When Science and Anecdote Collide

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For decades, declarations by perturbed relatives that a loved-one’s death was iatrogenic (induced by medical treatment), were often dismissed as anecdotal. Accounts imparted by concerned loved-ones were likely to be rejected, albeit often kindly – yet thrust aside as the demented rantings of a grieving loved-one. Placated with persuasive words, relatives often slink away, suitably chastised by the medic’s evidential superior knowledge. The rantings of the grieving widow or mother will be controlled and placated, with the vociferator patronized and often pitied as misinformed dissidents. Thus, relegated to the anecdotal tray, rather than adverse-reaction tray, the iatrogenesis will likely continue, surfacing some time later to harm another. Many feel this practice is particularly pervasive within psychiatry, where protecting the medical model seems paramount over the safeguarding of patients.

The perception of the American ‘shrink’ listening attentively, while the horizontal patient spills his innermost torment, is one that persists today. In reality, this is far from the norm, with the prescribing of psychiatric drugs taking precedence over the tedium of treating a traumatised patient. Drugs that often mask the problem with disinhibition and emotional blunting are seemingly prescribed with wild abandon, yet only the families affected can see the harms done – while medics seem oblivious. When Cochrane Scientists and expert psycho-pharmacologists, are publicly stating that antidepressants and other psychotropic drugs are causing ‘more harm than good’ and many deaths, dismissive medics who continue to recklessly prescribe are walking a fine line between acting irresponsibly and negligently. However, a vast disparity still exists between scientific findings that psychiatric drugs are the third leading cause of death in Europe (and the U.S) and psychiatry’s Key Opinion Leaders (KOLs) declaring these drugs are safe – even declaring that ‘the public should have no concerns about these drugs’. 

When publicly challenged, KOLs usually retaliate with the mantra ‘correlation does not imply causation’. Pushed a bit further, their hackles will rise and they’ll state ‘these people are causing harm, by stopping people from taking life-saving medication’. Yet, even a utilitarian argument that these drugs provide ‘the greatest good for the greatest number’ has been debunked by Peter Gøtzsche (scientist and co-founder of the Cochrane Collaboration). He stated recently, to no small uproar, that these drugs are ‘doing more harm than good’ and that almost all psychotropic drug use could be stopped without deleterious effect (due to withdrawal, discontinuing is not advisable without medical supervision).

However, the problems run deeper than the KOLs defence of psychiatric drugs. An interesting article on MIA (Mad in America) tells the sorry tale of a dad who recently discovered that the American drug regulator (FDA) is ‘hiding reports linking psychiatric drugs to homicides’. It will be interesting to see what happens next within the FDA.

Furthermore, the statement that ‘the public should have no concerns about these drugs’ was made following an inquest in Ireland, where concerns were raised by the deceased’s family about a recent prescription of Sertraline (Zoloft/Lustral). However, as is common practice, the family’s concerns were dismissed. They had no way of knowing that in 1998, the Irish Drug Regulator (HPRA), following reports of Sertraline-induced suicide, had requested that the drug company in question (Pfizer) search its database for similar cases. There were 594 ‘suicide events’ reported from non-clinical sources, of which causality was not investigated. Of the 252 from clinical trial cases, Pfizer’s internal report concluded that 54 were directly related to Sertraline treatment. Interestingly, 11 of the ‘suicide events’ reported (from both sources) came from Ireland, with 2 found causally related to Sertraline. The latter were from ‘confidential’ documents released through court proceedings and provided by Kim Witczak who lost her husband Woody to Sertraline.

Nevertheless, it seems that science may be catching up with the anecdotal evidence, with some interesting studies published recently. Following the Study 329 debacle (as yet unretracted), the latest study by Jureidini et al ‘The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance’ shows how Forest Labs, through greed and fraudulent practices, actively ignored the prospective likely harms to children. The study concluded:

Deconstruction of court documents revealed that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. However, the published article concluded that citalopram was safe and significantly more efficacious than placebo for children and adolescents, with possible adverse effects on patient safety.

Another study by Selma et al ‘The relevance of cytochrome P450 polymorphism in forensic medicine and akathisia-related violence and suicide’ expressed that a genetic predisposition to iatrogenesis can be traced back to pharmacogenetic interactions, namely the inability of some to metabolize prescribed drugs, making ordinarily ‘safe’ drugs, lethal for some. The study concluded:

“CYP450 status is an important factor that differentiates those who can tolerate a drug or combination of drugs from those who might not. Testing for cytochrome P450 identifies those at risk for such adverse drug reactions. As forensic medical and toxicology professionals become aware of the biological causes of these catastrophic side effects, they may bring justice to both perpetrators and to victims of akathisia-related violence. The medicalization of common human distress has resulted in a very large population getting medication that may do more harm than good by causing suicides, homicides and the mental states that lead up to them”.

