Accutane

Wednesday 7th March 2018 Westminster Hall

[Sir Roger Gale in the Chair]

16:30

[Bob Stewart (Beckenham) (Con)]

I beg to move,

That this House has considered the risks of the use of Accutane.

It is a pleasure to serve under your chairmanship, Sir Roger.

I particularly wish to speak about the impact of Accutane, which can cause depression and impotence when used to treat severe acne. Accutane is but one of a series of drugs, each based on isotretinoin. There are several versions of isotretinoin, known variously as Accutane, Roaccutane, Claravis, Sotret and Amnesteem. These versions of isotretinoin all perform in much the same way. Since all five drugs stem from isotretinoin, and indeed the Medicines and Healthcare Products Regulatory Agency—MHRA—uses that name, I will use it to cover all five of them collectively.

Originally, isotretinoin was marketed as a chemotherapy drug. Based on the evidence of friends who have undergone chemotherapy, I am immediately warned to watch out for side effects. I do not suffer any more from teenage acne or have the urgent need to get it under control that could easily make me overcome misgivings in a bid to get rid of such a curse.

The effects of isotretinoin were last debated on 3 December 2013 in this very place. I took part in that debate because I was concerned to hear about the effects of isotretinoin on the nephew of one of my then constituents. Worries about the effects of isotretinoin had been debated in Parliament some 10 years before that. This seems to be a problem that will not go away and for which we have no scientifically based answer.

I was spurred to call this debate by a constituent who prefers to remain anonymous, but whose son—a totally happy young man—has had his life totally disrupted since taking isotretinoin for severe acne. Having visited a dermatologist at the age of 16, the boy was given isotretinoin and kept taking the drug for eight months before he stopped using it. But its side effects were enduring. Despite having stopped using the drug, the boy—a first-class student who played a sport at a very high level—suffered total erectile dysfunction that continues to this day. He is now in his early twenties and trying to complete a university degree although, unsurprisingly, his hugely embarrassing situation plays havoc with that.

In 2013, I raised this very point in the debate. We were discussing the possibility of isotretinoin having a continuing impact on a patient once they had stopped using it. I suggested that there must be a link, especially as chemotherapy drugs tend to have some pretty unpleasant side-effects. I quote my words from five years ago:

“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.”—[Official Report, 3 December 2013; Vol. 571, c. 249WH.]

Perhaps I should have changed the word “may”.

Everyone present will totally understand what a disaster a sexual dysfunction would be for any young person. Isotretinoin, which was meant to cure my constituent’s son of what is normally a teenage affliction, has ruined his life. He has stopped playing sport, become utterly depressed and is a suicide risk. Imagine how difficult it must have been for him to even discuss such a matter with his mother, which he does no longer. His situation also has huge implications on his having children. Who present here today would not feel for him, or indeed his mother, who is probably denied the huge pleasure that grandchildren bring to any family?

It seems reasonable to assume that the perceived shame and dread about prospects for relationships brought about by sexual dysfunctions must be a factor in reported isotretinoin-inspired suicides. That certainly seems to be true in the case of 24-year-old Jesse Jones from Dorset, whose sad loss was mentioned in the 2013 debate. In a final email to his parents before he committed suicide, he wrote:

“Anything to do with the opposite sex isn’t psychologically appealing. I used to have to try and stop myself from thinking about girls all of the time; now, I could hardly care less.”

Loss of libido was one of the many symptoms that Jesse and his parents blamed directly on the drug isotretinoin.

I have not mentioned the effects of isotretinoin on young women. I gather though, also from anecdotal stories, that it has a similar effect to that of men—a loss of libido. Certainly, it is hugely dangerous if a woman becomes pregnant. It has long been known that isotretinoin is likely to cause birth defects in babies in rather the same way as in victims of thalidomide. I gather, therefore, that medical professionals are very careful about prescribing isotretinoin to young women and that they check carefully that they are not pregnant or will not become pregnant. But pregnancy can sometimes come as a bit of a surprise—then what?

In researching for this debate, I have read many sad stories about those who used isotretinoin. The effects on people’s mood and outlook can be very quick—sometimes within a few weeks. Patients can go from being carefree, outgoing and happy individuals to being utterly depressed, isolated and desperate in a very short time. I read of one case of that time being three weeks from the first use of isotretinoin to suicide. Surely, there is something amiss for some—perhaps not all—who take isotretinoin. Isotretinoin may be a curse disguised as a blessing to a minority of people who suffer severely after ingesting the drug. For those with a sexual dysfunction, the scars will be much deeper than any their acne would have ever caused.

I understand that to date, no direct link between isotretinoin and some of these side effects has been scientifically proven, certainly not in this country. But anecdotal evidence and existing studies point to a need for critical, scientific examination of what so many people have experienced. I accept, too, that for many people the side effects of isotretinoin may not have an obvious impact, but I am told that they do have an impact, albeit we may not see it immediately.

