☼ nz11 climbs onboard

March 8, 2016

I plan on speaking to him about SA at some point in the future. I hadn't seen that no - but very interesting. I have a feeling that for people who have touched drugs, MOST cases of worsening depression/anxiety are being caused by the drugs or WD. Saw this link in my FB feed just now and even though they dont mention drugs - i have a feeling too, that they were involved

http://www.stuff.co.nz/stuff-nation/assignments/share-your-news-and-views/8369353/Suicide-The-one-I-least-expected

There's the clue 'suffered years of mental illness' .What is that all about?

One of my favourite quotes is from Schuyler 1974

"Depressive episodes will run their course and terminate with virtually complete recovery without specific intervention". ..."Spontaneous recovery rates where so high exceeding 50% within a few months"

Note 1974 was before the ssri era.

Maybe i should attempt an open letter posted on sa to John Kirwan.

yep thats my project for the next month an open letter to JK

March 8, 2016

Just a little bit of trivia for today;

1 in 8 Americans takes a psychiatric drug on a regular basis.

'Anatomy' Whitaker pg 321, source document [s Giled "Better but not best "Health Affairs 28 (2009) 637-48. ]

1 in 5 American adults now take at least 1 psychiatric drug.

'Depression delusion' by Lynch pg23, source document [s Hyman 'Psychiatric drug development diagnosing a crisis.' April 2013]

Whats the guess for 2017....1 in 4 ?

March 8, 2016

1 in 5 ? That is crazy . I wonder if its similar stats here in NZ. It is actually atrocious. I am angry.

I know this family and they have the most awesome son. His names Nicky and he's autistic. The things he says and comes up with are amazing . Its really beautiful. His creativity is through the roof!

But this last summer i noticed he was different. I thought, well he must just be changing with age. Hes 15 now i think. And then one lunch time i saw it sitting there. A box of fluoxetine and a box of ritalin . His parents are lovely and his sister. I want to tell them - i want to see him as he was and i dont want him to suffer. What would you do in a situation like this NZ11?

March 8, 2016

Considering the way they are prescribing them in so many different forms for totally unrelated things, menopause, stopping smoking, general pain relief, sleeping aids there are a lot of people out there with no clue what so ever as to what they are taking. Because they are marketed under different names and for different uses the doctors have even less of a clue as to what they are pushing. The drug rep says its for stopping smoking and they don't even think to see that the active ingredient is Wellbutrin. Same way with paxil for hot flashes. Plus they're sub therapeutic doses so they can't cause trouble anyway. Throw in the fact that many schools are requiring "problem children" to be drugged I will have to guess that it is more like 1 in 3 or even 1 in 2.

March 8, 2016

Exactly BM its frightening.

Which is why i am putting this here...

. "Going to a psychiatrist has become one of the most dangerous actions a person can take"

See Breggin Toxic psychiatry page 176

"It is unsafe for people who suffer something that could be treated with an ssri to see a psychiatrist".

See Gotzsche Deadly psychiatry and organised denial. (its an e book no pg number)

The problem is if you are like me i didnt even know what an ssri was...and there i was swallowing one!! @#$%!

March 10, 2016

Dear NZ11,

I have already read the first pages of your thread, it is a most captivating reading for me and I learn lots of things in this way. You are also very funny, I really admire your strength because it is a lot of strength to be able to go beyond your own suffering and be even able to make a bit of fun under the given conditions. And I admire your determination and research in showing us the terrible truth about psychotic drugs.

I have a question for you which presently is very mindboggling to me.

I am suffering enormously due to the Paxil withdrawal (sure, I know that if I hadn't made a cold turkey, the pain wouldn't have been so atrocious). And just because I am so desperate,I keep thinking I would have been 10000000000% times healthier and happier if I had just continued taking my paxil, the way I did it for more than 20 years. I had at times more difficult periods, I recognise only now I was on tolerance, but then my GP doubled my dosage, even tripled it at times, then I came back to my usual dosage, life was not brilliant but it was livable, I could solve everything, I had an active life, now I am a wreck.

So please tell me, based on your extensive reading from Breggin and many others, what would have happened if I had continued taking paxil for the rest of my life and not attempted to make any change? Do you think there would have come a time when I had paid for 20 years of poisoning? And how? (I know there is not an easy answer, I know most things are hushed up by the doctors and even when somebody dies because of the drug, this would not be written in their death certificate because no GP is silly enough to do this and jeopardise his own well being) Or I could have continued this way and died happily in my eighties.

I am looking forward to getting your reply,

Many-many thanks,

Odwina

March 10, 2016

Hi Odwina,

First i am sorry you are suffering, it is truly a most dreadful uninformed place we have all found ourselves in.

Its a biochemical torture if you ask me ....but people are getting to the other side and getting their life back albeit slowly ... and you can too.

Thank you for the kind words.

In acute wdl i was unable to read anything and would have appreciated someone spoon feeding me or summarizing stuff for me ...to be told to read this book or that was too overwhelming and too much, not too mention beyond humiliating and frightening ..so to take some choice pieces and share them that's the motivation behind the postings.

My reading is not extensive and there are many here who have read more than me...i am merely scratching the surface my reading is ad hoc and piecemeal at the best of times (but i am managing to deface a few library books though). Concentrating to read is not easy and sometimes i have to tell my eyes to go to the beginning of the line and read from left to right.

I know there is not an easy answer

You might be surprised !

from Breggin and many others, what would have happened if I had continued taking paxil for the rest of my life and not attempted to make any change? Do you think there would have come a time when I had paid for 20 years of poisoning? And how?

Would you like my:

'a' 1 dollar answer, my

'b' 50 dollar answer or

'c' my 100 dollar -complete- with- references answer?

All funds must be deposited with...sa.

nz11

Just loved Victor Borge.

March 11, 2016

Sorry for my light hearted reply on this serious matter.

Actually it is well documented that long-term outcomes in all areas of measurement worsen ... Can't understand why no one is being told this. I certainly wasn't.

Many children today at skyrocketing levels are being set up for a new career path a lifetime of disability and a regular disability cheque from the federal government.

Whitaker says imagine a large auditorium filling up every day with 250 children and 850 adults newly disabled by mental illness, and you get a visual sense of the horrible toll exacted by this epidemic.

[When Whittaker refers to mental illness I believe he is referring to iatrogenic psychotropic drug injury].

Your question can be answered by reading Anatomy of an epidemic by Robert Whittaker.

If you don't feel up to reading the whole book simply read page 229-232. Headed up 'Depressing Results.'

You don't need to worry though because you have found SA and have been informed and you are going to get free of this drug and 'forge ahead with creating a wonderful life for yourself'.

Here is my all-time most favourite quote from Peter Breggin it's just as applicable to me today as it was 5 1/2 years ago:

"After withdraw from medication has been partially or fully completed previously medication- spellbound individuals often realise for the first time that they were significantly impaired and that they are now recovering and returning to themselves. They become much more able to ...enjoy life "

Even this month I still feel like Rip Van Winkle waking up. My two year update on another site was headed up just that titled Rip Van Winkle.

nz11

Oh yeah here is my $1 dollar reply:

Your life will continue to slowly spiral into a deeper and deeper mind numbing kafkaesque anosognosic world ... a world which will continually and revolving-ly interface with the pharmacologist-ized medical profession and be met by unprecedented and unmatched hubris, by a litany of orchestrated delusion untruths, verbal bovine excrement prior to a morphing and escalating diag-nonsense and a forever fine tuning of an ever increasing cocktail of drugs as you are held hostage and pushed onto a medicated train-wreck.

Another of my favourite quotes is from Breggin also:

"Because of medication spellbinding, prescribers and clinicians cannot take patient reports at face value when they say they are doing well on medication."

March 11, 2016

Dear NZ11,

Well, horrendous this biochemical torture. Now I've lost my sleep too, couldn't sleep a wink last night and today, so of course that it couldn't have been better....

Yes, I am in acute withdrawal so this is why I am good at almost nothing, reading included. So I really appreciate your spoon feeding us. As I said last time, your thread is my favourite reading at the moment and I also learn a lot from it. I am very grateful for all the effort you are doing for us, I know you are not yet fully recovered - but you will be soon!!!

Of course I would like your 100 dollar answer.... with references and all this...

Wittaker's image of that auditorium is dreadful, but unfortunately so true.

I think I am still very faraway from returning to myself... But your favourite quotation is most beautiful and I am convinced it is the sheer truth in it.

My problem is that I am now 68 and of course that during this withdrawal hell I have many regrets for starting this journey through hell because as poisoned as I was, you know, it was not this horrendous pain. And in my very weak moments (and today it is one) I just think I could have continued being on paxil and somehow I would have lived, just as I lived those 20 years. not happy, but it would have been bearable at least.

I listened last night to Peter Gøtzsche's talk in Melbourne - the link sent by you, I wouldn't have known it otherwise... - and I took this note:

"If you are above 65 years of age, anti-depressants become particularly dangerous for you because old people tolerate brain active chemicals very-very poorly, they can lose balance, fall, break their head and die. There is a study from the British Medical Journal that shows that for every 100 people 65 or older you kill free in just one year. This is a huge death rate, it means that we kill around 3000 old people in my country, we just have 5.5 million. Something like that. Why don't people talk about that?"

So could I at least have this consolation that if I hadn't stopped at least now, no matter how hard it is, I could have dropped dead in 2-3 years??? Or maybe no, I would have lived happily with the drug (as long as my GP said once again recently that paxil is for me like insulin for people suffering from diabetes).

I am sure you know much more about this topic, NZ11, so I am waiting for the 100 dollar answer....

Many-many thanks for everything,

O

March 12, 2016

oh shucks what can i say ...thanks for the kind words ...well that makes two persons learning from my thread because I am learning too.

We are learning together.

