Tagged: Australia

Australia Sues GSK Over Misleading Marketing Of Pain Gels…


So now GSK have moved some of their unethical marketing practices down under it seems..

Investigated for 4 years over Seroxat harming kids in the UK, and a an ongoing serious fraud office investigation there too (and accusations of fraud in several middle eastern countries and eastern European ones)- not to mention being fined 500 dollars in the biggest bribery scandal in China in 2014, and also their 2012 fine of 3 Billion in the US (biggest health care fraud of the time) it seems that GSK has now turned to the countries of the southern hemisphere to continue its fraudulent practices?…

Fair play to Australia for not tolerating GSK’s nefarious conduct..

https://economictimes.indiatimes.com/news/international/business/australia-takes-gsk-novartis-to-court-over-misleading-claims/articleshow/61941800.cms

https://www.ft.com/content/841831d6-da33-11e7-a039-c64b1c09b482

Australia sues GSK and Novartis over ‘misleading’ marketing Watchdog takes local units to court in crackdown on pharmaceutical sector

Australia’s consumer watchdog is taking the Australian subsidiaries of GlaxoSmithKline and Novartis to court over alleged false or misleading marketing of their pain relief gels. The action is part of a crackdown on “misleading representations” across the pharmaceutical sector by the Australian Competition and Consumer Commission. Last year Reckitt Benckiser, the UK consumer goods group, was fined a record A$6m by an Australian court for making misleading claims about Nurofen, the pain relief drug.

 

The ACCC’s case against GSK and Novartis centres on what it alleges are “false or misleading representations” claims in the marketing of Voltaren Osteo Gel and Voltaren Emulgel pain relief products. It alleges the companies marketed Osteo Gel as specifically formulated for treating osteoarthritis conditions and more effective than Emulgel, when the products had identical formulations. “We allege that consumers are likely to have been misled into purchasing Osteo Gel thinking that it is different to Emulgel and more effective for treating osteoarthritis conditions, when this is not the case,” said Rod Sims, ACCC chairman. The ACCC found that Osteo Gel was “sold at a significant price premium to Emulgel”, and alleges that the companies engaged in a deliberate commercial strategy to differentiate the products in a manner to mislead consumers. In price sampling at supermarkets and pharmacies, the ACCC found that Osteo Gel cost as much as 33 per cent more than Emulgel.

“The alleged conduct is particularly concerning, given the significant penalties handed down by the court against the makers of Nurofen for what we consider to be similar conduct,” said Mr Sims. Last year the ACCC successfully sued Reckitt Benckiser for misleading consumers over Nurofen’s painkilling effects, in a legal case and penalty that represented a blow to pharma groups that use branding and marketing to increase sales of medicines. Days after the Australian court ruling, the British Advertising Standards Authority began its own investigation into the marketing of Nurofen in the UK. GSK said it was disappointed by the ACCC legal action.

“Our intention in marketing certain products around symptoms is to help consumers choose a product containing an appropriate active ingredient for their condition from the vast array of options available,” it said in a statement.

“In response to new guidance from the ACCC around expectations of industry regulators and consumers, we proactively made changes” to the packaging of Voltaren Osteo Gel to make it clearer that the formulation is the same as Voltaren Emulgel, GSK added. “We continue to co-operate with the ACCC.” GSK acquired Novartis’s Voltaren products in 2016 and has since been responsible for marketing and selling the products. Novartis said it was aware of the proceedings but directed queries to GSK. “As the ACCC has stated, in 2016 GSK acquired Novartis’s portfolio of Voltaren products and has been responsible for marketing and selling Voltaren products since that time,” Novartis said. The ACCC is seeking declarations, injunctions, pecuniary penalties, a publication order, a compliance programme and costs against the companies.

 

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Do You Think GSK Give A F*CK About Your Health And Well Being?…


X RAY Dye Scandal So Big That They Buried It..

Derek Morrison tells of how the toxic X-ray dye affected him, and prompted his pursuit for justice

EXCLUSIVE

DEREK Morrison lost control of his bladder, his bowel and became impotent after he was injected with the dye Myodil during an X-ray on his injured back in May 1977.

“The myelin sheath around the nerves had melted and fused and I never thought I’d move again,” says the former laboratory technician and salesman.

The radiologist who performed the myelogram on Derek left 21mm of the dye in his back and X-rays show some of it travelled to his brain.

He lost his job and sensation in his legs and nearly died before doctors performed 15 hours of microsurgery to save his life.

“They told me I was hypersensitive to the myelogram. I accepted it. At the end of the day you believe your doctors,” he said.

While he gradually recovered the ability to move relapses over the years saw Derek hospitalised numerous times to have weights put on his muscles and nerves to control the pain.

He was in a wheelchair on and off for four years before he was taught to walk again at a rehabilitation centre using secondary muscles in his legs.

His doctors prescribed methadone for 27 years to control the pain and at times it was so bad he was suicidal.

READ MORE: How medicine watchdog failed us over spinal X-ray dye

Derek Morrisson has a disease called Arachnoiditis. Picture: Mark Scott

It wasn’t until 1992 that Derek fully understood what had happened to him.

His UK based mother Iris had also been injured after a myelogram and chanced upon an article about a court case on “spider’s disease” caused by myelograms.

The article in the Daily Mirror in 1992 was about how UK patients suffering arachnoiditis after an x-ray were suing drug company GlaxoSmithKline.

It was a Eureka moment for the pair.

Derek’s mother became paralysed by the dye left in her body and died on the operating table when doctors tried to ease her condition.

It was then Derek began a 25 year fight for justice for arachnoiditis victims collecting thousands of pages of official documents relating to the dye and its use worldwide.

Derek Morrisson possesses this document from the Australian Department of Health, confirming Pantopaque dye was used. Picture: Supplied

These documents are now contained in bulging folders that line his living room and the search this year finally unearthed documents that show the TGB failed Australian patients.

In 2001 Derek began legal action against his radiologist, the hospital and the drug company but in the end the lawyers only went after the radiologist and Derek lost his case.

They told him he would not win a case against the drug company. “They talked me out of it even though 140 other Australians received an out of court settlement against the drug company.”

When Derek lost his case legal aid services across the country refused to take on any more cases.

“The government knew what they’d done and they shut it down knowing there were hundreds and thousands of cases coming behind me. They shut it down,” he said.

Derek Morrison, who has helped expose the problem has spent the last 10 years doing more research and has documents that implicate the failure of our medicine watchdog in the scandal. Picture: Gary Ramage

“There were millions of injections it would have cost billions to fix it, it was so big they just buried it,” he said.

Despite his work in amassing thousands of pages of documents that showed researchers, doctors and government regulators knew of the dangers of the dye for decades only three pieces of paper were ever used in his court case.

Derek tried and failed to stage a protest at the Sydney Olympics against the company Kodak which made the dye, Kodak was sponsoring the Olympics.

Derek blames the pain and disability he suffered as a result of the dye for the break up of his marriage and estrangement from his children.

“This dye was used in 107 countries. I believe 186,000 people were injected with Pantopaque in Australia, more when you take into account Myodil,” he says.

“The important thing is the TGB was not at the gate at the time protecting us,” he says.

“If the TGB had done their job hundreds of thousands of my fellow Australians like myself would not have been abused in this way,” Mr Morrison said.

“My life would have been very different if it did,” he says.

What Derek wants most is for the truth to be told.

“I want recognition this did happen, that the TGB truly failed us, ninety per cent of the sufferers don’t even know the link or what caused their problems,” he says.


4

Adhesive Arachnoiditis

Australians crippled and in chronic pain from dye used in toxic X-rays

EXCLUSIVE

Hundreds of thousands of Australians are crippled by pain, and some are paralysed and wheelchair-bound because the nation’s medicines watchdog failed to check the safety of a dye used in spine X-rays for 42 years.

