Song Time…


I could never get into U2’s later work, or recent albums…

But.. U2’s early stuff was great, The Joshua Tree, Achtung Baby, etc.

‘Bad’ is one of their best..

 

 

If you twist and turn away. If you tear yourself in two again. If I could, yes I would If I could, I would let it go. Surrender, dislocate. If I could throw this lifeless life-line to the wind. Leave this heart of clay, see you walk, walk away Into the night, and through the rain Into the half light and through the flame. If I could, through myself, set your spirit free I’d lead your heart away, see you break, break away Into the light and to the day. To let it go and so to find away. To let it go and so find away. I’m wide awake. I’m wide awake, wide awake. I’m not sleeping. If you should ask, then maybe They’d tell you what I would say True colours fly in blue and black Blue silken sky and burning flag. Colours crash, collide in blood-shot eyes. If I could, you know I would If I could, I would let it go. This desperation, dislocation Separation, condemnation Revelation, in temptation Isolation, desolation Let it go and so to find away To let it go and so to find away To let it go and so to find away I’m wide awake, I’m wide awake, wide awake I’m not sleeping Oh no, no, no.

Paxil (Seroxat ) and Autism in Childen (born to mothers who ingested it during pregnancy).


https://www.equities.com/news/bailey-peavy-bailey-cowan-heckaman-files-lawsuits-over-paxil

Bailey Peavy Bailey Cowan Heckaman Files Lawsuits Over Paxil®

PR Newswire | Wednesday, 25 May 2016 16:00 (EST)

HOUSTON, May 25, 2016 /PRNewswire/ — The number of reported autism spectrum disorder (ASD) cases in the United States has skyrocketed by more than 750% since 1998.  The ASD epidemic has coincided with the explosive increase in the use antidepressants during pregnancy.  The number of women of childbearing age taking antidepressants increased 400% between 1994 and 2008. Since 2011, epidemiological studies have reported an increased risk of ASD in children of mothers who took antidepressants like Paxil® during pregnancy.

GlaxoSmithKline, plc (GSK) developed and marketed Paxil® and has been litigating for more than a decade against cases brought on behalf of children born with congenital birth defects allegedly linked to Paxil® exposure during pregnancy.  In 2005, at FDA’s request, GSK revised the Paxil® pregnancy warning to include a statement that Paxil® use during pregnancy may increase the risk of fetal harm.  Paxil® is the only antidepressant to include this warning.

Adam Peavy, lead counsel for the plaintiffs, says, “These are the first of what we believe will be many cases that will be filed against GSK on behalf of children with autism spectrum disorder.”

The alarming increase in the number of ASD cases has imposed a tremendous economic cost upon the nation, local school districts and families.  The CDC estimates that the total economic cost per year for children with ASD ranges from $11.5 billion$60.9 billion (2011 US dollars).

Children with ASD have higher medical costs than children without ASD. That burden is shared by taxpayers, as children with ASD enrolled in Medicaid have costs six times higher than those without ASD.  The greatest economic burden is placed upon public schools, which must bear the economic costs of federally mandated services for children with ASD.

The CDC reports that the annual cost to provide rehabilitative and intensive behavioral interventions for children with ASD range from $40,000 to $60,000 per child.  School districts are required to provide such services until the child is 21.

Mario D’Angelo, co-counsel for plaintiffs, says, “Taxpayers and local school districts should not have to bear the burden of providing services for those injured by GSK’s negligence. We are investigating what legal remedies our clients’ local school districts may have to recover these costs from GSK.”

The cases are pending in Superior Court of the State of Delaware.

Bailey Peavy Bailey Cowan Heckaman, PLLC is a team of national trial lawyers based in Houston. With decades of legal experience, its attorneys concentrate their practice on four major areas: mesothelioma litigation, serious injuries, drug and medical device injuries, and Fair Labor Standards Act (FLSA) violations. BPB was founded three decades ago by Ken Bailey, one of the attorneys responsible for the then-largest multi-billion dollar settlement in U.S. history. For more information, visit http://www.bpblaw.com/ or call (888) 367-7160.

 

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/bailey-peavy-bailey-cowan-heckaman-files-lawsuits-over-paxil-300274621.html

SOURCE Bailey Peavy Bailey Cowan Heckaman, PLLC

Is There Something Dodgy Going On With GSK’s Tafenoquine?


Tafenoquine is an experimental anti-malaria drug manufactured by GSK. It seems it might be just as dodgy as Roche’s Lariam (see here). Personally, after experiencing the horrors of Seroxat, I wouldn’t ingest any GSK product, and why would I?

Seroxat was horrific.

A great website worth checking out in relation to these drugs is

internationalmefloquineveteransalliance.org

And check out the post below for more on GSK’s Tafenoquine-


https://internationalmefloquineveteransalliance.org/2016/05/21/scientific-misconduct-in-the-australian-army-malaria-institutes-clinical-trials-of-tafenoquine-part-1/

Scientific Misconduct in the Australian Army Malaria Institute’s Clinical Trials of Tafenoquine – Part 1

images (59)

The New Mefloquine?

Mefloquine is now well known to be neurotoxic, one of several synthetic quinolines able to cause acute psychotic reactions and/or a chronic central nervous system (CNS) toxicity syndrome in a significant proportion of people given these drugs for malaria prophylaxis. The licencing of mefloquine by national drug regulators in the late 1980s and early 1990s occurred in the absence of phase III clinical safety and tolerability trials among normal study populations of healthy civilian volunteers. Instead the approvals relied on studies among vulnerable subjects including prisoners, military personnel and people in developing countries. The result of this regulatory failure is described by Dr Ashley Croft:

“Effectively, all users of Lariam, from the point of licensing onwards, have been involved in a natural experiment to determine the true safety margin, at current dosages, of [this] poorly understood antimalaria drug. Consumers have been unwitting recruits to this longitudinal study, rather than informed partners.”

Much of the recent media coverage of mefloquine’s adverse health effects has focused on the efforts of military veterans, including drug trial subjects, in seeking appropriate recognition and medical care from their national governments. Prominent among these are Australian veterans who participated in clinical trials conducted by the Australian Army Malaria Institute (AMI) in Timor Leste from 2000 to 2002. With doxycycline malaria prophylaxis having been pioneered by AMI in the 1980s in response to resistance in other drug classes, mefloquine has never been the first line anti-malarial in the Australian Defence Force (ADF) and was prohibited from being used by aircrew and other specialist personnel due to its neuropsychiatric side effects. This has led us to question why the drug was “trialled” for use in the ADF long after it had been registered, with its neuropsychiatric side effect profile so evident in the civilian market and previously published military drug trials. What has become apparent is that ADF personnel given mefloquine during these trials were simply “collateral damage” in an effort to support the development of another synthetic quinoline anti-malarial drug – tafenoquine.