Its actually a disgrace that we are forced to have to inform ourselves of this when i thought the doctors were being paid a massive premium part of which was to inform and protect us!

Hang in there Odwina

Please if you are not happy with your plight and feel you were not fully informed regarding the nature of this drug and have/are suffering adverse effects in withdrawal then seriously consider making exhaustive complaints to every regulatory authority there is.

March 14, 2016

Hi NZ,

Just seen this one mentioned in someone's post: Beck Depression Inventory Test. I hadn't heard of this one and wondering if you had come across it before.

March 14, 2016

yes i am aware of that one its been a while since i looked at it.

Im sure its just the same old nonsense.

March 14, 2016

Yep, I reckon it is. Some of the questions and the way they were asked, someone not even remotely depressed could have answered 2 or 3.

March 14, 2016

I actually don't like reading these questionaires as it makes me sick but I do know from notes that I have made the Beck depression inventorying (BDI) and its revision the (BDI-II) were written in compliance with the DSM-IV guidelines for the diagnosis of depression.

The items are comprised of four statements arranged in order of increasing severity with respect to a particular symptom of depression and focus on symptoms present during the preceding 2 weeks.

Note BDI was written in compliance with the DSM-IV guidelines.

Whitaker notes, DSM-IV (1994) was created with 57% of the task force members reported having ties to industry.

All of the panelists (100%) for the mood disorders and schizophrenia work-groups had ties to industry.

Of the 20 work-group members who prior to 2009, authored the APA's guidelines for depression, bipolar illness, and schizophrenia, 18 (90%) had financial ties to industry

(See Psychiatry under the influence, Whittaker page 40).

Beck is the father of cognitive therapy so one would think by nature he might be against drugs.

Who knows what his conflicts of interest are, he may have had noble goals in doing his questionnaire, but the DSM-IV guidelines are set up by people whose goals are clearly not noble, they have agendas, are being paid by companies who are wanting to push drugs as a first line of therapy. Doing all they can to loosen the boundaries.

March 14, 2016

"Beck is the father of CBT" (must get new mouse, can't copy and paste at the moment).

I didn't know that. I would like to think that his goals were noble, and that there are still people with noble goals out there. Unfortunately anything which starts out for positive can also be used for negative.

March 14, 2016

hey im having trouble doing copy and paste too!

I thought it was my computer or some glitch in going to windows 10 ...but its the mouse ...thanks for that.

March 14, 2016

My problems a combination. I dropped the mouse and the Right Click isn't working properly, but I've also found cat hair in the sensor.

March 15, 2016

You've been playing cat and mouse...

March 25, 2016

What follows has to be a MUST READ for all.

It is incredibly revealing.

It is excerpts from three books.

This post is titled ..........'All you wanted to know about PROZAC '

Deadly medicines and organised crime how big Pharma has corrupted healthcare.

by Peter Gotzsche

pg 202 – 207

Prozac a terrible Eli Lily drug turned into a blockbuster

The first SSRI was fluoxetine (Prozac), which was marketed in 1988.

It’s a terrible drug and senior management in Lilly, wanted to shelve it.

But Lilly had a problem. It was in serious financial trouble, and if Prozac failed, Lilly could go down the tubes.

Fluoxetine is such a poor drug that the German drug regulator concluded in its assessment:

‘Considering the benefit and the risk, we think this preparation totally unsuitable for the treatment of depression.’

When Eli Lilly showed some of its data to Swedish psychiatrists, they laughed and didn’t think Lilly was serious about seeking approval for the drug, and the FDA noted serious flaws in the trials.

However, to survive as a company, Lilly was determined to make Prozac a success, and it was crucial to get Prozac approved in Sweden, as it would then be easier to get it approved by the FDA.

The vice president for Europe left no doubt that the managing director for Sweden, John Virapen needed to do whatever it took to succeed.

Virapen, who felt his future career at Lilly depended on approval of Prozac, solved the problem with bribery.

He launched seeding trials before the drug was approved and invited doctors to the Caribbean for a week, with plenty of relaxation, including:

‘diving, surfing, sailing, pretty girls and hot nights.’

[its worth reading about what ‘seeding trials’ entails and I will write what Gotzshe has to say about this at the very end of this post. Its well worth a read.]

By planting indirect questions to the secretaries of prominent psychiatrists, Virapen found out the identity of the independent expert who was going to examine the clinical documentation for the Swedish drug agency.

The expert didn’t like fluoxetine at all and just two weeks earlier, he had laughed about the idea of ever getting fluoxetine approved. However already at their second meeting, he suggested $20,000 as a reasonable sum for a speedy approval, which, moreover, shouldn’t become known to the taxman but was to be handled by Lilly’s office in Geneva.

He furthermore demanded a good deal of research money to his department. The money was split so that the second half was to be paid when the drug was approved. This is how the mob operates when it orders a murder.

Next, one of Virapens associates met with the expert in Goteborg to improve on the registration application. Deaths disappeared in footnotes and it went somewhat like this:

‘Five had hallucinations and tried to commit suicide, which four of the test subjects succeeded in doing.’

was changed into:

‘Five of the other test subjects had miscellaneous effects.’

On top of this, the independent expert placed his own personal letter of recommendation.

It didn’t take long before Virapen received a phone call to start negotiations about what the drug should cost, which meant the drug would be approved.

When the price had been settled for a 20 mg dose, a top psychiatrist who had done research with fluoxetine postponed approval as she found that 5 mg was the maximum that should be allowed, and she demanded that the 5 mg dose should be made available.

However, Lilly managed to avoid this, which might potentially have reduced its income by 75%.

There weren’t many truly depressed people in the mid-1980s when the criteria for the diagnosis were much more stringent and relevant than today, and Prozac was therefore marketed as a mood lifter. Isn’t that something?

A drug with cocaine like effects is marketed as a mood lifter!

What’s the difference to street pushers?

The approval in Germany also followed unorthodox lobbying methods exercised on independent members of the regulatory authorities.

After having been so enormously helpful to Lilly, Virapen was fired.

This is also like a script from the mob. When the boss persuaded a lower person to murder a well-known political figure, it is safest to kill the assassin soon afterwards, as a dead man doesn’t talk.

The official explanation was that Lilly had certain ethical principles!

Two other people who knew about the bribery were also fired without reason.

Virapen tried to persecute the corrupt psychiatrist, but that wasn’t possible because the psychiatrist wasn’t an employee of the health authority. After this affair, the Swedish anticorruption law was amended. The psychiatrist just went on and, ironically, came to work for the court, as a psychiatric assessor for Sweden.

[://www.youtube.com/watch?v=KUJmTwFBRO4]

Eli Lilly promoted Prozac illegally for several non-approved ailments shyness, eating disorders and low self-esteem, and concealed the increased risk of suicide and violence associated with the drug.

However in 1990 only two years after Prozac came on the market Martin Teicher et al described six patients who had become suicidal and reacted in bizarre ways with intense violent suicidal preoccupation while receiving Prozac, which was something completely new to them.

Teicher’s observations were groundbreaking and the paper was highly convincing.

However, internal Lilly documents revealed later that the FDA worked together with the company on the suicide issue, and Lilly’s hired guns among the psychiatrists came in handy, while Lilly’s own scientists left out information that would have been incriminating for the company at the subsequent 1991 FDA hearings.

The chair of the FDA committee, psychiatrist Daniel Casey, brutally interrupted Teicher so that he couldn’t present his findings and reasons!

He was only allowed to present a few slides while Lilly staff presented many.

A few years later, Teicher’s wife was offered a job at Lilly as their top scientist in oncology without having applied.

This was hardly a coincidence. The standard procedure is to blacklist and haunt critical people and if that doesn’t work, to buy them or their close relatives.

His wife divorced Teicher and went to work for Lilly.

In 2004, the BMJ received a series of internal Lilly documents and studies on Prozac from an anonymous source, which the journal sent to the FDA. These documents were made available in a litigation case in 1994, but were not accessible for the public. They revealed that Lilly officials were aware already in the 1980s that fluoxetine had troubling side-effects in terms of suicide attempts and violence and sought to minimise the negative effect on prescribing.

Lilly was keen to root out the word ‘suicide’ altogether from its database record of side-effects experienced by patients and its headquarters suggested that, when doctors reported a suicide attempt on Prozac to Lilly it should be coded as ‘overdose’ (which is terribly misleading, as it is hardly possible to kill yourself by overdosing Prozac; the suicides occur on normal doses), and ‘suicidal ideation’ should be recorded as depression (blame the disease, not the drug).

Two Lilly researchers in Germany were unhappy with these directions:

“I do not think I could explain to the BGA (the German regulator) to a judge, to a reporter or even to my family why we would do this, especially on the sensitive issue of suicide and suicide ideation.”

One of the documents the BMJ received noted that in clinical trials, 38% of paroxetine treated patients reported new activation compared to only 19% of placebo treated patients. SSRIs often lead to agitation or akathisia, an extreme form of restlessness, which some patients described as wanting to jump out of their skin, and which increases the risk of suicide.

Early on, Lilly recommended that in their trials of fluoxetine such patients should also take benzodiazepines, which reduce the symptoms. We therefore don’t know what the true side-effects are, or even what the true effect on depression is, as benzodiazepines have an effect on depression.

However, when Lilly became interested in showing that it’s drug, Prozac, led to fewer withdrawal symptoms than its competitor’s drugs because of its longer half life, the result was overwhelming. More than half of the patients on paroxetine and sertraline developed abstinence symptoms within a week when they were switched from active drug to placebo. The most frequent symptoms clearly had nothing to do with relapse of the depression but with abstinence: worsened mood, irritability and agitation.

The bias in industry sponsored trials is really massive. In head-to-head trials where Prozac was the drug of interest, significantly more patients improved on Prozac then in trials where Prozac was the comparator drug.

