Editorial Note: This is part 2 of the post by Heather and David Roberts – See RoAccutane and The Perfect Circle.
Ever since in 2012 our son Olly died after using it, we have tried to learn what it does to the body and the mind. For the most terrifying thing about it, apart from the teratogenic damage to unborn babies, is that it can seriously, and we feel irreversibly, affect one’s thinking, via initially the lowering of mood of the person who takes it.
Acne is a menace for anyone, particularly when you are young, especially if it becomes cystic acne which means it graduates from a few intermittent spots to horrible lesions and eruptions like boils on the skin, which can leave scars. Back in the 1960s when presenting with the first signs of recurrent acne, a GP offered antibiotics and medicated washing lotions, and sunlight. Some doctors admitted 40 years ago that diet could affect it. Also hormones and stress played a part.
My own acne went on into my 30’s until I discovered, by chance, that when I ate butter, it got worse, and when I stopped eating dairy foods, it got better, and disappeared unless I ate a lot of chocolate. For me the damage had been done in my teens and I did have some residual scarring on my back but I have at least managed to keep my mind in reasonable working order. Sunshine was definitely helpful, but only Mediterranean sun was hot enough to really make a difference. I did use an Ultraviolet Ray lamp at one point too. I guess nowadays I could have laser work done if I wanted it to look really good, and could afford it.
Today however, young people are offered the supposed magic bullet of RoAccutane – isotretinoin.
Isotretinoin was originally developed for shrinking brain tumors and for pancreatic cancer. Roche discovered that whilst using it for these purposes, acne improved in those taking it. They have always admitted that they don’t know exactly how it works but it is a Vitamin A derivative and capable of changing DNA and shutting down hormones, stopping the skin from producing so much sebum, which can clog pores and produce spots.
When Dr Werner Bollag, the Swiss scientist who discovered it, realized that it was being used by Roche to treat acne, he disassociated himself from it and said he felt that using something so powerful to clear acne was ‘like using a ballistic missile to blast a garden shed.’ He feared it would become the new Thalidomide and he abandoned work on the drug in 1971.
Dr Yoder, one of a pair of scientists who went on to develop and launch the drug in 1982 also expressed concerns and feared that tragedy might arise from its misuse because the potential toxicity of the drug had been seriously underestimated. It can permanently alter brain tissue.
Dermatologists say they only have a limited amount of time to treat each patient, the young person is very unhappy about their acne which is sapping their confidence, and RoAccutane – isotretinoin works well. It is also cheap. In UK we have 200 consultant dermatologist posts unfilled, so there is a long wait on the NHS to see one. People taking RoAccutane – isotretinoin have to have blood tests from time to time to make sure their livers are able to tolerate it. They are supposed to be closely monitored. All this points to the fact that Roche accept that it is a very powerful drug. It is in fact listed on the FDA’s list of the 10 most dangerous currently prescribed drugs. So it needs to be used with great caution.
Set against this, young people want their skins to look good again and would not really want to believe that any dire side effects are likely to affect them. They are probably told that these drugs can cause low mood and suicidal thoughts, but they are also probably already feeling pretty wretched about their skin and believe that if they looked better, there is no way then that they’d ever become suicidal, just the opposite, in fact they feel they would be on cloud nine. The ‘hoped for’ good outcome is sadly not the case for many who take it.
Around 80% of teenagers will have acne at some point, and for 10-15% (around 250,000 in Britain) it is bad enough to warrant treatment with an isotretinoin product.
RoAccutane – isotretinoin is prescribed regularly now, and prescriptions have gone up massively over the last few years, having doubled from 13,500 in 2008 to 27,100 in 2012 in the UK alone, despite its having 150 known adverse side effects. The majority of prescriptions, over 80%, are given for mild to moderate acne, and therefore not within the terms of its license, which is only for use to treat severe cystic forms of the condition.
Another source suggests all prescriptions containing isotretinoin have risen from 1,687 in 2008 to 48,797 in 2012.
We discovered, from watching the BBC3 documentary, ‘Dying for a Clear Skin’ that there were others just like Olly who had died following taking the acne drug RoAccutane – isotretinoin so we banded together with them. Others way back had been from very high profile families. The first to raise concerns was Richard Todd, (the actor who played Guy Gibson in the Dambusters), whose son had died back in 1988.
We learnt that the PIL had been changed several times over the years to add in ‘the risk of suicide’ whilst Roche still insisted that there was no proven causal link for all the reported suicides. We found that there had been serious concerns about this drug for 30 years but miraculously, Roche have always managed to keep it on the market, even despite many lawsuits against them in the USA for colon damage and other problems, where it was withdrawn, supposedly, for commercial reasons. The MHRA had been lobbied, Parliament had been approached back in 2004, but still this drug went on magically existing.
RoAccutane is an example of an unhealthy alliance between the pharmaceutical industry and the drug regulatory authorities (MHRA and FDA). There seems little appetite to develop new and safer treatments. These drugs are cheap and two courses will often lead to an improvement in some patients’ skin but at great risk for the health of others.
Dermatologists and the drug companies cannot now admit that they have been wrong, there is too much at stake. In many cases patients have not been properly informed of the risks, monitored sufficiently, nor offered alternative treatments. When referred to a Dermatologist by their GP, so often they are told they are going to a clinic for RoAccutane and nothing else is offered or discussed as an alternative.
