Aussie Vaccine Trials: Does Government-Industry Collusion Put the Public at Risk?

david dees bioterrorism

The connections between government and industry over monopolizing a flu vaccine do not bode well for Australians.  Competition improves any product, and with something as serious as a vaccine, product safety.

I have just found a post by another person who appears to have better access to registries etc, and what he has to say…is sending a chill through me.

What I found out below re CSL ,Chiron ,Merk links has been not only supported, but for us Aussies -with no options, even more worrisome!

It has ANSWERED my QUESTION of WHY? they would be trialling Panveax, and then some.

read the Ausie background, then at bottom, read the continuation of the world saga unfolding. heres a taste.

{ conclusion and summation, it should be evident that the “2009 Swine Flu” could just as easily be called the “Bird Flu” ­ because it is as much H5N1 (bird flu) as H1N1 (pig flu.) Novartis knew this in 2005 when it received hundreds of millions of dollars from Mike Leavitt’s HHS to develop and patent the “bird flu” vaccine. I publicly charge that Novartis had advance knowledge of this “combination” because they had been in consultation with Jeffrey Taubenberger for years.

It is further evident that Novartis’ patent provides for “influenza vaccine kits” to be provided to other pharmaceutical manufacturers as well. These “kits” are the basic raw ingredients needed for the other companies to build their own vaccines under their own label.}

BINGO!!!

I’ve been watching the Swine/H1N1 saga from a distance and have written on Novavax.  For the early story in Australia and more background see my blogspot. Well, things got livelier here this past week with not one, but two, companies in a race to be the first swine flu vaccines to be using humans in official trials in Australia.

The biggest media blitz was launched by CSL, which was once Commonwealth Serum Laboratories and was truly Australian.  Now, however, CSL, whilst keeping the appearance of  being a government entity, is in truth no such thing.

I find it rather odd that they have exclusive and total rights to influenza vaccines via legislation. A 5-year deal means no other company can market flu vaccines in Australia. This deal was signed well after they became an autonomous entity and publicly listed on the Australian Stock Exchange. It’s curious that something so important managed to happen so very quietly.

Dates for that government back-out vary, even on the CSL web page itself. I take the latest Financial Report as possibly the most correct, either 1991 or 1994. (Both are listed.)

These next 2 paragraphs show just how “favoured” and Teflon-like CSL is:

ARCBS (Aussie Red Cross Blood Service) and its predecessors had a long-standing relationship with Commonwealth Serum Laboratories (CSL), a government medical body founded in 1916. The Red Cross supplied CSL with donated blood for use in research and manufacture of medical products (e.g. serum for transfusion).

In 1994, CSL was privatised, becoming CSL Limited. The ARCBS continued to supply CSL with donated blood. This caused a major public-relations crisis for the ARCBS when it became known that blood donated for public benefit, without payment, was being used by a private corporation for financial gain.

And…it still is! Go figure.

Their blood serum products are high revenue earners, and Aussies still donate blood for free.

Let’s wade through some of the connections between government and private industry. It becomes a Who’s Who of worldwide Pharmas all linked in “patent and sharing” deals, which are all massively profitable.

2001 – ZLB Plasma Services Established

ZLB Plasma Services commenced operations in September 2001 following CSL’s acquisition of 47 US-based plasma collection centres and associated laboratory facilities from Nabi. This acquisition secures plasma supply for the continued expansion of ZLB Bioplasma.

2000 – ZLB Bioplasma Established

In June 2000, CSL signed an agreement to acquire the plasma fractionation assets and business (ZLB) from Rotkreuzstiftung Zentrallaboratorium Blutspendedientst SRK, a non-profit organisation affiliated with the Swiss Red Cross and with strong links to the international family of Red Cross organisations. ZLB is the fifth largest manufacturer of plasma products worldwide.

They have the total Australian market, rated 5th largest in the world, and a whole slew of US blood banks all wrapped up. Anyone else think its a bit “monopolistic?”

1991 – CSL Limited is Incorporated

CSL Limited is incorporated as a Public Company in April 1991 under the Corporations Law. All shares are held by the Commonwealth Government.

Now, that last statement is a real bafflement.

Page 28 of CSL_AR_2007.pdf (application/pdf Object) conflicts with this incorporation and share detail.  It’s a private corporation that’s publicly traded, but all shares are owned by the Commonwealth.

The implication is that it is still Commonwealth to anyone who doesn’t know about this small detail, and that’s 99% of us Aussies! I called a nurse friend who admitted she had no idea it was not still government owned.