In 2004 the FDA issued a warning that antidepressants can cause a cluster of activating or stimulating symptoms such as agitation panic attacks insomnia and aggressiveness. Such effects were expected, as fluoxetine is similar to cocaine and its effects on serotonin.

Interestingly, however when the EMA in 2000 continued to deny that the use of SSRIs leads to dependence, it nonetheless stated that SSRIs, “have been shown to reduce intake of addictive substances like cocaine and ethanol. The interpretation of this aspect is difficult.”

The interpretation is only difficult for those who are so blind that they will not see.

In 1989, a man shot 8 people dead, wounded another 12 and then killed himself 1 month after he was placed on fluoxetine.

Lilly won a 9 to 3 jury verdict and subsequently claimed it was;

“proven in a court of law… that Prozac is safe and effective.”

However, the trial judge, who suspected that a secret deal had been struck, pursued Lilly and the plaintiffs, eventually forcing Lilly to admit that it had made a secret settlement with the plaintiffs during the trial.

Infuriated by Lilly’s actions, the judge ordered the findings changed from a verdict in Lilly’s favor to one of ‘dismissed as settled with prejudice’, saying ‘Lilly sought to buy not just the verdict but the court’s judgement as well.’

Lilly also bought FDA panel members.

An FDA advisory panel was convened in 1991 to review the fluoxetine data. It concluded that fluoxetine was safe despite the concerns raised by safety officer David Graham and others, which led critics to point out that several of the panellists had financial ties to Lilly.

Throughout the 1990s, while swearing publicly that Prozac didn’t increase the risk of suicide or violence, Lilly quietly settled lawsuits out of court and was able to keep the incriminating evidence hidden by obtaining court orders to seal the documents, just as it had done with its bestselling antipsychotic drug Zyprexa (olanzapine), until a batch of documents was leaked to the press.

Lilly’s internal papers disclose a long and successful battle against the idea that Prozac could induce violence or suicide, and they suggest that Lilly had an explicit strategy to blame the disease and not the drug, which some of Lilly’s own scientists had reservations about. Some of Lilly’s actions appeared fraudulent, e.g. the company excluded 76 of 97 cases of suicidality on Prozac in a post marketing surveillance study it submitted to the FDA.

In 1997, Prozac was the 5th most prescribed drug in the United States. It also became the most complained about drug, and hundreds of suicides were reported.

In relation to lawsuits, David Healy found early drafts of Prozac’s package insert that stated that psychosis might be precipitated in susceptible patients by antidepressant therapy.

It turned out that Lilly had known since 1978 that Prozac can produce in some people a strange, agitated state of mind that can trigger in them an unstoppable urge to commit suicide or murder.

The warning about induction of psychosis wasn’t included in the final package insert for the United States, where as the German drug agency required it.

By 1999, the FDA had received reports of over 2,000 Prozac associated suicides and a quarter of the reports specifically referred to agitation and akathisia.

As always, the FDA protected the drug and not the patients, as it said that it would not have allowed a company to put a warning about akathisia or suicide on the label; it would have considered it mislabelling!

The EMA announced in 2006 that parents and doctors should carefully monitor children and youth being treated with fluoxetine and watch out for suicidal tendencies.

A fake fix. Children commit suicide whatever the warnings are. Fluoxetine should never have been approved for children, or indeed for any creature, not even dogs ( SSRIs are used for ‘separation anxiety’ in dogs, which is when dogs howled too much when their owner leaves home).

Lilly also kept completed studies from public view. In 2004, the body of a 19-year-old college student was found hanging by a scarf from a shower rod in an Indianapolis laboratory run by Lilly. She entered a clinical study as a healthy volunteer in order to help pay her college tuition after having undergone thorough medical testing to screen out depression or suicidal tendencies. She had not taken Prozac but another SSRI duloxetine (Cymbalta), which Lilly wanted to develop for stress urinary incontinence under the trade name Yentreve. When researchers and the press started asking questions about duloxetine, the FDA didn’t scour its database and go public. It kept quiet and gave a legal rationale for its silence; ‘some clinical trial data are considered trade secrets, or commercially protected information.’

[Gotzsche doesn’t elaborate on the 19 yr old student but I believe it’s this one here http://www.nytimes.com/2004/02/12/us/student-19-in-trial-of-new-antidepressant-commits-suicide.html?_r=0]

It is outrageous that a drug regulator puts profits over human lives in this way.

Clinical trial data are not trade secrets and the FDA must change its attitudes and bring them on par with those at the EMA.

A BMJ journalist Jeanne Lenzer filed several Freedom of Information Act requests for all safety data related to Cymbalta and Yentreve and received a database that included 41 deaths and 13 suicides among patients taking Cymbalta.

Missing from the database was any record of the college student and at least four other volunteers known to have committed suicide while taking Cymbalta for depression.

Lilly admitted that it had never made public at least two of those deaths, and anonymous sources told Lenzer that duloxetine caused suicidal tendencies in patients who took the drug for incontinence and who weren’t depressed.

Lenzer couldn’t get access to this data, as the FDA is prohibited from releasing study data for a drug that fails to win FDA approval, and the FDA didn’t approve the Yentreve. It cannot be more absurd than this, as the active chemical is the same in the Yentreve as in Cymbalta. The United States must change the laws so that they serve the public.

The FDA did state later, however, that data from stress urinary incontinence trials had shown that middle-aged woman taking duloxetine had a suicide attempt rate of 400 per 100,000 person-years, more than double the rate of about 160 per 100,000 person-years among other woman of a similar age.

This suggests that SSRIs are not only dangerous in children but also an adults.

There is one more take-home message from this sad affair. Volunteers, like the dead college student, are told that even if they don’t personally benefit from taking a new drug, scientific knowledge gained from the study will benefit others. The volunteers should be told instead that people will learn about their experience only if it’s good news for the company. It’s unbelievable and deeply criminal that healthy volunteers can die without anyone knowing about it outside the company.

When Lenzer asked Lilly about Prozac again because the sealed internal Lilly documents had surfaced, Lilly sent her a written statement:

“Prozac has helped to significantly improve millions of lives. It is one of the most studied drugs in the history of medicine, and has been prescribed for more than 50 million people worldwide.”

When drug companies face trouble, they always try to escape by using big numbers. Millions of lives have not been improved significantly. In randomised trials, equally many patients stop treatment while on an SSRI as while on placebo, which suggests that, overall, considering benefits and harms together, the drugs are pretty useless.

A 2003 - 2007 study of 7,525 patients starting antidepressants, of which two thirds were SSRIs, showed that already after two months half of the patients had stopped taking the drug. What 50 million people tell us is that millions of people have been harmed, as many of those who continue to take the drug become addicted and cannot stop.

…………….//…………………..

Pharmageddon by David Healy page 212 – 215

When the first concerns about Prozac made headlines in 1990, Lilly understandably, rushed to defend their blockbuster. The company examined their clinical trials, which included over 3,000 patients, for suicidal acts and published the results of their analysis in the British medical Journal, claiming it showed no increase in risk on Prozac compared to placebo.

But smack in the middle of the article are the figures – six suicidal acts in 1,765 patients on Prozac versus one in 569 patients on placebo.

These figures indicate that while there is a chance there is no risk from Prozac, there is an equal chance that there is up to a 16 fold increase in the risk, and that the best guess is that there is roughly a doubling of risk on Prozac.

But according to Fisher’s test

[Ronald Fisher (1890-1962) a Cambridge mathematician who did most of his key work in developing modern statistical methods; he introduced two ideas –randomization and statistical significance. These ideas have now come to dominate modern medicine]

there was no significant difference between placebo and Prozac on this score.

The conclusion the company drew from this, fully endorsed by the British medical Journal with no subsequent objections recorded from any of the 100,000 readers of the journal was that “data from these trials do not show that fluoxetine is associated with an increased risk of suicidal acts or emergence of substantial suicidal thoughts among depressed patients.” The six suicidal acts simply vanished.

A 12-year-old schoolchild could have told the British medical Journal that a doubling of risk is an increase. Lots of the 100,000 readers of the British medical Journal work in fields that have nothing to do with pharmaceutical industry. Even in areas of medicine working closely with that industry, many of the brightest and the best have no conflicts of interest, so missing this doubling of risk cannot be put down to conflicts of interest.

Missing the problem in this instance cannot be put down to lack of access to the data either – the doubling of risk that the company denied was hidden like a boat in a harbour by being put on one of the most widely read journals in the world.

We seem to have entered an Alice in Wonderland world in which things are whatever the red Queen says they are.

Emboldened by the complete lack of objections to the depression paper, Lilly went on to analyze the suicidal acts from a series of trials they had done with Prozac and eating disorders. In these cases, any increase in risk could not be attributed to depression.

Again there was an excess of suicidal acts on Prozac – a 1.4 fold increase in risk but because this increase was not deemed statistically significant, it to apparently didn’t exist.

When the FDA convened their public hearing in September 1991, there was room on the program for presentations from the public and for a presentation of the science. In the three-minute slots they were given, many wives and mothers offered convincing testimony of how husbands and children had been prescribed the drug for anxiety, weight loss, or smoking cessation – conditions not linked to suicide – and, having apparently never been suicidal before, had gone on to commit suicide.

FDA officials and experts present acknowledged that testimonies were striking but made it clear they had to go by what the scientific data showed. The scientific data from their trials were presented by Lilly.

None of the experts convened by the FDA, nor any of the regulatory officials speaking that day, nor any of those whose tales of horror were weighed on a scientific balance against the clinical trial data and found wanting appeared to notice that, actually, the trial data of increased suicides was entirely consistent with the personal tragedies.

But there is skullduggery to add to mystery here and a case for saying lack of access to the data also played a part in Lilly’s getting away with the gamble. Unlike the readers of the British medical Journal, the FDA had had a chance to see the real figures from the Prozac depression studies and plenty of opportunity to come to grips with the fact that there had in fact been no suicidal acts on placebo – the real figures were six suicidal acts on Prozac versus zero on placebo.

