Botox: guilty of crimes against beauty?

A high-profile medical damages trial in Los Angeles is throwing doubt on one of the world's most popular cosmetic surgery procedures.<i> David Usborne </i>reports

When they hear of the goings-on these past few days in the Los Angeles County Superior Court, the pampered and the precious of Beverly Hills are not sure whether to wince or smile. Many of them are incapable of doing either, of course, thanks to their affection for the wrinkle-erasing drug called Botox, the enemy of all facial expression. Pay attention they will, however, because this is precisely about Botox; its wonder-drug reputation may be on the line.

When they hear of the goings-on these past few days in the Los Angeles County Superior Court, the pampered and the precious of Beverly Hills are not sure whether to wince or smile. Many of them are incapable of doing either, of course, thanks to their affection for the wrinkle-erasing drug called Botox, the enemy of all facial expression. Pay attention they will, however, because this is precisely about Botox; its wonder-drug reputation may be on the line.

True, the trial under way inside the courtroom of Judge Victor Chavez is just another fine example of justice-turned-entertainment in Tinseltown. Day after day, it offers spectators and members of the jury titillating glimpses of Hollywood at its most vain, narcissistic and back-stabbing. The John Travolta birthday bash sounded fun. And didn't Vanna White, America's most famous game-show glamour girl, look great on the stand? But more serious themes are in play. Most importantly: Is Botox a gift from the angels or a curse from the devil?

About half a million Americans are paying $300 (£180) a session to have their obliging dermatologists inject tiny doses of the modified toxin into their brows to smudge away those pesky crows-feet and frown lines. A good number of others are taking the drug for other more dubious reasons, such as combating crippling migraines.

This drama comes to us courtesy of Irena Medavoy, 45, a former actress ("Dallas") and model and the wife of Mike Medavoy, the mogul movie-producer behind films such as Annie Hall and Rocky. Ms Medavoy was a long-time fan of Botox and, by extension, the company who makes it called Allergan Inc. She was even more devoted to the dermatologist who, for years, kept stabbing her with it, Dr Arnold Klein.

Now, Ms Medavoy, who has arrived in court daily unmade-up, in sensible shoes and looking nothing like her glittering professional persona, loves neither the drug nor the doctor who prescribed it to her.

She is alleging that after Dr Klein injected Botox into her temples in March 2002 to help reduce migraines, the headaches grew worse and her health declined to the point where husband was deprived of "companionship, intimacy and services".

By launching a lawsuit against both Allergan and Dr Klein, with a claim for unspecified damages, she has taken on a new role for herself.

She wants to be the Erin Brokovich of the Botox brigade, sending out an alert to all devotees of the drug that the miracle it promises them can just as easily turn into misery.

"I'm going to be the voice", she declared at the start of the trial, expected to last into next month. "If I have to be stripped for it, I will." This is no paltry challenge. Botox is on trial here for the first time since it received government approval in America as a treatment for wrinkles two years ago.

Last year, the Society for Aesthetic Plastic Surgery said Botox injections had become America's fastest-growing cosmetic procedure. But if Ms Medavoy wins her case, it would sure put the Botox gold rush in immediate peril. Patients all across America and in countries beyond who have embraced the drug as the next best thing to an elixir for youth may become shy of it.

No wonder that California-based Allergan, which sold doses worth more than half a billion dollars last year, accounting for about a third of the company's entire profits, is taking it very gravely indeed, even launching a series of newspaper advertisements earlier this month under the headline, "The Truth about Botox".

Beneath the headline of the trial - is Botox less safe than we thought? - there lies another important and tangled issue: the relationship between drug manufacturers and the doctors that must prescribe their products. When it is proper and when does it become unethical? Enter Dr Klein, 59, whose fame extends around the globe.

South Korea gave him the sobriquet "Doctor Botox" and it has stuck. The British magazine Harpers & Queen crowned him Hollywood's top Botox doctor. Indeed, his list of celebrity patients runs to the likes of Elizabeth Taylor, Michael Jackson, Dolly Parton, Madonna and Cher. He told Los Angeles Magazine that he had probably injected the stuff in no fewer than 90,000 people.

And, over time, Dr Klein also became very important to Allergan. Like every other drug manufacturer, the company dedicates plenty of energy and money to recruiting physicians to spread the word about their products. Dr Klein, 59, who carries a cane and cuts a rather fragile figure in court, became its favourite cheerleader for Botox. So important, in fact, that Allergan, according to court documents, has been paying him $25,000 a quarter-year as a consultant on Botox. If he attends meetings to champion the drugs, he is paid another $10,000 a day plus travel expenses. (He recently returned from speaking in Britain.) Between September 2000 and December 2003, Allergan paid him and his company, Minimally Invasive Aesthetics, almost $500,000 for his services.

If Dr Klein is intimidated by his place at the heart of this trial, he doesn't show it. "I hope I never have to do this again," he said. "But it's actually very amusing." On the stand, he does not show much humour, however. When invited to take a seat, he tartly demurred. "I prefer to stand when I lecture."

Just how much sympathy this jury of ordinary, non-botoxed folk - not a mogul or film star among them - will feel for Ms Medavoy is hard to gauge. Some may see in this trial a parable of what happens when human vanity and ego gets the better of common sense. But Ms Medavoy is doing her best.