CSL has a spiffy manufacturing plant, and 650 staff. Some new buildings have gone up (a good pandemic will do that). A lot of business types, and a scarcity of real medico types on the Board of Directors certainly made for an eye opening read. It reads like a who’s who of Australia’s powerful and elite with an American with some “convenient” ties to Bio companies back home. There’s a lovely assortment of a lawyers, financiers, (two) doctors, and mining engineers.

CSL also markets in the U.S.:

“In September 2007, CSL achieved a major milestone when the FDA approved our seasonal influenza vaccine Afluria for sale in the US. For the next two to three years, significant clinical and regulatory commitments will continue with further clinical trials in adults, the elderly and the very young. In June 2008, the Therapeutic Goods Administration approved our Panvax prototype pandemic avian influenza vaccine for registration in Australia.”

What disturbs me is the lack of any data, and some rather odd anomalies in respect to claims of prior testing on a vaccine for bird flu. Yes, I know, that’s not the present issue.  Well, somehow CSL has managed to blend things and is also trialing their bird flu vaccine at the same time.

It appears they are using a very loose interpretation of a directive that this bird flu vaccine was not to be trialled unless a pandemic was announced. The intention was for a H5N1 pandemic, but they are using the new scare as a way to do a trial in what I find a surreptitious manner, on a vaccine that has no useful bearing in the current outbreak.

First Trials of Swine Flu Vaccine Begin in Australia (Update1) – Bloomberg.com

“CSL is also testing the pandemic vaccine, known as Panvax (H1N1 A/California) in Australia, in a regular and double dose to see which is more effective.”

Odd indeed?  Data below shows trials were already supposedly done sometime in 2008. This particular vaccine has only one set of trial data I could find, prior to being added to the Australian register on July 20, 2009. It was registered just three days before they started using it. Yet, this product has been around for some time according to info CSL states:

Melbourne, Australia — 17/06/2008

CSL Limited announced today that it has received approval from the Australian Therapeutic Goods Administration (TGA) to register Panvax®, CSL’s avian influenza vaccine. Developed by CSL in collaboration with the Australian government, Panvax is intended for use in the prevention of influenza caused by a pandemic strain of avian influenza virus.

About Panvax

Panvax is a vaccine that can be used only when an influenza pandemic has been officially declared by the Australian Government in consultation with the World Health Organisation. An influenza pandemic occurs when a new strain of the type A influenza virus emerges that is so different to the seasonal influenza virus strains that it spreads rapidly from person to person. In that case, it can cause serious illness because very few people have any immunity to the new virus strain.

H1N1 is not type A Avian though it has some avian in it. Panvax has no proven use or registration for anything but H5N1.

I found the same exact quote on many sites:

“Three randomised, double-blind clinical studies were conducted in Australia to assess the immunogenicity and/or safety of the vaccine in adults aged 18 to 64 years, and older adults aged 65 years and older. The vaccine, administered as a 2-dose regimen, was found to be safe and well tolerated.”

Where? When? And the chart’s data and results are just not available. Unusual.

Looking at CSL_AR_2007.pdf (application/pdf Object):

Page 9. mentions trials in 07/ 08 in Aus

Page 18  mentions a “recent application to TGA of a prototype Pandemic Vaccine.

Page 28 Finally shows that it is no longer a Commonwealth -owned enterprise, but I do not think that many Aussies are aware of this fact. Keeping the CSL logo was a great way to ensure that they did not notice.(page 28 is the above “copy of  dates and names)

Now the link under this shows the fees and charges for registering drugs. Amazingly well paid job, is proofreading reports $500+ an hour for 1 to 50 pages. If you had paid some of the costs listed here, I guess any way to claw some cash back seems like a good idea. However, the rationale behind a useless or INAPPROPRIATE product, in this situation, (unless there is more we haven’t been told) seems a bit weird.

And I wonder if the recipients are really, fully and well informed. I seriously doubt it.

Summary of fees and charges at 10 July 2009

Australian Healthcare and Hospitals Association – NEWS

CSL Limited and their involvement in clinical trials.

CSL has “arrangements with” Merck, Wyeth, Novartis, Chiron, and quite a few others in licensing, sharing and marketing, under various brand names all over the world. They are also heavily involved in cancer vaccine research.

To really top it off, they also have a deal with Gardasil’s creator, Ian Fraser. He and they profit on every dose.