Technically, the risk on Prozac was infinitely greater than on placebo.

Lilly had taken a suicide that had happened before the trial had started and filed it under the heading of placebo, in a manner that contravenes regulations and seems close to being fraudulent.

These data are now in the public domain – what is not public is any account from the FDA, or any other regulators worldwide faced with the same data, as to why they chose to overlook this clearly inappropriate manipulation.

The single placebo suicide was very important to the company, and maybe to the FDA, because its addition to the calculation meant the increased risk on Prozac would not be statistically significant and if not statistically significant six suicidal acts on Prozac vanished. The company knew that medics across the board could be depended upon to agree with this view of significance.

Following Lilly’s lead, GSK in the case of Paxil and Pfizer in the case of Zoloft also took prestudy suicides and suicidal acts from Paxil and Zoloft trials, respectively – seven in the case of Paxil and three in the case of Zoloft – and dumped them into the placebo group, against regulatory rules.

The FDA noted what was happening but did nothing, and again has offered no explanation since for their oversight. Quite astonishingly, when the British regulator (the MHRA) caught up with this manoeuvre 13 years later in 2003, and asked GSK for their Paxil suicide data, making it clear companies should not move prestudy suicides in the placebo group as they had been doing, GSK instead took suicides recorded after the trials of Paxil had concluded and coded them under placebo, even including in the placebo group a patient who had committed suicide after having started Prozac. The MHRA did not object.

For most readers the invented placebo suicides and suicidal acts in the Prozac, Paxil, and zoloft trials and the three deleted heart attacks in the Vioxx trials are unlikely to seem to be the major issue. These manipulations are both a real problem and possibly a criminal offence but they are a lesser problem than the invisibility of the 17 Vioxx heart attacks and six Prozac suicidal acts. Lesser in the sense that companies only occasionally have to move a dead body or two from an inconvenient spot in the dataset to a less problematic one, but at the click of a statistical button they hide far more deaths and academic articles that remain permanently in full public view.

……………………………//…………………………….

Talking back to Prozac by Peter Breggin 1994

Chapter 3

The real story behind Prozac’s approval by the FDA

Most people seem to believe that the FDA conducts its own independent studies of drugs and then decides whether or not to approve them. Nothing could be further from the truth.

The FDA, in fact, doesn’t have any money to perform its own studies during the approval process for drugs. All FDA drug studies are constructed, supervised, and paid for by the drug companies themselves, using doctors and research teams of their own choosing – often people with long established relationships with the company. It seems obvious, but should be underscored, that the pharmaceutical companies do everything they can to make their studies turn out right.

How the Prozac studies were constructed

Regulations require that a new drug must prove its efficacy in double-blind controlled studies comparing it to placebo and to other drugs of established efficacy.

Double-blind means that neither the doctors nor the patients know who is getting what kind of pill.

Placebo-controlled means that some patients and a comparison control group will be given an inactive substance in pill form – the placebo, or sugar pill.

The placebo is, in effect, a fake drug. If, for example, Prozac does not perform any better than the placebo, Prozac will be seen as ineffective.

Placebo plays a key role in scientific drug studies because it has been repeatedly demonstrated that up to 50% or more of depressed patients improve on the sugar pill. In some studies nearly 90% have improved on placebo.

The FDA allowed Lilly to use the ‘placebo washout’, a very questionable but commonly used technique in drug studies. All patients were started off on placebo for approximately one week (4-14 days). Those patients who showed improvement on placebo were then dropped from the study and the trials were begun all over again from scratch with a placebo and a drug group.

Using the placebo washout helps make a drug seem more effective than others. For example, some of those patients washed out of testing because they responded positively to placebo might not have reacted positively to the drug if they had received it in the second part of the testing. That is, if they had not been dropped from the actual trials, the placebo responders might have once again reacted positively to the sugar pill but not to the drug with its frequently unpleasant side-effects.

Even if the placebo washout reduced the number of positive responders equally in both the sugar pill and the drug groups, this reduction in the total number of positive responders in both groups would favour the drug. Why? Statistically, the same difference between two smaller groups is more significant than the small difference between two larger groups. The placebo washout purposely produces an unnatural pool of patients. It is unscientific.

Before the FDA approves a psychiatric drug, it typically requires that the drug company produce two or more research protocols that demonstrate significant efficacy for the drug. Each protocol has a specific set of rules developed by the drug company. In the case of Prozac, one protocol included 10 separate studies under different leadership at different sites.

The results were then pooled to make one pool of data for statistical purposes. The total number of individual studies or research projects in the various Prozac protocols varied from 1 to 10.

A typical Lilly protocol for Prozac in its FDA approval process required randomly dividing a group of depressed patients into two similar sections. One section was given placebo for 4 to 6 weeks and the other was given Prozac for the same period of time.

In other protocols, the group was divided into three parts: one taking placebo; one taking Prozac; and one taking an older proven antidepressant for comparison.

The protocols used a variety of tests to evaluate week by week improvement. Some of these involved self-assessment, but most entailed brief interviews with professionals who checked off symptoms lists. No intensive interviews were utilized.

Each individual study was directed by a principal investigator, a psychiatrist selected by Eli Lilly to ensure that the project was conducted according to the principles laid down by the drug company. Some studies were carried out at universities and others at private research firms that specialize in performing drug company – sponsored research.

How the Subjects Were Selected

Potential subjects were interviewed by investigators on each study to determine whether or not they met the standards for major depression as defined in the American Psychiatric Association’s Diagnostic and statistical manual of mental disorders, third edition, revised DSM-III-R.

To qualify for major depression, the individual must show signs of depressed mood or loss of pleasure or interest in life. These are the first two items on the list of nine items, and the individual must suffer from at least a total of five.

The other criteria include the following: significant weight change, sleep disturbance, psychological and physical agitation or retardation, fatigue or loss of energy nearly every day, feelings of worthlessness or excessive or inappropriate guilt, indecisiveness and other signs of difficulty thinking and concentrating, and recurrent thoughts of death or suicide.

Most people believe that when Prozac was approved for depression, it had been thoroughly tried on extremely depressed patients and had proven life-saving.

In actuality, the Prozac studies as designed by Lilly excluded all patients with serious tendencies towards suicide. This deliberate exclusion was part of the formal protocol, or organisation, of each study used for FDA approval in the United States. Advocates of the drug would wholly overlook this in their enthusiastic reviews, giving the false impression that Prozac is a potentially life-saving drug. No antidepressant has ever been shown to prevent suicide, and Eli Lilly apparently didn’t want to risk finding out whether Prozac would also fail to prevent suicide.

Hospitalized psychiatric patients were also excluded from nearly all of the studies, including every one that was used to approve the drug.

There were no children or elderly adults in the Lilly sponsored FDA studies of Prozac. Once a drug is approved for marketing by the FDA, however, there is nothing to stop psychiatrists from prescribing it for these vulnerable groups. Prozac, in fact, is being widely recommended for children and youth.

One such recommendation is in a recent popular book by Columbia University professor of psychiatry Ronald Fieve.

Fieve states :

“although scientific research in this area is scanty and incomplete the evidence so far indicates that children and adolescents can safely be given Prozac…”

The potentially tragic consequences of this practice are underscored in the findings of the government General Accounting office (GAO) investigation of the FDA -that children are especially likely to fall victim to adverse reactions that slip through the FDA pre-marketing tests of drugs.

How Large and How Long Were the Studies

Misleading totals for patients tested in clinical trials are common.

In Everything you need to know about Prozac (1991), psychiatrist Jeffrey Jonas from Fair Oaks Hospital in Summit, New Jersey and medical writer Ron Schaumburg defended Prozac by stating:

“Some of the reassurance comes from the data on over 11,000 patients who took the drug in clinical trials.”

The 11,000 figure appears in an August 31, 1990, “Dear Doctor” letter written by Eli Lilly to American physicians to counteract concerns that Prozac could increase suicidality.

The letter states, “more than 11,000 individuals participated in clinical trials for Prozac, including over 6,000 treated with Prozac.” Jonas and Schaumburg must have misread the statement since it indicates that the drug was actually taken by over 6,000 patients rather than 11,000 patients.

However when a drug company bandies about large – if relatively meaningless – numbers, the numbers are likely to be misread or misinterpreted in favor of the company. The figure of 6,000 patients, meanwhile, is itself potentially misleading.

The drug label as reprinted in the Physicians’ Desk Reference (PDR) states that there were “5,600 Prozac – exposed” individuals in the pre-marketing period of evaluation.

But this apparently includes patients given the drug under a variety of conditions other than actual clinical trials. In another place in the media it is stated that 4,000 patients received Prozac in “US pre-marketing clinical trials” but most of these patients, apparently, were not in placebo-controlled-studies - the only ones relevant for efficacy studies.

A table of adverse reactions in the PDR reviews 1,730 patients who are involved in “placebo-controlled clinical trials.”

When we focus on the actual numbers of patients in the trials used by the FDA and the drug approval process, the totals shrink much further.

Only three favourable protocols, involving 17 studies and several hundred patients were found scientifically adequate enough by the FDA to use them as evidence for approving the drug.

Using material obtained through the Freedom of Information Act, I went through each of these 17 studies, one by one, to add up the number of Prozac patients who actually completed the four–, five –, or six-week trials used as the basis for FDA approval. The grand total turned out to be a meagre 286 patients.

It is astonishing to realize that the approval of Prozac was based on fewer than 300 patients culled, by various means that we will examine, from the original cast of thousands.

It is safe to guess that few if any physicians or patients who rely on the FDA studies have any idea that the actual number of Prozac patients completing the trials was so small.

Most people imagine that patients in the FDA approval and studies take the test drugs for months and years on end before the drug can be approved, but as we have already pointed out the scientifically controlled trials for Prozac lasted only a few weeks.

