Generic Paxil Suicide Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Monday, March 18, 2019

BBC Fail on Antidepressant Mythology





Every time there's a chance to air the truth about brain pellets we fail, and we fail miserably.

Take a radio interview on the BBC2 radio show hosted by Jeremy Vine as a classic example.

Guests included Sarah Vine, Daily Mail columnist and wife of Conservative Member of Parliament, Michael Gove and also TV and social media health spokesperson, Dr Sarah Jarvis.

Sarah Vine has been quite vocal of late about her struggles with depression, moreover, with her prescription brain pellet, Cymbalta, prescribed to combat her depression.

Yes, it's great when a high profile name discusses the difficulties of withdrawing from a particular brain pellet, but it's not so great when that person doesn't really have a clue about the history of the said brain pellet. Quite who made Sarah Vine a spokesperson for the prescribed harm community remains a mystery. No doubt having a husband who is a high-profile politician helps.

Sarah Vine is not the right person to be talking about brain pellets, let's just make that abundantly clear. Her performance on Jeremy Vine's (no relation) radio show proved this.

I feel for her. Her withdrawal sounds bad, particularly with a brain pellet that comes in capsule form with beads of a toxic substance. Quite how she tried to withdraw is unknown as Cymbalta is particularly difficult to taper from as it has no liquid version nor can you cut it in half due to the capsule being full of beads reminiscent to the hundreds and thousands one places on top of an ice-cream.

Sarah Vine experienced brain zaps, tinnitus, joint pains and irritability when trying to stop Cymbalta - her tapering regime is, however, unknown as she never went into detail about this. She did, however, claim that Cymbalta helped with her depression. Speaking with Jeremy Vine and Sarah Jarvis, she told them, "I understand depression is chemical as well as circumstantial and I think that they (brain pellets) do redress the chemical imbalance."

I can only assume that Sarah Vine lives in a posh part of London with her MP husband and not in some hut on the planet Zog. I would assume that she has done her research on these brain pellets by trawling through drug company or psychiatry-based websites.

Hey Sarah, guess what? You're so wide of the mark?

Sarah Vine went on to say that, "For the majority of people the benefits outweigh the risks". Again, this is the mantra of drug companies and psychiatry.

Be nice to know if this journalist/columnist has evidence of this?

The resident doctor, Sarah Jarvis, played down the claim regarding a recent study that highlighted how the majority who take brain pellets have withdrawal effects by stating, "That was a study which was ONLY (her emphasis) identifying patients through a questionnaire.

The host, Jeremy Vine, never once asked the resident doctor if she had ever seen the full safety data for brain pellets.

Memo to Jeremy Vine - talk to people who can, at the very least, put the professionals in an uncomfortable position.

Journalism - a fucking dying art.

The interview can be heard approx halfway through the Jeremy Vine show.


Bob Fiddaman







Wednesday, March 06, 2019

Life-Saving Evidence





Last month the Q & A between myself and Carmine Pariante broke down. For those who don't know, Pariante is a professor of biological psychiatry at the Institute of Psychiatry at King's College, London, and consultant perinatal psychiatrist at the South London and Maudsley NHS Trust. He apparently has no sway in whatever the Royal College of Psychiatrists (RCP) say or do yet always seems to speak on their behalf.

Pariante was interviewed on BBC Radio 4 today after the subject of brain pellet withdrawal once again made the news in the New York Times. He was introduced as someone "from the Royal College" and proceeded to carefully and selectively bang the drum regarding the safety of brain pellets, so much so that even RCP were tweeting his quotes from the show (Fig1). Quite why Pariante is the College spokesperson is anyone's guess.



Check out the use of the word 'most'.

What irks me more than anything with the above tweet is that features a certain unproven claim in that brain pellets save lives. There will be many who claim that they do, I for one, find this ludicrous given that nobody can prove this. Sure, we get those people who claim, I would have killed myself if it wasn't for Prozac, Paxil etc but they cannot be 100% certain that they would have gone on to complete suicide, even if previously they had experienced suicidal thoughts.

