Cashing in on the HIV pandemic

First edition published on napnt.org on Monday 16th August 2004

Story and research: Gary Meyerhoff.  Edits: Rob Inder-Smith.

Further research: Scott White.

Introduction

When Australian Prime Minister John Howard promised a $30 million trial of retractable syringes in November 2001 the harm reduction sector saw it as another attack on the human rights of people who use illicit drugs. Three years later, the trial has commenced and we are still framing our response on the basis that the trial is part of John Howard’s war on drugs.

Little did we that know that the trial of retractable syringes in our needle/syringe programs (NSPs) is really a smokescreen for a global push to capitalise on the latest medical novelty device. The retractable syringe is a mega-fraud of chilling proportions by corporate snake-oil salesmen aided and abetted by corrupt politicians.

Underpinning the premise that the world ''needs'' these 21st century syringes, is the inescapable fact that unsafe injecting practices continue to play a major role in the spread of blood-borne viruses (BBVs) such as HIV and hepatitis C (HCV). But that is one of the few truisms in what is a lie of gargantuan proportions. Against this backdrop, has come the retractable, the invention of which is being billed by a cabal of manufacturers as the ''ultimate solution to unsafe injecting practices". (2)

The retractable will cost as much as 10 times more than conventional syringes and this threatens to trigger an increase in unsafe injecting practices in health-care settings in developing countries, and among people who inject illicit drugs. This could trigger a disastrous increase in HIV and HCV transmission rates, rather than end the pandemics, as promised by the corporations developing and/or producing retractables.

Healthcare workers in developing countries are forced to reuse syringes because they just do not have the funds to purchase the necessary medical equipment. People who inject illicit drugs share injecting equipment when they don’t have access to injecting equipment. There is no “ultimate solution” to unsafe injecting practices but syringe companies could put a major dent in the HIV pandemic by donating syringes to countries that can’t afford them and by aggressively lobbying governments to drop the failed war on drugs.

The Corporations dictate government policy, they can end the war on drugs. It is not surprising that they choose not to.

In 2003, nearly three million people died as a result of the HIV pandemic. In the same year, the world’s leading syringe manufacturer, Becton Dickinson made a five hundred million dollar profit (US). In line with their focus on “aggressively increasing revenue growth” the corporation has put profits firmly ahead of the millions of people around the world affected by BBVs.

Australian companies are circling like vultures trying to get a piece of the retractable syringe pie. They are misleading governments, lying to investors and capitalising on the growing numbers of HIV and HCV infections worldwide.

Our elected representatives are backing the corporations all the way, one has even joined them. When you realise that former federal health minister Michael Wooldridge is on the payroll of Ritract, an Australian retractable syringe company, it becomes clear that profit has been the driving force behind this initiative all along.

Retractable syringes are a chilling reminder that if we are serious about addressing the HIV pandemic we cannot rely on the corporate stooges that we call “democratic” governments. It is time we took action ourselves and I don’t mean forming another committee to discuss the “issues”. Corporations now dictate policy to our docile “leaders”.

The real cause of the global HIV pandemic is corporate domination.

If our elected representatives will not show leadership, we must show leadership ourselves.

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Crisis point: the leadership void

Kofi Annan's call for leadership to stem the global HIV pandemic comes as increasing numbers of people become infected with the virus. According to UNAIDS, an estimated 4.8 million people became newly infected with HIV in 2003. This is more than in any one year before.  Today, some 37.8 million people are living with HIV, which killed 2.9 million in 2003, and more than 20 million since the first cases of AIDS were identified in 1981.(3) 

Today’s youth generation is the largest in history: nearly half of the global population is less than 25 years old. They have not known a world without AIDS. (3)

UNAIDS estimates that unless efforts to fight the pandemic are stepped up, there will be 45 million new infections by 2010. Unsafe injecting practices dominate HIV transmission rates in Asia and Eastern Europe. Despite this, Kofi Annan's call for leadership has fallen on deaf ears. He himself has failed to show leadership in the face of this crisis, though his task is made more difficult because groups within the UN are at loggerheads about how to deal with the problem.

The International Narcotics Control Board is striving for a drug-free world, whereas UNAIDS realises that this is an impossible dream and is calling for the implementation of harm reduction (HR) measures such as needle/syringe and substitution pharmacotherapy programs.

While the World Health Organisation and UNAIDS have consistently expressed support for the introduction of NSPs to reduce HIV infection, neither has objected to the over-criminalisation of drug users by UN drug-control agencies. Even the UN General Assembly appears impotent. In 1998, participants pledged to eliminate or significantly reduce drug-trafficking and drug-use by 2008. Just a few years later, in 2001, the assembly endorsed efforts to reduce HIV transmission which included the establishment of needle and syringe programs (NSPs). (4)

Governments have also failed to show effective leadership. According to the Open Society Institute, "There is no question . . . that a divided approach to drug use and HIV is already common in countries with injection-driven epidemics, and that the split appears to be accelerating, rather than containing, the spread of HIV.” (4)

This lack of leadership on an international and national level left the door wide open to a coup by the corporate sector which, with true capitalist diligence, has taken on the mantle of "our leader". Strategies are based on the level of profit they can generate. Sadly, the number of human lives saved is secondary.

Announcing the appointment of former Eli Lilly CEO Randall Tobias (below left) as Coordinator of his Global AIDS Initiative, US President George Bush said: "I have chosen a superb leader who knows a great deal about lifesaving medicines, and who knows how to get results." (5)

The response of the major pharmaceuticals to the production of cheap anti-retroviral drugs by developing nations is a well known example of the corporate approach to human life. But the retractable syringe and the motives behind it are not so well known. (7,8) 

Syringe manufacturing is a multibillion-dollar industry dominated by three corporate giants, Becton Dickinson, Tyco Healthcare, a division of Kendall, and Terumo,  and their market power allows them to keep syringe costs artificially high. An inevitable result is the reuse of syringes by health-care workers in developing countries and in some regions, people who inject illicit drugs.

According to the New Jersey-based BD, 16 billion injections are administered worldwide every year. In the developing world, as many as 40 per cent are given with reused syringes, exposing people seeking medical care to possible infection by a BBV.

