Esteban Santiago is taken from the Broward County main jail as he is transported to the federal courthouse in Fort Lauderdale, Florida, U.S., January 9, 2017. Amy Beth Bennett/South Florida Sun Sentinel via REUTERS
The glaring failures surrounding Esteban Santiago, resulting in the tragic killing of five people and wounding of eight others in Fort Lauderdale, Florida, prompts me to make some points about our misguided mental health system.
First, psychiatrists have no ability to predict who is going to be violent. In a Jan. 3, 2013, Washington Post article, “Predicting violence is a work in progress,” after reviewing the research, writer David Brown, reported:
• “There is no instrument that is specifically useful or validated for identifying potential school shooters or mass murderers.”
• “The best-known attempt to measure violence in mental patients found that mental illness by itself didn’t predict an above-average risk of being violent.”
• “(S)tudies have shown psychiatrists’ accuracy in identifying patients who would become violent was slightly better than chance.”
• “(T)he presence of a mental disorder (is) only a small contributor to risk, outweighed by other factors such as age, previous violent acts, alcohol use, impulsivity, gang membership and lack of family support.”
In hindsight, the danger Santiago represented seems clear, but psychiatrists simply cannot predict violence.
Second, the mental health system clearly did not help Santiago. The system is fundamentally misdirected towards drug treatment for the completely unproven, and likely untrue, theory that what gets diagnosed as mental illness is the result of some brain defect.
It seems fair to assume what would most likely have benefited Santiago was help dealing with his traumatic war experiences. Because of patient confidentiality we don’t know, but it seems likely Santiago was instead just given psychiatric drugs.
Third, it is known psychiatric drugs are the cause of just the sort of inexplicable mass-shootings perpetrated by Santiago. As the International Society of Ethical Psychology and Psychiatry said in a statement following the Sandy Hook school massacre:
• Christopher Pittman was on antidepressants when he killed his grandparents.
• Eric Harris, one of the gunmen in the Columbine High School shooting, was taking Luvox. His partner, Dylan Klebold, had taken Zoloft and Paxil.
• Doug Williams, who killed five and wounded nine of his fellow Lockheed Martin employees, was on Zoloft and Celexa.
• Michael McDermott was on three antidepressants when he fired off 37 rounds and killed seven of his fellow employees in the Massachusetts Wakefield massacre.
• Kip Kinkel was on Prozac when he killed his parents and then killed two children and wounded 25 at a nearby school.
• In 14 recent school shootings, acts committed by persons taking or withdrawing from psychiatric drugs resulted in over 100 wounded and 58 killed.
• In other school shootings, information about the shooter’s prescription drug use and other medical history were kept from public records.
Fourth, the over-reliance on psychiatric drugs is extremely harmful and counterproductive. These drugs are so physically harmful that those diagnosed with serious mental illness by the mental health system have a lower life expectancy of 20-25 years.
In addition, it has been shown a noncoercive approach, that selectively uses neuroleptics (mismarketed as “antipsychotics”), can achieve an 80 percent recovery rate, while our system of “drugs for everyone forever” results in only a 5 percent recovery rate.
Dr. Loren Mosher, former chief of the Center for Studies of Schizophrenia at the National Institute of Mental Health, testified in one of my cases that he probably had more experience with unmedicated psychotics than anyone alive. He said he has never had to involuntarily commit anyone because he always made it a point to establish a relationship with his patient so they could agree on a course of action.
He testified that if somebody was about to do grievous harm he would stop them in any way needed, but he had never had to because of his approach.
Locking people up and drugging them against their will is not the answer. In addition to the drugs, the violence against patients by the mental health system begets violence from some of them.
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We need noncoercive programs that help people deal with their problems and the traumatic events in their lives. We need to make people feel safe, listen to what they are telling us are their problems, and what assistance they would like.
Even the craziest person is telling us something useful if we take the time to listen and interpret. There are places that successfully do not use force against psychiatric patients.
We should start doing what works and provide noncoercive, truly helpful services for people diagnosed with serious mental illness.
Jim Gottstein was a plaintiffs’ attorney in the 1 million-acre mental health lands trust litigation, resulting in the creation of the Alaska Mental Health Trust Authority. For the past 14 years, he has donated his services to the Law Project for Psychiatric Rights. He has won five Alaska Supreme Court cases regarding involuntary commitment and forced drugging on the grounds both are unconstitutional or illegal.
The views expressed here are the writer’s and are not necessarily endorsed by Alaska Dispatch News, which welcomes a broad range of viewpoints. To submit a piece for consideration, email email@example.com. Send submissions shorter than 200 words to firstname.lastname@example.org.
Campaigners are calling for a Europe-wide public inquiry into how a vaccine triggered devastating health sleep and brain disorders in a scandal they claim is as big as thalidomide.
Almost 1,700 people suffered narcolepsy after being vaccinated for swine flu. They are vowing to continue their fight for justice at the European Union.
The group of Europeans, including nearly 100 Britons, are calling for a public inquiry after suffering the debilitating disease which was triggered by use of the Pandemrix vaccine to treat the 2009/10 swine flu outbreak.
Narcolepsy is a rare neurological condition that affects the brain’s ability to regulate the normal sleep-wake cycle. This can lead to symptoms such as disturbed night-time sleep, excessive daytime sleepiness and cataplexy – the term given to sudden muscular weakness triggered by strong emotions such as laughter, anger and surprise. As a result, narcolepsy is often thought of as a sleep disorder, but its underlying cause means that it is better classified as a disorder of the central nervous system.