An occasional less scientifically rigourous project lasted longer, but 86% of all the patients in all the studies were treated “for three months or less.”

Only 63 patients were on fluoxetine for a period of more than two years before completion of the pre-marketing studies and the FDA approval of Prozac.

In effect anyone now taking Prozac for more than a few weeks is part of a giant ongoing experiment on its longer term effects.

According to the FDA approval process, it doesn’t matter how many times a drug fails to prove useful in its clinical trials. Innumerable scientific studies can show the drug to be ineffective, but as long as two or more show statistical superiority over placebo, the drug can win approval.

In its “Summary of Basis of Approval” dated October 3, 1988, the FDA states that 14 protocols involving controlled studies were submitted by Lilly. Four compared Prozac to placebo, and of these, three were used by the FDA as evidence of some beneficial effect. One showed none at all. Of the remaining 10 studies, eight showed Prozac to have no positive effect.

Overall, there were more negative efforts then positive, this made no difference in the approval process.

In 6 out of the 7 studies where it was included, imipramine (Tofranil), a very old drug, did better than Prozac. That, too, made no difference in the approval process.

These results do not sound very inspiring, but an examination of the three positive protocols will prove much more disheartening. The analysis that follows was painstakingly garnered from several volumes of FDA data that were decidedly not user-friendly. It is worth giving the reader this rare, and perhaps unprecedented, window into the FDA -a seldom illuminated region of the government.

Protocol 27: Scrambling to Make It

One of the three sets of protocols used to prove the efficacy of Prozac was called Protocol 27. The following information about the protocol is taken from the Food and Drug Administration’s March 28, 1985, review and evaluation of efficacy data. All page numbers refer to that document.

At the start, Protocol 27 involved more than 700 patients at six separate sites in studies run by different principal investigators. By the time the entire protocol was completed, and all the data from one of the six sites was excluded, fewer than 150 Prozac patients remained in the whole protocol. Of these, only 104 completed the six-week trials.

The protocol compared three agents: Prozac; an older antidepressant called imipramine (Tofranil); and placebo. The six separate studies, as reported by the drug company and then further analyzed and summarized by the FDA produced the following results:

J P Feighner, MD from the Feighner Institute in San Diego, according to the FDA found that the older antidepressant, Tofranil, showed significant improvement in the patients in “all variables.” However fluoxetine was not shown to be consistently different than placebo (page 21). In other words, Prozac was a bust.

An April 3, 1984 in-house FDA memo by Walter Sloboda , a psychologist in the division of scientific investigation, discussed criticisms of Feighner’s studies based on an on-site FDA investigation. Among other things, the FDA found that in Protocol 27 a patient was mistakenly given Prozac in addition to Tofranil and that the error had not been properly recorded. Also, in several cases, a variety of abnormal laboratory findings were ignored, entailing risks to patients.

Dr Feighner, the report said, agreed with these observations by the FDA and promised to remedy them.

In addition, Sloboda’s memo discussed a consumer complaint in which a patient alleged that she had been given Prozac in a trial and that this initiated an emotional deterioration resulting in hospitalization and electroshock treatment. We have no information on the outcome of the investigation concerning the patient’s complaint.

Feighner’s practices in conducting Prozac research were criticized again in an August 7, 1984 letter from the FDA’s Frances O Kelsey PhD, MD, Director of the Division of Scientific Investigation, Office of compliance, Centre for drugs and Biologics. Kelsey found that Feighner “had several departures from Food and Drug Administration regulations or commonly accepted drug investigational practices. “ Without mentioning specific deviations, the letter emphasized the need for Feighner to follow the inclusion and exclusion criteria of the studies.

J B Cohn, MD a psychiatrist from the University of California in Los Angeles, produced according to the FDA report “seemingly overwhelming positive results.” However, the statistical manipulations required to achieve them were scientifically unacceptable. For example, Cohn ended up comparing how the Prozac patients did at six weeks with how the placebo patients did at two weeks. Reluctant to come down too hard on a drug company, the FDA observed, “hence, this study can, at best, be said to be supportive” (page 27). In contrast to patients on Prozac, patients on the older antidepressant did show improvement. Another Prozac bust.

Cohn, meanwhile, had been sent an extraordinarily critical letter from Frances O Kelsey PhD MD Director Division of Scientific Investigations of the FDA.

The inspection under the FDA’s Bioresearch Monitoring Program found that Cohn had failed to indicate that two of the subjects suffered from a “past history of alcoholism” and that a third subject had been treated three times for alcoholism in the prior year had cirrhosis of the liver.

It was also found that in an earlier study in the Prozac FDA approval process, Cohn had failed to obtain written informed consent and had “backdated the consent form.”

Eventually the FDA discarded the Cohn study as invalid. Nonetheless, in 1985 Cohn and Charles Wilcox, M.B.A. published the study in the Journal of clinical psychiatry as part of an Eli Lilly- sponsored symposium.

They describe their study as an unambiguous success story for Prozac. They give no recognition of the fact that FDA invalidated and rejected the study. As far as the general medical community knows to this very day, the Cohn study unequivocally proved the efficacy of Prozac.

David L. Dunner, MD a psychiatrist from the University of Washington in Seattle, found the older antidepressant was effective but according to the FDA, “there was essentially no difference in efficacy between fluoxetine and placebo” (P.34). A third failure for Prozac.
Bernard L Grosser, MD, from the Department of psychiatry of the University of Utah, came up with the same negative result as Dunner. According to the FDA, “imipramine produce significantly more improvement than placebo on all major efficacy variables and endpoint.” However, fluoxetine was not shown to be consistently different from placebo (p. 42). A fourth negative outcome for Prozac.

Grosser’s seeming bias in favour of Prozac is disclosed in October 26, 1984, letter of complaint sent to him by FDA official Frances Kelsey. Among other criticisms, Kelsey observed that Grosser’s informed consent form did not conform with regulations because it describes Prozac “… as effective or more effective than imipramine…”

Kelsey explained, “Since the purpose of the investigational drug studies is to prove the drug’s safety and effectiveness, such statements cannot be made while the drug is being evaluated.” Interestingly, Grosser’s study failed to confirm his bias.

F.S. Abuzzahab, Sr, MD, from the University of Minnesota Department of psychiatry, again according to the FDA’s analysis, showed that Prozac “produced more improvement than placebo on a few variables. The differences, however, were not consistent and included only some key variables” (p47). The older antidepressant was no better. This was essentially a fifth bust.

A December 13, 1984, letter from the FDA’s Frances Kelsey to Abuzzahab was critical of his practices in Lilly-sponsored Prozac studies. The letter stated, “Objectionable conditions were found to exist in both of the clinical studies for most of the subjects audited.” In particular, the inspection found “that you did not adhere to the protocols and that you did not give proper notification” when making protocol changes.

James D. Bremner, MD, a psychiatrist in Olympia Washington, did find that Prozac, like the older antidepressant, was better than placebo on most variables, according to the FDA. This was the only positive study among the six for Prozac. The older antidepressant, however, seemed more effective than Prozac, showing improvement on all variables (p 30). Only 22 patients finished on Prozac. As another important confounding factor about one-third of the patients received other psychiatric medications – minor tranquillisers and sedatives – in addition to Prozac. There is no way to tell if the results would have been positive if the patients had taken Prozac by itself.

In addition to these individual problems with the studies in Protocol 27 that we have mentioned, all of the protocols came under severe criticism.

The FDA’s November 13, 1984, “In-House meeting on fluoxetine” brought together the leading agency of officials concerned with monitoring the Prozac application process, including the division head, Paul Leber.

The minutes of the meeting, written by Tony De Cicco stated,

“This Agency has discovered a flaw in the experimental design and execution of the fluoxetine studies.” The flaw was located in “the main efficacy trials,” seemingly indicating all the studies we will be examining in this chapter.

According to D Cicco’s minutes, patients who were not doing well after the second week of the efficacy studies had the double-blind broken and if found to be taking placebo or Tofranil, were then switched to Prozac. The blind was then broken at six weeks in patients doing well, in order to continue them on their assigned medication after the study.

The manipulations caused two extreme compromises of all the studies. First, as indicated in the analysis of the Cohn study, the efficacy of Prozac at six weeks ended up being compared to the efficacy of placebo at two weeks – a very “biased “ analysis. Second, with the blind broken, investigator bias could compromise the results.

In addition, the “In-House meeting on Fluoxetine” found that very large dropout rates were impairing the analysis of data. The minutes were especially critical of the seemingly positive results of the Cohn study, but the criticism also applied to all individual studies in all the main efficacy protocols.

The problems found in these efficacy studies should have invalidated them. But Lilly was allowed to present its data for approval by the FDA.

Despite the bias in favour of Prozac built into the studies by Lilly, at the conclusion of Protocol 27 the picture looked very grim for the drug. But Lilly did not give up. It reshuffled the data, first by removing some but not all of Cohn’s embarrassing data. Then Lilly excluded all patients who had received other psychiatric medications along with Prozac.

Finally, it pooled the pruned data from the remaining five studies into one batch for statistical analysis, treating them as if they belonged to one study. This increased the total number of subjects for analysis, making it easier to demonstrate statistical significance for relatively minor improvements in the Prozac patients.

According to the FDA’s March 28, 1985, efficacy review, the results of the strained effort to pool the data were not convincing: “imipramine was clearly more effective than placebo, whereas fluoxetine was less consistently better than placebo.”

The FDA concluded, “the study is supportive but not strongly supportive in demonstrating fluoxetine’s role in the treatment of depression” (p.49). Basically, Prozac had been shown, once again to be a bust.

Undaunted, Lilly reworked the numbers one more time and resubmitted the new calculations to the FDA, now excluding all of the Cohn data as invalid, and again pooling the other five sites. Discarding the Cohn study eliminated 25% of the total protocol patients who completed the six-week trials and, should have rendered the pooling process invalid; but the FDA accepted it.

