'Mr. Botox' Case Raises Some Brows

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By Denise Gellene Times Staff Writer

They call him "Mr. Botox" for good reason.

Arnold W. Klein, dermatologist to the stars, claims to have pumped
the anti-wrinkle drug into more faces than inhabit the entire city of
Newport Beach. He has talked up the purified toxin at small charity
events in expensive restaurants and at international conferences in
glittering halls.

Along the way, he has received hundreds of thousands of dollars in
fees from Botox manufacturer Allergan Inc., which pays him for acting
as a "media spokesman" for the drug and lending a hand with other
consulting chores.

Such arrangements typically are secret, but Klein's contract surfaced
in a medical malpractice case filed by Hollywood wife Irena Medavoy
against the Irvine-based drug company and the Beverly Hills doctor.

The injury-by-Botox lawsuit, set for trial this month in Los Angeles
Superior Court, provides a rare look at the relationships between
drug companies and the physicians who consult for them. Klein, along
with dozens of others, has lined up behind Allergan's biggest drug to
serve as both advisor and cheerleader.

Klein not only served as a mouthpiece, but he also agreed to review
advertising plans and offer advice on clinical trials, according to a
copy of his contract in the court record. His duties included
teaching other doctors to inject the anti-wrinkle drug.

And he wasn't alone. Forty doctors were groomed by Allergan's public
relations experts to act as media spokesmen for Botox, and the
company had 300 doctor's offices and medical clinics in its official
network of Botox training centers, court documents show.

Jerome Kassirer, a former editor of the New England Journal of
Medicine (news - web sites), said Allergan, in asking more from some
physicians than medical advice, was "turning doctors into sales
reps."

As for Klein, Kassirer said: "It is clear he is being paid to promote
the drug."

Medavoy's suit against Klein and Allergan made headlines when it was
filed last year, and not only because she was the wife of movie
producer Mike Medavoy, the studio chief behind "Rocky" and "Annie
Hall." Klein, 59, was a clinical professor at UCLA's David Geffen
School of Medicine, an unpaid position, and well known in Hollywood,
where his celebrity patients included Elizabeth Taylor and Michael
Jackson. Last month, UCLA announced that some of Klein's friends had
anonymously pledged at least $1 million to endow a dermatology chair
in his name.

Medavoy, 45, claims in her suit that Botox shots administered by
Klein made her ill and that Klein and Allergan misled her about the
drug's safety. He and the company have denied the allegations.

Klein's contract with Allergan, as outlined by Allergan's director of
aesthetic marketing in court documents, provided Klein with quarterly
payments of $25,000 for all his consulting duties. If Klein attended
meetings at the request of Allergan, he received an additional
$10,000 a day, plus travel expenses. When local sales reps scheduled
an appearance for him, Klein collected $2,000 to $4,000.

He or his company, Minimally Invasive Aesthetics, received a total of
$499,000 from Allergan between September 2000 and December 2003,
court records show. Kassirer, the former medical journal editor, now
a professor at Tufts University School of Medicine, called the
amount "huge - far in excess of anything I have heard anywhere."

Allergan general counsel Douglas S. Ingram would not discuss Klein's
contract. However, Ingram said that consulting deals were common in
the drug business and that none of the company's contracts was
unusual. He said consultants provided the company with medical
insights and advice and were not recruited to promote drugs.

Providing Guidance

The industry relies on guidance from consultants "to develop and make
available better products to the medical community and patients,"
Ingram said, adding: "Dr. Klein is an expert in the use of Botox and
has been benefiting patients with Botox for many years."

Neither Medavoy nor Klein would comment for this story. Medavoy's
lawyer, Arthur Leeds, didn't return calls. Klein's lawyer, Howard
Weitzman, said he didn't want to discuss the case before its Aug. 31
trial date.

Although consulting contracts between academics and drug companies
are widespread, some high-profile deals recently have come under
scrutiny. The National Institutes of Health (news - web sites), the
nation's premier medical research organization, was criticized last
year for allowing its top scientists to advise drug companies. The
NIH is revising its ethics policy to prevent conflicts of interest.

Ingram said Klein wasn't acting on behalf of Allergan in his medical
practice. "Nothing could be further from the truth," he said.

There's no question that Klein has been an enthusiastic booster of
Botox. Klein lectures extensively on Botox in the United States and
around the world, according to his own website. South Koreans call
him "Mr. Botox," Klein once said. Last year, the British style
magazine Harpers & Queen named him Hollywood's top Botox doctor.