Families denied compensation
British families have been denied compensation from the Department of Work and Pensions under its compensation scheme as the Government does not recognise the condition as a “severe disability”.
Representatives of national narcolepsy groups from the UK, Ireland, Sweden, Finland, Denmark and Norway, and parents of affected children, met Vytenis Andriukaiti, EU commissioner for health and food safety, in Brussels in December.
They pressed him for recognition of the incident, and a public inquiry into lessons learnt for future pandemics. The group also called for the introduction of vaccine injury compensation standards across the EU, as there is a wide disparity in statutory vaccine injury compensation methods. They also called for clarity surrounding funding for research into treatment.
Unclear how vaccine triggered condition
While the vast majority of Pandemrix recipients had no adverse effects, there are now 1,698 adults and children across Europe registered in the EU database of adverse drug reactions who have developed narcolepsy following use of the H1N1 vaccine. While GlaxoSmithKline (GSK), the maker of Pandemrix, has acknowledged the link, and some patients and their families have been awarded compensation, how the vaccine triggered the condition is unclear.
Peter Todd, a solicitor who represents 88 injured people, compared the situation to the thalidomide scandal of the late 1950s and early 1960s. “Everybody is aware of thalidomide, but I think Pandemrix/narcolepsy is a bigger incident because the EU’s database has 1,698 people registered – and that’s a passive surveillance system,” he told i.
Similar to Thalidomide
“While there were hundreds of cases of birth defects caused by thalidomide, most cases involved shortening of one limb. I know that there were a few cases of multiple limbs shortening, but most cases were one and overall, if you weigh it up, it’s broadly comparable. Yet it doesn’t have the same public recognition.
“It’s now about seven years on from the pandemic and it did take considerable time for the epidemiology of Pandemrix and narcolepsy to become clear – the UK’s study in relation to adults and Pandemrix/narcolepsy was only published earlier this year. While the science is now settled you can’t find any clear acceptance of the incident on any EU or national government website. You can’t point to anything that amounts to official recognition. That’s why recognition from the EU is so important.”
‘Round-the-clock care for my daughter’
Narcolepsy is incurable and sufferers have a lifetime of managing the symptoms. Claire Crisp’s daughter Mathilda is one of the children affected following her swine flu vaccination. She began suffering extreme night-time sleep disturbance within two weeks of the vaccine and subsequently developed cataplexy. Within two months Mathilda, now 10, needed round-the-clock care.
“Mathilda was eventually diagnosed with narcolepsy with cataplexy,” Ms Crisp, 46, told i from the family home in California, where they felt compelled to go to seek help. “What followed was a year of battling for effective treatment whilst Mathilda continued to deteriorate.
“My husband looked for a job in California, which was not in our life plan, but we were desperate as carers, as a family, and convinced that if Mathilda didn’t get the treatment she needed, she would lose her childhood.
“Mathilda’s case was extreme, and extreme measure were needed to rescue her. I did everything I could to give her her life back. It was huge risk as we sold our home [to pay for treatment] and left our families and lives back in the UK. But I could never have lived with myself if I didn’t fight for her.”
Ms Crisp has written a book on her family’s trauma called Waking Mathilda – A Memoir of Childhood Narcolepsy, to be released this spring.
Mr Todd said: “We don’t want to undermine the vaccine or do down [its maker] GSK, but … for those that have been affected, it is quite important to have some kind of official recognition of what happened.”
Interesting story today regarding president elect- Donald Trump. Regardless of your views on Trump (mine are very mixed) he certainly does seem to be causing a stir. I have to agree with him about Big Pharma ‘Getting away with murder’ though. I have been in contact with many people harmed by Big Pharma over the last decade or more, and I have even met and spoken to people who have lost loved ones and friends to Big Pharma.
GSK’s track record on (what we could perhaps call) ‘Corporate Murder’ (or corporate manslaughter) has been well documented over the years.
I cover science and medicine, and believe this is biology’s century.
The drug industry is just wrapping up what looked like an upbeat week here at the J.P. Morgan Healthcare Conference in San Francisco, where all of the healthcare industry’s biggest executives come every year to court investors and negotiate deals. This is the where big mergers are conceived. But now every pharma and biotech executive has a lump in his throat (they’re mostly men). Because of Donald Trump.
Many pharmaceutical executives hoped that because of the Republican Party’s long-term opposition to price controls and love of free markets, a Trump presidency would involve fewer controls on drug prices than a Hillary Clinton one. But at his first press conference today, Trump made it very clear that is not the case. Here’s what he said, via NPR:
I think a lot of industries are going to be coming back. We have to get our drug industry coming back. Our drug industry has been disastrous. They’re leaving left and right. They supply our drugs, but they don’t make them here. To a large extent. And the other thing we have to do is create a new bidding procedures for the drug industry because they’re getting away with murder.
Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there’s very little bidding on drugs. We’re the largest buyer of drugs in the world, and yet we don’t bid properly. And were going to start bidding and were going to save billions of dollars over a period of time.
The “we have to get our drug industry coming back” refers to tax inversions–companies like Mylan, Allergan, and Valeant that have tax domiciles outside the U.S. but operations based here. It also seems to refer to that fact that many drugs are manufactured outside the U.S. So it might sound like a hug, but it’s not. But it’s that second part that will really hurt pharmaceutical companies: the idea that Medicare, the biggest buyer of drugs, will start negotiating drug prices. This is an idea that was popular with Bernie Sanders and Hillary Clinton. It is something drug companies have spent years fighting, because if Medicare has power to insist on a price, they will probably have to pay it.