Perhaps we will just have to wait for the hapless KOL to catch up, not only with the scientific evidence but with collective anecdotal evidence from families. It would seem that underestimating anecdotal evidence is unwise – not least as science often evolves from this very valuable source.

The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance.

The relevance of cytochrome P450 polymorphism in forensic medicine and akathisia-related violence and suicide

Family calls for more research into anti-depressants

The FDA Is Hiding Reports Linking Psych Drugs to Homicides

Meet Larry..

Larry 1Meet Larry, 63. Larry underwent a ‘triple bypass’ operation last Christmas, which involved spending 26 days in the Mater hospital, Dublin. Open heart surgery is known to be a very serious procedure; not least because the sternum (which is opened during surgery) can take up to 12 weeks to heal. Cardiologists acknowledge that Heart surgery is life-changing, both physically and emotionally.

Larry was a good guy, the eldest of six. He was relaxed, funny, and easy-going, with a wife whom he knew since they were teenagers. He had 4 children and 7 grandchildren who adored him. Following Larry’s triple bypass, as is common following big operations, he started to feel a little down. He was prescribed an antidepressant Lexapro (Lundbeck’s poison and the same drug Shane was prescribed). He took Lexapro as prescribed for about a week. He told his son that his head felt like it was exploding, that it wasn’t in sync with the rest of him and that he was ‘all over the place’.

Larry went back to the doctor and his medication was changed, this time to a newer antidepressant, Valdoxan (AKA Agomelatine, manufactured by Servier) and the Benzodiazepine Xanax, another potentially dangerous drug. Larry was prescribed this drug despite recent reports that Valdoxan is associated with serious hepatotoxicity (liver damage) and that caution is advised when prescribing for overweight/obese patients. I’m sure Larry wouldn’t mind me saying that he was more like Pavarotti than Rudolf Nureyev. Either way, I’m not quite sure why any medical professional would prescribe this drug considering the doubts surrounding its efficacy and the possible dangerous adverse effects. Warning here.

According to Larry’s family, following the later prescription for Valdoxan and Xanax, he became manic, unable to function; the simplest of tasks became mammoth. He behaved bizzarely, for example: he wouldn’t allow his wife out of his sight, insisted on holding her hand at all times, seemingly afraid to let go. This was totally out of character for the usually easy-going Larry. As usual, this change was put down to the after effects and trauma of this huge operation, not the mind-altering drugs which are prescribed to unsuspecting patients, including Larry.

On 27th Febuary 2013, Larry took a rope into the garage of his old family home and less than the required 12 weeks it took for his sternum to heal, this easy going 63 year-old man was dead.

There are 2,370 suicides and 1,539 Cardiac arrests reported as a drug- reaction (of Xanax) in the RxISK website. Valdoxan (Agomelatine) is not on the RxISK website because it is not approved by the FDA in America. This drug has been called ineffective, potentially dangerous and ‘a dog’ and had 3 (acknowledged) suicides in clinical trials, before it was even approved. For more of Valdoxan’s dodgy trials and other dodgy dealings with this IMB approved drug, retired psychiatrist and scientist ‘1 Boring Old Man’ explains it here.

The Valdoxan patient information leaflet (PIL) has the usual IMB inadequate suicide warning, although directed at under 25s:

 A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

The fact that the so-called psychiatric ‘experts’ in Ireland deny that these drugs can cause suicide, arguably negates the above warning. Even though Larry was aware of Shane’s case and the role that antidepressants played, he, like most people, trusted that the medical professionals knew better.

RIP Larry.

Lexapro PIL

Valdoxan PIL

Xanax PIL

Like taking candy from a baby.

Big PharmaYesterday the New York Times reported that a drug named ‘Acthar’, which is used to treat Infantile spasms, used to cost $50 but is now priced at $28,000. Despite questions over its efficacy and drug trials which were suspended, aggressive marketing by Questcor Pharmaceuticals and the support of a ‘Dr. Thrower’ (who also happens to be a paid speaker for Questcor), Forbes list Questor’s Market Capital at $1.33 Billion. Considering Acthar is listed as its ‘primary product’, that’s a sizable profit made from defenseless babies. Because Acthar was approved in 1952, before the FDA required clinical trials to show that a drug is effective, it seems that Questcor has carte blanche to market this drug for whatever condition it chooses, without the added burden of large trials to prove efficacy.Pharma targeting children

Does the targeting of children sound unbelievable to you? The pharmaceutical industry has a history of targeting the most vulnerable of society, not least with unapproved ‘mind altering’ drugs for depression, which can and have had tragic consequences. So just how much money can a pharmaceutical company squeeze out of a parent with a sick baby? Do you think I’m being a bit skeptical of the pharmaceutical industry, or maybe just a little bitter? Remember Pfizer’s illegal drug trial on Nigerian children. Eleven children died and 189 other children were left injured, some blind, paralysed or brain-damaged. Yet the billion dollar Pfizer spent years fighting the parents of these children before finally settling the case, for some.