The story of tafenoquine’s development and introduction to date is alarmingly similar to the story of mefloquine – marred by regulatory shortcuts, cosy relationships between military officials and the pharmaceutical industry, breaches of ethical standards, scientific fraud and medical negligence. This is the first in a series of posts that aims to document this misconduct by ADF officials involved in the AMI’s clinical trials of tafenoquine. In this post we will provide background on tafenoquine and an overview of the trials, then in subsequent posts we will describe the conduct of each trial and the emerging evidence of misconduct.

Tafenoquine

Tafenoquine is an 8-aminoquinoline drug manufactured by GlaxoSmithKline (GSK) that is being investigated for prophylaxis and treatment of malaria. Like mefloquine, tafenoquine is a synthetic quinoline that was first developed by the U.S. Walter Reed Army Institute for Research (WRAIR) as part of an enormous anti-malarial drug discovery program that commenced during the Vietnam war. Two of the drugs developed earlier in this program were mefloquine (Lariam™) and halofantrine (Halfan™).

The first investigation of tafenoquine in this program was in the treatment of relapsing vivax malaria, as a more effective alternative to primaquine. Later it was seen as a useful preventative against multi-drug resistant falciparum malaria. A series of pre-clinical studies were undertaken from the late 1980s to the late 1990s, with clinical studies commencing in the late 1990s using “volunteers” in the U.S., Thailand, GabonKenya and Ghana. Researchers who were instrumental in these studies and later moved to Australia include former AMI Director Karl Rieckmann, the current AMI Head of Drug Evaluation Michael Edstein, and the current AMI Director Dennis Shanks. Further studies were conducted with Australian military personnel in the 1999-2001 clinical trials that are the subject of this post, while Rieckmann was the Director of AMI.

Despite these AMI trials having found tafenoquine to be safe and effective, the drug’s clinical development did not substantially progress towards registration for almost decade. Eventually, in 2008 the manufacturer GlaxoSmithKline (GSK) entered an agreement with Medicines for Malaria Venture (MMV) to develop tafenoquine as a radical cure for vivax malaria. Five years later the U.S. Food and Dug Administration (FDA) granted “breakthrough therapy” designation for tafenoquine, and several months later GSK and MMV announced the commencement of Phase III clinical trials. The FDA states that Breakthrough Therapy designation “is intended to expedite the development and review of drugs for serious or life-threatening conditions”, and “conveys all of the fast track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.”

Another parallel with the mefloquine story is that there has been a reluctance to undertake laboratory studies of tafenoquine’s potential neurotoxicity prior to registration. Like another 8-aminoquinoline primaquine, tafenoquine is able to cause haemolytic anemia in individuals with G6PD deficiency, and many of the clinical studies have carefully assessed this toxic property. However the 8-aminoquinoline class includes several other drugs that are also known to be neurotoxic, including pamaquine and plasmocid, based on extensive histopathological testing conducted as long ago as the 1940s. A leading expert in quinoline toxicity wrote in 2013:

“While tafenoquine has been eagerly anticipated for its utility against vivax malaria and potentially against leishmaniasis, the recent granting by the U.S. FDA of Breakthrough Therapy status, in the absence of any published neurohistopathological testing, risks recreating the sense of urgency that contributed to the approval of mefloquine in the absence of appropriate CNS safety data.”

Yet In 2009, long after the AMI tafenoquine trials in Bougainville and Timor Leste, a study comparing in vitro toxicity levels between various anti-malarial drugs co-authored by WRAIR scientists found that tafenoquine is “more neurotoxic than mefloquine.” More recent laboratory studies have also raised doubts about the efficacy of tafenoquine, finding that the CYP2D6 enzyme is involved in metabolising the drug in several ways that affect the drug’s toxicity as well as its effectiveness as an anti-malarial. CYP2D6 levels are highly variable from person to person, which may also answer why the drug’s neurotoxic effects vary from person to person.

Emerging Evidence of Misconduct

Evidence of the misconduct documented in this series is drawn from a variety of sources, many of which are now publicly available. These include published trial reports, related journal articles, minutes of Australian Defence Human Research Ethics Committee (ADHREC) meetings, a review of ADHREC annual reports that matches approved trial protocols to published reports, media reports, and other documents from Defence, GlaxoSmithKline and the Australian Therapeutic Goods Administration (TGA). Additionally, hundreds of the trial subjects have recently formed an Australian Mefloquine and Tafenoquine Veterans group to share and publicise their personal accounts.

Several years after the AMI’s tafenoquine and mefloquine clinical trials in Timor Leste, hundreds of the ADF subjects initiated legal action against Defence, reporting that they were not adequately informed of side effects and complaining of symptoms such as depression, paranoia, and suicide ideation. When this story was first reported in the media in 2004, ADF Surgeon General Tony Austin initially claimed that the number of personnel involved in these trials was in the “dozens rather than hundreds”, however Chief of Army Peter Leahy admitted several days later that the actual number of trial subjects in Timor Leste was 1,351. The legal action was discontinued after the Australian government introduced legislation that would have required them to forfeit veterans entitlements in the event their claim succeeded. The majority of these veterans continue to experience chronic neuropsychiatric disorders including depression, anxiety, misdiagnosed PTSD, personality disorders and conversion disorders. Many of them were discharged from the ADF on medical grounds, now suffering debilitating side effects of anti-psychotic drugs prescribed off-label, and there have been a number of suicides.

The published study findings and other official ADF reports of these trials universally portray tafenoquine as a “safe” and “well tolerated” anti-malarial drug. As public scrutiny has intensified in recent months, senior Defence officials have insisted that serious neuropsychiatric side effects from tafenoquine are rare. However the disturbing truth is that the incidence of acute psychotic reactions and chronic neuropsychiatric illness attributable to the use of tafenoquine in these trials almost certainly meets the MedDRA definition of “common” (1-10%) or “very common” (>10%). There can be little doubt that the published findings of these trials constitute comprehensive scientific fraud, achieved in a number of ways that will be more fully documented in subsequent posts, including:

  • Providing false and/or misleading information to the trial subjects.
  • Coercing subjects into participating in the trials.
  • Relying on the prevailing stigma of mental health problems to minimise subject reporting of neuropsychiatric adverse effects.
  • Recording serious adverse events as “withdrawals” to avoid attributing them to the trial drug in the published study report.
  • Misattributing adverse events to extraneous causes.
  • Failing to include follow up medical examinations in trial protocols, to avoid recording chronic adverse effects attributable to the drug.
  • Failing to publish reports for several of the ADHREC-approved trial protocols, most likely to conceal unfavourable findings.
  • Failing to note known limitations in malaria reporting systems in the published study reports, resulting in over-estimations of tafenoquine’s anti-malarial efficacy.