The drug may have disastrous effects for only a small percentage of patients who take it, yet I am assured that since the last debate on this subject in 2013, which I took part in, 33 more deaths attributed to isotretinoin in the United Kingdom have been reported to the MHRA. In 2005, the American Food and Drug Administration posted an alert that patients taking isotretinoin should be watched closely for serious symptoms, including depression, suicidal tendencies, sadness, short tempers, anger, loss of social interaction, psychosis, loss of motivation and changes in appetite. I do not think I ever want to take this wretched pill.

The percentage of people who develop obvious side effects from taking isotretinoin may be small, but it is clear that there may well be huge danger for some of them. As it is prescribed under circumstances where severe acne has failed to respond to other treatments, I presume that the balance of professional opinion continues to accept that it can have a place on the shelves of dispensing chemists—but I wonder whether it should, given the amount of anecdotal evidence about its harmful side effects.

I gather that the Department of Health has agreed that, when a patient is prescribed isotretinoin, the accompanying patient information leaflet—the so-called PIL—should specifically warn about the possibility of erectile dysfunction and diminished libido. Those additional cautions appeared on the Government’s website in October 2017, yet, as I understand it, at least some PILs handed out by medical practitioners have not yet been updated. I hear that, as of last Friday, the pharmacist at one of my local hospitals apparently remained innocently unaware of those changes, too. Perhaps many other pharmacists and even dermatologists are in the dark about those new warnings.

I checked whether I could get hold of isotretinoin pills with relative ease and without a prescription. Of course, I used the internet. I discovered that British companies such as Lloyds Pharmacy insist on a prescription, but that is not so for companies based overseas. The very first company that appeared on my screen—even before any British ones—was called Online Pharmacy, which is based in the United States. Somewhat ironically given the reason I was looking at the website, its strapline was “Safe and High Quality Medicines”. The Online Pharmacy website informed me that I could purchase 10 isotretinoin pills for £45.07. For a further £18.10, I could get them delivered to my home in a “discreet package” by express mail direct from the United States. Incidentally, Online Pharmacy also promised to include two free Viagra tablets, which is even more darkly ironic considering the problems I am talking about.

Last weekend, I asked Delphine, our 21-year-old daughter, whether she had ever heard of isotretinoin for solving problems with acne. With her, I called it Roaccutane, which is the name used in the UK. She replied that she had and that some of her friends had used it. Of course, I immediately warned her to tell them about the potential dangers. If a young person suffering badly from acne hears of a “miracle” pill that they can get over the internet, might they not just do so, ignoring or perhaps just in ignorance of the risks? After all, my daughter knew nothing of the associated dangers.

After three debates in Parliament in which Members have expressed concern about this drug’s impact on patients, surely it is time for a well-funded and sizeable Department of Health study into the possible problems of using isotretinoin so that we know the answer. In the meantime, it might not go amiss to ensure that mandatory warnings are given to and by medical practitioners who prescribe isotretinoin.

16:15

[The Parliamentary Under-Secretary of State for Health (Jackie Doyle-Price)]

It is a pleasure to serve under your chairmanship, Sir Roger, and to respond to my hon. and gallant Friend the Member for Beckenham (Bob Stewart), who spoke movingly about the impact of isotretinoin on those who have an adverse reaction to it. He gave me a lot to think about, and I will reflect on the points he made.

It is worth reminding the House of the statement that the Secretary of State made only a couple of weeks ago about the review of medical products and devices, which comes on the back of similar concerns having been raised about other drugs and whether patients are properly advised of the potential side effects of those treatments. He announced that that review would look at three particular products, but also at whether we need to learn wider lessons.

My hon. Friend gave a good example of why we perhaps need to reflect on whether we think sufficiently about how we advise patients to best look after themselves. Our licensing and regulation process for medicines is very scientific and very much based on the product, but, as he explained, the impact of adverse reactions is on human beings. We need to ensure that we deal with these things in the most humane way, because there are real human impacts, which he powerfully outlined.

I welcome this opportunity to amplify the points that my hon. Friend made by providing an update on the risks associated with the use of isotretinoin and on what else we can do to advise patients of its potential side effects. Isotretinoin is licensed on the basis that it is seen as a highly effective medicine for the treatment of severe and resistant acne. Acne affects around 80% of adolescents at one time or another and can affect adults, too. Acne can have a significant negative impact on the lives of sufferers, and it can be very debilitating and distressing. Many forms of acne respond well to treatment with creams, ointments or antibiotics; isotretinoin is reserved for the most acute and resistant cases.

We estimate that 30,000 patients use isotretinoin each year in the UK. Worldwide, more than 18 million people have used the drug. For most people, a single course of treatment leads to the end of their acne, but, as with all medicines, there is the risk of side effects in some people. It is impossible to predict which individuals will suffer a side effect from a medicine. The most important thing we can do is to ensure that, when patients are prescribed a drug, they are fully aware of the risks associated with it so that they can make an informed choice. As my hon. Friend suggested, we are often talking about teenagers, whose stage of development means they are not best placed to make such an informed choice, so we also need to ensure that doctors and prescribers can have sensible and mature conversations with their patients and that we make all the information readily available.

