, paranoia and episodes of psychosis can be remotely compared with any feelings of lowered self-esteem that might be experienced by people because they suffer from acne.

Jon Medland, my constituent, had no history of depression. Similarly, the heartbreaking suicide note of James Sillcock, who died last year, told how he had “loved” his life, but it also said that Roaccutane had “changed his world completely”. Worryingly, a European Medicines Agency report in 2003 confirmed that discontinuing the drug may not be enough to alleviate adverse reactions. That was certainly true in a number of suicide cases, where young people realised they were “not themselves” and stopped the course of treatment, only to find themselves falling deeper and deeper into depression afterwards, which comes back to the point I was making earlier.

At the very least, this issue highlights the need for a greater awareness at all levels of the patient’s interaction with doctors; direct approaches must be made to monitor the patient’s mental state. Ultimately, we may never know how many people have been affected. Roaccutane was linked to nine suicide cases between September 2010 and September 2011, but with suicide such a sensitive topic, we can imagine that some victims’ families have not come forward. Indeed, others may not have realised the full picture—that the container of insignificant-looking pills, kept in the bathroom, for a few spots could have led someone to take their life in a state of psychosis.

It is also worth mentioning again that Roche has pulled Roaccutane from the US market. The drug first came on to the market for chemotherapy and then was marketed to a wider audience when its acne-curing properties became apparent. A number of doctors have been keen to argue that it is being overprescribed as a first-line treatment; it is only supposed to be used after at least two other medicines have been tried. In 2009, Dr Tony Chu said:

“You know with Roaccutane you can get patients off your books in six months rather than go through the mill and try them on a variety of things until you hit on the thing that will actually work for them...it’s bad medicine.”

If doctors are doling out Roaccutane with little thought about the bigger picture, they are also ignoring the psychiatric risks.

[Caroline Nokes]

Will my hon. Friend give way?

[Sir Nick Harvey]

I have an eye on the clock, but I will give way briefly to my hon. Friend.

[Caroline Nokes]

Does my hon. Friend agree that Roaccutane can only be prescribed by a dermatologist, so the vast majority of patients would have gone through products prescribed by their GP before they ever get to a dermatologist and have the possibility of having Roaccutane prescribed?

[Mr Gary Streeter (in the Chair)]

Order. Before the hon. Gentleman responds, can we make sure the Minister has time to respond to the debate?

--- Later in debate ---

[Norman Lamb]

I was going to make that point. It is important that proper advice is given to patients when a drug is prescribed. My hon. Friend raises a serious concern on behalf of his constituent. I accept his point. The patient information leaflet is an essential document if the patient is to be fully aware of the possible risks of treatment and make informed choices about their care. Of course, unless they are directed to it and advised to read it by the clinician, the chances are that they will never read it. That is an important point.

[Caroline Nokes]

I have sat in on four consultations when Roaccutane has been prescribed. I reassure the Minister that consultant dermatologists tend not to just hand over a leaflet; they stand over a patient while they read it.

[Norman Lamb]

I am grateful to my hon. Friend for her intervention. I am sure that that is the usual practice. However, the concern expressed by my hon. Friend the Member for Beckenham (Bob Stewart) suggests that that may not uniformly be so, though it certainly ought to be.

Since 1998, there has been increasing awareness that Roaccutane may be associated with psychiatric adverse reactions, particularly depression and suicidal behaviour. The assessment of this issue has been complicated by the fact that young people with acne are already at an increased risk of depression, regardless of treatment. All psychiatric adverse reactions were assessed by the working group on isotretinoin in 2005. This working group of the Committee on Safety of Medicines consisted of independent experts, including psychiatrists and dermatologists, who considered the available data from published literature and case reports. All new information on psychiatric adverse reactions has remained under close and regular review since that time.

The product information for Roaccutane, and the other generic alternatives, states that particular care needs to be taken where patients have a history of depression, and that all patients should be monitored for signs of depression and referred for appropriate treatment if necessary. It also states that stopping taking Roaccutane may not lead—as hon. Members have mentioned—to improvement, and therefore further psychiatric or psychological evaluation may be necessary and appropriate.

As it is associated with rare, serious side effects, Roaccutane can only be prescribed by, or under the supervision of, a consultant dermatologist. The British Association of Dermatologists has published guidelines for its members on when to prescribe Roaccutane and how best to monitor patients for adverse effects during treatment. The guidelines recommend that patients be asked about any previous psychiatric illness, and the patient and their family should be made aware that the medicine may affect their mood. Patients should be asked about psychological symptoms at every clinic visit.

I appreciate that, in the case of the constituents of my hon. Friend the Member for North Devon, there appeared to be a rapid deterioration of mental health—certainly, a deterioration that immediately followed the start of taking Roaccutane. Female patients will be asked about such symptoms every four weeks because of the need to rule out pregnancy before a new prescription is issued. The Medicines and Healthcare products Regulatory Agency keeps this issue under close review. Any new information is carefully assessed to see whether there is a need to take action to alert health care professionals and patients.

This debate has provided an important opportunity to update the House on developments relating to the prescribing of Roaccutane, which was last debated about 10 years ago in this place. As with any effective medicine, difficult issues of risk and benefit must be grappled with. Few hon. Members will not have known someone who has suffered, physically or mentally, with the scars of acne—severe and acute acne can be a disabling condition—and few would doubt the serious nature of the potential side effects of this powerful medicine, and their tragic potential consequences. In the short time available, I hope that I have been able to update the House on the measures in place to ensure safe prescribing of Roaccutane.