Ethical Standards

The relevant ethical standards for the conduct of these clinical trials are laid down in the TGA’s Note for Guidance on Good Clinical Practice, which is mandated by the National Health and Medical Research Council Act. This standard describes “members of the armed forces” as vulnerable subjects “whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.” Relevant provisions in these standards include:

  • “Foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society.”
  • “The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.”
  • “During and following a subject’s participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events, including those related to the trial.”
  • In obtaining the informed consent of trial subjects, the institution should adhere to “the ethical principles that have their origin in the Declaration of Helsinki.”

Chronology of the Tafenoquine Trials

The tafenoquine trials on ADF personnel are summarised in a 2011 PhD thesis by Dr Peter Nasveld and included:

Part 2

Part 2 of this series will examine the emerging evidence of misconduct in the c. 2001-2002 clinical trial of tafenoquine in the treatment of recurrent vivax malaria. Subsequent posts will address the larger prophylaxis trials. These will be updated as additional evidence becomes public.

References

P. E. Nasveld, Tafenoquine in the prophylaxis and treatment of malaria in Australian Defence Force personnel, PhD thesis, James Cook University, 2011.

P. E. Nasveld, M. D. Edstein, M. Reid et al., Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects, Antimicrobial Agents and Chemotherapy, vol. 54, no. 2, pp. 792–798, 2010.

S. Kitchener, P. Nasveld and M. Edstein, Tafenoquine for the treatment of recurrent Plasmodium vivax malaria, American Journal of Tropical Medicine & Hygiene, vol. 76, no. 3, pp. 494-6, 2007.

P. Nasveld, S. Kitchener, M. Edstein and K. Rieckmann, Comparison of tafenpquine (WR238605) and primaquine in the post-exposure (terminal) prophylaxis of vivax malaria in Australian Defence Force personnel, Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 96, no. 6, pp. 683-684, 2002.

Therapeutic Goods Administration, Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), Department of Health and Ageing, Canberra, Australia, 2000.

To The Greedy Vicious Sociopathic Troll From Gig Harbor Who Sent Me Another Vile E-mail (Today)….



And just to set the record straight ..

I don’t blog for people like you, this blog has nothing to do with you.

Nada. Zilch.

You are not my audience. I would regret firing one neuron of a thought about anything to do with you, you are not important to me, or to my blogging. Your existence is insignificant to me.

You’re paranoid. And you are also projecting your character traits on to me.

The 3 billion dollar fine that GSK had to pay was a white-wash, a gift to GSK, and an insult to all those killed from GSK meds like Paxil and Avandia. To promote it as anything more than that or spin it as if it was really justice or a big success, is a total joke and an insult.

I don’t see you exposing the real story about the department of Justice Sham fine, Eric Holder’s revolving door, or the involvement of vulture lawyers looking for payoffs- you just spin the same old bullshit, like a broken record.

There’s a lot more I could say here but I will bite my tongue for now…

Here’s the definition of ‘Donation’, because you don’t seem to understand what it is and just so you know for future reference

Don’t e-mail me again you sociopath…


Simple Definition of donation

  • : something (such as money, food, clothes, etc.) that you give in order to help a person or organization


 

And one last thing…

Anyone who thinks that they were somehow chosen by God for anything has more than a few screws loose…

Seriously..

 

Get a grip…

GSK And The “Toxic Batch”… Glaxo’s Unethical Shenanigans Stretch Back Decades…


http://www.vaccineinjury.ie/vaccine-support-history.html

Irish Vaccine Injury Support Group

History

In the late 1960’s and early 1970’s there was an upsurge in the number of severe adverse reactions in children who received the 3 in 1 DPT Trivax vaccine manufactured in the UK by Wellcome.

 

Because of this upsurge Eastern Health Board records (1973) show that the official in charge of the administration of the vaccine within the Dublin Health Board region was inundated with reports of severe reactions among children.  On the 24 September 1972 the official in charge wrote to Wellcome enclosing a list of the LOT numbers of the DPT vaccine that had caused severe reactions and to express her concern. (Child Abuse (Amendment) Bill 2005 Second Stage Speech by Denis Naughten TD Vol  601 28-04-2005 No 4).

In the first 6 months of 1973 more than 80 reported adverse reactions were recorded in the inner city of Dublin.

There were so many reactions to the 3 in 1 vaccine in the early 1970’s that by 1974 only 50% of parents were opting for the 2 in 1 vaccine omitting the whooping cough/pertussis element.

 

The IMB received notice of 324 suspected adverse drug reactions to the DPT vaccine since 1972.  87 of these were classified as serious in accordance with agreed international criteria (Dail reply No 791-29 Nov 2004).

 

The EHB co-operated with Wellcome in carrying out a study in 1973 comparing 4 types of DPT vaccine.  A total of 116 children were involved – 59 from the community and 57 from two children’s homes in the Dublin area.

Vaccine Trials in the Orphanages

The vaccine trials known as ‘Vaccine Trials In the Orphanages’ were part of the Child Abuse Commission investigation set up by the Government in 2000 to examine child abuse in the State. The inquiry had been looking at three trials of vaccines involving children in orphanages and children in the community in 1960/61 1970 and 1973. On 28 November 2006 Health Minister Harney halted the vaccine inquiry module following ‘a detailed examination of judgments in court cases related to the vaccine trials in both the High and Supreme Courts’.

Expert Group

An Expert Medical Group was set up by Health Minister Michael Woods in 1977 to 1984 to assess whether individuals who presented themselves to it were brain damaged by whooping cough vaccine – the decision was on the ‘balance of probabilities’. 93 people went before the committee – 16 were offered an ex gratia payment of £10,000 – 77 applications were declined.

 

Best Case

A DPT vaccine Batch that was administered in the late 1960’s and early 1970’s was Batch No 3741 and a vaccine LOT from this Batch was administer to a child from Co Cork called Kenneth Best.  In 1992 this case came before the Supreme Court and it was successfully proven that Toxic Vaccine was used widely in Ireland and caused brain damage. Batch 3741 failed 2 laboratory tests for potency and toxicity.  It was 8 times more potent than the recommended strength.

 

At the conclusion of the Best Case Justice Liam Hamilton described Wellcome as negligent and criticized the company’s quality control procedures.

 

Following the Supreme Court Judgment Kenneth Best received £2.75M by the vaccine manufacturers Wellcome for the permanent brain damage he suffered when vaccinated with vaccine from Batch 3741.

 

The ‘Best Case’ was the only successful vaccine damage litigation case in Ireland to-date.

 

Wellcome withdrew the wholecell pertussis vaccine in Ireland in 1993.

 

The Government under Health Minister Michael Noonan introduced acellular pertussis vaccine in 1993 because of the adverse effects of the wholecell pertussis vaccine.

TOXIC BATCH 3741

A search for Batch 3741 was ordered by the then Health Minister Brian Cowen after Glaxo Wellcome the drug company now called Glaxo Smith Klyne (GSK) made available the LOT numbers taken from the “Toxic Batch” at the centre of the Best Case.

