Esketamine UK: The Good News ~ The Bad News

Yesterday, the National Institute for Health and Care Excellence (NICE) announced that Spravato (esketamine) not be recommended for use because of uncertainties over its clinical and cost-effectiveness.

The media picked up on this and many, initially including myself, were happy that such a strong message had been sent out by NICE.

However, there's a big clue in the words 'not recommended'.

Spravato is a nasal spray and according to Janssen, a subsidiary of Johnson & Johnson, the company that market and manufacture it, is indicated for treatment-resistant major depressive disorder in adults.

Treatment-resistant depression, for those who don't know, means, if you've been treated for depression but your symptoms haven't improved, you may have treatment-resistant depression. Big clue in the word 'may'.

In a nutshell, those patients who have been taking antidepressant-type medication, including antipsychotics, to treat their depression may not have needed them in the first place because, it appears, we are now being told that this type of medication has no effect on certain groups of people. Nobody knows who those 'people' are or why antidepressants don't work for them. Pretty much in the same way nobody knows why they work for some people.

One would have thought that investigative research into this was paramount but instead we have a new label, 'treatment-resistant depression' and, wonder of wonders, a new drug that can help this group.

It makes me wonder why a person who takes a product becomes the fault of that product. If I purchased a box of matches and they didn't light when struck, would I be labelled as having some sort of disorder?

I first became aware of ketamine to treat depression back in 2013 when I learned of one of the most bizarre studies I'd ever read. I've read many more bizarre studies since then but this one piqued my interest.

The 2011 study was carried out by Gregory Larkin and Annette Beautrais, the conclusion of which found that the intervention of administering the horse tranquillizer, Ketamine, to patients suffering from depression or displaying suicidal tendencies is "likely to be effective and appropriate for only some subgroups of the depressed and suicidal emergency department population."

The study, carried out on 15 patients, ran over a period of just 10 days and saw patients given a single dose of Ketamine [dose depending on weight] and then monitored over a period of four hours whereby they were given a set of questions using the Montgomery–Åsberg Depression Rating Scale [MADRS]. These ratings were obtained at baseline, and at 40, 80, 120 and 240-minute intervals. Patients were then contacted over a period of 10 days.

There was no control group in this study.

In essence, it appears that the study only lasted 4 hours and the follow-up [10 days] was presumably to follow-up on the 15 patients to see how they were coping [ie; side effects, if depression or suicidal thoughts had returned]

Back in 2013, I laughed off the study, I mean who in their right mind would prescribe a party drug to depressed and suicidal people? It will never take off, I thought.

How wrong was I?

March 5, 2019

Some 8 years after the bizarre study carried out by Larkin and Beautrais, the FDA announced that it was approving Spravato for treatment-resistant depression. Their blurb read:

The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).

The approval came despite mixed results in the esketamine clinical trials. Esketamine improved depression in two late-stage studies compared with placebo. But the drug fared no better than placebo in two others. I'd say that was a 50/50 benefit/risk type of drug, wouldn't you?

Moreover, the FDA seemingly glossed over the adverse events in the clinical trials. Three patients who received the drug died by suicide during clinical trials, compared with none in the control group. This, to me at least, makes the drug more of a 40/60 benefit-risk type of drug.

Two months after FDA approval, the European Medicines Agency (EMA) recommended that it be approved in Europe too. This recommendation was sealed on December 19,2019 when Janssen announced that the European Commission (EC) had approved Spravato nasal spray, in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), for adults living with treatment-resistant major depressive disorder.

28 January 2020

The NICE website runs with the headline, "Nasal spray medicine for treatment-resistant depression not recommended by NICE"

The statement, if one reads between the lines, seems more about the cost of Spravato more than the concerns about its efficacy and safety. However, one line from the statement is striking. It reads, "...there is uncertainty about the effect of stopping esketamine treatment."

So, what does Janssen make of all this? Well, pulling statements from various media articles it appears they're not happy.

Here's what Janssen-Cilag executive Jennifer Lee had to say:

“...current NICE technology appraisal processes are not fit for purpose in terms of evaluating innovative technologies for complex mental health conditions.”

Ouch!

What's complex about someone not benefitting from antidepressant treatment?

