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Lets remember the Isolagen scandal

I hope ICX is not the same…

Isolagen was also a british company, traded in the stock market, running clinical trials, etc…

Is the ‘grow your own facelift’ just a con?

By ANNA SEAMAN and PAUL BRACCHI - More by this author » Last updated at 08:49am on 28th August 2007

No more frown lines or facial folds, they said. Wrinkles? There wouldn’t be any. Even scars would miraculously disappear.
Like thousands of women, Julie Stepney, 56, from Bournemouth, believed the hype surrounding ‘revolutionary’ anti-ageing treatment Isolagen.
After all, Dynasty actress Emma Samms was used to promote it, and other celebrities including Tamara Mellon, Linda Barker, and Anthea Turner were said to have tried it.

Frankly, thought Julie, £3,500 - and 144 injections - was a small price to pay to turn back the clock. So, too, was the swelling which would leave her looking as if she had tangled with a swarm of bees.
Alas, it was all for nothing. When Julie looked in the mirror, the same face she had always had was staring back at her - with the same sagging jawline and crow’s feet.
“I didn’t expect to look like a 20-year-old,” she said. "But after forking out thousands of pounds, I expected some sort of results."
We now know that Julie was a ‘guinea pig’ for a product that was unproven and unregulated. In America, the company behind Isolagen was forced to withdraw it from the U.S. market shortly before its launch in the UK four years ago after the Federal Drugs Agency (FDA) expressed concerns over its scientific trials.
Julie was unaware of this. So was Patricia Bailey from West London, Josephine Campbell from Dorset and Mary Johnson from North Yorkshire.
As the Mail reported yesterday, Julia Hall from Kent was also so disgusted by the lack of results after spending her life savings on two courses of the treatment that she set up a campaign group.
Now up to 50 members are suing the company in a class action for breach of duty and misrepresentation. They hope to receive at least £5,000 each.
In Britain, it is still unclear whether Isolagen should be considered a beauty treatment or medical procedure, which is why it went on sale here - helping to make making millions for the manufacturers - but not in America where there is a stricter assessment regime.
The lawyers call it a “grey area”; Julie and all the other “guinea pigs”, who were left financially disadvantaged and emotionally distraught, call it a scandal.
It is too early to say if there will be any long-term side-effects such as bloating or disfigurement, which could take years to emerge, according to the British Association of Aesthetic Plastic Surgeons.
“No surgeon who is a member of our organisation would consider using this procedure until there are fully documented facts about its safety and effectiveness,” said a spokesman.
However Isolagen is not the only non-surgical cosmetic procedure to come under the spotlight in recent times. The consumer group Which? revealed recently that 415,000 people undergo non-surgical cosmetic procedures in Britain each year.
Yet many of the substances used on these patients have never been approved in other countries and, as a result, women are being put at risk or ripped off by clinics and beauty parlours.
Already, lip implants culled from cadavers in the U.S. are available in London and “placenta shampoo” (harvested from a selection of new mothers in the U.S.) and anti-wrinkle gel containing an ingredient from the foreskin of a circumcised baby - the tissue cells of which were replicated in a laboratory - can be purchased with a few clicks of a computer mouse.
What a Frankenstein’s monster the beauty industry has become.
Isolagen itself would not be out of place in a sci-fi movie. It’s a technique sometimes referred to as the “grow your own facelift” programme.
A tiny sample of skin is taken from behind your ears. Collagen-promoting cells are culled from the sample and cultivated in a petri dish before being injected into the areas of concern.
Over time, the transplanted cells, full of the body’s natural proteins, are supposed to rejuvenate the skin. Or, at least, that was the claim.
Isolagen was marketed ruthlessly in Britain as an alternative to Botox and had instant appeal. First, it did not require botulism to be injected into your face (Botox is a trade name for the botulinum toxin); and second, the benefits would last much longer - “18 to 20 months in most patients”.
Representatives from the U.S. biotechnology firm which invented the treatment held “introduction evenings” up and down the country; there were promotional videos and glossy brochures and a laboratory was opened in North London.
Soon Isolagen was being offered at scores of clinics. As many as 7,000 patients paid up to £4,500 in the hope of reversing the ageing process.
One of them was 37-year-old Julia Hall. She read about Isolagen in a celebrity magazine last year. “I visited the Isolagen website and read testimonials from burns victims whose lives had been transformed,” said Julia, who had suffered with terrible acne scarring on her cheeks since she was a teenager.
"I was really excited. I thought I’d finally found an answer. I told my partner about it and we decided to spend the money we’d been saving to buy a house.
"I wanted treatment for my acne scars and my partner, who is a little older, wanted to address the wrinkles in his ageing skin."
Both Julia and her partner subsequently had two sets of injections, in September and October, which cost £9,000. They were told they might not see any benefits for six months; six months later, however, the ugly scarring remained. Julia went back to the Harley Medical Group in London and asked for her money back.
“I was told, rather curtly, that on rare occasions the treatment does not work,” said Julia, from Orpington in Kent.
"They pointed out that I had signed a disclaimer, so the money would not be refunded.
"I was furious and upset. We had spent our life savings on something we thought was pretty much a dead cert. I just couldn’t understand. If I was such a rare case, then why had my partner not noticed any difference in his appearance either?"
In fact, Julia and her partner were far from alone. By this time, scores of other women had suffered a similar experience. Like Julia, widow Patricia Bailey, 57, visited the respected Harley Medical Group back in 2005.
“I’m not the sort of person with money to burn,” she said. "But I felt treatment would boost my selfesteem, so I borrowed nearly £3,000 from my mother. I went back three times over a year to have my neck, mouth, forehead and around my eyes done at Harley Street.
"It was a humiliating process. I was shuffled from room to room having needles poked into me and people taking photographs of me. To make matters worse, my face swelled hugely and it was very painful. I couldn’t bite down on food properly for a week after the injections."
Patricia asked for her money back. The clinic refused. Did the Harley Medical Group know about the controversial background surrounding Isolagen?
“It is proven therapy for reducing frown lines, facial folds, wrinkles around the eyes, vertical lines around the lips and scars caused by acne, chicken pox or trauma,” boasted the promotional literature.
Would Julia and Patricia have parted with thousands of pounds if they had been aware that Isolagen had still to receive approval in the U.S.? The technique was first used on American women in 1996 - when it did not fall within the jurisdiction of the FDA.