As with most of Trump’s statements, there is no detail on how this would happen. If Medicare doesn’t have the ability to refuse to offer a medicine, it won’t really be able to lower prices much. Much of Medicare is now run by private sector insurers like Humana or Aetna, who already bid on drugs to get lower prices (this is known as Medicare Advantage). Republicans in Congress may not go along with this. Creating real government bidding on pharmaceuticals could be difficult and tiresome.
Those are details. Donald Trump doesn’t care much for details. The message here is simple and clear:
Donald Trump is going to be a populist president. Pharmaceutical companies are a popular villain. That’s it.
And there are ways Trump could use executive power to hurt drug companies that charge high prices. When Dendreon, a Seattle biotech since bought and sold by Valeant Pharmaceuticals, introduced a cancer drug that cost almost $93,000 in 2010, Medicare put it through a gauntlet called a National Coverage Determination, slowing adoption of the drug. (It flopped.) There are plenty of steps a Medicare administrator motivated by working for an angry Donald Trump could take to hurt a drug company whose price had been deemed too high.
Drug company executives have not been blithely unaware that this might happen. Some have been addressing it publicly. In December, at the Forbes Healthcare Summit, Allergan Chief Executive Brent Saunders announced an expanded patient assistance program to make sure that patients could get access to Allergan medicines for mental illness and infectious disease. He’d also pledged not to take large price increases, limiting Allergan to 10% increases no more than once a year. Here’s what he said about Trump at the time:
I worry today that the pharmaceutical industry has a very false sense of relief or security because of a Trump administration and a Republican Congress. I think we should recognize that the drug pricing issue is a populist issue. Americans are rightfully angry. The fault is not, surely, on the pharmaceutical industry’s shoulders, but we bear that because we make the drugs. We innovate the drugs, and as a result of that, whether we like it or not, or we want to try to explain it or not, we have to deal with it.
To think that President-elect Trump isn’t a populist, that he won’t jump on the next EpiPen scandal and tweet more than Hillary Clinton tweeted, or anybody else, because he’s a prolific tweeter, against any company that does something like that, you’re fooling yourself. I think perhaps the best thing that came out of this election is we have a moment in time to solve it ourselves. Maybe it’s a few months, maybe it’s several months, but we don’t have a lot of time. The next big scandal will revive the debate and probably then some because I think President-elect Trump will be more vicious, more focused on taking down or fighting whoever does something egregious again.
It turns out that Trump didn’t wait for the next egregious drug price increase. He just threw his comments into his first press conference. It doesn’t matter that Gilead Sciences cured hepatitis C, or that vaccines made by Merck and Pfizer and Sanofi keep American kids from dying of meningitis or measles. (In fact, yesterday, Trump said he was considering a commission on autism that might look at the issue of whether vaccines cause the disorder–even though it is settled.) People are mad about drug prices, and they don’t like drug companies, and that makes this a great issue for Trump.
Better yet, it could become a bipartisan issue, one of the few where Democrats will come across the aisle to support change, if anybody can figure out what change is. The pharmaceutical industry has just been thrown in a hole, handed a shovel, and told to dig itself out.
One of the key voices to listen to on this is that of Leonard Schleifer, the founder of Regeneron Pharmaceuticals, a Tarrytown, N.Y., biotechnology company. Regeneron has become a $4.7 billion (sales) company thanks largely to a drug called Eylea, which treats age-related blindness. Schleifer, who is a billionaire because of his Regeneron stake, has become a critic of his peers. Here at the J.P. Morgan meeting, he went off-script during his investor presentation and spent more time talking about drug pricing and the industry’s reputation than about his own company’s finances.
It was a line of discussion that he’d started at the Forbes Healthcare Summit. I asked a panel of pharmaceutical chief executives why the industry is so hated. After the others had answered, Schleifer was literally quivering in his seat. “If you look at the prices of drugs, they have gone up, sometimes double digits twice a year as a very efficient way of increasing profits without coupled to any innovation,” Schleifer said. “It’s ridiculous. It’s no wonder. I hate us also when I see all this stuff.”
Ian Read, the chief executive of Pfizer, disagreed. “The point I want to make is that the total cost of drugs as a percentage of healthcare has not changed in two decades,” Read says. “I don’t know whether you talk about three prices a year, two prices a year, double digits, not double digits. The cost of drugs have not changed as a percentage of healthcare in two decades, so it’s a red herring.”
Schleifer zinged back that drug companies are not “entitled to a fraction of the GDP,” but Read had a point. John Milligan, the chief executive of Gilead, had an even better one when he said, “Let’s talk about the people who are alive.” Gilead was vilified for charging $96,000 a year for Sovaldi, its hepatitis C drug. It didn’t get any credit for the fact that the drug was a cure, and arguably a cost-saving one. But here’s the reality: Schleifer and Saunders are reflecting the popular mood. The arguments Read and Milligan are making are arguments drug companies have been making for years. The pharmaceutical industry used to be one of the most respected in the country but now–maybe because of bad things it’s done, maybe because of a general anti-science sentiment, perhaps because of both–it is one of the least. And those arguments aren’t about to start working in 2017.
There’s no doubt that Trump’s statements are merely an opening salvo, a negotiating position. Things may not be as bad as they sound. It’s also almost certain that Trump and the Republican Congress will put through tax policies that will allow pharmaceutical companies to bring back many billions of dollars in off-shore cash they’ve been protecting from U.S. taxes. The industry is still launching all sorts of innovative products, and these will make money. But for the drug industry as a whole, things just got materially worse.
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.
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.
“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.
Australians crippled and in chronic pain from dye used in toxic X-rays
Sue Dunlevy, National Health Reporter, News Corp Australia Network
December 10, 2016 11:02am
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.