Klein "likes to get out and speak and help train other people," Tom
Albright, vice president of Botox global marketing, said in a
deposition. "He will actually go out to a dinner meeting, if it
doesn't interfere with patient practice, and lecture a group of
doctors" about Botox.

In an interview with Los Angeles magazine two years ago, Klein said
he had injected 90,000 patients. "Collagen solved the biggest problem
of a woman's face, the lower third, and Botox was a home run to the
forehead," he told the magazine.

Botox is a purified form of a deadly poison called botulinum toxin,
which blocks nerve impulses to muscles. When tiny amounts of Botox
are injected into muscles, they relax. The effect lasts three to four
months.

Until 2002, Botox was an approved treatment for only a handful of
medical conditions - crossed eyes and muscle spasms affecting either
the neck or eyelids. In the mid-1990s, Klein and other dermatologists
began experimenting with it as an anti-wrinkle treatment. Two years
ago, the Food and Drug Administration (news - web sites) approved
Botox as a cosmetic treatment but only for glabellar lines - wrinkles
between the eyebrows.

Allergan's successful promotion of Botox drove sales of the drug to
$564 million in 2003, 32% of the company's total revenue of $1.75
billion. Last year, the Society for Aesthetic Plastic Surgery said
Botox injection had become America's fastest-growing cosmetic
procedure.

Twice in the last two years, the FDA (news - web sites) has warned
Allergan about ads that, in the agency's view, minimized side effects
and implied Botox was approved "for use in all tough wrinkles." The
agency required Allergan to change the ads. The FDA doesn't regulate
doctors.

Off-Label Uses

Since 1999, Klein has written more than two dozen articles about
Botox, many of them in publications aimed at dermatologists. Klein
coauthored a 2002 article in the Archives of Dermatology (news - web
sites) that provided how-to advice; it was accompanied by diagrams
that showed where Botox should - and shouldn't - be injected for
wrinkles around the eyes, chin and lips and on the forehead. Klein
also has written about unapproved uses outside the field of
dermatology, such as injecting Botox to prevent migraine headaches.

Allergan doesn't use its consultants to promote so-called off-label
treatments on its behalf, Ingram said. "We don't promote off-label
uses, and consultants do not have [that] marketing function," he
said.

Klein's writings about unapproved treatments nonetheless are
beneficial to Allergan, said Kassirer, who has written a book on the
relationships between doctors and drug companies.

"Doctors will listen to him because he is an avowed Hollywood
expert," Kassirer said. "That's what makes him so valuable" to
Allergan.

The contract between Klein and Allergan figures into Medavoy's
lawsuit. She said that Klein should have told her about his financial
arrangement with Allergan and that she would not have consented to
treatment had she known about it. She claims that keeping the
contract secret was an unfair business practice.

One legal expert said that aspect of Medavoy's suit might resonate
with a jury.

"She may not be using these exact words, but what she is saying is
that there was a conflict of interest," said Marjorie Shultz, a
professor at UC Berkeley's Boalt Hall School of Law.

Eric Rakowski, also a Boalt Hall professor, said the consulting
contract was irrelevant.

"If doctors had to disclose any time they got money from a drug
company, then a large number of academic physicians would be guilty
of malpractice," he said. "It is not typical to disclose such
relationships."

The plotline of Medavoy's suit is widely known. Seven days after she
received Botox injections in March 2002, Medavoy said, she became
ill. Klein had given her shots to smooth creases in her forehead and
near her eyes. Klein also had injected Botox into each side of her
head and her neck to treat her migraine headaches.

Medavoy blamed Botox for her symptoms, including an unrelenting
headache that kept her sidelined for months.

"I missed the Vanity Fair Oscar party, missed going to the Oscars
(news - web sites)," she told Vanity Fair magazine last year. "We
were going to spend the month of June in Europe, going to Paris and
then on a boat in the South of France. I missed that. People had
invited me to Aspen for August. I missed that."

Medavoy said that neither Klein nor Allergan fully warned her about
Botox's side effects and that Klein never told her that Botox was not
an approved headache remedy. The company and the doctor used her as
a "guinea pig," she claimed.

Her suit seeks unspecified damages and an order that Botox doctors
tell their migraine patients whether they have received money from
Allergan.

Klein and Allergan said in court documents that Botox didn't make
Medavoy ill and that they did nothing wrong. Allergan said it listed
the side effects associated with Botox, including headache, on the
product's package insert, as required by the FDA. The company said it
had no control over what doctors tell their patients or how doctors
use the drug.

Allergan lawyer Ingram said the company was looking forward to the
trial so it could address any doubts about the safety of Botox.

"We are confident in our belief that her complaints are not related
to Botox," he said.