I thought that I would make my last post for 2010 a recap of the fight against quackery and shonky medicine in Australia. The ACCC and TGA seem to be finally growing some balls because we have seen public action against Fatzap, Power Balance Bands, and now AMI. So far, AMI has filed for liquidation, Power Balance's Tom O'Dowd has admitted that his claims are rubbish, but FatZap is still standing.
Power Bands
The company claims (via its US website, as the Australian website has been ordered to take down these claims):
WHAT IS POWER BALANCE?
Power Balance is Performance Technology designed to work with your body’s natural energy field. Founded by athletes, Power Balance is a favorite among elite athletes for whom balance, strength and flexibility are important.
HOW DOES THE HOLOGRAM WORK?
Power Balance is based on the idea of optimizing the body’s natural energy flow, similar to concepts behind many Eastern philosophies. The hologram in Power Balance is designed to resonate with and respond to the natural energy field of the body.
The NineMSN report (below) of copycat competitor Eken Power Bands makes very similar claims. Notice how despite having a series of experts saying it is rubbish, they still add in an upbeat soundtrack, fall for some nonsensical "tests" which are clearly admitted to be nonscientific and easily manipulated, and suggest that a "placebo effect" (which is basically when a subject thinks a treatment is working even when it isn't) is a good thing, and still a good reason to waste money on a $60 elastic band on the wrist. What next? Magical staples? Psychic paperclips?
The Power Balance guys say that you can test that the band is working and help spot "fakes." Obviously, this is a rigorous and high-tech process as the following image shows.
Personally, I'd prefer to trust the tests done by Choice Magazine and Australian Skeptics, which clearly prove that these devices are ineffective and that the ACCC is justified in forcing Power Balance to withdraw their claims and offer a full refund to all customers.
"We'd made claims in the start that said that our product improved strength, balance and flexibility," he told the ABC's AM program.
"And we didn't have the scientific peer-reviewed double blind testing or the level of proof that we needed to substantiate those claims."
- Tom O'Dowd, Power Balance CEO. ABC Radio AM - 23/12/2010
"Advanced" Medical Institute
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| One of AMI's controversial billboards. |
As for AMI, or Advanced Medical Institute, a sister-company to my much-favoured Heart-Check Clinics (see Heart Check? Blank Cheque! and Part 2), they have had a series of devastating blows in the UK and Australia. This is the company responsible for those horrible billboards and TV advertisements (above) promoting treatment for erectile dysfunction (and inviting every form of sexual innuendo and pun available). This effectively rides on the coat-tails of big-budget pharmaceutical promotion for Viagra, and offers a series of expensive, escalating treatments ranging from nasal sprays to penile injections - all in direct competition to that blue pill.
There is no doubt that AMI has been very successful, and despite being under the spotlight for many years, it has managed to continue raking in the cash and staying in business. Why? Well, Jack Vaisman, founder of AMI has managed to find a little niche by:
- utilising a growing market and consumer demand fostered by other parties (such as Pfizer)
- making use of a sensitive and embarrassing topic (impotence or erectile dysfunction), with many patients unwilling to air their dissatisfaction in public or approach authorities
- boldly pushing ahead with mass advertising, successfully made them a household name
- advertising a plausible, publicly tolerable (apomorphine nasal spray) treatment with minimal further detail, and then sucking consumers into overpriced conventional erectile dysfunction therapy using typical bait-and-switch sales techniques
- locking customers into expensive, 6-month "contract sales" where they pay a large fee (either lump sum or monthly) for a supply of the aforementioned spray, with the only means of backing out being to complete a series of conventional but increasingly undesirable therapies (such as Papaverine or Prostaglandin Penile Injections) - like mobile phone companies and their contracts
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| AMI Founder Jack Vaisman |
Whilst it is good to see that authorities have finally done enough to cause Jack Vaisman to liquidate AMI, the most disturbing thing is that it does not really address the heart of his success - the ability to make unsubstantiated and fraudulent claims about his treatments. It is not the TGA that has been successful as exposing him as a shonk and shutting him down - it is the ACCC which has fined him for unconscionable sales conduct, and allowing non-medical staff to provide medical services and advice. To me, it highlights the impotence of the TGA at regulating the claims of therapies in its register, which is much more serious than the impotence of AMI's customers. It also demonstrates the lack of moral and ethical behaviour amongst unregistered, pseudomedical practitioners who fall outside any effective professional regulatory framework.
FatZap
Which leads us to FatZap. This company claims that by applying heat (via infrared laser, ultrasound, radiofrequency or whatever) to an area of subcutaneous fat that it can just make it go away.
Fatzap™ Ultra Sound Treatment uses low frequency ultrasound resonance technology to disrupt fat cells. An ultrasound beam selectively targets fat cells in the chosen body area, and brings them to self resonance. This process triggers the fat cells to release their fatty substance in that particular area. The fat cell content, primarily comprised of triglycerides, is dispersed into the fluid between the cells and then transported through the vascular and lymphatic systems to the liver. The liver makes no distinction between fat coming from the Fatzap™ treatment and fat originating from consumed food. Both are processed by the body’s natural mechanisms. So that your body metabolises this excess liquefied fat rather than stores it elsewhere in the body, we recommend a low carbohydrate eating plan with overall negative calorie intake for several days following each treatment.
- FatZap.com.au
Personally, I don't want ultrasound to damage any of my cells, be they fat or otherwise. Did you know that the myelin sheath around your nerves is composed of 80% fat? If FatZap's claims are true, I'm waiting for an explosion in legal suits for peripheral neuropathy.
Like many cosmetic clinics, FatZap pushes its products through social media seeding - where someone posing as a satisfied customer makes comments on community forums or blogs saying how great the treatment is - a cheap and nasty way to make unsubstantiated claims as the comments can't be traced back to the source. Look at the following forums / chat boards for examples, and notice how the most enthusiastic comments are from new members with only 1 post.
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| Walking Adipose from Partners in Crime, Doctor Who (BBC 2008, Episode 1, Series 4) |
Personally, I would have thought that these treatments are about as realistic as this episode of Doctor Who, but then again, some people will believe anything. Let's hope that FatZap and its copycats don't last beyond 2011.
Links:
Power Bands Let Loose
- Watchdog says power wristbands a crock - ABC News Australia Dec 2010
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Watchdog says power wristbands a crock
By Barbara Miller
Updated Thu Dec 23, 2010 2:53pm AEDT
The Australian Competition and Consumer Commission says a wristband with a hologram inserted into it claiming to boost performance is a fraud.
The ACCC has ordered the company Power Balance to remove any claims that its wristband improves flexibility and strength and to offer dissatisfied customers a refund.
Power Balance Australia chief executive Tom O'Dowd has now accepted that is just too good to be true.
"We'd made claims in the start that said that our product improved strength, balance and flexibility," he told the ABC's AM program.
"And we didn't have the scientific peer-reviewed double blind testing or the level of proof that we needed to substantiate those claims."
