Rejecting Afghanistan’s Gift – Part One

Niaz Mohammad Hussaini worked for the Canadian Forces as an interpreter during the war, at great risk to himself and his family. When he needed Canada the most, he was turned away.

Afghan interpreter for Canada during Afghanistan war denied entry into Canada

https://www.cheknews.ca/afghan-interpreter-for-canada-during-afghanistan-war-denied-entry-into-canada-565594/?fbclid=IwAR0IO3Ung8K3Q9Qg9DBIR-Qpa9EkyADSlhuM5m4RBUu1Ft8bvbKtvyVpok8

On June 7th, Niaz Hussaini landed in Victoria, British Columbia aboard a flight from his home in California. He was coming to visit his friend Canadian veteran Sgt.(ret.) Mike Rude. Once inside the airport however he was informed that he would not be allowed into the country. The reason: last minute arrangements and a lack of time to process his paperwork.

This was not this first time Canada had refused entry to Niaz. In 2011 Niaz was working as an interpreter for the Canadian Forces in Kandahar, Afghanistan when he applied to come to Canada under a program that began in late 2009. In February, 2011, one month before the Canadian mission in Afghanistan came to an end, Niaz was fired, being told he was a danger to the mission.

Afghan interpreters have high hopes for relocation plan

https://www.ctvnews.ca/afghan-interpreters-have-high-hopes-for-relocation-plan-1.436244

This is the story of Niaz Hussaini, an interpreter from Afghanistan who lost both legs below the knee in an explosion while working for the Canadian military in Kandahar. It gives us a glimpse into the life of the “average” Afghani family, and shows how people and families everywhere are all very much alike.

In order to give this piece some context, I will provide you with a brief overview of the history and politics af Afghanistan. Like every TV sports color analyst has said at least once, you don’t know who the players are without a program.

Afghanistan

Image result for afghanistan 1986 public domain image

The story of today’s Afghanistan goes back to 1955 when the Soviet Union granted a request from the prime minister, Prince Mohammad Daoud. for military aid. This would come shortly after the United States had rejected a similar request from Daoud.

Close ties developed between Afghanistan and the Soviet Union, and in 1956 Soviet influence became evident when women began to enter to workforce and the government. In 1965 the Afghan Communist Party was formed and in 1973 Daoud Khan and the Afghan Communist Party head up a successful military coup. The Republic of Afghanistan is established after Khan abolishes the monarchy and declares himself president.

Khan would himself be killed in a coup in 1978, the victim of a plot within the Communist Party itself. The new president, Babrak Karmal, then signed a treaty of friendship with the Soviet Union. Shortly after this came the birth of the mujahideen (plural of “those at jihad”), the resistance movement that would go on to face the Soviets after they invaded Afghanistan in 1979, in an effort to keep the communist regime propped up.

The enemy of my enemy is my friend

During the time of the Cold War, the Soviets were enemy number one in the eyes of the United States. They were the only enemy really, so stopping them wherever they ventured in the world was a key concern for the U.S., in order to keep the communist threat at bay.

This would lead to a number of proxy wars between the two superpowers over the years,with the war in Afghanistan being the final one. It would come to be known as “Russia’s Vietnam”, as the Soviets began to suffer heavy losses against the guerilla army, and would contribute to the ultimate downfall of the U.S.S.R..

The mujahideen were fighters that came from all over Afghanistan, drawn together in jihad to remove the infidel communists from the country once and for all. Men from different tribal areas would fight together with a single purpose in mind. Although passionate, these fighters were poorly trained, lightly equipped, had no combat experience, and had no leadership.

The United States would support the mujahideen by providing weapons and training through the CIA, with the Stinger anti-aircraft missile becoming valuable asset in their arsenal much to the dismay of Soviet pilots.

The CIA was also funding a program called “Operation Cyclone”, which began to train a group of mujahideen in neighbouring Peshawar, Pakistan. One of the men involved was a young Saudi who was the heir to his family’s construction empire, Osama bin Laden. After the Soviets had left Afghanistan for good, he would go on to form the terrorist organization Al Qaeda, which is Arabic for “The Base”.

Map of Afghanistan

Niaz Mohammad Hussaini

Niaz Mohammad Hussaini was born in 1986, in a village near Lashkargah in Helmand province to a police officer father and a mother who was a full-time homemaker. His father, Mohammad Hussain Andiwal, is a retired police officer with 45 years of proud and honourable service to his country.

His father is a man not unlike many you will find in countries around the world, a man who does what he does for the betterment of the society he lives in. He wasn’t driven by ideology or creed, but instead by the universal notion of justice and the rule of law and order within a society. He was just an average guy who wanted to live his life and raise a family, things that men from countries around the world can relate to.

He wouldn’t be allowed this however. When Niaz was about a year old, the mujahideen attempted to assassinate his father by planting a bomb at their front door. Instead of killing Andiwal, the blast took the life of his firstborn (Niaz’ older brother), and severely injured his second child (Niaz’ older sister).

For Niaz’ mother, the blast would prove to be devastating psychologically, and its impact would become apparent. Not so for Niaz’ father, as Mohammad Andiwal would do what his culture demanded of him by not openly expressing his feelings.

After the Soviets Pulled Out

The last Soviet troops in Afghanistan pulled out in early 1989 and the country was in the control of a group of mujahideen. It wasn’t long before fighting had started to break out among the various factions, and Afghanistan would descend into a chaotic free for all between competing warlords.

Going into the early ’90’s, Niaz and his family were able to live comfortably by Afghani standards because of his father’s position within the government of the day. This would essentially mean having enough food to eat and water to drink for the entire family. It was by no means lavish, but their essential needs were met, which could not be said of all Afghanis.

The civil war would eventually make its way into Helmand, and the invading mujahideen ransacked the provincial capital of Lashkar Gah. All the schools were shut down, they killed every government employee within sight, and set alight every piece of government property that would catch fire.