This "life-saving" claim really has no substance and shouldn't be allowed, or at the very least should be preceded by, "they can induce suicide in people." One thing I've noticed about high profile shrinks such as Pariante is that they never ever talk about brain pellets inducing suicide, at least not on radio or TV shows, and certainly not in the mainstream media.

During my Q&A with Pariante last month he had this to say to me about brain pellet-induced deaths:

"I accept that it is possible that some patients might have died as a consequence of taking antidepressants, and my heart goes to them and to their families. But these, as tragic and sad as they are, are very rare events."

No mention of this in today's BBC show though.

Pariante was invited to speak today after the show had previously aired Daily Mail columnist, Sarah Vine, who spoke about her own troubles trying to withdraw from brain pellets. Adding their voices were Prof John Read and Patient safety advocate James Moore. Everything they said was pretty much undone with Pariante's 'life-saving claim'.

I'm getting sick to the back teeth of this outlandish claim and it beggars belief why nobody ever presses these key opinion leaders for evidence.

If, as both Pariante and Vine suggested, brain pellets save lives don't you think this would be a huge marketing advantage for the drug companies? I've read through every single leaflet in brain pellet boxes (SSRIs) not once do the drug companies claim that their product can save your life, so why does Pariante et al claim otherwise? If drug companies had evidence that their product was, in fact, a miracle pill, don't you think they would have used this as a major selling point?

What does Pariante know that we don't?

The radio show was, for me at least, disappointing. Why is nobody asking these shrinks how they can prescribe brain pellets when they have never seen the full safety data of the said brain pellets? Has journalism become so poor that the newer breed of writers have not grasped how to ask for supporting evidence when someone makes outlandish claims, or have they not grasped how to get to the root of a problem with decent questions?

If prescribers, such as Pariante do not have the full safety data then they know very little about withdrawal. They have no withdrawal data from drug companies either unless they care to trawl through countless pages of files released in drug company litigation. The evidence is there, they're just too lazy or pig-shit ignorant to read it.

Brain pellets do not save lives, to suggest that they do is a real kick in the teeth for those who have lost loved ones to brain pellet-induced suicide. It's a carefully crafted piece of PR spin, it's a trump card that they hold because (they claim) they have seen many patients saved by SSRIs.

Quite strange then, that these same shrinks have, for nearly 40 years not witnessed 'anyone in their clinical practice' suffering from severe brain pellet withdrawal. They see what they want to see, or what they are paid to see.

That not so nice acronym, N.I.C.E, was mentioned in the BBC show. They claim they are working on developing new guidelines for prescribers - they, just like every man and his dog, have never seen the full safety data that the drug companies hold, they, just like every man and his dog, are assuming that the evidence supports brain pellet use because they have published papers to prove this. What they don't tell you is the published papers are ghostwritten by the drug companies who pay key opinion leaders to add their names to these shoddy publications.

Here's a thought to ponder on. Why do you think drug companies don't say "THESE DRUGS WILL SAVE YOUR LIFE" on the insert in the box that accompanies brain pellets? Would it be something to do with making fraudulent claims?

Have you ever heard of anyone suing drug companies because the brain pellets didn't save their loved one's life? Of course not, because drug companies don't make this absurd claim.

Meantime, these brain pellets are responsible for endless misery, be it through the mourning of a loss of a loved one or watching a loved one's personality change as he/she tries to cope with the horrendous withdrawal effects these toxic chemicals cause.

I'm reminded of a quote from the late, great, Christopher Hitchens:

"What can be asserted without evidence can also be dismissed without evidence."

Pariante has, in the past, received funding from brain pellet manufacturers, Johnson & Johnson, GlaxoSmithKline, Lundbeck and Pfizer (source)

Bob Fiddaman


Monday, February 18, 2019

Q&A with Carmine Pariante






Carmine Pariante FRCPsych is a professor of biological psychiatry at the Institute of Psychiatry at King's College, London, and consultant perinatal psychiatrist at the South London and Maudsley NHS Trust. He received his PhD from the University of London and his MD from Gemelli University, Rome (Source Wikipedia)

Toward the end of last year, I became increasingly concerned about the behaviour of some of the psychiatrists on Twitter, many of whom were (and still are) belittling patients harmed by brain pellets.

I was hoping to discuss this in person with Carmine Pariante but due to logistics and time restraints, this never happened. Instead, we both agreed on a Q&A.

Sadly, for me at least, communication between us (via email) came to an abrupt end.

My reasons for ceasing communication can be seen in the thread of emails below. I will leave it to readers of this blog to decide whether or not I made the correct decision in ending the conversation.

Carmine wanted the last word but because he opened the questioning and was given ample opportunity to express himself, I have denied this request. I did inform him, however, that he can leave a comment on here if he wishes or publish this Q&A with his additional comment on his own website.

As a side note, when I eventually retire from this often dark and depressing arena, I hope some of the newer advocates, of which there are plenty, take up the issue of clinical trial data that is withheld and ghostwritten literature. It's the single most important issue regarding brain pellets, any other debate is irrelevant until this issue has been tackled and resolved. We need to speak about this because it has been sidestepped for far too long.

Bob Fiddaman

--

Q&A with Carmine Pariante

** Some grammatical errors have been rectified

Pariante
All medications have profound side effects: antibiotics, painkillers, or drugs for cardiovascular disorders. People suffer severe and life-threatening, unpredictable adverse effects taking many common medications. Do you think that antidepressants are simply like any other drugs: helpful and safe for a lot of people; ineffective, unsafe and intolerable in an important minority of patients; and tragically able to cause severe, unpredictable, life-threatening adverse effects in a small minority of patients? If not, how are they different from other medications?

Fiddaman
First off, I'm happy you raised this issue as it seems to be the defence of many psychiatrists when the efficacy and dangerous issues of antidepressants are raised.

Yes, all medicines carry risks of adverse events but, in the main, those other medicines target specific areas or diseases. I wouldn't really class suicidality as an "adverse event", to do so plays it down and it becomes lumped together with headaches, nausea, dizziness etc, as do the issues of withdrawal, birth defects, sexual dysfunction.

Antidepressants can induce suicidal thinking and, in some cases, completion of suicide, I hope we can agree on that?

To take a gun and pull a trigger, to tie a noose and wrap it around your neck, to take a knife and stab yourself through the heart, to jump from a bridge to your death, all carry horrifying images but this is the stark reality of it for some people. These should never be classed merely as 'adverse events' - these are people, both young and old, who, because of antidepressants, killed themselves because of an inner restlessness (akathisia) caused by these drugs. Nobody in authority, except for a small handful, seems to want to address this issue, opting instead to deflect by wishing to talk about the adverse events of 'other drugs.' I have never seen any discussion by yourself or RCP that tackles this issue. It's almost as if its a taboo subject for you or something you, and your peers, are ignorant of?

Do I think antidepressants are safe and effective for a lot of people and not safe for a minority? - No. I think both prescriber and patient believe they are safe and effective when in actual fact this may just be the placebo effect at work. If, as you suggest, they do help people then I'd like to know how? Aspirin, for example, helps by targeting the pain and swelling - What do antidepressants target, why do people seem to do well on them (group A) when others don't (Group B)? What is it that group A has that group B doesn't? Also, one should not use the term 'safe and effective' when one knows that they cannot clearly state this because of the suicide link. Isn't it more important to say, these drugs could induce suicide but are safe and effective for others? What's more important to you given that you, or anyone else for that matter, have never seen the raw data that drug companies seem reluctant to release?

I think depression is over-diagnosed and, as a result, antidepressants are over-prescribed. If you see today's figures as a modern-day clinical trial then the results will, of course, favour their safety and efficacy - the more taking them actually masks the problems people face whilst on them, be it suicidal thoughts or withdrawal problems. If, for example, two in ten people suffer at the hands of antidepressants then prescribing more would eventually bring this figure down. In any event, the apparent safety and efficacy of these group of drugs are based on 8 to 12-week clinical trials. In the real world, people are taking them for much longer. In the real world, people aren't 'severely' depressed, as they are in clinical trials, they may just be going through a bad stage of their life because they may need help due to circumstances in their environment. A pill cannot magically pay bills, fix broken marriages, or help a child pass exams but, for some prescribers, this seems to be the reason why they prescribe them.