It may come as no surprise that Lundbeck are also guilty of the practice of using infants for profit. When Lundbeck acquired the rights to Indocin IV, a drug used for a certain heart defect in premature babies, their vice president had this to say: “We can price these almost anywhere we want given the product profiles.” Lundbeck then raised the price by 1,300 percent.

This year GlaxoSmithKline were fined for, among other things, actively promoting dangerous drugs for use in children. So where will it end? Will the corruption of the pharmaceutical industry enter your head when you take that pill recommended by your family doctor? The ‘med of the moment’ seems to be statins. Doctors are pushing these drugs on healthy individuals in order to cut the risk of heart attacks and strokes. Professor Rory Collins of Oxford University, says “Statins should be given to all over-50s, regardless of their health history, because they dramatically cut the risk of heart attacks and strokes in later life.He lists his conflicts of interests as “engaged in research activities for Merck, Bristol-Myers Squibb, Sanofi, and AstraZeneca.” My cynicism is showing I fear!

Giving statins to healthy people seems ridiculous considering that there are a number of serious adverse effects which can occur with these drugs, including Depression, aggression and Sexual Dysfunction. Ben Goldacre in his new book ‘Bad Pharma’ says: “The MHRA (UK Medicines Regulator) has previously stated ‘Patients should be made aware that treatment with any statin may sometimes be associated with depression, sleep disturbances, memory loss, and sexual dysfunction.’ The agency also planned a new warning that – very rarely-statin therapy might be associated with interstitial lung disease, a serious medical condition.” There are further concerns that these drugs can cause diabetes; so why would a healthy person take a drug which could make them sick? Never underestimate the marketing power of the pharma industry.

So it begs the question; If a person (taking a statin) presented to his/her doctor with symptoms of depression, would the doctor relate the depression symptoms to the statin? OR would the friendly doctor just prescribe an antidepressant which may come with similar adverse effects adding to the ones caused by the statin?

How many deaths, as a result of taking medication that was never needed, are attributed to a drug induced death? How many ‘natural deaths’ are actually caused by the pharmaceutical industry? Where will it all end?

Marcia Angell: “The combined profits for the top ten drug companies in the Fortune 500 were more than the profits for all the other 490 businesses put together.

Reuters: Pfizer settles Nigerian case.

NY Times: Questor finds profit at $28,000 a vial.

Litigation & Trial: We can price these almost anywhere we want given the product profiles

Mail Online: GSK fined $3billion

Mail Online: Give statins to all over-50s

Marcia Angell: The Truth About Drug Companies.

Ben Goldacre: Bad Pharma

GlaxoSmithKline awarding the Irish media? No thanks!

‘RTE Radio 1’ has a Facebook page which proudly states “We’re delighted that RTÉ took home three awards at this year’s GSK Irish Medical Media Awards.” Two of the awards were won for documentaries, one on depression and another for clinical trials involving children.

Seriously though? That’s GSK; GlaxoSmithkline! Why is a pharmaceutical company (which has consistently been proven corrupt), sponsoring Ireland’s ‘Medical Media Awards’ and why is this acceptable?

Here’s an Irish article from 1998 which refers to Seroxat/Paxil called ‘Pill to melt shyness‘. The article states that people suffering from this ‘crippling’ illness ‘aren’t aware that they have such a condition’ and that ‘By itself, social phobia doesn’t bring on suicide but combined with other psychiatric illnesses victims are six times more likely than the general population to kill themselves‘. OK, so these poor unfortunate sufferers may go on to kill themselves from shyness and taking Seroxat should fix the problem? The article further states that the time this illness or ‘social phobia’ usually strikes is between the ages of 14 and 16 years old. Hang on a sec!! Panorama did a series of TV documentaries ‘outing’ GSK and the notorious Seroxat. They revealed, among lots of corrupt practices, that in one of GSK’s drug trials, adolescents were six times more likely to become suicidal after taking it. So the illness increases the risk of suicide by 6% and the cure by another 6%; a better mathematician than I would tell you, that’s not a good percentage for a so-called cure!

