Direct-to-Consumer Advertising: Have We Got a Deal for You!

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!!!!!!!!!!

Another Pharmaceutical Company Settles Illegal Marketing and Promotion Lawsuits

The New York Times reported today that AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistle blower lawsuits over the sale, marketing and off-label promotion of its blockbuster antipsychotic drug Seroquel. Despite this settlement, UK-based AstraZeneca still must contend with 14,444 civil lawsuits filed by many patients who developed diabetes and other health related conditions because of misleading marketing that failed to adequately disclose that the drug caused abnormal weight gain.                     

AstraZeneca joins a growing list of pharmaceutical companies that have been penalized for off label promotion and misleading advertising. Earlier this year Eli Lilly & Co paid $1.4 billion over its marketing of another antipsychotic drug Zyprexa and Pfizer announced that it would pay $2.3 billion including a record-breaking criminal fine of $1.195 billion mostly for its painkiller Bextra which was withdrawn from the market.

Despite the size of the fines and settlement figures for these recent cases, they are a drop in the bucket when compared with the amount of money generated by illicit marketing and advertising. For example, the $520 million that AstraZeneca has agreed to pay to settle the Seroquel case pales in comparison to the $17 billion that the drug has generated in US sales since 2004. The same was true for Zyprexa and Bextra.

While these settlements cannot repair much of the damage that has been done to unknowing patients, it signals that the US government is beginning to live up to its pledge to provide safe and efficacious medicines to the American public.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!