At the FDA’s request, Lilly also re-included all the patients who had been given additional psychiatric drugs during their Prozac trials. And at last, paydirt.

Lilly managed to come up with a positive result for the pooled studies on four of several measurements of improvement. Based entirely on the reworked figures, and ignoring the multiple flaws and the failure of all but one of the individual studies to demonstrate efficacy, the FDA concluded:

“The revised pooling of Protocol 27 can be said to contribute to the judgement of substantial evidence of efficacy” (p.50-A).

Pooling data from separate negative studies in order to get a positive overall result is open to criticism. In fact, the FDA’s own regulations on advertising specifically reject the use of such manipulations.

The regulations state that drug company ads should not “use statistics based on pooled data from inconclusive studies.” These particular pooled studies were worse than “inconclusive” all but one were outright negative.

Pooling negative studies is questionable enough. Dropping one of the studies in the process, eliminating 25% of the Prozac patients who completed trials, is wholly unacceptable.

Notice the extremes to which Lilly and FDA had to go to make the numbers work. Notice how much this has to do with statistical juggling and how little with real people. There is no indication that any person actually recovered from major depression, because that wasn’t even addressed. Instead, they were tested for relative degrees of improvement compared to the placebo patients as measured on symptoms checklists.

Although patients had to meet the DSM-III-R criteria for major depression in order to be admitted into the study, the patients were not reinterviewed at the conclusion to see if they had recovered and no longer warranted the diagnosis.

There is evidence that the patients themselves did not feel dramatically improved on Prozac. Of the two rating scales that allow the patients to record their own impression of the drug, one showed no difference between Prozac and placebo, and one showed some efficacy for the drug.

Could the clinicians have been influenced on the positive judgements of Prozac even though they were not supposed to know which patients were getting the drug? Yes.

Prozac patients, as we shall see, have characteristic side-effects – such as insomnia, nightmares, anxiety and nervousness, upset stomach, and weight loss – that could have allowed the rating physicians to guess who was on what drug.

In particular, the other drug in the study, Tofranil (imipramine), is really sedating, while Prozac is activating. Consciously or unconsciously, accurately guessing who was on the drug could have influenced the ratings by the doctors.

Earlier we pointed out that studies that fail are forgiven. There is another way this forgiveness takes place within each and every study.

Overall in Protocol 27, only slightly more than one half of the Prozac patients managed to stay on the drug for the whole six weeks. The others dropped out, usually because of adverse drug effects and lack of efficacy. How was it possible to claim, as many psychiatrists have, that 70 to 80% of patients benefit from Prozac, when as much as 50% of the patients do not even continue taking the drug for a brief six-week trial?

The high dropout rate in the six week long studies in part answers a frequently asked question, “Why are the drug studies so short?” In the case of Prozac, if the studies had been even a week or two longer, the trend indicates that the vast majority of the Prozac patients would have dropped out, underscoring the failure of the drug as a therapeutic agent.

In summary, in a multisite protocol in which only one of six studies turned out positive for Prozac, pooled data were shuffled and reshuffled, with much of it eliminated, in order to reach statistical significance on a few measures. These machinations were essentially flawed from the start by conditions such as the placebo washout, the extremely short length of the trials, the very small numbers of Prozac patients who completed the trials, the use of superficial symptom checklists to determine efficacy, the exclusion of suicidal or hospitalized patients, the inclusion of patients on multiple psychiatric drugs, and the better performance of the older antidepressants.

Interestingly, Lilly employees Paul Stark, PhD and C. David Hardison PhD, published the results of the pooled data from the five studies without mentioning the fact that the individual studies failed to show efficacy for Prozac, without mentioning the various FDA criticisms, and without giving the impression that Prozac’s performance was at best weak.

Unlike the FDA analysis and conclusion, which shows Tofranil to be superior to Prozac, the Lilly version claims Prozac to be as effective as (“comparable to”) Tofranil.

Protocol 19: More Doubts

Another of the three key positive Prozac protocols, Protocol 19, was conducted by Louis Fabre Jr Houston, Texas, psychiatrist who frequently does FDA research on behalf of drug companies.

According to the FDA’s March 28, 1985, review, the placebo washout was again employed, and “serious suicidal risk” was an excluding factor (p.52). Fabre compared Prozac and placebo. Only 47 patients were entered into the study, 10 were then dropped because they couldn’t be properly evaluated, and ultimately only 25 finished the trials. Of these completers, only 11 had been given Prozac (p.58).

With the slim number of patients completing the protocol, obtaining a positive result involved considerable statistical manoeuvring. For example, an additional five Prozac and seven placebo patients were counted in the statistical analysis for efficacy, even though they never finished the trial (p.58).

The trial as planned, was only five weeks in duration. But according to D Cicco’s critical analysis from the in-house FDA meeting, “Fabre has a four week trial at the most.”

Considering all this, the study should have been discarded as worthless, yet it became one of the cornerstones for approving Prozac.

How did the Prozac patients in the Fabre patients rate their own response to the drug?

They rated themselves no better than the placebo patients rated themselves. In other words, Prozac was no better than placebo from the patient’s viewpoint. These negative results occured despite the placebo washout, which tends to put placebo at a disadvantage compared to the drug. The same critique of the double-blind – that the doctors probably could tell the drug patients from the placebo patients – applies to this and all the FDA Prozac studies.

Meanwhile, is there any reason to question Fabre’s integrity? While no legal actions have been brought against him in regard to his studies on Prozac for Eli Lilly, Fabre has recently been accused in the civil suit of gross misconduct in regard to testing Halcion for the Upjohn Company.

He is charged, along with Upjohn, and participation in a “conspiracy, first to market Halcion and keep Halcion…… on the market.”

In regard to studies he concluded for Upjohn from 1973 to 1975, he is accused of the following:

All of the studies done by Dr Fabre at the Portland clinic were falsified. The studies were not double-blind, as they should have been; the drugs were decoded, and both the patient and the investigator knew what drugs the patients were taking.

The “Petition and Jury Demand” of the suit, dated December 22, 1993, also charges Fabre with running more than one study at a time on individual patients, to that they were taking multiple drugs, making it impossible “to determine which side effects were a result of which drugs.”

It also accuses him of having patients participate in one study after another without the required waiting period between medications.

Dr Faber and Upjohn have denied all allegations.

Protocol 62: “Seriously flawed”

According to the FDA’s October 3, 1988, “Summary Basis of Approval,” Protocol 62 was considered to be the weakest of the three positive protocols.

It was also the largest, initially involving 900 patients at 10 centres, although a variety of factors pared the numbers down considerably. The study consisted of two distinct parts, one testing the drug on “mildly” depressed patients and other “moderately“ depressed patients.

The following analysis is taken from the Food and Drug Administration “Review and Evaluation of clinical data: Amendment, “ dated December 30, 1985.

On various measurements, including the patient’s ratings of themselves, the slightly larger group diagnosed as mildly depressed showed no improvement on Prozac – an observation that becomes more interesting in light of currently publicized claims that Prozac is especially helpful to mildly depressed people.

The moderately depressed group included only 171 Prozac patients who actually completed the six-week trial. The moderately depressed patients did show some improvement, including on their subjective rating of themselves. There were no seriously depressed patients in the protocol.

In Protocol 62, the dropout rates were high in all dose ranges: over 35% at 20 mg, over 40% at 40 mg, and over 50% at 60 mg. The most common reason for dropping out was adverse side effects and the second was lack of effectiveness.

The most frequent side-effects when nervousness, anxiety, insomnia, nausea, anorexia, and diarrhoea, each of which occurred in more than 15% of patients. Even at the lowest dose, more than 70% of the patients experienced at least one side-effect, and at the highest dose, 90% endured one or more.

The FDA is very critical of this protocol. It was unable to identify a specific “time period when the results became significant.” There was no significant differences between the drug and the placebo before the fourth week. According to the December 30, 1985, FDA evaluation, the study was so “seriously flawed” in design that interpretation was difficult (p 12 and 13).

The concluding line of the FDA’s amended analysis states, “It is not possible to arrive at a single, unequivocal interpretation of the results.” Keep in mind that this protocol, like the others, used the placebo washout strategy that skews the results in favour of the drug, and that this protocol was one of the three most positive in a much larger field of negative protocols.

As already noted in regard to Protocol 27, both Feighner and Cohn were seriously criticised by the FDA on various grounds. Both were principal investigators in Protocol 62. Fabre, whose legal situation we discussed in regard to Protocol 19, was also a principal investigator in Protocol 62.

Fieve Presents a Different View on Protocol 62

One of Lilly’s hand-picked principal investigators in the 10-site Protocol 62 was psychiatrist Ronald R Fieve, a professor at Columbia University and chief of psychiatric research at the New York State Psychiatric Institute. Fieve is the author of the 1994 mass-market book Prozac: Questions and Answers for Patients, Family, and Physicians.

In the preface to his book, Fieve describes how eager he was to participate as one of Eli Lilly’s principal investigators and he tells the reader that the protocol did obtain the anticipated positive result for Prozac.

But his analysis of Protocol 62 bears little resemblance to the facts on several critical points:

Fieve says that the protocol included a comparison antidepressant, Tofranil but it did not.

Fieve states that the “pooled data” showed that Prozac worked better than placebo. As noted, there were two studies, and the pooled data for the mildly depressed patients showed no efficacy. A positive effect was barely measured only for the moderately depressed patients, a factor Fieve does not share with the reader. And, of course, there were no seriously depressed patients in the study, another fact Fieve does not share with the reader.

Fieve states that “Prozac patients experienced a startling absence of side-effects compared to imipramine patients.” Not only were there no imipramine patients for comparison, adverse side-effects afflicted the vast majority of Prozac patients and helped to cause a very substantial dropout rate.