To say that BD did well in 2003 would be an understatement. Reported revenues increased 12 per cent to $4.528 billion and net income, by 14 per cent to $547 million. Like all true capitalists, however, BD want bigger profit margins and in a letter to shareholders, Edward J. Ludwig - who is lucky enough to be not only BD's chairman, but its president and CEO - said:
 
“Over the course of our history, BD has made important contributions to better health the world over. Yet, it is the way we have gone about our business that brings to life a key BD character trait: We are never satisfied with our accomplishments.”  In his letter, Ludwig (below) outlines the core strategies of BD which include "to aggressively increase revenue growth". (9)

The means to this end is the retractable: no more reuse of the conventional first-generation device by people who inject illicit drugs or by poorer countries forced to such recourse because costs prevent renewal of each ''sharp'' as it is used. Along comes BD and Co. who, in what might have been a moment of drug-induced entrepreneurial genius, come up with the magic formula to milk profit from each and every one of their syringes. Not only do they blast profits into the ionosphere, they plug the ''money hole'' of reusability.

Tyco Health Care - which has made no secret of its ''aggressive organic growth effort” -  was recently awarded a contract worth well over $100 million to supply its retractables to US hospitals. Japan's Terumo is almost soothing in its stated aims: "By . . . introducing a range of products to prevent infection and reduce risk to patients and medical practitioners, (Terumo) advance our longstanding commitment to offer products that are as safe, patient-friendly and trouble-free as possible . . . Ultimately, such peace of mind is priceless.” (10,11)

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Corporate leadership

Chris Talbot, writing for the World Socialist Website, puts it simply: "The massive gap between what could be done and what is being done about HIV/AIDS is an indictment of the entire capitalist system. When a small group of wealthy people holds in their hands the means to prolong the lives of millions and refuse to give what is needed, the only answer is for the majority to take these selfishly hoarded resources and put them to use.”  (7)

States marked in dark blue had mandated use of retractable syringes
as at the date of publication (14)

Ludwig, a board member of both organisations, was recently elected chairman of New Jersey-based Health Care Institute of New Jersey (HINJ) whose membership, as stated on the HINJ site, ". . . is comprised of 20 research-based pharmaceutical and medical technology companies. These companies, many of them world leaders in their field, play a major role in determining the state's economic well being and quality of life.” (15)

HLC and AdvaMed play the same role at a national and international level.  HLC's members include Pfizer Inc, Merck & Company, Inc., Johnson & Johnson, and Abbott Laboratories. HLC bills itself as the "exclusive forum for the leaders of our nation's health care system to jointly develop policies, plans and programs to achieve their vision of a 21st century health care system.” (12)

AdvaMed has a similar membership. According to AdvaMed, the US is a major exporter of medical devices, with companies exporting $17.4 billion in 2000 - a whopping 22 per cent of total US production. AdvaMed claims its members produce nearly 90 per cent of the $71 billion worth of health care technology products consumed annually in the US, and nearly 50 per cent of the $169 billion purchased around the world annually. (13)

HINJ, AdvaMed and HLC are where the drug companies and the drug-delivery companies collaborate to ensure mutual benefits for shareholders.

The role of the medical technology companies cannot be overstated. An article in the March 2002 edition of Bioshares, an independent Australian biotech investment magazine, reported that there were now 400 companies throughout the world with more than a dozen Australian companies active in the sector. (16)

Bioshare's editors argue that: "Drug delivery technologies have proven to be a viable tool to provide what is called 'life cycle management' of valuable pharmaceutical products." So viable, the world drug-delivery market was valued at $69 billion. Although well short of the global pharmaceutical market of $330 billion, the industry is growing at twice the rate of the pharmaceuticals. (16)

It is not surprising that Edward J Ludwig has been listed in Forbes' America's Most Powerful People. These so-called industry associations and the syringe manufacturing companies are powerful pressure groups, and they probably rate third behind the military and prison industrial complexes in the US. (17)

The retractable syringe, serving no real purpose, was a hard-sell to the US health system. BD directors realised that government regulation was the only way to guarantee a market for their expensive product. In June, 1998, Ludwig's predecessor, Clateo Castellini, wrote a letter to all members of the US Congress in which he said:

"The cost pressures that currently exist in the health care industry . . . directly affect which products are available to those providing care to patients. It may be the case that the availability of medical supplies with safety features is significantly impacted by these factors. Some form of regulation or other government involvement may be required to address this problem.”

"I want to stress that Becton Dickinson would support government action to further ensure health care worker safety, including legislation, regulations, guidelines, or other solutions . . . we would appreciate the opportunity to participate in the evolving discussion of this issue in partnership with government leaders.” (18)

It didn't take long for the US government to meet the demands of our new leaders. On October 3, 2000, the House of Representatives passed the Needlestick Safety and Prevention Act. This was the first in a series of steps required to mandate the use of retractable syringe technology in the US Health Care system by 2007. The legislation passed the Senate on October 26 and was signed by President Bill Clinton on November 6 (below). (19,20,21)

BD shareholders are already benefiting from the legislation. This is clear from their 2003 annual report: "U.S. revenues from safety-engineered devices increased 19 percent to $680 million, keeping this category our largest single driver of revenue."  They are doing so well, they have announced plans to discontinue US sales of many conventional sharps products.

An example of the intensity of competition, is the $US100 million paid by BD to Retractable Technologies Inc to settle accusations that it had used its commercial muscle to block rival products from reaching US hospitals. (22,23)

Even the war on terror is no obstacle to BD: "The non-discretionary nature of our core products, our international diversification, and our ability to meet the needs of the worldwide healthcare industry . . . will continue to cushion the long-term impact on BD of potential economic and political dislocations in the countries in which we do business, including the effects of possible healthcare system reforms.” (9)

The only challenge remaining for the drug-delivery industry is to sell their lie to the rest of the world - a task made easier by US global hegemony and the various Free Trade Agreements that are spreading like a cancer around the globe.