He says it was made without a clear understanding of the level of proof required.
"The advice that I got on that was flawed. But I'm not blaming anybody else on that; that's my mistake. In reality I didn't go to the right people to get the right advice," he said.
The company has been ordered by the ACCC to remove any performance enhancing claims about its wristbands and pendants from its website and the products.
"It's a crock frankly. And we're very disappointed that so many people have paid hundreds of thousands - if not millions - of dollars to buy these Power Bands," said ACCC chairman Graeme Samuel.
"There is no credible evidence at all to support the fact that they do anything more than if you were to buy a packet of rubber bands from the local newsagent."
Mr Samuel says the company has been cooperative during the process.
"We had visitors from the Unites States come out to meet with several of our officers and one of our commissioners to talk this matter through," he said.
"But I think they realised that we caught them out, that these bands were nothing like what they were being claimed to be.
"I don't think they're on their own, I might say. I think there are other bands that are out there under different names that are making similar claims and we'll be working on those as well now."
The Power Balance products can still be sold but Mr Samuel says he does not think there will be many takers.
"I suspect that after the publicity that'll be received in the next 24 hours as to the action that we've taken, they'll have a great deal of difficulty in actually selling too many of these bands except to those that are the most gullible," he said.
Mr O'Dowd disagrees.
"Our return rate, our refund rate to date has been way less than 1 per cent. I understand that because of all the way it's being reported in the media that that will go up a little bit," he said.
"But I don't honestly believe that the people that have bought this product are going to be concerned."
Anyone who has purchased a Power Balance product and would like their money back can call 1800 733 436 during office hours. - Power band no better than a rubber band: ACCC - The Australian Dec 2010
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Power band no better than a rubber band: ACCC
AAP December 24, 2010 12:00AM
The makers of a controversial wristband have been ordered to offer full refunds on sales of their product.
They claim it improves balance, flexibility and strength by working with the body's energy flow.
The consumer watchdog has delivered a crushing judgment on the popular Power Balance bands by declaring them to be no more beneficial than wearing a rubber band.
It has told the company to give customers their money back if they feel dudded by the sales pitch that the band tunes the body's energy frequency to an ideal 7.83 hertz.
Australian Competition & Consumer Commission chairman Graeme Samuel said Power Balance Australia couldn't provide any scientific evidence to back up the claim.
"Consumers should be wary of other similar products on the market that make unsubstantiated claims, when they may be no more beneficial than a rubber band," he said in a statement.
"Suppliers of these types of products must ensure that they are not claiming supposed benefits when there is no supportive scientific evidence."
Power Balance bands originated in the US and have since adorned the wrists of celebrities and sportspeople the world over.
In Australia, they have been seen on members of the visiting English cricket team, the NRL's Benji Marshall, the AFL's Brendan Fevola, jockey Damien Oliver and dual world surfing champion Mick Fanning. With even actor Russell Crowe an apparent fan of the bands, Mr Samuel said it was easy for Australians to be duped.
"When a product is heavily promoted, sold at major sporting stores and worn by celebrities, consumers tend to give a certain legitimacy to the product and the representations being made," he said. He warned that retailers could face similar legal action if they continue to sell bands in the existing misleading packaging.
Power Balance has promised to remove the offending words from packaging and the band itself, and to publish "corrective advertising". Those seeking a refund have been advised to contact Power Balance. - Do power bands really work? - NineMSN Sep 2010
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Do power bands really work?
Wednesday, September 8, 2010
Power bands are the latest craze to sweep the sporting world, with former AFL player Jason Akermanis, US basketballer Shaquille O'Neal and Real Madrid's Cristiano Ronaldo all jumping on the bandwagon.
The bands are worn around the wrist and manufacturers claim they boost the wearer's balance, strength and flexibility. One manufacturer, Power Balance, says the bands use "holograms embedded with frequencies that react positively with your body's natural energy".
Eken Power Bands have just become available in Australia. "For most of us, our bodies are running at a lower or higher vibration than is optimal as a result of pollution and modern pressures," Eken co-founder Brendan Howell said in a media release.
"Eken Power Bands simply help to restore your body's natural sense of balance and bring energy levels back in order so you have a better chance of performing at your best."
However the bands are not without their sceptics: "There is no scientific evidence whatsoever to back up the power of these Power Bands," anthropologist Stephen Juan told TODAY.
ninemsn producer and marathon runner Amanda Pitcher tried an Eken Power Band to see if they really deliver on their promises.
The verdict
"I wore the Power Band for three separate work-outs: a long run, a short and fast-paced tempo run and a weights training session," Pitcher says.
"I definitely noticed a strange sensation in my wrist, directly underneath the band. I did notice my balance was improved, mainly during my weights session, particularly when doing lunges, I had much less issues balancing and felt a lot more even — compared with how I would usually feel. I'm not sure if I'm a believer, but I would definitely recommend giving it a go."
The Eken Power Bands retail for $69.95 and are available at selected retailers and www.ekenpowerbands.com.au. - Power of holograms or just a big scam? - Sunday Mail Apr 2010
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Power of holograms or just a big scam?
Jesper Fjeldstad, Scott Walsh, David Riccio From: Sunday Mail (SA) April 04, 2010 4:26pm
IT'S the latest phenomenon sweeping world sports and Australian football codes: a $60 bracelet that claims to increase an athlete's core strength by as much as 500 per cent.
It has flown under the radar - mainly because it is hidden either under tape over players' wrists or covered by their socks if it's around their ankles - but pictures prove the world's best athletes have been won over by Power Balance bands.
Among the believers is NRL top liner Benji Marshall, who wore it uncovered in a game for the first time last week against the Roosters - he was man of the match.
The AFL's Nick Riewoldt and Brendan Fevola, US basketballer Shaquille O'Neal, champion jockey Damien Oliver and Real Madrid's Christiano Ronaldo are also on board.
If you look closely at most AFL games you can see there has either been a spate of wrist injuries, or Power Balance bands are catching on at an incredible rate. In fact, one insider told the Sunday Mail that the bulk of the St Kilda team wear the bands.
Most leading sports doctors and fitness men are incredulous when asked about it, because they have seen little research to support the claims of the manufacturer.
"Power Balance is performance technology that uses holograms embedded with frequencies that react positively with your body's natural energy field to improve balance, strength and flexibility," the Power Balance website claims.
Peter Barnes, one of the country's leading sports doctors with extensive experience in the AFL and Australia's Olympic teams, was unconvinced.
"I don't think there's a lot of science behind it but some people swear by them, just as they swear by magnets and all sorts of things," Dr Barnes said. "I haven't really bothered about them.
"You get one (fad device) every few years. They go into circulation - from the magic nose things to the magnets to the power things to the copper bangles - you name it.
"If there's money in it, someone will say it's great and use it.
"The problem is with elite sportsmen that they will grasp at anything.
"They'll have a go at anything, even if it's proven to be absolutely ridiculous. They'll advocate it - especially if they get it for free and especially if somebody pays them to use it.