Explosive new documents reveal for the first time how the government body charged with protecting the public approved the X-ray dye Pantopaque without ever obtaining the studies that showed it was toxic to animals and humans.

“There is no evidence that any animal or clinical studies were specifically requested, submitted or evaluated as part of the approval process,” the Regulatory Services Group at the Department of Health admitted in a letter to dye victim Derek Morrison in February.

The dye called iophendylate sold under the brand name Pantopaque and Myodil contains benzene, hydrochloric and sulphuric acids and is toxic enough to eat polystyrene cups and linoleum tiles.

Medical experts who gave evidence to a 2013 parliamentary inquiry have compared the case with the harm caused by tobacco giants and asbestos company James Hardie.

The phones went into meltdown when News Corporation in 2002 revealed the terrible impact of the dyes on Australians.

RELATED: The man who blew the whistle on the X-ray dye scandal

Derek Morrisson was injected with a dye for a medical X-ray that resulted in him contracting a disease called Arachnoiditis. Picture: Mark Scott

Medical tests in the 1940s on 15 dogs at Rochester University in the US showed the dye killed one dog, paralysed another and left most of the animals with inflammation of their nerve roots.

Ernie Hughes, one of several importers of the dye, says he never knew the dye was toxic and says it was approved by the FDA in the United States.

“If I’d known I wouldn’t have sold it and I would have demanded that Myodil be taken off the market too,” he said.

There is no suggestion that Mr Hughes knew or should have known about the dye’s risks, or that he was involved in any wrongdoing.

Pantopaque was mysteriously approved by the FDA on the February 22, 1944 after previously being refused a license weeks earlier due to it being ‘too toxic’ for human use.

In 1969 an application for a licence to sell a half strength version of the dye was withdrawn after a dog study found connective tissue lesions in half the animals, three dogs died, and another became partially paralysed. Rabbit studies show it produced malformed babies with bulging eyes and malformed heads. The full strength version remained on the market.

Ernie Hughes, who used to import the X-ray dye Pantopaque. Picture: Gary Ramage

The Health Department never checked these studies before approving the dye for use here.

Now the victims of the dye are demanding the department and the pharmaceutical companies that marketed the dye publicly admit it harmed thousands of patients.

They want their health and support costs covered, funding for research into the best way to alleviate their pain and fund a charity to support sufferers.

Their calls were backed by a parliamentary inquiry into the dye in 2013 which called on pharmaceutical company GSK to set up a charity for the victims, it has refused to do so.

“GSK considers it has acted responsibly at all times in regard to the supply of Myodil including appropriate testing and monitoring, updates to product information, fair engagement in all legal proceedings and participation in the roundtable process,” a spokeswoman for the company said.

“Taking all these points into consideration, GSK came to the view that it would not be appropriate to establish a charitable foundation,” she said.

Mr Morrison believes there has been a massive cover up by doctors, companies and governments who are ‘just waiting for us to die’.

“They couldn’t fix it, it was so big so they buried it,” he says.

A dye that was injected into people’s spines to get a better picture on an X-ray has left many patients in great pain and many disabled as it ate away their spine. Picture: Gary Ramage

Other victims have told News Corp they are furious that the medical records they need to take legal action over the dye “went missing”.

A spokesman for the Minister for Health and Aged Care, Sussan Ley, said they X-ray dyes were considered to be the best method available to diagnose serious conditions of the spine. at the time.

“We are all concerned for those who have the painful and debilitating side effects from the two medicines (Myodil and Pantopaque) which were used in patients from the 1960s until the 1970s,” he said.

“The concerns of patients who received these medications was the subject of a House of Representatives Standing Committee on Health Roundtable on Adhesive Arachnoiditis on 21 September 2012, he said.

“The committee report recommended that the sponsor of the medication, GlaxoSmithKline (GSK), should consider establishing a charitable foundation to assist sufferers of adhesive Arachnoiditis.

Jenny Carter from NSW is still suffering from being injected with the X-ray dye.

“I understand that GSK has compensated some patients, however, access to further assistance for other sufferers should be taken up with GSK.

“If there is any new evidence on this issue it should be brought forward and assessed,” he said..

Actress Jean Howell who co-starred with James Bond star Roger Moore in the television series The Saint was a famous victim of the dye.

Associate Professor Mal McLeod from the ANU’s Research School of Chemistry says the dye iophendylate was marketed under many names including the brands Myodil and Pantopaque in Australia “it’s the same compound,” he says.

In Australia the dye was injected into patient’s spines before X-rays called myelograms for 42 years, it was withdrawn from the market in 1987 and replaced by a new water based dye.

Radiologists knew iophendylate could cause arachnoiditis but say at the time it was the only way to get a decent X-ray image.

They admit they never warned their patients the painful condition called arachnoiditis was a potential side-effect.

Experts told a parliamentary inquiry the condition causes inflammation and fusion of the nerves and membranes of the spinal cord pain and delivers burning pain “like bolts of electricity”.

Victims also suffer loss of muscle function, paraplegia, incontinence, unpleasant sensations such as ants walking on the skin or having hot water poured on one’s legs. Many patients are wheelchair-bound.

Alan Wood from Queensland has also been left with side effects after his encounter with the dye.

In 2000 around 140 Australian victims of the dye received compensation from drug company GlaxoSmithKline which marketed the Myodil brand of the dye.

However, many victims are unaware the dye is the cause of their health problems and those who do have been unable to get compensation cases through the courts.

Now News Corp has learned when it had a chance to check the safety of the dye in the 1970s the Therapeutic Goods Branch (TGB) of the Department of Health failed to get the studies that should have raised alarm.

The Myodil brand of the dye was first used on humans in the 1940s well before Australia had a government body that checked the safety of medicines and medical products.

However in 1966 after the thalidomide scandal the Australian Government introduced the Therapeutic Goods Bill to regulate the sale of medicines and other therapeutic goods.

This meant that in 1972 when Myodil became contaminated and a Melbourne doctor began importing a US brand of the same dye called Pantopaque it was regarded as a new product and was covered by the new medicine regulations.

A letter from the Department of Health Therapeutic Substances Branch to Epworth Hospital in June 1972 explains:

“Pantopaque is regarded as a new therapeutic substance and has not been approved for general marketing in Australia.”

Glenda Nelson of Victoria says her life took a turn for the worse after she was injected with the dye.

The hospital was granted approval to use it in emergency cases only and as long as guidelines for experimental use were followed and chemistry and quality control data were provided.

In 1973 Nicholas Pharmaceuticals applied to the TGB for a licence to import Pantopaque into Australia.

Over the next two years various arms of the company were repeatedly asked by the TGB to supply studies on the safety and toxicology of the dye.

In February 1975 Cook Industries took over supplying the dye in Australia various Health department documents show.

The company was unable to obtain the studies from the US company Lafayette Pharmacal that marketed the dye.

Ernie Hughes the former managing director of Amyl Chemical Industries, the Australian branch of Nicholas that imported the dye and also former managing director of Cook Industries says he never knew about the studies in dogs that showed the dye was toxic.

“We only dealt with the commercial company selling Pantopaque, it had FDA approval,” he said.

There is no suggestion that Mr Hughes knew or should have known about the dye’s risks, or that he was involved in any wrongdoing.

He says medical practices at the time were very different to today and many radiographers as well as patients were injured by chemicals and X-ray dyes.

Gaye Hilder from South Australia also suffers from chronic pain every day.

“Who do you go to for compensation? … you can go back in history … here were an entirely different set of things done years ago,” he says.

Despite the fact the TGB did not get the safety and toxicity studies it allowed the various companies to import over 13,500 ampoules of the dye for use in hospitals and X-ray laboratories while the marketing permit was being considered.