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Big Lie No. 1: Needlestick injuries
                       
Occupational settings

The Australian National Hepatitis Resource Manual (2001) states: "In the health care setting, the risk of getting hepatitis C from a needlestick injury is estimated to between 2% and 8%. This contrasts with a needlestick injury risk of 0.3% for HIV, and 30% for hepatitis B." These figures are supported by the US Centre for disease control and prevention. The CDC puts it succinctly: HCV "is not transmitted efficiently through occupational exposures to blood.” (24)

If you believe the syringe companies, the numbers of health care workers living with HIV or hep C because of needlestick injuries at work have reached plague proportions. Terumo tells us that 600,000 to 800,000 injuries occur annually in the US. Australia's very own Unitract, quoting BD, claims that in 1998 at least 13,000 health care workers in Australian hospitals had a needlestick injury. If true, this is an unbelievable 35 per day. (25,26)

 

Even The Australian has fallen for the con. In his advertorial of June 23, 2004, "Syringe makers take the plunge", ''reporter'' James Dunn cut-and-pasted the press releases disgorged by the company, stating: "In the developed world, there are an estimated 1million needlestick injuries (NSIs) - accidental prickings - among healthcare professionals a year, with a treatment cost of $6billion."  (27)

This seems highly unlikely in light of  statistics  provided by the US Centres for Disease Control and Prevention which reported a total of 11,784 exposures to blood and body fluids from June 1996 through November, 2000 (24)

Data from Canada also refutes the manufacturers' line. Only 626 exposures had been reported through the Canadian national surveillance system as of January, 1996. (28)

What the manufacturers don't tell us is that injuries from hypodermic needles are only a small component of overall needlestick injuries. Manufacturers are using the term needlestick injury to describe a range of percutaneous (skin penetration) injuries, which put health-care workers at risk of contracting a BBV. As can be seen in the graphic below, only 29 per cent of percutaneous injuries were related to hypodermic needles. Butterflies and intravenous catheters have been associated with a high proportion of needlestick injuries in healthcare settings.

 
Hollow-bore needles and other devices associated with
percutaneous injuries in NaSH hospitals, by % total
percutaneous injuries (n=4,951), June 1995—July 1999. (29)

There are many cheaper ways to reduce the risk of BBV transmission from hypodermic needle injuries than introducing retractable syringes. Canada's CCOHS report a number of factors that could increase the possibility of needlestick injuries -

• "Work conditions that might contribute to an increase in the number of needlestick injuries include:

• staff reductions where nurses, laboratory personnel and students assume additional duties.

• difficult patient care situations.

• working at night with reduced lighting."

The CCOHA reports that inexperienced staff or students are at a higher risk of needlestick injuries. Failure to comply with basic protocols account for a substantial amount of occupational BBV transmission, "while recapping (which) can account for 25 to 30 percent of all needlestick injuries of nursing and laboratory staff. Often, it is the single most common cause . . . up to 30 percent of needlestick injuries of nursing and laboratory staff occur when workers attempt to dispose of needles using sharps containers." (28)

It is fair to say that with nurse shortages forcing greater work loads on hospital staff, there will inevitably be a greater risk of needlestick injuries. But this supposed epidemic of such occupational injuries can be easily contained by improving conditions of health workers and by developing and implementing workplace protocols and guidelines around blood awareness.

Healthcare workers in Australia have been relatively quiet on this issue. This contrasts with the approach of the American Nursing Association who have established a website devoted to increasing awareness of issues surrounding needlestick injuries. The ANA doesn't tell readers that the site is funded by none other than BD. (30,31)

This is not to say that needlestick injuries are not an issue that needs to be addressed. In Australia, three health care workers have died as a result of exposure to HIV in healthcare settings since 1993. The issue at stake here is the motive of the corporations, beating up hysteria in order to maximise profits. The needlestick issue pales in comparison to the millions of people dieing from HIV because of unsafe injecting practices. (32)

Even the Australian government has been forced to admit that the demand for retractable syringes in Australian healthcare settings is very low. Then Federal Health Minister Senator Kay Patterson told the senate in June 2002: “Uptake of currently available technology in health care settings has been low.” (33)

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Needlestick injuries in public spaces

Confirming funding for the Australian trial of retractable syringes in May 2002, Senator Kay Patterson told the Senate "we want to make our public places safer for our children. So the Government will fund a strategy for the introduction of retractable needle and syringe technology into Australia.”  Patterson failed to mention the consequences of the war on drugs and zero-tolerance policing. Drug-users are often forced "underground", where they are forced to weigh the odds of safely disposing of injecting equipment, and being busted on their way to the local NSP. (34)

Running the gauntlet this way is just one aspect of the war on drugs being waged at the street level, and which is evidenced in Australia by sniffer dogs at big-city train stations and random police searches. The effects of zero-tolerance are harshest in cities such as Melbourne and Sydney, where all but the richest drug-users have reason to be concerned for their rights. Yet the fact remains, in the right environment and with the right information, people who inject drugs safely dispose of injecting equipment. (35,36)

Even in Australia, people in possession of used needles and syringes still face “self-administration” charges if arrested.

In the June edition of the Journal of Paediatrics and Child Health, a Royal Melbourne Children’s Hospital study of 50 children over a period of 32 months who had sustained community needlestick injuries, found that none had contracted HIV, HBV or hep C, despite evidence that HIV remained viable in a syringe for four weeks, HCV for five months, and HBV for 12 months. (37)

The findings of this study are supported by much bigger studies in Rome (408) and Madrid (249). In those studies there were no cases of HIV infection among patients who had suffered a needlestick injury. (38)

Delegates at the 2004 ANEX Harm Reduction Conference were told that syringes are a strong symbol of fear and that their presence can contribute to an increased perception of danger. This is despite the fact, always ignored by the Murdoch press, that there are no known cases of transmission of BBVs through needlestick injuries sustained by members of the public in Australia. (39)

It is reasonable to suggest that the risk of contracting a BBV from a needle/syringe discarded inappropriately in a public place - one subject to the ravages of time and weather - is much lower than in an occupational setting. Community perceptions about the dangers of discarded sharps are a result of the low level of understanding within the community of BBVs in general and the deliberate stigmatisation and demonisation of people who inject drugs by governments at all levels.

A fundamental fact ignored by the syringe manufacturers and governments alike is that people who inject illicit drugs dispose of injecting equipment appropriately more than ninety-nine per cent of the time. In fact they feel they have a responsibility to do so. When they don’t, it is nearly always because of government policy. (35,36).

