Del Bigtree misleads his audience over vaccine safety testing

In a second episode dealing with the Lies of Vaxxed published by More Truth © an old standard of the anti-vaccine lobby is subject to facts.

The lie Del Bigtree smothers his uncritical audience with is that, “there is not a safe vaccine out there” presumably because as he continues to lie, “there is not a decent safety study on any of the vaccines”.

Lies of Vaxxed: Episode 2 “Vaccine Safety Testing”

What we learn from the video above is that there are six main stages of vaccine development is the US. Including;

  • Exploratory
  • Pre-clinical
  • Clinical development
  • Regulatory review and approval
  • Manufacturing
  • Quality control

During the exploratory stage scientists focus on identifying an antigen that can prevent a specific disease. Without success during this process development goes nowhere. It cannot continue. Nonetheless, the exploratory stage takes years of diligent laboratory research.

When the exploratory stage yields viable results production continues into the pre-clinical stage. Here progress with tissue or cell-culture preparation involves animal testing. This aspect of the pre-clinical stage will assess the safety, or lack thereof, of any potential vaccine. Another aspect of the pre-clinical stage is assessing the ability of the potential vaccine to stimulate an immune response.

Despite the cost and time invested by this point, the majority of potential vaccines do not satisfy the rigour of the pre-clinical stage. In these cases again development cannot continue.

The diligence of the clinical stage can be seen as a three part process.

  • In the quest to ascertain safety, trial vaccines are tested on a small sample of healthy adults.
  • Vaccines are tested on a sample of several hundred adults.
  • Finally the clinical stage involves testing the vaccine on tens of thousands.

With vaccines being developed for children the clinical stage process continues. The age of test subjects is lowered incrementally until the target age is safely reached.

The final stages of clinical development include randomised and double blind trials. The potential vaccine is tested against a placebo. It takes from six to ten years to complete these safety tests. Whilst medications in the USA are subject to the same intense testing it’s worth noting that sample populations are three times smaller than for vaccine studies.

There are six more stages overseen by the FDA for regulatory review and approval of vaccines. This involves safety inspection of manufacturing facilities by the FDA and even more testing.

Safety monitoring, including phase IV trials, continues indefinitely once a vaccine has been approved. In the USA there is the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink – a nationwide set of linked databases.

I certainly recommend watching this video because it is clear that safety is the primary element in vaccine manufacture. Claims to the contrary by Del Bigtree and the Vaxxed cronies are demonstrable lies. Under present manufacturing guidelines and restrictions most potential vaccines do not reach clinical development. As is clear in this video the reason is safety.

Professional anti-vaccinationists like Bigtree, or any who promote Vaxxed in order to consciously profit from their manufactured controversy, are a malignant force in public health. As such they deserve our derision.

 

♣ Despite this reality, in Australia the self appointed “vaccine experts” from the anti-vaccine lobby such as Meryl Dorey, Judy Wilyman and Tasha David insist no randomised double blind trials or testing against placebo has ever been carried out.

♥ Australians may likely remember from 2010, a significant number of AEFI. Febrile seizures in children aged 6-59 months following administration of CSL’s Trivalent Influenza Vaccine. One chid was ultimately compensated. This event resulted in the FDA inspecting CSL laboratories and outlining five “objectionable conditions”. Australia’s TGA reported at length on the event, the FDA inspection and the process of TGA inspection of CSL manufacturing facilities.

Whilst this was an unwanted, unfortunate event, it is also an example of safety and quality control procedures being firmly implemented.

 

Alternatives to medicine continue to sail a wave of misinformation

Every week up to a thousand Australians are dying in the public hospital system alone from adverse reactions to properly prescribed medication and hospital borne infections and medical error. This is the elephant in the room. If the government and medical community are really concerned about the health of Australians, why aren’t they doing something about this obvious, um, huge cause of death in Australia instead of worrying about measles?

Meryl Dorey, anti-medical science lobbyist – October 19th, 2013

The arguably spectacular misinformation Meryl Dorey pushes as an antivaccinationist, comes often as what can most kindly be called an utterly ridiculous mantra designed to promote fear of scientific based medicine.

double standards

This was in response to eight infant fatalities associated temporally with Hepatitis B vaccination in China. Regrettably China’s growing success with mass hepatitis B vaccination has now met a challenge. Fortunately in China the medical community is working effectively with the evidence and training they have. Despite the unambiguous harm HBV has caused China and the success of HBV vaccine programmes worldwide, Dorey commented on Facebook as seen above.