It's here we learn that Janssen are now widening their net. They have now applied for an addition to the label stating that Spravato be used for people with major depression considered to be a suicide risk, based on its rapid onset. (Refer back to Larkin & Beautrais)

The publication of the NICE draft guidance kicks off a consultation period until 18 February 2020, with a second appraisal committee meeting expected in March or April to consider the comments received.

In the meantime, Janssen executives will be liaising with NICE officials, no doubt to tell them how wonderful Spravato is and to ignore the three suicides in the clinical trials. Who knows, they may even offer Spravato to the UK along with a subsidizing plan, given that the NICE draft seems to be more focused on its cost than the safety of the patients who take it.

One thing though, if NICE does a U-Turn then they will have to show the public the evidence that suggests the effect of stopping esketamine treatment isn't an issue. Given the shortness of these clinical trials I suspect they will approve it with the caveat, "Patients must be monitored, particularly during withdrawal of esketamine."

Russian Roulette, folks!

Or am I just an old cynic?

Bob Fiddaman

Related

Suicide Prevention and Ketamine - Larkin & Beautrais

Psychiatry Going All Monty Python!

It's been a strange week, for me at least. First, my beloved Aston Villa were relegated from the Premier League into the Championship ~ I was going to write my thoughts on it but so many have already done that, besides I've become disillusioned with modern day football over the years ~ inflated ego's kicking an inflated pig bladder over grass doesn't really appeal to me anymore. I'd rather watch a goldfish swimming around a fish bowl or, better still, use Canadian dwarfs as tenpins whilst bowling tennis balls down a shiny alley to knock them over. (that's a personal joke so, puhleeease, no hate-mail)

Next, I hear that Axl Rose has joined AC/DC and will take over vocal duties from Brian Johnson who is having problems with his hearing ~ I was going to offer my thoughts on this too, again, so many have already done that. Besides, despite being a fan since 1978 and seeing them perform live more times than I can remember, last year was my farewell to them. Wembley stadium was packed with fans, the majority of whom being there because it was "fashionable" to see AC/DC. I can't sit with those type of people anymore.

Then came along something that sent me into a state of apoplexy. It's the latest from the field of psychiatry that had me biting the leg of the chair in efforts to control my hysterical laughter, much to the bemusement of the old lady sitting next to me on the bus (I jest)

The headline comes from Medscape, an online magazine aimed at professionals in the field of medicine, it reads, "Undetected ADHD May Explain Poor SSRI Response in Depression."

Okay, okay, calm down folks. Sometimes headlines can be misleading. Let's just take a look at the article more closely.

The research cited in the article was  presented at the Anxiety and Depression Association of America (ADAA) Conference 2016. (Plenty of chair leg biters present) and was, according to Tia Sternat, Mood and Anxiety Disorders Program, University of Toronto, the result of "collected data from 123 referrals to a single tertiary-care mood and anxiety clinic. The mean age of patients was 39.8 years; ages ranged from 17 to 71 years. A total of 105 patients were included in the final analysis."

The  diagnosis was performed using the Mini International Neuropsychiatric Interview Plus 5.0.0.

So, no brain scans, blood samples, urine tests?

Just an "interview"

Class.

It gets better. Here's Tia Sternat again...

"...symptoms of ADHD morph as people age, and what happens is that they'll end up with treatment-resistant depression or anxiety," she said.

The article finishes with...

"Tia Sternat has disclosed no relevant financial relationships."

So, not the same Tia Sternat who was once employed by Janssen Inc and who is a business learning manager at Pfizer then?

Honestly, what a load of codswallop!

Here we have a situation where antidepressants are not working so, let's not blame the antidepressant, let's blame the patient, furthermore, let's tell the patient that the reason the medication doesn't seem to be working is because they have an underlying mental illness that cannot be seen on any modern day scan or through blood or urine samples...but they have it because the answers they gave in a questionnaire proves this.

Talking snakes, fig leaves and apples, anyone?

Now, the majority of my Facebook and Twitter friends won't even read this when I post the link, they may leave a comment on social media and, in general, it will be something along the lines of "Crazy" or "Madness", even "Stupid morons" may even make comment sections?

