HC Deb 17 September 2003 vol 410 cc1042-50

Motion made, and Question proposed, That this House do now adjourn.—[Mr. Jim Murphy.]

12.20 am
Clive Efford (Eltham)

I have requested this Adjournment debate because of the widespread concern that exists about the side effects of the drug Roaccutane, which is used to treat people suffering from the most acute cases of acne.

The most common side effects of this drug are worth putting on record: Dryness of the skin especially the lips and face and you may get some mild itching and slight peeling. The face may be redder than usual. A dry throat which may cause hoarseness. Dryness of the mucous membranes inside the nose, that may become crusted causing minor nose bleeds…Dry eyes that may irritate. This may be a particular problem for patients who wear contact lenses… muscle aches…you should avoid vigorous exercise. Temporary loss or increase of hair.

The less common side effects include: headaches, nausea, fatigue, sweating, changes of the menstrual cycle, slight loss of hearing, changes in vision, jaundice, liver disease, anaemia, seizures and inflammatory bowel disease…Some people have experienced mood changes (depression or symptoms of mental disorders)…and in rare cases suicide and attempts of suicide. You may also suffer from systemic infections, localised bacterial infections such as infection of the tissue surrounding the base of the nail, swellings which discharge pus, increased facial pigmentation and swollen glands. There may also be inflammation of the blood vessels, blood in the urine and changes in blood glucose levels (especially for patients with diabetes)…On rare occasions the uric acid level in your blood may increase and if you suffer from gout, it could trigger an attack. Very high levels of uric acid may affect the function of your kidney. You may also bruise or bleed more easily due to changes in blood cells, which are needed to clot the blood. Other blood changes may make you more prone to infections.

My hon. Friend the Minister may think that I have cobbled together that list to sex up my case, but in fact I have just read out the patient's advice that is issued with this drug. I spared him the list of possible side effects for pregnant women. Irony on irony, the advice says: If any of the above side effects become troublesome you should consult your doctor", which is probably unnecessary advice given the scale and seriousness of those possible side effects.

Mr. Peter Kilfoyle (Liverpool, Walton)

My hon. Friend is being very kind to the Minister. Perhaps I can play the hard cop to his soft cop routine on listing the side effects of this dreadful drug. I remind my hon. Friend of the case of Luke Garner, who took this drug at the age of 13.

If I may assist my hon. Friend, I will list the after-effects that Luke suffered. They include mental disturbance, arthralgia, bone pain, bone tenderness, cheilitis, cheilosis, epistaxis, inflammation or burning lips, ocular irritation, skin rash, dry eyes, dry mouth, hair loss, dry skin, severe headaches, nasal dryness, peeling skin, unusual tiredness, depression, joint stiffness, mood changes, muscle stiffness, myalgia, optic neuritis, trouble with concentration, fatigue, weakness, paraesthesias, dizziness, nausea, vomiting, weight loss, loss of appetite, malaise, lethargy, swollen glands, various infections, extreme facial and body flushing, difficulty in walking and panic attacks. According to two neurologists, he also suffers from Guillain-Barre syndrome as a direct result of taking the drug.

Clive Efford

My hon. Friend illustrates the scale of the problems and conditions faced by people who take the drug.

I accept that acne can be a serious condition for the people who suffer from it and that there is a balance to be struck between the risk of medication and the effect of the continuing condition on a patient. However, none of the advice that is given to practitioners or patients warns that any of the side effects may be permanent, which is the most important issue in the debate.

The problems with Roaccutane reached my attention when I was approached by Mrs. Stokes-Perkins. Her son Jack was diagnosed with acne at the age of 13. He was a successful student at school and one of those sickening individuals who are good at just everything they do. He was doing well academically and achieving a great deal at sport. He was a confident and outgoing young man. He developed acne at the age of 13 and tried every course of medication available but although he experienced slight remissions, the acne continued to return.

In January 2001, it was decided that Jack should take a course of Roaccutane. It was his choice to take the drug. He discussed the situation with his family and knew that there was a potentially serious risk of major side effects such as depression, but with the support of his family, he decided to go ahead with the course. Jack was 6 ft 2 in by that time. He was the house captain of his rugby team and played rugby for the Old school under-18 team and, at weekends, for Blackheath rugby club. He organised sport and social events and was part of his school debating society.

Jack took the course of Roaccutane and everything seemed fine. On returning to his doctor, he was prescribed another course, which seemed to go fine until the last week of the course when the skin on Jack's lips started to fall away. Consequently, Jack finished up with a condition meaning that sunlight dried and cracked his lips, cold weather made them swell and water made the skin fall off. If he went to places such as pubs, the smoky atmosphere made his lips crack. By August 2002—a year later—he would go out only if he was wearing a mask.

