Impotence clinics are big business and their practices have long been controversial. BIANCA NOGRADY reports on how these clinics slip beneath the radar.
SYDNEY GP Dr Peter Craig gained a disturbing insight into how some impotence clinics work when one of his patients presented at his surgery with vomiting, nausea, headaches and feeling faint.
The patient had been prescribed apomorphine lozenges by an impotence clinic to treat his erectile problems.
“He said he had been feeling dreadful since the medication was given,” Dr Craig says.
Knowing his middle-aged patient had poorly controlled hypertension, Dr Craig asked how and why he was prescribed the medication.
“They didn’t take a medical history,” Dr Craig says.
“[The consultation] consisted of a fellow saying, ‘We know what you’re here for’ and examining his penis.”
The patient was told to return the next day for the $850 treatment, which would be specially made up.
“He was told it might make you feel sick, but just keep taking it.”
The patient persisted with the lozenges, felt unwell and did not achieve erections.
Professor David de Krester, director of Andrology Australia — a government-funded organisation focusing on men’s reproductive health — also has a patient who visited several impotence clinics seeking a cure for his erectile problems. The patient left after being asked to pay $3500 for lozenges that were on special.
“I think it’s fair to say that these clinics prey on the concerns of embarrassed men with impotence,” says Professor de Kretser, an andrologist who is also director of the Monash Institute for Reproduction and Development.
“Unfortunately, the service that is delivered could in some instances be called into question.
“I would be extremely concerned as to the service that’s offered [by some clinics] and the financial imposition that is placed on patients.”
Not all impotence clinics are controversial. Most of the issues stem from clinics that advertise broadly and make strong claims about treatments.
In the past five years, complaints to health care complaints commissions about impotence clinics have focused on pushy and aggressive marketing, costly treatments, refunds being refused despite money-back guarantees being offered, medical consultations occurring without a doctor present, and inadequate information being given about medications and their side effects.
In this time, the number of complaints has been more a trickle than a flood — 16 in NSW and 15 in Queensland, while WA has received 12 since 2001. However, Brett McCann, head of consumer organisation Impotence Australia, believes these are just the tip of the iceberg.
“When you’re talking about impotence, most men won’t complain,” says Mr McCann, who is also a sex therapist.
“You’re talking about a vulnerable group of men who don’t want to expose their difficulties.”
Impotence clinics have been on the radar for some time, according to NSW Medical Board registrar Andrew Dix, who was involved in a 1998 NSW Health Department inquiry into the industry.
He says few complaints against impotence clinics warrant serious disciplinary action by a medical tribunal. Health care complaints commissions have referred some complaints to state medical boards, but Mr Dix could not recall any that had proceeded to disciplinary action in NSW.
“I would have little doubt that there is a lot of unhappiness in the [medical] profession about them because it’s not always good medicine,” Mr Dix says.
While the NSW inquiry had reservations about some aspects of the clinics’ operation, they did not appear to be operating at a “cavalier level”.
So, how do the more controversial impotence clinics operate?
There are some surprises. For instance, it is possible for a patient of Advanced Medical Institute — a network of 39 impotence clinics around Australia — to receive a prescription without visiting a doctor. What’s more, the medication they are prescribed may not have been approved by the Therapeutic Goods Administration.
Advanced Medical Institute CEO Dr Jacov Vaisman told Australian Doctor he has permission from the NSW Health Department and from insurance companies to consult patients via video or phone, as long as the consultation is not bulk-billed.
Dr Vaisman, a gynaecologist with a PhD in medical science, says that in phone consultations the clinic doctor asks about the patient’s condition and what medications they are using.
There is “always communication between [the patient’s] GP and our doctors”, Dr Vaisman says.
A NSW Health Department spokesperson says the department has not given permission to allow a centralised clinic doctor to consult with a patient over the phone without a physical examination.
“This would be an ethical medical practice issue, which may be of interest to the medical board,” the spokesman says.
According to the NSW Medical Board, phone consultations are not illegal, but they are not considered good practice.