Here’s some background on Gardasil, supposedly created to stop the HPV virus:

Revealing the Dangers of Gardasil:

“This revelation should be quite shocking to anyone who has been following the debate over Gardasil and mandatory vaccinations of teenage girls. First, it reveals that Gardasil appears to increase disease by 44.6 percent in certain people — namely, those who were already carriers of the same HPV strains used in the vaccine.

“In other words, it appears that if the vaccine is given to a young woman who already carries HPV in a ‘harmless’ state, it may ‘activate’ the infection and directly cause precancerous lesions to appear. The vaccine, in other words, may accelerate the development of precancerous lesions in women.

“This is information that has simply not been made available in the debate over Gardasil vaccination policies. The pro-vaccination rhetoric has always been about “saving lives” and it carried the implied statement that Gardasil is perfectly safe for all women, posing absolutely no increased risk of cancer. What these documents reveal, however, is that Gardasil may, in fact, pose a serious increase in the risk of cervical cancer in some recipients of the vaccine.”

And is there the slightest mention anywhere of this by CSL? You bet there isn’t.

While nothing apart from complete monopoly is overtly questionable, the anomaly on approval registration and testing seems to raise a question or three.

What is a Clinical Trial?

A clinical trial is a series of research studies in which people volunteer to receive a treatment (such as a drug) and be observed for its effects-both in terms of its safety and its effectiveness.

  • Any type of treatment can be tested in a clinical trial. Most clinical trials look at a specific illness; however, many evaluate new medical procedures or even preventive measures.
  • Before a clinical trial can begin with humans, it is first tested extensively in the laboratory and in animals. (One page mentions guinea pigs, but not amounts and times, etc. with just one graph, but no reactions, deaths or any of the usual info I do expect to be able to access.)
  • Clinical trials are carefully supervised, monitored, and documented. The applicable regulatory authority must grant approval to conduct testing in humans, and clinical trials are overseen by an independent review body.

And who was the independent reviewer? I doubt independence is possible as the Network here (worldwide) is all so close and entwined. What bothers me is that I cannot find any records of such trials.

ISCOMATRIX® Adjuvant (from CSL info page)

Adjuvants are used to enhance or modify the immune response to antigens in vaccines. The ISCOMATRIX® adjuvant has antigen delivery as well as immunomodulatory capabilities which combine to provide enhanced and accelerated immune responses. A range of ISCOMATRIX® adjuvanted vaccines have been evaluated in clinical trials. The results of these completed and ongoing studies indicate that the ISCOMATRIX® adjuvant is safe and generally well tolerated and increases the vaccine immune responses.

The ISCOMATRIX® adjuvant is made from saponin, cholesterol and phospholipid (lipids from comprising cell membranes), which, under defined conditions, form cage-like structures typically 40-50nm in diameter. In recent years the focus has been on developing an improved ISCOMATRIX® adjuvant to meet the ever increasing regulatory standards for components of human vaccines while maintaining strong immune responses. The result is an optimized ISCOMATRIX® adjuvant that is well defined, has minimal impurities and does not use any materials of animal origin. Additionally, improvements have been made to manufacturing processes to ensure it can be reproduced on a large scale.

CSL has several license and option agreements with major vaccine manufacturers including Merck & Co., Wyeth and Novartis. We also continue to use ISCOMATRIX® adjuvant in our own vaccine development programs such as influenza.

(NOTICE it does not say no bug vector, however.)

As part of the licensing agreements, CSL will be the worldwide supplier of the ISCOMATRIX® adjuvant. To support this large scale manufacturing capability, a manufacturing plant was established at the Kankakee, Illinois site.

Patent from USA: United States Patent: 6,506,386
Issued: January 14, 2003
Inventors: Friede; Martin (Farnham, GB); Garcon; Nathalie (Wavre, BE)
Assignee: SmithKline Beecham Biologicals, S.A. (Rixensart, BE)
Appl. No.: 744800
Filed: June 4, 2001

How interesting, now CSL has world rights.

03_drane.pdf (application/pdf Object)

The sole and only info on any of the CSL products I can find after three plus days of hunting is on guinea pigs and monkeys, but no details. There are childlike charts but no real data, like, how many animals start to finish, what percent of issues if any, all the sorts of information that would tend to prove their statements.

At pages 23 and 27, “severe” adverse events are mentioned but no details except that one patient refused the third dose.