"But I'm not aware of any proper research about it."
Another sports medicine pioneer, Socceroos doctor Peter Brukner, said Power Balance's explanation of how it worked - "embedded frequencies" and natural energy fields" - didn't make much sense.
"I'd like to see the research that shows it makes a difference - you would suggest there isn't any," he said.
But even if it smacks of a placebo effect, nobody is prepared to miss the boat - or take the mickey out of it just in case it works.
The US-based company, through its website and Australian sales reps, is happy to put the Power Balance bands to the test. But the test, a string of exercises that are improved after the subject puts on the band, is clearly open to interpretation.
One interpretation is that the subject grew stronger after putting on the band. Another is that the exercises will always be performed more effectively the second time around, band or not.
In fact, a recent Today Tonight report conducted blind tests where the subjects did not know if they had a hologram in their pocket. A Power Band representative failed to pick the holder of the Power Band device every time.
But none of this has stopped the runaway success of the bands.
Adelaide physical performance manager Stephen Schwerdt, a leader in his field, said several of the Crows had had a crack at wearing them, more in their day-to-day chores than specifically in training or on match day.
As is the club's philosophy, he has kept an open mind, but he knows of no research that validates the claim.
"We keep an open mind; that's our approach to all of these things," Schwerdt said yesterday as the Crows went through their final training session ahead of today's game against Sydney at West Lakes.
"We had a guy who gave us some of them, and by that time, some of the guys had bought their own, so quite a few of them have tried them out. But I haven't seen too much of them lately. Maybe the novelty has worn off.
"It's whether it stands the test of time that will decide."
But all sporting organisations face a dilemma with the bands. If they do what they claim to do, surely they should be banned because they are performance enhancers.
It is claimed the wonder band can increase an athlete's core strength and power by as much as 500 per cent.
Have a think about that. Does that mean a man who can bench press 100kg can all of a sudden lift 500kg?
Forget about tackling: there could soon be a day when a footballer is hurled over the grandstand by a charged-up opponent.
Last week the NRL confirmed it will investigate the use of Power Balance wrist bands after Marshall exposed one of sport's best-kept secrets.
"It's a distinct case of one player having an outside advantage over another," one NRL player agent said.
NRL chief operating officer Graham Annesley said the impact of the bands would be investigated.
"We've also got rules in the NRL operations manual that says no items of non-standard equipment can be used in the game without prior approval by the NRL," Annesley said.
"It's the first I've heard of it, so we'll obviously need to look at it and determine whether we allow them or not. We'd also take medical advice on it."
AFL spokesman Patrick Keane said the issue had not yet been discussed by the AFL's medical officers, but would be looked at in the future.
He said a wristband that was taped properly and was not a danger to other players was not illegal.
"Referees and touch judges have the responsibility before a game of checking every player to make sure that they're not wearing anything that would be considered dangerous," Annesley said. "It's something we'll look into."
Scott Borlace, a former SANFL player with Norwood and now an assistant coach, wears a band but still doesn't know if it works.
Borlace underwent the radical LARS knee surgery made famous by Sydney's Nick Malceski and Port Adelaide's David Rodan, but saw none of the stunning recovery enjoyed by both.
He was then advised to try a Power Balance band.
"I was looking for any possible edge to get back and play some league footy and this was another idea to give me an edge," Borlace said.
"According to the athletes that endorse the product - surfers, basketballers, elite sports people that say this actually works - it was something I thought might help me get back and play some league footy again.
"All players in the SANFL are looking for some sort of edge over their opponents, obviously legally, and this is some sort of way that a lot of the players are thinking can give them an edge."
The former state captain began wearing the band about four months ago, while still hoping to extend his 177-game career, and remains uncertain about its benefits.
"The bottom line is I'm not convinced," he said.
"But if it does give you any edge, even if it is mental, I think it is worth it.
"It's not scientifically proven - I'm a science teacher as well so I like to see the scientific facts.
"But in terms of the mental side of things, I was trying anything to get back." The onballer - who has joined Port Adelaide's AFL staff as a runner - said when he first wore the band he also noticed changes in his sleep patterns and his golf game.
"I felt like I was hitting the ball better when I was wearing the Power Balance band - again, probably in the mind," he said. "I'm not the best golfer going around and to hit a few better was quite exciting for me at first.
"The only thing I did notice, which made me think (the band) was doing something, was I wasn't sleeping when I was wearing the Power Balance band. I took it off to sleep and started sleeping better."
Norwood is 0-2 this season after losing to South Adelaide on Friday night. At least six Redlegs, in both senior and reserves sides, wear the bands and Borlace joked they might need to include the gadgets in their match-day uniforms.
"Possibly - I've also heard of AFL players wearing them on their ankles, maybe we should get a whole heap in and chuck them around the ankles for the next few games," he said.
- Sex ripoff 'unconscionable' - SMH Dec 2010
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Sex ripoff 'unconscionable'
Kate McClymont and Kelly Burke
December 24, 2010
On the eve of his company's questionable practices being exposed by the Herald, the medical entrepreneur Jacov "Jack" Vaisman has placed his erectile dysfunction company, AMI, into administration.
The Ukrainian-born Mr Vaisman, who runs the company famous for the billboards and ubiquitous radio ads promoting "Longer Lasting Sex", has waged a year-long battle in the NSW Supreme Court to prevent the Herald revealing many dangerous and unethical practices. These show that the company routinely put profit before patients' health.
During that time, the Department of Fair Trading continued to receive hundreds of complaints about the company's predatory sales tactics from disgruntled consumers who had signed up for expensive treatments which often did not work.
Supreme Court Justice Paul Brereton ruled yesterday that not only was the Herald free to publish the allegations, but that Mr Vaisman's company Advanced Medical Institute would have to pay most of the Herald's legal costs, which were more than $500,000.
However, the previous day Mr Vaisman moved to place his companies into voluntary administration.
That same day Mr Vaisman and two of his doctors were informed by the Australian Competition and Consumer Commission that they were being prosecuted for "unconscionable conduct". The prosecution relates to inappropriate medical treatment and failure to properly inform patients about what they were signing up for.
Former employees said patients were pressured into expensive medical treatments and then refused refunds unless they tried all medications including penile injections.
In June last year the Herald was set to publish an insider's account of the unethical practices at AMI.
A doctor who had worked at the company for more than two years revealed staff jeopardised AMI patients' health by failing to tell them of potentially dangerous side-effects. At the same time the company gouged from them thousands of dollars for often ineffective treatments.
Patients were not aware that AMI managers monitored calls.
Other AMI employees revealed that non-medical staff were giving medical advice over the phone and that sales people were illegally taking as much as $5000 out of credit cards without permission.
One former employee told the Herald he was horrified when a blind, 90-year-old man was refused a refund. AMI insisted he honour his contract by having his 86-year-old wife, who had Parkinson's disease, administer penile injections.
Former employees also admitted that AMI staff lied to customers about the effectiveness of treatment, using words like "guaranteed to work".
