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Taking aim at Botox

The drug is still wildly popular, but for how long? Critics are zeroing in on it.

September 22, 2003|Gina Piccalo | Times Staff Writer

The phenomenon called Botox, which has moved rapidly from obscure eye-disorder treatment to mass-market wrinkle cure used by 500,000 Americans, has achieved such broad success that doctors at the prestigious Johns Hopkins School of Medicine have thrown Botox parties and lexicographers at the venerable Oxford English Dictionary included an entry in their latest edition.

Doctors and patients swear by Botox's ability to bring a youthful glow to aging faces with few side effects. Now the drug's maker, Allergan Inc., is aggressively pursuing new medical uses for its biggest product, which already is generating several hundred million dollars in sales annually. At the top of Allergan's list: treatment of two problems that plague millions of Americans -- migraine headaches and excessive sweating.

Indeed, Allergan executives sound almost breathless when they talk about the future of Botox. Says company Vice President Mitchell Brin: "Botox will transform the world the way penicillin has transformed infectious diseases."

The drug already has transformed Irvine-based Allergan from a low-profile eye-drop and acne-treatment company into one of corporate America's glitziest success stories. But controversy often follows in the shadow of success. Even as Botox sales continue to soar, the pharmaceutical firm is beset by complaints from federal regulators over its marketing tactics and growing consumer wariness about the safety of the drug.

For The Record
Los Angeles Times Thursday September 25, 2003 Home Edition Main News Part A Page 2 National Desk 1 inches; 50 words Type of Material: Correction
Botox treatment -- In a Health section article Monday about Botox, a photo caption labeled "Wining and Dining Clients" mistakenly implied that alcohol was being served at Dr. David Amron's Beverly Hills office. No alcohol was served at the gathering, and the glasses shown in the photograph held mineral water.
For The Record
Los Angeles Times Monday September 29, 2003 Home Edition Health Part F Page 10 Features Desk 1 inches; 49 words Type of Material: Correction
Botox treatment -- In a story about Botox last Monday, a photo caption labeled "Wining and Dining Clients" mistakenly implied that alcohol was being served at Dr. David Amron's Beverly Hills office. No alcohol was served at the gathering and the glasses shown in the photograph held mineral water.

The Food and Drug Administration repeatedly has chastised Allergan for advertisements that it says suggest the drug is effective for unapproved uses and has criticized the company for minimizing the drug's side effects. In December, the FDA expects to release a report on consumer and doctor complaints about Botox side effects. Allergan also faces a lawsuit, set for trial early next year, in which a prominent Hollywood socialite claims that her Botox treatments caused a raft of maladies that left her bedridden.

Botox is also facing competition from other products that threaten to topple the drug from its perch as king of the wrinkle remedies. Santa Barbara-based Inamed Corp. is developing the European botulinum toxin Type A, Dysport, for cosmetic use in the U.S., Canada and Japan. And a new class of synthetic wrinkle fillers that, for some people, have longer-lasting results than Botox are gaining popularity.

There is also concern that some doctors, in their enthusiasm for Botox, may not always be acting in their patients' best interests. Interviews with Botox patients and an informal review of consent forms that physicians have patients read and sign suggest that some doctors are failing to disclose important information about some serious potential side effects of Botox.

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Allergan takes action

Allergan, meanwhile, has aggressively defended its product in the face of increased public scrutiny. In June, "NBC Dateline" aired a segment on the suit filed by Irena Medavoy, whose husband is movie producer Mike Medavoy, against Allergan and a prominent Beverly Hills dermatologist, Arnold Klein. The TV report featured interviews with doctors and former Botox patients who claim the drug caused months-long illness, even permanent fatigue and facial paralysis.

By the next morning, Allergan had bought full-page ads that carried the headline: "The Truth About Botox" in newspapers across the nation and company sales reps were scurrying to physicians' offices with a "talking points" letter aimed at easing doctors' anxiety about the product.

"You may be aware," the Allergan letter read, "that there has been some recent negative attention in part caused by claims from a high-profile Hollywood producer's wife, that may have created misconceptions among current and prospective patients. This campaign serves to reinforce the positive and long-standing safety profile of Botox."

After weeks of widespread media attention on the Medavoy suit, Allergan dispatched physicians to shopping malls in 24 U.S. cities to assuage the fears of potential patients. The promotional tour, explains Allergan spokeswoman Christine Cassiano, "was a way to correct some of the general misunderstanding that we believe existed in the marketplace."

Botulinum toxin (Botox is a trade name) is the most deadly substance known. It was identified in the 1820s as the bacterium found in contaminated food that causes botulism poisoning, which can be fatal. During World War II, U.S. scientists studied the neurotoxin's effectiveness as a weapon. And during the 1980s and early 1990s, it was a key part of Iraq's arsenal of biological weapons. The danger associated with botulinum toxin perhaps has fueled the public's fascination with Botox -- the biological beast turned into a thing of beauty. But the substance's ugly past, says Allergan's Brin, "is not something that we tend to expand on very much."

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