What we have here is an apparent medical 'profession'  (I invert the word with comma's because to be professional you really should be good at something) who have had to come up with a reason why prescriptions they dish out don't work. It's not the drug, it's the patient, let's find a way that we can convince fellow professionals that ADHD is laying dormant in this particular group of patients and then let's show our findings to all those gathered (fellow psychiatrists) at the Anxiety and Depression Association of America (ADAA) Conference 2016.

I'm wondering if the presentation was greeted with enthusiastic applause or if it was greeted by open-mouths and fellow 'professionals' staring into the abyss (Oops, first sign of ADHD folks)

It reminds me of the famous Monty Python parrot sketch. Customer buys parrot ~ takes parrot home ~ realises said parrot is dead ~ returns it to shop only to be told that it's not dead, it's sleeping. Not the purchase ~ it's the customer, which is, in essence, what we all are to the white-coated brigade.

Psychiatry really shoots itself in the foot with this kind of research, particularly when using pens and paper as a means to determine if someone has a disease in their brain. They may as well determine mental disorders by playing 'pick-up sticks with your butt cheeks.' One who picks the least sticks up has Bumpolar or Attention Buttcheek Disorder (ABCD)

What a clusterfuck!

Bob Fiddaman.

ADHD - Market Challenge - Unknown Etiology

A market report carried out by TechNavio analysts predict that the Global ADHD Drugs market will grow at a rate of 5.33 percent over the period 2013-2018.

The 80 page report, if you are financially well off, costs a staggering $2,500 to purchase. The report covers...

The present scenario and the growth prospects of the Global ADHD Drugs market for the period 2014-2018. To calculate the market size, the report considers the revenue generated from the sales of various therapies used in the treatment of ADHD, which include:

Stimulants

Non-stimulants

TechNavio's report, the Global ADHD Drugs Market 2014-2018, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the Americas, and the EMEA and APAC regions; it also covers the Global ADHD Drugs market landscape and its growth prospects in the coming years. The report also includes a discussion of the key vendors operating in this market.

Interestingly, one of the main market challenges the report found was...wait for it... are you ready yet?

Unknown Etiology

In other words, those manufacturing the drugs to treat ADHD don't actually know the causes of ADHD.

To combat this (small flaw) the Pharmafia (that's pharmaceutical companies and medicine regulators combined) will use various marketing strategies to say how bad ADHD can be if not treated... and actually skip the fact that they, themselves, do not know the etiology of it.

The report suggests that the Pharmafia must "increase the awareness" so expect a lot of pseudo-science over the coming years folks.

Drugs discussed in the report include Strattera, Concerta/Ritalin, Focalin, Intuniv and Vyvanse/Elvanse/ Venvanse.

The key vendors, according to the report, are Eli Lilly, Janssen, Novartis and Shire.

Between now and 2018 it appears that the goal is to not only target children who have a brain disease but adults too.

A brief abstract of the report reads...

ADHD is a psychiatric disorder, which is mostly found in children. However, adults have also been reported to be diagnosed with ADHD. The patients with ADHD suffer from several problems including hyperactivity, impulsiveness, and lack of focus and concentration. The causes of ADHD are not known. It is believed to be linked with genetic and environmental causes. However, it has been reported to be related with the decrease in the extraneuronal levels of norepinephrine and dopamine. In addition, the patients have an abnormality in the brain structure. It is more prevalent in boys than girls. The management of ADHD is done by counseling, medications, and lifestyle changes.

Notice how the causes of ADHD are played down and followed with the standard Pharmafia scaremongering line... "It is believed to be linked with genetic and environmental causes. However, it has been reported to be related with the decrease in the extraneuronal levels of norepinephrine and dopamine. In addition, the patients have an abnormality in the brain structure."

What you, as a prospective consumer, need to take from this are two key words...

1. Believed
2. Reported

In other words, the Pharmafia "believe" in a theory because it, coincidentally, means they will be able to treat a population based on this theory.

It has been "reported" basically means that the Pharmafia have cherry-picked reports, once again to suit their own agenda (selling drugs)

They did this with SSRi's when they were first launched. Back then we were told that SSRi's such as Prozac and Paxil could correct a chemical imbalance... (the cause of the anxiety and depression we were feeling)

When this theory was proven to be incorrect one would have thought that trading standards would have slammed the Pharmafia for selling products on a lie. However, the Pharmafia still had the luxury of tweaking their wording.