And in June 1975 it inexplicably gave up asking for animal studies on the dyes, crossing the word “animal studies” off its request for information from the company.

The department should have been alert to adverse events because in 1969 the US FDA demanded the US supplier of the drug include warnings on the label that adverse reactions included “severe arachnoiditis producing headache, fever, meningitis, pain in the back and extremities and elevation of the white blood count”.

In 1977 our health department was asked by the US FDA to supply details of adverse reactions after it emerged the US company had never filed adverse reaction reports as required by law.

A departmental file note in 1971 shows the TGB had received “a number” of adverse reaction reports but was “not investigating these in the laboratory at this stage as an individual approach to each of these is not possible because our background in the testing of these drugs is rather limited”.

Later, in 1978 our National Biological Standards Laboratory had complaints from 8 doctors about Pantopaque.

And in June that year a Heidelberg Hospital patient died after being administered with the x-ray dye and the adverse drug reaction report says “maybe drug casualty possible”.

A copy of a document from Derek Morrisson from the Australian Department of Health, confirming the use of the X-ray due Pantopaque. Picture: Supplied

Despite this the dye was finally approved for marketing in 1979 without the TGB ever obtaining the animal and human studies it asked for to prove it was safe for use in humans.

“Pantopaque was assessed for safe use in humans as part of the assessment for its marketing approval, but as mentioned to Mr Morrison this did not include specific clinical studies or animal studies,” the department told News Corp.

“The sponsor did provide a list of over 100 publications on the use of the dye as part of the evaluation. There was also knowledge of the use of the dye over many years,” the Department said.

Flinders University Emeritus Professor Michael Sage. A radiologist, says he can’t believe the TGB approved Pantopaque for use in 1979 because he was warning them at that time it caused arachnoiditis.

“It was madness to approve it in the 1970s” he says.

“I struggled to get water based dyes approved in the 1970s because I was aware of arachnoditis,” he said.

“At the same time as they were approving Pantopaque we were asking them to approved a new water based dye because of arachnoiditis,” he said.

“They should never have approved Pantopaque in the 1970s, if they approved Pantopaque in the 1970s it was without taking on board people’s concerns about arachnoiditis,’ he said.

Radiologists used the oil based dyes Myodil and Pantopaque until the 1970s because there was no alternative way to get an image of the spine, he said.

“(They) used it because there was nothing better,” he said.

The dye ceased being marketed in Australia from 1987 but many thousands of patients who suffered its adverse effects have never been compensated and many may be unaware the dye caused their symptoms.


http://www.dailymail.co.uk/news/article-4024788/Disabled-solicitor-faces-rest-life-wheelchair-poisoned-doctors-child-suing-drugs-giant-Glaxo-millions-pounds-damages.html

Disabled solicitor who ‘faces the rest of his life in a wheelchair after being poisoned by doctors as a child’ is suing drugs giant Glaxo for millions of pounds in damages

  • Disabled Keith Lewin, 59, had suffered with back pain since his childhood 
  • Solicitor says Glaxo chemical injected into his back at 15 has led to life of pain
  • In 2013 surgeon found oily myodil still inside his spine, the High Court heard
  • Drugs giant GlaxoSmithKline says that Mr Lewin has left it far too late to sue
Keith Lewin, 59, had suffered with back pain since his childhood, and claims an agent injected into his spine as a child means he will spend the rest of his life in a wheelchair

Keith Lewin, 59, had suffered with back pain since his childhood, and claims an agent injected into his spine as a child means he will spend the rest of his life in a wheelchair

A disabled solicitor who faces the rest of his life in a wheelchair because he was inadvertently poisoned by doctors as a child is suing drugs giant GlaxoSmithKline for millions in damages, the High Court heard.

Keith Lewin, 59, suffered with back pain since his childhood but his health issues spiralled out of control in middle age and led to a devastating diagnosis in 2012.

He was told he had adhesive arachnoiditis, a rare spinal condition which causes debilitating pain and which has left Mr Lewin tetraplegic and confined to a wheelchair.

Mr Lewin, of Farington Moss, near Preston, claims that the blame lies in a procedure he underwent as a 15-year-old boy at Merseyside’s Whiston Hospital.

There, medics injected a ‘contrast agent’ called myodil into his spine so that it could be better viewed on an x-ray.

But the procedure did not reveal the source of Mr Lewin’s pain and instead led to his disability decades later, his legal team claims.

When he underwent an operation in 2013, a surgeon found the yellow oily myodil still inside his spine, the High Court heard.

Suing myodil’s maker and supplier GlaxoSmithKline for compensation, Mr Lewin claims it should have been withdrawn for use in diagnostic procedures years before it finally was in 1988.

‘He has suffered devastating injury,’ his barrister Simeon Maskrey QC told Mr Justice Goss.

‘And its attributability is clear to him and the surgeon who discovered myodil in his spine.’

Counter-claim: Drugs giant GlaxoSmithKline says that Mr Lewin has left it far too late to sue over something which happened so long ago

Counter-claim:

Drugs giant GlaxoSmithKline says that Mr Lewin has left it far too late to sue over something which happened so long ago

Myodil was used as a contrast medium in imaging of the back from the 1940s, allowing medics to better identify problems around the spine.

Mr Lewin’s lawyers claim it had not been sufficiently tested and, even if it could be used, Glaxo should have warned that it must only be in the most extreme cases.

A ‘better’ warning should also have been given about the need to remove the ‘unstable and toxic’ myodil immediately after x-rays, his lawyers claim.

The drugs giant denies all of the allegations and is trying to have Mr Lewin’s case thrown out.

Glaxo barrister, Jonathan Waite QC, argues that Mr Lewin has left it far too late to sue over something which happened so long ago.

He should have suspected by 1977 that he was suffering from the condition and took action to begin a claim before 1983, he said.

Mr Maskrey told the court that the first symptoms of adhesive arachnoiditis which Mr Lewin had were in 2007 when he felt a sudden excruciating pain while out walking.

But pointing to entries in the 20-year-old Mr Lewin’s diaries back in 1977, Mr Waite said the possibility of arachnoiditis was on his mind even then.

The young man, who was still being investigated for the cause of his back pain, had written of having ‘some symptoms’ of a condition which he spelled ‘racnoiditas’, said the barrister.

That must have come from either his orthopaedic surgeon or GP and should have been the moment when he began to investigate whether he could make a claim.

That he instead left it until he had a diagnosis three decades later meant his claim was ‘time-barred’ by the Limitation Act and should automatically fail.

‘Glaxo’s case is that the information about arachnoiditis imparted to him in 1977 was what should have prompted him, as a reasonable person, to be curious enough to start investigating what the cause of this might have been,’ said Mr Waite.

But Mr Maskrey said Mr Lewin had been told of a variety of possible causes of his pain in the mid and late 1970s, of which arachnoiditis was only one.

The pain he had suffered in those days was totally different from that which led to the discovery in 2012 that he had the condition, he continued.

Mr Maskrey said the earliest time in which Mr Lewin could have begun investigating a potential claim was 2007, but that he only had ‘actual knowledge’ of potential for damages in 2012.

That meant he was in time when he launched his claim and it should continue – unless Glaxo, with its ‘vast financial reserves’, decides to settle, he said.

Mr Lewin’s arachnoiditis, which causes inflammation of the membranes which surround the spinal cord, has left him severely disabled.

He suffers from debilitating pain and is confined to a motorised wheelchair both inside and outside his home.

He has had to make extensive adaptations to his home and his partner provides care. The condition is permanent and the prognosis is said to be ‘poor’, the court heard.

In 1995, Glaxo settled – without any admission of liability in relation to myodil – 426 claims which were due to go to court.

The judge reserved his decision on Glaxo’s bid to have Mr Lewin’s claim thrown out until a later date.


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.