In July of this year GSK were fined $3 billion in the US for, among other things, illegally promoting this drug for children, despite being aware that the same drug could cause these children to kill themselves.

GSK’s ‘Better Together‘ campaign states…” to ensure Irish patients and consumers can get access to the health care they need, GSK recognise that we must work in partnership with Government, policy makers, healthcare professionals, patient and citizen groups.” I bet they do! Also this, “GSK wants to be healthcare partner of choice, valued for our expertise and trusted for our integrity.” What integrity is that exactly?

Ok, forgetting the fact that they have caused numerous ‘Seroxat induced’ deaths in children and adults; maybe it’s the ‘Avandia Scandal‘ integrity they’re talking about? Avandia is the drug that the FDA scientist ‘Dr. David Graham’ said ‘may have caused as many as 100,000 heart attacks, strokes, deaths and cases of heart failure’ before the drug was finally taken off the market. GSK still clung to the mantra the drug was safe though. Never admit anything? Surely GSK is the last company (apart from Lundbeck) that the Irish Medical Media should associate with? In my humble opinion, the medical media, whose job it is to investigate, should have done a little research into the company who was sponsoring these awards. Then they may have had some integrity of their own and told GSK to stick their awards where the sun doesn’t shine!

https://leoniefennell.wordpress.com/2012/07/04/irish-reports-on-gsks-fraudulent-marketing/

http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all

http://fiddaman.blogspot.ie/2012/10/gsk-flying-flag-of-hypocrisy.html

Lundbeck’s Vortioxetine (Lu AA21004) Will the FDA and the EMA approve another ‘killer’ drug?

So Lundbeck are seeking approval for their latest offering Vortioxetine. This is the drug which Lundbeck director ‘Torsten Madsen’ is referring to in this video. He says ”Some of the studies that we conducted did not have the outcome that we had hoped for, so we speculate that, emm, the reason is due to a too low dosing of 21004″ (Or maybe it’s because it’s another of Lundbeck’s useless offerings!)

Lundbeck’s supposed ‘antidepressant’ patent is due to run out very soon, so they’re scrambling around for a new ‘billion dollar’ pill. Will you be the next guiney pig? Citalopram and Escitalopram (same product) have caused untold suffering and numerous deaths including suicide and homicides, so will the new offering be any different? How many people will die from this drug if it does happen to be approved by the regulators?

The Clinical Trials website include 5 ‘Vortioxetine’ clinical trials conducted in India, here. Lundbeck has already been found guilty of fraud and corruption in India. Nowone would have to consider, if Lundbeck are continuously using corrupt practices in India, as with the licencing of Deanxit here, how can their findings with LU AA21004 be relied upon? Who did they have to pay to get the right results this time?

Will the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) allow another killer drug to slip through the net?

Deanxit Fraud 

Lundbeck ethics

Brussles Court find Citalopram and Escitalopram to be the same product.

Peter Needham (another victim) and yet another Coroner’s warning.

In March of last year, an Inquest was held into the death of  Peter Needham, 40 (a former British Aerospace inspector). Mr Needham was described as a normal, happy, sociable, lovely guy. His dad described him as ‘a beautiful son’. How did Peter (a sociable and popular man) get to the Inquest stage at 40? Very easily!

(1) 40-year-old Peter had been diagnosed with diabetes last March and prescribed a drug to deal with a tingling sensation in his foot. The medication he was prescribed is also used as an antidepressant. Duloxetine (aka Cymbalta) comes with warnings of suicidality, agression and depression. The sad fact is that at least 5 people killed themselves while trialing this drug in clinical trials for Eli-Lilly. This should have raised a red flag but no! The drug went on to be licenced and Eli-Lilly made billions. What’s a few bodies between drug companies?

(2) After voicing concerns about feeling down, Peter was prescribed a different anti-depressant, Sertraline, five days before his death. Sertraline (aka Zoloft) also comes with warnings of suicidality, aggression and depression. Pfizer discovered in their clinical trials that this drug also increased suicidal behavior and fared negatively in treating depression. Despite the negative results of these trials, Zoloft went on to be licensed and Pfizer made billions. What’s a few bodies between drug companies? Just ask Woody.

(3) Two days after taking Sertraline/Zoloft, Peter started to visit websites on how to take his own life.

(4) Five days after taking Sertraline/Zoloft, Peter hanged himself at his home in Springhead.

The Coroner (Simon Nelson) said it was “difficult to ignore” the link between Peter taking the medication and his death. He said that he would write to the Royal Pharmaceutical Society and British Medical Association to raise his concerns about prescription-medicine labelling.

Holding up a page filled with small-print instructions, he said: “To the untrained eye and in particular the first-time user this would be completely off-putting. To discover those warnings half way down the small print is wholly inappropriate.”