I won’t overly review Dorey’s claims on medical error and hospital borne infection. Although (updated in December 2011) a 2009 report from the Australian Group on Antimicrobial Resistance cited Commun Dis Intell 2011;35(3):237–243, and notes in the Abstract (bold mine):

Given hospital outbreaks of CA-MRSA are thought to be extremely rare it is most likely that patients colonised at admission with CA-MRSA have become infected with the colonising strain during their hospital stay.

We can place the general figure on medication in context by looking at adverse reactions. The TGA reporting system kicked off in the late 1960’s becomming computerised in 1972. As 2011 came to a close there were 247,000 suspected adverse events in the TGA database. It’s also worth adding that a primary aspect of “medical error” is indeed that of Adverse Drug Reaction, making Dorey’s claim somewhat meaningless.

Adverse reactions_TGA_drop shadow

Origin of Adverse Events 2006 – 2011 (TGA)

In 2011 the TGA received approximately 14,400 reports with 52% from pharmaceutical companies, 12% from hospitals, 7% from General Practitioners (GPs), 18% from State and Territory Health Departments and 3% from consumers. The sources for other reports (8%) include community pharmacists and specialists.

Placing the scale of insult inherent in Ms. Dorey’s deceit even more in context we should note that the TGA received an average of 1,200 reports each month. This includes all events – not just those involving mortality. More so the TGA receive data from six sources with the category of “hospital” enveloping public and private. The Department of Health and Ageing regards hospital outbreaks of community-associated MRSA as “extremely rare”.

Thus, Meryl Dorey’s 1,000 fatalities per week in Australian public hospitals appears to be beyond tenuous.

However there are a number of problems facing those taken in by the growing trend of “natural” or “alternative” choices to medicine. Not only is there growing evidence of harm, the absence of any efficacy at all is frequently documented.

Seventeen year old Christopher Herrera is one of a growing number who face organ damage, organ failure or death thanks to herbal supplements each year. In his case a “fat burning” dietary supplement resulted in liver damage. Initially placed on a transplant list, Chris was able to keep his liver but his lifestyle is now markedly compromised.

The New York Times report that such supplements account for 20% of drug related liver damage. This is a three-fold increase from a decade ago and comes from a review of the most severe cases in the USA. Evaluators believe the actual figure is higher. As is the case in Australia a lack of strict regulation standards for these products result in over-inflated claims, not backed by evidence, and the potential for adulteration of the product itself.

This December 17th, The Annals of Internal Medicine published three conclusive articles on both the harm and inefficacy linked to alternatives to medicine. An editorial Enough Is Enough: Stop Wasting Money On Vitamin and Mineral Supplements, summarised the research.

After reviewing 3 trials of multivitamin supplements and 24 trials of single or paired vitamins that randomly assigned more than 400 000 participants, the authors concluded that there was no clear evidence of a beneficial effect of supplements on all-cause mortality, cardiovascular disease, or cancer.

In another instance the efficacy of daily multivitamin usage to prevent cognitive decline in just under 6,000 men aged 65 or older was evaluated.

After 12 years of follow-up, there were no differences between the multivitamin and placebo groups in overall cognitive performance or verbal memory. […] … compatible with a recent review of 12 fair- to good-quality trials that evaluated dietary supplements, including multivitamins, B vitamins, vitamins E and C, and omega-3 fatty acids, in persons with mild cognitive impairment or mild to moderate dementia. None of the supplements improved cognitive function.

Another study looked at supplement with high-dose, 28-component multivitamins involving 1708 males and females who had previously suffered a myocardial infarction.

After a median follow-up of 4.6 years, there was no significant difference in recurrent cardiovascular events with multivitamins compared with placebo (hazard ratio, 0.89 [95% CI, 0.75 to 1.07]). The trial was limited by high rates of nonadherence and dropouts.

The authors note that research into vitamins and minerals in the prevention of chronic disease “have consistently found null results or possible harms”. Data from tens of thousands of people in randomly assigned trials show “β-carotene, vitamin E, and possibly high doses of vitamin A supplements increase mortality”.

Yes – increase mortality.

Later they stress most supplements do nothing when it comes to preventing chronic disease or death and with no justification for use, should be avoided.