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.
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.
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.
“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.
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.”
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.
“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”.
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.
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.
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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.’
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.
Texas, other states reach $105 million agreement with pharmaceutical maker
News release | Posted Jun 4, 2014
AUSTIN – Texas Attorney General Greg Abbott and 43 other state attorneys general today secured a $105 million agreement with drug maker GlaxoSmithKline, LLC (GSK), Abbott’s office stated in a release.
The agreement resolves a multi-state investigation against GSK for “unlawfully promoting its asthma drug Advair and its antidepressant drugs Paxil and Wellbutrin,” the release stated.
Under the settlement agreement, GlaxoSmithKline must pay the state of Texas a total of $6.2 million. According to the states’ investigation, GSK violated state consumer protection law by misrepresenting the uses and qualities of Wellbutrin, Paxil and Advair. State and federal law generally prohibits pharmaceutical manufacturers from marketing their drugs for “off-label” uses that have not been approved by the U.S. Food and Drug Administration.
Among its terms, today’s judgment prohibits GlaxoSmithKline from the following actions:
Making false, misleading, or deceptive claims about any GSK product;
Promoting or distributing information describing any off-label use for a GSK product;
Representing in promotional materials that a GSK product is better, more effective, safer, or has less serious side effects than has been demonstrated by substantial evidence or substantial clinical experience;
Presenting favorable information or conclusions in promotional materials about a GSK product from a clinical study that is inadequate in design, scope, or conduct; and
Providing GSK product samples to health care professionals who would be expected to prescribe the sampled product for an “off-label” use – rather than for an FDA-approved use.
“To the benefit of patients, today’s judgment also confirms a major change in the way pharmaceutical sales teams are motivated and compensated,” the release stated. “Under the terms of today’s agreement, GlaxoSmithKline is required to continue its ‘Patients First’ program at least through March 2019.”
The “Patients First” program reduces financial incentives for sales representatives to engage in deceptive marketing, the release stated. Scientifically trained personnel must develop and approve unbiased and non-promotional responses to health care provider questions.
Oregon and Illinois led the Executive Committee, which included attorneys general from Texas, Arizona, Florida, Maryland, Pennsylvania, and Tennessee.
Additional states participating in the agreement are Alabama, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming.
Solicitor’s legal challenge against GlaxoSmithKline can continue
Myodil spine injury claim can proceed after High Court limitation ruling
22 December 2016
A 59 year old solicitor, Keith Lewin, has succeeded in the latest stage of his seven figure legal claim against Glaxo Operations UK Limited (part of the corporate structure of the pharmaceutical company GlaxoSmithKline) who he believes is responsible for the illness that has left him a wheelchair user.
Mr Lewin is suing Glaxo Operations UK Limited (part of the corporate structure of GlaxoSmithKline) for a seven figure sum arising out of his exposure to Myodil, an oil based contrast medium, which was injected into his spine in 1973 when he underwent a diagnostic Myelogram procedure to investigate back pain as a 15 year old.
It is alleged that his exposure to Myodil caused him to develop the spinal condition known as adhesive arachnoiditis which is a serious inflammatory condition of the spinal cord. Mr Lewin is now severely, permanently disabled. He requires the use of a motorised wheelchair in order to mobilise.
Mr Lewin alleges that the Defendant (the successor of Glaxo Laboratories Limited) was negligent in respect of the manufacture, supply and use of Myodil.
Myodil was used as an oil-based contrast agent in the imaging of spines of patients with back pain in the United Kingdom from the 1940s until its product licence expired in 1987.
There was previous UK Group Litigation brought by a large number of other Claimants (eventually 426) in negligence against Glaxo in the early 1990s arising out of their alleged exposure to Myodil. That litigation settled in July 1995 for the sum of £7 million without an admission of liability.
Glaxo argued that Mr Lewin’s claim was time barred and should not be allowed to continue. They say that he should have been put on a train of enquiry in the late 1970s or early 1990s which would have led him to make a legal claim much earlier.
Mr Lewin argued that it was not until 2012 that he was diagnosed with adhesive arachnoiditis before he underwent exploratory spinal surgery known as a laminectomy. It was submitted that even if the Court were to deem that his claim had been brought outside the three year statutory limitation period, it would still be equitable to allow the claim to proceed.
Mr Justice Goss handed down his judgment on 20 December 2016 in the High Court ruling that Mr Lewin’s claim was brought within the legal time limit, and that he would allow the claim to continue.
Leigh Day product liability solicitor Jill Paterson said:
“My client is very pleased that his spinal injury claim is allowed to proceed. He suffers with constant debilitating pain and has to use a wheelchair. His life has been significantly affected”.
As 2016 came to a close, the death of singer George Michael made headline news across the world. Post-mortem results have been- thus far- inconclusive. However similar to the other celebrity deaths in recent times, it seems a lot of these cases usually involve multiple uses of prescriptions drugs over long periods of time – something termed- Polypharmacy.
George Michael’s erratic behavior has been well documented over the years, as has his experiences of depression, and anti-depressants too…
“…Chawla said the singer – who had used prescription medication to deal with his anxiety, depression and insomnia over a long period – had attempted to wean himself off drugs in March this year. He had some success, but later found “the feelings of anxiety and insomnia appeared to have redoubled”…”
He told police after his arrest:
“I’m so ashamed of it. It is so ridiculously dangerous and that is why I have stayed away from them [the antidepressants], even though I still have insomnia and I had some anxiety.” He had only started taking the drug recently, he said, adding: “They are a recent thing, and it’s taken me a whole week to fuck up again.”