But it was taken off the market in 1999 when it was reclassified as needing a licence. Even now, testing to make sure it is safe and it works has not been completed.
It gets worse. In November 2004 - after Isolagen became available in this country - the six directors of Isolagen Inc in the U.S. allegedly sold their shares in the company for $6.33 (£3.15) each - netting the management $2.5 million (£1.24 million) each.
Legal documents in the U.S., where the biotechnology firm is being sued by investors, suggest the directors boosted the value of the company by making false claims about the effectiveness of Isolagen in Britain. The product was tested in a number of different studies and the results varied widely.
In one case, 73 per cent of the patients responded to the treatment, in another the success rate was only 7.6 per cent. How galling for all the women who lost thousands here in the UK.
The Isolagen laboratories in Park Royal, North London, closed in March. This month, a firm of valuers and auctioneers are preparing all of the company’s equipment for sale.

Isolagen, headed by chief executive Nicholas L Teti, was unavailable for comment, but a posting on its British website insisted the “reason for closure is financial and is not product or safety related”.
That will come as little consolation to Julia Hall who has now formed the Isolagen Support Group. The group has 50 members and is “growing every day”.
They are now considering following the example of Julie Stepney, who, took the National Slimming Centre in Bournemouth - where she underwent Isolagen treatment, to the small claims court to recoup her money after the treatment didn’t work.
The centre has now refunded the money she had spent on Isolagen with interest. The payment, which included court costs, totalled £4,000.
The Harley Medical Group, however, would not comment on individual cases or whether it knew Isolagen had not been approved in the U.S., insisting: "Any patient concerns are always followed through with careful attention in compliance with the Healthcare Commission standards."
Among the members in the support group is Josephine Campbell, 57, who was given the treatment by her dentist. “I’ve been with the same dentist for most of my adult life, so I trusted him implicitly,” explains Josephine.
"When he offered me the treatment he had just been to an Isolagen introduction and was really impressed. He showed me fantastic before and after shots of women in their mid to late 60s who looked visibly younger after treatment.
"I thought it was dubious at first but then he said he was treating his wife at the same time, so I figured he must really think it was a good thing.
"The appeal for me was that it was very gradual - not like a surgical face lift where I would have to deal with comments from the friends and neighbours. This was supposed to work over time.
"So, telling my husband I had a business meeting, I went to the dentist’s practice in Bournemouth and paid £4,000 for treatment. I wondered why it was done at the dentist but he assured me the cell regeneration technology could be used all over the body and was particularly popular on receding gums.
"Reassured, I had the cell sample taken. Twelve weeks later it was reinjected into my face and neck. I suffered from bad swelling and couldn’t return home for three days. When I did, I was devastated to see no difference at all.
"My dentist was really understanding. He said that his wife hadn’t noticed a difference either and he had contacted Isolagen. They had said that occasional cases do not respond.
"I knew then I’d been the victim of hype."
Douglas McGeorge, president of the British Association of Aesthetic Plastic Surgeons, described Isolagen’s claims that it ‘rejuvenated’ the skin as ‘nonsense’ and said the product was ‘completely oversold’. He said it was no more than ‘an expensive biological filler’ used to plump out wrinkles.
But it is difficult to avoid the conclusion that clinics, and not just the men behind Isolagen, failed women like Julie, Julia, Josephine and Patricia, who says: "What they did to me and everyone else who spent good money on this useless treatment, was sell false dreams.
“They preyed on the vulnerable and lonely. I am angry and upset and to be honest - even if I do get my money back, it won’t take away from how cheated I feel.”

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