When asked to comment on the claims in June last year, AMI tried to prevent the story from being published, claiming a breach of confidence on the part of the whistle-blowing doctor. AMI also alleged that the proposed article "contained falsehoods the publication of which would be malicious and injurious to AMI's business".
Justice Brereton said that while he understood the doctor's motivation was to expose "inappropriate practices", he did not believe that her allegations were true.
Mr Vaisman has had a long and troubled history with regulatory authorities, with repeated findings that his companies have engaged in misleading or deceptive behaviour.
Last month an AMI doctor, Sergio Staraj, was found guilty of unsatisfactory professional conduct after he prescribed a $4000 nasal spray treatment after a cursory telephone conversation with the patient.
The patient had complained that in February 2008 Dr Staraj prescribed an 18-month course of nasal spray without checking his medical history, what medications he was taking, performing a physical examination, or advising what to do if there were side-effects.
AMI's administrators did not return the Herald's calls yesterday. It is understood they suggested to potential creditors that they accept 10¢ in the dollar in satisfaction of the money AMI owes to them.
After taking over AMI's debts earlier this month, Mr Vaisman's private company has emerged as one of the largest creditors.
Earlier this year AMI's impotency clinics in Britain went into liquidation owing $7.4 million.
The Herald phoned Mr Vaisman for comment yesterday but he did not return the calls. - The hard sell for longer-lasting sex - SMH Dec 2010
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The hard sell for longer-lasting sex
December 24, 2010
Staff at the anti-impotence company AMI lied and non-medical personnel manned the help line, write Kate McClymont and Kelly Burke.
A wave of panic spread through Advanced Medical Institute's Sydney headquarters when staff learnt an elderly patient had died within 30 minutes of taking impotence medication prescribed over the telephone. But when concerned doctors confronted AMI's owner, Jack Vaisman, over the incident they were dismissed with a flourish of the hand.
Nothing was going to happen, the medical entrepreneur reassured his staff. The doctors might be asking inconvenient questions but an autopsy looked unlikely. "There's no way the family is going to go to court and say their father was having injections into his penis," he chuckled.
This case was one of many detailed to the Herald more than a year ago by a former AMI doctor turned whistleblower. It happened when she was working for the impotence clinic between 2007 and 2009. The Herald does not suggest that AMI caused the death of the patient but her account highlights the often cavalier conduct of AMI towards its patients.
AMI's owner, Jack Vaisman ... dismissed as "ridiculous" allegations that salespeople overrode doctors' concerns and at times wrote prescriptions for patients. Photo: Jacky Ghossein
She said non-medical staff routinely lied to patients and omitted information on potentially harmful side effects. AMI management listened to doctors' private consultations with patients.
"I've lied to people when they have asked if this is being recorded," she said.
Staff failed to inform AMI patients that erectile dysfunction could be a symptom of heart disease, potentially putting them at risk if they did not consult a doctor.
Working for AMI, the doctor had challenged the clinic's practices and also the lack of adequate training in the area. She said her only training was on her "sales pitch".
"They were a very sell-sell oriented place," she said.
The recent push to sign up women for sexual dysfunction treatment had caused additional concerns for some doctors, she said. They were worried about being sued because the medication AMI was prescribing, containing glyceryl trinitrate and phentolamine, was used to treat angina and blood pressure.
The doctor said Mr Vaisman dismissed their concerns saying, "No, no, no, it's not going to happen … the girls in the office have used it and it works."
The doctor said that on occasions when one doctor refused medication because of pre-existing ailments such as heart conditions, another doctor over-ruled the medical advice.
Sales staff confessed they were effectively working as untrained health professionals.
"When [patients] would come to pick up the medication there was no doctor there to show them or to talk them through it," one said. "So we were basically doing the dosing, how to take it. We also told them when to increase the medication."
One former non-medical employee told the Herald he and others had been rostered on the 24-hour emergency line and had to give advice to people suffering side effects.
Sales staff pressured customers into spending thousands of dollars on AMI medication. Yet the active ingredient in the product, the antidepressant clomipramine, can be bought from pharmacies for $30 a packet.
AMI staff debited patients' credit cards for up to $5000 for an 18-month supply of clomipramine, and more than $6000 for an 18-month supply of an apomorphine-based product to treat erectile dysfunction.
Some of the doctors at the call centre earned up to $400,000 a year, the doctor told the Herald.
When still under an injunction that prevented publication of any of the doctor's allegations, the Herald was approached by former sales staff at AMI, who backed up her claims.
Sales staff were encouraged to lie, saying the AMI nasal sprays were approved by the Therapeutic Goods Administration and could be claimed through Medicare and private health insurance.
Clients frequently called AMI after suffering frightening side effects, such as severe headaches, breathing problems and stomach reactions, but the 24-hour help line promised by the company was staffed by people with no medical training.
"Sometimes, they'd get a bit cross, these old blokes, and say they wanted to talk to a doctor," one of the sales staff said.
He also recalled instances of doctors in emergency units in hospitals trying in vain to seek information on injectable medication prescribed by AMI to patients suffering from priapism, or extended erection, for more than 12 hours.
"I remember one patient who was 90, blind and couldn't do his injections," one sales person said. "He wanted a refund and was told, 'Get your wife to do it.' She was 86 and had Parkinson's, she had the shakes so she couldn't do the injections."
AMI often considered refunds only when a patient's lawyer or the Office of Fair Trading was involved, he said. "Otherwise, we would keep on making them try new medication."
In Britain in February, AMI's subsidiary was prosecuted by the Trading Standards Office for predatory sales tactics and unfair contracts.
Investigator Tim Gass, posing as a client, recorded AMI trying to pressure him into signing a £2995 ($4600) contract, telling him only AMI could fix his problem.
When he said, "That's just a ridiculous amount of money," the AMI salesman ridiculed him: "Well, you're the only man that thinks that. I have 30 patients a day and I've never heard anyone say that in seven years … well I guess it depends how much your sex life is worth to you."
He told Mr Gass: "Doctors, if you go the GP, there's absolutely nothing they can give you."
Before securing the injunction against the Herald, Mr Vaisman responded to several of his former employee's allegations.
He admitted calls were monitored but that was to "ensure that staff members and contractors do not provide misleading or deceptive information to patients". In a written statement, he said: "I have reviewed doctors [sic] consultations with patients which confirm that side effects have been explained to patients."
The allegations that sales people overrode doctors' concerns and at times wrote prescriptions for patients were "ridiculous" and had never happened, he said.
As the Herald continued to fight to have the injunction lifted in the Supreme Court in February, the Australian Competition and Consumer Commission raided AMI's William Street headquarters.
About 50 officers spent 10 hours going through records before taking away boxes of documents.
Yesterday the ACCC announced it had begun proceedings in the Federal Court, alleging among other things that doctors engaged by AMI had conducted consultations with patients in a manner that did not provide an appropriate diagnosis and medical treatment. The matter will be before the court in Melbourne on January 31.