Six weeks later another Inquest was held, this time in Ireland, which involved the same drug, only this time it was Nicolas Maguire, 52, from County Cork.

So another Coroner’s warning and the governments are still doing nothing? How many people have died today because these useless, spineless, pen-pushers are not doing their job? That includes our own Kathleen Lynch and James Reilly!

How safe is Lundbeck’s new drug LU AA21004?

Lundbeck’s PR department are going into overdrive at the moment. Due to the patents expiring on Celexa and Lexapro, Lundbeck are heavily reliant on finding the next block-buster drug. They seem to think they have found it in LU AA21004. This drug is also known as vortioxetine and according to Lundbeck, 8 out of 10 trials have shown the drug to be effective in depression. The information on Lundbeck’s proposed new drug on the Clinical Trials website include 5 clinical trials conducted in India, here.

It’s unfortunate that in the same week that Lundbeck are found to be flouting the rules by advertising their “anti-anxiety” drug Deanxit contrary to Indian law, it has also emerged that the company may have been ghostwriting their own material.

A report published this week by the Parliment of India has found; In case of sertindole (Serdolect of Lundbeck), an anti-psychotic drug, three experts located at three different places (a Professor and Head of the Department of Psychiatry of Stanley Medical College, Chennai; Professor of SKP Psychiatric Nursing Home, Ahmedabad and a Professor and Head of the Department of Psychiatry of LTM Medical College, Mumbai) wrote letters of recommendation in nearly word-to-word, identical language and not surprisingly all of them used the incorrect full form of DCGI in the address! Is such a coincidence possible unless the person behind the scene who actually drafted the letters is one and the same person?  Full report.

Now, one would have to consider, if Lundbeck are continuously using corrupt practices in India, as I have previously shown with the licencing of Deanxit here, how can their findings with LU AA21004 be relied upon?

Deanxit

Deanxit is another of lundbeck’s controversial and dangerous drugs and another example of Lundbeck committing corruption, deceit and fraud within the approval process.

Lundbeck lied to get approval for this drug by stating that at one meeting, 7 leading psychiatrists recommended that the drug should be registered for sale in Sri Lanka, when in fact journalist Anne Lea Landsted was able to prove that 3 of the psychiatrists had never even been at the meeting! Her letter can be found here…Link.  Lundbeck later apologised and offered to withdraw the drug from the Sri Lankan market, but surprisingly, it’s still there!


Celexa 

Carl Hugod is a medical expert who worked in the Danish National Board of Health. He was contacted by two journalists investigating Lundbeck’s Cipramil/Celexa. Carl agreed to look through the scientific papers which Lundbeck submitted for the licencing of this drug. What he found was that scientifically, the evidence was very poor and there was nothing to show that this drug was any better than other ssri’s and in fact could possibly be worse. He said that on a scientific level this work would not have been accepted in a university and was another case of Lundbeck doing whatever was needed to get a drug licenced, by fraud and corruption. Lundbeck manipulated the data from the Cipramil studies to show that this drug was better than other ssri’s when in fact it clearly wasn’t. Carl made a complaint to the board of scientific fraud and said“In my opinion the National Board of Health should never have been satisfied with this utterly disgraceful lack of scientific documentation concerning the drug’s effectiveness.” He publicly voiced his concerns that some professionals on the licencing board were being paid by “The Lundbeck Fund” which Lundbeck said was an entirely different company…! Link.

Lexapro 

Lexapro was another dubious example of the way Lundbeck got through the approval process. This drug came about immediately after the patent for Celexa ran out. A Brussels Court found both to be the same product here. The Bureau of Investigative Journalism also raised questions whether the trial was truly independent or if Lundbeck’s connections with Arbacom, a Russian company that sponsored the ‘independent’ trial was an issue here. The BMJ reported that Lundbeck breached the UK industry ‘code of practice’ by claiming that its new offering, escitalopram (Lexapro/Cipralex), was more effective than citalopram (Celexa), even though the two drugs have exactly the same active ingredient here.

Then there is the small matter that Lundbeck is currently being investigated by the European Commission. The EC has opened a formal antitrust investigation to examine potential breaches of EU rules on restrictive business practices and on the abuse of a dominant market position under Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU). Link.

So considering Shane and all the other deaths associated with these drugs, can Lundbeck be trusted when they talk about the efficacy of their latest invention LU AA21004?

https://leoniefennell.wordpress.com/2012/01/08/lundbecks-hall-of-shame/

https://leoniefennell.wordpress.com/2011/05/27/deanxit-the-new-delhi-government-and-lundbeck-fraud/