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Big lie No. 2: Unsafe injecting practices

Unsafe injecting practices in health-care settings

"Every year Sub-Saharan Africa spends $14.5 billion dollars repaying debts to the world’s rich countries and international institutions. Often they spend so much on debt payments that they have very little left over for health or education– in Nigeria, debt payments are eleven times higher than the national health budget.” (40)

The reason syringes are reused in the first place, is because health-care agencies in poorer countries can't afford to buy them. The World Health Organisation makes a lie of anything to contrary:

"Adequate supplies should be made available to comply with basic infection control standards, even in resource constrained settings. Provision of single use, disposable injection equipment matching deliveries of injectable substances, disinfectants and 'sharps' containers should be the norm in all health care settings. Attention should also be paid to protective equipment and water supplies . . . While running water may not be universally available, access to sufficient water supplies should be ensured.” (41)

The key WHO recommendation is that drug companies should provide the required amount of injecting equipment with drugs that they sell. This is easy enough, especially when the drug companies and syringe manufacturers are sitting around the table together in New Jersey. Obviously they have decided that to do this would not be in line with their aim of “aggressively increasing revenue growth.”

The retractable syringe will not be the ultimate solution to unsafe injecting practices in the developing world. If anything, the cost of the device will force healthcare workers to reuse conventional syringes more times than they do at the moment. There is no guarantee that retractable syringes can’t be reused and it won’t take long for people in desperate situations to work out how to disable the retract mechanism.

Another ignored factor in the global HIV pandemic is war. BD may be protected against the impact of “political dislocation” but for many healthcare workers, adhering to the WHO protocol is extremely difficult, sometimes impossible, wherever there is armed conflict. (3)

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Unsafe injecting practices by people who inject illicit drugs

Syringe manufacturers claim that the retractable syringe will save millions of lives by preventing unsafe needle use. What they don’t point out is that unless countries move away from the zero tolerance approach to drug use and implement needle and syringe programs in the first place the retractable syringe is useless.

As previously identified, the UN's contradictory approach to the enormous web of issues surrounding the HIV-illicit drug equation is preventing any real reduction in the rate of HIV transmission.

"Drug-use and HIV vulnerability remain issues of great concern for many countries in Asia and the Pacific . . . in some geographical areas, more than 60 per cent of all drug-users are HIV positive.”  In Indonesia, the rate of spread 1999 and 2003 was three-fold - from 16 per cent to 48 per cent. (3,42)

Eastern Europe has similarly high rates of infection among people who inject drugs and in Russia, a staggering 90 per cent of people diagnosed with HIV in 2002 were injectors. In 2002, people who inject drugs accounted for more than 10 per cent of all reported HIV infections in Western Europe. In the United States, which shuns NSPs, about 25 per cent of HIV infections are attributed to drug injecting. (3)

The prevalence of hep C among people who inject drugs in all those countries where it is present, are higher than rates of HIV infection. In Australia, more than a quarter of a million people have been affected by the virus. As Stuart Loveday, president of the Australian Hepatitis Council told ABC Radio on August 28, 2003, hep C ''shows no signs of slowing." (43)

Epidemics that the syringe companies purport to be able to halt with their new device could be addressed for a tenth of the cost with conventional syringes - something that is being conveniently omitted from the marketing campaigns. There is a common denominator wherever the rates of HIV are high among people who inject illicit drugs; the lack of government-supported NSPs, or where they are present, their extremely limited resources and scope. Many NSPs around the world face a mammoth task in the face of criticism from the media and politicians and in some countries, arrest, beatings, or death.

Paradoxically, Australia, where governments at all levels are hell-bent on taking the country back to the 1950s, has provided NSP services second to none. Statistics show that less than four per cent of HIV infections are related to injecting drug use which is a record to be proud of. Even more encouraging is the fact that only one per cent of NSP attendees are HIV positive. It isn’t all good news; the rate of HIV among indigenous Australians who inject drugs has reached alarming levels and needs urgent action. (32)

Rather than waste money on research and development, BD or Tyco Healthcare could donate the equivalent of a tenth of their profits in syringes for NSPs in developing countries, directly contributing to a major reduction in the transmission of HIV among people who inject drugs. Instead, through their representatives HINJ, HLC, AdvaMed and the like, they provide implicit support for US governments that drive the global war on drugs.

They even have an awards program for politicians who have toed their line. HLC have the "Medical Miracles Award” that "salutes outstanding achievements by a lawmaker in the health care arena.” and AdvaMed gives awards for service to the medical device industry and the US Food and Drug Administration. (44,45)

The failure of these corporate "leadership" bodies to lobby against the war on drugs is evidence that they are benefitting from the drug prohibition. The ongoing drug prohibition is playing a major role in the high rates of BBV transmission among people who inject drugs. The retractable syringe will not be able to address this serious policy issue.

A significant reason for the failure to adopt NSPs is because "governments anxious to adhere to the terms of the UN Convention of drugs sometimes misinterpret the meanings and intent of the conventions.” (42)

In the joint UNAIDS-UNDCP study in Asia, Drug use and HIV vulnerability, three issues are identified as barriers to effective implementation of HR polices and strategies:

"The first is the criminalisation and punishment of drug-use itself.

The second concerns the possession of needles and syringes and other drug use paraphernalia and the extent to which these may be used as evidence in convicting drug users for possession and use.

The third concerns the legitimacy of prescribing opioid agonist pharmacotherapy as a maintenance substitution treatment." (42)

Retractable syringes will not stop these problems. There are many other factors that need to be taken into account when communities try to address the transmission of BBVs via unsafe injecting practices.

An important cultural factor ignored by syringe manufacturers affecting the rate of BBV infection among people who inject drugs in the South-East and South Asia regions is"the use of self-made injecting equipment” and “ . . . the presence of 'professional' injectors who use the same needle and syringe to inject many customers, sometimes dipping the equipment into pots of opium that are contaminated with blood.” (46)

Viruses such as HIV and the more virulent hepatitis C can survive outside the body, contaminating other equipment used in the injecting process and the drug mix itself. (46)

According to the National Hepatitis C Resource Manual, "safer using means more than just using new and sterile needles and syringes. It includes being aware of how easy it is for blood to be transmitted. People may come into contact with someone else's blood when sharing any injecting equipment. Blood from used needles and syringes, tourniquets and fingers - even in microscopic amounts - can get into a shared mix, filters or water and onto injection sites.” (47)

Our prisons are another problem for the corporations who are promoting their new invention as the panacea for unsafe injecting practices.