Once we had learnt all this, we joined together with a group of other bereaved parents and managed to be heard with MP support, in a Westminster Hall debate, chaired by Norman Lamb. This led to a further meeting with Earl Howe and the MHRA representative, and many of our own MPs. Earl Howe commissioned yet another report to be undertaken by the MHRA, which took 9 months entitled MHRA Review of Isotretinoin and Psychiatric Adverse Reactions, November 2014. When it came out, sadly all we parents thought it was a complete whitewash, yet again, and were bitterly disappointed, even by the team of chosen experts to contribute to it, having seen their previously well known and voiced opinions on the drug.
Whilst awaiting the results of the Report, we parents (and some users of RoAccutane who were still alive but suffering horrendously), staged a Protest with a huge banner, candle lit lanterns, posies of flowers, and pictures of our dead children, outside Roche’s premises in Welwyn Garden City in Hertfordshire. We had Press coverage and timed our demonstration to coincide with one in the USA on 24 April 2014.
We were eventually invited into Roche’s boardroom to speak with the Directors and we each told the story of our lost child, and one of the living users described emotionally what the drug had done to him, bravely explaining how it had permanently caused him sexual dysfunction. (Kevin Pezzi MD explains this in ‘The Science of Sex’, stating that in some people it can permanently affect libido and sexual pleasure).
We asked whether Roche would consider inventing and substituting a safe acne drug and so take RoAccutane off the market. We knew that reportedly they were making over £3 billion from it. They declined, saying this one was effective and anyway, they only make oncology drugs, which of course RoAccutane is, designed originally to shrink brain and pancreatic tumors.
We voiced our concerns that this medication could be bought online without prescription but Roche reassured us that they only sell directly to authorised pharmacies and that the MHRA monitors any such problems so if there were any, which they doubted, they would deal with them at once. We knew it was possible to order on line because some of us had tested it out. Roche seemed surprised to hear this, in total denial.
A year passed and the BBC, after hearing Olly’s story on local BBC News coverage, decided to monitor the online ordering of the drug themselves. In their investigative series ‘Inside Out: West Midlands’ they proved how easy it was for anyone to get hold of RoAccutane without prescription or monitoring, despite the assurance that Roche had given us all so many months before. They also tested its effectiveness and side effects, getting people to describe their own experience of using it.
One woman had become pregnant whilst on it and had had to have an abortion as the damage to the foetus is so horrendous. The BBC also told the story of a young woman who had been taking it for 3 months and had so far not suffered any ill effects. The reporter himself had taken it years before and had been fine, but he told us that his brother also took it and had had to stop it within a few weeks as it made him so very ill.
Roche declined to be interviewed but issued their usual ‘this drug has no proven causal link with suicide’ disclaimer, and said they take the safety of medicines very seriously.
The representative from the MHRA, when challenged about their lack of effective and protective monitoring, said yes, there was more work to do, and implied that if there were problems, it was the fault of those ordering online, as ‘there will always be criminals out there trying to get your money.’
The BBC tracked down the director of the Turkish pharmacy who were supplying the drug back into UK for sale in an online pharmacy site, and he said he hadn’t realised it was a dangerous drug. Roche had supplied him legitimately but hadn’t apparently told him about the UK safety restrictions. Asked if he would now stop selling it on line, he said he would look into the European legalities. We wondered who the ‘criminals’ actually were perceived to be. It was obvious to all the viewers that the MHRA had totally missed the point of the programme.
Action we have taken
We have created a website and facebook page for ‘Olly’s Friendship Foundation’, linked to the ‘Acne Awareness Group’ facebook page, and we bereaved parents all try to write about our lost loved ones and raise awareness of the dangers of this drug, as well as offering information on other methods of treatment for acne.
We also describe Olly’s experiences of using SSRIs and anti-psychotic medication, which are routinely prescribed by GPs and psychiatrists to counter the low mood triggered by RoAccutane – isotretinoin. We have discovered that in some people, the combination can cause temporary psychosis and cause the sufferer to be permanently labeled as mentally ill, leading to more and more drugs being prescribed, creating ‘The Perfect Circle’.
We welcome reports from anyone who has experience of side effects of RoAccutane/isotretinoin so that we can piece together more evidence.
We continue to lobby Government, but fear that the financial might of Big Pharma is probably indomitable, as in 34 years of endless raising concerns by the public, nothing has really made a real difference to the magical survival of this dangerous drug; at least 5 people per year die after taking it, according to the statistics of the MHRA Report, which states it is 1 in 10,000.
Many of us feel that this is a very conservative figure, due to a great deal of under-reporting. Youngsters are continuing to die, often after terrible mental and physical suffering, like our son, and we seem powerless to change this. But we go on trying….however, what we really need is safe affordable effective acne treatments for all. How can one tell a desperate young person that there is a magic bullet treatment to take away their acne, but they can’t have it if anyone in their family has ever been mentally ill, and that if they themselves take it, it may make them ill. Many won’t even know their family’s mental history, and those that do might be tempted not to report it if they think it will prevent them from getting access to the so-called miracle drug RoAccutane, which they feel will heal their skin.
If RoAccutane were outlawed, new research could be done.