The president of the Australian Medical Association, Andrew Pesce, said AMI's practices if proven would be a serious breach of acceptable medical standards.
Dr Pesce said there appeared to be a clear conflict of interest in AMI's model of operations, where diagnosis and treatment decisions appeared predetermined and medications were dispensed for profit by the same practice.
The "flawed model of medical practice" seemed to focus on a business model rather than individual patient needs, he said. - ACCC alleges unconscionable conduct in promotion and supply of men's sexual dysfunction treatment program - ACCC Website Dec 2010
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ACCC alleges unconscionable conduct in promotion and supply of men's sexual dysfunction treatment program
Release # NR 289/10
Issued: 23rd December 2010
On Tuesday 21 December 2010 the Australian Competition and Consumer Commission instituted proceedings in the Federal Court, Melbourne, against Advanced Medical Institute Pty Ltd and AMI Australia Holdings Pty Ltd (AMI), Mr Jacov (Jack) Vaisman and two doctors.
AMI’s legal representatives were informed early Wednesday afternoon of the proceedings and all respondents, except one of the doctors, were served with the court documents on Wednesday afternoon.
The ACCC alleges that from 2008 to 2010, in promoting and supplying medical services and medications for men suffering from erectile dysfunction and premature ejaculation AMI engaged in unconscionable conduct in contravention of section 51AB* of the Trade Practices Act 1974.
The ACCC alleges that, among other things:
doctors engaged by AMI conducted consultations with patients in a manner which did not provide an appropriate diagnosis and medical treatment of male sexual dysfunction, and
AMI's sales representatives represented to patients they would be entitled to a refund if the AMI treatments were ineffective in circumstances where the sales representatives did not accurately or clearly disclose the conditions on which the refund was offered.
The ACCC alleges that Mr Vaisman and the two doctors were knowingly concerned, a party to or otherwise aided, abetted, counselled or procured the contraventions by AMI.
The ACCC is seeking declarations and injunctions against each of the respondents together with a disqualification order against Mr Vaisman, disclosure orders against AMI, costs and other orders.
The matter is listed for a directions hearing at 10.15 a.m. on 31 January 2011 before Justice North.
*Section 51AB prohibits a corporation from in trade or commerce, in connection with the supply or possible supply of goods or services to a person, engaging in conduct that is in all the circumstances, unconscionable. - London clinic’s £3,000 ‘cure’ for impotence was only a nasal spray - London Evening Standard Jul 2010
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London clinic’s £3,000 ‘cure’ for impotence was only a nasal spray
Sri Carmichael, Consumer Affairs Reporter
9 Jul 2010
A Harley Street clinic allegedly selling a fake £3,000 “cure” for impotence has closed after an operation by trading standards officers.
Westminster council received more than 100 complaints about AMI Clinic Ltd from people who said they were mis-sold a treatment for erectile dysfunction.
They claimed staff gave an overly aggressive “sales pitch”, misled them on price and promised a “money back guarantee” which was later refused.
Three Westminster trading standards officers investigated by posing as members of the public seeking treatment last August and September.
Each had an initial consultation by a “doctor” involving no physical examination. They were simply asked to fill in a questionnaire, which was followed by a brief discussion. All were prescribed a nasal spray for their claimed problem.
Another representative of the firm discussed payment with the men and said that without immediate treatment their relationships would end as they could not satisfy their partners.
The employee said their dysfunction would get worse to the point where they would require injections to the base of the penis if they wanted to have sex. They were told if they did not sign up there and then, the treatment would cost an extra £500.
The price for the treatment was unclear as it was hand-written on paper and initially appeared to be £29.95. It was in fact £2,995.
The undercover officers were promised a “money back guarantee in writing”, but it later became clear this refund would only be given if the patient attempted every different medical treatment on offer at the clinic, including the injections.
The council suspects that the 100-odd complaints are a “small proportion of the suspected victims in view of the sensitive nature of the clinic's work”.
Sue Jones, Westminster's head of trading standards, said: “While some might think this is all rather amusing, these people would have been very vulnerable and this company was making money selling something that was essentially a fob.
“Residents handed over thousands of pounds and all they got was a nasal spray.”
Shortly after the inquiry the firm ceased trading and voluntarily went into liquidation in April.
Parent company AMI still operates in Australia, where a court found it guilty of “misleading and deceptive” advertising. - Advanced Medical Institute to pay compo - SMH 7 Dec 2010
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Advanced Medical Institute to pay compo
Margaret Scheikowski
December 7, 2010
AAP
A company treating men with erection problems has been ordered to pay $30,000 compensation for unlawfully discriminating against an HIV-positive client.
AMI Australia Holdings Pty Ltd trading as Advanced Medical Institute also was directed to fully refund the man his $1,995 treatment payment.
The orders were made on Tuesday by the Equal Opportunity Division of the Administrative Decisions Tribunal.
The man, whose name has been suppressed, sought treatment at AMI for erectile dysfunction and was assessed at its Bondi Junction office in Sydney in December 2008.
He spoke to a nurse in person and a doctor over the phone, telling them of his medical conditions and medication regime, and was recommended treatment including injections and gel.
After paying for an eight-month program, he received and used a vial of injectable material and a container of gel but soon after was told he was not suitable to have any further injectable treatment due to his HIV status.
He initially was told this resulted from "a recent change in legislation" and was only given a partial refund of $1295.
"There is no dispute that this refusal of the provision of services amounted to less favourable treatment on the ground of (his) disability, than someone without (his) disability would have received," the tribunal said.
But AMI submitted it was lawfully justified in doing so to protect public health because of the possibility of the spread of an infectious disease.
This outcome could allegedly flow if it provided treatment that enabled an HIV-positive person to have sexual contact with another person in circumstances where there may be contact with the blood of the HIV-positive person through the use of injectables.
The tribunal noted none of AMI's witnesses had any specific expertise in the treatment of HIV/AIDS.
The company's chief executive said the general consensus with the other doctors was not to prescribe injectables for men whowere HIV-positive.
The man called evidence from experts, including his treating specialist Dr Ronald Penny.
"Dr Penny's unchallenged evidence is that there is no significant risk to public health if the person with HIV pays meticulous attention to hygiene and prophylaxis," the tribunal said.
It concluded the refusal to provide the man with penile injection therapy treatment was not necessary to protect public health.
It was satisfied the man was not highly infectious, adding he was an intelligent and responsible person. - Doctors give sex drugs a spray - SMH May 2009
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Doctors give sex drugs a spray
Kelly Burke
May 24, 2009
MEN who are spending thousands of dollars on the Advanced Medical Institute's unverified erectile dysfunction treatments are doing so as a desperate last-ditch measure, sexual health experts have warned.
"These men may have tried Viagra once or twice, it hasn't worked and they do not know where else they can go," said Darren Russell, a clinical associate professor and the president of the Australasian College of Physicians' chapter of Sexual Health Medicine.