The ever-expanding prison-industrial complex is a breeding ground for BBVs. Dr Margaret Hillard, from the Macfarlane Burnet Institute for Medical Research and Public Health, told this year's ANEX Conference that 68 per cent of prisoners in Victoria with a history of injecting drug-use were hepatitis C positive. As well, she said that 70 per cent of prisoners with a history of IDU reported injecting drugs while in prison. Prophetically, Ms Hillard added that "continuing to incarcerate drug-users as a solution to the drug problem is negligent.” (48)

This highlights the fundamental flaws in the retractable, whose ''healing qualities'' are not up to such a complex problem.

To the contrary, the retractable could well increase rates of BBV among people who inject drugs. People will not be used to the new piece of equipment and it is probable that more of them will be forced to help each other to inject.  Drug-user advocates are concerned that mandatory replacement of conventional syringes with retractables will result in a black market for conventional syringes, with the attendant risk that these will be reused as they become scarce. (49)

They argue exorbitant cost will be a further impediment to the introduction of NSPs in countries still debating the legitimacy of such a program.

There is also the risk of blood-spatter on retraction of the needle, further increasing the risk of blood-sharing.

There are proven cost-effective responses to this challenge, including minor changes to legislation, implementation of NSPs and outreach services, and most importantly, peer-education programs run for and by people who inject drugs. Government must engage with this target group if they are to ever to check the rate of BBV transmission in their regions. (50)

Australia’s needle and syringe programs are the best example of a cost-effective response to the HIV and hepatitis C pandemics. According to the Australian Government Return on Investment in Needle/Syringe Programs report, approximately 25,000 HIV infections by 2000 are estimated to have been prevented among people who inject drugs since the introduction of NSPs in 1988, and by 2010 approximately 4,500 deaths are projected to have been prevented. (51)

There are similar results for hepatitis C. “By the year 2000, approximately 21,000 HCV infections are estimated to have been prevented among injecting drug users since the introduction of NSPs in 1988, (of which approximately 16,000 would have developed chronic HCV); while by 2010 approximately 650 fewer injecting drug users are projected to be living with cirrhosis and 90 HCV-related deaths would have been prevented.” (51)

For an investment as low as $141 million between 1991 and 2000, total treatment costs avoided over the life of the cases of HIV and HCV avoided by NSPs are approximately $7,808 million (Australian dollars). (51)

“In summary, the study indicates that the financial return on investment will exceed manyfold the original investment in NSPs, and that the original investment had been fully recouped and surpassed by the end of the investment period, before any future savings are taken into account. The investment in NSPs is justified by the effect on HIV alone, with the effect on HCV providing an additional financial benefit, albeit a smaller one than HIV.” (51)

This has been achieved without retractable syringes.

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Retractable syringes in Australia

It is nearly three years since the announcement that the Australian Federal Government would fund a trial of retractable syringes. Billed as the ultimate solution to unsafe injecting practices, much of the harm reduction (HR) sector adopted a wait-and-see approach.

Workers expressed concerns about the impact of the trial on their efforts to reduce the number of HCV infections and maintain the very low level of HIV among people who inject illicit drugs. Some workers saw it as just another attack on illicit drug-users by a government determined to make every aspect of our lives difficult. (49)

While some HR agencies and drug-user groups reluctantly participated in the retractable syringe trial, others called for a boycott of the process. Those on the ''inside'' outlined their own concerns. But the fact remained: the initial ''sign-on'' was more like conscription and nobody really understood the true motivations behind the trial.

The Government was always going to introduce retractables whether we liked them or not. There was something else we didn't know about, the Wooldridge connection.

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Official corruption

The retractable syringe adventure was set in motion by former federal Health Minister Michael Wooldridge before he resigned from federal parliament in September, 2001.

After aggressive lobbying from syringe manufacturers, in July, 2000, the Ministerial Council on Drug Strategy set up a sub-committee to develop an options paper and cost benefits analysis on retractable syringes. As federal health minister, Wooldridge would have been present at the meeting and if not, he would have been privy to the discussions that took place around these syringes.

Wooldridge has a history of corrupt behaviour. His antecedence shows at least two scandals out of which he managed to wiggle his way unscathed. (52)

Wooldridge left the big house under a cloud, after revelations that just before resigning, he had promised $5 million to the Royal Australian College of General Practitioners. He was promptly employed as a consultant with the college. Before that was the controversial MRI scandal that blew up in his face in October 1999, in which he was accused of divulging sensitive budgetary information to radiologists over dinner. He escaped both embarrassments, but the public attention and aroma of corruption became too much for the GPs who were forced to terminate his contract in July 2002. (53,54)

At least seven Australian companies stand to make a killing from the introduction of retractables. For them, the Wooldridge Trial is the backdoor to distribution across the board, and not just into NSPs. Unitract, Analytica, Medigard, Ensi-Med,  Occupational Medical Innovations, Eastland Medical Systems and Ritract are just some of the companies who are trying to break into the market. (26, 55, 56,57,58,59,60)

The government had assured stakeholders that the initiative would only be advertised within Australia to ensure that an Australian company would successfully tender for the trial. (61)

Our sources indicate that only one Australian company responded to the request for information for the Wooldridge Trial - OMI. Others included Texas-based Retractable Technologies Inc, with its Vanishpoint syringe, and Lucra Trading (Securegard). At time of publishing, it is believed that the US manufactured Vanishpoint had won favour.

Perusal of the companies' websites reveals certain striking similarities. But one company, Ritract, stands out for the fact that it has a former federal health minister on its team - the architect of the retractable trial, Michael Wooldridge. The company also aims to buy out other retractable syringe patents, so it is very useful to have Wooldridge, with access to privileged information, on their team. (62)

Wooldridge timed his resignation perfectly, setting up a buffer between the date he finished as health minister and the date of commencement of the pilots. He has done spectacularly well to keep his relationship with the company quiet. The Australian is playing along with the appalling charade, with at least two of its scribes conveniently neglecting to mention that Wooldridge is on the Ritract take.