“…He went on a diet of Prozac and cannabis. The Prozac made his head even worse, he says. “At first you’re flying about, snapping at people one minute, really happy the next, and I made some disastrous business decisions,” he said….
The Press and the public, still largely seem to think, that just because medication for depression is available for prescription that it must be safe. The fact that anti-depressants legally prescribed (by a doctor) gives these drugs an aura of legitimacy which illegal drugs don’t have.
However, often prescribed drugs (such as SSRI- anti-depressants, Benzos, etc) can induce horrific side effects and withdrawal symptoms, and they can also be just as dangerous as any illegal drugs (if not more so- in some instances).
The polypharmacy induced deaths and shortened life-spans of celebrities highlights the generally dangerous and irresponsible prescribing habits of many doctors. Of course medication induced deaths, injury, disability and shortened lifespans/quality of life etc – has been happening to the general public, as well, for decades.
Robert Whitakers ‘Anatomy of an epidemic’ is essential reading in this regard.
In Whitakers award winning book- he describes how psychiatric patients’ lives are considerably blighted by the drugs they are prescribed…
It will be interesting to see what they have been prescribing George Michael all these years..
Unfortunately it’s likely his death is linked to the polypharmacy prescribing habits of many celebrity doctors nowadays..
“….India, where a lot of clinical trials have already begun, is likely to get a breakthrough anti-malarial drug Tafenoquine by 2018. The drug, a one-day two-dose treatment, has already entered phase-three trials and once approved will replace the current 14-day treatment for plasmodium vivax malaria, which is prevalent in India…’
“…Many of them have since suffered an illness classified as an Acquired Brain Injury. There is sturdy scientific proof that ABI can occur after treatment with mefloquine. Scientists from the US military research institute that developed the drugs found that mefloquine was able to cause a “lasting or permanent” brain injury. Other scientists at the same institute found tafenoquine, an experimental drug that has not been registered for sale anywhere in the world, “is more neurotoxic than mefloquine”….
The anti-malarial drug trial scandal that has embroiled the Australian Defence Force for the last two years simply won’t go away, despite the government’s best efforts to whitewash the controversy with a flawed “military justice” inquiry.
There are growing calls for a public inquiry to investigate ethical breaches which occurred during a series of Army Malaria Institute (AMI) clinical trials conducted in Bougainville and Timor Leste from 1999 to 2002.
The drugs in question are mefloquine, a neurotoxicant able to cause a “lasting or permanent” brain injury in a sizeable minority of users, and the experimental drug tafenoquine. The latter was found to be “more neurotoxic than mefloquine” by scientists from the US military research institute which developed both drugs.
Tafenoquine was given to more than 1,500 ADF personnel during these trials, while mefloquine was used on 1,300 personnel. Mefloquine has probably been given to an additional 2,000 personnel since its introduction in the early 1990s.
Hundreds of Australian veterans have since been diagnosed with serious neurological and psychiatric disorders, often mistaken for post-traumatic stress disorder. Many maintain they were compelled to participate in the trials. The Department of Veterans Affairs (DVA) has belatedly launched a health outreach program, admitting that the first cases “could be the tip of the iceberg”.
Media attention has to date focused on the health concerns of those affected and the ethical question of whether the subjects provided fully informed consent.
Yet a deeper question is emerging, namely a fundamental conflict between the commercial interests of the pharmaceutical industry and the public interests of the ADF. This could even result in criminal charges against ADF medical officials who conducted the trials and now hold senior military appointments.
How could the ADF leadership have allowed this to happen?
Mefloquine and tafenoquine are both products of the US Walter Reed Army Institute of Research (WRAIR) anti-malarial drug discovery program which commenced during the Vietnam War. The results of early military tests of mefloquine were given to the manufacturer Roche in one of the first public-private partnerships of its kind. These questionable results were then used to shortcut the approvals process by the US Food and Drug Administration (FDA) and other regulators.
By the late 1990s mefloquine was well known for its serious side effects and fell out of favour to the extent it is no longer manufactured by Roche in many countries. Linked to numerous war crimes, murders and suicides over the last 15 years, mefloquine is now banned or regarded as a drug of last resort.
Tafenoquine is already repeating this tragic history, with the direct involvement of WRAIR and the closely affiliated AMI.
The ADF’s deployments to Bougainville and Timor Leste provided an ideal opportunity for AMI and WRAIR to conduct large-scale drug trials on a captive pool of “volunteers”. Tafenoquine and mefloquine were tested on almost every battalion of the Royal Australian Regiment. The results of several of these trials have not been published, presumably because they were unfavourable.
Of the reports that were published, none commented on the serious adverse effects that emerged from the trials. One report that was published found there was “no statistical difference” between tafenoquine and mefloquine in the rate of neurological and psychiatric side effects. Many of the subjects are to this day admitted to psychiatric hospitals or have subsequently suicided — yet the ADF has refused to conduct follow up health studies.
A co-author of the published study has been stonewalling the proposed outreach program for years. Recently, he falsely informed doctorsinvolved in the outreach program that there were “no recorded neuropsychiatric side effects” from tafenoquine; contrary to his original report which found one in eight of his subjects experienced such side effects.
The results of this trial were re-analysed in a 2014 paper co-authored by the current Director of AMI to find that tafenoquine is 100% effective in preventing malaria. The lead author of this paper is a former WRAIR employee who now owns a niche pharmaceutical company awarded a contract by the US Army to develop the drug for registration with both the FDA and the Australian Therapeutic Goods Administration. Should the FDA approve, his company would be given a tradeable “priority review voucher” worth several hundred million dollars.