GlaxoSmithKline to face class action over anti-depressant used on children


“…Mr Nikolic said one person joining the class action had been prescribed Paroxetine as a six-year-old, and soon began having suicidal thoughts….”

Imagine being prescribed Seroxat at 6 years old…

I wonder does Glaxo CEO Andrew Witty ever think about stuff  like that?

http://www.smh.com.au/national/glaxosmithkline-to-face-class-action-over-antidepressant-used-on-children-20160311-gngt7n.html

GlaxoSmithKline to face class action over anti-depressant used on children

Date
March 11, 2016 – 9:37PM

Bianca Hall
Bianca Hall
Legal Affairs Reporter for The Age

 

Paroxetine was once the most commonly used anti-depressant in Australia.

A Sydney law firm has launched a class action on behalf of people who as children and adolescents were prescribed the anti-depressant drug Paroxetine.

Drayton Sher Lawyers has called for expressions of interest from people who were prescribed the drug, commonly known as Aropax in Australia, when they were 18 or younger.

Solicitor Tony Nikolic​ said hundreds of people had indicated they would join the class action, which he expects to file in the Federal Court at the end of May.

Paroxetine was a commonly-prescribed anti-depressant more than a decade ago and for a time was the most commonly used anti-depressant in Australia.
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In 2001, GlaxoSmithKline (then SmithKline Beecham) funded a randomised trial of the drug that showed Paroxetine was safe for use in adolescents.

But concerns about its use persisted. In 2004 the Therapeutic Goods Administration’s Adverse Drug Reactions Advisory Committee said there was international concern about the risk of increased suicidal ideation and self-harm among children and adolescents using Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants.

“It should be noted that none of the SSRIs is approved for the treatment of MDD [major depressive disorder] in children or adolescents in Australia, but these drugs are being used for this purpose.”

A team led by the University of Adelaide’s Professor Jon Jureidini re-examined the GlaxoSmithKline research last year and found there were “quite striking” rises in the suicidal thoughts experienced by those taking the drug compared with those taking a placebo.

The review team found that 11 people who took the drug in 2001 experienced experienced suicidal thoughts or behaviours, compared with one person who took the placebo.

Mr Nikolic said one person joining the class action had been prescribed Paroxetine as a six-year-old, and soon began having suicidal thoughts.

“Now, if someone is assisted by this, fine. But they know that these things have suicidal thoughts or ideations attached to them.”

Mr Nikolic is calling for anyone who was, as a minor, prescribed Paroxetine – which also traded under a number of generic names including Chemmart Paroxetine, Extine, GenRx Paroxetine, Paroxetine Actavis and Terry White Chemists Paroxetine – to come forward if they experienced side effects.

These side effects could include suicidal feelings, attempted suicide, and causing others an injury.

Fairfax contacted GlaxoSmithKline for comment.

For help or information call Lifeline on 13 11 14.

Read more: http://www.smh.com.au/national/glaxosmithkline-to-face-class-action-over-antidepressant-used-on-children-20160311-gngt7n.html#ixzz42bl0ISQ6
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Australian Health Minister slams GSK’s Panadol Osteo price hike


http://www.thepharmaletter.com/article/australian-health-minister-slams-gsk-s-panadol-osteo-price-hike

Australian Health Minister slams GSK’s Panadol Osteo price hike

31-12-2015 Comments (0)Print

Australian Health Minister Sussan Ley says she has asked her Department to urgently alert the Australian Competition and Consumer Commission (ACCC) to plans by the maker of Panadol Osteo to increase its price by 50% on January 1, 2016.

There are no obvious market changes that justify such a substantial increase, she said, adding: “This includes changes to the listing of a small number (15%) of over-the-counter medicines on the Pharmaceutical Benefits Scheme, which I understand impose no additional administrative or regulative costs for these products.

In fact, these changes aim to address inconsistencies in the PBS that see consumers without a prescription purchasing a common over-the-counter medicine such as Panadol Osteo or an equivalent brand for under A$5 off-the-shelf or online from many pharmacies, while a concessional patient buying it through a prescription pays A$7.52.

Earlier this month, UK-headquartered pharma major GlaxoSmithKline (LSE: GSK) told its wholesalers it would lift its prices for Panadol Osteo by 50% on January 1. “In moving to an over-the-counter business model, GlaxoSmithKline is no longer able to sustain its current pricing of Panadol Osteo,” the letter to its wholesalers said.

An ACCC spokesman confirmed the watchdog was assessing the matter and seeking more information, reported the Sydney Morning Herald. “The Australian Consumer Law prohibits business from engaging in conduct that is misleading or deceptive or from making false or misleading representations,” the ACCC spokesman said.

Myodil Australia: Glaxo Wellcome faces significant damages claim over xray dye


http://www.afr.com/business/legal/glaxo-wellcome-faces-significant-damages-claim-over-xray-dye-20150705-ghzn35

Glaxo Wellcome faces significant damages claim over xray dye

Glaxo Wellcome faces significant damages claim over xray dye

The group of patients argue Glaxo Australia continued using Myodil despite that it knew or should of known about the risks which had been published in medical reports since 1956.
The group of patients argue Glaxo Australia continued using Myodil despite that it knew or should of known about the risks which had been published in medical reports since 1956. Reuters
by Marianna PapadakisPharmaceutical and chemical manufacturer Glaxo Wellcome Australia is facing legal action brought by 19 people for personal injuries arising from a dye used in a medical procedure.

The 19 patients are seeking damages for their contraction of a rare inflammatory condition called adhesive arachnoiditis because of the alleged use of the company’s oil-based dye Myodil during a myelogram.

A myelogram is a spinal x-ray that involves using a special contrasting dye that is injected into the cerebrospinal fluid of the spinal canal to enable the spinal cord and nerve roots to be examined.

Adhesive arachnoiditis is a painful and debilitating condition that results from the long-term scarring of the arachnoid, one of the membranes that surrounds and protects the nerves of the spinal cord.

In some very severe cases it can cause paralysis, bladder and bowel dysfunction and impaired sexual function.

The group of patients argue Glaxo Australia continued using Myodil despite that it knew or should have known about the risks, which had been published in medical reports since 1956.

They also claim Glaxo failed to warn patients and healthcare professionals about the risks of using the dye.

Glaxo Wellcome Australia is now known as GlaxoSmithKline Australia. The company manufactures pharmaceuticals, antibiotics, surgical equipment and laboratory chemicals.

A spokeswoman for the company said it considers it acted responsibly at all times in regard to the supply of Myodil including appropriate testing and monitoring, and updates to product information.

Statutory time limit

NSW Supreme Court judge Peter Garling ruled on Friday that a hearing on whether some of the claimants were outside the statutory time limit to bring a claim should be held ahead of a full trial.

According to the judgment twelve of the claimants were based in NSW, four in Queensland, two in Tasmania and one in Western Australia and all undertook the procedure between 30 to 43 years ago and were diagnosed between 1976 and 2012.

Glaxo Australia argues that if the patients did contract adhesive arachnoiditis it could have resulted from using another oil-based contrast medium called Pantopaque, which it did not manufacture but was used in Australian hospitals and radiology practices at the time.

The company also claims it could be prejudiced because of the unavailability of medical records and evidence for many of the patients as well as the inability to join any other medical practitioners as cross-defendants.

It contends it does not owe the patients a duty or care and that it gave particular warnings on product information leaflets and at different points in time.

Plaintiffs’ evidence

The company is paying for the plaintiffs’ evidence to be taken either in or close to their homes as many argue they are incapacitated and are not able to attend two hearings.

One patient has since died and the others are between 57 years to 86 years and largely confined to their homes.

Justice Garling said there were significant issues with respect to plaintiffs who received their diagnoses at a time well prior to the commencement of proceedings.