Three days after an advertorial by her co-staffer, James Dunne, the Oz's Helen Matterson beefed up the snow-job with a 13-paragraph piece that included a plug in the heading: "RiTract early jab gets judge's points in contest". (63)

The Ritract prospectus says it all: "From 1996 to 2001 he (Wooldridge) was a member of the Cabinet Budget Committee (Expenditure Review) and thus played an integral part in federal budget allocations not only in the health sector but across all sectors of the Australian government." (62)

And further: "Through his supervision of the Health Insurance Commission, Dr Wooldridge had overall responsibility for the Pharmaceutical Benefits Scheme and for the Therapeutic Goods Administration in Australia.”

The Australian's pair of news hounds also failed to mention that Wooldridge was appointed by health minister Tony Abbott as the chair of the new Ministerial Advisory Council on AIDS, Sexual Health and Hepatitis (MACASHH), which had its first meeting in March this year. This means that Wooldridge will still have his finger on the pulse and be able to steer Ritract toward financial success. (64,65)

No mention that he also served as the chair for the World Health Organisation’s East Asia and Western Pacific Region and was also Global Chairman of UN AIDS, the peak UN body dealing with HIV. (66)

The fact that Wooldridge continued to access his parliamentary email account until March 2002 was also ignored. For four months Wooldridge had access to information that he should not have been privy to. (65)

It's no surprise that Ritract's is the second Australian syringe to be approved by the Therapeutic Goods Administration for distribution locally. As managing director Rupert Northcott told Helen Matterson: "We have managed to accelerate our development to overtake other competitors in the syringe market,” (62)

The 1984 Readers Digest Great Illustrated Dictionary defines corrupt as: "1. Immoral; perverted; depraved. 2. Marked by or guilty of venality and dishonesty, especially bribery.” A strong case has been made out for official corruption - a charge that Wooldridge and some current cabinet members should forced to answer. (6)

The least the HR sector could do is demand Wooldridge be sacked from MACASHH, and that he and those MPs who have aided and abetted him, such as Patterson, Abbott and Howard, be arrested and put on trial.

As a footnote, there are similarities between the Wooldridge retractable trial and the MRI scam of 1998. In both scams he escaped any criminal charges. Both scams also relate to medical technologies that Wooldridge has a financial interest in; the retractable syringe via Ritract and magnetic resonance imaging. Wooldridge was elected chairman of MRI technology company Resonance Health Limited in October 2003. (66)

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Reaction to the trial

The deceit had its genesis in September 2002, when the government invited industry to submit information on retractable needle and syringe technology already in the market place or under development. Interested companies were told that they may be invited to tender for the supply of retractables for the Wooldridge Trial.

In November 2002, the community sector was conscripted into the process. National "consultations" were held around Australia to discuss the initiative and seek the views of stakeholders. People from government agencies and the health care sector, plus people who inject drugs, diabetics and retractable syringe manufacturers, attended the meetings.

Health care workers and diabetics were never keen on the retractable. They made their disdain clear, with the result that both sectors were jettisoned by the Government, leaving people who inject illicit drugs alone to bare the dubious honour of being crash-test dummies for the Wooldridge Trial. Undeterred and indifferent in the face of universal rejection of the concept, the Government ran with the Trial. (61)

The government even knew that the retractable syringes they were trialling were not appropriate for the target group. Senator Kay Patterson told the Senate in June 2002: “There are a number of designs of retractable needle and syringe technology, either in the prototype stage or currently available for use in Australia, and these are predominantly suitable for use in health care settings by health care workers and not by people who self-administer injectable drugs.” (33)

An implementation reference group was established as a reference and advisory group to, as the government put it, "provide independent advice to the Department on implementation of the initiative . . . comprised of stakeholders with a range of expertise relevant to implementation of the Initiative.”  (67)

Stakeholders included members of the Australian Needle Exchange Association (ANEX). Also on board were representatives of those people the government and companies involved needed more than anything to legitimise the whole deal - illicit injectors themselves, via the Australian Injecting and Illicit Drug Users League (AIVL). (68,69)

The Wooldridge Trial was revised in the 2003-04 Federal Budget and reduced to $17.5 million. Budget papers confirmed that retractables would be trialled only in NSPs and not in health-care settings. Some of the initial funding was to go towards development of prototypes. But when the Government admitted that some companies were already manufacturing retractables, the funding package was revised accordingly. (70)

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Top secret

The Government obtained an ethics clearance easily for its prototype trials on NSP users. For the privilege of being a guinea pig for an unproven piece of equipment, each participant receives a small monetary reward. With enormous veils of secrecy flapping from the masts, it was plain sailing for the government and by mid-2004, retractables were being trialled in NSPs in at least three cities. (71)

The government is being so secretive about the Wooldridge Trial that they have forced the members of their implementation reference group to sign a “deed of confidentiality”. (61)

The Wooldridge Trial is being conducted by the Department of Health and Ageing's population health division. The department's website suggests that everything is kosher. The truth is, the Trial is far from transparent, and should be retitled the retractable X Files. So anxious are the people driving this scam to conceal details, they have gone all-out to hush up events such as this year's ANEX HR conference, which was told unabashedly by one speaker that NSPs and companies participating in the pilots would not be named.

The speaker, Jennie Shortt, was assistant director for the retractable needle-syringe technology intitiative, and her job was always going to be difficult - trying the hard-sell on a room full of NSP workers vehemently opposed to retractables. Her talk was not well received but she did let slip one line that summed up the entire modus operandi: ''We need to be strategic and calculated in how we do this.”

One journalist who did not hear these prophetic words was Radio Triple J's Ali Benton. In an astonishing demonstration of what our leaders think should and should not go on the public record, conference organisers ejected her before Ms Shortt began speaking. Later, Ms Benton interviewed several delegates. But curiously, her reports never reached the airwaves, suggesting that censorship was at work outside the conference as well as within.

For the record, one of the participant NSPs was Sydney's Kirketon Road Centre. The Sydney based drug user group, the NSW Users and AIDS Association withdrew from the trial “due to concerns about the safety of the proposed retractable syringes.” (72)

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Experimenting on human subjects

Aside from the Wooldridge connection, there are many reasons why the outrageous Wooldridge Trial should never have been allowed to proceed. It is a human rights covenant, however, the Nuremberg Code, which alone is sufficient to force the Trial's immediate abandonment. The Code was drawn up in 1946 during the Nuremberg Trials, in which 23 Nazi physicians went on trial for crimes committed against prisoners of war. It consists of 10 conditions that must be met to justify research involving human subjects. (73)

Half-a-century later, the Wooldridge Trial was granted its ethics clearance by the Australian government. Though a political initiative, the Trial is being conducted by a private Sydney firm, the Research Forum, which is faced with the impossible task of conducting the trial in an ethical manner.