Nimruz province.

Shortly after the mujahideen took control of Helmand, the family moved west to neighboring Nimruz province. There, Niaz’ father would open a grocery store and once again be able to provide a comfortable life for his family. They would be there for three years when malaria, which had been on the rise in Nimruz, would force the family to separate. While Niaz and his father stayed in Nimruz to earn money, the rest of the family moved back to Helmand where they would have greater access to a physician and adequate medications to treat malaria, things that were not available in Nimruz.

Hated by everyone.

https://upload.wikimedia.org/wikipedia/commons/b/bb/US_Army_ethnolinguistic_map_of_Afghanistan_–_circa_2001-09.jpg

A number of different ethnic groups live in Afghanistan, speaking a number of different languages. The 2004 Afghanistan constitution recognizes fourteen different ethnic groups that speak ten different languages.

https://www.cia.gov/library/publications/the-world-factbook/geos/af.html

The largest of these groups is Pashtun, who are “ethnic” Afghani’s. The country gets its name from the Persian for “Place of the Pashtuns”. According to estimates, the Pashtun make up approximately 48% of the population of Afghanistan, which is thought to be about 38 million by the U.N.

http://worldpopulationreview.com/countries/afghanistan-population/

Things in Nimruz had become difficult for Mohammad Hussain Andiwal after his family returned to Helmand. By this time the Taliban had taken control of most of the country, including Nimruz. The Taliban hated him because he had worked under the former communist government at the time the Soviets invaded, and so they viewed him as a communist and a kafir (an infidel). The mujahideen (who were fighting the Taliban) also wanted him dead for the same reasons, on top of the fact that Mohammad Andiwal was Pashtun, and the majority of mujahideen in Nimruz were not Pashtun. There were very few places that were safe for him, and so eventually father and son also went back to Helmand province.

Finally reunited the family once again began to work their farm, earning money from the milk, yogurt, and butter their livestock provided to help care for one of Niaz’s younger sisters who was recovering from malaria. She had required surgery as a result of it and was left with intestinal problems. At around that time Niaz started working as a tailor’s apprentice to earn money to buy bread for his family.

Arrested By The Taliban.

Image result for mullah mohammed omar
Taliban leader Mullah Mohammad Omar, believed to have died from TB in 2013

There were few places in Afghanistan that Mohammad Andiwal would be safe, including Helmand, and the Taliban would ultimately get their hands on him, arresting him for the usual reasons. He was accused of being a communist and an infidel and was thrown into prison where he was beaten and tortured on a daily basis and frequently deprived of food and water. This went on for a month until Niaz was able to sell their farm, livestock, and most of their possessions to secure his father’s release from his cruel captors.

Andiwal was in bad shape, but his family feared that he might disappear if he was taken to a hospital. So, he was treated at home, and Niaz became the sole breadwinner for his family. He attended school for a couple hours in the morning, skipping many days, then headed to the tailor shop to work until sunset. After sunset he worked at a construction job that a friend of his father’s got him. For the next 2 years, he would get whatever work he could find, seasonal, day labour, tailoring, pretty much anything that would allow him to earn a wage to support his family, and give him a sense of honor and pride.

The Taliban Are Forced Out

Niaz had graduated high school around the time the Taliban regime was being removed by the U.S. in the wake of September 11th. He began working for the Helmand province Directorate of Agriculture, Livestock, and Irrigation, and his father had once again joined the ranks of the police force, serving as the education officer at police headquarters. Andiwal would later work for the Interior Ministry in the Kandahar Provincial Reconstruction Team (KPRT) and it was then that he was able to convince his son to become a police officer.

In 2004, impressed by his command of English, members of the PRT approached Niaz as he went to attend the police academy in Kandahar and not long after, he was extended an invitation to work as a translator by the PRT commander. Later that year he would go to Kandahar to apply for a job as a translator with the Provincial Reconstruction Team and would soon after be working for them.

In 2005 Canada took over the PRT and requested that the translators stay behind instead of moving on with the American troops. Niaz and the rest accepted the offers and they all signed contracts with the Canadian forces.

For Niaz Hussaini, life would never be the same.

To be continued……

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Exclusive: International Fraud, Corruption Scandal Brewing

Current, former ADF members implicated.

Pharmaceutical concerns on two continents involved. Fraudulent studies used to obtain regulatory approvals.

Hundreds of millions of dollars, tens of thousands of lives at stake.

An investigation has revealed that a massive fraud and corruption scandal could soon erupt in Australia and North America. At issue is the recently approved anti-malarial drug tafenoquine, as evidence shows that regulatory processes were obfuscated and the drug was approved under fraudulent circumstances. Many of the people involved are current or former members of the Australian Defense Forces as well as at least one former member of the United States Army. The people implicated have had or currently occupy senior positions in the ADF, and could go even higher yet.

The Caligari Brief

I received a copy of a brief to Lt.Gen. (ret.) John Caligari of the Australian Defence Forces that is dated December 20th, 2017. It is in relation to his capacity as the head of the Operation COMPASS Steering Committee in Townsville, a group committed to preventing suicide among ADF veterans. Its contents are explosive and the author wished to remain anonymous, however this person is a former senior officer in the ADF with direct knowledge of the situation.

https://www.opcompass.org.au/

Purpose 1. This brief requests your assistance for Australian veterans who have been adversely affected by drugs given to them as part of the Army Malaria Institute (AMI) drug trials conducted in Bougainville and East Timor during the period 1998-200 1. Your help is now urgently needed as recent developments internationally have brought one of these drugs, the antimalarial drug ‘tafenoquine’, a step closer to registration.

Importance 2. Why is this so important? Tafenoquine has caused serious long-term adverse health effects in a proportion of veterans who were exposed to this drug as part of military and pharmaceutical industry-funded clinical trials in the United States and Australia. These veterans have not been properly compensated or had their health conditions accepted by the Commonwealth, yet senior Defence of ficials have already stated that they will adopt tafenoquine as a key antimalarial drug for ADF personnel once the drug is registered in Australia. This is despite poor evidence of safety and appears only due to the involvement of the ADF in bringing this drug to market.