Look at any SSRi on the market today and you will see a key line...

"It is thought"

So, "it is thought" that anxiety and depression are caused by a chemical imbalance. It still gives us the message that they are right and we have something abnormal with us.

And that's exactly how they want it to remain folks.

If you want an alternative treatment for your child then read Psychiatric Medication or Play Therapy?

If you are an adult who has been diagnosed with ADHD and, as a result, you have been offered medication to control it then... well, you are grown up enough to know that the Pharmafia just want your money and want you hooked on their wares.

Some of the side effects of the drugs mentioned in the report are pretty severe - Pharmafia will play those down too.

In a nutshell, before you decide to go down the road of drugging yourself...or your children, do your homework.

Don't believe me? When diagnosed answer your doctor with a two-worded question and watch his face.

The 40 second video perfectly shows this.

Bob Fiddaman.

Rebadge, Reinvent and Reap Rewards of ADHD Medication

One thing I've learned over the past 8 years of writing this blog is that the system that is supposed to protect us from dangerous drugs is a system that has been infiltrated by pharmaceutical dollars. Be it the FDA, MHRA or any other drug regulatory agency.

I've also learned that the only way one can change how we, as patients, view these psychiatric medications is by opposing the claims of pharmaceutical companies that they actually work and are safe for human consumption.

Be a pain in the ass, the big man doesn't like it. Ask questions, the big man doesn't like it.

I've got a lot of admiration for other folk who have dedicated their lives to getting to the truth about antidepressant type medication, be they human rights movements, professors, journalists, grieving parents or just folk who have the tenacity to never give up in their pursuit for the truth.

Janne Larsson is one such person.

Larsson, who hails from Sweden, has, for many years, been investigating the drug Concerta, an investigation that has now led him to the doors of the British drug regulator, the MHRA.

What we have here is deception of the highest order...a deception that Larsson wishes to make public.

Larsson has wrote to the new chief at the MHRA, Dr Ian Hudson. The question he has put to the former World Safety Officer for SmithKline Beecham is simple...Will the MHRA handle the Concerta scandal by approving Ritalin for adults?

Larsson, after many years of investigation, has kindly copied me in on the email to Hudson. It makes shocking reading.

He writes...

In the beginning of 2011 secret internal MHRA documents revealed: The application to get the ADHD drug Concerta approved for adults was refused; Concerta was found to have “negative benefit/risk balance” for adults.

The disapproval of the drug for adults has been a well-kept secret: NO information whatsoever has been issued by the MHRA or the other European medical agencies about the disastrous results.

Let’s look on what was hidden for doctors and the public.

This is the not published table over the Adverse Events of Concerta in clinical trials. It is part of the manufacturer Janssen’s “Response Document” (page 84) to the MHRA, from 11 January 2011.

In the Company’s three best (!) studies of Concerta on adults, the ones chosen for Janssen’s application, the following harmful events emerged in the short-term studies (up to 13 weeks), where Concerta was compared to placebo:

·         The persons who received Concerta had a 270% increased risk for heart disorders in form of Arrhythmias;

·         The persons who received Concerta had a 116% increased risk for Aggression;

·         The persons who received Concerta had a 62% increased risk for Depression;

·         The persons who received Concerta had a 225% increased risk for neurological disorders in form of Tics/Dystonias;

·         The persons who received Concerta had a 190% increased risk for Psychosis/Mania;

·         The persons who received Concerta had a 295% increased risk for Anorexia;

Meantime, in Larsson's native Sweden, Concerta prescriptions have risen by 60%, netting the manufacturer, Janssen, a cool 488 million SEK (45 million GBP)

Fear not... If one bad drug can be pushed in one country then expect the very same drug to be pushed in other countries. Step into the fray Novartis, manufacturer of Ritalin, an ADHD drug that is, in essence, exactly the same as Concerta.

Larsson finishes his email to the MHRA with the following...

I am sure Novartis has learned from the failed Concerta submission and that there is a big interest from the officials mentioned above to push through the approval of Ritalin for adults. We can expect that the submitted studies will get a positive assessment this time – no embarrassing questions – and suddenly the concealed and alarming Concerta results can be expected to no longer exist! Janssen will also be saved; no criminal actions will be taken.