An audio summary of these editorial points can be accessed here.

An audio summary of the editorial is below, or an MP3 may be downloaded here. (Firefox Users. If you’re using the Bluhell Firewall add-on click “allow” as the file is quite safe).

Thus whilst the anti-vaccine and anti-medical science lobby continually manage to distort discussions on the value of conventional medicine, the evidence is time and again not in their favour. We are either hearing of the dangers of modern medicine itself or the wonders of natural concoctions.

Both trends are dangerous and fallacious.

Medical Observer Interview: Dr. Ken Harvey

Former editor of the Medical Journal of Australia and GP Dr Annette Katelaris interviews Dr. Ken Harvey.

Dr. Harvey originally graduated from the University of Melbourne. Initially specialising in infectious disease and medical microbiology Ken’s interest in antibiotic resistance led to a study of the forces that drive prescription. Ken moved to the School of Public Health at La Trobe University to continue his work on medicinal drug policy.

He now holds the position of Adjunct Associate Professor in the School of Public Health at La Trobe.

INTERVIEW – CAMs regulation and pharmaceutical industry influence – Assoc Prof Ken Harvey – Obserations

Noted public health advocate Associate Professor Ken Harvey on what’s lacking in regulating complementary medicines, and the influence of the pharmaceutical industry on ‘the hand that writes the script’.

Ken talks about his extensive role in prodding Australia’s regulator of complementary medicines and shortfalls in the present system for regulating these “listed” therapeutic products. He is also asked about the personal impact of holding shonky products, advertising and ultimately – dishonest, unforgiving individuals – to account. Ken’s interest in information technology makes him a welcome source of advice to overhaul the TGA’s Electronic Listing Facility.

For a self confessed “stubborn bastard” in chasing blatant advertising breaches, it’s clear that Australian consumers are in Ken’s debt. Ken holds life membership of the Australian Consumers Association, Choice, and is also a member of their Policy Advisory Group. Dr. Harvey is Chair of Health Action International, Asia Pacific (HAIAP). He was a member of the WHO expert group that drafted their Ethical Criteria for Medicinal Drug Promotion. [22 page PDF]

mp3_mic
INTERVIEW AUDIO

Or direct download MP3 here. 21 min 13 sec. 21.4 MB
Listen or download file at chirbit.
———————————————————
Copyright symbol

Interview Source – © Medical Observer, Sound Cloud. Published August 26th, 2013.

 

———————————————————

Natasha Bita: Award winner to crisis spinner?

The TGA is concerned by assertions that a number of deaths resulted from influenza vaccinations. In fact there have been no recorded deaths from influenza vaccine in Australia.

– Australian Therapeutic Goods Administration respond to Natasha Bita’s article “linking” vaccination to fatality –

Natasha Bita published Virus in the system on May 28th, 2011.

The article presents an extended account of the heart wrenching story of Saba Button who suffered permanent brain damage due to the CSL Fluvax influenza vaccine, in April 2010. A combination of H1N1 and seasonal influenza strains Fluvax is tolerated very well by adults. However for children under five a febrile convulsion rate of 0.33% was later clearly established in the only state to involve this age group: Western Australia.

At the time the ABC reported hundreds of reactions. Of the 47 children taken to hospital, The West Australian reported 23 admissions. Saba Button was one such admission. Bita doesn’t provide these details, though to her credit does report that in 2009 fifteen kids under the age of 15 died after contracting swine flu. Each year between three and nine children die from influenza in Australia.

The situation in W. A. following the use of Fluvax on small children reflects a 2006 study in which 1 febrile convulsion was recorded in a sample of 272. What emerged as deeply concerning is that 2006 fever (not convulsion) trial data rates were 39.5%. Yet Fluvax manufacturer CSL informed the TGA of their 2005 trial data on fever. A much lower 22.5%. Public confidence in regulation, safety, Good Manufacturing Practices (GMP) and ultimately use is vital. I’ve previously looked at the importance of holding CSL to account.

A primary reason is that such stories are fodder for anti-vaccination lobbyists. Public confidence in immunisation was at stake, and proper context was much needed. One glaring absence from Bita’s article was reinforcement of the importance of vaccination in preventing influenza. With the internet awash with dangerous anti-vaccination propaganda readers need to know that all vaccination schedules are of paramount importance.