I feel the question you asked here is irrelevant when the focus should not be 'other meds cause problems' - the focus should be, 'we acknowledge that these drugs can make people self-harm, have suicidal thoughts or, at worst, kill themselves and/or others.' This is what needs to be addressed, along with a whole other multitude of dangerous adverse events associated with these drugs. Talking about it and referencing 'other drugs have adverse events' is shying away and playing down the risks.

If an airline company had a fleet of ten 737's and one of those planes was unsafe to fly in, I doubt very much if the airline CEO would say 'one of our planes, we don't know which one, is unsafe to fly in but the other 9 are safe'.

In the case of antidepressants, prescribers are, in essence, playing Russian Roulette when they prescribe them. It's an unfair advantage prescribers have as they never take turns in pulling the trigger.

Pariante
I should probably start by stating one thing on which I am sure you and I both agree. I am, like you (and many others) very concerned that antidepressants (especially the selective serotonin reuptake inhibitors) may have more frequent negative effects than originally thought, in terms of reactions to both taking the antidepressants and to stopping them. The reasons behind this slow building of awareness within the medical and psychiatry communities are multiple.

Certainly, there has been a lack of transparency on such data from clinical trials conducted by pharmaceutical companies in the 90’s and early 2000’s , before current guideline and practice changed.

But there is also an objective difficulty, at times, to distinguish between these described negative effects of antidepressants (for example, the increased anxiety, physical agitation and suicidal ideation, which has been typically described in young patients) and the increased anxiety, physical agitation and suicidal ideation that are common symptoms during a depressive illness.

Withdrawal symptoms at the time of stopping these drugs (especially if stopped abruptly) have been well described and are recognizable, but distinguishing symptoms that develop weeks or months after stopping antidepressants from the relapse of the depressive illness  (which, in most patients, has a continuous, peak-and-trough natural course), is very difficult.

Of course, we do need to develop better clinical and research understanding of these negative effects.

There is one thing on which we obviously disagree: you believe that antidepressants are not helpful at all, to any patients, and thus, for you, any negative effect is an unjustified burden. I do not agree with you on this.

Most of the medical and psychiatric communities, and hundreds of studies conducted so far, clearly show that antidepressants do work in improving the core symptoms of depression – especially, the pervasive sadness and lack of hope and motivation that so many patients describe as unbearable, in their account of this serious condition.

We shall not forget that most people who commit suicide suffer from depression and that antidepressants, when you study a large population of patients taking antidepressants, do reduce suicides rates in adults and older people (although in young people, as I have said before, it might be different).

You say that antidepressants do not work, that they have only a “placebo effect” and thus that they are like “dummy” pills. But this is simply not correct: hundreds of studies have been conducted comparing antidepressants to a placebo (“dummy pills”), showing that antidepressants are better than placebo in improving the aforementioned core symptoms of depression – the pervasive sadness and lack of hope and motivation.

Moreover, there have been many studies who have examined other drugs that affect the brain (for example, opioids and benzodiazepines), which in theory should have a very strong placebo effect, yet they lack this specific antidepressant effect of improving the pervasive sadness and lack of hope and motivation.

Of course, you are right that antidepressants are not safe and effective for everybody, for 100% of patients who take them. In fact, only 50% of patients respond very well to an antidepressant, and probably only around 75% are somehow helped. And yes, some people suffer from severe negative effects, sometimes life-threatening.

I accept that it is possible that some patients might have died as a consequence of taking antidepressants, and my heart goes to them and to their families. But these, as tragic and sad as they are, are very rare events.

Many more patients do not die, do not take their own life, because they are on antidepressants.  Not only the scientific and clinical studies demonstrate this, but also the testimony of many such patients who have gone public with their positive, life-saving experience with antidepressants.

