We’ve been here before – a woman in come hither mode or able to plunge into come hither mode at a moment’s notice without the worry of being compromised by a minor skin blemish just below her hairline. See Stacy London and Welcome to Troy.
AbbVie pioneered advertising like this for Humira, a hugely costly and highly dangerous drug. Humira can be very useful for some severe arthritic and inflammatory bowel conditions, but the money lay in expanding its sales out into as wide a range of lifestyle conditions as possible. Psoriasis was one of those conditions. AbbVie produced an almost grotesque set of advertisements that felt a bit like “Come surf here in this Great White playground”.
Pharmaceutical advertising is nothing if not romantic. It wants you to think you can be restored to an Eden, where there are no difficult decisions to make. Where your life is not compromised by a condition that might require balancing the problems caused by the condition against the risks of a poison. Where there are no snakes in the grass or Great Whites in the water.
What does Otezla Do?
Having a Mab attached to your name adalimumab (Humira) or brodalumab (Siliq) is a license to print money at the moment even if your drug is an injectable and you’re hoping to persuade people with very little wrong with them to take it.
But Mab is not an action. It means monoclonal antibody – its a delivery system. Siliq acts on Interleukin – 17 (IL 17), Humira doesn’t. At least, Siliq is pitched as acting on IL 17, and other drugs in the pipeline are pitched as acting on IL 23. This all sounds new but its probably not. Lots of drugs have acted on IL 17 and 23 before this but you’d never know this.
Otezla? Otezla is not a Mab. It, apremilast, is pitched as a PDE 4 inhibitor – phosphodiesterase 4. This supposedly underpins an anti-inflammatory effect, and offers hope for people with severe psoriatic arthritis – it will reduce the swelling in their joints.
PDE 4 inhibitors have been around a long time. In the 1990s there were hopes that Rolipram would be a blockbuster – as an antidepressant. But it disappeared from the radar. Nothing ever vanishes though no matter how “demonic”.
Otezla does inhibit PDE 4 enzymes. And this may make it somewhat anti-inflammatory – but not particularly so. It apparently does not deliver the kinds of clinical benefits that would warrant the price being charged.
Another PDE4 inhibitor, Daliresp aka roflumilast, is being pitched for Chronic Obstructive Pulmonary Disease (COPD).
But no drug just does one thing either biochemically or clinically. Otezla can cause you to become suicidal and can cause birth defects.
Inhibiting PDE 4 may be what causes some people to become suicidal when they take it or to be at risk of giving birth to a child with birth defects if they take it after a successful come hither moment.
But then again it may be the fact that it is something else about it being an analogue of thalidomide that leads to these problems. Thalidomide may also have PDE 4 inhibitory properties – I don’t know. What we do know is that we still don’t know why it causes birth defects. It causes peripheral neuropathy, sexual dysfunction and birth defects – just like the SSRIs for instance do.
Celgene
Thalidomide never went away. It ended up with a newly formed company called Celgene in the 1980s. In 1987, FDA gave Celgene a license for thalidomide for leprosy despite there being almost no cases of leprosy in the USA. The company put it into trials for multiple myeloma where it can produce marginal benefits and they could charge a high price.
They later marketed thalidomide’s left handed isomer – Revlimid aka lenalidomide – for multiple myeloma, again very profitably.
And now we have Otezla, basically the same molecule with some side chain tweaking.
It was a Celgene Dear Doctor letter warning about the risks of suicide and birth defects – see Here – which got some of us looking more closely. This led to Siliq and its risks of suicide – even though its supposedly working on something quite different.
Part of the reason to explore all this further was a letter from someone called Kim Papp to the BMJ in response to our Study 329 – which was all about ghostwriting and the hiding of data on suicidality. Papp thought our work smeared good companies and good researchers.
This letter, coming out of nowhere (rural Ontario) was so strange it deserved to be followed up. When you follow it up it seems Dr Papp runs a clinical trial mill through which many of these new drugs have gone resulting in publications that have all the signs of being ghostwritten.
Dr Papp also appears to think that psoriasis, and almost anything else you care to think of, is more likely to cause people to be suicidal than a fine pill like Otezla or Siliq or paroxetine.
Taking the Plunge
AbbVie pioneered adverts like the one above and the one below. But over the top efforts to get a drug in the drinking water by so called ethical companies go back a much longer way . Grunenthal, the original makers of thalidomide, pushed the promotional envelope to a grotesque extent. Thalidomide was a sleeping pill that among other things was promoted as Kinesaft – the kind of juice kids could be given when their parents were going out to the cinema (Kine).
