Helen Wright and Simon Wright knew that attending an inquest into Annabel’s death was going to be a difficult experience.
The parents were however determined to keep the deal alive in hopes that Roaccutane would be reviewed by the coroner, who shared their concerns and used his powers to place an order for the medical watchdog to look into its use in youth.
Instead, at the inquest in Northallerton last month, they were dismayed when the assistant coroner for North Yorkshire declared there was ‘no settled and agreed view’ on a link between the drug’s active ingredient, isotretinoin, and self-harm.
Instead of concluding Annabel took her own life, he recorded a suicide verdict.
Helen, 49, told Good Health that the coroner declined to look at a dossier of studies compiled by their expert witness, an eminent dermatologist with decades of experience, ‘even though the link between isotretinoin and suicide is in the patient information leaflet’.
Helen Wright and Simon Wright knew that attending an inquest into Annabel’s death was going to prove difficult. But they were determined to get it done in the hopes that the coroner would also share their concern about Roaccutane.
This states that, while on the drug, ‘some people have had thoughts about hurting themselves or ending their own lives, have tried to end their own lives, or have ended their lives. These people may not appear to be depressed.’
Helen felt that the verdict of the Inquest was a blow. She tried to raise awareness about the dangers of isotretinoin to spare other parents from the horrors she has experienced.
She is now even more discouraged by the lack of any positive outcomes from the official, one-year-long, review of side effects of Roaccutane. This was done for the Medicines and Healthcare Products Regulatory Agency (MHRA), which will make recommendations over the next few weeks.
Helen believes the only way the risks associated with isotretinoin can be managed ‘is by the immediate banning of this drug to all under the age of 21, or at the very least to adolescents under the age of 18 as they are often unable to recognise the effects of this drug on their mental state, given the normal mood instability associated with teenagers.
‘Similarly, it is difficult for those around them to notice any changes in their mood due to this drug.
‘In an age where the safeguarding of children is paramount, it is wrong that we allow our children to take such toxic drugs for non-life- threatening conditions. Doctors are not being honest with patients about side-effects, monitoring is ineffective and my child is dead as a result.’
Following the inquest the Wrights’ expert witness, Professor Tony Chu, a leading dermatologist with 35 years’ experience, called on the medicines watchdog to alter the prescribing guidelines for the drug.
‘This drug needs to be regulated properly,’ Professor Chu told Good Health.
Isotretinoin is taken by many thousands of young people in the UK — prescribing data collated by the NHS Business Services Authority, shows that between January and October 2021 alone, more than 45,000 prescriptions for isotretinoin were handed out in England.
Professor Chu acknowledges that Roaccutane is an effective treatment for acne, which he has used throughout his career — but only ever cautiously.
Too often, he says, it is prescribed in mild cases, such as Annabel’s, where its use is not justified and where the risks are not spelled out clearly enough.
Following the inquest the Wrights’ expert witness, Professor Tony Chu, a leading dermatologist with 35 years’ experience, called on the medicines watchdog to alter the prescribing guidelines for the drug
The current law requires that women give written consent to the use of isotretinoin. This acknowledges that the drug can be harmful to unborn children or cause miscarriages, and also that the woman must refrain from getting pregnant during treatment.
Professor Chu told Good Health: ‘There should be a consent form for all patients to sign, not just women. The consent form would outline in detail any side effects and explain that this drug can be fatal.
‘That would mean patients are properly informed.’
The appeal to the MHRA by Professor Chu, founder of the Acne and Rosacea Association UK, comes as campaigners await the outcome of the watchdog’s review of the ‘suspected psychiatric and sexual side-effects’ of the drug. Its remit includes making ‘recommendations to improve the balance of benefits and risks for isotretinoin, to raise awareness of the associated risks and for further research to evaluate the risks’.
Together with patients and parents, The Wrights have participated in the review. In December they were invited for a confidential briefing via virtual communication.
The Wrights declined to attend — for Helen despairs of anything positive coming out of the review.
This isn’t the first time this has happened to a parent. Another parent who attended the virtual meeting told Good Health: ‘It came across to me that they will support the use of isotretinoin and have barely any concerns at all.
‘I did not pick up on any outrage or concern, no empathy that families have lost loved ones, no concern that dermatologists are misleading patients.’