Jack cannot eat normally because anything that comes into contact with his lips causes the skin to fall off. He cannot work to subsidise his activities because he never knows what his daily condition will be. His social life has been virtually destroyed. He is on permanent medication to try to minimise the permanent side effect of Roaccutane. He has seen two senior consultant dermatologists who both concluded that Roaccutane is to blame for his condition. Dr. Chu from Hammersmith hospital has publicly called for an inquiry into Roaccutane and its side effects.

Jack has been permanently disfigured as a result of taking the drug but other people have had their lives wrecked and some have committed suicide. The drug is a derivative of vitamin A, an overdose of which can have damaging effects on people's mental state. He was aware of those warnings and, thankfully, did not suffer such side effects but other people have. I have seen figures from the World Health Organisation that report 20,000 cases of adverse drug reaction reports relating to Roaccutane as far back as 1997. Figures for the United Kingdom show that, of 170 million prescriptions of drugs relating to acne, there were 239 adverse drug reaction reports, of which 135 related to Roaccutane—more than 50 per cent. There were nine suicides, eight attempted suicides and six cases of people indicating that they had a desire or intention to commit suicide. All those cases related to people who had taken Roaccutane. Of those 170 million prescriptions in the UK, Roaccutane accounts for just 12,400, yet every suicide-related case related to Roaccutane.

In the past year, I have tabled a number of questions relating to the drug but unfortunately the answers have not been forthcoming because the Medicines Control Agency has been undertaking a review on behalf of the European Commission. I contacted the MCA today and it has advised me that it has finished its review, has passed its report to the European Commission and is waiting for its conclusions.

I have discovered today by talking to the MCA that the review will be about not whether the drug should continue in use but what advice will accompany the drug when it is prescribed. I have chosen to have the debate ahead of that report not only because we have been waiting far too long for conclusions but because we need to try to influence the conclusions that the European Commission may come to on the drug.

I accept that there may be a place for Roaccutane in the treatment of acne sufferers but more needs to be known about the potential damage that it can cause. Roche, the manufacturers, will not accept that its drug caused Jack's condition. How many others is it denying whom we do not know about?

There are many examples that we do know about, however. Charles Bishop was the teenager who flew a plane into the Bank of America Plaza in Tampa. Hon. Members may recall that that happened soon after the 9/11 twin towers catastrophe. It was seen to be a copycat attack at the time but turned out to be by someone who had been taking Accutane, the United States equivalent of Roaccutane.

Congressman Bart Stupac's son BJ unexpectedly committed suicide on the night of his school prom at a party at his house. He was a young individual with a life in front of him. The description of him sounds very much like that of Jack. Luke Hassett finished up in a psychiatric unit having taken Roaccutane.

Today, I went on to the web to find out more information about the drug. I have discovered that it is available on the web. The website that I visited listed 200 countries from which it can be purchased over the internet. In the UK, evidence of prescribing for conditions for which the drug was not originally intended are rife.

In an article in The Sunday Times, a spokeswoman from Roche said: We have had external scientists and internal scientists look into the side-effects and we have found no causal relationship between Roaccutane and any psychiatric events, from depression or suicide. The response from the company is denial and it is the most disturbing aspect of the whole affair. While it remains in denial of the potential permanent effects that its drug can have, the suspicion about the safety of the drug will grow. The list of side effects in the advice that accompanies the drug is simply to cover its back from any legal challenge that may be mounted by someone who has suffered these side effects. Roaccutane should not be prescribed unless it is by a specialist dermatologist who has undertaken a pregnancy test in the case of a female, and there has been a thorough blood test and a psychiatric assessment of the patient concerned, including an assessment of any history of psychiatric conditions in the family. There is clear evidence that that is not taking place. A full inquiry into the drug should be carried out, and is well overdue. We need to determine whether it is safe to prescribe Roaccutane in the first place and, if we decide that it should be prescribed, practitioners need to set clear and enforceable guidelines for its use. Patients need to be warned of the drug's possibly permanent side-effects. The suggestion in the notes that I have read that all the conditions are temporary and that people will return to normal after they have completed a course of treatment is not sufficient.

I hope that my hon. Friend the Minister has listened to what I have said and to the case described by my hon. Friend the Member for Liverpool, Walton (Mr. Kilfoyle). If this situation continues and the European Commission does not come to a satisfactory conclusion in its deliberations on the drug, we will back on the Floor of the House debating this matter again. People cannot continue to be put at risk as a result of taking the drug without being given clear advice and information about its possible risks.

