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Late last week the US Food and Drug Administration (FDA) approved Botox, Allergan’s anti-wrinkle injection, as a treatment to prevent chronic migraine headaches. Botox is already approved to treat uncontrolled blinking; crossed yes; certain neck muscle spasms; excessive underarm sweating; and stiffness associated with muscle spasticity in the elbows and hands. However, Botox is approved and largely used for cosmetic purposes—to smooth wrinkle lines on the forehead and between the eyebrows. Interestingly, a little less than a month ago Allergan paid $600 million to settle allegations that it had illegally marketed Botox for unapproved indications like headaches for years.

Botox had worldwide sales last year of approximately of $1.3 billion which is thought to be divided equally between medical and cosmetic uses. Allergan believes that its use for treating chronic migraines will quickly outstrip and eclipse Botox use as an anti-wrinkle treatment. While much money has been invested in developing treatments for chronic migraine sufferers, there are very few effective treatments currently on the market. Botox is also being investigated as a treatment as a treatment for overactive bladder; a huge and quickly emerging market directly related to an aging population.

Financial analysts predict that sales of Botox as a treatment for chronic migraines could range from $250 to $1.0 billion per year by 2015.

While the treatment may help patients with chronic migraines, it is a fairly painful one that requires a total of 31 injections in seven areas—the forehead, temples, back of the head, neck and shoulders. And, injections are given every three months. The cost of each treatment is expected to range from $1000 to $2000 which may inhibit its uptake unless private insurers cover much of the cost. Also, some critics argue that the treatment is no better than placebo in reducing the incidence and severity of migraines.

Nevertheless, whether or not Botox works to control migraine headaches, patient who receive the treatment will likely look much younger—not that there is anything wrong with that!

Until next time...

Good Luck and Good Job Hunting (younger-looking people have an easier time of it!)

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Medicis Pharmaceutical, the maker of Dysport a drug approved by the US Food and Drug Administration (FDA) to smooth skin furrows between the eyebrows, recently introduced a marketing campaign that offers people who use Dysport drug discounts and a patient satisfaction rebate guarantee. The campaign, which runs through April 30, was intentionally designed to elevate Dysport’s image and cannibalize market share in the anti wrinkle market from Allergan the maker of Botox and the market leader.

The Dysport promotion, running on the product’s Web site and in a few glossy magazines like Us Weekly, offers a $75 rebate check on an initial Dysport treatment for wrinkles between the eyebrows, a procedure that can cost consumers $300 to $500. Satisfied customers can receive a $75 rebate on a follow-up Dysport treatment, while dissatisfied customers who want to switch can receive a $75 rebate on a Botox treatment.

While this is an unprecedented and novel campaign, it demonstrates the lengths that Medicis is willing to go through to garner market share from Botox which enjoyed a monopoly on injectable toxins in the US until the introduction of Dysport last year. Last year, worldwide sales of Botox were roughly $1.3 billion. Industry analysts estimate that Medicis may be able to capture a 20 to 25 percent share of the US market.  

While the marketing campaign may seem a bit odd and brash, Medicis isn’t the first pharmaceutical company to use rebates and drug discounts to inspire patient brand loyalty. For example, Sepracor offers a seven-day free trial of its popular sleeping pill Lunesta. Merck is running a print ad with a voucher for a free 30-day supply of its Januvia tablets for Type 2 diabetes. Another Merck ad carries a $20 coupon for the allergy and asthma drug Singulair. However, the use of product rebates and drug discounts is mostly used to market so-called vanity medicine drugs (like Latisse, Botox and Dysport) which have been approved by FDA for clinical use but are not covered by medical insurance. Patients who use these drugs are paying out of pocket and, in essence, are buying from physicians. Many worry that this practice may induce doctors and patients to make medical decisions based on money not safety or efficacy. 

In the case of Botox and Dysport neither product is entirely risk free. For those of you who may not know, both are purified forms of botulinum toxin — a toxin produced by Clostridium botulinum that interferes with nerve transmission and involuntary muscle contractions. The injections cause temporary cosmetic problems like droopy eyelids or uneven eyebrows. And these drugs now carry federally mandated “black box” warnings on their labels stating that botulinum toxins have been associated with rare but potentially life-threatening health problems.

Although promotional programs like the one being offered by Medicis may be inappropriate or seemingly reckless, it—like those of Sepracor and Merck—are permissible under current direct-to-consumer (DTC) advertising regulations. Isn’t it time to reevaluate regulations that allow powerful, potentially-dangerous prescription drugs to be treated as consumer goods where price, not medical need, safety or efficacy, promotes their acceptance and use?

Until next time...

Good Luck and Good Looking!!!!!!!!!!

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