Fieve says that Prozac was proven as effective as the older antidepressant, Tofranil, when the latter wasn’t even included.

Elsewhere in his book, without citing the FDA studies, Fieve states,

“approximately 65% to 70% of depressed patients who take their Prozac are fully relieved within 2 to 6 weeks”

but he couldn’t have concluded this from Protocol 62 or from any other Lilly sponsored FDA study of Prozac.

The high dropout rates in all of those research projects make it impossible to conclude that 65 to 70% of the patients were improved.

At least one third of the patients usually failed to finish the trials and dropout rates sometimes reach 50%. Besides, the vast majority of protocols and individual study showed no positive effect from Prozac.

In a telephone interview on April 6, 1994, I asked Fieve to clarify the discrepancies. Initially, Fieve thought he recalled an antidepressant control group in his Lilly sponsored FDA study: but after taking a moment to check with his assistant, he acknowledged that his memory had been inaccurate. He thanked me and said he would fix the error in the next edition of his book.

In the interview, Fieve repeated that other FDA studies did prove Prozac to be as effective as the older antidepressants, and was surprised when I assured him that in fact Prozac consistently proved less effective according to the FDA.

Fieve’s misperception about this is understandable, since Lilly’s (as opposed to the FDA’s) published version of Protocol 27, as we have already noted, claimed that the drugs did show comparable efficacy. Almost no one reads the FDA’s analysis, which must be obtained through the Freedom of Information Act.

When I reminded Fieve, he acknowledged that his Lilly sponsored Prozac study showed no positive effect on more than half the patients in his study – those diagnosed as mildly depressed – and that the FDA found the whole study very flawed.

I asked Fieve how he could write in his book that up to 70% of patients will improve on Prozac when the FDA study showed that up to 50% were likely to drop out due to adverse effects and lack of efficacy. The numbers were contradictory.

Fieve explained that the 70% improvement rate cited in his book was based on his personal impressions from his extensive clinical practice in which he gives Prozac and other SSRIs to most of his depressed patients. When pressed, he said that the 70% estimate did not include the one third of his Prozac patients who dropped out, mainly due to adverse side-effects.

He explained that the 70% improvement rate was based on those patients who remain on the drug, not on all the patients who start taking the drug. But simple maths shows that an improvement rate of only 47% – less than placebo in many studies.

Prozac Plus?

In chapter 4, we shall find that stimulus effects- including insomnia, nightmares, agitation, anxiety and nervousness are very commonly caused by SSRIs especially Prozac.

To counteract these adverse effects, clinicians frequently prescribe an additional drug along with Prozac. These include sleeping pills, such as chloral hydrate, or benzodiazepines (minor tranquilizers), such as Klonopin, Dalmane, or Xanax.

Sometimes the sedative is prescribed with the first dose of the SSRI, sometimes it is prescribed only after stimulant symptoms, such as insomnia or agitation, begin to appear. Either way, the patient is exposed not only to the hazards of SSRIs but to those of sleeping pills and minor tranquilizers, which include addiction, withdraw, and mental dysfunction.

In setting up and carrying out its protocols, Lilly seem to recognise that some Prozac patients will also need to be put on sedatives or tranquillisers. According to the FDA’s March 28, 1985, report, Protocol 27 states that patients will be excluded from the study if they take psychotropic drugs “other than benzodiazepines or chloral hydrate” (p 5). Under “concomitant medications,” the protocol seems to set a more narrow spectrum of permissible sedatives, stating the only allowable medications were chloral hydrate or flurazepam (Dalmane) for sleep.

In Protocol 19, patients were supposed to be excluded if they took any other psychoactive drugs (p 52). However, there is a seeming contradiction, because under concomitant medications, it is stated that “According to the protocol, the only allowable concomitant medication was chloral hydrate for sleep and benzodiazepines (not further specified) for agitation” ( p 54.)

In Protocol 62, as described in the FDA’s December 30, 1985, report, patients were supposed to be excluded if they took any additional drug except chloral hydrate. However, in “actual practice” patients were not excluded if they took benzodiazepines (p. 2).

It is obviously important to know how many of the patients taking Prozac in the FDA trials were in fact taking Prozac plus sedative, yet the numbers involved are not reported in Protocols 19, 27, or 62. However, during one of the attempts to pool the data for Protocol 27, Lilly decided to exclude all patients who took other drugs.

According to the FDA’s March 28, 1985, report, it turned out that patients were taking a wide variety of sedative drugs, including sedative tricyclic antidepressants, phenobarbital, and benzodiazepines (p 48). Not counting the Cohn study, which had been dropped, 25% (135 of 540) of the enrolled patients were taking an additional drug.

Of critical importance is that when patients taking sedative drugs were removed from the pooled data, Prozac failed to show significant efficacy.

Prozac proved efficacious only when patients taking the additional sedative drugs we included in the pool (p50-A).

The inclusion of sedative drugs in Lilly’s approval studies completely distorts them. In effect, the FDA ended up approving Prozac in combination with sedatives.

Prozac’s Tests Show It to Be Anything But a Miracle Cure

To sum up, the three protocols we have examined were the only ones that the FDA judged valid enough to use for demonstrating efficacy.

A large number of other studies were even more scientifically questionable or showed Prozac to be ineffective. These three badly flawed efforts, with many patients suffering adverse reactions, are the basis for the FDA allowing Prozac to be given to millions of Americans.

A lot of fancy numbers – crunching was required to make Prozac look any better than a lowly sugar pill. In addition, several of the investigators were severely criticised by the FDA for their practices, including failure to observe protocol rules.

It bears repeating: these three protocols – with only 286 Prozac patients finishing the four- to six-week studies – were the best that Eli Lilly and the FDA could come up with to prove the value of Prozac.

We believe the FDA, based on its analysis, should not have approved Prozac. All in all, this is anything but an encouraging outcome for the drug – hardly the stuff National crazes are made of.

March 25, 2016

Heres Gotzsches comment regarding 'seeding trials'. as mentioned in the previous post.

Seeding Trials

Seeding trials usually have no scientific value and usually don’t even have a control group. The doctors are given a portion of the company’s new drug and asked to try it out on the patients and note how it goes. The assembled data are pretty useless and are rarely published. The real aim of seeding trials is to lure as many doctors as possible into using the new drug. The doctors get a fee for each patient, and although the companies call it research, it has the character of bribery.

A German survey found that two thirds of such ‘studies’ didn’t even have a study plan or an aim for the study, and only 19% mention anything about publication. The drugs being promoted in the seeding trials were 10 times as expensive, on average, than the drugs generally being used. When a German journalist exposed the corruption, the CEO of Novartis wrote to his employees that his company in all respects strictly lived up to the codes of honour Novartis had bound itself to follow. bullsh*t on paper has the advantage that it doesn’t stink, at least only indirectly.

Few physicians would knowingly enroll their patients in the study that placed them at risk in order to provide a company with a marketing advantage, and few patients would agree to participate. Seeding trials can therefore occur only because the company doesn’t disclose the true purpose to anyone.

We need a societal consensus that it is immoral to deceive ethics committees and participants in this way about the true purpose of the trial.

The hallmark of seeding trials is that they involve huge numbers of doctors who treat few patients each. The law varies in different countries, but seeding trials really require approval by research ethics committee or a drug regulatory agency because they are not regarded as research, but ordinary use of an approved drug. The irony is total because at the same time many doctors think they contribute to research. In contrast to ordinary clinical trials, seeding trials are usually run by marketing people and salespeople trying to influence prescribing practices while they collect data in the doctors offices.

In 2006, Danish researchers documented that their participation in a seeding trial led to a significant increase in the use of the company’s drugs in their practices even though the effect was much diluted, as only 11 of the 26 general practitioners recruited patients for the study.

The rationale for the study was very thin, to compare an asthma drug with itself given in two different ways, and a non-blinded trial. AstraZeneca paid the doctors $800 for each patient. We have no idea how many doctors or patients were enrolled, as the study has never been published, although it appears to have ended in 2002.

I found an undated internal company report that mentioned 796 patients and that the data were on file.

A PhD thesis revealed AstraZeneca’s purpose with the study: ‘AstraZeneca is very concerned with the production of clinical evidence both as a means of making doctors aware of upcoming products and as a prerequiste for further commercial marketing’, and ‘in my view it was a much easier way to get a number of GPs aboard, instead of having to go out and convince them.’

An accompanying editorial noted that when a gift or gesture of any size bestowed, it imposes on the recipient a sense of indebtedness. The obligation to directly reciprocate, whether or not the recipient is conscious of it, tends to influence behaviour. Food, flattery and friendship are powerful tools of persuasion, particularly when combined.

A final point about research is worth noting. Even when academic investigators perform so-called independent clinical research on drugs, the drug industry tries to meddle with it. Internal documents that were never meant to become publicly known, but which were released through US court proceedings, are revealing.

An internal AstraZeneca email says that:

'Lilly run a large and highly effective IIT (Investigator initiated trials) program… They offer significant financial support but want control of the data in return. They are able to spin the same data in many different ways through an effective publications team. Negative data usually remains well hidden.

BMS (Bristol-Myers Squibb) IIT program is growing very fast in launched markets… Most proposals are modified by BMS. Strategic focus is unlicensed indications.

Jansen have a well-organised IIT plan… no IIT data is allowed to be published without going through Jansen for approval and communication is controlled by Jansen. High expectations are set on investigators who publish favourable results but they are well rewarded for their involvement. They seem less concerned than Lilly about negative data reaching the public domain.'

It seems rather strange to me that companies can run investigator initiated trials and even have programs for this.

And if it is correct that Jansen rewards investigators who publish favourable results, it looks like corruption.