In the 1990s the Canadian government responded to a similar scandal involving an unlawful mefloquine drug trial on peacekeeping troops in Somalia by disbanding the regiment that was subjected to the experiment.
On the evidence already publicly available, a more appropriate response from the Australian government would be to disband AMI and prohibit the conduct of clinical drug trials on ADF personnel deployed on military operations. The ADF is clearly incapable of providing the corporate oversight needed to protect the interests of its troops against those of the pharmaceutical industry.
Townsville veterans angry over lack of consultation for adverse effects of antimalarial drug trials
December 6, 2016 12:00am
VETERANS who believe they have been adversely affected by Defence-sanctioned antimalarial drug trials are angry they were not consulted about the delivery of an urgent “outreach program”.
Official letters about the program only began circulating yesterday after the Bulletin revealed last week an outreach program was to be held in Townsville next week for former ADF members and others concerned about mefloquine or tafenoquine.
The Department of Veterans’ Affairs told the Bulletin it also planned to begin an advertising campaign for the program from today.
Melbourne-based veteran Michael Kruizinga said he was given tafenoquine after contracting malaria on the drug Doxycycline before being given mefloquine on a second tour of East Timor.
He recently helped organise a health forum in Melbourne and said people there were desperate for help and would have liked to be consulted on a possible program.
“It’s absolutely pathetic the way the Government has played this because this program is absolutely necessary,” he said. “Groups have been pushing for this outreach program and it seems they’ve just rushed it through to get us off their backs.”
DVA said the concept for the outreach was developed by the DVA-Defence Links steering committee.
“All material that is provided to attendees of the outreach program will be available online, supplementing current information on both DVA and Defence websites,” a DVA spokesman said.
“This will include the names of Townsville-based GPs who are currently known to DVA as being able to assist individuals who may present with symptoms or conditions that they attribute to having taken mefloquine while in the ADF.”
Six sessions are being offered and can accommodate about 50 attendees at the Townsville VAN Office.
“The Townsville outreach sessions will be evaluated and this will help inform the Government as to what additional steps should be taken to assist veterans with concerns,” the spokesman said.
Retried colonel Ray Martin said the Government made an election commitment to set up an open dialogue, but he believed this had not occurred.
“To announce a program with little notice, when many are unavailable, away or on leave, without consultation, input or feedback — from those most affected is very disappointing,” he said.
WHEN you sign up to fight for your country, you accept you have to put your life on the line. In recent years, scores of those who have served in dangerous or inhospitable places haven’t made it home. To them we are grateful.
Those such as the 41 who were killed in 14 years of the Afghanistan War, faced traditional opponents. That enemy carried weapons. They laid roadside bombs. And the horrors of what many experience last well beyond deployment and into an unsettled civilian life. Many, as revealed by government figures last week, have taken their own lives.
But PTSD isn’t the only hazard that can cause impairment in our Australian veterans. Since the late 1980s, 5000 personnel were administered two antimalarial drugs — mefloquine and the experimental tafenoquine — when sent on military service in countries with a malaria risk.
Many of them have since suffered an illness classified as an Acquired Brain Injury. There is sturdy scientific proof that ABI can occur after treatment with mefloquine. Scientists from the US military research institute that developed the drugs found that mefloquine was able to cause a “lasting or permanent” brain injury. Other scientists at the same institute found tafenoquine, an experimental drug that has not been registered for sale anywhere in the world, “is more neurotoxic than mefloquine”.
Prime Minister Malcolm Turnbull said in August, on the evidence of an alarming veteran suicide rate, that “we have to go beyond the memorials and the monuments and focus on the men and women, the real challenges they face, ensuring that they are supported”. This week, Veterans’ Affairs Minister Dan Tehan and Health Minister Sussan Ley are expected to launch the government’s veteran suicide prevention initiative. With more than 60 veterans having taken their own lives this year, this response is welcome.
Turnbull’s words are encouraging, but there is a glaring omission from his government’s response thus far — an outreach and treatment program for veterans affected by exposure to mefloquine and tafenoquine. Although Defence has recognised that mefloquine can have long-term health effects, Defence and Veterans’ Affairs have initiated no consultation to ensure the advice they are providing to those affected is suitable. Yet Australian veterans who suffer serious, chronic illness since their exposure to the drugs are in the hundreds.
Difficulties in correctly diagnosing this type of brain injury have meant that few of those affected have been able to access the appropriate rehabilitation, medical and other support services. Most who have sought medical help have been diagnosed and medicated for PTSD or other mental illnesses without having been referred to brain injury specialists. That misdiagnosis has led to further disabling drug reactions, family breakdowns, homelessness and suicide.
During this year’s election, the government committed to formal consultation with affected veterans and their families to address these concerns. Despite news of an “outreach” event in Townsville this month, the consultation has not happened. Discussions with senior Veterans’ Affairs medical officers indicated that “consultation was not required”. Meanwhile, Defence and Veterans’ Affairs officials have trivialised the nature and extent of the problems, unfairly suggesting those affected are exaggerating or inventing their symptoms.
The numerous diagnoses of bipolar disorder, schizophrenia, major depression and anxiety, seizures, hallucinations and psychosis, suicide attempts and suicide indicate this is a serious issue. Equally serious steps need to be taken by the government to embrace those suffering and give them suitable assistance.
Providing the right assistance is not hard. There are existing ABI outreach and rehabilitation programs available in every state that receive significant federal funding. Indeed, some fortunate veterans who have persisted to obtain the right treatment are already receiving those services. Sadly, these are in single figures.