It also mentions partnering with Chiron, which had to pay a lot out for contaminated flu vaccine in UK, and has had other “issues” since. At the time, I didn’t pay much attention, but the name is so like Charon, the ferry man for the dead, that it stuck in my mind. Rather too close to reality.

Panvax use and trials
CSL is the only vaccine supplier that manufactures influenza vaccines in Australia. Through its recent and continuing investment of more than $80m in Fluvax® (a vaccine against seasonal influenza) CSL remains committed to the ongoing provision of influenza vaccines to the Australian community.

CSL acknowledges the significant contributions made by those Australians who participated in the clinical studies to enable the development of this important vaccine. (Did any die? Severe adverse events cover a few scenarios)

The Sydney Morning Herald listed the company’s 07/08 financial report.

H1N1 Influenza virus vaccine

US buys $US180m in Swine flu vaccine from CSL’s Biotherapies unit

U.S. has bought 195 million doses of H1N1 vaccine on Yahoo! Health

———————————————————————

The problem-plagued Chiron Company is… (drum roll please) NOVARTIS, under a “branch” name:

Media Releases – Novartis

Novartis Vaccines and Diagnostics is a division of Novartis focused on the development of preventive treatments and tools. The division is comprised of two activities: Novartis Vaccines and Chiron. Novartis Vaccines is the world’s fifth-largest manufacturer and second-largest supplier of influenza vaccines in the US. The division’s products include influenza, meningococcal, pediatric and travel vaccines. Chiron, the blood testing and molecular diagnostics business, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools.

We have to question the safety of only one vaccine supplier, as this article articulates: Ethics of Vaccines: More problems for Chiron vaccines

From the Vaxine Web Site FEB 2008 press release:

This new trial is a particularly exciting project and the team here at Flinders are looking forward to making a global breakthrough in prevention of influenza-related illness and death by applying Vaxine’s novel influenza vaccine technology to high risk chronic disease populations,” said Dr Dimitar Sajkov, the principal investigator for the latest study.

“It is often forgotten but the current commercial flu vaccines are only partially effective in preventing flu complications, and hence the importance of our developing a more effective flu vaccine” he said. In addition to the coming seasonal influenza vaccine trials, Vaxine is also in final stages of planning for initial human studies of a novel pandemic influenza vaccine.

“Whilst the National Health and Medical Research Council and the previous LIberal government’s Australian Technical Advisory Group on Immunisation didn’t place any importance on such research into improved influenza vaccines, we believe these views to be extremely shortsighted and leaving the Australian public at extreme risk in event of a serious influenza outbreak,” said Professor Nikolai Petrovsky.

The Australian 22 August 2007: Sweet discovery on flu vaccine:

“MEDICAL researchers have found that adding sugar to flu vaccines could make them 100 times more potent. And the man behind the breakthrough, Nikolai Petrovsky, yesterday said he was living proof that the method worked: when he injected himself with the compound, tests showed his immunity to influenza had increased 50-fold.”

This I like.  The man has the guts to use himself as a test pig. Well done!

“‘I suppose you could say the proof’s in the pudding,’ said Professor Petrovsky, director of diabetes and endocrinology at Adelaide ‘s Flinders Medical Centre. But the announcement, trumpeted by the South Australian Government as the ‘world’s best flu protection,’ was greeted coolly by the nation’s medical research establishment after Professor Petrovsky said he had yet to report his findings in a scientific journal.”

Funny that! I also find no records of CSL publishing either.

“‘His research sounds potentially interesting and I await some published results with interest,’ said David Isaacs, a member of the federal Government’s Australian Technical Advisory Group on Immunisation.

“The key ingredient in Professor Petrovsky’s flu vaccine booster is a plant sugar known as inulin, a staple of some health food products linked to improved immune performance.

“Professor Petrovsky’s team came up with a way to convert inulin into crystal form, which they then used as an adjuvant to increase the potency of existing commercial vaccines. Testing on 15 different animal species – ‘mice, cattle, horses, dogs’ — showed that levels of influenza virus antibodies were up to 100 times greater than what standard vaccination produced.”

Vaxine awarded $2.5m bioterrorism grant – Australian Life Scientist

AdelaideNow… David and Goliath v. swine flu

AdelaideNow… Monopoly blocks swine flu vaccine

Professor Petrovsky said CSL had a multibillion-dollar operation with thousands of staff, while Vaxine operated on “zero” money and less than 20 staff, yet it had created one of the most advanced vaccines “in the world.”