Health Minister Michael Martin issued a report on the use of 3 in 1 vaccine

Report:

The Minister for Health and Children, Micheál Martin, T.D., today (27 February 2001) issued a report on the usage in Ireland of Trivax three-in-one vaccine from the batch which was at issue in the case of Kenneth Best. In 1992 the Supreme Court found that the Wellcome Foundation was liable for the disability of Kenneth Best, who had been immunised with this product in 1969. The particular vaccine batch involved was number 3741, which had been produced in 1968 and is believed to have had a shelf-life of two years.

The Minister said that in the light of the Best judgement, he and his Department had been approached from time to time on behalf of a number of individuals, whose families believe that they may have suffered damage as a result of receiving three-in-one vaccine, seeking assistance in tracing the batch or lot numbers administered in these cases.

The Department has been in contact with the manufacturer of this product, and also asked the health boards to examine their records to establish what information is available. “Much of the information obtained about the usage in Ireland of vaccine from batch 3741 has already been placed in the public domain. The purpose of this document is to set out clearly and comprehensively the information obtained by my Department about the issues involved”, the Minister said.

The report issued by the Minister indicates that 296 individuals are recorded as having received vaccine from lots produced from batch 3741 in the period 1968-1971. The number of recipients in each of the health boards concerned (the Mid-Western, North-Western, Southern and Western Health Boards) is as follows:

  No. of persons Period of usage
Mid-Western Health Board 183 October 1969 – October 1970
North-Western Health Board 3 November 1969 – February 1970
Southern Health Board 107 June 1969 – October 1971
Western Health Board 3 September 1969

Full details are contained in the report. The other health boards did not succeed in tracing any records containing the lot numbers concerned. The report issued by the Minister is available on the Department of Health and Children’s website “www.doh.ie”.

The health boards had undertaken detailed searches of their records for a period which predated the establishment of the health boards. In many cases immunisation records for this period no longer exist, or where they exist do not contain vaccine lot numbers involved. It would appear reasonable, however, to assume that vaccine from the batch concerned was administered more widely than in the 296 cases documented in the records which have been traced.

The records obtained suggest that in some instances vaccine may have been administered after its expiry date. However it is difficult at this stage to be certain about this, as full information on the expiry date of all vaccine lots is not available.

The Minister said that he has written to the Chief Executive Officers of the four health boards concerned, asking them to endeavour to trace the individuals who received this product and to inform them accordingly.

The Minister added that the expert medical consensus is that wholecell pertussis vaccine has not been proven to be a cause of brain damage. He said that this view has been confirmed by the Immunisation Advisory Committee of the Royal College of Physicians of Ireland, which has stated that “although there has been controversy about pertussis vaccine the consensus from authoritative bodies is that it is a safe vaccine” (Immunisation Guidelines for Ireland, RCPI, 1996, p.25).

Joint Oireachtas Committee on Health and Children

As part of it work programme for 2000 and 2001 the Joint Committee examined the issue of ‘Childhood Immunisation’ to include an examination of current vaccination policy and practices – poor take-up rates and public concerns about the risks and adverse effects of vaccination. In excess of 100 submissions were received from the public and the medical profession and other interested parties. In its Report of July 2001 this committee recommended that a vaccine damage compensation scheme be set up at the earliest possible date.

Vaccine Damage Steering Group

Following on from the Report of the Joint Oireachtas Committee on Health & Children on ‘Childhood Immunisation’ the Minister for Health & Children Mary Harney established a ‘Vaccine Damaged Steering Group’ early in 2007. Chaired by Chris Fitzgerald Principal Officer Public Health Division the group’s brief was to examine the issue of vaccine damage including compensation options. Submissions were invited from members of the public or interested groups on the issue of vaccine damage – 124 submissions were received from members of the public and 7 from interested groups up to 15 November 2009.

The Report of the Vaccine Damage Steering Group was released on 17 November 2009

The Group recommended that a ‘no fault’ ex-gratia compensation payment scheme be established and administered by the Department of Social and Family Affairs. A scheme consisting of a three tiered structure depending on the severity of damage is recommended and this applies to all cases of vaccination whensoever they occurred – provided they meet the eligibility criteria.

The Minister for Health and Children Mary Harney and her Department are currently considering the recommendations of the Vaccine Damage Steering Group Report in detail.

www.dohc.ie/publications/


http://www.theguardian.com/uk/2002/jun/30/tracymcveigh.antonybarnett

UK babies given toxic vaccines, admits Glaxo


British drug giant GlaxoSmithKline has finally admitted that thousands of babies in this country were inoculated with a batch of toxic whooping cough vaccines in the 1970s.

Some experts believe that these Trivax vaccines – which had not passed critical company safety tests – may have caused permanent brain damage and even fatalities in young children.

In 1992, the family of an Irish boy, Kenneth Best, who suffered brain damage from one of these toxic vaccines, was awarded £2.7 million in compensation by the Irish Supreme Court.

Despite a long and fierce battle with the drug giant, the boy’s family finally won this historic case after his mother Margaret made a startling find when sifting through tens of thousands of company documents.

She discovered that the Trivax vaccine used on her son, from a batch numbered 3,741, had been released by the company despite it having failed to pass a critical safety test. Documents revealed that the 60,000 individual doses within this batch were known to be 14 times more potent than normal.

At the time the Irish judge accused GlaxoSmithKline – then known as Glaxo Wellcome – of negligence and attacked the company’s poor quality control at its Kent laboratory. Immunology experts condemned Glaxo in court for what one US scientist described as an ‘extraordinary event’.

Last year an investigation by The Observer found evidence to suggest that vaccines from this faulty batch, which may have wrecked Kenneth Best’s life, had also been used in Britain.

Liberal Democrat MP Norman Baker raised questions in the House of Commons, asking whether vaccines from this batch had been given to British babies. Then Health Minister Yvette Cooper wrote to the company asking for information.

Now, almost a year later, GlaxoSmithKline has replied that it is ‘highly probable’ the toxic batches had been used in Britain.

The Department of Health is under pressure to make efforts to trace the children who received the suspect vaccines.

Last week in the House of Commons, Health Minister Hazel Blears said: ‘Unfortunately they no longer have details of the quantitites of vaccine or the places where the vaccine was supplied.

‘Since vaccines were not centrally purchased and distributed at that time there are no central records either. Information on individuals who received these vaccines will only exist if the general practioner at the time of the immunisation recorded the batch number and the patient’s notes are still available.’

Baker will now write to the Minister to demand that she asks health authorities to check the records to find out who received the vaccine. It is believed that at least one boy from Wales died after receiving a jab from toxic batch 3,741, although the parents have never been informed.

A spokesman for GlaxoSmithKline told The Observer : ‘We do not accept that these batches were harmful.’

Some Interesting Recent Comments By Whistle Blower Greg Thorpe


Greg Thorpe was the first (and in my opinion- the only genuinely authentic ex-GSK employee/ whistle blower) who choose to blow the whistle on GSK’s unethical shenanigans in the US, and he regularly comments on this blog.