“As a general rule, there may be circumstances where it is appropriate to issue a repeat prescription based on a phone conversation, but the general view is the initial consultation should be a face-to-face interaction,” Mr Dix says.
Dr Vaisman says he operates the biggest network of impotence clinics in the world, which sees about 45,000 men a year and offers four unique treatments that no other doctors “in the world” have.These include a nasal spray and lozenges containing apomorphine and phentolamine, lozenges containing sildenafil, an intra-urethral gel and injections.
Abbott Australasia recently gained TGA approval for its apomorphine tablet (Uprima), which is indicated for erectile dysfunction. Abbott Australasia pharmacist David Clayton says apomorphine delivered intranasally may be effective, but there are no data to support the efficacy of this delivery model in the treatment of erectile dysfunction. As for adding phentolamine — a vasodilator that is only approved for use in severe hypertension — to the apomorphine, he says data on the safety and efficacy of this combination, if it exists, have not been evaluated by the TGA.
But it’s not only impotence clinics that have seen the potential benefit in combining phentolamine and apomorphine.
“We have had comments from specialists asking why didn’t we put phentolamine in Uprima because it would have enhanced it,” Mr Clayton says.
Dr Vaisman’s lozenges and nasal spray are not listed on the Australian Register of Therapeutic Goods and so have not met the TGA’s safety, efficacy and manufacturing standards.
So, how can these products be supplied directly to consumers?
The answer lies in the distinction between manufacturing and compounding a therapeutic good, according to NSW Pharmacy Board registrar Ian Dean. The difficulty is proving when a compounding pharmacist has crossed the line to become a manufacturer.
“If a medical practitioner writes you a script for an apomorphine nasal spray and they can find a pharmacy that’s prepared to compound it for you, there is nothing to stop that,” Mr Dean says.
“It’s a legitimate prescription, taken to a pharmacy that has the skill and experience to compound and dispense — that’s what [compounding] pharmacists do.”
However, once a pharmacist starts compounding on a larger scale — a scale that could be considered to be manufacturing — they step into the federal jurisdiction of the TGA.
A TGA spokesman says drug companies require a licence from the TGA to manufacture medicines.
“The medicines the drug companies make are required to be registered with the TGA and those medicines are subject to TGA evaluation,” he says.
The TGA has swung into action when clinics have strayed too far from the line. In 1996, it prosecuted On Clinic Australia for importing and supplying unregistered therapeutic goods — injectable paparverine and Regitine (phentolamine). Dr Vaisman was owner, director and founder of On Clinic Australia at the time.
This year the TGA struck again, taking successful legal action against AMH Holdings (NSW), for supplying unregistered sildenafil lozenges. The TGA is also taking action against a Sydney compounding pharmacy for the unlawful manufacture of the same lozenges.
The way in which therapeutic goods are advertised to consumers is another area where Australia has tough restrictions. However, once again, impotence clinic advertisements seem to bypass controls.
Compounding pharmacists are not allowed to advertise and make claims about a drug that they are compounding. Obviously, advertising prescription-only medicines direct to consumers is also prohibited. However, impotence clinics advertise products, including nasal spray, in metropolitan and regional newspapers.
One of Advanced Medical Institute’s ads states that a “new, medically proven nasal spray for all types of impotence and premature ejaculation is now available”, subject to a doctor’s prescription.
TGA spokeswoman Kay McNiece says this appears to infringe advertising laws because prescription products cannot be advertised to consumers.
“The TGA is really concerned that the advertising suggests to the public that this prescription medication would have been evaluated by the TGA for efficacy, for safety and for quality, as is the normal course of events with prescription medication and, for that matter, over-the-counter medications,” she says.
“None of this is true. The company is using a legitimate provision in the [Therapeutic Goods] Act to maintain the ability of pharmacists to make up a compound in their own pharmacy.
“It is bypassing all of the safety mechanisms that are in place to protect consumers. We have approached the company to explain their actions.”
The TGA is investigating Advanced Medical Institute’s use of compounding pharmacists and its advertisements.