12.36 am
The Parliamentary Under-Secretary of State for Health (Dr. Stephen Ladyman)

I congratulate my hon. Friend the Member for Eltham (Clive Efford) on securing this debate on the prescribing of Roaccutane and on the efforts he is making on behalf of his constituent. He is a strong and persistent advocate. I also congratulate my hon. Friend the Member for Liverpool, Walton (Mr. Kilfoyle) on the efforts that he is making on behalf of his constituent. I understand the distress faced by both my hon. Friends' constituents․their condition and the symptoms from which they are suffering must make things extremely difficult for them. Nothing that I say tonight diminishes the Government's sympathetic view of their condition. I listened carefully to my hon. Friend the Member for Eltham․I promise to read his comments in the Official Report, and shall make sure that all the officials in the Department involved with the issue read them as well. If there are points that I do not deal with today, I shall write to him.

Neither of my hon. Friends would want me to try to intervene on the Floor of the House in any dispute between their constituents and the makers of Roaccutane, and neither of them have asked me to do so. If they have not done so already, I am sure that they will both advise their constituents to seek appropriate legal advice. I will, however, try to address the general points that have been raised. I shall discuss the broad issues around the use of the drug, its prescription and regulation, and am grateful to my hon. Friend the Member for Eltham for giving me the chance to update the House on these issues. I will also try to address the serious concerns that he raised about the safety of the drug, including the debilitating chapping and inflammation of the lips known as cheilitis.

Roaccutane is the brand name for the drug substance known as isotretinoin, which is the name that I shall use for the remainder of my speech. Isotretinoin is the active component of Roaccutane, and is an important medicine that has been on the market for about 20 years. Without in any way minimising the distressing side effects suffered by my hon. Friends' constituents, it is important to recognise that it has helped very many people during that time and has changed many lives for the better. I can assure both my hon. Friends that whenever this issue is raised in public, the Department of Health receives many letters from people whose lives have been changed for the better by the drug, and who want to make sure that we are aware of their experience as well as the negative experience of others.

Isotretinoin, as my hon. Friend the Member for Eltham said, is a derivative of vitamin A that is used for the treatment of severe and resistant acne. Acne is a common condition that affects about 80 per cent. of adolescents at one time or another and occasionally affects adults. Although it is not life-threatening, it can have a significant impact on the lives of sufferers. In its severe forms, acne can be extremely debilitating and distressing, and can cause disfigurement and permanent scarring. Many forms of acne will respond well to treatment with topical preparations or systemic antibiotics, but for severe and resistant acne, effective treatment options are very limited, and isotretinoin is one of the limited number of effective treatments available.

Isotretinoin has been authorised in the UK since 1983. It is available worldwide, has been used by millions of people, and is a highly effective oral treatment for the type of severe and resistant acne that I have described. It is important that hon. Members understand that all effective medicines have side effects. There is always the risk of side effects in some people, and unfortunately it is often impossible to predict which individuals will suffer a side effect from a medicine. A medicine will be issued with a licence for use in certain circumstances only if it is considered that, in those circumstances, the benefits of treatment outweigh the risk of side effects. The risks and benefits of isotretinoin were carefully considered at the time of licensing, and because of the known safety profile of the drug, it is licensed for use only in severe forms of acne that are resistant to other treatment.

Clive Efford

There has been an inquiry at Leeds infirmary, where a number of cases came to light in which people with mild forms of acne were prescribed Roaccutane. If it is decided that Roaccutane can be used, there must be stricter guidelines because it is not being prescribed in accordance with the licence issued back in 1987.

Dr. Ladyman

I understand my hon. Friend's point, but I emphasise that we issue a licence that describes the conditions under which the drug should be used. It is open to any clinician at any time to issue a particular type of treatment to an individual if they think that it is in that patient's best interest. If clinicians depart from the licence conditions, they do so on their own responsibility because they believe that it is in the clinical interest of their patient. They must answer for that decision under the terms of normal clinical governance․in other words, what happens in those cases becomes the doctor's responsibility. Those are the only cases in which it is possible to diverge from the licence arrangements. I shall have my officials look into the case that my hon. Friend mentions. Unless the doctors involved can answer for their decision to depart from the licence conditions, they are in the wrong. That needs to be investigated and they need to answer for it.

I emphasise that when isotretinoin is to be prescribed in cases of severe acne, it should be used—this is another of the licence conditions▀×only when other treatments have been tried and have failed. It is a treatment that should be considered last, not first.