The Present Danger 3. The developers of tafenoquine have recently applied to United States and Australian health authorities for regulatory approval. The results of the AMI tafenoquine trials, particularly the East Timor 1 RAR trial in 2001 (“Study 033”), are being cited in support of these applications to justify tafenoquine as a safe and effective antimalarial drug, despite strong evidence to the contrary. Evidence of ill-effects that have been presented to the drug manufacturer GlaxoSmithKline (GSK) by our group have been submitted to the FDA as part of the GSK registration package, acknowledging that long-term health effects have been caused by exposure to tafenoquine for those involved in the AMI trials. Despite this acknowledgement by the drug manufacturer, the Departments of Defence and Veterans Affairs continue to deny a causal relationship.

Brief for Lieutenant General (ret.) John Caligari AO, DSC Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug Tafenoquine

The bottom line here is that faulty and inaccurate data was presented to the FDA in an effort to get tafenoquine approved. An effort had even been put forth to have the approval granted expeditiously. The FDA was not informed of the numerous reports of adverse rections to the drug, which would have likely at the very least delayed approval but more likely would have resulted in a rejected application.

Institutional Denials Both Defence and DVA leaders have been informed of the serious health issues experienced by the Bougainville and East Timor drug trial veterans. They have failed to fund any investigation into these cases, despite proposals being submitted to them on a number of occasions, and after their requests for us to make those proposals. Worse, in late 2016, senior Defence leaders prevented any retrospective investigation occurring into the health outcomes for these veterans by placing restrictions on data access which deny researchers access to any past trial data for these and other ADF trial cohorts . The ethical and intellectual ramifications of this action are still in dispute with senior Defence officials by the key Defence and DVA research providers, with no acceptable outcome to date despite Ministerial intervention. Senior Defence officials have ‘shut down’ research into this question.
This is simply unethical.

Brief for Lieutenant General (ret.) John Caligari AO, DSC
Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug
Tafenoquine

This is fairly self-explanatory.

The Risk Should tafenoquine be approved by drug regulators, there is a likelihood this drug will cause extensive harm to ADF members, including loss of life. This has already occurred with its counterpart mefloquine over the past three decades. We do not want to see the same situation repeated. A clear statement of support is needed now, to prevent further harm to ADF members and their families in future.

Brief for Lieutenant General (ret.) John Caligari AO, DSC
Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug
Tafenoquine

There is clear and convincing evidence that tafenoquine has harmed a number of ADF personnel, even contributing to a number of deaths, and that it is more neurotoxic than mefloquine.

Detailed Background Tafenoquine is an experimental quinoline drug which was initially developed by the US Walter Reed Army Institute of Research (WRAIR) and is manufactured by GSK. The AMI trials were conducted in close cooperation with WRAIR and GSK, involving a total of 1,540 ADF tafenoquine subjects (including 492 personnel from the 1 RAR BG in Study 033), to investigate the safety and efficacy of tafenoquine for prevention and treatment of malaria. A large proportion of those subjects have since suffered serious, chronic symptoms consistent with adverse neurotoxic effects common to a number of similar quinoline antimalarial drugs.

Despite continued development of tafenoquine since the AMI trials, and despite our repeated requests, there have been no follow up studies on this large cohort (comprising more than a third of the total number of individuals administered
tafenoquine worldwide to date) to assess the long term health risks of exposure to
this drug.

In 2009, laboratory studies co-authored by WRAIR scientists found that
tafenoquine was “the only [antimalarial] drug more neurotoxic than mefloquine”. Mefloquine is known to be able to cause “lasting or permanent” brain damage at standard malaria prevention dosages comparable to the tafenoquine dosages used in Study 033. The symptoms of this brain damage are commonly mistaken for PTSD and other neuropsychiatric disorders.

Few if any of the AMI trial subjects adversely affected by tafenoquine (or mefloquine) have been provided with appropriate or effective specialist health care. Typically, those seeking help have been diagnosed and treated for PTSD or other psychiatric disorders, then subjected to ineffective and/or harmful treatments including antipsychotic drugs and electro-convulsive therapy (ECT). Unemployment, self-harm and family breakdown have been common, as well as cases of homelessness and suicide.

Brief for Lieutenant General (ret.) John Caligari AO, DSC
Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug
Tafenoquine

Not only has it made ADF personnel sick, but those personnel are not receiving the proper treatment, which can have fatal results.

In 2014, WRAIR found that tafenoquine needs to be metabolised by the CYP2D6 enzyme in order for it to work against the malaria parasite, i.e. it does not work against malaria for individuals who have reduced CYP2D6 function, which is very common (e.g. in the range of 12-23% of Caucasians). A number of the AMI tafenoquine trial subjects who contracted vivax malaria despite supervised, documented compliance have since paid for their own CYP2D6 tests to find that they have reduced CYP2D6 function. Individual variation in CYP2D6 metabolism is also one of the possible explanations as to why only a certain proportion of individuals are susceptible to quinoline neurotoxicity.

Our own research has found that ALL individuals who report significant
long-term health issues that can be causally linked to being administered
tafenoquine during the AMI trials are of a CYP2D6 metabolism type which makes
this drug both ineffective as an antimalarial and potentially toxic at normal treatment levels. This information has been passed to both the ADF and GSK. The ADF has ignored the potential ramifications of these findings. GSK acknowledged that they are aware of the risks for CYP2D6 poor metabolisers and were ‘surprised’ we had come to the same conclusion.

Brief for Lieutenant General (ret.) John Caligari AO, DSC
Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug
Tafenoquine

Put simply, about 25% of the people who take tafenoquine will NOT be protected against malaria and will get it regardless. Not only that, but the chances are greater that you will end up with brain damage as a result of taking this drug than if your took mefloquine, which already carries an unacceptable risk of brain damage.