Meanwhile, Abbott Australasia, which holds a patent on apomorphine (Uprima) for the treatment of erectile dysfunction, has raised concerns with the TGA.
“Certainly we’re concerned about the actions of these clinics, as are the vast majority of those who are specialising in the treatment of erectile dysfunction,” Mr Clayton says.
Sildenafil (Viagra) manufacturer Pfizer has also been keeping watch.
“We’re not happy about our product being used as an adulterated product,” says spokesman Craig Regan. However, the pharmaceutical giant is not taking any action on the matter. “[It’s] not our job to police this.”
The Australian Competition and Consumer Commission has locked horns with impotence clinics over claims made in advertisements. In 1996, the ACCC successfully litigated against three clinics for false and misleading advertising.
Like the TGA, it is once again engaged in a legal battle with the clinics. This time the case is against Dr Vaisman and Advanced Medical Institute (also trading as Australian Momentum Health, Health Services for Men, and Impotency Anonymous at the time the action was launched).
ACCC allegations include that the company advertised guaranteed results when treatments for impotence and erectile dysfunction cannot be guaranteed, and that the treatment was advertised as suitable for all ages and conditions when it is not. The ads also say there are “no needles or tablets involved” and that if there is “no performance”, there will be “no charge”.
The ACCC alleges needles and tablets are sometimes prescribed and refunds are not always given to unsatisfied patients.
Dr Vaisman vigorously defends his clinics’ reputation, saying he has 70 testimonials from satisfied customers to back it up.
“We are fair to patients,” he says. “We don’t offer to the patient medication; we are offering solution.”
He dismisses the ACCC action against Advanced Medical Institute, which he says was launched 2.5 years ago.
“We believe they are wrong … Would something serious wait … 2.5 years?”
He also says patients coming to his clinics get a good deal, pointing out that a 6-12-month program of treatment from his clinics is half the price of a similar-length course of Viagra. He’s proud of Advanced Medical Institute’s money-back guarantee, but he stresses this guarantee is conditional on a patient trying all the treatment options, including injectables.
“[Our ad] says clearly that [we] will use four treatment options and guarantee money back if those are used,” Dr Vaisman says. “If all are not effective, [we] refund the money.”
Meanwhile, organisations such as Andrology Australia are encouraging men to see a GP before contacting an impotence clinic.
“Our push is that the GP ought to be the first person that sees such a patient and we are doing everything we can in terms of educating GPs,” Professor de Kretser says.
“We’re saying beware of people who advertise in the press and be suspicious if offered non-prescription drugs and asked to make a substantial financial commitment.”
But Associate Professor Merrilyn Walton, the former NSW Health Care Complaints Commissioner who chaired the 1998 NSW Health Department inquiry into impotence treatment services, believes these clinics are here to stay. The inquiry conducted a thorough investigation of the industry and identified many problems with the clinics’ operations. But this was the pre-Viagra era, when the only treatment available was intraurethral injection.
“I think everyone thought that [impotence clinics] would not be a problem after Viagra,” says Professor Walton, now at the University of Sydney’s faculty of medicine. But they were wrong.
“It’s as important an issue now as it was then,” she says.
“Sometimes they just discover new ways to do things. Health is big business, and if there is a market niche, business will find it.”
Complaints about impotence clinics
n Being pressured into having treatment
n Pushy and aggressive marketing
n Refunds not given
n Fees not disclosed up-front
n A lack of information about the type of medication and the risks
n Not being seen in person by a doctor
n A lack of expected follow-up
n One mother complained that her 18-year-old son was sent home with an injectable treatment and a video explanation
n One patient was told that if he didn’t take the treatment, he’d never be able to perform
What to look out for
Andrology Australia — a government-funded organisation focusing on men’s reproductive health — warns patients to obtain a second opinion if:
— Medication is sold to them by a health practitioner
— They feel pressured to make long-term financial commitments
— They do not feel they are being offered ongoing review and care
— They feel that the consultation does not cover all aspects of general health, lifestyle and other possible illnesses
— They feel uncomfortable about any suggested course of action or the way they are treated seems unusual
Submit your feedback here: