When four Floridians were injected with a rogue formulation of the toxin behind Botox in November, Allergan Inc. knew about what had happened a day before it grabbed national headlines.
Irvine-based Allergan learned about the episode, in which the four were temporarily paralyzed, thanks to an emergency room doctor in Palm Beach Gardens, Fla., who called the drug maker.
The call triggered a rush by Allergan to figure out what happened. The link to Botox, Allergan’s flagship drug for reducing wrinkles and easing neck spasms, was a potential nightmare with nightly news headlines such as “Are Botox Injections Safe?”
“We knew from the inception that this wasn’t Botox,” said Douglas Ingram, Allergan’s executive vice president and general counsel.
Allergan was vindicated soon after the incident when federal investigators said Botox wasn’t the cause of the Florida illnesses. Even so, the incident points to a side effect of having a popular drug like Botox: Imitation isn’t always flattering.
Turns out, the drug used in Florida was a mega dose of an unapproved formulation of the botulism toxin, a purified version of which is the basis of Botox.
The federal government has indicted three people in the incident, Chad Livdahl, Zarah Karim and Bach McComb, along with four companies owned by Livdahl. One of those companies provided the toxin, made by Campbell-based List Biological Laboratories Inc., for the Florida injections.
Allergan has sought to take the high road, stressing how Botox wasn’t involved and downplaying media stories of “fake Botox.”
The issue “isn’t one of counterfeit Botox,” Ingram said, but rather “one of a few unscrupulous individuals who have decided to purposely and knowingly use an unlicensed and unlawful botulinum toxin to make a little money while at the same time risking someone’s health.”
The Florida case was an isolated incident, he said.
“The general problem of unlicensed botulinum toxins isn’t a problem to Allergan nor does it have a direct impact on the reputation of Botox,” Ingram said.
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Botox: purified form of botulism toxin |
When news of the Florida case broke, Allergan took the same approach as it did during a high-profile lawsuit trial over Botox last year. A jury in that case cleared celebrity dermatologist Arnold Klein and Allergan of wrongdoing in the suit brought by the wife of former Hollywood movie studio boss Mike Medavoy.
During the trial and after the Florida incident, Allergan stressed Botox’s 15 years of safety data.
A particular concern for Allergan: the watering down of the Botox brand name in stories about the Florida incident and the botulism toxin.
Allergan took part in the Florida investigation with an eye toward patient health and safety, according to Ingram.
“Allergan, is at its essence, a healthcare company,” he said. The company takes the issue “very seriously and we participate with the federal and other authorities whenever we can in the investigation of these unlicensed botulinum toxin users.”
The drug maker doesn’t have anyone on its staff with a specific title of “Botox detective.” But Ingram said sales and marketing people, scientific and medical experts and a group of “pharmacovigilance” lawyers take part in investigations such as the Florida incident.
“I can tell you because I was intimately involved in the investigation, we immediately initiated contact with all the appropriate authorities,” Ingram said.
Allergan, along with the Food and Drug Administration, the Centers for Disease Control and the Florida Department of Health, were “all able to determine fairly rapidly this had nothing to do with Botox,” he said.
Allergan issued frequent press releases about the investigation starting on Nov. 29, when the incident first hit the news, and up until Dec. 13, when the FDA officially confirmed that Botox wasn’t involved. It also sent faxes directly to doctors’ offices with information about Botox’s safety record.
As for Wall Street, Allergan spokeswoman Caroline Van Hove said the drug maker was in touch with analysts and investors “so they understood that Botox was absolutely not involved, which is what they expected from the beginning.”
Analyst reports appear to back that point up.
“Our clinical consultants say any potential culpability of Allergan/Botox specifically is likely remote,” wrote Citigroup Smith Barney analyst Peter Bye in a research note after the Florida news broke.
“Botox has an extensive safety record the past (15-plus) years for a variety of therapeutic and cosmetic uses,” he wrote. “There have been no incidents of patients (developing) botulism due to Botox.”
David Maris, who follows Allergan for Banc of America Securities, kept a “neutral” rating on Allergan’s stock.
“We would not be surprised to see an unwarranted overreaction on the news,” he wrote.
Allergan’s shares did slip after news of the Florida case broke but bounced back soon after. As of last week, Allergan counted a market value of $9.5 billion, second alone among Orange County companies to Irvine-based Broadcom Corp.