If Turnbull is serious about addressing veteran suicides — and there is no reason to believe he isn’t — he should now direct both ministers to make those programs available to all veterans who were exposed to these neurotoxic drugs during their service to the country.
Stuart McCarthy is an army officer who served in Afghanistan, Iraq, Ethiopia and Eritrea and Bougainville. He is undergoing rehabilitation for an acquired brain injury after being exposed to mefloquine and tafenoquine
Documents obtained by Fairfax Media reveal the Therapeutic Goods Administration wrote to senior doctors at the Balmoral Naval Hospital in Sydney to warn they had no authority to acquire or use the drug under existing arrangements.
Six months later, the hospital received 13 capsules of tafenoquine from pharmaceutical giant GlaxoSmithKline to use on a 26-year-old on the condition it would not be held responsible for side-effects.
The company urged the doctors to contact US Army Medical Research and Materiel Command within 24 hours of serious or unexpected reactions by soldiers. It also told doctors to supply detailed records of patient history and health outcomes.
Tafenoquine remains banned in Australia and has been linked to blood cell damage and anaemia. Common side effects include nausea, vomiting, diarrhoea, headaches and eye disease. It was trialled on 461 ADF personnel as part of a clinical trial in East Timor during 2000-01.
A Department of Defence spokesman said the TGA warning related to the treatment of soldiers with recurrent malaria rather than the clinical trials. But correspondence reveals Australia’s drug regulator did not shy from expressing concern about the drug.
Military doctors were initially granted full access to tafenoquine although this was overruled once the TGA realised the doctors would not comply with relevant safety regulations.
The letter, sent by the TGA’s director of drug safety Dr Leonie Hunt, told doctors they were not authorised to use the drug outside a controlled clinical environment and without the approval of a hospital ethics committee.
“It has been brought to my attention that you do not satisfy these requirements and therefore the authorisation should not have been issued,” Dr Hunt said.
“Accordingly you are no longer authorised to supply or prescribe tafenoquine for use in defence personnel for the treatment of recurrent vivax malaria.”
According to the Department of Defence, the warning was the result of “an administrative error” caused when military doctors applied for the drug under the wrong subsection of the relevant act.
The doctors were eventually granted the drug for “compassionate use” under a special access scheme that judged patient needs on a case-by-case basis. Another 30 ADF personnel were treated under the scheme after a spike in malaria cases during 2001-02.
A TGA spokeswoman said the only way to acquire the dug remained the special access scheme.
“Were the TGA to become aware that unregistered products were being supplied without obtaining appropriate exemption, the matter would be investigated,” she said.
GlaxoSmithKline told the military doctors all patients needed to be provided with information about the drug including alternative options. Written consent forms were also required.
“An integral component and condition of approval for supply of an experimental drug is the documentation of safety and efficacy data,” the letter said.
“It is extremely important that we, as the manufacturers of tafenoquine, obtain detailed information regarding treatment and we ask for your co-operation to document details of patient history and therapeutic outcome.”
Patient outcomes were recorded by military doctors at the Australian Army Malaria Institute and published in the American Journal of Tropical Medicine and Hygiene in 2007.
According to the journal article, the authors were full-time ADF employees and received funding from GlaxoSmithKline to present their findings. They insist no other potential conflicts of interest existed.
Andrew George, a former infantry soldier and public relations officer with the Army Reserve, was treated with tafenoquine in Sydney and claims it left him with damaging side effects.
Mr George, who features in promotional material for the reserves, said he was given the drug after being diagnosed with malaria but does not recall giving informed consent after a detailed explanation of the drug.
He is one of many veterans seeking answers about the drugs with many believing it complicated their diagnosis and management of post-traumatic stress-disorder.
“I am still proud of my service,” he said. “I am proud to have done what my dad did – a Vietnam veteran,” Mr George said.
Australian Defence Medical Ethics Committee documents, released late last year under freedom of information laws, showed the ADF was concerned about whether the trials were properly explained to soldiers.
“It would be preferable to have all information conveyed openly and honestly to every member involved in current and previous tafenoquine trials,” the document said. “This will markedly reduce the risk of a perceived cover-up”
Since the release of the document, the Department of Defence has made a catalogue of information about the trials and the drug available for veterans online.
Surgeon General of the ADF, Air Vice-Marshal Tracy Smart, has also met with veterans at a community event in Townsville and insisted the military was being transparent as possible.
Last month, a senate committee called on the Australian Defence Force to explain all potentially damaging side effects of the antimalarial drugs to every veteran or soldier who has taken them since 2001.
Defence force admits soldier shouldn’t have been included in East Timor anti-malaria drug trial
The Australian Defence Force has acknowledged it accidentally exposed one of its soldiers to controversial anti-malarial drugs during trials in East Timor, despite the soldier having a medical history of mental illness which should have precluded his involvement.
ADF apologises for including soldier Chris Salter in anti-malarial drug trial in East Timor
Mr Salter should have been precluded from trial due to history of mental illness
First time ADF has publicly accepted it made mistakes during Timor drug trials
The soldier, Chris Salter, developed chronic depression and psychosis after inclusion in the Timor trials of psychoactive drugs mefloquine and tafenoquine.
His illness has led to repeated suicide attempts and more than a dozen stays in psychiatric hospitals. He is unable to work or care for his family.
Since the trials, which included thousands of Australian soldiers between 2001 and 2003, a small group of veterans have developed severe mental illnesses.
They believe the ADF erred by giving them the drugs even though there was a significant body of research which pointed to the drugs’ side effects, which in some cases are permanent.
The letter to Mr Salter is the first public case of the ADF accepting it made mistakes during the Timor drug trials. It may open the way for other veterans to seek similar apologies and could lead to compensation.