The United States has funded much of the research, and Vaxine is negotiating sales to the U.S. and Japan.

“I think CSL are immensely powerful in science research circles in Australia,” Dr Petrovsky said. “In effect they . . . control the decision-making. They’re very powerful lobbyists and they like having a monopoly.

“They have a monopoly on vaccine manufacture in Australia and I’m sure they’ll do everything in their power to maintain that.”

CSL public affairs spokeswoman Dr Rachel David said that in the current situation it was important to respond as quickly as possible with proven technology, and that only CSL had the capacity to do that.

“Obviously any new advances in the areas of flu vaccination are interesting and exciting,” she said.  “(But) even to get a priority or a fast-tracked approval for a new technology is 12 months. Then you would have to secure manufacturing capacity. All this takes years, so we are not intentionally, and we would not intentionally, shut anyone out of the market.”

Federal Health Minister Nicola Roxon’s spokesman said the Government had signed contracts with CSL five years ago for the provision of vaccines.

Ironically, Vaxine’s struggle comes just a fortnight after it was announced the research company had been nominated for the state’s highest award for a small business.

VAXINE 1st to treat humans H1N1

“Whilst we must be cautious until the outcome of these studies are known, if successful then it signals the beginning of the end for old-fashioned egg-based vaccines”, said Prof. Petrovsky.  “This new approach offers major safety advantages over traditional influenza vaccines as it is free of viral contaminants and is safe for people with egg allergies”.

This new swine flu vaccine includes Vaxine’s Advax adjuvant that induces powerful influenza protection through anti-influenza antibodies, but also T-cells, key components of the body’s defence against the influenza virus.

Clinical trials of the new vaccine are being conducted for Vaxine by Prof. David Gordon at Flinders Medical Centre, Adelaide, Australia and are targetting 300 healthy subjects aged 18-70 years. Vaxine last week won the AMP Innovation Award of the 2009 Telstra Business Awards. Vaxine’s preclinical vaccine research is supported by grants from the US National Institute of Health.

The third player of note in the South Australian “bug boom” is to my mind very opportunistic. It has a board of similar interests to the CSL one, people from Mining, Inc. Uranium, a lawyer as a handy thing to have around, and a huge desire to make lots of money from proposed vaccines. To my mind, this one could fall over, if it doesn’t have some approved products fairly soon. As to how rushed, safe, etc. it is, is anyone’s guess.

Acuvax info see page 6

HBI advisory Board, and Dr Ian Fraser pops up again (the inventor of Gardasil which worsened HPV for women who had the mild form). My, this man sure gets around!

This market has great developmental potential, both therapeutically and commercially. There are currently more than 1000 vaccines in research and development worldwide, and a number of recently announced strategic transactions of between USD $300M to $1B for companies who have promising vaccine products.

Acuvax Limited

Acuvax Limited (ASX:ACU, formerly Avantogen Ltd) is an Australian-based holding company with core competencies in in-licensing, development to demonstrable clinical relevance and early clinical trials, and subsequent revenue transactions which generate up front and progress payments as well as good running royalties.

As Avantogen, the company’s oncology (in partnership with SciClone Pharmaceuticals, NASD: SCLN), nutraceutical (in partnership with Medingen LLC USA) and related portfolios have collectively earned multimillion dollar up front payments . Investment in ACU permits shareholders to participate in revenue generating activities in some of the most promising areas of medicine and biotechnology. The company holds major shareholdings in the publicly listed oncology drug developer Avantogen Oncology Inc, the private US company ACT USA, which is engaged in nutraceutical development, and the privately held Hawaii Biotech Inc, engaged in vaccine development.

As Australians look at all the connections in the vaccine pipeline, we have to question the integrity of the process and the safety of the product. It is our right to make informed choices about which, if any, vaccines to take. I hope some of the info here informs and helps you make a safe choice. It is your right to be able to ask exactly what is in any vaccine (or other medication) before you consider taking it.

HERE: is the brand new info.

http://www.prisonplanet.com/new-evidence-that-the-%e2%80%98swine-flu%e2%80%99-pandemic-is-man-made.html

I am staggered at the timing and NO Coincidence, of this chaps findings. He has done a great job.

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4 responses to “Aussie Vaccine Trials: Does Government-Industry Collusion Put the Public at Risk?

  1. Pingback: CSL H1N1 vaccine gets Australia nod of approval « COTO Report

  2. Pingback: COTO Report Tops 100,000 Visitors « COTO Report

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