Just when you thought it was safe to go back in the water.
Otezla and Siliq Takers Unite.
We would be interested to hear from anyone taking either of these two drugs about any side effects you may be having. Any evidence for peripheral neuropathy – any alteration in sensations from skin or nerves or bowel or anywhere in the body – would be particularly interesting. Or evidence of agitation, in particular agitation linked to being suicidal or homicidal. Or any evidence of effects on sexual functioning.
mary says
Whilst I find this such an interesting read, it also frightens the life out of me! It’s interesting how companies are now owning up and providing warnings of possible side effects of their drugs – but, knowing these companies as we do, I immediately find myself working out what’s in it for them. The warnings are there for a reason for sure – but, unfortunately, we can bet that the reason is not the well being of the patient.
With so many drug names – and a variety of names for each single drug, I can certainly see how easy it would be to find yourself using one of these drugs without realising what could happen. Yes, it warns you on the box – but if ALL new drugs, from now on, are appearing with such a warning, will we still heed the said warnings? I think I’ll need a ‘wallet card’ listing the names of these new drugs – just in case!
Why, oh why, can we not be satisfied with changing our lifestyles to suit our ailments – many of which, after all, are outward signs of a reaction within, to something which does not agree with us. Why do we feel that pumping chemicals into an already suffering body is going to work to the good? We are so aware of the dangers of pollutants in the air that we breathe – caused by chemicals and yet we merrily add to our systems by means of a prescription. Is it any wonder our systems fail – be it physically or mentally?
Heather says
Well said Mary! Madness is in the air, and it’s not coming from the patients. Why doesn’t Joe Public see it? Why are they sleepwalking into trouble, clutching their prescriptions, shutting down their intuitive brains and common sense? Like you say, it frightens the life out of me too. Is all this Pharma stuff going to ultimately annihilate us, the equivalent of plague or dinosaurs?
mary says
I reckon that Joe Public doesn’t see it because Joe Public hasn’t experienced it Heather. We fully appreciate the possible harms simply because we’ve witnessed them. I’ve often said that, had I not witnessed the devastation these drugs can cause, I would not believe it either. The reactions are so sinister that, to my mind, words cannot possibly create a true picture of the suffering. Each and every one of us draws on personal experience to understand a message communicated to us by language – lack of experience leaves us unable to truly picture the real depths of the experience. I think it is for this reason that Joe Public cannot picture the possible reactions of taking these drugs – this, plus the fact that such things happen to others and never to one’s self. The message of ‘safety versus danger’ has always been one that we have difficulties with – we see that with tobacco, for example; ‘smoking kills’ is stated on the cigarette packet, yet many still smoke. This is my fear for the new ways with prescribed drugs – the warning may be there, but many will make the choice to ignore it. It is so obviously beneficial to the big companies to ‘show their hand’ in this way – no one can then turn round, when in the depths of the side-effects, and say that any of their suffering was unexpected. If ever there was a ‘win win’ situation – this is it!
annie says
James Moore
https://www.change.org/p/make-pharmaceutical-firms-help-users-who-want-to-stop-taking-anxiety-depression-drugs/u/19551989
28 Feb 2017 — Hello
As we approach 1,500 signatures again I want to say thank you, you’re amazing.
Also, I’m posting this because I need your help with a little project. I am in the early stages of putting together a new audio podcast, which will discuss antidepressants and withdrawal. As part of the podcast, I want to interview people to get the real experiences of someone who has either tried to come off or who has stopped completely. As well as users experiences, I want to interview practitioners/professionals about the alternatives to the biomedical model of treatment and also about the worrying trend of increasing antidepressant prescribing.
What I need is a 20 minute slot to interview you via Skype, you could see the questions in advance and you can even be anonymous if you wanted to.
I have already interviewed Professor John Read and Dr. David Healy, amongst others. There is a huge amount of positive promotion of antidepressants out there, but very little which tells the real story. I want to help change the balance.
If you wanted to find out more, or you were interested in being interviewed, please email me on feedback@jfmoore.co.uk I am planning on making the podcast available by mid to end of March. Thanks so much for your time, for your signatures and for your support.
