Personal World News

Roaccutane; ban or brilliant?

(scientific outlook)                   untitled

Isotretinoin, globally known as ‘Roaccutane’ is the highly controversial acne treatment, originally licensed by drug company Roche, used to treat patients with persistent and severe cystic acne. For decades the drug has been the topic of countless debates and the reason behind hundreds of lawsuits which correlate the drug to serious birth defects, suicide, and serious gastrointestinal side effects including Crohns disease. Roaccutane boasts a long list of side effects with seriously high risk complications. However, it also boasts to be the one treatment continuously offering hope to severe acne sufferers with an 80% success rate. The amount of lawsuits filed against Roche because of Roaccutane before it was discontinued in 2009 reached an estimated amount of a staggering 5,000 cases according to the Daily Mail. In 2009 lengthy court proceedings resulted in Roche awarding $33 million in damages to people who claimed Accutane caused bowel disease, though many manufacturers had begun to sell their own versions of the drug. It was later banned in countries such as the USA and Australia because of high profile side effects and cases. Victims claimed the adverse side effects of the drug were too harmful to be so readily available, prompting scientific studies investigating further into the hell of Roaccutane and its side effects. This debate aims to accurately address both sides of the Roaccutane debate; ban or brilliant?

The stigmatism surrounding Roaccutane has grown over the past few years, however so has its sales. Health reporter Jo Waters (2013) reported: ‘prescriptions for acne products containing isotretinoin rose from 1,697 in 2008 to 48,797 in 2012’. Arguably this could support the popular catch phrase that ‘all publicity is good publicity’. Roaccutane is being increasingly prescribed by medical professionals as the ‘go to’ for all acne sufferers, but some critics have reported that this is not through popularity of the drug but it’s quick effectiveness at fully treating most acne sufferers to ‘get rid of patients quicker’. Unfortunately, Tony Chu (2013), professor of dermatology at Hammersmith Hospital agrees with this view: ‘There is a lot of pressure in the NHS for dermatologists to clear patients from their books quickly – we’re told we should have a maximum of two follow-up appointments because of financial pressures, so I think Roaccutane is sometimes prescribed to speed things up when it’s not always the most appropriate drug’.

Brilliant

The growing bad press for the drug has been fuelled recently by countless documentaries and ‘horror stories’ of patients committing suicide and suffering irreversible damage to their bodies. However, acne sufferers will admit the devastating affect the condition can have destroying self-confidence and deflating mood with every spot – these feelings occur without any stimulus from any medication, the acne alone can cause this depression. Lisa Turner (2013), who took Roaccutane, spoke of the ‘misery’ she endured before the drug, admitting that she: ‘even decided against university because it affected my confidence so much. My face, neck, back and chest were all covered in ugly red pustules, which left scars.’. Lisa commented how her depression lifted within weeks, as did her spots: ‘I’d never felt so good,’ proving that both acne can be the only factor for depression and the drug here helped to lift her mood not crush it. Also, it’s important to recognize that all anti-biotics come with small print, dangerous side effects and horror stories just a click away on the internet. It’s common sense that you’re more likely to write about it on the internet if you’re unhappy. Yes, always check the fine print but it’s important to remember that most of these side effects reported are said to be suffered by a minority. Last year Covo Denver (2014) from the American Academy of Dermatology examined recent studies on side effects when patients take a full course of Roaccutane, he found that ‘in a small group of patients taking isotretinoin found a marked improvement of psychiatric symptoms in conjunction with improved acne’ and that in the study he examined a large number of acne patients taking isotretinoin. He then explained that there was a reported negative effect on mood in a small number of patients — likely about four per 1,000 in his estimates. Expert advice concerning the drug from Dr. James (2014) advises that: “Isotretinoin remains the gold standard for treating severe acne, but there are many aspects that must be taken into consideration before it is prescribed,”. Also that “It is important that dermatologists and patients who are good candidates for isotretinoin work together to ensure the safest and most effective treatment outcome. It is encouraging that new studies continue to be conducted on the use of isotretinoin, and I expect more studies will further expand our knowledge of this powerful and effective medication in the future.”.