In response to one of your comments, I would like to stress that this is the same exact situation that afflicts all branches of medicine. People suffer from negative effects of medications, or even die, because they take drugs for pain, hypertension, infection, cardiac problems: all drugs have the potential to induce negative (and sometimes life-threatening) effects. Your example of the airline company applies to all of medicine.

Yet we take medications because we know that in general, we are more likely to benefit than to suffer from them; that many more people benefit from them than suffer from their negative consequences.

It is the same for antidepressants – although I acknowledge that, if you think that there is no benefit from taking antidepressants, you may only see the burden. But clinical and research evidence (and patients’ accounts) tell us that these drugs do help patients.

Of course, you are right that there is a risk that antidepressants may be prescribed too much, to people who do not need them – and, for these people, the negative effects would outweigh the benefits.

However, all the clinical guidelines are strongly preventing this from happening. Clinicians and psychiatrists are reminded over and over again that antidepressants should only be prescribed to people with ‘clinically-significant depression’, and not to people with a ‘bad stage in their life’, to use your words.

‘Clinically-significant depression’ means being so sad and hopeless and tired that we cannot go to work, or socialize with friends, for weeks and months; that our work and family life suffer; that we feel that life is no longer worth living; that we think about taking our own life, or that we plan to do so. These are the people that should be prescribed antidepressants.

Yes, more antidepressants are prescribed today than 10 years ago, but this may also mean that more people are seeking help because the stigma against depression has reduced. It does not need to be a bad thing if these drugs are taken only by the people who really need them.

Where do we go from here?

Personally, I am grateful to the ‘harmed’ patients community who, through social media and advocacy, has raised awareness of the fact that antidepressants may have more serious negative effects than we originally thought.

The question now is: how do we help these patients, and help the patients who may be suffering from such negative effects in the future, while also at the same time protecting the patients who are benefiting from taking antidepressants, and will continue to do so in the future?

How do we bring my community and your community together, since we both want the same things: help people who suffer from depression?

Fiddaman
You and I will have to agree to disagree on the points you raise, Carmine, otherwise, we will get bogged down in missing the glaringly obvious. Before I answer your question, regarding the prescribing community and the prescribed harm community moving forward, I'd like for you to answer the following...

Do you think withholding clinical trial data is appropriate?

Do you think ghostwriting is acceptable?

Pariante
**Note**
Carmine added a personal note to this email suggesting that I was being discourteous. I have not added the personal note but it can be provided should the need arise


Let me first clarify that I can only express an opinion as a scientist. I have never been involved in conducting or participating to, a commercial clinical trial, or a trial for regulatory purposes, nor I have ever worked work for a regulatory agency; so I am not familiar in details with the process required by the FDA or equivalent regulatory bodies.

Having said that, as a scientist, let me say again that I believe that, in general, it is not appropriate to withhold any type of clinical data, and, in fact, any type of data.

As I have mentioned before, pre-registration of clinical trials and of analyses has changed the culture both for scientists and for pharmaceutical companies. Analyses of both efficacy (whether a drug work or not) and safety (what are the side effects)  should now be routinely pre-registered as part of the process, and the data presented when the study has been completed.

Again, as I have said before, for releasing individual-patients data there are additional issues such as confidentiality of patients, but there are procedures in place to do this, when ethically possible, and there are different types of processes based on whether the data are released to a public database or to an independent group of scientists for re-analyses.

I repeat again that clinical trial data – and in fact, any data – should never be withdrawn just because the researchers do not like the results!

Regarding ghostwriting, again as a scientist, to me being an author of a scientific paper requires full knowledge of the data. For a clinical trial, these include efficacy, safety, and other clinical, biological or psychological measures that are relevant to the paper.  In addition to the knowledge of the data, an author would need to be fully aware of the analyses and their implications. If you define as ‘ghostwriting’ the practice of appearing as an author on a scientific paper without such full knowledge, then let me say again that I am always against it.

Fiddaman
Having re-read your note to me, I'm surprised at your hurt tone. I and lots of others have been damaged by treatment. This is not something to handle lightly by saying something along the lines of, "Now, don't be angry." I am angry with the system. I'm also now concerned. I had no idea whether you do clinical research or not. The issue is your practice as a clinician and that of your colleagues. I fail to see how any of you can safely treat me or those I love if you have no access to the data and if the entire literature on meds is ghostwritten.