But it’s hard to see how the above can fit with the MHRA declaration: “We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.”

So Mr Hudson, will the MHRA take part in this dirty game of approving Ritalin, so that we can forget about the Concerta scandal?

It's a fair enough question but I don't expect an immediate response from Dr Ian Hudson. I wrote him in November as I was concerned about MHRA consultant, Stephen J W Evans and his recent call for a re-evaluation of the current prescription of SSRIs in young people.

Ironically, I received a reply a few hours ago, not from Hudson but from Sarah Morgan, Group Manager, Benefit Risk Management Group, Vigilance and Risk Management of Medicines.

My query wasn't really addressed by either Hudson or Morgan [no surprise there] - it was the bog-standard "the MHRA has comprehensively reviewed evidence on the benefits and risks of SSRIs" type of email.

I have to take off my hat to Larsson for pursuing this. I hope he is made of strong stuff, my experience with the MHRA and their limp-wristed buck-passing cahoots has been highlighted on my blog and in my book on many occasions.

Good luck Janne!

The full email sent to Hudson from Larsson can be downloaded here.

Bob Fiddaman

Child Medication [ADHD] Linked to Sexual Organ Abnormalities

So, we know about Risperdal causing breast enlargement in boys. Janssen's own clinical trials, with just 1,885 children, showed that 43 of them developed abnormal breasts. [1]

Now we learn that boys, such as the four year-old who developed a breast on one side and began producing milk, are at further risk. This time, we are told, it's priapism, a condition that can permanently damage a patient's penis.

So, let's just get this straight.

Using psychiatric medication in children can cause suicidal thoughts, completed suicide, abnormal breasts in boys and now permanent penis damage.

If that wasn't enough we already know that these drugs, when taken by pregnant mothers, can cause birth defects. If your child is lucky enough not to develop birth defects in the womb then they can die from overdose when ingesting breast milk from their mother.

That some huge net pharma have cast out.

Psychiatry and Pharma must be very proud of themselves.

Who needs birth control pills when psychiatric medication does pretty much the same thing.



Priapism story here


Bob Fiddaman


[1] The New Drug Of Choice - CBS Video - May 2009

Adult ADHD - The Comic

I've heard about adult ADHD before, never really took much notice as I honestly thought that grown-ups wouldn't be taken in by such mumbo-jumbo. I didn't even know [my naivety] that adult ADHD was being promoted here in New Zealand - kind of makes sense that it is though seeing as the NZ government tackle everyday emotions with drugs. Quit smoking - try Champix - Depressed - Try an SSRi.

Adult ADHD is, it has to be said, one of the more ridiculous mental disorders to hit the streets and make the pharmaceutical industry even richer.

Yesterday, whilst sitting in the waiting room of a doctor's surgery, I was thumb twiddling, bored out of my mind as the only magazines available to read were trashy gossip types, you know the kind, the close-up paparazzi shots of actresses in their mid thirties who [shock-horror] have rings under their eyes or a crease or two on their thighs.

Not one for reading about rings and creases I turned my attention to the array of brochures lining the waiting room wall. Two in particular caught my attention, one was a quit smoking brochure, the other 'Adult ADHD'.

The quit smoking brochure was basically promoting Champix, the smoking cessation drug that can make you want to kill yourself. I've highlighted the whole Champix promotion here in New Zealand in a previous post [see - Sometimes the New Zealand Government Get It Wrong]

In this post I will focus on the second brochure I picked up yesterday. [See Fig 1 and 2]

I was giggling to myself whilst reading the 'science' or lack of. There's even a test adults can take to seek help from their doctor if they score 4 or more out of the 6 questions provided.

I took the test, hey I had nothing better to do and I found it more entertaining than reading about creases and rings on the latest celebrity to be dragged down from a pedestal she never wanted to be on in the first place.

I scored 4 and the brochure recommends that I make an appointment to see my doctor.

Yikes! I may have adult ADHD - How on earth did I get this mental disorder?

Well the brochure tells me, in no uncertain terms, that adult ADHD may be a result of my kids having ADHD?