Since licensing, the safety of isotretinoin has been closely monitored by the Medicines and Health Care Products Regulatory Agency—formerly the Medicines Control Agency—with expert advice from the Committee on Safety of Medicines. Isotretinoin is a highly effective medicine, but it is widely understood that it is associated with some serious side effects, and these must be considered when the clinician decides to use it.

Most importantly, isotretinoin is extremely harmful to the unborn foetus and therefore must not be taken during pregnancy or when there is a risk of pregnancy. Other common known side effects include dryness of the skin and the lining of the mouth, nose and eyes. The dryness of the skin associated with isotretinoin can take the form of cheilitis, which is the cracking or inflammation of the lips, a condition that can become severe, chronic and debilitating in some patients. It sounds very similar to the symptoms experienced by the constituent of my hon. Friend the Member for Eltham. There has also been significant concern about the possibility that isotretinoin may be associated with depression and suicidal behaviour.

Isotretinoin is licensed only for use in severe forms of acne that are resistant to other treatment. That narrow indication is not the only restriction to its use in the UK. Isotretinoin can currently be given only by or under the supervision of a consultant dermatologist—one of the conditions that my hon. Friend said needed to be strictly adhered to. In addition, the supply of isotretinoin is restricted to availability through hospital pharmacies or specified retail pharmacies at the request of a consultant dermatologist. The intention of restricting prescribing in that way is that it is those health professionals with most experience and who are best placed to give patients advice about the important safety issues related to the prescribing of isotretinoin who are making prescribing decisions.

My hon. Friend referred to the internet, which is not a legal and licensed source for the drug. It might be available there, but I fear that many things that are not in our constituents' best interests are available on the internet these days. To underpin the process, all licensed medicines have a summary of product characteristics. The summary, which my hon. Friend described, contains important information for prescribers. Licensed medicines are also accompanied by an information leaflet for patients. These documents are changed and new information is added as it becomes available. 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. In the case of skin dryness and inflammation, there is clear advice to expect such effects and on how to relieve or minimise symptoms.

My hon. Friend mentioned that the leaflet contained no advice about permanent risk. I was not aware that that was the case, and I shall ensure that the people responsible for drafting the leaflet and other officials are aware of that concern. I shall have the matter investigated and I shall ensure that it is acted on if it is within my power to do so.

Clive Efford

I thank my hon. Friend for that statement. Many people are suffering permanent conditions as a result of having taken Roaccutane. That is the issue that is of most concern and the reason why I have initiated this debate.

Dr. Ladyman

If there is a risk of permanent side effects, they should be described in the leaflet. I certainly promise to ensure that that is looked into.

Despite the guidance in the British National Formulary about the narrow licensed indication for isotretinoin in the UK, its use is not always restricted to patients with severe and resistant acne. Ultimately, the clinical care of an individual patient is the responsibility of their doctor and it is an important principle that doctors can prescribe medicines outside the licensed indication if they consider that that is in the best interests of the patient. The doctor is responsible for the safe use of the product in those circumstances and is answerable under clinical governance rules.

Because of the harmful effects of isotretinoin during pregnancy, it has been the aim of regulatory authorities in Europe and worldwide to introduce measures to ensure that no one takes isotretinoin while pregnant. The summary of product characteristics lays down stringent conditions for use in women who are of childbearing potential. However, the current safeguards have not succeeded in preventing all exposed pregnancies, which has highlighted the need for further measures to be introduced.

My hon. Friend has also given me the opportunity to update the House on some important European work on the safety of isotretinoin. The UK and France have led a recent European initiative to harmonise the product information for the drug. The aim of the review was to get up to date and consistent product information for prescribers and patients across all member states. The procedure has also developed a set of important principles for nationally agreed pregnancy prevention programmes. The completion of the procedure is imminent, and the Medicines and Health Care Products Regulatory Agency is having discussions with key stakeholders to plan communication of these important new prescribing principles to health professionals and patients who use isotretinoin. The UK lead in the European review has allowed us to ensure that the important restrictions on isotretinoin use that are present in the UK now are not relaxed and are taken forward in Europe. The UK input into the review has been informed by an expert working group of the Committee on Safety of Medicines. The group includes representatives specialising in dermatology, general practice, family planning and psychiatry.

I hope that I have dealt with all the points that my hon. Friend made. I assure him that I shall write to him if I have missed any and that I will take action on whether the product description should include information about possible permanent side effects.

Question put and agreed to.

Adjourned accordingly at ten minutes to One o'clock.