GSK questioned on corporate tax avoidance in Australia..


wouldn’t be the first time..

http://www.abc.net.au/news/2015-07-01/big-pharma-faces-senate-grilling-on-alleged-australian-tax-dodge/6585780

Nine major drug makers are being questioned about their tax minimisation strategies at a Senate committee hearing today after data showed they allegedly only paid a combined $85 million in tax out of $8.2 billion in revenue.

The powerful Senate Economics References Committee is focusing on revenue big pharmaceutical firms derive from the Government-funded pharmaceutical benefits scheme (PBS).

Companies including Pfizer, AstraZeneca, Novartis, Merck Sharp & Dohme and GlaxoSmithKline are be questioned at the hearing in Sydney about profit-shifting techniques through transfer pricing and royalty payments to subsidiaries in other countries.

The senate committee has received official data showing that between the nine companies more than $3.5 billion was received from PBS funding in 2014.

Of $8.2 billion in total revenue, it is claimed the companies paid tax of $85 million, which equates to a 1 per cent tax rate.

Remembering GSK’s Myodil Again: “This has been going on for years and years”


60, 000 people affected by a GSK product, Myodil, and GSK do nothing for their suffering!

100, 000 excess heart attacks in the US alone because of GSK’s Avandia, and GSK do nothing to help these people and their families. At least in the US- there is some chance of legal success- in the UK- GSK do everything in their power to squash claims against them…

Hundreds of thousands of lives ruined from Seroxat/Paxil, and in the UK, at least- nothing is done to bring GSK to book over these grave abuses of human rights. We are talking about dead children here! Due to Seroxat’s suicidal side effects! That could be anyone’s son, daughter, child, sister, brother!

GSK… Once again… You are an utter disgrace to humanity.

Your Motto of “Do more, feel better and live longer” must be a sick bloody joke!

Shame on you..


http://www.canberratimes.com.au/act-news/answers-may-give-some-rest-20130302-2fdlg.html

Answers may give some rest

Date
March 3, 2013
  • Read later
Joern Hagemann showing the xray where an oil-based contrast media used in myelography called Myodil.Joern Hagemann showing the xray where an oil-based contrast media used in myelography called Myodil. Photo: Jay Cronan

THE simplest movements – walking, sitting and even lying down – cause Joern Hagemann extreme pain. In 1978 his spine was injected with Myodil after a construction accident. But the dye used in X-ray procedures has been linked to adhesive arachnoiditis, a deteriorating and debilitating condition that leaves sufferers crippled with terrible pain, paralysed and incontinent.

Mr Hagemann considers himself lucky. He is able to walk around his Spence home with the help of his wife, Ursula, and a cane. He does not want pity, he wants answers. Why the oil-based ink was considered safe for internal use when doctors were warned to be careful about spilling it as it corroded rubber; and why it was used until 1987.

He said the February findings of a round table on adhesive arachnoiditis by the standing committee on health and ageing left many questions unanswered.

The committee’s first recommendation was for GlaxoSmithKline, the company that marketed the product for 42 years, to consider establishing a charitable foundation to assist the sufferers of adhesive arachnoiditis.

 

”I want it investigated further. I tried through the round table but they sugar-coated it,” Mr Hagemann said.

”I wanted the government to finally sort out what’s going on with the drug company. That’s not asking much when there are more than 60,000 people involved.”

He said a suggestion to start a charitable foundation was not enough for a dark incident in Australian medical care that Throsby MP Jennie George called a ”conspiracy of silence”.

”We were never told it was dangerous. We were never asked if we wanted it. This is the whole point.”

In a statement a spokeswoman from GlaxoSmithKline said the company acted responsibly in relation to the supply of Myodil.

”We are currently considering the information within the report, including recommendation one, which encourages GSK to establish a charitable foundation to assist sufferers of adhesive arachnoiditis,” she said.

But Mr Hagemann wants a real investigation.

”This has been going on for years and years and years.”

Read more: http://www.canberratimes.com.au/act-news/answers-may-give-some-rest-20130302-2fdlg.html#ixzz2NpMeLxQe

Aropax (Seroxat/Paxil/Paroxetine): “Once You’re on it You Can’t Get Off”


“And that’s the most terrifying thing of all.”

http://www.patientsrights.org.nz/aropax-nation

Aropax Nation

AROPAX NATION: A HARD HABIT TO BREAK

This article was written by Clare Swinney and published by Ian Wishart in the Investigate Magazine in April 2004.http://www.investigatemagazine.com   It has been made available to readers on this website by kind permission of the author.

Are modern anti-depressants actually making people crazy? CLARE SWINNEY investigates the growing controversy over the side effects and withdrawal sympoms of the SSRIs:

Janet Frame touches on the association between doctors and patients in Faces In The Water, (1980) on page 28. “The doctor would pause sometimes to inquire, smiling in a friendly manner, but at the same time glancing hastily at his watch and perhaps wondering how in the hour before lunch he could possibly finish his rounds of all the women’s ward and get back to his office to deal with correspondence and interviews with demanding puzzled alarmed ashamed relatives”. Although this was set in an asylum in New Zealand in between the First and Second World Wars, it bears a familiar flavour.

Propelled by a need for efficiency, psychiatry’s enthusiasm for symptomatic, push-button remedies, has led to life’s transient symptoms, such as forms of mild depression, to be clinically diagnosed and, once diagnosed, seemingly quickly alleviated, if not eliminated, by a pharmacological intervention. Many clinicians today consider it more practical, economical and speedier to prescribe medication than psychotherapy. But is dispensing tablets, such as the family of Selective Serotonin Reuptake Inhibitors (SSRIs), the best course of action for treating common ailments, such as mild to moderate depression? Or is it doing damage to those it is supposed to be helping?

Doctors have administered and prescribed a series of addictive drugs as sedatives for psychological distress since the early 1800’s, ascribing to the belief that they wouldn’t lead to dependence, and if they did, their patients were probably accountable in some way. Initially, there was opium and alcohol, then heroin, morphine and cocaine. Then in came the bromides, barbiturates and associated compounds. And an assortment of benzodiazepines ensued, including Librium and the iconic one, Valium, which was deceptively denoted “mother’s little helper”.

As a consequence of the relationships between governments, almighty drug companies, the medical profession and patients, it took over two decades of comprehensive use before benzodiazepines were accepted as addictive. When this occurred in the late 1980s, prescriptions for them went into sharp decline, but by then, thousands of addicts had been spawned worldwide, many for whom the sole motivation for continuing to take the drugs was that it was too distressing trying to cease using them. They were dependent upon them – in a similar manner some get hooked on drinking. It wasn’t an obvious addiction. Its effects were, for the most part, respectably concealed behind the white net curtains of suburbia. But the households were haunted.

A few weeks ago, an evening talkback show on Radio Pacific elicited calls from people who’d taken SSRIs, the antidepressants which soared in popularity when benzodiazepines lost favour. SSRIs affect the brain’s ability to reabsorb serotonin, a neurotransmitter in the brain, which is supposed to affect mood, sleep and appetite. That night numerous people phoned the radio station. Said the program’s host: “We were inundated”. People related how difficult it was to come off SSRIs owing to a melange of atrocious withdrawal symptoms. Some divulging that they experienced anger, fierce rage and suicidal thoughts. A number regarded it as too difficult to give up, and regarded their medication as addictive.