Without Greg’s initial concerns I don’t think that GSK’s 3 Billion dollar fine would have happened.

He did- after all- provide the majority of the original evidence in the department of Justice complaint (see here).

Some of his more recent comments have been very thought provoking for reasons of which I will comment upon later.

Greg left the following comment on this post of mine-

Former Pharma Exec Heads To Trial On Kickback Allegations

https://truthman30.wordpress.com/2016/05/18/former-pharma-exec-heads-to-trial-on-kickback-allegations/#comment-51624

“…I am sick and tired of TAF…so called Taxpayers Against Fraud saying what should be done in these cases. They are not partially funded by attorneys. I would say they are for the most part TOTALLY funded by attorneys and while Patrick Burns calls for tougher action !–!-
his “nonprofit “, which actually is quite profitable for the attorney group…coddling up to the Department of Justice, having high ranking Pharma investigators at DOJ speak in exotic, costly forums, including the Attorney General.

This group only exists to keep the cost of filing a qui tam FCA complaint as high as possible..they grab over 50 % of the award to some whistle-blowers . …while the government is allowed to put illegal 9 year seals on cases, while gutting the guidelines of FCA law.

So they all gladly contribute, have yearly extravaganza events at taxpayer expense, all over the planet.

It is a write off for them, and then each year they name some me too attorney, like Erika Kelton their “attorney of the year”..while at the same time, the “giant killer”and founder, John Phillips tells me when I first wanted them to take the GSK case in Feb 2002. “WE DO NOT BELIEVE OFF LABEL MARKETING IS FRAUD”.

Later, his firm, under Erika Kelton files essentially the same information I gave them, after I had to get inexperienced help to file the case…and they found out.
So two ex GSK employees are recruited to become whistlblowers instead of me.
…one Matt Burke, a Regional GSK manager, terminated for the very things I told the company about OFF LABEL MARKETING. So they threaten their way into the case as second to file, with a complaint mirroring the things I gave them 8 months before I filed in Jan. 2003.

Phillips and Kelton wrote me that ” OFF LABEL MARKETING IS NOT FRAUD”.
I have the letter for anyone to read, including Burns..who has talked tough, yet done absolutely nothing about it regarding
Pharma execs…

This is a true tax exempt monopoly, preying on Whistleblowers and letting the government get by with the pitiful settlements, and settling for an easy buck. All they have to do is march in lockstep with the fraud they know that occurs in the prosecution of all these Pharma companies, not just GSK.

This group of self appointed Kings of Qui Tam Whistleblowers is more corrupt or just as corrupt as big Pharma, hiding behind tax exempt status and handing out huge Quid pro quos to the Department of Justice. …only so they can make their huge money grab, while they essentially sit on their asses and let the gov’t conspire under seal for 9 years, as in my case.

In spite of the efforts of my excellent attorneys… Kenney, McCafferty firm with Tavy Deming and Emily Lambert, (by the way also TAF members, of necessity I believe, not choice) the government has set up a situation where again TAF gets its tax exempt status (bullshit), and in return does NOT dare rock the boat of the Ship of Fools at DOJ, who in fact make money for big Pharma…not reach any logical, reasonable settlements for the defrauded taxpayers under the FCA. Again just follow the money, all smoke and mirrors and in the end an Attorney who wrote me in part —
“OFF LABEL MARKETING IS NOT FRAUD”, Erika Kelton ,”Queen of Qui Tam Law”
is named Attorney of The Year by TAF.

So long story short, do something or quit talking out of both sides of your mouth Burns, and everyone else at TAF.

I know the truth, and you should be investigated. ..right along with the killers in big Pharma.

YOU ARE ENABLERS OF THE CONDUCT, NOTHING MORE. YOU ALLOW EXECUTIVES TO GET AWAY WITH MURDER, JUST SO YOU REAP YOUR MILLIONS OF THE TRUE WHISTLE-BLOWER’S AWARDS….ASAP…”


Greg’s other interesting comment, left recently, was in relation to this post-

One thought on “How Did GSK Market The Horrible Death Drug Seroxat To Unsuspecting Doctors?”

https://truthman30.wordpress.com/2016/05/19/how-did-gsk-market-the-horrible-death-drug-seroxat-to-unsuspecting-doctors/#comment-51622


“…I have seen and witnessed first hand, worse marketing in the US…although the DOJ did not seem to interested in digging very deep with Paxil fraud.
Why, because they were protecting the executives, including the infamous JP Garnier, Bob Ingram, and others. This would include the criminal Witty, who had to know about Paxil. He was in the antidepressant marketing arm after the merger, the then “commoner”-Andrew Witty.

His transgressions and crimes were ignored by prosecutors…I believe so it would not interfere with his ungodly ” knighting”…He was there in the period after the merger, a main player in the Wellbutrin scams. Paxil and Wellbutrin were marketed in a way, so that business from one did not cannibalize the other one.

This was also another elaborate scheme, that I brought forward…in addition to my main concern, not only marketing both to children under 18….but for very young children also.

What can be said about a company that does this, with the knowledge hidden from physicians and patients ..resulting in unnecessary suicides-side effects (including horrible withdrawal symptoms),
and conning the gov’t and insurance companies into paying.

Now we see a couple minor players in the industry indicted and facing trial, for much less than the deadly “three amigos”, listed above. Smoke and mirrors, diversion from the worst of the worst.

So now all 3 living the good life on blood money, murder money or at the very least manslaughter.

It sickens me that I spent 12 years plus, shining some light on these cockroaches for nothing, not even a fine or any punishment worth a damn, end of story.
SIR Witty, can spin it all he wants. He along with all the others are truly pathological liars. If what I say is not true, the bastards have hundreds of GSK and other outside attorneys to sue me. I believe they spend more on attorneys to save themselves, rather than do any significant Research and Development…Judicial Watch, here in the US …has been informed of some of this, but has declined to investigate anything? Who paid them off ?

The inside information is in the bowels of the DOJ, if they have not destroyed evidence already. Why they did not go all the way back to the year 1996, when they could have on Paxil and Wellbutrin is no mystery to me..Filing in Jan 2003, they had every right to, but again the whole illegally sealed case stinks and I am holding my nose trying to put my life back together…

It was all a sick joke, and they all are above the law, “to big to prosecute”. Now as I predicted with the non-penalty here, they have gone global, with Witty at the helm.
Everything else gets older every day, but there is no Statute of Limitations on criminal acts…and Witty, Garnier, Ingram, Viebacher, Stout, Rajaratnum and their foot soldiers, who orchestrated all these scams resulting in morbidity and mortality
should still be investigated….and not by a Crook like Eric Holder, once a GSK defender always a GSK defender and highly paid…both in govt. and by his cronies at the revolving door law firm…Covington Burling, a den of sociopaths in its own right. Justice it seems will never happen, at least on earth.