Now, I'm confused? My kids don't have ADHD, although if they had taken any of the tests designed to make them have ADHD then I'm sure the brochure would have reeled me in.

Okay, so my kids don't have it, how come I do?

According to the brochure common symptoms of adult ADHD are:

Difficulty in relationships - Yup, myself and Maria do have our disagreements and, hey, I was divorced many years ago due to having difficulties in a relationship - They got me.

Difficulty in starting complex tasks and completing tasks - Um, does that include putting a shelf up or prepping a wall to be plastered? If so, they got me again.

Increased incidence of car accidents/traffic violations - well, I don't drive but I do cross the road without using pedestrian crossings - I think that's called Jaywalking in America - maybe it's now been deemed as a mental disorder? You laugh but almost everything else is so why not Jaywalking?

Lack of organisation - Oops, they got me again. I couldn't organise a drinks festival in a brewery!

Apparently, when compared with adults who don't have adult ADHD, I may have higher rates of anxiety, depression and substance use disorders. I'm doomed, doomed I tell ya.

Fear not, the brochure tells me some important news, a lovely big green box with bold white writing tells me, "While ADHD cannot be cured, medication and behaviour management strategies can help to control the symptoms associated with ADHD."

Oh yippie! I'm saved... saved I tell ya.

Okay, so how did I get this brain disorder? - I know it's a brain disorder because the brochure tells me so.

"ADHD is a brain disorder that can cause hyperactivity, impulsivity and difficulties paying attention"

Oh, someone just walked in the waiting room with a limp....

Dang it there goes my concentration.

The brochure continues with the science behind adult ADHD:

"It is estimated that 4% of adults in the US have ADHD" - Golly, must be something they put in the water, right? Anyway, I live in New Zealand and drink rain water [through a filter of course]

"If this rate of occurance is true for NZ", according to the brochure, "this means that approximately 86,000 adults between the ages of 18 and 50 years of age have ADHD."

Gadzooks!

Furthermore, the brochure tells me:

"ADHD is a highly heritable disorder, and approximately 20% of parents of children with ADHD have ADHD themselves."

The test is based around six questions, the answers range from never to very often. You can take the test yourself, just click on Fig 2.

I have to say the whole brochure kept me entertained and lifted my boredom whilst sitting for almost an hour in the waiting room - very uncomfortable on those hard plastic chairs that I found myself fidgeting a lot, ironically that's yet another symptom of ADHD.

The 6 question test that appeared in the brochure, called 'The Adult ADHD Self Report Scale Screener' [ASRS] is copyrighted to the World Health Organisation [WHO]

The information sourced in the brochure comes courtesy of Janssen Pharmaceuticals. Janssen manufacture and market Concerta [methylphenidate], a drug used for ADHD.

The brochure may fall into the hands of someone who actually believes the garbage written within it. How often do people get emails telling them they have won the Nigerian lottery? Many of us do, but many of us recognise that it's just a scam - sadly there's a small percentage sucked in and it's those that often part with money to release the lottery winnings from the Bank of Umberjaja.

This brochure was written in exactly the same way as those Nigerian email scams. They were designed to target the vulnerable, to make those vulnerable people believe that, a; they could have something and b; they just needed to part with some cash to get to that something.

That's pretty much how the pharmaceutical industry work - they plant the seed then offer the remedy. They offer no science but selective science. They'll gather 50 or so studies on ADHD, cherry pick all the bits that benefit them and bury the bits that would actually benefit the patient.

If written in the 1970's, early 80's this brochure would have made a great skit for the 'Not the Nine O'Clock News' team. Messrs Atkinson, Smith, Jones and Stephenson wouldn't have needed to work out a funny routine, the brochure is basically the screenplay.

I've used 'Not the Nine O'Clock News' as an example because the brochure reminds me so much of the 'Constable Savage' skit performed by Rowan Atkinson and Griff Rhys Jones. It's so ludicrously absurd that one has to laugh at the belief.

Constable Savage [Jones] likes to take the law into his own hands. This is frowned upon by his Sergeant [Atkinson]. It's not difficult to make comparisons here.

The comedic brochure, complete with The Adult ADHD Self Report Scale Screener, is below.

Fig 1

Fig 2

Bob Fiddaman

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