The day Bita’s story was published anti-vaccination guru Meryl Dorey falsely claimed that “the skeptics” and Stop The AVN were “organising forces” to complain.

Meryl Dorey’s Yahoo! Twitter and Facebook libellous claims

I emailed Natasha that day seeking confirmation. After no reply I tried again on June 1st and CC’d The Australian online address. 16 days later I repeated this. Natasha eventually replied that no, she had received no complaints. Not one. However she had been away, she qualified. Strange, I thought. Was Bita suggesting that her absence equated to an inability to access emails, either later or indeed at any time?

I began to feel somewhat uneasy about Bita’s impartiality. Clearly she knew who Meryl Dorey was. She was the woman who had just hijacked her published account to falsely claim, “babies were being used as guinea pigs in a trial that was paid for by the drug companies involved.” Dorey was also harassing the Buttons by phone and had appointed herself the family’s unofficial conspiracy consultant.

Shortly after I’d finally received a reply from Natasha Bita she published an article on the very rare past occurrence of transverse myelitis following oral polio immunisation. Bita did little to quell the fear and uncertainty to follow in the wake of Virus in the system. The purpose of her piece was to report on the MJA article, A no-fault compensation scheme for serious adverse events attributed to vaccination published by Kelly, Looker and Isaccs. I was familiar with the article having referred to it myself almost three weeks earlier.

It’s inexcusable that Australia lacks such a scheme when we note Germany began theirs in 1961 and across the Tasman no-fault compensation has been a reality since 1978. Seventeen other nations have a scheme that relies upon WHO criteria for Adverse Events Following Immunisation (AEFI). It is of even greater relevance in Australia because arguments for its implementation rely upon factors anti-vaccination lobbyists deny. Firstly that vaccination provides immunity and secondly the principle of herd immunity.

The authors write:

Any person who is injured while helping to protect the community — for instance, by contributing to herd immunity, such that there are sufficiently many people immunised to prevent widespread disease transmission within the community — should not bear the consequences of injury alone. In essence, the community owes a debt of gratitude to that person.

Natasha Bita, whether consciously or not, fed the anti-vaccination machine. The piece firmed her position as a journalist lacking in scientific literacy or having a grasp of risk-benefit ratios. She belittles the term “adverse reaction” and leaves the most crucial fact that Australia’s current inactivated polio virus vaccine carries no such risk, until the last few words. In a poorly written piece she completely misses the reality that Australia’s vaccine injury chic groupies will not back this scheme, have never mentioned it and deny the merit raised by Kelly, Looker and Isaacs.

When Virus in the system won Natasha Bita a Walkley for Sustained Coverage Of An Issue Or Event, she was embraced totally by the Dark Side. Her appearance on conspiracy and vaccine denialist site The Refusers perhaps underscored just how important a few lines reminding parents that vaccines save lives can be.

On August 3rd, as Queensland mum Katrina Day lay fighting for her life against influenza, Natasha Bita published a fraudulent article falsely “linking” 10 deaths to influenza vaccines. Bita ignored the TGA warning on interpretation of data. The article highlights how dangerous it is to allow sensation-seeking journalists to consult such information. Her headline outs her as unconscionable and callous as she proceeds to ignore any difference between correlation and causation.

Bita writes misleadingly:

TEN deaths have been linked to the nation’s flu immunisation program since the 2009 swine flu pandemic, including elderly patients and unborn babies.

The CSL flu vaccine, Panvax – which taxpayers spent $131 million stockpiling for the 2009 swine flu outbreak – triggered 1716 adverse-event reports, including seven deaths.

Whilst it is well understood that seasonal influenza vaccines will not include all circulating strains (meaning one may still catch influenza) she offers:

The Therapeutic Goods Administration database of adverse events, made public this week, lists the death of a grandmother who caught the flu after vaccination last year.

This is exactly the problem faced by VAERS in the USA, which is set to be superseded. Events are reported so that trends will be picked up and viable research launched in response to perceived problems. Nonethelesss all events remain on the database. Here we have an apparent award winning journalist reporting 10 deaths “linked” to ‘flu vaccines, whilst the total is actually zero. Visitors to TGA’s Database of Adverse Event Notifications are met with:

Her article drew the following response on the same day from the TGA:

TGA is concerned by a media story that may mislead consumers and could potentially discourage them from receiving influenza vaccinations.

