Tuesday, September 27, 2011

Vaccine for acne

Sanofi Pasteur Acquires Exclusive, Worldwide License for Acne Vaccine


The above link will take you to Sanofi Pasteur's press-release detailing their vaccine for acne. This vaccine is in the pre-clinical stage at the University of California, San Diego. This news was released about three days ago, on September 21, 2011, and seeing it leaves me with a  few questions...




Is acne a disease?


In the beginning of their article, Sanofi Pasteur states,
"Acne vulgaris (acne) is one of the most common skin diseases worldwide and affects more than 50 million people in the United States alone..."
However, the National Center for Biotechnology Information (NCBI), on their PubMed website, for the US National Library of Medicine at the National Institutes of Health (NIH) states this (emphasis in bold is mine):
 "The fact that acne, which is almost universal and not a true infection, is (1) initiated at puberty by the action of pubertal hormones on likely distinct, pro-acne follices, and (2) typically resolves in one's early twenties when prefrontal cortex development is complete, suggests that the condition's timeframe is meaningful."
Some medical affiliations consider acne a disease, and some consider it a hormonal condition or a disorder. Regardless how it's classified, for most people acne is typically only a problem in the teenage years. Very rarely does it persist into adulthood. Although acne is not pleasant, it is not a life-threatening condition. It does not require hospital stays. As a matter of fact, in most cases, changing the way you take care of your skin resolves the problem.




Do we really need a vaccine for acne?

Since acne isn't life threatening, doesn't require hospital stays and doesn't cause missed days of work or school, do we really need a vaccine for it? Without a doubt, there will be some people who will jump all over a chance at getting a vaccine for acne. But who will these people be? What ingredients will the vaccine contain, and what kinds of risks will they pose to a young person who's desire not to get acne will outweigh their desire to consider vaccine safety?




Who will get the vaccine?


There is no way for us to know who will have an issue with acne and who will not. We generally don't know we have a problem with acne until it happens. Since acne problems usually present in the early teen years, and theoretically an acne vaccine would need to be given before it is a problem, obviously it will be young people who are targeted to get the vaccine. So that leaves the window open for, let's say, the ages of birth to about twelve years.


Speaking from a business standpoint, if you are Sanofi Pasteur, your customer base for the vaccine will dwindle as the people in the available market get older. Children, as they get older, do not come in for regular check-ups as often, reducing a doctor's access to them. Vaccine manufacturers know this. They know that to get their vaccine into the most children, it has to be done when they are very young while parents are still bringing them in for their well-visits.


The hepatitis B vaccine given at birth is an excellent example of this. There are literally zero newborns who are sexually active and/or intravenous drug users, which is how you acquire Hep B. So unless the mother is infected, and all mothers are tested when they become pregnant, the baby is not at immediate risk for the disease. So why are ALL babies immunized with the HepB vaccine? Convenience. Because they can. Because doctors have access to them. Because if they don't do it when they're babies, and the babies grow up, they may never decide to get the HepB vaccine and at that point they become customers who have been lost. There is not a business on the planet who wants to lose customers, and those in the business of making vaccines are no different.


So, the only way to ensure a large customer base would be to put an acne vaccine on the childhood immunization schedule with the rest of the vaccines. It is my belief that Gardasil will be there too someday, for girls and boys. Here are some quotes for the Sanofi article dated September 21, 2011:
"According to Sanofi Pasteur’s estimates, the annual worldwide market for acne therapeutics is in excess of US $3 billion."
In Glaxo Smith Kline's annual report for 2010, it shows that their Hepatitis vaccinations produced worldwide revenues of 700 million British pounds, which is equivalent to approximately $1.1 billion US dollars. The only way Sanofi will make anywhere close to the $3 billion quoted on an acne vaccine, will be to put it on the childhood immunization schedule.
"Moderate to severe acne occurs in 14 percent of five to 17-year olds and this group is more likely to seek treatment and currently faces an unmet medical need."
Do you know any five year old with an acne problem? This definitely gives us a clue of the age group Sanofi will target with this vaccine. Since according to Sanofi, five year olds apparently have acne problems, I'm certain they will want this vaccine on the childhood schedule.
"Acne is considered a chronic disease for a limited life-time period and, although often a simple and self-limited condition, it can result in psychological, physical and social implications"
Here Sanofi Pasteur admits that acne is only a problem for a 'limited life-time period' and that it is a 'simple and self-limited' condition. What they don't mention is that not everyone gets acne and that not everyone who does get it, has it to the same degree. Some people get one pimple here or there, some people only break out when they are nervous, and so on. However they are going to target five year olds for the vaccine to save them from the 'phychological, physical and social implications' that acne can cause. Really?


Maybe, with a vaccine, someday we will all be physically and socially perfect.

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