The Forum's past customers include, AusIndustry, the Australian Customs Service, the Australian Taxation Office, Centrelink (Australia's welfare payment agency), the Commonwealth Department of Finance, the Department of Immigration and of course, the Pharmaceutical Society of Australia. (74)

After a presentation by the Forum's Dr Fadil Pedic, at this year's ANEX Harm Reduction conference, it becomes startlingly clear that the Trial violates almost all of the Code's principles.

The Code states:"The protagonists of the practice of human experimentation (must) justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study . . . however . . . certain basic principles must be observed in order to satisfy moral, ethical and legal concepts.”  (73)

The failure of the Trial to comply with the Code's principles should be grounds for the cessation the Trial.

Principle 1: ". . . consent . . . is absolutely essential (and the subject) must have legal capacity to give consent”. There is also reference to fraud and deceit, and the stipulation that volunteers have "sufficient knowledge and comprehension of . . . the subject matter” so they can make an informed decision. They should be privy to all possible "inconveniences and hazards” that might arise from the experiment.

The consent form issued to participants states:

"Potential physical risks include skin irritation or bruising due to using a different syringe type. Potential psychological risks include distress, fear, anxiety and frustration associated with trying the new syringe type, completing the survey or taking part in the focus group or being asked to do any of these.” (75)

The Forum has conveniently left out reference to other possible harms associated with injecting drug use such as vein collapse, complications associated with injecting into arteries, "dirty hits'', impact on the immune system, endocarditis, abscesses, overdose, septicaemia, tetanus, embolism, not to mention the risk of arrest and incarceration by police. (46)

They also ignore risks associated with the presence of blood and fail to warn participants about other things that could potentially increase the risk of BBV transmission, such as helping each other use the devices, and the risk of blood-splatter when the syringe retracts. Yet in the Forum's methodology document, they merely state: "While vein care problems and infection are risks associated with injecting and injecting drug users, there is no evidence to suggest participation in the current study will increase these risks.” This is a cynical way for the Forum to say that " 'junkies' are taking these risks anyway, and therefore we don't have to worry about that stuff". (71)

This clause in principle one is also a worry: "The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.”

Responsibility for recruitment of Trial participants has been delegated to assistants who, while qualified to meet the requirements of most NSPs, have neither the knowledge nor expertise to conduct the Wooldridge Trials. The Forum has contravened the above clause by delegating responsibility with impunity. (71)

Principle 2: “The experiment should . . . yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.”

The Wooldridge trial is the most cynical exercise in making a cabal of powerful corporations richer. No good will come from it.

Principle 3: which states that "anticipated results (should) justify . . . the experiment”' - invalidates the Trial because of the fallacious arguments that brought it into being,

Principle 4: “The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.”

This experiment is conducted by the subjects of the Trial themselves, people who inject drugs. On attending their local NSP, service users are asked to participate in the Trial. Volunteers are given a package of retractable syringes to take home (if they have one) to inject illicit substances without any supervision whatsoever from the Trial organisers. (71)

The researchers would require a change in commonwealth and state/territory legislation if they were to properly comply with the Code's fourth principle. It would be illegal for researchers to assist or observe the volunteers with the drug administration process, they could be charged with "administering a dangerous drug to another person". This important legal point ensures that the fourth principle of the Nuremberg Code cannot be complied with in the current climate.

Principle 6: "The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.”

"Humanitarian importance'' has nothing to do with the Wooldridge Trial. As clearly indicated by the evidence, the retractable syringe will have a limited impact on the HIV/hep C pandemics. There is however, a degree of risk that as nations mandate the use of these devices - at the behest of their corporate leaders - rates of transmission of BBVs will increase.

Principle 7: "Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.”

As previously stated, volunteers are provided with a package of retractable syringes to take-away from the premises and use at their home or usual place of injection. Volunteers are not supervised at any stage of the injection process, due to the legal minefield facing the Forum and the Government. The only facilities provided for volunteers in the Wooldridge Trial are a website and a 1800 phone number, and a small monetary reward as compensation  - hardly adequate enough to "protect . . . against even remote possibility of injury". (71)

Principle 8: "The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.”

The volunteers in this Trial are forced to test this experimental medical device on themselves, without adequate supervision or facilities. The volunteers in the trial receive no training whatsoever prior to their involvement, they are laypeople and should not be expected to conduct this experiment on themselves. (71)

The Nuremberg Code determines "criminal culpability and punishment" and should have been the reference point when determining whether or not the Wooldridge Trial received its ethics clearance.

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Calling on the watchdogs - ACCC, ASIC, TGA

Australian Competition and Consumer Commission

Complicit companies have embarked down the well-travelled road of misinformation and deception. Health-care workers are being misled, governments are being duped and investors are being sold a croc.

The Australian Competition and Consumer Commission (ACCC), a supposedly independent Commonwealth statutory authority formed to administer the Trade Practices Act,  needs to take action to stop this diabolical fraud. (76)

The ACCC makes it clear that staff and representatives of organisations can not mislead or deceive, regardless of whether the misrepresentation is deliberate or accidental. "What matters is the impression left in the customer's mind." All of the retractable companies are breaching Section 52 of the Trade Practices Act and relevant legislation in the state/territory in which they are based. This deception is so widespread and extreme, that it also breaches Section 51 of the Act which deals with "unconscionable conduct". (76)

Following are two examples of deliberate misrepresentation by Australian companies:

Case study 1
Needlestick injuries in occupational settings

"Needlestick injury, which occurs when a person is accidentally injured from a used needle point, is an increasing concern with medical staff and the community exposed to high risk blood borne diseases such as HIV-AIDS and Hepatitis B and C.” (56)

 

"Needlestick injuries occur frequently in the healthcare industry. They are common, dangerous and, in some cases, lethal . . . Injecting drug use is increasing across the world and coinciding with the ongoing epidemic in Hepatitis C.” (55)

We have already dispelled manufacturers' claims that there is an epidemic of needlestick injuries in occupational settings. Statements from Medigard and Analytica confirm that they are deliberately misrepresenting the need and value (both economical and social) of their product. All of the syringe manufacturers are making similar false claims.