Vaccinations play an important role in the prevention of diseases such as influenza, which can be life threatening in some patient groups. […]

The first line of text on the Database of Adverse Event Notifications states that: An Adverse Event does not mean that the medicine is the cause of the adverse event.

The TGA is concerned by assertions that a number of deaths resulted from influenza vaccinations. In fact there have been no recorded deaths from influenza vaccine in Australia. […]

To my knowledge Natasha Bita is yet to publish a retraction, explanation or apology. On August 27th it was reported that Katrina Day had passed away after falling into a coma. The 38 year old leaves behind four children and a husband.

Yesterday new directions for the CDC were reported in Flu Creates High Risk Of Death In Children With Neurological Problems:

A disproportionately high number of children with neurologic disorders died from influenza-related complications during the 2009 H1N1 pandemic, according to a study by scientists with the Centers for Disease Control and Prevention. The report in the journal Pediatrics underscores the importance of influenza vaccination to protect children with neurologic disorders. CDC is joining with the American Academy of Pediatrics, Families Fighting Flu and Family Voices to spread the message about the importance of influenza vaccination and treatment in these children.

Influenza kills and vaccination saves lives. For certain groups this is a very real decision arising every year. In very, very rare cases adverse reactions occur. To date in Australia no fatalities have been conclusively linked to influenza vaccines, including during the CSL debacle.

It’s a shame that so-called “consumer editor” Natasha Bita has to mislead her readers to suit her own agenda.

Advanced Medical Institute: The “unconscionable conduct” continues

In a nation awash with health scams that pitch themselves as natural alternatives to medicine, it’s less common to find scams that position themselves as “medical”.

Even further apart are the medical tricks that prey upon vulnerable members of the public, such as Dr. Death Sartori. Or those that position themselves in a predatory manner, ready to strike when average Aussies suddenly find themselves vulnerable and in unfamiliar territory.

This definition easily applies to the one third of Aussie men aged over 50 who deal with sexual dysfunction or erectile dysfunction every year.

Enter Advanced Medical Institute whose defence against The Australian Competition and Consumer Commission for “false and misleading” conduct goes back at least to 2003. The man behind the scam is Soviet Era trained doctor, Ukrainian Jack Vaisman, unregistered in Australia. He apparently also earned a PhD from the USA which enables his title as “Doctor” to get a misleading airing.

Another company he earlier owned, On Clinic led Professor David Handelsman head of andrology at Concord Hospital’s ANZAC Research Institute to remark under oath in 2009:

I’ve got to say, one of the most scarifying experiences as a medical practitioner I’ve had [was] seeing just how low quality this sort of medical care can be,” he said. ”It really shouldn’t occur in Australia in the 21st century … It goes back to a pre-thalidomide type of regulatory standards.

Professor Handelsman was referring to his mid 1990’s encounter with Vaisman. At that time Professor Handelsman was sitting on a Health Care Complaints Commission inquiry into On Clinic, called by the NSW Government. In 1996 the company pleaded guilty to charges of illegally importing individual constituents of Vaisman’s penile injection concoction. Each component was unregistered with the TGA, mixed in unregulated conditions then provided to patients with a syringe and instructions.

In March 2003 another company Vaisman (below) had acquired, Australian Momentum Health Pty Ltd, was convicted of supplying unregistered therapeutic goods. Even before AMI kicked off the last person Aussies needed dealing with male sexual dysfunction was Jack Vaisman.

Advanced Medical Institute gamble on blokes being too embarrassed to seek recompense for ineffective and outrageously priced off label use of dangerous or common and cheap medications. These are sold under long term contracts costing thousands of dollars in a practice described in 2009 as “pernicious, nasty and unethical”.

Of serious concern also is that erectile dysfunction may be an indicator of diabetes, kidney dysfunction, drug interaction, neuroses, neurological disorders, blood pressure irregularities or cardiovascular disease, prostate problems, penile conditions and other chronic conditions.

By hitting below the belt as it were with the famous “Longer Lasting Sex” advertisements, Vaisman was both targetting a symptom in older men and appealing to vanity or anxiety in younger men. A phone call was all it took.

Clearly, as the most cursory checkup – for example taking BP or physical examination – cannot take place over the phone, patient health wasn’t, and still isn’t part of the deal. This practice of “consulting”, diagnosing and prescribing medication ensuring locked in contracts over the phone at break neck, Gish Galloping speed, was the subject of a House of Representatives Standing Committee on Health and Ageing on August 25th, 2009. The litany of bogus science, cruel treatment and vile scheming is as extensive as the witnesses are impressive.