The mother, a school secretary from Essex who wishes to remain anonymous, says her ‘happy, sporty’ son became depressed and developed sexual problems after taking the drug for eight months at the age of 15. His depression thoughts are still a problem.
Roche, a Swiss pharmaceutical company, markets isotretinoin as Roaccutane in the UK. Roche ended the sale of isotretinoin in America in 2009 due to increased competition.
But it also admitted it had been ‘faced with high costs from personal-injury lawsuits that the company continues to defend vigorously’.
There is no doubt isotretinoin is effective and has helped transform patients’ skin.
But as Good Health has previously revealed, isotretinoin is linked to a hidden epidemic of sexual dysfunction in young men that continues long after the drug is stopped, with a 2018 paper published in the International Journal of Risk & Safety in Medicine finding that some men suffered erectile dysfunction for between ten and 20 years.
Statistics recorded by the MHRA’s Yellow Card system, where doctors, drugs companies and patients can report the adverse effects of medicines, reveal that since isotretinoin was introduced in the UK in 1983 there have been 140 reported cases of sexual dysfunction and 1,776 of psychiatric reactions linked to the drug.
The latter ranges from anxiety disorders (235 cases) and depressive disorders (416 cases) to ‘suicidal and self-injurious behaviours’ (319 cases) — a category that includes 82 suicides, 61 suicide attempts and 22 incidents of self-harm.
These figures will be significantly underestimated, however. The Yellow Card scheme is voluntary and the MHRA admits by its own estimate, published in 2018, ‘only 10 per cent of serious reactions and between 2 and 4 per cent of non-serious reactions are reported’. This could mean as many 800 youth have lost their lives due to taking the drug.
Among them was trainee accountant Luke Reeves, 21, who in 2017 became ‘irrational and lethargic’ while on Roaccutane, and made two attempts at suicide before taking his own life at the family home in Copford, Essex.
After the inquest his father Richard said his son ‘was never the same after taking Roaccutane’.
He added: ‘It permanently changed him physically but more importantly it permanently damaged his brain. It changed his personality, his ability to rationalise.’
Annabel Wright died in tragic circumstances in May 2019 when her body was found in her bedroom. Her Roaccutane dosage was increased shortly before her death.
In August 2020, Good Health reported how Annabel’s death had come completely out of the blue. The mother of Annabel said her daughter had been studying Spanish in her bedroom that evening and was chatting on the telephone with her friend, who confirmed she would be going on vacation in Spain that summer.
Later, after a family dinner, Annabel picked up and cuddled the family dog, Monty, which that morning had woken her by licking her face, and said: ‘Are you going to wake me up like that every morning?’
‘She didn’t know she wasn’t going to wake up again,’ her mother Helen told Good Health last year.
Simon, her 55-year-old husband, and she became convinced their normal teenage daughter was suddenly overcome by suicidal thoughts.
‘I know Annabel didn’t want to leave us,’ Helen said. ‘Whatever hit her, hit her like a tidal wave.’
Professor Chu provided written evidence at the inquest and stated that Annabel died after being given a low dosage of isotretinoin for six months. Annabel experienced no mood swings during this time.
‘If British Association of Dermatologists’ guidelines and the product licence of isotretinoin had been followed … Annabel should not have been offered the drug,’ he wrote.
These guidelines refer to advice from the National Institute for Health and Care Excellence in June 2021, which states ‘taking into account … the possibility of psychiatric side-effects’, isotretinoin was recommended for use ‘only in situations when … benefits outweighed the risks’. Professor Chu added: ‘There is no doubt that oral isotretinoin led to an idiosyncratic reaction in Annabel that resulted in her suicide.
‘If Annabel and her mother had been made aware by the dermatologist of the very rare possibility of suicide with this drug, Annabel would have refused it.’
Patient information leaflets, says Professor Chu, are not enough — ‘Who reads them?’— and all patients should be asked to read and sign a detailed consent form. Existing guidance from the MHRA reminds doctors of concerns about the ‘possible risk of psychiatric disorders’ associated with isotretinoin, and that they should ‘monitor all patients for signs of depression and refer for appropriate treatment if necessary’.
But at Annabel’s last appointment, on May 1, 2019, this monitoring amounted to a single question: ‘How’s your mood?’ Annabel just said ‘Fine’, and a few hours later she killed herself.
