Challenges in Ophthalmology with April Steinert

Taking a chance on Botox paid off for Allergan

Gavin Herbert Jr. reflects on the early challenges involving the neurotoxin, including manufacturing controls, security measures in storage and distribution.

Visionary. A word often used to describe prescient leaders, which fits Gavin Herbert Jr., founder of Allergan, perfectly. A friend of presidents, influential political operatives and leaders in the ophthalmic industry, he is still seeing the future at the sage age of 86, and he shows no signs of slowing down.

I met with Gavin in his office at Roger’s Gardens, his successful home and garden center in Newport Beach, California, on the day after my return from the American Society of Cataract and Refractive Surgery meeting. Surrounded by beautiful things, Gavin and I began with his early years, before Allergan, when he worked in his dad’s pharmacy on Wilshire Boulevard in Los Angeles while he was taking pre-pharmacy courses at USC. Gavin dusted shelves and labeled bottles in the shop. It was during that time, in 1950, when Stan Bly, a chemist and friend of Gavin’s father, Gavin Herbert Sr., approached Gavin’s dad about an anti-allergy nose drop he had formulated and called Allergan, which was a combination of the words allergy and neoantergan. With the same entrepreneurial spirit he passed on to his son, Gavin Sr., along with Stan Bly, began producing and selling the drops in his drugstores. Gavin Sr. then incorporated the business and called it Allergan Pharmaceuticals.

Gavin Jr.’s dynamic and fruitful career in ophthalmology is a storied one, and as you can imagine, he had no shortage of compelling challenges to share with me, but it took him no time in choosing the one that stood out the most: botulinum.

An ophthalmologist named Alan Scott began studying the deadly neurotoxin, which is produced by the gram-positive anaerobic bacterium Clostridium botulinum, in the 1970s for the treatment of strabismus. In 1978 Dr. Scott named the drug Oculinum and formed a company under the same name, and in 1989 the drug received FDA approval for the treatment of strabismus and abnormal eyelid spasms. Two years after Oculinum’s FDA approval for strabismus, Gavin received a phone call from Dr. Scott while he was sitting in the casual den called Truman’s (affectionately named after an East London brewery founded in 1666) located within the Allergan complex. Dr. Scott asked Gavin if Allergan would be interested in working with him to obtain FDA approval for broader applications for Oculinum. Gavin was about to tell him he was not interested, that the market for the product would be too small, but he paused and remembered his “key strategy” at that time, which was for Allergan to surround ophthalmologists with all the “key products” that they would need to treat their patients. And in 1991, Allergan entered the neural care market and purchased Oculinum. It renamed the product Botox, and by the end of 1991, Botox brought in about $13 million in sales.

Botox has been an incredibly lucrative product for Allergan, but there have been many obstacles along the way that one would not have considered. Gavin addressed the numerous difficulties in the creation and implementation of rigorous manufacturing controls and strict security measures in the storage and distribution of one of the world’s most deadly neurotoxins. Botox is not patent protected, but rather a trade secret. A recipe. Few know the reagents used and the anaerobic fermentation process, and all of this takes place at the Allergan facility in Westport, Ireland, which is closely monitored by cameras and 24-hour security.

In 2010, Allergan was accused of unlawfully promoting off-label uses of Botox and agreed to pay $600 million to resolve the allegations. Allergan denied any wrongdoing but at the same time felt the settlement was in the best interest of its stockholders and would allow the company to refocus and reinvest its energy in developing new treatment applications.

Gavin, an avid sailor, did what came naturally to him during those early and challenging Botox days. He believed in the product and stayed the course while piloting Allergan through the storms with his sharp intellect and unrivaled tenacity. With dogged perseverance, Gavin has found unparalleled success in both of his professional ventures, which also happens to be his passion: Allergan and Roger’s Gardens.

We all know Gavin is a giant in the world of ophthalmology, and as I was reflecting on my interview with him, it became clear to me that Gavin’s philosophy is to not just do the job, but to love the job you are doing. If you live in that space, I think we can all agree you are more likely to find the success you are striving to achieve.

