Roaccutane

Tuesday 3rd December 2013 Westminster Hall

[Mr Gary Streeter (in the Chair)]

We are ready to move on to our next debate. The protagonist has entered the Chamber. There is a lot of interest in this extremely serious health matter. As the Minister takes his place, I am delighted to welcome the hon. Member for North Devon.

16:24

[Sir Nick Harvey (North Devon) (LD)]

It is good, Mr Streeter, to have the opportunity to debate this topic this afternoon. I have been aware of the issue for a long time. Roaccutane raises a lot of understandable passion among those who are directly affected. It is a form of the drug isotretinoin, used to treat severe acne and manufactured by Swiss pharmaceutical giant Roche. It was licensed for use in the UK 30 years ago, in 1983. Since then, in the UK alone, it has been implicated in reports of 878 psychiatric disorders, including 44 suspected suicides.

Next month, in January, it will be 10 years since my constituents’ son, Jon Medland, tragically took his own life while studying for a medical degree in Manchester. Having heard of its “miraculous” effects, Jon began taking Roaccutane to clear a relatively mild case of acne. Just three and a half weeks later, he died, having transformed from a successful, outgoing, happy young man to a withdrawn and depressed individual. Jon had never suffered from depression. Everything in his case points to an adverse reaction to the medicine. As the coroner said:

“For a drug to affect a person of a very solid life foundation...deserves further investigation”.

Despite a number of similar cases and mounting scientific evidence, we seem to have lost sight of the precautionary principle when it comes to Roaccutane. It is impossible for my constituents—Jon’s parents, Pamela and Jonathan, who are here today—and the other families affected, to achieve genuine closure while young lives are still at risk and reports continue to come in.

The purpose of today’s debate is to call for a thorough re-examination of the evidence and an investigation into the use of Roaccutane, for stricter guidelines to medical professionals on prescribing the drug and for the Department of Health and the Medicines and Healthcare products Regulatory Agency to show greater will in warning of the risks.

[Richard Drax (South Dorset) (Con)]

I congratulate my hon. Friend the Member for North Devon (Sir Nick Harvey) on securing this debate on a subject that has affected one of my constituents, Mr Derek Jones. Forgive me if I am jumping the gun by raising this issue. My constituent, Mr Jesse Jones, committed suicide, and someone who wrote to Mr Derek Jones after reading an article in The Mail on Sunday related another case. In both cases, the deceased were referred for psychiatric treatment after stopping the drug, but because suicide occurred after they stopped taking the drug, no warning was given to the right officials.

[Sir Nick Harvey]

My hon. Friend makes an important point. The point when people are at the greatest risk can be as long as six months after taking the drug. In the case of John Medland, the impact was swift and profound, but in other cases, it has occurred some time later.

[Bob Stewart (Beckenham) (Con)]

Is it possible, therefore, that there is a link? If the drug is a toxic chemotherapy agent, it may well have a permanent effect on the brain. Consequently, after the person stops taking the drug, it can affect their personality. Could that be the reason?

[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?

[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.

[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.

[Richard Drax]

On that point, Robyn Cole, who is not my constituent, wrote a moving letter to Mr Jones saying that the best cure that she had for acne was sunshine, and if only she had been told that initially. On the dysfunctions caused by the drugs, Mr Jones wrote in an e-mail to me:

“Sexual dysfunction is not included in the patient information notes; Roche said that they were not aware of this side effect. But as one sufferer told me, if they put ‘sexual dysfunction’ in the leaflet, no one would take it.”

His son was severely affected, and Robyn Cole also tells me that she is still physically affected some years on, having given up the drug.

[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.

[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?

[Sir Nick Harvey]

Indeed, Mr Streeter.

What my hon. Friend says should be the case, but there seems to be some evidence from some medics that Roaccutaine is being used rather too quickly.

Young people full of potential and leading happy lives have been crippled by their use of this drug. On the face of it, perhaps the proportion of users of the drug who become victims does not appear to necessitate any action being taken, but if we look at the actual numbers involved and reflect that these cases are real, we must ask what has become of the precautionary principle.

In the absence of a consensus that a link exists, the burden of proof should fall upon the manufacturers and drug agencies to prove that there is no link, given the scale of the anecdotal evidence and the picture that is building up. We need a thorough, well-funded and sizeable study into the link between Roaccutane and the adverse effects that I have described. There is a clear need for stricter guidelines to medical professionals when prescribing the drug. The Department of Health should be clear about the risks and ensure that that advice permeates through every level of the NHS. Young lives are at stake and we can no longer afford inaction.