Since the AMI trials at the turn of the century, the development of tafenoquine
has continued as follows:
a. GSK has continued to develop tafenoquine for the single dose treatment (aka
“radical cure”) of vivax malaria, in collaboration with the Medicines for Malaria
Venture (MMV). The current AMI Director, Professor Dennis Shanks, is a
member of the MMV scientific advisory committee.
GSK recently announced that it has applied to both the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) for regulatory approval.
b. 60 Degrees Pharmaceuticals (60P), a company established by former US
Army employee Dr Geoff Dow in 2010, has continued to develop tafenoquine for malaria prevention in collaboration with the US Army and individuals from AMI (specifically, Professor Shanks).
60P recently announced that it has applied to the FDA for regulatory approval and we anticipate that it will soon (if not already) make a similar application to the TGA.

Brief for Lieutenant General (ret.) John Caligari AO, DSC
Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug
Tafenoquine

This is where the confusing and convoluted conflicts of interest begin. Be forewarned, you are about to enter a nightmarish set of interconnected relationships that will leave you with a headache at the end of it. That being said, it will all make sense.

60P is attempting to downplay the importance of CYP450 phenotyping for
tafenoquine use as this would make an application for prophylaxis commercially
unviable.

Brief for Lieutenant General (ret.) John Caligari AO, DSC
Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug
Tafenoquine

If I could give someone considering taking tafenoquine any advice it would be this, don’t take it, but if you absolutely insist upon taking it, then when you go to your doctor for the Rx, ask for a blood test to check the levels of the CYP450 enzyme in your blood. If they are below a certain level you shouldn’t take it anyway, it will be dangerous to your health.

While we are concerned about the development of tafenoquine in general, we
are particularly concerned about the activities of 60P:
a. 60P was founded by Dr Dow while he was a contracted employee of the US
Army. Dow had previously been employed at WRAIR on antimalarial drug
research, then founded 60P while working on the development of tafenoquine
as a contractor for the US Army Medical Materiel Development Activity
(USAMMDA). Dow’s supervisor at USAMMDA was Colonel Bryan Smith, who
has since retired from the US Army and is now employed by Dow as the 60P
Chief Medical Officer. During this period, Dow/60P was awarded the US Army license for tafenoquine.

b. In 2014, 60P was awarded a US Army contract to “assist in the development of
tafenoquine as a malaria prophylactic drug for FDA-TGA (Food and Drug
Administration-Therapeutic Goods Administration) approval first in Australia
and then in the United States.” Dow’s most recent tafenoquine paper indicates
that 60P continues to receive funding from the US Army for this purpose

c. In 2014, Smith was requested in writing to undertake follow up research on
the AMI tafenoquine subjects, involving a senior US military specialist doctor,
to investigate the drug’s long term adverse effects. Smith acknowledged this
request but declined to undertake the follow up research.

d. In 2015, Dow stated in an interview that his motivation in registering tafenoquine was to obtain a US FDA “priority review voucher” (PRV), valued at up to several hundred million dollars. In a 60P media release of 18 December 2017, Dow states “It is our belief our dossier will receive priority review, expediting the review of tafenoquine, and 60P may qualify for a priority review voucher.”

e. Having previously declined to undertake follow up investigation of the long term adverse health effects of tafenoquine on the AMI trial subjects when
they were employed by the US Army, 60P employees continue to cite the
original AMI Study 033 findings in a 2017 “integrated safety analysis” paper
which provides the basis of their regulatory applications.

f. The above situation reflects these comments by Professor Aaron Kesselheim
(of Harvard University) when he said of the FDA PRV system last year: “I think
it’s problematic and potentially dangerous to use this crucial process as a
lever to try to artificially create value for a for-profit company, even for an
area like neglected diseases that desperately needs more attention.”

Brief for Lieutenant General (ret.) John Caligari AO, DSC
Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug
Tafenoquine

I don’t know how many more ways this can all stink, and it’s also all about the money.

Since 2015 we have made repeated efforts to raise our concerns about the
safety and efficacy of tafenoquine in Australia and internationally, including but not limited to:
a. A Townsville health forum attended by senior ADF health of ficials, medical
experts and a number of the original AMI tafenoquine trial subjects.
b. Numerous meetings with Ministers and senior of ficials from the Departments
of Defence and Veterans Affairs.
c. A written proposal to the Minister for Veterans Affairs to fund a dedicated
program of outreach, rehabilitation and research for ADF veterans adversely
affected by tafenoquine and mefloquine.
d. Meetings with GSK representatives in Australia and the UK.
e. Written complaints to the TGA and the Minister for Health

f. Written complaints to the Australian Federal Police.

Brief for Lieutenant General (ret.) John Caligari AO, DSC
Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug
Tafenoquine

The matter has been taken to the federal police. What else can be said?

Despite these efforts, there has been no follow up investigation into the long term adverse health impacts of tafenoquine among the 1,540 AMI trial subjects and
our requests for a dedicated outreach and research program have been repeatedly rejected. During this period, senior ADF medical officials hav repeatedly misled Ministers, Parliamentary committees, the media and the ex service community. We believe that this misinformation has been intended in part to facilitate the successful registration of tafenoquine for the financial gain of 60P.

In the event that tafenoquine is granted regulatory approval, we are also
deeply concerned about the serious distress among the AMI tafenoquine trial
subjects when they learn of the substantial financial gain to 60P after our requests for follow up research and medical have been repeatedly declined. In essence, many of these veterans and their families are begging to charity for health care while 60P stands to profit up to several hundred million dollars from the tafenoquine trials which caused so much harm.

Brief for Lieutenant General (ret.) John Caligari AO, DSC
Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug
Tafenoquine

Nothing needs to be said here.