Keep plugging Truthman, I admire your tenacity…seemingly everyone else has clocked out and left. GSK is still there however, and as bad as ever.”…

-G. Thorpe.

Irish Examiner: Pysch drug link to violent episodes analysed


http://www.irishexaminer.com/ireland/pysch-drug-link-to-violent-episodes-analysed-400571.html

Pysch drug link to violent episodes analysed

Forensic testing of blood can now determine if anti- depressants were the cause of violent behaviour, including murder or suicide, new research has found.

Genetic variations in metabolism affect how different people react to anti-depressants, and now medical examiners say they can identify those variations, and use the evidence to “potentially absolve people charged with homicide”, and explain why they acted like they did.

The research, published recently in the Journal of Forensic and Legal Medicine, was carried out by a medical specialist, a forensic psychiatrist and a pharmacogeneticist. It looks specifically at three cases where people with no previous diagnosis, who were prescribed antidepressants for stress-related issues, ended up killing others, with two attempting suicide.

“An out-of-character unmotivated homicide or suicide by a person taking medication might be chemically induced and involuntary. The capacity to use frontal lobe functions and control behaviour can be impaired by brain toxicity,” the paper states.

“None improved on medication, and no prescriber recognised complaints as adverse drug reactions or was aware of impending danger.”

The researchers took accounts of restlessness, akathisia (a state of severe restlessness associated with thoughts of death and violence), confusion, delirium, euphoria, extreme anxiety, obsessive preoccupation with aggression, and incomplete recall of events.

“Weird impulses to kill were acted on without warning. On recovery, all recognised their actions to be out of character, and their beliefs and behaviours horrified them,” the paper notes.

The research concludes that the “medicalisation of common human distress” has resulted in a very large number of people getting medication that may do more harm than good by causing “suicides and homicides and the mental states that lead up to them”.

Irish mental health campaigner Leonie Fennell, whose son Shane was prescribed anti-depressants and soon afterwards killed himself and another person, said she has been aware of this evolving science for some years, and has had Shane’s blood tested in Australia.

The researcher who tested Shane’s blood, Dr Yolande Lucire, is one of the papers’ authors. She cited his case in another research project she carried out in 2011. Dr Lucire noted Shane was initially prescribed a double dose of the common SSRI anti-depressant, citalopram.

Five days later he overdosed on the tablets, and two days later he told his doctor, who then restarted him on a lower dose of the anti-depressant.

“He immediately became violently akathisic, unable to stay in one place, moving constantly between the houses of friends, unable to sit and have a conversation. According to his mother, communicating with him was like ‘talking to a brick wall’. His friends reported that, immediately after taking citalopram, he became agitated, emotional, irrational, and aggressive. His brother saw him throw a mobile phone, destroying it, with trivial, if any provocation,” Lucire writes.

Post-mortem toxicology of blood revealed levels of citalopram of about 30 times the therapeutic level.

Dr Lucire, a forensic psychiatrist who specialises in adverse drug reactions to psychiatric drugs, said in her experience patients do not need the drugs they are being prescribed.

How Did GSK Market The Horrible Death Drug Seroxat To Unsuspecting Doctors?


 

Paroxetine
“…Things go wrong. We have inevitably of course, we go through all the processes with the regulators to get a drug to be as safe and effective as it can possibly be. But the reality is, every time a human takes a drug, it’s like a clinical trial. You don’t really know what’s going to happen. Everybody can react a different way…”


A doctor friend of mine sent me a very interesting document, called ‘Understanding Depression’- INFORM- (published by SmithKlineBeecham) from the late 90’s. SmithKlineBeecham merged to form GlaxoSmithKline in 2000. This is the kind of leaflet which GSK published in order to encourage doctors to prescribe SSRI anti-depressants to their depressed patients.

Basically this document is an SSRI marketing advertisement disguised as a harmless ‘depression awareness’ campaign. Pharmaceutical companies have been using tactics like this for years, they even infiltrate and influence depression help groups such as Aware In Ireland and Depression Alliance in the UK. They do this by means of donations to these groups, sponsoring ‘awards’, and ‘lending a hand’ in creating leaflets about depression etc. Of course there is always the obligatory section on treatments with meds in these leaflets- because it’s in a pharmaceutical company’s interest to get as many depressed patients on meds as possible (they pretend that there are other options such as therapy, light boxes etc, but in reality people were – and still are- prescribed SSRI’s as first line treatments for depression, by GP’s).

In the case of Seroxat, GSK failed to warn people that they could become hooked. I guess Seroxat dependence meant that GSK often had customers for years, despite the reality that most people would have liked to come off Seroxat (because of horrific side effects like akathisia, self harm personality changes etc)- they often found it impossible to quit.

In the late 90’s companies like GSK were aggressively marketing their drugs (such as Seroxat) to consumers, and oftentimes their methods were dubious to downright fraudulent. The SmithKlineBeecham INFORM campaign is one of the most cynical and deceptive of these  types of campaigns (whose sole purpose was to sell more meds to an unsuspecting public). Glaxo don’t (and never did) give a fiddlers about depressed people, we were sitting ducks for them, and the Seroxat suicides were road kill on the highway to GSK’s profit driven agenda. It’s a shame that CEO Andrew Witty didn’t think of telling those who were prescribed Seroxat over the years- what he said to Evan Davis of the BBC-in the quote here-

“..But the reality is, every time a human takes a drug, it’s like a clinical trial. You don’t really know what’s going to happen. Everybody can react a different way…”

(AW- BBC- 2015)

Anyone who took Seroxat was effectively a human guinea pig, the Seroxat clincal trials were shoddy and dodgy, and there is no way that this drug should ever have been passed as safe and effective.

It simply should not be licensed. It’s dangerous and causes immense harm. GSK wanted their own billion dollar blockbuster Prozac-type drug and they were hell bent on making Paroxetine (Paxil/Seroxat/Aropax) that drug. Whether it caused suicide, self harm, birth defects, or severe withdrawal, was not part of the business model- but getting it down as many people’s necks and into as many people’s bodies as possible was…

This leaflet is so utterly full of misinformation about depression, SSRI’s and SSRI side effects, that I don’t know where to start …

Take a look and judge for yourself..