Difficulties coming off the SSRIs are well documented. An Internet search of MEDLINEPlus using the search terms “SSRI” and “withdrawal” in combination drew out 278 entries and in Google, 51,900. Some experts stated that many patients, who go off the drugs, mistake their withdrawal symptoms for a return of the original symptoms they were using the drug to treat. They then commonly restart the medication. Other experts said that in many cases there may be a re-emergence of the symptoms people took the drug to alleviate, such as panic attacks for example, and that this was the deciding factor for some patients who restarted their SSRI medication.
Aropax, (paroxetine), which has a relatively intense impact and short duration of action, is associated with the most severe withdrawal reactions. It was approved for introduction into New Zealand in April 1992 and is now the most widely prescribed antidepressant in New Zealand – 209,054 prescriptions were written for it in 2003 alone. And this states Pharmac, the government-sponsored Pharmaceutical Management Agency of New Zealand, is in spite of it having come under scrutiny in Europe and North America, owing to reports linking it to an increased incidence of suicide and a heightened risk of dependence.

In 2003, the number of prescriptions for expensive antidepressants rose and cost taxpayers an additional $4.6 million from the year before. Clinicians’ preference for the SSRIs: Aropax, Fluox and Cipramil, over the old style of antidepressants, such as the tricyclics and monoamine oxidase inhibitors, accounted for most of this unwelcome gain.

One of the reasons for SSRIs popularity is that doctors do not regard SSRIs as addictive. Withdrawal from SSRI’s, such as Fluox and Aropax, can cause a range of unpleasant symptoms, such as dizziness, insomnia, virtual reality nightmares and headaches, but this in itself is not indicative of an addiction. According to Associate Prof Doug Sellman, a psychiatrist who specialises in addiction research at Christchurch, there is a crucial difference between a withdrawal syndrome associated with drugs taken for reward and attendant drug-seeking behaviour and a discontinuation syndrome from medications generally. He states: “There is no doubt that there is a discontinuation syndrome from SSRIs, such as Aropax, but not a withdrawal syndrome that will reignite drug-seeking behaviour.”

“Oh yeah?” responds Jane, one Auckland woman who tried to give up Aropax six weeks after starting. “By day five of climbing the walls, fighting the urge to kill yourself, fighting the urge to kill somebody else, feeling nauseous with the most horrific dreams I’ve ever experienced in my life – of course you go crawling back and start taking the drugs again! I suggest these doctors try taking these drugs themselves for a while, then try kicking the habit. Then you’d see their views change.”

Interestingly, a US clinician interviewed by Time magazine dismissed the link between SSRIs and suicides, saying a study of suicides failed to find evidence that an SSRI had been taken in the hours beforehand. But according to Jane and others, he missed the point – the suicidal thoughts come when you try to give up the drug, and you haven’t taken a pill.

Jane had gone to her doctor for exhaustion, and came away carrying a 20mg a day prescription for Aropax. When some of the side effects started to kick in after four weeks, she went back to the medic who decided to double Jane’s dose to 40mg a day. Things went from bad to worse – and the discovery that Aropax is one drug you can’t quit cold turkey.

“Once you’re on you can’t get off,” she says. “And that’s the most terrifying thing of all.”

The Diagnostic And Statistical Manual of Mental Disorders, 4th Ed., (DSM IV), is the clinicians’ bible. Amongst other things it categorises 307 different types of depression, other mental illnesses, the personality disorders, and substance abuse problems. According to this guidebook, ‘addiction’ requires at least 3 of 7 criteria to be met. (p. 181).

Offers Dr Alistair Dunn, a GP, who specialises in the field of addiction: “A withdrawal syndrome is but 1 of those 7 criteria. I don’t think taking an SSRI, such as Aropax, fulfils any of the others. And I don’t regard it as addictive because it may in some cases, require careful tapering off. If medication for blood pressure is stopped abruptly, a rebound rise in blood pressure can result, or in other cases, a return of angina may occur. Therefore, it must be tapered off slowly. But that doesn’t make it addictive. Addiction does not equal withdrawal syndrome. It’s much more complex, involving effects across a wide range of domains in someone’s life.”

A DSM IV diagnosis of addiction requires evidence of outright abuse. One of the 7 criteria assigned is self-destructiveness manifested in drug-seeking behaviour, such as visiting multiple doctors or driving long distances. Obviously, this would be most unlikely to occur with an SSRI, given that physicians readily prescribe and actively encourage their use. Asserts Dr Dunn: “It can sometimes take a long time for a GP to convince a patient to try a medication, even when the need is obvious to the doctor and the benefits are significant”. Dunn seemed quite annoyed this article was being written. “What about the benefits of the medication and the harm of someone stopping it because they have read an article stating it’s an addictive drug”, he queries.

A review of the medical literature on the SSRI withdrawal syndrome by Tamam and Ozpoyraz, concludes that the best approach for a doctor in dealing with patients experiencing withdrawal symptoms is to educate them, reassuring them that it is a reversible condition, while reinstating the original SSRI, and further slowing the rate of tapering off the drug. (Source: Adv. Ther, 2002).

Anna De Jonge of Hamilton is the Liaison Officer for the Patients. Rights Advocacy Waikato Inc, (PRAWI), a group

of 570, that advocates having will power over pill power. PRAWI’s principal aim is to empower people with information and knowledge. And it, amongst other activities, assists victims of medical misadventure to make formal complaints. Says De Jonge, who is opposed to the use of the SSRI’s because she says they’ve been associated with “suicide, murder, self-harm and mental turmoil,” if in time SSRI’s turn out to be no improvement on latter-day antidepressants, this will be owing to and in spite of the minimisation of the risks of taking them. “If SSRI’s were in some regard, drugs of dependence, but not being categorised as such, it will increase the element of risk of self-harm using them, and their effectiveness will naturally be over-estimated,” maintains De Jonge.

Is their effectiveness being over-estimated? Effectiveness of numerous drugs is. Although it’s seems baffling given the drug industry’s culture of maximum possible sales for maximum possible profit, Dr Allen Roses, an employee of GlaxoSmithKline, (GSK), which is Britain’s largest drugs empire, publicly disclosed that most prescription medicines don’t work on most of those who take them. Amongst those working in the pharmaceutical industry, this was no secret. Seemingly paradoxically, Roses, worldwide Vice-President of genetics at GSK, stated late in 2003 that most drugs only work in 30-50% of people – a substantial proportion prescribed some of the most expensive drugs do not derive any benefit from them at all.

Could this be a reason why the SSRI, Prozac, which is the most widely prescribed antidepressant drug in history, made a fortune for the company, Eli Lilly, yet couldn’t save the CEO’s own spouse? In May 1994, Mrs Marilyn Tobias, the wife of Randall L Tobias, chief of Eli Lilly, committed suicide. Tobias told a magazine in 1995 that his wife was depressed and had tried Prozac.

Prozac was approved for use in New Zealand in February 1988. Eli Lilly’s www.prozac.com website states: “since its introduction in 1986, Prozac has helped over 40 million patients worldwide, including those suffering from depression”. Yet, as Charles Medawar, who has worked in consumer protection in the UK and held appointments with the World Health Organisation, pointed out “there has been no discernible effect on suicide rates, since the start of the new war on depression”. Suicide rates in the USA, where SSRIs have been most used, and in England, provided no evidence of any national dose-response. (Source: “The Antidepressant Web – Marketing Depression and Making Medicines Work,” in International Journal of Risk and Safety in Medicine, 1997, p.23).

And now the 24,500 or so anti-depressant prescriptions provided for treating children and adolescents each year in New Zealand are under scrutiny as researchers look for a possible link between SSRIs and suicide. SSRIs are not registered for use here in children, but some doctors prescribe them to youngsters. In Britain, authorities have advised doctors not to prescribe the SSRIs Lustral, Cipramil, Cipralex, and Faverin to young depressed people as clinical trials found a higher rate of insomnia, agitation, weight loss, headache, tremor, loss of appetite, self-harm, and suicidal thoughts in children taking the drugs.

