Accutane

Jackie Doyle-Price Excerpts

Wednesday 7th March 2018 Westminster Hall

[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.