It is worth saying that the risks and benefits of isotretinoin were carefully considered at the time of licensing. Because of the serious side effects associated with the drug, as outlined by my hon. Friend, it is licensed only for use in the most severe forms of acne that do not respond to other treatments. However, as he said, people can find it easy to track down medicines via the internet. Therefore, while we can put in place procedures to ensure that prescribers give the right advice, the opportunities to track down drugs via the internet remain, where such protections are not available. We therefore need to think about what to do through education. While our licensing system is a scientific process that is respected around the world, we need to consider properly whether we are doing enough to inform patients about how they should consider risk.

In Britain, isotretinoin can be given only under supervision of a consultant dermatologist, and it is generally dispensed via hospitals—however, my hon. Friend found it easy to identify a supplier. We need to ensure that prescribing decisions are made by healthcare professionals who have the most experience. We need to get the message out that, when it comes to these drugs, people need to take the advice of those properly qualified to give it. That does not include Mr Google.

My hon. Friend talked about the information leaflet for patients, which is included in all licensed medicines packs. That is an essential tool, but we need to ensure that people do read it. He mentioned that some supplies do not contain the most up-to-date guidance. That is because supplies are being worked through—all new stocks contain the up-to-date leaflet. We will, however, ensure that the Medicines and Healthcare Products Regulatory Agency continues to communicate that best advice to address some of those issues.

We really need to think more carefully about how we can ensure that patients are owning their treatment and properly assess whether they are considering the risks associated with using a particular medicine. I want to start a debate about the principle of informed consent. I am sure that, in the cases my hon. Friend outlined, had the risks of potential depression been properly communicated there might have been a very different outcome. They may have chosen to use the products anyway, but what is important is that patients make an informed choice, in full knowledge of potential side effects.

The MHRA continues to review side effects. The review of medicines safety is an ongoing process, which recognises that clinical trials will not always pick up every single side effect. The most common known side effect of taking this drug is dryness of the skin. That condition can be severe, chronic and debilitating in some patients, and that can exacerbate the depression that my hon. Friend alluded to.

My hon. Friend also referred to the risk of suicidal behaviour. We can debate whether there is a causal association, but it cannot be ruled out. It is complicated by the fact that young people with acne have an increased risk of depression before the additional effects of that treatment. We will continue to keep those side effects under review and disseminate the best possible information.

The national confidential inquiry into suicide and homicide by people with mental illness highlighted that health conditions were a theme, and within that acne was an evident theme in suicide. When someone—often people with conditions such as acne—has been diagnosed with depression, we expect the NHS to follow guidelines on the management of that depression, which include reviewing how they are interacting with any medicine they are prescribed. Again, we must ensure that that work is undertaken properly.

Isotretinoin is a highly effective medicine that has changed many lives for the better. However, as with any effective medicine, the benefit must be balanced against the risks, and decisions about prescribing and taking medicines need to be supported by clear and comprehensible information. Few here will not have known someone who has suffered physically or mentally with the scars of acne, but few, too, would doubt the serious nature of the potential side effects of this powerful medicine.

I should refer to the point my hon. Friend made about a possible association with male sexual dysfunction. Many reports have come to light through the UK yellow card scheme and similar reporting schemes worldwide. In the latest review, conducted just last year, there was sufficient cumulative data to add warnings to patient information about the possibility of experiencing lower libido, or problems getting or maintaining an erection.

The MHRA communicated information about those possible side effects to healthcare professionals in the UK in its drug safety update bulletin in October last year. It is therefore making efforts to raise awareness of the issue and support discussions with patients regarding their treatment. The issue is being closely monitored in order to gain more information about possible side effects and to try to establish whether there are any trends or particular at-risk patients. Although some patients recover after treatment is stopped, for others, as my hon. Friend outlined, the side effects have continued after treatment was completed. It is not clear from the available evidence how the medicine may be causing that problem, but the MHRA will continue to gather intelligence.

My hon. Friend also referred to the risk to unborn babies in the event that women get pregnant. Women taking this drug generally need to have a pregnancy test every month and use effective contraception throughout their course of treatment. That illustrates the awareness of risk management in that context, but we need to consider whether we need to do more to ensure that male users are properly informed of the risks.

I repeat that I am grateful to my hon. Friend for bringing this issue to my attention. I am concerned about the whole issue of informed consent of patients. The conversations that happen when drugs are prescribed are based on an asymmetry of knowledge and information. Perhaps in deference to medical expertise, we do not always ask the right questions when we are offered a treatment. Perhaps in deference to professionals’ expertise, we take it as given and trust that we are being given something that will make us better. However, we all know that, whatever drug we take, there is always a risk of side effects. Perhaps we should all, in our own way, use our voice to encourage patients to think widely about risk.

Let us be frank: there is risk in taking an aspirin or a paracetamol, and more sophisticated drugs carry even more risks. We would all be better at looking after our own health if we were prepared to have two-way conversations with medical professionals when we ask for their help so that we do not end up with the upsetting stories my hon. Friend shared with us today. I thank him for bringing the issue to my attention, and I will reflect on his comments.

Question put and agreed to.