A lively exchange took place the next day between 2UE’s Mike Carlton, self appointed director of the deceptively named Australian Centre for Sexual Health, Richard Doyle and Jack Vaisman. An AMI shareholder Doyle (who also acted as Vaisman’s legal defence) is close to hilarious, suggesting everyone else is stupid for not keeping up with the latest science, including a remarkable study (not cited) showing that a phone call is superior to an actual consultation. Vaisman himself must be remembering a different inquiry.

You may grab the short MP3 here or listen below:

Ian Turpie admitted in 2006 he had lied about AMI “advanced technology” nasal spray. Vaisman had raged “Who gives a f**k?”, when AMI’s General Manager had asked if the advertisement was indeed a sham. The spray contains apomorphine, a drug used to treat Parkinson’s disease, and has been shown a dismal alternative to traditional solutions such as Viagra. AMI or it’s doctors did not advise clients of the superior alternatives.

Apomorphine is deemed ineffective by over 70% of doctors and it’s use for erectile dysfunction has been largely discontinued. In fact in cases that AMI would attract it is contraindicated. It’s mode of action works by increasing desire – not improving erectile function. In any case it is not worth thousands of dollars.

Vaisman was getting away with breaching TGA laws that render his spray a second-line therapy only if commercial alternatives are not available. Still, TGA impotency is hard to miss over the 20 or so years Vaisman has scammed Aussies. His “compounded products/prescriptions” came under TGA regulations that have exempted him from having to run any clinical trials.

Kelly Burke wrote in November 2009 following the report released by the Standing Committee on Health and Ageing:

By AMI’s figures, about 15 million nasal sprays, lozenges and sundry potions have been sold to the gullible and desperate over a decade. Yet not a single one has been subject to the administration’s quality control and safety requirements.

Vaisman has been permitted to exploit a regulation that allows doctors to prescribe individually tailored medications for patients for whom no alternative effective treatment is commercially available. […]

The vague wording of the National Policy for Technology-based Patient Consultations also needs to be tightened. […]

Close the Therapeutic Goods Administration loophole and tighten the telemedicine regulations as proposed in the report, and Australians will be able to wave goodbye to the screaming billboards, excruciating radio ads and tacky late-night television campaigns. And Jack Vaisman will be out of business.

By 2010 the Australian Competition and Consumer Commission (ACCC) had taken an new interest, raiding Vaisman’s offices in February. In December 2010 the same day the ACCC began legal proceedings against AMI, Vaisman placed the company into voluntary administration. The ACCC had launched proceedings against Vaisman, Advanced Medical Institute Pty Ltd, AMI Australia Holdings Pty Ltd, and two doctors.

On June 9th, 2011 The Brisbane Times reported:

The Australian Competition and Consumer Commission has started fresh proceedings in the Federal Court alleging that the company, famous for its billboards and radio advertisements promoting ”longer-lasting sex”, has failed to inform its customers that it is insolvent, and may not be able to provide medication for which some of them paid thousands of dollars.

AMI had continued trading since the time it went into voluntary administration. In a shifty move the business was sold to NRM Corporation Pty Ltd and NRM Trading Pty Ltd [collectively NRM], and very shortly after went into voluntary liquidation. NRM continues to conduct the AMI business.

The Australian Consumer Law (Schedule 2 of the Competition and Consumer Act 2010) had Unfair Contract Terms provision added in July 2010. This has allowed the ACCC to pursue a case against AMI for alleged unconscionable conduct. This is a significant move in consumer protection.

Nasty, deplorable, pernicious, predatory and coercive were the terms used during the House of Representatives Standing Committee inquiry into Vaisman’s conduct. His abuse of clients from 17 to 87 years of age is despicable. Unconscionable Conduct sounds about right.

The ACCC reported on it’s website last September that the Federal Court had granted orders to add NRM as respondents in the ACCC case against the AMI for unconscionable conduct and granted leave for the ACCC to pursue action “against the AMI companies in liquidation”:

The ACCC alleges that AMI engaged in unconscionable conduct in breach of the Trade Practices Act 1974 and NRM is engaging in or proposing to engage in unconscionable conduct in breach of the Competition and Consumer Act 2010.  The ACCC also alleges that Dr Lonergan was knowingly concerned in AMI’s conduct and Mr Vaisman being a former director of AMI and a current director of NRM was and is knowingly concerned in the conduct of those respondents.