The extreme example of this at present is the ever-increasing use of antidepressants for teens where up to 100,000 children are on them. Yet there is not one positive trial of these drugs for children who are depressed, not one. Even the Prozac trials, that got Prozac licensed, are negative. Ditto for the paroxetine trials for children when the FDA issued an approvable letter for it.

Some doctors won't be too concerned by the sufferings of their patients (out of sight, out of mind). But even for you, the worry must be that patients in general, or the managements who employ doctors, are eventually going to wonder if you're worth having. Unless someone like you gets to grips with these issues, which you're better placed to do than I, you are at risk if/when things go horribly wrong. If there is no place in the system for recognising that treatment can kill or maim, you, the prescriber, are likely to end up in the firing line. Despite what you may think about my stance on antidepressants, I don't want this to happen to you or your colleagues.

How can any prescriber at the moment relay informed consent to any of their patients? From my point of view, I'd love some sense that you were bothered by this issue, Carmine, because then I'd think we might make some progress.

As I stated, I'm surprised at your hurt tone. Yet I do find it refreshing to see a doctor who feels and shares emotion. I say this given that many doctors cannot recognize, or refuse to acknowledge, the "hurt" they cause others when blindly prescribing. Blind prescribing is common given that doctors give people antidepressants without knowing the risks because doctors, yourself included, haven't seen the data.

Pariante
Why do you say I am not bothered by the data not being available - I keep saying that I am! I am also saying that the situation is improving with new rules and regulation

I have not said “don’t be angry” at the situation or the system - I said don’t be angry at me, Carmine, who is talking to you

Doctors in all specialities prescribe based on guideline; guidelines are written based on independent review of the evidence by experts, and the evidence includes safety and efficacy data. It is simply not true that all the l literature on meds is ghostwritten - and in any case, I condemn ghostwriting and I am confident that data transparency is much more advanced now.

So I am really not sure I understand where you and I disagree.

Fiddaman
This is a very important subject we are talking about please try and stop taking things personally. I am just asking questions that I feel many may like to see your answers.

Close to all the literature on on-patent drugs is ghostwritten. Nice Guidelines, where they refer to drugs, are based on ghostwritten literature and they have no access to the data. Being independent is meaningless if the conclusions are predetermined by the ghostwriting.

Where is the evidence to show anything is better?

Pariante
I disagree that the situation is, today, as grim as you depict it, although I agree that this has been an important problem in the past.

First of all, all the drugs that you and the community of harmed patients are concerned about (such as SSRIs) have been off patent for many years, often decades. The data have been released in the last few years and in fact, this is the reason why we do know so much more now about their adverse effects, as the many scientific papers on antidepressant-induced suicidal ideation or severe withdrawal symptoms testify.

Second, for the (very few) newer drugs still on patent or in development, there are clear rules and regulations for all trials to be registered before the results are known, and for all data (efficacy, safety, factors influencing response) to be published when the study has been completed.

Ghostwriting is unequivocally criticized or banned, and rightly so, by scientific journals and medical organisations.

The NICE or other experts panels have access to published scientific data which today is presented with excellent ethical and professional standard – because of the new rules and regulations, and also because of a change in culture about data transparency across scientists, pharmaceutical companies and regulatory bodies.

Has this been a problem in past? Yes, of course. But I think that the present is better and the future will be even better.

Fiddaman
You casually claim, “the present is better and the future will be even better.” yet provide no evidence to support your claim. You don't know whether the drugs you prescribe are safe because you've never seen the clinical trial data. NICE doesn't know either as they have never seen the drug company data. It is deeply disturbing that none of these facts appears to bother you and fellow prescribers.

Patient safety cannot be a chief concern and the Hippocratic Oath cannot be honoured when ghostwriting and cherry-picked data is an accepted, routine practice. Despite your claims, things have actually gotten worse, not better. Consider:

The recent approval of esketamine, a new mind-altering drug marketed to treat depression, is based on some of the shoddiest trials ever conducted.
Current antidepressant trials in children are now being conducted in Colombia, the Russian Federation, Ukraine, American foster homes and correctional facilities (Lundbeck's vortioxetine trials). Everyone knows the reasons why and none are for the benefit of product consumers.

