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!!!!!!!!!!

Influenza Vaccines, Women and the Immune Response

There was an interesting article in the New York Times this past week entitled“Do Women Need Such Big Flu Shot.” The gist of the article was that we would have more doses of influenza 2009 H1N1 vaccine if we accounted for the biological differences between the immune responses in men and women follow influenza vaccination (the article cites a study that contends that less vaccine is need to elicit an protective response in women as compared with men.

I was going to write a post about the article but I got distracted and thought I would revisit it when I had more time. Much to my surprise, Vincent Racaniello, a Bio-Crowd founder, virologist extraordinaire and host of the popular TWiV podcast series, had already “scooped” me. Professor Racaniello graciously allowed me to crib his entire post and let BioJobBlog readers decide for themselves whether or not there are real differences in the male and female immune responses to influenza vaccines or the results obtained by the scientists who conducted the study may be explain by strain to strain variation among influenza A isolates? Read Professor Racaniello’s post below and let me know what YOU think!

Do women need the same amount of influenza vaccine as men?

by Vincent Racaniello

Do Women Need Such Big Flu Shots?” suggests that we would have more doses of influenza 2009 H1N1 vaccine if we accounted for the biological differences between men and women. The idea is that women generate a stronger antibody response than men, and therefore require less vaccine. Does this idea have scientific support?

The opinion is based in part on a study carried out in 2004-05, in which adults were immunized with full (15 micrograms) or half-doses of trivalent inactivated influenza vaccine. This vaccine, made by Aventis Pasteur, contains influenza H3N2, H1N1, and B strains. Serum samples obtained before immunization and 21 days later were assayed for antibody response to each strain of influenza by hemagglutination-inhibtion. I’ve taken the data on geometric mean serum HI titers according to age, sex, and dose and plotted them on a graph:

GMT_HA

Based on the results the authors conclude that “Significantly higher geometric mean titer responses in women were identified for all ages, regardless of dose or influenza strain. Half-dose vaccination may be an effective strategy for healthy adults younger than 50 years in the setting of an influenza vaccine shortage.” But are these immune responses protective?

HI titers of 1:40 or more (which would be reported as 40 or higher in the graph) are believed to indicate levels of antibody that would protect against infection with influenza virus. By this criteria, the full and half dose of vaccine would provide protection agains the influenza H3N2 and B viruses in both men and women. The results confirm that females respond more strongly to the same dose of vaccine than men. But look at the results with the H1N1 strain – in all subjects, no matter the dose of vaccine or gender, the antibody response would not be sufficient to protect against infection. Furthermore, the response is only slightly better than in women.

In interpret these observations to mean that the antibody response to inactivated influenza virus vaccine is not universally more robust in women compared with men – it appears to depend on the virus strain. Clearly clinical studies are required to address this question. Even after spending millions of dollars to decide whether to give women less influenza vaccine, a new strain of influenza virus might come along that induces no better antibody response in women than in men.

My conclusion is that it would not be possible to determine conclusively that women could receive half the amount of inactivated influenza virus vaccine as men. I would rather spend money on developing new ways to produce as much influenza vaccine as needed as quickly as possible – such as by making virus-like particles in plants.

Engler RJ, Nelson MR, Klote MM, VanRaden MJ, Huang CY, Cox NJ, Klimov A, Keitel WA, Nichol KL, Carr WW, Treanor JJ, & Walter Reed Health Care System Influenza Vaccine Consortium (2008). Half- vs full-dose trivalent inactivated influenza vaccine (2004-2005): age, dose, and sex effects on immune responses. Archives of internal medicine, 168 (22), 2405-14 PMID: 19064822

 Until next time...

Good Luck and Good Reading!!!!!