“Very little which tells the real story”
http://www.thepillthatsteals.com/stolen-lives/
http://www.thepillthatsteals.com/temporarily-stolen
Johanna says
I can’t help but get angry at the targeting of women for these toxic drugs. Again. And using the same ancient, toxic message: Your looks are the most important thing about you. Nothing else really matters. So, no risk is too big to take, right? (Of course, they also count on us not to really take in the enormity of the risks, which are hard to focus on when you’re watching something that looks for all the world like a perfume or cosmetics ad.)
Actually, psoriasis affects equal numbers of women and men, they say. And onset can be anywhere from childhood to late middle age. A look back at last week’s column, with links to the studies of brodalumab or “Siliq,” showed me one more trick in the drug-company playbook.
Pharma puts young women front and center when *promoting* these drugs. Yet Siliq, at least, was *tested* on a group that was 69% male–and about two-thirds over forty! What an odd choice … or is it?
In fact it’s a smart dodge when you are dealing with a drug that’s showing worrisome levels of both suicidal behavior, and heart attacks. Although the popular press might lead you to think teens and young adults are at highest risk for suicide, actually it’s middle-aged men. In 2015, the suicide rate for U.S. women in their twenties was between 5.5 and 6 per 100,000. The rate for men in their fifties was roughly 31 per 100,000. And older men, of course, have far more heart attacks than younger women. (All this is in addition to above-average rates of both depression and cardiac problems in people with psoriasis, for reasons that are not well understood.)
Looks to me like the makers of Siliq went out of their way to assemble a test pool with a high background rate of suicidal and cardiac “events.” A couple of each in the placebo group can go a long way to make a dicey drug look not quite so bad …
Madge hirsch says
Perhaps low votamin d levels have a role in psoriasis. This would explain the depression and cardiac problems as well. It would be far less dangerous to optimalise vit d levels by means of supplements and heliotherapy before considering any of these rubbishy drugs. Not much money in that though.
Amanita says
Vitamin D doesn’t make psoriasis go away. People aren’t taking these drugs just to look better— well, maybe teenage girls are, but psoriasis is more than just unsightly, it’s incredibly physically uncomfortable and in many cases dbitating, limiting people’s ability to walk, or to use their hands, due to their skin cracking open and bleeding and getting infected. Diet does not cure psoriasis any more than these meds do. Nothing cures it, your only hope if you have psoriasis or psoriatic arthritis is that you will find something or some combination of things that gets you to a less uncomfortable place and gives you some portion of your life back long enough for you to be a somewhat productive member of society. And many people, like myself, have no choice but to try the big pharma drugs, because we are too sick and in pain to do our jobs anymore, and in order to collect disability, you have to document that you are following the doctor’s treatment plan, and guess what the doctor says when you say you’re afraid of the side effects or you’ve heard it doesn’t work well? Mine says, “I’ve had hundreds of people on it and I’ve never seen that. The benefits outweigh the risks. You’re free to find another rheumatologist if you don’t agree with my treatment.” She’d never heard of someone getting a full body rash with facial swelling from Gumira, either, and yet the rash miraculously went away when I stopped taking it. It didn’t help anyway. Otezls is next.
Mimi Bergeron says
I took Otezla for 3 months in 2014. I developed peripheral neuropathy while taking it, so I stopped taking it. I still have peripheral neuropathy that causes severe burning pain in my feet. I had to stop working and I have applied for SSD. I am 53 and have Sjogren’s Syndrome. The doc who prescribed Otezla insisted I had psoriatic arthritis, but all other doctors have said that it is Sjogren’s and Discoid Lupus. My blood is positive for Sjogren’s. The doc who prescribed the Otezla said that my newly developed peripheral neuropathy could not possibly be from Otezla. She tried to say it was from pre-diabetes (type II) stupid woman! My non-fasting blood sugar was 76… no diabetes!
Valerie says
Exactly what birth defects are caused by Otezla? And how did you arrive at this conclusion?
Dr. Evelyn Whiter says
I have had some patients with suicidal thoughts that they attribute to Otezla. I had not seen that letter, good to know.
Ben says
Please stop the ranting and raving about big bad drug companies and post something relevant. Yes, the big pharma wants to make a profit, but competition is high in this market and so is the statistical data. I was prescribed Otezla several months ago. I have not decided if I will take it or not yet. I have inverse psoriasis, a very painful type of psoriasis that causes any place that skin touches skin to get inflamed to the point of bleeding. For those questioning why someone would take a medication with such possible side effects; for myself I just want the pain to stop. This started when I was about 30 and has gradually progressed over the last few years. It causes me anxiety just thinking this could get worse. I have tried diets. I have tried vitamins including fish oil, vitamin D3, probiotics, tumoric, and a daily multivitamin with little notice of improvement. The only thing that has brought relief has been cold compressions, meditation and prayer. I thank the writer, as the article did present some valid points to consider.