March 25, 2016

Interestingly as i have been working at typing out the above over the past week 3days ago this came out:

A call for an independant review of use of prozac to treat depressed children.

http://healthinsightuk.org/2016/03/22/prozac-is-the-safest-drug-for-depressed-children-why-this-is-a-myth/

March 25, 2016

Hi, nz. I'm reading through your posts here and I'm really impressed with all you've read! This is really great information. Thanks for sharing it.

I was placed on psych drugs at 17, actually not "placed" but locked up and "forced". And then lied to for 30 years about a mythological chemical imbalance for 30 years.

Robert Whitaker's book Anatomy of an Epidemic literally saved my life.

It's nice to "meet" you. I look forward to reading more of your posts.

March 25, 2016

Thanks for popping in to say hi in my intro Shep.

Nice to meet you too.

March 29, 2016

After reading about Protocol 27 above in post #524

Now consider this ...here is Richard Wood the chief executive of Lilly (up to 1991) in a court deposition questioning session:

Question: Do you know how many patients were covered by Protocol Number 27?

[This was the key study submitted to the FDA in the license application for Prozac.]

Answer: I haven't the foggiest idea.

Question: Do you have any reason to suspect that protocol number 27 was not done in a good and scientific manner?

Answer: I haven't the foggiest idea.

Question: Do you know if it was done by Lilly?

Answer: I never heard of Protocol 27.

Source: Let then eat Prozac. Healy p257

[i just don't understand how people can get away pleading such disgustingly absurd foggy ignorance]

'

It is interesting to read further that in the case of Upjohn and Lilly in the 1980s and 1990s, one of the legal firms used was Shook, Hardy and Bacon, legal advisers to major tobacco companies.

As Ian Oswald's libel lawyer, David Hooper would put it:

"Upjohn's legal tactics were honed by a United States law firm renowned for its successful defence of tobacco firms. It is a moot point whether the tobacco companies have learned from the drug companies how to fight product liability cases or vice versa."

Against this background, the words of former US attorney general Janet Reno, applied to the tobacco story in 1999, become even more unsettling:

"The companies that manufacture and sell tobacco have waged an intentional and coordinated campaign of fraud and deceit… It has been designed to preserve their enormous profits whatever the cost in human lives, human suffering and medical resources… The truth represents a mortal threat to their business. At every turn, they denied that smoking causes disease and denied that it is addictive."

On April 8, 2000, the Lancet published a study showing how the tobacco industry spent large amounts of money on coordinated efforts to discredit studies on passive smoke inhalation. A Lancet editorial stated:

"Tobacco is not the only aspect of medicine open to twisted corporate communication strategies. A 1998 study reported that published opinions on the safety of calcium channel blockers were related to the financial rewards bestowed by pharmaceutical companies on those giving such opinions. All policymakers must be vigilant to the possibility of research data being manipulated by corporate bodies and of scientific colleagues being seduced by the material charms of industry. Trust is no defence against an aggressively deceptive corporate sector."

p261

.

Here's Healy on page 260 with another interesting insight :

Interestingly, in the 12 years following the public emergence of concerns over Prozac, there is not a single study designed to answer the question of whether Prozac or any other SSRI can induce suicidality. Lilly spent a year designing one, but it was never undertaken. Simply mentioning this point appears to have brought the Toronto house down.

[if you don't know the meaning of the reference to 'Toronto house' then thats another post.]

March 31, 2016

http://www.stuff.co.nz/dominion-post/news/78366259/Questions-over-care-of-mentally-ill-woman-who-stabbed-Wellington-man-to-death

Saw this pop up on my Facebook feed today NZ11. You've probably seen it but thought it may be of interest to you.

Nick

March 31, 2016

Thanks Nick,

No i hadnt seen it and thanks for sharing it. Very revealing.

Nick did you manage to get a copy of Kirwans book from the library he says,

"I came off them too quickly, got sick again, and had to go back on them" p217

[You didnt get 'sick again' John , you suffered classic debilitating withdrawal symptoms possibly even akathisia and i suspect you were uninformed regarding this ].

"Yes it took me a while to find one that worked and didnt cause me problems. I had dry mouth and a bit of blurred vision with one of them. The trouble was i didnt know whether they were side effects or just my nutty brain." p219

[John you didnt and dont have a nutty brain you have a very good brain].

Clearly Kirwan's own words infers he has been exposed to the switching game of psychotropic drugs.

Kirwan was "Afflicted with depression for many years ...battling with depression...." see back cover of book.

[How does that happen ...the many years bit i mean. Depression generally lasts only a few months ("3"-Healy). Unless of course one is having to endure uniformed ssri protracted withdrawal ...and as we know that sure can go on for years and boy is it a battle to survive it.]

"At my very worst moments, i lost all sense of hope for the future. I began to slowly get better, I began say to myself, 'This will pass, you'll get through this. Hang on to hope." see back cover.

JK has clearly been sold the biological? germ? myths...."You know how germs attack our immune system? Well in the same way, depression attacks hope, which is partly why its such a deadly disease." p35

In light of Johns admission to psychotropic drug exposure now read this.....Kirwan says:

"By the time morning came, I was completely in the grip of my darkest thoughts and feelings. The deep, messed-up thoughts that i'd grabbed hold of- that i was going to do real harm to somebody- had become completely real to me and i was in bed physically shaking and sweating and continually crying." p8

I think we all know what John is describing here and its ~~struggling with depression~~ classic withdrawal symptoms imo.

Here is the thing in 2010 as i went drug free and trying to get answers for what can only be described as a psychological torture i was driven to see a councellor as i talked to him about what i was experiencing trying to get off paroxetine he gently leaned forward and quietly said "nz11 i have many people coming to see me who are trying to get off these drugs and they have ALL described the withdrawal exactly as you have."

How did i describe it to him,...i described it like this, "I wake up in the morning psychologically distraught and wanting to die lying in my bed in a fetal position sweating profusely, shaking, and i cant stop crying".

nz11 (4-6am)

We are all iatrogenically suffering together!

We are all recovering together!

We are all not sleeping together!

April 1, 2016

We are all iatrogenically suffering together!

We are all recovering together!

We are all not sleeping together!

Oh boy, that was my best laugh all day... thanks NZ :lol: :lol:

April 1, 2016

Not sure what you mean there ?!!

lol!

April 1, 2016

rofl

April 1, 2016

I have no idea what Karen and Fresh are thinking about!

April 1, 2016

Here is an interview with Kelly Brogan

http://seancroxton.com/008-kelly-brogan/

"We were taught bullsh#t" (approx 30min)

"I dont prescribe anymore" (approx 43min)

These are "some of the most habit forming medications on the planet"

On learning she had been taught false paradigms she said ..."I was pissed"

To those who say that school shootings are because the kids need to be on more drugs, she says, "bullsh#t".

11% of American population is on an ad ,and

1 in 4 American woman in there 40's and 50's is on an ad.

[This is a most tragic situation].

The suicide rate among ad users is 15 times higher than what the FDA reports. (25.30min)[Wow!]

Learnt a new word 'data dredging',-making the data say what ever you want it to say. eg negative studies are made to look positive.

The host was pretty intelligent too he refers to her book as a 'Code yellow' ...that means just about every page in the book is in yellow highlighter. (Sounds like Healys books.). What a great phrase ..never heard of that term before ...awesome phrase.

I really liked this interview because i am currently reading Kirsch and i was able to hang in there as she talked about his work.

Gee she sure can articulate this stuff from memory so well.

April 1, 2016

Listening for a second time to the KB interview

She says:

"[ad] withdrawal i would argue is potentially the worst of all chemical withdrawals, i cannot think of a chemical on earth that is more challenging to come off of than 15 yrs on celexa' for example. I have patients in my practice that i taper off by one thousandth of a mg a month. I have never heard of someone struggling to come off of heroin or oxycontin at this rate. I have never heard of anything comparable to this it is so disabling that patients develop neurologic symptoms, they develop cataclismic mood syndromes, they develop impulsivity and violence totally out of character for them. Its pretty horrifying."

K. Brogan, NY Psychiatrist, 11 March 2016

Anyone now how they measure one thousandth of a mg ? Wow that is something.

Had to laugh when the host asked her whats this thing you write about only needing 2 positive studies to get a drug approved by the FDA... 'is that a typo or something' ! ?

I can still hear my doctor saying no not addictive.

On Healys website there is a list of 12 questions to ask your doctor before taking a drug.

http://rxisk.org/tools/drug-checklist/

But at the end of the day what can you do if you are ask those questions and are still given false/untruth/misinformed/propaganda-ized info anyway.

I invited a pdoc to try some of his own medicine and he dodged the question (in fact his body language spoke volumes) until the third time i asked it and then he reluctantly said,

"i wouldnt take anything without googling it first".

There is the answer for all of us. Took 8 or so yrs at med school to learn that ...!

Its unfortunate that he didn't seem to think that what was unsafe for him might in fact be unsafe for others too.

What could be damaging/addictive to him might be damaging to others too.

April 1, 2016

Love your passion , NZ. We are " insomniac buddies " . Take care .

April 1, 2016

Hey AliG i know for a fact that you have been up since 2am aussi time.

Stop reading and commenting in posts and get some sleep!!

lol

Thankyou for wording it like that!

Such a wise word-er!

nz11

Gotta run ...goin fishing!

spot ya tomorrow same time ...3am

April 1, 2016

"Anyone now how they measure one thousandth of a mg ? Wow that is something."

Digital jewellers' scales measure to 0.001 mg , which is 1 / 1000.

April 1, 2016

Sorry, digital jewelers scales measure 0.001g which is 1mg. One one thousandth of a milligram is 0.000001g which takes some extremely expensive laboratory scales to measure.

There is a small device inside the scales called a load cell. It's a piece of metal that has an electric current running through it. When you put weight on it, it bends a little and that changes the electrical properties which can be measured and translated into weight.

☼ nz11 climbs onboard

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