"They are often too embarrassed to speak to a GP, and they cannot go up to their mates in the pub and say, "Hey guys, I'm having trouble getting it up, what should I do?"
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They see the AMI ads, and latch onto the promise of an instant solution to what has become an enormous source of anxiety, which is threatening their very image of themselves as men."
Jack Vaisman, the founder and owner of AMI, has dodged persistent questions the Herald has put to him relating to the human trials he claimed he had conducted in patent applications lodged in Australia and overseas for his premature ejaculation treatments.
Instead Mr Vaisman forwarded The Sun-Herald a number of articles published between 1999 and 2004 relating to the use of nasal sprays and a 2001 announcement by an American pharmaceutical company - unrelated to the treatment of premature ejaculation - about a clinical trial it had conducted on 184 men who were impotent.
Between 69 and 82 per cent of the men had achieved an erection after nasally inhaling an apomorphine-based preparation, the company reported.
AMI also offers an apomorphine-based treatment for impotence, which as far as The Sun-Herald can determine has not been the subject of any patent applications by Mr Vaisman. He has, however, lodged an Australian provisional patent application for a similar apomorphine-based product to treat low female libido, after announcing in July last year that he had conducted a pre-clinical trial that found that "more than 70 per cent of female patients experienced orgasm after using the new treatment … and in one case a patient, who had had experience of orgasm, reported multiple orgasms".
Dr Russell said he was unaware of any research into the use of apomorphine for the treatment of low female libido.
"The most likely effect it would have was to make a woman feel nauseous, which was not usually an ideal prelude to sex," he said.
Moreover, since 2001, drug companies have gradually abandoned further studies into the use of apomorphine for male erectile dysfunction because the early results had been so underwhelming, Dr Russell said.
"There are plenty of cheaper and more effective drugs now available, such as Viagra, Levitra and Cialis, and they do not have the same negative side effects."
In the absence of any clinical trials, perhaps the most telling data comes from the manufacturer that holds the licence to prepare AMI's drugs, NxGen. Figures provided to shareholders this year showed that 5000 AMI prescriptions are filled each month, totalling 60,000 units a year.
With prescriptions valid for three months, and Mr Vaisman claiming he treats 45,000 men each year, it appears at least two-thirds of patients never bother to get their repeats filled.
AMI'S PRODUCTS
Premature ejaculation Cost: $300 for a 7ml nasal pump. With the prescription holder instructed to use up to six squirts of the spray a session, the cost can work out about $100 for a maintained erection.
Male impotence Cost: $3995 for an 18-month supply of apomorphine hydrochloride spray after signing a contract. The fine print reveals that the money-back guarantee applies only after the client has tried all treatments available, including "self-injection therapy".
Low female libido Cost: $1495 for a six-month supply of two products, paid monthly via direct debit. The "transdermal delivery system" - often used as medico-speak for ointment - contains glycerol nitrate and phentolamine, used to treat heart conditions. - Want longer lasting sex? Steer clear of AMI’s ‘Nasal Delivery Technology’ - CounterKnowledge.com Feb 2009
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DWant longer lasting sex? Steer clear of AMI’s ‘Nasal Delivery Technology’
By Raf Sanchez
5 February 2009
The ads exhort readers to face up to their crippling erectile dysfunction issues, restore their confidence, and take charge of their lives. Or put more simply: “Bonk Longer”.
But this isn’t just standard-issue inbox spam. Instead the ads are part of a billboard advertising campaign by Australian firm Advanced Medical Institute (AMI) to promote their flagship product: a nasal spray designed to treat both erectile dysfunction and premature ejaculation.
The brash ads have led to well publicised clashes between AMI and advertising standards commissions on grounds of decency both in Australia and in the UK, where the firm recently opened a Harley Street clinic. Last year the Australian Advertising Standards Bureau somewhat prudishly forced the company to cover up the word “sex” (admittedly written in six-foot-high letters) on hundreds of billboards around the country, while the British campaign has already generated hundreds of complaints.
Less well known, however, are the two investigations currently underway by different government agencies following claims that AMI’s wonder-product (illustrated in a bizarre video here) simply doesn’t work. The New South Wales Office of Fair Trading as well as Victorian Consumer Affairs are looking into the company’s practices after receiving complaints from customers. The regulator “believes the disaffection is probably much higher than the actual complaints received as men are too embarrassed to lodge formal complaints over the $4000 contracts”. Support group Impotence Australia estimates it receives four complaints a week about the organisation.
The spray’s main component is the drug apomorphine, used mainly for treating Parkinson’s disease. While it is thought to have some usefulness in fighting erectile dysfunction it’s widely considered to be less effective than Viagra and other treatments. The excellent Bandolier concludes “apomorphine is effective, in that it is better than placebo”. One would hope.
But regardless of the effectiveness of apomorphine, AMI’s nasal spray, the key weapon in its floppy-firming arsenal, remains clinically untested and totally unproven. Dr. Chris McMahon, associate professor of the Australian Centre for Sexual Health said of the spray:
“There’s a certain logic to it… [but] I could also argue that because Panadol is effective as a tablet for a headache we could crush it up and put it into some K-Y Jelly and rub it into the scalp. Now we all know that is ridiculous - the way that you would prove or disprove that is to do a clinical trial.”
More sinister still is AMI’s ‘money-back guarantee’. In order to qualify for a refund if the nasal spray doesn’t work (AMI’s services can often run into the thousands of dollars) patients have to agree to undergo three additional rounds of treatment to see if they can’t get it right. The last treatment? Self-administered injections directly into the penis. In other words: if the quacks can’t cure you the first time you have to give them three more goes, including needles, before you get your money back. The Sydney Morning Herald reports one case in which a one-armed man was told he would have to give himself injections if he wanted any chance of seeing his money again.
But none of this commotion or outcry should be unfamiliar to AMI’s colourful director, ‘Dr’ Jack Vaisman. Despite being a high profile business figure running a NASDAQ-listed company relatively little is known about “Doctor Droop”. One profile of the man begins this way:
Jack/Jacov/Jakov/Javov Vaisman/Vaysman/Waterman was born in Moscow/Ovruch/Odessa/Kiev/Ukraine/place unknown on August 23 and 28, in 1945 and 1946, according to the personal details provided by the company director and shareholder to the Australian Securities and Investments Commission.
Two things that seem incontrovertible are that Vaisman (let’s call him that, it’s easier than all the forward strokes) is not a registered medical doctor and that his run-ins with pesky medical regulations are frequent and nasty. In 1996 Vaisman’s then-company On Clinic Australia pleaded guilty to 34 charges of importing drugs not registered with Australia’s Therapeutic Goods Administration. He later was forced to re-title AMI’s nasal spray as “nasal delivery technology” after the Administration took issue with his marketing. In 2002 the Australian Competition and Consumer Commission moved against AMI for “misleading and deceptive conduct in relation to the advertising and promotion of treatments for erectile dysfunction (impotence) and premature ejaculation.”