Genni says
I have been taking Otezla for 3 months. I was currently doing research for a letter I am writing to my insurance company, who are denying me coverage for Otezla. They want me to use Humira first..then Enbrel. Well, from the lawsuits I have just read against both those drugs, no way would I ever take those drugs. I must admit, today I feel extremely agitated. In fact, I am weeping right now for no reason. I am a some what healthy 58 year old woman. I have had moderate psoriasis for 45 years. My hands have become stiff, lately hence the use of Otezla, which was given as a free trail from an RA dr. I am going to be honest. The last few weeks, I have felt down. Been thinking of my dead parents a lot. And thinking about my own death, and when it might happen. Thankfully, I was aware of this side affect, from Otezla. I might just chuck it…(the meds) and go back to wearing long sleeve blouses again…I am usually really up beat. I mean we all feel sad sometimes. But, this feeling is close to blah, as blah can get. Even running 2 miles…no lift in spirits. So, I might finish this box they gave me…go back to slight suffering. The hand stiffness, is worrisome, as I love to work in the garden, clean house and yes I wax and wash my own car. Take care kids.
Sheila says
Please stop taking the Otezla and tell your doctor about the crying for no reason. This Med caused me to to almost end my life, it’s really bad and they warn you up front but the reality is that it ended up being a horrible med for someone already taking anti-depressants (Cymbalta 60mg) to take, I’m so thankful for my supportive Family and Friends that saw something was severely wrong with me and caring enough to tell me to stop taking the med and call my doctor. Please be careful and be aware that the side effects they warn you about are Very Real and can cost you your life.
Laura says
I started Otezla in July 2016. It worked wonderfully and my skin cleared within two months. Amazing results. Fast forward several months to May 2018 I got a severe infection in my foot, and had to go off Otezla (at the recommendation of my doctor) while I was on an antibiotic. I went back on the meds, after being cleared from my doctor, with a titration pack (same way I started the first time). Within two weeks of starting it I began to experience severe low moods. I assumed it was depression, which I’ve had before, and that it would pass. My mental health continued to decline throughout the year and I suffered daily with low mood and emotional responses: aggression, agitation, hopelessness, etc. A strep infection caused a hiatus in the meds again, May 2017. After being off Otezla for two weeks I noticed an immediate change in mood. Went back on, low mood increased again. Stopped taking it and have felt amazing, back to my old self. The mental health change is DEFINITELY attributed in my case to this medication. Unfortunately, since I discontinued the medicine my skin has flared to such a degree it now covers 90% of my body and I am in constant pain. I’m sad that I have to chose between having physical pain/mental clarity and depression/somewhat better clearer skin (less pain). Otezla has not cleared my skin since the first time I took it. This is no way to live.
DJ says
I too had depression, mood swings, anxiety (led to breathing problems). I would be bad off and one time the doctor took me off to see what my skin did, all of the above went away, had a clear mind, felt like my old self.. got back on it and they came back.. got back off it and I was good again.. started humira a few months later, it too gives me that a couple days after I take it but it seems to be better then the otezla was..
Janet says
Hi All
I am on day 12 of starter pack Otezla. Last night I was so agitated and despairing, II considered going to my kitchen to slit my throat. Thankfully my husband noticed how I was and helped me through the night. I will stop Otezla now as It scares me too much. Have never felt such despair in my life.
Thank you all for your thoughts and views. Janet
Brian says
I can certainly vouch for the peripheral neuropathy in the form of an insane amount of itching; various parts of my body, especially my lower legs, were itching so bad that I was ready to start cutting myself to stop it. No exaggeration. On another happy note, complete impotence was a thing by the end of my 4th month of being on Otezla.
I stopped taking it cold, without bothering to even consult with my dermatologist, and those symptoms vanished almost entirely within just a few days. At this point, I don’t even care if I’m on a medication as long as I’m not on this overpriced garbage.
To be honest, it’s been a stressful time in my life so I’m not sure suicidal thoughts were caused by Otezla but I was sure having them. It’s been 2 weeks now and I haven’t had any of those feelings so it’s at least 50/50 that it was the cause.