Conclusion Given that the above concerns about the safety and efficacy of tafenoquine have thus far been ignored, and health authorities are now considering applications for registration, we are now requesting you to publicly support our calls for a dedicated outreach, research and rehabilitation program those affected. This would ensure not only that the Commonwealth fulfils it’s duty of care to the drug trial veterans and their families, but would also reduce the risk of unnecessary harm to ADF personnel who may be given tafenoquine in future.

Brief for Lieutenant General (ret.) John Caligari AO, DSC
Safety and Efficacy Concerns Regarding the Experimental Antimalarial Drug
Tafenoquine

The man in charge of overseeing the drug trials, Brig. Gen Leonard “Dr. Death” Brennan, once told someone that their efforts to see such a program put into place would end in frustration. This then raises the question of his involvement in this scandal, and now raises the possibility that Brennan could also have some conflicts of interest of his own going on here.

Image result for leonard brennan

60 Degrees Pharmaceuticals

The lie printed in a news release.

60 Degrees Pharmaceuticals Fast Tracked For Malaria Drug

WASHINGTON, Jan. 4, 2018 /PRNewswire/ — 60 Degrees Pharmaceuticals (60P) has received Fast Track designation from the United States Food and Drug Administration (USFDA) for the investigation of Tafenoquine for prevention of malaria in adults.

60P entered into a cooperative research and development agreement with the U.S. Army Medical Materiel Development Activity (USAMMDA) in 2014 to develop Tafenoquine as a weekly prophylactic drug for the prevention of malaria. Since malaria is the top infectious disease threat to U.S. Military service members overseas, the military maintains a robust anti-malarial drug development effort through internal research and commercial partnerships.
The NDA submission is a culmination of over 30 years of research and development with the U.S. Army Medical Research and Materiel Command, from the discovery of Tafenoquine at the Walter Reed Army Institute of Research through the current collaboration between 60P and USAMMDA.
A recent analysis of five clinical trials to assess the safety and tolerability of Tafenoquine has been published in Travel Medicine and Infectious Disease, a peer reviewed journal. The authors concluded that Tafenoquine appeared to be safe and well tolerated when the anticipated clinical regimen (ACR) was administered.
In all five studies, the majority of adverse events (AEs) were mild or considered unrelated to the study drug.
For the full article, “Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis,” by Moreno et al., 2017, please go to: http://www.travelmedicinejournal.com/article/S1477-8939(17)30079-0/fulltext   

NEWS PROVIDED BY
60 Degrees Pharmaceuticals Jan 04, 2018, 09:45 ET

https://www.prnewswire.com/news-releases/60-degrees-pharmaceuticals-fast-tracked-for-malaria-drug-300577651.html

There are some serious questions as to the ethics and legalities of the trials performed in Bougaineville and Timor Leste, study 033 in particular. It it this data that was used on the application to the FDA for fast track approval last year, which it received on July 20th, 2018 under the brand name Krinfantel. No mention was ever made of any of the adverse events that were reported, and the drug was made out to be reasonably safe.

A Letter to the Senate Foreign Affairs, Defence and Trade References Committee

This letter was sent by Karl Herz, Managing Director of a company called Biocelect Pty Ltd.

Image result for karl herz biocelect

About Biocelect

Biocelect is a Sydney-based company that sources, in-licences and commercialises biopharmaceutical products for Australia, New Zealand and the South Pacific that address unmet medical needs of patients. In Australia, Biocelect has just registered its first specialty prescription product, KODATEF (tafenoquine), the first new drug molecule for malaria prevention in 20 years. Biocelect launched KODATEF (tafenoquine) in early 2019. 

Thank you for the opportunity to provide evidence to the committee on 8 November 2018. I would like to provide some additional information to further clarify one area of my evidence on page 17 of the transcript and the sentence is highlighted below: Mr Herz: Biocelect would like to thank the committee for the opportunity to appear before you today. As an individual I feel and as an organisation we feel for the plight of the veterans and what they are experiencing and hope that they receive all the help that they need. During the hearings, I have observed the overwhelming amount of information presented to the committee from various sources. Whilst the veterans’ stories are harrowing, we believe that we need to respect the findings of the various regulators and their experts. We have been working with 60 Degrees Pharmaceuticals since 2013 on the commercialisation of tafenoquine, and we made a decision to license tafenoquine for malaria prevention for Australia and other countries in the region, the first new product in 20 years for malaria prevention in Australia.

Karl Herz, B. App. Sc. (Biomedicine) Managing Director Biocelect Pty Ltd

http://www.biointelect.com/our-people/

Knight Therapeutics

Canadian connection.

Image result for knight therapeutics jonathan goodman
Jonathan Goodman

https://60degreespharma.com/investors/

HISTORY

2010: 60P established

2012: Secured $2 million in initial funding

2013: Established an Australian subsidiary to support global research projects

2014: Commercialization of tafenoquine for malaria prophylaxis initiated with U.S. Army

2016: Knight Pharmaceuticals provided $4 million in financing to support the 60P tafenoquine program

2017: 60P filed IND for tafenoquine with a target indication for the prevention of malaria

Overview Knight Therapeutics Inc. (TSX:GUD) is a publicly-traded, specialty pharmaceutical company focused on acquiring, in-licensing, out-licensing, marketing and distributing innovative prescription pharmaceuticals, consumer health products and medical devices in Canada and select international markets. In addition, Knight invests in or finances other life sciences companies with the goal of securing product distribution rights. Knight has acquired or in-licensed a portfolio of over 20 products that are marketed, under regulatory review or in various stages of development. Knight is headquartered in Montreal, Quebec, Canada and has over 45 employees.

https://www.gud-knight.com/overview/

Knight Therapeutics CEO: I made a mistake in selecting my partner

https://www.bnnbloomberg.ca/video/knight-therapeutics-ceo-i-made-a-mistake-in-selecting-my-partner~1652451

Jonathan Goodman, well known player in the Canadian pharmaceutical industry, has had a rocky last couple of quarters, and this news may not improve the overall outlook.