The lesson of all this? Promises of a miracle cure for erectile dysfunction are probably best ignored, whether they’re in your inbox or being peddled on Harley Street.
Hat tip: Alexa Delbosc - The controversial life and times of Doctor Droop - The Age Feb 2009
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The controversial life and times of Doctor Droop
February 1, 2009
His clinics are a hit, but experts wonder if the science is on the nose. Michael Bachelard and Kelly Burke report.
"Dr" Jack Vaisman, the king of erectile dysfunction in Australia, has a lifelong habit of sliding around regulations.
His "Longer lasting sex" billboards were found to be offensive, so he covered the s-word with "censored" stickers, followed by new signs urging men to "Do it longer" and "Bonk longer". When a series of his claims were found by the Australian Competition and Consumer Commission to be false and misleading, he amended them just enough to avoid future prosecution.
When the Therapeutic Goods Administration ruled against his advertisements for "nasal spray", he began advertising "nasal delivery technology", which apparently satisfies the rules, even though the regulator has no idea what is in the sprays, and "has not tested or evaluated them for quality, safety or efficacy".
Mr Vaisman even adopts the title "Dr" by claiming that he was trained overseas, but admits that he is unregistered in Australia.
Last week, yet another regulator, Consumer Affairs Victoria, confirmed it had started investigating how Mr Vaisman's company, Advanced Medical Institute, ties clients to 18-month, $4000 commitments to treat impotency, with little chance of a full refund.
In NSW, Fair Trading Minister Virginia Judge has asked dissatisfied customers to come forward with complaints of unconscionable contracts and undeliverable guarantees. She admits embarrassment on behalf of clients is a big impediment to her inquiries.
But as the regulators watch, some customers have attacked Mr Vaisman's clinics, saying they are a scam devoted to hard-sell techniques designed primarily to separate them from their cash.
And the medical fraternity is becoming increasingly concerned that his nasal spray treatment is ineffective and that his clinics funnel impotent clients towards the much more invasive technique of self-injecting drugs directly into the penis.
None of it, however, has affected Mr Vaisman's business empire. It is growing fast — and branching out into other areas of medicine. He is now offering heart disease diagnosis with his heavily advertised Heart Check clinics, and treating female sexual dysfunction, claiming 65 per cent of women suffer from it.
His company says almost half a million men have come to its private clinics over the past decade. More than 20 now operate in Australia and New Zealand, as is a discreet consultancy in London.
Last year AMI, which is registered as a public company on the US NASDAQ, posted a 50 per cent increase in gross profit, from $8 million to $12 million.
Mr Vaisman, a Ukrainian migrant, is unrepentant. He claims he is delivering savings worth millions to taxpayers every year. "All my consultations, we never use Medicare," he told Sydney's Sun Herald. "Can you imagine if 90,000 impotent patients went to their GP every year? At $45 or $50 a consultation, what would happen? The government would lose millions of dollars."
Sexual dysfunction, he says, is a quality-of-life issue and "if you want good quality of life, you have to pay". And pay you do. An AMI contract shows a client signing up for an 18-month course of treatment for $3995 — treatment the Urological Society of Australia and New Zealand says could be got cheaper at a GP.
Blog contributors have described the services offered at the Vaisman-owned Heart Check clinics, at $590 to $1000, as a scam driven by heavy pressure from sales staff. Consumer Affairs Victoria is also investigating these reports.
Mr Vaisman says of his impotence treatment: "We cannot guarantee a result but we always guarantee money back."
But in the fine print of the AMI contract, under the heading "Guarantee", the clinic agrees to refund money only if the client agrees to try all the different methods the AMI doctor prescribes, which could include spray, lozenges, gel and "self-injection therapy". Even then, the cost of the medicines and a 15 per cent "administration fee" are deducted from the refund.
As worrying are the medical side-effects. Dr Chris McMahon, of the Australian Centre for Sexual Health, said he has dealt with a large number of former AMI patients. "Some are satisfied, but the majority express to me that they are not," he says, pointing out that the apomorphine-based nasal spray used in Mr Vaisman's products has never been the subject of clinical trial data, or submitted to peer review, and that the drug, in any form, was found to be ineffective in 80 per cent of patients in a British study.
The not-for-profit group Impotence Australia says it received, on average, about five complaints about the AMI each week. When patients fail to respond to the nasal spray, lozenges are offered but invariably the patient ends up facing injection therapy, the group says.
Dr David Malouf, vice-president of the Urological Society of Australia and New Zealand, said that with injections, 30 per cent of men would develop pain at the injection site.
"I've seen bruising, scarring, curvature of the penis and priapism (persistent painful erection). I had one patient who was treated with one of these agents. He was given a sheet of paper with a number to call if anything went wrong, which it did.
"He was effectively told (by AMI) 'there is nothing we can do — you have to go to a hospital emergency department' … That case of priapism was so severe, it permanently damaged his erectile function. He went from having a mild erectile problem to having a non-functioning penis. And he was a young guy, too."
Formal complaints, however, are comparatively rare, says Professor Basil Donovan of the University of NSW, because men are embarrassed to come forward.
"It is an area prone to exploitation. It is an area known for charlatans."
The Australian Medical Association is also concerned.
Mr Vaisman, though, defends his product, saying that, with the exception of occasional crustiness or bleeding around the nose, nasal sprays are effective and have practically no side-effects. He says the risk of priapism is no more prevalent with the use of injectibles than with more conventional treatments.
He says he is a victim of his own unconventional success and if only he had the time to publish his results, the findings would silence his critics. "I believe I am a pioneer," he says. "Yes, we have a lot of criticism. But I am fighting for what I believe is right."
With RACHEL BROWNE and ALEX McDONALD - Rise of nasal spray guru - Daily Telegraph Oct 2006
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Rise of nasal spray guru
By Neil Mercer
The Sunday Telegraph
October 29, 2006 12:00AM
The man behind the controversial nasal spray that promises to help impotent men is raking in $50 million a year and receiving thousands of calls a week from distressed men.
Dr Jack Vaisman, the Sydney entrepreneur often dismissed as a shonky operator, told The Sunday Telegraph that he had "successfully treated" more than 300,000 Australian men for impotence and premature ejaculation.
The medico shrugged off recent court findings that his company had engaged in misleading and deceptive conduct.
Speaking at the Botany Rd headquarters of his company, Advanced Medical Institute, Dr Vaisman accused big pharmaceutical companies, such as Pfizer and Bayer, of trying to destroy him.
He said they were attacking him because he had patented his own nasal spray treatment for impotence which competed with drugs such as Viagra, made by the pharmaceutical giants.
"Of course, I take the customers from them - I take the money from them," he said.
"In 1993 I opened my first clinic; since then, it has been war."
As he spoke, more than 100 employees fielded a constant stream of calls about impotence from Australia, New Zealand, China and Japan.
Dr Vaisman said 20 AMI clinics in Australia now took 9000 calls a week from worried men.
His teams of nurses and doctors handled about 3000 consultations a week.