InformInform1Inform2Inform4Inform5Inform6Inform7inform9inform10Inform11inform12inform14inform15inform17inform19inform20InformSmithklineBeecham

Former Pharma Exec Heads To Trial On Kickback Allegations


Interesting to note that, despite leading to a 3 Billion dollar fine, and despite immense detail and its huge scope, Whistle-Blower Greg Thorpe’s 7th Amended Complaint resulted in no jail time for any GSK executives. In retrospect it seems that GSK’s 3 billion fine was a slap on the wrist for GSK (and perhaps the revolving door between GSK and the department of justice had something to do with that?) and then it was business as usual.  Until high level executives in these corrupt companies are held to account for their role in these scams, nothing will change…

Former Pharma Exec Heads To Trial On Kickback Allegations

https://www.statnews.com/pharmalot/2016/05/17/allergan-kickbacks-bribes/

By Ed Silverman @Pharmalot

May 17, 2016

Between 2009 and 2012, W. Carl Reichel allegedly orchestrated a campaign to give doctors money, free meals, and phony speaking fees in exchange for prescribing medicines sold by Warner-Chilcott, where he had been the president of the pharmaceutical division, according to federal prosecutors.

Next week, he goes on trial in what is expected to be a closely watched case in the pharmaceutical industry. That’s because the case marks one of the relatively few instances in which federal prosecutors have sought to hold a high-ranking executive from a drug maker accountable for such activities.

“To the extent the executive is convicted, it will impact the industry,” said Anne Walsh, a former associate chief counsel at the US Food and Drug Administration who is now a director at Hyman, Phelps & McNamara, a law firm that specializes in regulatory matters.

To be sure, other drug company executives have faced penalties for illegal activities. Notably, three former executives at Purdue Pharma pleaded guilty in 2007 to misleading the public about the risk of addiction posed by the OxyContin painkiller. They were also banned from any dealings with federal health care programs, notably, Medicare and Medicaid.

But such instances are relatively rare in the pharmaceutical industry, even as a parade of drug makers has paid large fines for civil and criminal violations. Moreover, the Reichel trial gets under way just eight months after the US Department of Justice issued a memo that serves as a blueprint for pursuing individuals who engage in corporate malfeasance.
Read More
Former sales rep for opioid drug maker pleads guilty to kickbacks

There is now a “more uniform, systematic, and sustained focus on individuals,” said Sally Yates, a US Deputy Attorney General at a New York City Bar Association meeting last week. She originally issued the DOJ memo.

“There is one system of justice — one in which wrongdoers can and must be held accountable based on facts and evidence, not on position or title, power or wealth,” she said.

The emphasis on individuals also emerges after a drop-off in the number of settlements that the Justice Department has reached with drug makers for illegal activities, such as paying kickbacks to physicians or illegally marketing medicines. From a high of 18 deals in 2013, which capped a rising trend, the number of settlements fell to 11 last year, according to data compiled by Public Citizen.

In the Reichel case, the feds allege that he developed and oversaw an illegal strategy to boost prescriptions for several drugs, including the Actonel osteoporosis treatment and the Doryx acne medicine. Among the charges: Reichel provided sales reps with unlimited expense accounts in order to wine and dine doctors, and he suggested targeting doctors who were already frequent prescribers, according to the indictment.

He faces no more than five years in prison, three years of supervised release, and a fine of $250,000. We asked his attorney for comment and will update you accordingly.

“I think the Justice Department needs and wants to send a signal,” said Patrick Burns of Taxpayers Against Fraud, a nonprofit that that advocates for tough penalties and is partially funded by attorneys. ”I hope this will become a larger effort to bring personal accountability to corporate suites, because if they bring pain to the executive, it will bring change to the corporation.”

At the time that Reichel was indicated last fall, Allergan, which now owns Warner-Chilcott, agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil charges in connection with illegally promoting several drugs, according to the settlement.

Three former sales managers — Timothy Garcia, Landon Eckles, and Jeff Podolsky — also pleaded guilty for directing sales reps to access confidential patient data after insurers denied coverage for the drugs. The company sought the patient data in order to submit what are called prior authorization forms, which refer to specific requests made by doctors to insurers to provide coverage for a medicine.

They each face no more than 10 years in prison, three years of supervised release, and a fine of $250,000. Their respective sentencings will not occur until between July and September.

Ed Silverman can be reached at ed.silverman@statnews.com
Follow Ed on Twitter @Pharmalot

Seroxat Study 329 Opens The Pandora’s Box For All Bogus Anti-Depressant Studies….


http://www.madinamerica.com/2016/05/researchers-deconstruct-ghostwritten-industry-trial-for-antidepressant/

Interview: Researchers Deconstruct Ghostwritten Industry Trial for Antidepressant

Researchers, Jon Jureidini, Jay Amsterdam and Leemon McHenry, have taken a closer look at the data from a randomized control trial of citalopram (Celexa) that was ghostwritten and then used by the manufacturers to support claims of the drug’s efficacy and safety in the treatment of child and adolescent depression. Their analysis used 750 recently-released court documents from a lawsuit against Forest Labs concerning the marketing and sales practices involved in the off-label promotion of Celexa. Drs. Jon Jureidini and Jay Amsterdam were expert witnesses in the case. The article is published, open-access, in the International Journal of Risk & Safety in Medicine. 

To get the background on this story, we connected with Dr. Leemon McHenry, an investigator in this study and a lecturer in philosophy at California State University, Northridge.

Citalopram_film-coated_tablets

Can you discuss how you first came across this citalopram study and what caused you to look into the claims in more detail?

I am a research consultant for the law firm of Baum, Hedlund, Aristei & Goldman in Los Angeles, California that takes up cases against pharmaceutical companies. This law firm is committed to exposing the misdeeds of drug companies by making sure that the confidential documents produced in the course of litigation are ultimately released to the public and independent researchers.

Following the revelations of Study 329, in which Glaxo Smith Kline (GSK) misreported the efficacy and safety of paroxetine (Paxil)  for adolescent depression, we began to look at all of the studies that came out during this push by pharmaceutical companies to get psychiatric drugs approved for pediatric use.  So, what your readers may already know in this case is that paroxetine did not get licensed, and so all of the prescriptions of this drug to adolescents were “off-label.” That is legal for doctors to do that but it is illegal for pharmaceuticals to promote drugs for off-label uses.  Forest’s citalopram was in the same situation.

Citalopram study CIT18 was one study that was used to get approval for escitalopram (Lexapro) use in adolescent depression, so that made this study particularly important. Ultimately, the FDA granted the license based on two studies that were supposed to be positive, but it turns out that this study CIT 18 that we wrote about was, in fact, negative, and the other one was questionably positive.

This study was used to justify the FDA’s approval of citalopram for the treatment of depression in adolescents. In your estimation, should the FDA have made this approval given the existing evidence?

I don’t think that the FDA was fully aware of the extent to which this trial had been misrepresented.

This is the kind of thing that comes up in litigation where lawyers file suit, and the companies are obligated to make these document productions available as evidence. So you are going through millions of pages of documents and, you know, the FDA just doesn’t have the manpower to do anything like that. The FDA pretty much has to trust that the companies are giving them reliable data when in fact they are not. Therein lies the problem.

Only a relatively small number of the documents, in this case, were made available, and we posted these on the University of California San Francisco website,  Drug Industry Document Archive,  (DIDA). Those documents provided the opportunity to critique study CIT 18 and write this paper.