16:47

[The Minister of State, Department of Health (Norman Lamb)]

I congratulate my hon. Friend the Member for North Devon (Sir Nick Harvey) on securing this debate, and I say right at the start that I take the issue that he raises extremely seriously. I cannot begin to imagine what families have gone through after suffering such tragic losses, but if I was in their shoes, I would be campaigning and fighting, just as they are. I applaud the work that they have done in raising an issue that is obviously of intense concern to them.

Roaccutane is the brand name for the drug substance isotretinoin—my hon. Friend and I have both had some difficulty in pronouncing it. During my speech, I will refer to “Roaccutane”, although it is one brand name of that drug. I am grateful to my hon. Friend for providing this opportunity to update the House on issues relating to the prescribing of this medicine. I will aim to address the serious concerns that have been raised about the safety of Roaccutane, including the adverse psychiatric effects that my hon. Friend and other Members have expressed concern about.

Roaccutane is a derivative of vitamin A that is used for the treatment of severe and resistant acne; it is important to stress that. My hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) made the point that it is used only in those cases.

Acne is a common condition that affects around 80% of adolescents at one time or another; it affects adults more rarely. Although acne is not life-threatening, it can have a significant impact on the lives of sufferers. In its severe forms, acne can be both extremely debilitating and distressing, causing real disfigurement and permanent scarring. It can also have a genuine impact on someone’s mental health. Many forms of acne will respond well to treatment with topical preparations or systemic antibiotics. For severe and resistant acne, however, effective treatment options are more limited.

Roaccutane has been authorised in the UK since 1983. It is available worldwide and has been used by millions of people. Roche, which first licensed Roaccutane, has withdrawn its product for commercial reasons in a number of countries, including the USA. However, other brands of the same drug—so-called generic drugs—are still available in those countries. It is a highly effective oral treatment for severe and resistant acne. However, all effective medicines are associated with a risk of side effects in some people. I appreciate that the side effect, or potential side effect, that we are talking about is of the most serious nature possible.

Unfortunately, it is impossible to predict which individuals will suffer a side effect from a medicine, but a medicine will be issued a licence only if it is considered that the benefits of treatment in the licensed indications outweigh the risks of side effects. The risks and benefits of Roaccutane were carefully considered at the time of licensing and, because of the known safety profile of this drug, it is licensed for use only for severe forms of acne that are resistant to other treatment. Since licensing, the safety of Roaccutane has been closely monitored by the Medicines and Healthcare products Regulatory Agency, with expert advice from the Commission on Human Medicines.

Roaccutane is a medicine that is highly effective at doing what it is designed to do. It is associated with some serious side effects. Roaccutane is harmful to the unborn foetus and therefore must not be taken during pregnancy. When Roaccutane is taken, common side effects include dryness of the skin and the lining of the mouth, nose and eyes. The dryness of skin that is associated with Roaccutane can take the form of cheilitis, which is cracking or inflammation of the lips. This condition can become very severe, chronic and debilitating in some patients. There has also been significant concern about the possibility that Roaccutane may be associated with psychiatric adverse effects, such as depression and suicidal behaviour.

Roaccutane is licensed for use only for severe forms of acne that are resistant to other treatment. This narrow indication for use is not the only restriction on its use in the UK. As my hon. Friend the Member for Romsey and Southampton North said, it can only be given by, or under the supervision of, a consultant dermatologist. The intention behind restricting prescribing in this way is to ensure that the health professionals with the most experience, and who are best placed to give patients advice about the important safety issues related to the drug’s use, make the prescribing decisions.

To underpin the discussions between prescriber and patient, all licensed medicines have a summary of product characteristics, which contains important information for prescribers, and are accompanied by an information leaflet for patients.

[Bob Stewart]

The nephew of a constituent, Elliot Brandon, was prescribed this drug by the doctor, but neither he nor his mother were given any indication that there might be side effects. That has to be stopped. We have to correct that, as soon as possible.

[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.

[Sir Nick Harvey]

I sense that my hon. Friend is reaching his peroration. He has offered us reassurance that the drug is used only under the auspices of specialist doctors and, apparently, only in severe cases, although my constituent’s was a mild case. Is he minded to take any further action at all, because as yet he has not suggested anything?

[Norman Lamb]

I am grateful for that intervention. I was going to suggest, at the end of my speech, that I am happy to talk to my hon. Friend and his constituent, if he wants that, because this concern cannot be dismissed in a half-hour debate. I am happy to look further at his concerns, because they could not be more serious. I recognise that other hon. Members are interested as well, and I am happy to meet others, if that would be of some use. I understand the seriousness of the issue that my hon. Friend raises.

Question put and agreed to.

16:59

Sitting adjourned.