You should be more concerned about the data you don't see, rather than what you do see. I asked a critical question about clinical trial data and ghostwriting because this is the foundation upon which fraudulent and harmful psychiatric prescribing is built. Whether it be delusion or deceit, most psychiatrists cannot or will not acknowledge that they are unsure about drug safety. To do so would expose psychiatry's cracked foundation and bring the walls tumbling down.

I have been a drug safety advocate for more than a decade. My readers are intelligent and I respect their time. Your limp-wristed response is offensive. I must conclude that continuing our Q&A is unfortunately of little or no benefit to readers.

Thank you for your time. I will post our brief Q&A on my blog as previously promised. You are free to do the same.


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Tuesday, January 08, 2019

Supreme Court Analyzes Merck's Ambiguous Wording




I'll admit it: I'm a legalese geek. But unlike certain companies peddling certain products, if I was too self-conscious to admit such, my failure to do so wouldn't hurt anyone.

Lately, I've been keeping a close eye on the court proceedings regarding Merck's Fosamax. Fosamax is a drug used in the treatment and prevention of postmenopausal osteoporosis. Ironically, Fosamax has been causing bone fractures in some consumers just as SSRIs can and do cause "depression," anxiety and akathisia in some consumers. But many Fosamax lawsuits haven't been heard by juries because Merck claims the company informed the FDA regarding bone fractures and the FDA failed to act by changing, or agreeing to change, the labeling.

The Merck case which was heard yesterday by the Supreme Court bears striking similarities to the GSK vs Dolin case. GSK also argued that it informed the FDA about the suicide links related to its Paxil product. (Paxil is an SSRI "brain pellet" that wreaks havoc among users while reaping billions in GSK profits. GSK claims it did everything to warn the public and doctors about Paxil-induced suicide risks. However, just as in the Fosamax case, GSK claims the FDA failed to agree to update the label.

Reading yesterday's Supreme Court transcript is fascinating and I highly recommend you download the 50-page transcript which is linked at the foot of this post. It provides an up-close look at how drug companies use the FDA's impotence to their advantage. Not only does the FDA fail to protect consumers, it proactively protects drug makers by serving as a revolving-door employment agency between pharma, the FDA and back again. Drug companies and the FDA create ambiguity and seem to enjoy a mutual understanding that this ambiguity will later be used to avoid lawsuits, protect shareholders and keep consumers in the dark regarding adverse drug effects.

Déjà vu: Dolin vs GSK

Wendy Dolin filed suit after her husband, Stewart, died when he jumped in front of a Chicago train. Stewart was taking a generic version of Paxil made by Mylan Pharmaceuticals, but GSK, the original manufacturers of Paxil, was responsible for the labeling and any subsequent label updates.

GSK tried to weasel its way out of a trial by citing the circumstances that Merck is now using as a defense in the Fosamax trials. GSK failed and the Dolin trial was heard by a jury who found for Dolin. Not only did the jury find that GSK was responsible for failing to warn consumers of the increased suicide risks created by Paxil, the jury also recognized that Paxil caused Stewart to suffer from akathisia, an adverse drug effect, prior to his death. Dolin was awarded compensation for both Stewart's Paxil-induced death and for Stewart's Paxil-induced suffering prior to his prescribed demise.

The Dolin trial, which lasted six weeks, ended with the jury awarding Wendy Dolin $3 million. But GSK appealed and the jury's decision was later overturned by the Seventh Circuit Court of Appeals. The overturned ruling didn't relate to the jury's finding that Paxil caused Stewart's death. Rather, it related to whether the label and failure to update the label, was the responsibility of GSK or the FDA. Dolin appealed but the Seventh Circuit refused to reconsider its decision to overturn the verdict. Dolin has taken her case to the Supreme Court where attorneys representing victims of Fosamax were yesterday.