The ACCC further alleges that NRM is in breach of the Australian Consumer Law by entering into long-term agreements for the treatment of male sexual dysfunction which contain unfair contract terms in relation to the termination of a contract.

Incredibly, so it came to pass. Under Vaisman’s shady direction NRM took “control” of AMI and continued to lure customers into unconscionable long term non efficacious rip off contracts with zero regard for consumer health.

You may have noticed the shift from Sniff and Stiff the piano playing penises on late night TV to the Genie who magically cranks up libido using a strip on the tongue. As noted by genuine experts in 2009, these advertisements are “destructive… a carefully constructed legal fiction.”

UPDATE: On April 22nd 2015 the ACCC reported that the Federal Court found Advanced Medical Institute had engaged in unconscionable conduct. The media release (MR 63/15) reads in part:

In his judgment, Justice North said “It is immoral to seek to harness the fears and anxieties of men suffering from ED [erectile dysfunction] or PE [premature ejaculation] for the purpose of selling medical treatments. To target the patient’s vulnerability in this way is to use an unfair tactic and that is a possible marker of unconscionable conduct”.

Justice North also stated “The technique of frightening men by telling them of the dire adverse consequences of not agreeing to treatment and assuring them that the treatment was effective was part of the business system of AMI and NRM. It was formulated by management and imparted in an organised fashion through scripts and training sessions.”

His Honour also found that NRM further breached the Australian Consumer Law by entering into long-term agreements for the treatment which contained unfair contract terms in relation to the termination of a contract.

The Court declared that the conduct of the respondents was unconscionable and made orders:

  • requiring that NRM compensate a number of the patients whose evidence was considered by the Court
  • permanently restraining NRM from:
    • making agreements with a patient or in respect of the supply of medications for the treatment of male sexual dysfunction unless the patient has a consultation with a qualified medical practitioner
    • making any statement about the efficacy of NRM treatments or the patient’s need for those treatments unless that statement is made by a qualified medical practitioner
    • making an agreement with a patient for the supply of medications or medical services for the treatment of male sexual dysfunction without providing a written statement of the terms of the agreement and termination rights;
    • making an agreement with a patient for the supply of medications or medical services for the treatment of male sexual dysfunction unless that agreement has a cooling off period and can be terminated by giving 14 days’ notice.
  • restraining Mr Vaisman from continuing his main role in the business of NRM which was involved in the unconscionable conduct for a period of seven years
  • requiring corrective advertising.
  • For further enquiries contact the Media Team on 1300 138 917

END UPDATE

It also emerged in a January 2011 article in The Age Business section, that a “silent partner” in this failed venture is behind Astarra Strategic Fund, which resulted in Australia’s largest superannuation theft. In fact the “partner” is a network of “dodgy brokers” headed up by John Flader the supposed master swindler of the Astarra theft.

Meanwhile the AMI swindle rolls on. The last notable action involving AMI was a directions hearing in Melbourne in October 2011. A feature of the pre NRM AMI if you will, was the inability for customers to cancel their contract until they’d tried every single treatment AMI could dream up. Whilst boasting high success and ensuring that every unsatisfied customer received a full refund, the reality was virtual theft from customer bank accounts.

The only way to stop AMI withdrawing money from an account is to have the account closed and another opened with new details.

Recently AMI wheeled out a Debt Collection department. Their job is to chase up clients who still “owed money” on the futile contracts before AMI went into voluntary liquidation. The problem here is any liabilities accrued by AMI then become those of the liquidator. Not AMI and certainly not NRM.

Despite “NRM Corporation Trading As AMI” actually not being liable for any so-called contract debts the threats to “go legal” and destroy any non-compliant customer credit ratings is standard. For 15% of the outrageous contract total NRM will allow clients off the hook. But only if clients bring up the possibility first, or happen to laugh heartily down the phone at NRM’s new take on post liquidation liability. They will not inform customers who don’t raise dissent. From the ACCC site:

NRM patients are required to provide 30 days’ written notice to NRM to terminate the contract and must also pay a number of fees including a fixed administrative fee of 15 per cent of the original contract price. The ACCC alleges that each of the fees had the effect of penalising a consumer who gave notice of termination and therefore causing a significant imbalance in the parties’ rights under the contract.