Already, we have heard plenty of what happened - or did not happen in the marital bed and elsehwere - after the Botox shots were administered in her temples and neck for her headaches. She returned to Dr Klein on a March day two years ago, for her quarterly Botox boost. She had already been receiving additional injections in the temples for her migraines, but this time, she alleges, the doses were much higher.

By her account, she fell into a tailspin of ill health about eight days later. Almost worse, her plans at the time for a summer season of high-life fun and travel, to St Tropez an beyond, fell apart as did a proposal to launch a TV talk show to be called Behind the Gates - conceived as " Ab Fab come to life", she said. The show never got developed. She cancelled her travel schedules. She even missed the annual Vanity Fair party for the Oscars.

"I couldn't hold my head up," she said before the trial. "My neck muscle, where it was injected in my neck, could not support my head. It was like a bowling ball on a pin. I couldn't sleep. When I laid down, it was as if someone was torturing me."

In court, she testified that she "had a headache like I had never experienced in my life". It was "like a thunderclap, as though half your scalp is being pressed up ... unrelenting, like a vice grip, like being tortured every day".

And friends, including Ms White, have come to back her up. "She could hardly speak," Ms White assured the jury. Another pal, Donna Estes Antebi, said she had "never seen her so sick. She could not hold her body up".

Not all the testimony has been so helpful, however, especially from her other doctor, Robert Huizenga, who painted a picture of a patient obsessed with demons of self-imagined illness. Saying that in her opinion, she suffered from "anxiety syndrome", he recalled that, "if she had a pain on her breastbone, she was convinced she was having a heart attack.."

Juicing up the proceedings is the presence of Howard Weitzman as Dr Klein's lead lawyer. Mr Weitzman is well-known on the Hollywood legal scene having represented clients that include OJ Simpson and Michael Jackson. It happens also that the lawyer was once a family friend of the plaintiff and her husband. His role today is not to be chummy with Ms Medavoy, but instead to make her look small and silly.

Mr Medavoy avoided all eye contact with Mr Weitzman from the stand, apparently feeling the awkward irony of the turning of the tables of old acquaintance. When asked by reporters what it was like to be cross-examined by someone who was once a friend, he replied, "Friends? In Hollywood? Is there such a thing".

The nub of the defence is that Ms Medavoy suffered sudden illness for reasons not associated with the injections. In a statement before the trial's start, Allergan said she was affected by a "a host of unrelated medical and psychological symptoms that were present long before her treatment for migraine with our product".

Allergan has also defended the widespread practice of injecting its drug for headaches, rather than for the smoothing out of age lines. It argued that the, "scientific and medical facts demonstrate that Botox is safe and effective therapy that has improved the health and quality of life for millions of patients with serious and debilitating neurological disorders, which account for 60 per cent of all Botox use."

And Dr Klein's legal team has been equally adamant of his innocence. In a written statement before the trial, his lawyer asserted: "We believe the evidence will show Dr Klein did nothing wrong and Mrs Medavoy's illness and symptoms resulted from other causes". And it added that "Dr Klein's consultancy with Allergan has no bearing on Mrs Medavoy's claim or on the doctor's treatment of any of his patients."

Nonetheless, the picture is not so clear when it comes to the exact scope of Botox's approved uses. The drug is a distilled form of the botulism food-poison toxin and is injected into nerves to block the release of acetylcholine, a naturally occurring chemical that activates muscle movement. For years, doctors used the drug to treat abnormalities like eye squints and unwanted spasms in the neck or eyelids.

Some might say there is a separate problem with Botox - the relationship between patient and their bathroom mirrors. Vanity is not limited to the mansions of Hollywood and nor is the popularity of Botox. The future of the drug could be less than wrinkle-free.

POISONED TO PERFECTION

What is botox? A highly purified, weak form of the botulinum toxin.

What does it do? Botox is used to smooth out expression lines, or wrinkles. It cannot, however, fill out deeper age lines, tighten skin or improve its texture.

How? When injected, botox blocks the nerve transmission and temporarily freezes the muscle, thus preventing it from making the movement that created the wrinkle. It will smooth out over a few weeks. Some lines disappear but deeper wrinkles will only be softened.

Where? Botox is most commonly used on the forehead but it can also be used on crow's feet, and around the brows. It can be used around the lips to soften smoking lines.

How long does it last? Up to three months after the first treatment.

The more you have it, the longer lasting the effects.

How much? £150+ per area

Side-effects? The most common side effect is bruising. The Botox may also paralyse the wrong muscles and cause droopy eyelids and brows if it is injected too low, or if the patient rubs the treated area. These effects will wear off within a few months. Allergic reactions are rarer and more serious, causing swelling and pain. There have been some reports of impaired swallowing and burning leg muscles.

Pro-Botox celebs Vanessa Feltz: "I'm pumped to bursting with Botox and I adore it." Lulu: "It's a poison, but so's chocolate."

Anti-Botox celebs: Halle Berry: "I'm really saddened by the way women mutilate their faces." Julianne Moore: "The Botox craze is frightening. It's not beautiful."