For years, drug manufacturers and regulators in the UK and US maintained that antidepressants would reduce the risk of suicide. Perhaps most notably, Dr David Healy, Director, North Wales Department of Psychological Medicine, a psychiatrist with an international reputation, having authored 12 books and over 120 peer-reviewed articles, strongly disputes this claim. Healy has examined many confidential internal drug company documents, to which he gained access in his capacity as an expert witness in a lawsuit against GSK. These internal documents, Healy states, show the results of the company’s own clinical trials testing the SSRI, paroxetine (Aropax). The evidence, he alleges, shows that rather than reducing the risk of suicide, the drug increases it. He told the BBC that the evidence indicates that roughly 1 in 60 people who go on this drug makes a suicide attempt, whereas only 1 in 550 on a placebo or sugar pill do. Dr Healy says both the drug company and the regulators in the UK and US knew this data for 13 years.

At the heart of the problem, Healy believes is that SSRIs cause akathisia, a syndrome involving motor restlessness, and it is this that causes some patients to commit suicide. GSK’s own studies, and Healy’s, show that SSRIs can cause 1 in 4 healthy volunteers to become agitated. Healy, who is also involved in legal action against Pfizer, following the suicide of the 13-year old American called Matthew Miller, who hanged himself after taking the SSRI sertraline for a week, carried out a trial in healthy human volunteers comparing sertraline with Pharmacia’s Edronax, which does not work on the serotonin system.

The results showed that one third did not respond well to sertraline at all. Of this third, 2 volunteers became acutely and seriously suicidal just being on a normal clinical dose for 2 weeks. They were absolutely normal people. Healy claimed that the archives of the 2 companies contained evidence supporting his own findings.

In excess of 30 studies on sertraline carried out before the drug was licensed, showed that 1 in 4 people taking the drug became agitated. The healthy volunteer studies carried out by the company showed that about 50% of patients suffered withdrawal problems when they came off the drug. Healy claimed this suggested that some patients had become physically dependent on the drug. But instead of warning patients and doctors, he said the company argued that the patients with problems coming off drugs were suffering a recurrence of depression and needed to resume medication.

It can be difficult to conceive of what could be going through someone’s mind when they consider suicide. According to 31-year old, Ashburton mother of two, Diane Blakemore, of how she felt while taking an SSRI: “My life was totally miserable. I wasn’t living – I was surviving. I had horrific nightmares, usually quite satanic. Irrational fears on the drug, were the norm too”.

She continues: “I would lie on the couch, too lethargic to move and felt suicidal, as I was highly anxious and depressed. My whole body had inner shakes, I was sweating all over and I had headaches and unbearable muscle tension. My nervous system was overstimulated to the max”.

“I felt suicidal because I felt like this and really didn’t like it. I didn’t know how to handle it. The doctor told me to keep taking the tablets, saying that these side effects would go away after 4 weeks. But they didn’t.”

“I’d never had any of these symptoms prior to taking the drug. I recently had a bladder and uterine prolapse with terrible backache as a result of giving birth, which made me feel very tired. And as my child had colic, I had to walk the floor, and this walking made my backache worsen. The longer I was on my feet, whether I be sitting or standing later, the worse the pressure and resultant pain would be. And it affected my legs too, as they felt heavy. My backache would ease if I lay down and I took my body weight off my sacrum – so I knew it wasn’t a psychological problem. And I was aware that prolapses might cause this pressure pain. But unfortunately, I just did what the doctor told me and took the medication for the ‘chemical imbalance’ I was told I had.” In this case, the chemical imbalance her doctor referred to was a diagnosis of depression. Blakemore wrote to members of parliament in March 2004 regarding her experiences. In her opinion the medical profession is too ready to categorise behaviour as indicative of depression and far too disposed to prescribe antidepressants.

As with the withdrawal syndrome, problems such as Blakemore’s SSRI experiences have been documented, yet SSRI popularity continues to soar worldwide. For example, in the UK in 1992, 500,000 prescriptions were written for SSRIs. A decade later, the figure was 15 million. Likewise, in 1993 in New Zealand approximately 50,000 scripts were written for SSRIs and by 2003, this mushroomed to almost 450,000.

Investigate asked GlaxoSmithKline how many packs of Aropax – a drug subsidised by the government – they sold in 2003, in New Zealand. Neil Jarvis, the sales manager responded: “Unfortunately the information you have requested cannot be provided. As you appreciate, sales data is confidential and is not readily available from a majority of pharma [sic] companies.” While GlaxoSmithKline regarded this as classified information, it is in the public arena that in 2003, doctors wrote 203,636 prescriptions for Aropax and that the Ministry of Health paid $19,269,716 for it. Pacific Pharmaceuticals, which supplies the Prozac equivalent, Fluox, a drug which is also subsidised by the government, told Investigate that the company sold 193,000 packs of capsules in New Zealand in 2003. Each pack contains 90 capsules.

In light of the show-stopping number of these drugs being sold each year, it is little wonder the Radio Pacific talkback session on SSRIs became deluged with callers a few weeks ago. When the BBC broadcast a show on SSRIs in the UK in late-2002, it also received a huge response from viewers – 1,374 e-mails and over 5,000 telephone calls. A published medical paper presents an analysis of these e-mails and finds that 17% rated paroxetine as “very positive to worth taking”, 48% rated paroxetine negatively, from not worth taking to severely disabling, and 35% were uncertain, giving no or insufficient evidence of having taken the drug.

Investigate went to a pharmacy to take photos of SSRI packs. The pharmacist, who does not wish to be named, regarded the number of people he knew who were taking it as “sad”. Although not being handed out like sweets by the medical profession, because of restrictions, he knew of people taking it because their friends were.

According to Dr Jay M. Pomerantz of Harvard University, since antidepressants have severe adverse side effects,

most patients stop taking them before they might have any positive effect. Investigate found evidence that SSRIs aren’t being swallowed according to doctors’ orders. A near full pack of Aropax was found in a skip outside someone’s apartment. A friend handed me 35 Fluox tablets to take photos of, saying he didn’t ask his doctor for anything for depression, but was prescribed them. He took the medication for 15 days, before deciding it more prudent to address the cause of his unhappiness. In addition, there were packs of Prozac 20 located at a relation’s residence, abandoned in a kitchen drawer.

It is not difficult to fathom that the medical profession is eager to promote these drugs’ use.

The British government is now cracking down on reckless over-prescribing of SSRI drugs, which are depleting public health care budgets. New draft guidelines from the UK.s National Institute of Clinical Excellence (NICE), the British government agency that decides which drugs should be available through the National Health Service, state that antidepressants are not recommended for the initial treatment of mild depression in adults “because the risk-benefit ratio is poor”. NICE will publish guidelines for the treatment of depression in children in 2005.

Investigate asked Pharmac’s Medical Director, Dr Peter Moodie, if there were any plans to curtail the burgeoning sum being spent on SSRIs here. Moodie advised that a cheaper source of paroxetine was in the process of being sourced, as the patent for the drug had expired. However, he said it would take some time before a cheaper, generic equivalent to Aropax could be obtained, as its producer is fighting tooth and nail to keep its market share. He said it would help reduce costs to taxpayers if doctors were more prepared to look at the basic causes of depression, before reaching for a prescription pad.

Do SSRIs work? They inhibit serotonin reuptake. They inhibit the action of receptors on cells near neurons, thus making the serotonin stay in the synapse longer and consequently activate the next neuron for a longer duration than would otherwise occur. However, it is merely hypothesised that depression and anxiety are related to abnormal levels of serotonin and altering its effectiveness with an SSRI may alleviate the symptoms.

Depression, which, as mentioned, falls into 307 categories in the DSM IV, is also believed to be associated with abnormal levels of other neurotransmitters, such as norepinephrine and dopamine, which can, some experts say, be regulated by other drugs. A problem with prescribing the “right” drug to treat depression, is that there is no scientific way to prove that a person has a low or high level of a specific neurotransmitter – so finding the appropriate drug for someone is deemed to be on a trial basis.