 Case study 2
Unsafe injecting practices

 

"Unsafe injections are the most common cause of Hepatitis C infection in developing and transitional countries."  (26)

 

 "Illicit drug users and people in developing countries are at risk from the re-use of needles and syringes." (60)

Despite claims by Australia's Unitract, it is clear from the evidence that this technology is not "the ultimate solution to unsafe injecting practices that will mean a safer world for everyone." (2)

According to the ACCC website, the failure to make any mention of an important matter in the context of an overall presentation can sometimes be misleading conduct. “What is not mentioned may be an important element in creating the correct overall impression about the product or service.” Silence can thus be conduct that misleads, or is likely to mislead. (76)

All of the Australian syringe manufacturers are deliberately leaving out facts from their presentations, facts that blow the whole concept of retractable syringes out of the water. There is clear evidence of this omission of facts at each of the websites of the offending companies. The ACCC states that it makes no difference whether the omission is intentional or not in order to mislead. In this case, with all of the evidence in front of us, it is clear that these companies are either being run by morons, or that this is a calculated attempt to mislead governments and other potential buyers of their products.

The ACCC also remind companies not to engage in unconscionable conduct, what they describe as being taken advantage of in a transaction in a way that offends the conscience.  When corporations start to play on the deaths of millions of people around the world to sell a product that is not needed, that is unconscionable conduct.

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Therapeutic Goods Administration

Australian companies are also breaching the advertising guidelines of the Therapeutic Goods Administration.

The TGA states: "Advertisements for therapeutic goods, including devices, directed to consumers are required to comply with the Therapeutic Goods Act 1989, Part 2 of the Therapeutic Goods Regulations 1990 and the (TGA) Advertising Code.” (77)

Goods advertised must . . . contain "correct and balanced statements only and claims which the sponsor has already verified”.

It seems unlikely that the advertisers in this case have verified all of their claims. Unitract’s claim about “a safer world for everyone” is absolutely ridiculous. When you note that Unitract quote the world’s leading syringe manufacturer BD rather than any credible sources of evidence it would seem that they are breaching TGA guidelines. The fact is no scientist in their right mind would verify the claims of syringe manufacturers that their invention will save millions of lives. 

Advertisements . . . "must not be likely to arouse unwarranted or unrealistic expectations of product effectiveness . . . mislead directly or by implication or through emphasis, comparisons, contrasts or omissions; abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or distress (or) contain any claim, statement or implication that it is infallible, unfailing, magical, miraculous, or that it is a certain, guaranteed or sure cure . . .” (77)

Abuse of trust, exploitation of the lack of knowledge of consumers, sounds like the catchcry of the pharmaceutical industry. These are the tactics that have been adopted by Australian syringe manufacturing companies without hesitation.  In the introduction to this article, the manufacturers were compared with snake-oil salesmen. The syringe lobbyists are marketing their devices on the basis that they are going to save millions of lives and virtually end the HIV and hepatitis C pandemics.

The response to these pandemics is complex on all levels, economic, political and social. There is no magic bullet and it is improper and obscene for corporations to claim to be able to do so.

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Australian Securities and Investment Commission

Potential investors are required by law to be fully informed of a company's operation. The stupefying sums of projected income are one thing. But it is unlikely that in the least, investors and shareholders in companies pushing for the introduction of retractables are fully aware of the extent of competition. One company has already gone broke and the license to produce its product, Uniject, has been bought by BD.

Shareholders would be concerned by two Sydney Morning Herald reports from mid-January 2004 in which the business record of Unitract CEO and executive director Alan Shortall took a hammering, as did the company's shares. One name that leapt from the SMH of January 17, was that of disgraced former New South Wales detective Roger Rogerson, who is a Shortall associate. The Scotsman of July 25 explored the magnitude and volatility of competition. (23,78)

Alan Shortall (left) Unitract CEO, Roger Rogerson (right) Corrupt NSW Policeman

Unitract is the best example of the deceptive baiting of investors that syringe manufacturers in Australia have engaged in over the past few years. This company has conned many an investor to back their syringe and they have grown substantially over the past few years. They fail to tell their investors that they are up against four hundred companies in the US – and competition with those companies will be a reality now that we have signed the free trade agreement – and they fail to tell their investors that the whole size of the retractable syringe market relies on myths.

We can only hope that ASIC will take some action against these companies for misleading investors who risk losing millions of dollars. Ritract deserves special attention after the revelation that Michael Wooldridge has used inside information to benefit that company and in turn, himself.

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Summary

Koffi Annan's call for leadership to tackle the HIV pandemic has been hijacked by corporations whose primary stated aim is to increase revenue for their shareholders, not to reduce the growing number of HIV related deaths on every continent.

Through organisations like the Health Institute of New jersey and the Health Leadership council, corporations have taken charge of national and international health policy to the detriment of billions of people worldwide.

Syringe manufacturers have adopted tactics of deception, asserting that needlestick injuries and unsafe injecting practices, and the subsequent risk of BBV transmission, can be avoided by the use of their product. They have ignored the complexity of the issues faced by health care workers in developing countries and people who inject drugs across the globe.

The introduction of retractable syringes in Australia has been through the back door. The trial of these devices in Australian NSPs has been veiled in secrecy, possibly to prevent the media and the public from making the Wooldridge connection. The fact that former health minister Michael Wooldridge is set to make a direct financial gain from the opening of an Australian market for retractables, is enough to prompt the Australian Federal Police to commence an inquiry into his conduct.

Australian companies have mirrored the multi-nationals' marketing strategy and have blatantly flouted trade practice laws and guidelines issued by the Therapeutic Goods Administration for the advertising of medical devices. Potential investors are being sucked in to this fraud and stand to lose significant amounts of money when the bubble bursts.

Despite the lack of support across the board, the Australian Government has pushed ahead with this trial of an experimental device on human beings. The Trial breaches numerous principles of the Nuremberg Code and should be stopped immediately.

Nearly three million people died of HIV related causes in 2003. If the syringe manufacturers and their drug-producing allies are allowed to continue their reign, this figure will continue to grow until HIV has affected every family on the planet. It is time we did something about it.

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