Bad/ban

However, science doesn’t lie and over decades evidence repeatedly supports a causal relationship between Roaccutane, suicide and serious health problems. The drug manufacturer Roche have supplied Roaccutane to a massive 17 million people worldwide. Thousands have continuously reported severe and sometimes fatal side effects though Roche (2013) said: ‘no causal link had been established between Roaccutane and either depression or suicide’. Though thousands would disagree. Though The Medicines and Healthcare Products Regulatory Agency (MHRA) said “no medicine is without risk and Roaccutane is no exception”. From 1982 to 2000 the FDA reported a whopping number of links correlating a strong relationship between Roaccutane use and psychiatric disorders. The FDA (2000) reported 37 suicides linking to the drug, 110 hospitalisations for depression/suicidal behaviour and 284 cases of depression without hospitalisation – thirteen of these suicides occurred within three months after the patient had stopped using the drug. After these findings were released Roche added a warning label to the acne drug but did nothing else to help. This does not include the ‘hidden figure’ of unreported depression and/or low mood. Acne expert Angela Palmer (2014) found that: ‘Accutane ranks fifth in reports connected to depression, compared with all drugs listed in the FDA’s Adverse Event Reporting System (AERS) database through June 2000. It is also listed within the AERS top ten drugs associated with suicide and suicide attempts. It is the only non-psychotropic drug listed’. These overwhelming figures tell just the figures of the countless lives lost to the drug, the lives of: Jesse Jones (18) whose father described the drug as ‘Russian roulette’ in 2012, Melissa Martin-Hughes who hung herself also aged 18 years, Angela Lee (28) who stepped in front of a train while also on the medication – the list seems endless. Arguably the only way to stop the growing list is to ban this horrendous drug. Father of Jesse Jones, Derek (2012) said: ‘This drug could drive your child to suicide and that risk is too high a price to pay for clear skin.’. This is why patients now taking the drug must sign a kind of ‘disclaimer’ to accept full responsibility during a course of Roaccutane for their own duty of care after being thoroughly explained the side effects.

However, suicide is not the only severe side effect of the devastating drug, while taking Roaccutane women must also sign and agree to participate on a ‘pregnancy prevention program’ because during a course of Roaccutane a woman’s body is so severely harmed that it can be fatal to a unborn child. Every four weeks, as a women taking Roaccutane, it’s compulsory to take a pregnancy test before being prescribed your next four weeks. This is why Roaccutane is prescribed only on a monthly basis. If pregnancy does occur during the course of the treatment or within a month afterwards the chances of a healthy baby are slim. This system was put in place in 2006 called the i-Pledge program. Before this the FDA had already given Roaccutane a pregnancy rating of ‘X’ – thus meaning the drug cannot be taken while pregnant because of the high risk. The FDA reported that infants whose mothers took Accutane were born with both internal and external abnormalities such as cleft palate, missing ears, facial dysmorphism and central nervous system malformations. Among Roaccutane pregnancies, 42% of infants suffer from birth defects.

Many lawsuits blame Roaccutane for triggering serious stomach problems such as Crohns disease. Drug Watch (2014) researched the claim that the acne drug is a trigger and said: ‘the Internal Causality Assessment, issued on Jan. 6, 1994, noted that 104 cases of colitis syndromes, including Crohn’s disease, were experienced by Accutane users. Of those cases, 33 probably were linked to Accutane’. These reasons, among many others are factors as to why the drug has been banned within the USA and a handful of other countries and also why thousands of court cases have awarded millions of dollars to patients who have been seriously affected by the drug. The ban may soon be put in place in the UK if these statistics keep rising as it already has the attention of MP’s.

Conclusion

This controversial debate is of interest to me as only within the last fortnight have I stopped taking the drug myself after six months of treatment. Yes, my skin has become clear – for the first time in a decade. However, months of depression, vomiting, nose bleeds, nausea and dryness were not worth it. The drug, however appealing, is not worth it. The price to pay for clear skin shouldn’t cost your health, or your life.

 

 

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