Annabel began taking 20mg of Roaccutane a day, the most common dosage, on November 14, 2018, after a hospital dermatologist ‘frightened her into taking it’, according to her mother, by saying she might be at risk of scarring — even though her daughter’s acne was relatively mild.
Helen raised concerns about the risk of depression, ‘but the dermatologist’s exact words were “It could be argued that those children took their lives because they were depressed about their skin”,’ says Helen.
A month later, Annabel’s dose was increased to 30mg. The dose was raised to 40mg on March 7, 2019. Professor Chu believes this was not necessary. He believes Annabel’s acne only had a grade of 1 on the scale, which rates severity between 1 and 10.
‘I wouldn’t consider Roaccutane until you’ve got to at least a grade 5 or 6, and not unless you’d had at least two different antibiotics, and she’d only had one,’ he says.
Annabel took her own life less than 2 months later. However, the coroner decided there was ‘no evidence the balance of Annabel’s mind was disturbed and the fact she took her own life does not in itself mean the balance of her mind was disturbed and, if it was, there is no evidence that this was caused or contributed to by isotretinoin’.
The only evidence of that, he said, ‘was from Annabel’s parents’, and that of Professor Chu, ‘and that part of his evidence was outside of his expertise’.
Professor Chu did submit a collection of papers to the Coroner. This included extensive research linking the drug with depression and suicide.
‘As a dermatologist, I’ve always been known as somebody who uses Roaccutane but who is totally aware of the potential problems,’ the professor of dermatologic oncology at the University of Buckingham told Good Health.
‘I have helped a lot of people who have had problems with the drug. It is mostly problems with dry skin or extremely dry lips that cause the problem. But some people have had mental health issues.’
Professor Chu said he had been shocked by the coroner’s attitude. ‘If you have a drug that causes a rash, you would ask a dermatologist’s opinion. You have severe psychological issues and your drug causes you to consult with a neurobiologist.
‘Consequently, I spent a lot of time sorting out a dozen good scientific papers, mainly from neurobiologists, who have done a lot of work on Roaccutane, showing that it can and does affect the brain.
‘That was all sent to the coroner, but during the inquest he said he wasn’t going to read it.’
At the inquest the coroner said: ‘I do not accept that Annabel and Helen were not properly advised about the risks of isotretinoin and I find the treatment options discussed and recommended were correct and proportionate.’
Good Health approached the coroner, a retired solicitor, for a comment but a spokesperson said it was ‘not his practice to enter into correspondence with persons who are not interested parties as to what occurred in an inquest’.
While some want to see the use of the drug in children and teenagers banned outright, Professor Chu does not: ‘It is a very effective drug. However, it needs to be controlled properly. The potential side-effects are rare, but unless you are warned about them you can’t make a properly informed decision.’
He believes that ‘the majority of patients’ on the drug are not told about the serious potential side-effects — because these are very rare, ‘there is a terrible complacency in dermatology about the drug’.
‘I have seen hundreds of patients who’ve not been warned of the possible side-effects beyond the risk of some dry skin.’
Professor Chu says that, like Helen, he fears the MHRA ‘will do nothing’, he says. ‘The trouble is there is too much pressure from dermatologists who will not agree that this drug needs to be better licensed.’
The suggestion that it’s the acne, rather than the drug, that leads to depression is a fallacy widespread among dermatologists, says Professor Chu. ‘The evidence that everybody quotes is from a single paper which looked at about five people.’ During the MHRA review, ‘this came up time and time again, people saying “Oh well, of course acne causes severe depression”. Well, it doesn’t, and there’s no good evidence for that at all.’
A spokesperson for the MHRA told Good Health: ‘Patients, their families and other stakeholders have been an integral part of the review of isotretinoin.’
A spokesperson for the British Association of Dermatologists said they ‘fully support the approach of discussing the benefits and possible risks with patients and young people, so a shared and informed decision is made’.
Roche said: ‘We take the safety of all our medicines very seriously. Roaccutane is used worldwide by millions. But, like all medicines, side-effects can occur. It is vital that patients are fully informed as to what to expect when they take it and that they are monitored closely to ensure they get the ongoing care they need.’
Roche said it was not ‘appropriate for us to comment on the MHRA guidance review’.
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