If tafenoquine is pulled from the market, Goodman and his company could be out $4 million. Ironically enough, the trouble Goodman seemed to be having stemmed from the fact that he wasn’t being enough of a risk-taker. Goodman may have risked it all on tafenoquine.

Investigation only just begun.

There is still a lot of investigating to be done, but one thing is abundantly clear to me, I’m not the only one that should be doing this. At this point there should be enough to warrant a commission of inquiry as well as investigations and hearings by the senate, the judiciary, and law enforcement.

Let me also be clear that all of the people implicated in this affair who were ADF personnel are senior or general officers. There is no evidence of complicity on knowingly doing wrong on the part of any junior officers or NCO’s of any rank. It is a pervsive cancer that appears to have run rampant through the upper echelons of the ADF, and as the investigations move forward the true scale of this scandal will become overwhelmingly apparent.

For now though, the investigation goes on.

Australian Media Continues To Miss Mark In Whistleblower Case

Is it that they just can’t see the big picture, or have they become a part of it?

https://www.dailytelegraph.com.au/news/national/whistleblower-mcbride-says-he-would-do-it-all-again/video/7ea77bb7d67b9ad88f9dad368c279fae?fbclid=IwAR0HDIeZjP8Xd0TTRbz228pjAJ7EscQcQ_Oab4zBFb1DwHSL6Ta6YvTk9B8

In a video Thursday on the website of the Daily Telegraph, former army lawyer Maj. David McBride defiantly stated that given the opportunity to do it over again he would, speaking of the actions which now have him facing the possibility of 60 years in prison.

He is accused of passing secret documents to the media, documents that he says show that the Australian government engaged in illegal activities which resulted in the deaths of ADF personnel in Afghanistan.

But, once again, the media have completely missed the point, and mischaracterized Major McBride’s actions and intent. They are instead characterizing it thusly: “August 22, 2019. Military lawyer David McBride who blew the whistle on alleged war crimes by Australian troops in Afghan…”. If this continues it will only serve to obscure the truth from the Australian public at large.

A man’s life is at stake for God’s sake, you at least owe it to him to report the story accurately. The media’s place in a democratic society is to unbiasedly report the news, not to become the news.

Do better Daily Telegraph, do better all of you, mainstream journalists. This is democracy you are dealing with, and the people deserve nothing less than your best.

The “Dr. Death” Of The ADF

Brig.Gen. Leonard Brennan given dubious moniker by ADF troops.

When you hear someone referred to as Dr. Death, most people of a certain age will automatically think that person is Dr. Josef Mengele, the SS-Haupsturmfuhrer (Captain) and physician also known as The Angel of Death. He held doctorates in medicine and anthropology and it was his work in research anthropology during World War II that earned him his monikers.

He was perhaps best known for his research on twins, often performing cruel experiments on one while leaving the other as a control subject. Mengele’s actions were horrific, seemingly incomprehensible for a medical doctor, and as a research anthropologist he viewed these lives as though they held no more value than a laboratory rat.

Josef Mengele, Auschwitz. Album Höcker (cropped).jpg

There are those who will take exception with the tag of Dr. Death being hung on anyone but Mengele, but for those in the ADF who call him that, they have very good reason for doing so when it comes to Brig. Gen. Leonard Brennan. Although they aren’t glaringly obvious, there are a few parallels that can be drawn between Mengele and Brennan.

I will lead in by saying that I do NOT believe Gen. Brennan to be a Nazi nor am I implying that he in any way has now or at any time ever been one, or aspired to be one.

Gen. Brennan, to the best of my knowledge, has not performed any sort of experiments on twins and has not had a direct hand in the selection of people to be put to death, as Mengele was. What we do see however is that both men have foregone medical ethics for the cause of scientific research. Pure science does not operate in a world of ethics, it deals with facts, obtained through experimentation and observation. It does not care that the experiments being done to obtain those facts are done on a laboratory animal or a living breathing sentient human being.

In Mengele’s case, he blatantly flouted medical ethics, choosing instead to follow his own moral code in the place of the hippocratic oath, he did have a degree in medicine after all. As for Brennan, his ethical lapses are a little more subtle, as demonstrated in an email exchange I obtained from a former ADF senior officer who asked to remain anonymous. In it, the officer had been asking for Brennan’s assistance in helping to establish a rehabilitation program for ADF veterans who had suffered brain damage as a result of taking mefloquine, tafenoquine, or both.

It was not an unreasonable request, given that the ADF had adminstered the drug to thousands of it personnel during illegal and unethical drug trials. After expressing his exasperation at Brennan’s stonewalling and denials, the senior officer received a reply from Brennan that alluded to the fact that this officer would be having his efforts frustrated by him (Brennan).

The Director of Military MEDICINE (at that time) would be blocking any attempt at getting help for personnel who were injured at his behest. He was the one that was in charge of the drug trials, he oversaw the whole thing for the ADF. He knew what was happening, yet did NOTHING to stop it.

The men and women of the ADF were nothing more than subjects in an experiment to Brennan, laboratory animals to be experimented upon without regard for their lives. They were the unwilling participants in a scheme that involved high-ranking members of the ADF, the pharmaceutical industry, and hundreds of millions of dollars.

It’s difficult to say what has motivated Brigadier General Leonard “Dr. Death” Brennan up to this point, whether it’s the opportunity to perform scientific research thus securing himself in the annals of science, or simply just plain old vanilla greed. What seems pretty apparent to me is that Leonard Brennan fits his grotesque moniker more than he does not.

Evidence Destroyed In Midst Of Somalia Inquiry

Documents containing words ‘Airborne Regiment’ shredded prior to mass search.