Leslie Nelson says
I took Otezla for 13 days, the whole time I suffered with horrible migraines, nausea and worse ning of pain. I could feel myself getting more depressed. On the 13th day I had a total breakdown..I was never more depressed in my life..I couldn’t stop cryng, I went manic..it was like being attacked by a demon. The next day, Iim feeling totally worn out, still depressed
Megan says
I don’t think people understand that psoriasis isn’t just a cosmetic disease, even though advertisers like to portray it that way, but that it is incredibly painful and that the itch can literally drive you mad. You can’t sleep through the itch during a flare. I feel full body flu-like symptoms during a flare. Many of us end up with secondary infections, I’ve had MRSA infections develop in the psoratic lesions. I’ve tried severe diets for 3 years and I developed psoratic arthritis in the last year, have seen no improvement in psoriasis through diet, and the PsA got so bad I couldn’t sleep and every step was painful so I started Otezla a month and a half ago. It’s done nothing for the skin manefestations of my psoriasis – and to be fair the literature says it can take a full four months to show improvement, but the PsA has very noticeably improved.
But like everyone else I am experiencing pretty severe depression and irritability. I see my derm today and will go over the options. From methotrexate to biologics, there is no easy safe fix for severe psoriasis and PsA – Otezla has the best safety profile of the current options. I really feel like I’m stuck with an ogre’s choice.
Dr. David Healy says
Megan
Otezla does not have the best safety record. The literature on it is ghostwritten and there is no access to the clinical trial data. Neither your doctor nor you know or even can know what the safety of this drug is like
D
Lori Jones says
I just went to my rheumatologist and because I’m hurting and been sick he prescribed Otezla. I can’t take biologics cause I’ve had basal cell skin cancer. He just doesn’t feel comfortable in giving me any drugs like that. On the other hand I have rheumatoid Arthritis. I’m on a DMARD already. I’m starting the trial pack tomorrow morning. We will see what happens. Much love to you 🥰
Tiffany says
Fortunately, I have not yet experienced these s/e. I was covered head to toe in psoriasis and absolutely miserable. I tried multiple natural remedies (diet changes and even quit my job because I began to have panic attacks due accumulated stress. I started Otezla two weeks later and saw no results until a little over 3 months later. During this time, my psoriasis continued to get worse but I kept taking this med due to no s/e experienced. When it started working, I was so thrilled.
My husband and I want to start a family very soon so I will work with my doctor on coming off Otezla. I would prefer to not take any medication and have heard pregnancy can sometimes resolve psoriasis, temporarily.
Tee says
I appreciate a possible positive experience on this medication. I’m about to start. I’ve been living with severe psoriasis for years and it just keeps getting worse. It’s not cosmetic for me, it’s uncomfortable and irritating. I wanted to wait until after child to start internal meds and here I am. I hope your weaning off, and pregnancy journey go well for you.
Dimitri says
Hi,
After three weeks of Otezla, I experienced numbness, tingling and burning on my hands and feet etc, symptoms of peripheral neuropathy. I stoped the medication a month ago. I really hope that the symptoms will resolve. I tried to find reports of people experiencing neurological side effects taking Otezla without great success. I’m happy to find this forum. Please if anyone else have experienced these side effects, it will be of a great help: how they dill with it, if after stopping the drug they saw remission…
Dr. David Healy says
D
Thanks for this comment. For people who don’t know peripheral neuropathy was the key symptom that pointed to birth defects before the birth defects on thalidomide came into view.
D
Dimitri says
Dear Dr. Healy,
Thanks a lot for your reply. I really appreciate it. The fact that Otezla is a “variation” of Thalidomide and in general drugs that suppress TNF-a (Otezla also tries in its way to suppress TNF-a) can produce neuropathies, could we assume that there is a possibility that my peripheral neuropathy is due to Otezla? Have been taking this drug for 5 weeks. Could these symptoms eventually resorb in the future due to the discontinuation of Otezla? Thanks again.
Dr. David Healy says
D
Keep an eye on the PSSD story – thalidomide and SSRIs act on the same p63 mechanism – both cause peripheral neuropathy and sexual problems and agitation – so whatever answers come from our research on p63 and the use of anticholinergic drugs to regenerate peripheral nerves may offer some help to you also.
Even without this help, hopefully you will recover
D