AMI in the past has used celebrities such as Ian Turpie, Tim Webster and "Ugly" Dave Gray to promote its nasal spray.
It was a newspaper ad that led to his most recent run-in with authorities.
The Australian Competition and Consumer Commission took AMI to court, saying the company's claims about its impotence cure were "misleading and deceptive".
The Federal Court agreed.
Justice Kevin Lindgren said TV personality Ian Turpie had lied when he said AMI's nasal spray had helped him overcome impotence.
The judge found that Turpie had never been impotent and had engaged "in a gross deception of the public".
The judge was also critical of Dr Vaisman, describing him as "a defensive, assertive, argumentative witness".
It's not the first time the doctor, who says he qualified as a gynaecologist in Ukraine, has hit the headlines.
In December, 2003, the Federal Court declared that he and his company had engaged in misleading and deceptive conduct.
It found AMI's claims that all of its treating doctors had six years experience in sexual medicine were not true.
In a separate matter,the Medical Board of Victoria found in 2004 that a doctor working for AMI had engaged in "unprofessional conduct of a serious nature".
This followed a complaint from a patient that his telephone consultation with the doctor had lasted about 60 seconds.
Of the Turpie matter, Dr Vaisman said: "It is such a stupid case - the whole world was laughing at this case."
The only problem he had with authorities was over advertising.
"If there were any medical problems, do you think I would still be sitting here?" Dr Vaisman said.
As for his troubles with the ACCC, he said: "BP has problems with the ACCC, Harvey Norman has problems with the ACCC.
"I have problems with the ACCC. So what?"
- Fat zappers may be a fad too far - The Age Sep 2010
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Fat zappers may be a fad too far
Jill Stark
September 12, 2010
Ever wish you could lose your love handles and banish those man boobs with the wave of a magic wand?
Well, wish no more - your fairy godmother has arrived and she's armed with a handbag full of tricks to help you "zap", "dissolve" or "melt" away that stubborn fat.
Or at least that's the tale being peddled by the cosmetic industry.
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Some companies are charging more than $6000 for "fat-dissolving" injections, while others promise to "liquefy" your flab.
But this fat-busting fad might not have a fairytale ending.
Two Melbourne companies are being investigated by the Therapeutic Goods Administration (TGA) to determine whether their claims breach the law.
The medical regulator is scrutinising FatZap, which has centres across Melbourne and charges up to $3000 for a treatment that promises to "zap" customers into shape.
They claim their "state-of-the-art" machines can help reduce fat, cellulite, stretch marks and saggy skin by using "radio frequency controlled volumetric heating of the skin", and an ultrasound beam that "targets fat cells, bringing them to self resonance".
Also under investigation is Armadale company CDC Clinics, which offers laser treatment to "melt" fat, using a method called laser lipolysis.
If the companies are found to be making medical claims which are not backed by scientific evidence, they could be ordered to withdraw their advertisements.
A spokeswoman said the TGA is "concerned about alternative treatment providers making health claims that cannot be substantiated and that have the potential to mislead consumers".
The regulator's complaints panel has twice ordered FatZap to stop claiming it can zap or melt fat but the company continues to advertise that it can zap fat.
The Victorian president of the Australian Medical Association, Harry Hemley, said tighter regulation of the industry was needed to protect the public.
"At best you may just be left out of pocket, but at worst the therapy could actually cause you harm," Dr Hemley said.
CDC Clinics offers "Fat Dissolve", spruiked as a new way to banish cellulite and fat by injecting clients with "soy bean extract, vitamins and medicines" to break down fat cells permanently. The company refused to answer questions from The Sunday Age.
Its website states that redness on the skin, bruising and swelling can occur for up to 10 days after treatment. FatZap warns that some people may experience superficial burns and swelling.
Weight-loss specialist Leon Massage from the Body Metabolism Institute said some of the companies' claims went against the principles of physiology.
"They're talking about zapping fat and dissolving the fat away. The question is, what happens to the fat then?" said Dr Massage.
"Let's just assume for the sake of the argument that they actually can achieve what they say and break down a fat cell - what's going to make that fat cell disappear into the ether and be excreted? Nothing."
In an emailed statement, a spokesman said FatZap was not a weight-loss program but a method of "removing localised areas of fat".
The spokesman said studies in the Journal of Cosmetic and Laser Therapy and numerous clinical trials confirmed the efficacy of their machines, which have been registered by the TGA.
He said the previous complaint referred to a device the company no longer used.
However, while TGA registration means the therapy has been deemed safe, it does not mean the regulator endorses the treatment or the company's claims.
In the last financial year Consumer Affairs Victoria received 35 inquiries and 20 complaints about weight-loss services.
Consumers needed to ensure that any promises made about the effectiveness of any treatment claiming to reduce body fat were put in writing, a Consumer Affairs Victoria spokeswoman said.
"Don't sign anything until you're certain you know what you've agreed to and how much you'll pay overall," she said. - Fatzap Centres continue to claim to melt away weight - Herald Sun Aug 2009
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Fatzap Centres continue to claim to melt away weight
Ben Butler
August 24, 2009 12:00am
WEIGHT-loss group Fatzap Centres is continuing to make misleading claims it can "melt" fat away, 10 months after being told to stop.
Three experts have told the Herald Sun there is no evidence the treatment, which costs between $150 and $250 a session, helps people lose weight.
Fatzap can ignore the Therapeutic Goods Complaints panel ruling because it lacks enforcement powers.
And the doctor who blew the whistle on Fatzap says the government medical devices regulator does not crack down on rogue operators.
Fatzap's website says it uses radio frequency radiation to heat fat, "causing some of the fat to "melt away".
"It is then excreted by the body through the lymphatic system and eventually is eliminated naturally," it says.
In October the TGC panel ruled the claims were "unverified, misleading and likely to arouse unwarranted expectations as to the effectiveness of the devices" and asked Fatzap to withdraw them.
"I can't find any published literature other than from the company that says this is effective," said weight-loss industry expert Dr Samantha Thomas.
The Monash University senior research fellow said the extravagant claims were typical of the weight-loss industry.
The Federal Government's preventative health task force has recommended health loss firms be made to prove their programs work.
Fatzap's small print advises a healthy diet and exercise.
"If you followed the things that they recommended, you probably wouldn't have to have Fatzap anyway," Dr Thomas said.
Psychology of weight management specialist Dr Rick Kausman said there was "no research evidence that this treatment helps people achieve a healthy weight".
"How can something like this make a difference to the complex reasons someone might be above their healthy weight?" he said.
La Trobe University public health physician Dr Ken Harvey, who made the original complaint, said: "You might feel something's happening, but there's no evidence you will lose any weight as a result of using Fatzap."
He said the Complaints Resolution Panel could only refer breaches to the Therapeutic Goods Administration but Dr Harvey said it "does nothing".
"I've got a portfolio of at least 20 complaints that have ended up like that -- they've been referred to the TGA and nothing happens," he said.
The Herald Sun could not contact Fatzap Centres for comment.
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