What Did He Know?, Page 16 | APRIL 15, 1996 | Maclean's

https://archive.macleans.ca/article/1996/4/15/what-did-he-knIow

In April of 1996 the Somalia Commission of Inquiry, led by Justice Gilles Letourneau, was hearing testimony from the then Chief of Defense Staff Gen. Jean Boyle. He was evasive in his answers and his overall demeanor hinted that he was being far from truthful in his responses.

It had been revealed by the commission that a number of documents, which were of vital importance to the inquiry, had either gone missing or had been altered. In an over the top response, Boyle announced that all but essential DND personnel would spend the day searching for these documents on April 9th, but to no avail.

I have been contacted by someone who tells me that sometime prior to this day, they were ordered to shred any document that contained the words “Airborne Regiment”. They do not recall exactly who it was that gave them the order, but they do remember that it was coming from somewhere “high up”.

This person has asked to remain anonymous, and I will not reveal anything about where they worked or the job they did, but I am satisfied that they are who they say they are. This is not the first time that I have heard this, however it is the first time that I have not heard it second hand. I heard it right from the source this time, so now I’m going to publish it and let the chips fall where they may.

This exercise would have been taking place at every Canadian Forces base and station, by a large number of people. It’s possible that some of those people may have just forgotten about it, or it could be that everyone was ordered to keep quiet about it, or both I’m not entirely sure what exactly went on. What I do know is that orders were given and documents were destroyed, documents that were important evidence in an the Somalia Commission of Inquiry.

CV of General Joseph Édouard Jean BOYLE, CMM, CD

The Somalia Inquiry MUST be re-opened.

By the admission of the disgraced former CDS Boyle, documents were altered, and now we know many were also destroyed, most likely at his behest. His call to have the entire military search high and low for the missing documents was disingenuous, a feeble attempt to salvage a reputation that was being ripped to shreds.

There is absolutely NO QUESTION, the Somalia Commission of Inquiry must be re-seated, it would be a travesty for it not to. Key evidence relating to mefloquine has not been heard and the matter of the cover-up absolutely needs to be addressed. This is not ancient history, and now is the time to set the record straight, while most of the participants are still alive to give sworn testimony.

The men of the Airborne Regiment that had their reputations torn to shreds deserve to have them restored. Yes, racism was rampant within it, but not every man had that in his heart. I firmly believe that were it not for the influence of mefloquine, the incidents that happened in Somalia would not have happened.

D.B.

Tafenoquine Stories – Colin

Participant in Study 033 tells his story.

Tafenoquine is the next generation anti-malarial, and even more dangerous than the drug that came before it, mefloquine. From 1999-2002 the ADF conducted a number of illegal and unethical drug trials on personnel during peace-keeping missions in Bougainville and Timor Leste. One of these was Study 033.

This is the story of one of those soldiers. It is the testimony of Mr Colin Brock to the 2018 Australian Senate Inquiry into Quinoline Antimalarials in the ADF.

I enlisted in the Australian Regular Army in August 1990. After recruit training I was sent to the school of infantry and was allocated to the 1st Battalion Royal Australian Regiment, and other placings, until my discharge in August 2010. I discharged, after 20 years, as a warrant officer class II. At the beginning of the year 2000, 1 RAR was warned out for deployment to East Timor. I was a section commander in Mortar Platoon, Support Company. My section consisted of nine men, including me.

I am not sure of the specific date—I think it was sometime in September 2000—a battalion parade was held on the main parade ground of 1 RAR. We were formed up in companies and the commanding officer, Lieutenant Colonel John Calagari, briefed the battalion on a new malaria drug or drugs that we all were to take to prevent malaria. We were told that it was a trial to benefit the Defence Force. I now know the drugs to be mefloquine and tafenoquine. Lieutenant Colonel John Calagari then informed the battalion, ‘This drug is voluntary, but if you do not consent to take this drug, you will not deploy to East Timor.’

Image result for lt.col. john caligari
Then Lt.Col. John Caligari

I can categorically state, 100 per cent, that he did say this. There was numerous talk about it after the parade. No-one in the battalion was going to say, ‘No, we won’t take it,’ as everyone wanted to deploy. If you knew about the Army culture, that is what you would want to do. If we knew of the consequences of these drugs, I and a lot of others would have told them to find someone else.Some time after the parade, 100 persons were selected at random and put in a group called ‘the 100 club’. My nine-man section was part of this group. The persons I remember were Lieutenant Colonel Brennan and a pair of identical twins, who were lieutenants, but I can’t remember their names. Before the loading phase of the drug commenced we conducted medical tests, numerous blood tests, ECGs, breathing tests, X-rays on the backs of our eyes, which consisted of an IV drip in our arms, which turned our skin yellow and our eyes black.

When we came back from seven months in East Timor, the exact same tests we had completed earlier were conducted on the same 100 to see if there were any changes. These final tests were the last time I ever saw anyone from the Army Malaria Institute. We were told there would be follow-up tests in six months and in 12 months, but these never eventuated. I suppose they got their data from us guinea pigs.

While in East Timor the medics and some of the Malaria Institute conducted blood tests on us. We were not told what drug we were on. In 2005—I think I was back in Townsville—I received a letter from the institute saying that I was on mefloquine and that if I had problems with my eyes I should see a specialist. Apparently, one of the side-effects was carbon deposits on the back of your eyes. I thought this very strange, as we had taken this drug some five years before. A couple of weeks later I received another letter saying, ‘We are sorry. Actually, you were on tafenoquine.’ I was not having much faith in the Army Malaria Institute. What this did enforce for me, though, was that they knew where I was posted because I was still in the Army, so, if there were any side effects of this drug, surely they would get me and others in for further testing.

In my later years in Defence, I knew there was something not right with me. I thought it might have been PTSD, as I’d completed numerous deployments to some of the worst countries on Earth, but it was something else. My hearing was failing. There was ringing in my ears. I was having dizzy spells; vertigo issues, which I still have today; bouts of depression and anxiety; and anger issues. But, like a lot of people in Defence, you just put up with it. I loved being deployed, and nothing really fazed me.