A bit confusing, perhaps, but in short: Dolin won and GSK appealed. GSK won and the Dolin case is now in the hands of the Supreme Court.

Dolin's attorneys, Baum Hedlund, likely kept tabs on yesterday's proceedings given Merck's defense is similar to GSK's. The pharmafia conveniently blames its buddies at the FDA because partners in crime don't squeal on each other. Their silent pact sometimes helps both legally avoid responsibility for harming and killing unsuspecting consumers.

Like GSK, Merck is attempting to blame the FDA. Both companies try to adeptly muddy the legal waters so much so that jurors-even those who find the product causes adverse effects-become confused about who, exactly, should be accountable for faulty labeling and related tragic outcomes.

In cases such as Dolin vs GSK, it seems the amount awarded to plaintiffs is sometimes reduced not because the jury doesn't believe the product causes harms, but because the jury is effectively confused by pharma's legal strategy to "blame" its FDA pals. At the end of the day, pharma execs and FDA regulators likely slap each other on the back over dinner and drinks and cryptic "atta boy" correspondence. The end result is that consumers harmed by pharmaceutical products are further harmed by these cozy corporate/FDA ties.

Stress Fractures vs Emotional Lability

Merck is claiming that the FDA denied Fosamax label updates after it was learned a large number of atypical femoral fractures occurred among Fosamax users. Merck claims it proposed a change to the label but the FDA told them the wording in Merck's new proposal was inadequate. The FDA's complete response letter, in essence, said it didn't believe Merck had done a decent job with their proposal to change the label. Therefore, the FDA covers itself by responding to pharmaceutical companies and pharmaceutical companies understand they are essentially off the hook given the FDA won't follow up regarding proposed label updates and pharma won't either.

Merck did indeed inform the FDA about Fosamax related fractures but Merck labeled them stress fractures and not atypical femoral fractures. Thus, when the FDA read Merck's proposal for a label change they may have assumed these stress fractures were a relatively minor adverse drug effect. The FDA tends not to include extensive risk info in patient information leaflets because doing so might prevent consumers from seeking drugs as "treatment."

GSK used the same Merck tactic with its Paxil product after it was forced to acknowledge the number of suicides related to Paxil that occurred during Paxil clinical trials. GSK didn't tell the FDA that Paxil can cause adults to end their lives when suffering from a terrifying Paxil-induced condition called akathisia. Instead, GSK labeled suicidality as "emotional lability" just as Merck labeled atypical femoral fractures as simply "stress fractures."

Tossing the Egg

Imagine the CEO of an egg factory learns that many eggs contain bacteria that can cause serious harm and/or death to consumers. The CEO contacts a government regulator and says they have a problem. The government regulator doesn't think it's a severe problem and simply tells the egg factory to monitor the situation. But the egg CEO only told the regulator part of the story, stating that many eggs were cracked. The CEO didn't mention the bacteria inside the eggs that had grown as a result of said cracks.

It's a win-win for the egg factory. They can continue to sell eggs that are cracked, further, if a wrongful death lawsuit is brought against them, they can deny liability by stating, "We warned the government regulator but they decided not to do anything about the problem."

Both GSK and Merck had secrets hidden in their cracked eggs. The eggs were never fully opened by either company and the FDA only took a sneak peek through the cracks. GSK and Merck don't believe a jury should decide whether the FDA would have approved a label update had either company submitted an updated label change after receiving a first response from the FDA. Both companies claim the FDA wouldn't have sanctioned a second proposed label change. These companies are making assumptions, assumptions they aren't entitled to make despite that the CEO's likely have learned what to expect from their FDA friends.

Why nobody has thought to subpoena the current FDA Commissioner, Dr. Scott Gottlieb, is beyond me. Put Gottlieb on the stand, make him take an oath and ask him the very same questions the judges and legal teams are fighting over. Then again, Gottlieb would probably side with the drug companies given the FDA's incestuous relationship with pharma.

GSK, Merck and the FDA enjoy having their cake and eating it, too. But I doubt they use cracked eggs when together they cook up their half-baked legal excuses.

Bob Fiddaman



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