There are cases where clients – who are in fact patients – eventually consult their GP and then a urologist, cardiologist, oncologist or another specialist. Information is passed to AMI specifically stating they can do nothing to improve the condition. Indeed many “treatments” are dangerous and have exacerbated serious medical problems for months. AMI go through the motions of ensuring a refund for expenses paid. They have been known to then debit bank accounts to the tune of the total contract cost.

Of course, there is no written contract that clients sign outlining any of these eventualities. The famed refunds are a scam from day one because they do not exist. There simply is no document wherein lies any customer contract. Clients should remember this in the event of AMI Debt Collectors calling to terrify. You are thus still waiting on the official contract.

If clients have been clever enough to realise the scam and ditch their bank account AMI Debt collection ring to intimidate, threaten and bully. To “go legal” as they say. Exactly what ageing, ill and often pension dependent patients need.

At this point getting consumer and legal advice, alerting and perhaps lodging a complaint with the ACCC and making some well advised choices about taking that 15% option is in order. After you’re certain that they can effect your credit rating. Remember that AMI are engaged in unconscionable conduct, and NRM intentionally set out to engage in unconscionable conduct.

There is no evidence the so-called Debt Collection isn’t another scam, and it alone is unconscionable conduct by extension. The ACCC will confirm this. As I note above, any debt AMI accrued pre June 2011 is not legally theirs to recover. With luck they will soon be shut down and prosecuted. If contacted clients should not hesitate to summarise this ACCC entry.

Medications sold via their contracts include SSRI’s like fluoxetine (Prozac), paroxetine (Aropax or Paxil), escitalopram (Lexapro), sertraline (Zoloft) etc. These were introduced over the late 1970’s – 1980’s with Lexapro introduced some years later.

AMI also favour old style tricyclic antidepressants such as Clonipramine. This cutting edge technology has been around since the 1950’s with clonipramine added to common tricyclic antidepressants in the 1960’s. The pain killer Tramadol is another.

Their super advanced Path Breaking Research and Development also includes, as mentioned, the Parkinson’s drug apomorphine via lozenge, nasal spray or tongue strip. Apomorphine has been around since the 1940’s.

Why these drugs? SSRI’s and tricyclic antidepressants have a side effect in prolonging time to ejaculation. This effect may persist or may be prove to be transient. Remembering the conditions they are prescribed for, and the side effects they already carry I’ll leave you to consider the value of such off-label use.

The shocking aspect here is rather than pay $250.00 per month and be locked in for two years patients could consult their GP and pay around AU $20.00 per month. For those on a pension or any benefit it’s $5.80 per month. No contracts, no threats and no gambling with side effects.

It gets worse. Men have been scammed into a $3,000 contract and bullied into payment long after the penny dropped, only to report they were already on an SSRI reaping any potential benefit of “lasting longer”. In these cases they need not have spent a cent.

A major drawback with SSRI and tricyclic medications is the interaction with some migraine specific medications or even pain killers such as Tramadol. Serotonin Syndrome can be a serious and potentially life threatening reaction to using two or more of these drugs.

A major cause of premature ejaculation is fast neurological response time in pelvic muscles. Guys can even save that $20.00 per month and learn pelvic floor exercises known as Kegel Exercises. Searching for those key words will provide millions of hits. In cases of erectile dysfunction consult your GP to be sure it’s not a more serious problem.

In conclusion do keep in mind that Advanced Medical Institute is neither “advanced” or an “institute”. It’s a scam run by professional parasitic predators who pressure vulnerable, ill and everyday Australian men out of their money. They can offer nothing to improve sexual health – quite the opposite.

In researching for this post I was appalled, infuriated and disgusted by the tactics creatures such as Vaisman use to scheme struggling Aussies who conduct themselves with dignity, strength and poise. To be unwell is one thing, to make a less than ideal decision and be scammed is another. Yet to navigate the resultant quandary with optimism and humour takes a trait I hope I have, somewhere deep inside.

One hopes the ACCC get to use the unconscionable conduct laws with gusto.

  • ACCC resources. Keywords – “Advanced Medical Institute”

http://www.accc.gov.au/search/accc-funnelback/Advanced%20Medical%20Institute