What is “medical ghostwriting” and how does it affect research on psychiatric drugs?

I think ghostwriting is the vehicle for misrepresenting the actual study results. There are hundreds of these medical communication companies proliferating all around the world, but in particular in the United States, England, and Australia; they are basically public relations companies engaged in marketing.  These are the businesses that employ the medical ghostwriters who produce articles for the publication plans of pharmaceutical companies.  This includes all of the articles they plan to publish based on their clinical trials, and it is the ghost writers at these medical communication companies who do all of this work writing up articles based on the data summaries provided by the statisticians.

Then what happens is that articles go through a lot of drafts, maybe 10-15 drafts, that get passed around between the statisticians and the marketing people at the companies and then, after most of this has already been written, they go looking for the so-called “author” of the paper. What often happens is that the academic physician they identify, the so-called “author,” doesn’t even see the article until it has already been drafted and revised by all of these people internally at the companies. This is just a dirty little secret of how marketing in medicine works. The ghostwriters are these individuals who are completely invisible in this process of promotion.

What is the potential harm done in this case?

Well, first of all, what we want is a system that is transparent and honest – and that’s what we don’t have because all of this ghostwriting is meant to be kept secret from the public. Even prescribing doctors don’t know that this is going on. If you tell prescribing doctors that the medical literature that they rely on is ghost written by agents of the pharmaceutical companies, most won’t have the slightest idea what you are talking about. They might look at you as if you’re crazy.

So, first of all, there is a question about scientific honesty, transparency and academic integrity. What we have is a situation where these academic physicians at universities work as “key opinion leaders” for the pharmaceutical companies. They will have as much as seven hundred, eight hundred, or even nine-hundred publications on their curricula vitae. They are supposed to be models for professors to emulate at their universities, but this is essentially academic plagiarism. They might not have done any of this writing at all. They might not have even checked the data, and they certainly have no idea whether the data that is being reported in these studies is accurate or not.

So that’s one problem. Now the other problem is the potential harm that comes from this situation and ghostwriting has been documented as a vehicle for misrepresenting results when there are serious safety issues. The most famous case, of course, is Vioxx. That drug contributed to all kinds of deaths and serious harm to people and then it was discovered that the one key article on this drug that was distributed to prescribing physicians all over the world was ghost written.  The lead author on that paper said afterward that he didn’t write the paper and that he just trusted the data he was given.

The same thing has been going on with the SSRIs and, in particular, when you’re dealing with a very vulnerable patient population such as children and adolescents, you have a real problem concerning trusting the medical literature. This is not only an issue for prescribing doctors, but it is also a problem for people who set health care policy in government. Also, these articles are very often used in court when the pharmaceutical companies try to defend themselves. So, not only do you have fraud on the medical community but you also have potential fraud in the courts.

So, when you talk about harm, you can point to cases like Merck’s Vioxx or GSK’s Avandia or to cases of antidepressants like Paxil or Zoloft that have contributed to birth defects and, it turns out, that these manuscripts were ghostwritten.  Those are the most egregious cases. With regard to children, you’ve got the problem of suicidality. There is a definite association between SSRIs and these episodes where you get these uncharacteristic suicide attempts or successful suicides shortly after antidepressant therapy. Now it is tough to demonstrate a causal link between these two, but it is concerning enough that the FDA did put a black box warning on the SSRIs.

What is it like trying to get the criticism of misleading studies like this published in major journals?

I personally think that medical journals are not scientific journals. They have not acquired the same status as journals in physics, biology, and chemistry, which are rigorously critical of any kinds of results from scientific testing. Now, you’ve already got the problem that medical journals knowingly act as vehicles for misrepresentation through ghostwriting. But when you try to correct the scientific record, and you go to a medical journal with sound evidence that an article has been ghost written and has fraudulently reported data, the journals still won’t retract the articles. That happened in the case of Study 329, and it is happening right now in the case of this article that we are currently discussing that reported on study CIT 18.  A major problem with this is that the article will continue to be cited in the medical literature, hundreds of times, as evidence of the safety and effectiveness of these drugs. What they are doing, in fact, is citing an article that is fraudulent.

Now, if you try to publish criticism of a fraudulent article, what you’re going to find is that you are certainly not getting published in one of the high-impact medical journals, like BMJ or Lancet in the UK, or JAMA or NEJM in the US.  First, there is a very deep concern that pharmaceutical companies will file libel suits and in the UK, where the libel laws favor those allegedly defamed; they are very cautious about publishing anything that could lead to such a suit. In the US, you’ll find that the lawyers advising the journals will suggest that they not publish critical pieces like this. So this has far-reaching consequences for the integrity of the medical literature.

But, another problem is that these journals are taking on vast quantities of money from pharmaceutical companies in the form of drugs advertisements, CME courses, reprints and supplements and that is what I would consider a considerable conflict of interest when it comes to editorial decisions on critical manuscripts submitted to the journals.

So what does all of this mean for that state of the medical literature and research on psychiatric drugs?

I think that one of the most important things going on here is that we are supposed to live in an age of Evidence-Based Medicine, and physicians are keen to suggest that they have an evidence-based practice — that they are in fact following the results from the golden standard of scientific evidence, randomized placebo-controlled clinical trials.

So, how can you possibly claim to have evidence-based practice if it turns out that what you are relying upon is medical journals that are publishing ghostwritten misrepresented results from clinical trials?  The vast majority of studies published are industry-funded studies. You have a serious problem here for evidence-based medicine.

What you find in pediatrics is the academic investigators in the industry-sponsored clinical trials who have prescribed the SSRIs off-label to children and adolescents see some evidence that these drugs are helpful. But then, they get negative results in the clinical trials. So now there is a contradiction. Are they going to trust their own experience or the results of the placebo control trials, that turn out to be negative? Well, you can’t claim to believe in Evidence-Based Medicine, if now you’re going to ignore the results of the trials. So this is where you get the slicing and dicing of data. The company scientists and academics investigators  might start to move the outcomes around and say, “well maybe these secondary outcomes are what we really want to focus on, so we’ll just forget the negative primary outcomes and focus on this.”  But, if they are looking at data in order to get it to match what they have seen in their prescribing experience, that’s got things backward.   They can’t claim to be engaged in the serious scientific testing of medicine. We often see that the study drug fails to beat placebo, but often prescribers don’t consider that they might be seeing a placebo effect in practice.

When you have researchers who are seeing this glaring contradiction between the results of these trials and what they think they see in their practice, it almost like a pilot that can’t trust the instruments on his airplane anymore. In their defense, they might really believe that these drugs are safe and effective for adolescents, but there is a sort of confirmation bias going on where they are discounting the evidence to the contrary.

 

*

Jureidini, Jon, Amsterdam, Jay, McHenry, Leemon, The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance, International Journal of Risk & Safety in Medicine. 2016 28[1]:33-43. (Full Text)