“The gem cannot be polished without friction, nor man perfected without trials.” – Chinese proverb

Disclosure: Steinert reports no relevant financial disclosures.

Visionary. A word often used to describe prescient leaders, which fits Gavin Herbert Jr., founder of Allergan, perfectly. A friend of presidents, influential political operatives and leaders in the ophthalmic industry, he is still seeing the future at the sage age of 86, and he shows no signs of slowing down.

I met with Gavin in his office at Roger’s Gardens, his successful home and garden center in Newport Beach, California, on the day after my return from the American Society of Cataract and Refractive Surgery meeting. Surrounded by beautiful things, Gavin and I began with his early years, before Allergan, when he worked in his dad’s pharmacy on Wilshire Boulevard in Los Angeles while he was taking pre-pharmacy courses at USC. Gavin dusted shelves and labeled bottles in the shop. It was during that time, in 1950, when Stan Bly, a chemist and friend of Gavin’s father, Gavin Herbert Sr., approached Gavin’s dad about an anti-allergy nose drop he had formulated and called Allergan, which was a combination of the words allergy and neoantergan. With the same entrepreneurial spirit he passed on to his son, Gavin Sr., along with Stan Bly, began producing and selling the drops in his drugstores. Gavin Sr. then incorporated the business and called it Allergan Pharmaceuticals.

Gavin Jr.’s dynamic and fruitful career in ophthalmology is a storied one, and as you can imagine, he had no shortage of compelling challenges to share with me, but it took him no time in choosing the one that stood out the most: botulinum.

An ophthalmologist named Alan Scott began studying the deadly neurotoxin, which is produced by the gram-positive anaerobic bacterium Clostridium botulinum, in the 1970s for the treatment of strabismus. In 1978 Dr. Scott named the drug Oculinum and formed a company under the same name, and in 1989 the drug received FDA approval for the treatment of strabismus and abnormal eyelid spasms. Two years after Oculinum’s FDA approval for strabismus, Gavin received a phone call from Dr. Scott while he was sitting in the casual den called Truman’s (affectionately named after an East London brewery founded in 1666) located within the Allergan complex. Dr. Scott asked Gavin if Allergan would be interested in working with him to obtain FDA approval for broader applications for Oculinum. Gavin was about to tell him he was not interested, that the market for the product would be too small, but he paused and remembered his “key strategy” at that time, which was for Allergan to surround ophthalmologists with all the “key products” that they would need to treat their patients. And in 1991, Allergan entered the neural care market and purchased Oculinum. It renamed the product Botox, and by the end of 1991, Botox brought in about $13 million in sales.

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Botox has been an incredibly lucrative product for Allergan, but there have been many obstacles along the way that one would not have considered. Gavin addressed the numerous difficulties in the creation and implementation of rigorous manufacturing controls and strict security measures in the storage and distribution of one of the world’s most deadly neurotoxins. Botox is not patent protected, but rather a trade secret. A recipe. Few know the reagents used and the anaerobic fermentation process, and all of this takes place at the Allergan facility in Westport, Ireland, which is closely monitored by cameras and 24-hour security.

In 2010, Allergan was accused of unlawfully promoting off-label uses of Botox and agreed to pay $600 million to resolve the allegations. Allergan denied any wrongdoing but at the same time felt the settlement was in the best interest of its stockholders and would allow the company to refocus and reinvest its energy in developing new treatment applications.

Gavin, an avid sailor, did what came naturally to him during those early and challenging Botox days. He believed in the product and stayed the course while piloting Allergan through the storms with his sharp intellect and unrivaled tenacity. With dogged perseverance, Gavin has found unparalleled success in both of his professional ventures, which also happens to be his passion: Allergan and Roger’s Gardens.

We all know Gavin is a giant in the world of ophthalmology, and as I was reflecting on my interview with him, it became clear to me that Gavin’s philosophy is to not just do the job, but to love the job you are doing. If you live in that space, I think we can all agree you are more likely to find the success you are striving to achieve.

“The gem cannot be polished without friction, nor man perfected without trials.” – Chinese proverb

Disclosure: Steinert reports no relevant financial disclosures.