I discharged in 2010 and commenced working in the civilian industry. After a couple of different jobs, I started working in the fire protection industry, which I did until I had a mental breakdown in early 2016. I knew this was coming, as I had feelings of anger, hatred et cetera towards colleagues. Some days I had to leave, or I would have actually killed someone, with no regret at all. The anxiety and anger were uncontrollable. This was not the life I wanted to live. I was admitted to a psychiatric hospital in 2016. While admitted, I left work for my safety and the safety of other people.

I’m not sure when or where, but I read something about the drug trial that I was involved in and some of the symptoms associated with these drugs. I could not believe how my symptoms matched. I researched myself, I looked through my medical files, but not much was there. I was also aware of a number of ex-soldiers who were suffering PTSD from Timor and my tour. This was strange, as on our tour not much actually happened. It was intense and harrowing at times, but not like other high-risk deployments. In the meantime, I submitted claims with DVA, which accepted PTSD, major depression, IBS et cetera. That’s when I came across a Facebook page started by a fellow veteran whose name is Stuart McCarthy, who was also suffering. This was a godsend for me.

I think it was in March 2016 that a forum was held at the Townsville RSL, which I attended with a number of other people who were severely affected by these drugs. A number of dignitaries attended, with key speakers and subject matter experts. Defence was represented by Air Vice Marshal Tracy Smart, Commander Joint Health. I have no words for Tracy Smart. All she did was deny any wrongdoing by Defence, saying the drug trials were conducting morally and ethically, and there was nothing wrong with us. She had no answers for us, just denial. One of my close friends, Chris Styles, had an open argument with her at the forum which was captured on visual and audio. Chris committed suicide less than two months later. Tracy Smart is a Defence toe-the-line person. She is fully aware of these drugs and does not care.

Image result for Tracy smart
Air Vice Marshal/Surgeon General Tracy Smart

In May 2016, I was contacted by Brigadier Andrew Dunn as part of the IGADF inquiry into allegations of unethical and unlawful use of antimalarial drugs in Defence. This was a phone interview which lasted around 90 minutes. I answered truthfully all the questions asked of me. I have a clear recollection of these events, and one in particular. The main question I was asked was: what did Lieutenant Colonel John Caligari say on the parade ground as to the drug being voluntary? I answered: ‘John Caligari said, “The drug trial is voluntary, but if you do not consent to the trial you will not deploy to East Timor.”‘ As I said, I am 100 per cent correct that I heard this. I would not lie about this. I know the man’s reputation is at stake; I would not lie.

I received the findings for my part in this inquiry a while later. The report suggests that I basically lied to the inquiry—and so did four or five others that were with us—finding that John Caligari had never said those words. I was gobsmacked. He was an officer I respected, trusted and looked up to, as I had worked for him again in later years. He categorically denied it. There are hundreds of people from that 1RAR parade ground who will agree with me. We are not liars. What would I have to gain by saying this? Nothing. Also, if you look at submission No.80, I don’t know if you have that with you, what he’s said in there—I saw that the other day in the submissions—is what I’m saying.

Everyone affected by these drugs wants answers. My section in East Timor consisted of nine fit men. Six out of the nine are now experiencing all of these symptoms and are unable to work; that’s a 75 per cent ratio. Why were Defence used as guinea pigs? Why were we forced to take these drugs? What do we have to do to get help—more suicides? There is blood on the hands of the malaria institute, Defence and the leaders of these so-called trials. I personally have been to two funerals as a direct result of these horrendous drugs, and it will keep happening. Just three days ago a former member of 1RAR who was on these trials committed suicide. That was three days ago. It’s still happening. The fraud and corruption involved in these trials is huge. The lying and deceit is incomprehensible. People and organisations need to be held accountable for the damage they have done to hundreds if not thousands of officers and soldiers.

That’s all I’ve got, but yesterday I heard in the Brisbane senate two professors or scientists—one was from Melbourne University, I think—who basically said there is no evidence and there’s nothing wrong with these drugs. It’s been 18 years since we took these drugs. I was in the 100 club. My file here, which is an inch thick, shows that you have abnormalities after seven months. Get those two people, load them up with double dosages, take the drug for seven months, give it to their kids, give it to their families—see if they would do that. I guarantee they won’t. All of them—Tracy Smart—let them take it. See what they feel like.

Finally, I want to thank Jane Quinn, Brian McCarthy and, especially, Stuart McCarthy, for their tireless efforts in this.

Testimony of Mr Colin Brock to the 2018 Australian Senate Inquiry into Quinoline Antimalarials in the ADF

This testimony is significant for a number of reasons. First, it highlights the fact that the Study 033 report (published in 2010) is a fraudulent document. Adverse events like were commonplace but were fraudulently excluded from the published report. The report found “Tafenoquine appears to be safe and well tolerated as malaria prophylaxis.

https://www.ncbi.nlm.nih.gov/m/pubmed/19995933/

Notably, the Australian Therapeutic Goods Administration quietly approved tafenoquine for malaria prophylaxis even as many of the Study 033 subjects were testifying to the Senate inquiry with personal accounts like these. The TGA’s approval was based largely on the fraudulent Study 033 report.

https://60degreespharma.com/…/Biocelect-Welcomes-TGA-Approv…

Second, it highlights serious breaches of the ethical standards for human research, namely that informed consent to participate must be voluntary, free from coercion.

https://www.wma.net/…/wma-declaration-of-helsinki-ethical-…/

Third, it highlights criminal negligence on the part of the Army Malaria Institute. Study subjects who raised safety concerns about tafenoquine were forced to continue on the drug, sustaining lasting or permanent brain damage as a result, while being denied access to safer, alternative registered drugs.

https://www.wusa9.com/…/concerns-over-new-anti…/65-553751590