“Following the disclosure by your wife on the 7.30 Report (sic) in June that you were prescribed mefloquine despite a history of depression, I determined that I should conduct a review of your medical documents,” the ADF’s Surgeon-General, Tracy Smart, wrote in a letter late last month.
In that same letter Air Vice Marshal Smart wrote: “I apologise on behalf of Defence that you were prescribed mefloquine given your history of depression. This represented an unacceptable risk.”
Ms Salter has become a vocal critic of Defence, and says the ADF has failed to provide assistance to people who are suffering chronic illness as a result of taking the drugs.
After her husband received his letter she asked people in a mefloquine and tafenoquine support group on Facebook whether anyone had a similar experience.
“I’ve had three or four responses of people who’ve come back and said yes, they were diagnosed with depression and didn’t have a medical to see whether they were eligible [for inclusion in the drug trials],” Ms Salter told 7.30.
All those veterans could be eligible for formal apologies and compensation.
The high stakes of Ms Salter’s campaign for recognition were highlighted two weeks ago, when one of the Timor veterans, Chris Stiles, took his life.
Since then a group of mefloquine and tafenoquine-affected veterans in Townsville have told 7.30 of their anger over the death of Mr Stiles, who was given the drugs and experienced a significant downturn in his mental health.
“It’s happening to a lot of people, it’s not just Chris. Chris is just the latest one, and it will continue happening,” said one of Mr Stiles’s Timor colleagues, Colin Brock.
The veterans say Defence and the Department of Veterans Affairs have failed to provide meaningful assistance and have left many who served in East Timor to shoulder the burden of mental and physical illness caused or exacerbated by the drugs on their own.
Defence has been approached for a response.
Banned or limited by other militaries around the world
Mr Brock helped carry Mr Stiles’s coffin to his grave a week ago. He was one of two of the pallbearers who were given the drugs in Timor and have since developed mental illnesses that have seen them admitted to psychiatric hospital suffering a host of mental and physical symptoms.
Mefloquine — also known as Lariam — and tafenoquine are psychoactive anti-malarials that, according to the World Health Organisation and neurological researchers, have a history of links to severe depression, anxiety, irrational anger, memory loss, suicidal thoughts, psychosis and hallucinations.
Across the world militaries are seeking to ban or limit the use of the drugs, given serious concerns about their side effects.
In 2013 US special operations forces banned the drugs after the Food and Drug Administration issued its highest alert — a so-called “black box” warning.
“Neurologic side effects can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent,” the FDA said.
Last year a UK parliamentary inquiry found the Ministry of Defence prescribed the drug too liberally and recommended it be redesignated as a “drug of last resort”.
The ADF’s Inspector-General has launched an inquiry into the East Timor drug trials. He is due to report by the end of this year.
Defence has so far refused to commit to reporting publicly.
GlaxoSmithKline – The company that keeps on giving.
Glaxo have been dealth yet another blow in the Paxil suicide case filed by Wendy Dolin over 5 years ago.
To date Glaxo have made endless requests that have been denied by the Judge, they have tried to get expert witnesses barred from giving evidence and even wanted to hold their own kangaroo court for one of Dolin’s witnesses, David Healy – once again they were denied.
Their latest attempt is, or was, a wonderful attempt at skullduggery. It defies belief that they would try to even go down this particular route but, I guess, they have exhausted every possible line of trickery and manipulation so one final attempt before trial commences shouldn’t really come as a surprise to those who know exactly how Glaxo and their highly paid law team, King & Spalding, like to operate.
Some time ago Glaxo were informed by the Judge that they should not try to blind the jury in this case with irrelevant documents. The jury just need to know the facts and endless documents would just confuse them. So, what did Glaxo do on the back of this request from the Judge? Well, they submitted a 170 page exhibit list with roughly 1,500 proposed defense trial exhibits – so, no attempt at burying the jury in paper, right? (See Judge Backs Widow’s Objection To GSK Trial Documents)
The documents are hundreds of pages long and, according to Dolin, if printed out would fill more than 20 bankers’boxes.
Wendy Dolin, through her law team, Baum Hedlund Aristei & Goldman PC, objected to the mountain of paperwork and the Judge, U.S. District Judge William T. Hart, has sustained her objections, leaving Glaxo and King & Spalding with their tails between their legs and having to spend Christmas with the knowledge that they cannot dupe the Judge or jury in this case.
Better luck next time folks (I’m sure there will be another Paxil related suicide case to defend)
Furthermore, GSK objected to evidence being presented to the jury by Dolin, namely, correspondence between Glaxo and the FDA. The Judge denied them this and many other objections they had filed regarding Dolin’s evidence to be presented – (Boo-hoo)
The antics of Glaxo and their crispy white shirts has prompted yet another ditty from yours truly. I hope Glaxo and King & Spalding enjoy this latest offering.
I trust in you, O' Lord, my Savior, the One who died and rose again…. the One who brought me in and will carry me out, the Almighty waters and tides that bring us life. I come to You when there is no where else to turn, I come to You when there is. I look to You as my guiding Light, my Savior…. the One who created all I see- created my life and dreams before I knew myself~ created my talents and style before I knew the value~ I praise You and adore Your mystery. I will be strong and conquer as You would want for me. I beg of your blessings and miracles even though I am unworthy of Your power…. Yet, I trust in You~ and know You have already begun Your work. I love You. I don't know if that is a good enough word, "love"~ But I know You on a level---beyond words. Save me Lord. I will not let go of You. Hear me O' Lord. In Christ's Powerful Name Amen ~ By Brandon Heath