Ironically, while doctors continue to give SSRIs the red carpet treatment, numerous studies have demonstrated that drugs are not required to treat depression. Placebos or dummy tablets, such as disguised sugar pills, can do just as good a job. Indeed, numerous reputable studies have found that patients may respond to placebos, in much the same way they respond to antidepressants. One such study, a major government-funded study in the US, found that neither Zoloft, nor St. John’s wort are any more effective than a placebo in patients with major depression. (See: JAMA, Vol. 287, No. 14, April 10, 2002).

Similarly, research by a team led by University of Connecticut psychologist, Irving Kirsch, did an analysis of clinical trial data submitted to the US FDA for the 6 most widely prescribed antidepressants in the US, that were approved between 1987 and 1999. Namely fluoxetine, paroxetine, sertraline, venlafaxine, nefazodone and citalopram.

The group found that 80% of the response to medication was duplicated in placebo control groups. Thus, those who received only the pretend pills felt better to about the same degree than those who took the SSRI drug did. The average difference in improvement was only 2 points on the Hamilton Depression Scale, which produces scores up to 50 or 62 points, depending on the version used. The difference was so small that it was obvious the people got well because they expected to.

Kirsch et al concluded that if the drug affect is as small as it appears when drug-placebo differences are estimated, then there is little justification for the clinical use of SSRIs. (Source: “The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration,” published by American Psychological Association, 2002).

These studies raise very serious questions about whether SSRIs should be the treatment of choice for depression -questions that seem to be falling on deaf ears.
A placebo poses no risk and costs next to nothing, and research findings have demonstrated repeatedly that they work as well as antidepressant medication. So why do psychiatrists prescribe expensive SSRI drugs despite the serious risks and side effects? The risks associated with highly prescribed antidepressants can be severe: in some patients they produce suicidal thoughts.

Investigate asked Pharmac if the many studies that have shown a placebo is as effective in treating depression as an SSRI, have influenced any decisions Pharmac has made? Dr Moodie said: “No. We are aware of those papers. How quickly doctors prescribe SSRIs is up to good medical practice. If Pharmac perceives that there is something obviously going awry in the prescribing of various drugs, then there is a responsibility to promote responsible use.”

Aropax is repeatedly advertised in full-page ads in the New Ethicals Catalogue, a handbook used by GPs to select medications, as “more than just an antidepressant.” Indeed, SSRI antidepressants are advertised and prescribed as safe for a myriad of complaints that have nothing to do with severe, clinical depression for which they were approved.

Dr. Pomerantz notes that “SSRIs in particular, have replaced benzodiazepines as the drugs of choice when the physician is at a loss for what to do to get a patient out of the office.” And: “If what we are seeing is a pattern of widespread antidepressant prescribing for a multitude of subsyndromal, amorphous, patient complaints, it suggests that antidepressants have become the modern-day sugar pill, or placebo. It is quite likely that antidepressants have largely replaced benzodiazepines in this regard.” (Source: Antidepressants Used as Placebos: Is That Good Practice? in Drug Benefit Trends 15 (8), 2003).

If antidepressants are being prescribed as a placebo, New Zealand taxpayers are paying the pharmaceutical companies a ridiculously high price. It is a joke and a telling one. We would be misguided blaming the drug industry for this state of affairs. Effective corporate monsters like GSK and Eli Lilly exist to make a profit for shareholders, not to help provide premium health care for people. Providing good health care is the job of the medical profession.

When Coming Off Antidepressants:

Work closely with your doctor.
Taper the medication. Experts agree that the best way to avoid withdrawal side effects is to wean off the medication. By reducing the dosage in small increments, the brain can adjust to the change in chemical balance and slowly adapt to living without the drug. For some people, experts say, this process may take up to a year.
Get psychotherapy or counselling. While drugs can often mask problems, therapy can help address underlying causes. Psychotherapy is far superior to medication in the long term.
Exercise. Even if you don’t feel like it. Force yourself to. There’s strong evidence exercise plays a major role in lifting one’s mood and reducing stress.
Eat a healthy diet.
Laugh. Laughter is one of the best medicines.

Living with the pain of GSK’s Myodil


As Deputy Chair of the House of Representatives Standing Committee on Health and Ageing, I rise to respond to the chair’s statement on the report Living with the pain of adhesive arachnoiditis: report on the roundtable into adhesive arachnoiditis. I start with the following statement:

Our guiding principles are to focus on patient needs, respect people, communicate honestly and act with integrity. We are bound by a promise to keep our customers at the heart of everything we do. We do this work in partnership with Government, industry, the community and our peak industry association,

Any suffers of adhesive arachnoiditis will recognise this motherhood statement taken from the GlaxoSmithKline website. GSK is the company that released the Myodil and Pantopaque products into the medical world, which are a cause of the condition known as adhesive arachnoiditis, described in the report as a painful condition. We heard the chair say in her statement that this is a horrific condition.

The report states that the committee very much appreciates the contributions of all participants to its inquiry. The roundtable made clear to the committee how debilitating adhesive arachnoiditis can be to sufferers. The committee very much sympathises with and hopes that the recommendations of the report will help to improve the quality of life for sufferers and their families and carers. I particularly mention Mr Max Scott from my electorate of Swan, who first brought to this terrible condition to my attention. I also thank Mr Joern Hagemann and his daughter and carer, Mrs Erika Zorzit, who both came to visit me about Mr Hagemann’s condition. Their visit gave me the extra impetus to cajole, urge and convince the Standing Committee on Health and Ageing to commit to a roundtable and I thank my fellow committee members for their support in agreeing to the roundtable.

In particular I thank Steve Georganas, the previous chair, and Jill Hall, the current chair, both of whom played their part in getting this roundtable up. I thank the secretariat for their work on this difficult report as I felt there was a level of trepidation in dealing with this subject due to the long litigious history of the subject and the ongoing litigation. Thanks must also be given to the previous member for Throsby Jennie George for tackling this issue back in the early 2000s with the support of Jill Hall.

I also mention Mr Jonathan Martin from my office who spent a considerable amount of time dealing with sufferers and providing me with valuable research. His efforts should not go unnoticed by the people who read this report. During my time involved with the forgotten Australians apology more than three years ago, the comment that the Leader of the Opposition at that time, Malcolm Turnbull, made in his speech when he said, ‘We believe you,’ was, for many people, a significant moment. I think the same significance could be taken by arachnoiditis sufferers from the comments made by Professor Michael Sage, a radiologist, when he stated:

I believe that the most common cause of chronic arachnoiditis is Myodil, and most people have been suffering for 40 years. … These people have suffered, mainly because we were using a dye, Myodil, with no alternative. … there was a gradual recognition—with poor literature, I might say—that there was a problem. A needle was introduced to allow us to suck it out; the problem was that it was often impossible to suck it all out anyway. The bottom line was that, if there was some alternative, we should not have been putting it in. I was very concerned about this.

The report’s recommendation 1 goes back to the first part of my statement that was taken from the GSK website. This recommendation’s first paragraph states:

In the context of corporate social responsibility the Committee encourages GlaxoSmithKline to consider establishing a charitable foundation to assist sufferers of adhesive arachnoiditis.

This is a decision that only GSK can make. However, if we are to believe all the motherhood and community caring messages stated on their websites around the world, we can only hope that they honour these statements. If they do not act, their response to this recommendation will give us a true indication of GSK’s real community concern. In the report there is a comment that states there is an acceptable failure rate of 10 per cent for people who contract arachnoiditis from a myelography. I ask: would that be an acceptable failure rate for a motor vehicle manufacturer? The clear answer is no. My experience with manufacturing is that a one per cent failure rate is acceptable before they have a recall. I encourage people to read this report and again thank all the people who were able to finally have this debilitating condition brought to public awareness through this report. I commend this report to the House.

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