Twenty-Five Percent of American Teenage Girls Were Vaccinated with Gardasil in 2007

The Centers for Disease Control and Prevention said about 25% of teenage girls received at least one dose of Merck & Co.'s Gardasil vaccine in 2007, providing the first national estimate of usage of the company’s controversial anti- HPV (cervical cancer) vaccine.

A 25% usage rate for a a new vaccine during its first year on the market is outstanding. That said, Merck’s Gardasil is the only approved anti-HPV vaccine in the US. Approval of GlaxoSmithKline’s competing product, Cervarix, by FDA has been delayed for so-called “regulatory issues.” Also, Merck has been heavily promoting Gardasil use via well-crafted DTC ads and a variety of clever promotional campaigns aimed at adolescent girls and their mothers.

Despite all the negative press and Merck’s questionable marketing practices, Gardasil appears to be doing very well—something that Merck desperately needs.

Until next time…

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

 

HPV and Homeland Security

 On the surface, you wouldn’t think that the Human Papilloma Virus (HPV, the causative agent of venereal warts and cervical cancer) and US Homeland Security have much in common. However, they have more in common than you think as reported in yesterday's Pharmalot blog.

According to a report by the TheStreet.com , Homeland Security’s US Citizenship and Immigration Services (USCIS) is the first government agency to mandate that all female immigrants’ ages 11 to 26 years old be vaccinated against HPV. Because Gardasil is the only cervical cancer (HPV) vaccine that is approved for use in the US it will the vaccine used for the mandatory immunizations. Surprisingly, there is no HPV vaccination requirement for US visa holders or American citizens.

Since the policy was begun, an estimated 233,000 females aged 11 to 26 who entered the US as prospective citizens paid a combined $52 million or so for the vaccinations according to the Street.com article. Curiously, the USCIS is requiring only a single injection for females who receive the vaccine—the Gardasil label indicates that three injections are required for full anti-HPV effectiveness.

As you may recall, more than 20 states rejected plans backed by Merck to make Gardasil vaccination mandatory. Merck abandoned its campaign after parents and medical experts expressed concern about safety and effectiveness. While Gardasil vaccination is optional for American citizens, there is apparently no opt-out provision for females who simply want to immigrate to the US. The confusion may like lie in a document issued by the US State Department called form DS-3025, or “vaccination documentation worksheet which says vaccination against “Human Papillomavirus is required for US immigrant visa applicants.” Here is the form.

John Abramson, the former chairman of the CDC’s Advisory Committee for Immunization Practices when the HPV requirement began in April 2007, and an opponent of mandatory vaccination said “This is not a disease that is communicable like SARS or pandemic flu or even measles.” “I am stunned. It was not the intention of the policy to mandate vaccination of immigrants,”

Ironically, Merck which has been pushing as hard as it can to promote Gardasil use isn’t aware of the Homeland Security policy, according to a Merck spokeswoman. It just goes to show how effective unregulated pharmaceutical lobbying can be!!!

Until next time…

Good Luck and Good Job Hunting

 

Despite a Few Warts, CDC and FDA Say Gardasil is Safe and Effective

A post at the Pharmalot blog said that the US FDA and the Centers for Disease Control issued a statement today indicating, that after reviewing side effect reports, Merck’s anti-HPV (cervical cancer) vaccine Gardasil is safe and effective, and its benefits continue to outweigh its risks.

According to the statement, the joint agency review determined that 94 percent of  all side effects reported after Gardasil vaccination were not serious. The most commonly reported adverse events fainting, pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents, the agencies noted.

Although there have been 20 reported deaths following vaccination, there was no common pattern or tend that would suggest they were caused by the vaccine itself. The statement went on to say that in cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.

The statement was likely issued in response to highly publicized and widely circulated adverse events reports issued by the ultraconservative Judicial Watch which is morally opposed to HPV vaccination. It is extremely unfortunate that a small but vocal group of conservative Christians are willing to risk the health of their daughters because they are morally opposed to premarital sex and birth control. 

Until next time….

Good Luck and Good Job Hunting!!!

Salmonella in the News Again

This may be one of the more notable years for Salmonella food poisoning. First, there was a modest outbreak in the eating clubs at Princeton University and now a larger outbreak in Texas and New Mexico. This is the first time that I can recall in my almost 30 years as a card-carrying food microbiologist that there has been this many highly-publicized cases of Salmonella food poisoning in one year. Although I don’t wish Salmonella gastroenteritis on anybody, it is kind of rewarding that an organism that led to my PhD is making headlines once again. Typically, Salmonella outbreaks are not noteworthy and rarely receive much notice— usually taking a backseat to potentially life-threatening outbreaks of enteropathogenic Escherichia coli.

Like the Princeton outbreak, the exact source of the Salmonella infection is unclear. That said, public health and CDC officials are leaning towards large, raw tomatoes. In 2006, the Food and Drug Administration discovered that consumption of tomatoes in restaurants had caused a salmonella outbreak that affected 21 states. , “until the source of the outbreak is identified federal and local health officials in both states have recommended that infants, the elderly and anyone with an impaired immune system avoid eating Roma and red round tomatoes that are not grown at home or sold attached to the vine.” So far, 40 confirmed cases, with patients ranging in age from 3 to 82, have been reported in New Mexico and Texas since April. To date, 17 people have been hospitalized, but no deaths have been reported.

Molecular analyses indicated that all of the cases in New Mexico and Texas were caused by the same strain, a relatively rare serovar called Saint Paul (6th most common serovar infecting humans). Federal health officials at the Centers for Disease Control in Atlanta, GA fear that this may be the beginning of a large national outbreak of Salmonella gastroenteritis. This is because about 30 cases caused by the Saint Paul strain, have also been reported this year in Arizona, Colorado, Idaho, Illinois, Indiana, Kansas and Utah. Like the New Jersey, Texas and New Mexico outbreaks, the cause of those other outbreaks is under investigation.

Salmonella gastroenteritis generally last between four and seven days, and most people are able to recover without medical (antibiotic) treatment. But, it can sometimes lead to death in immunocompromised adults or young children. Symptoms include headache, nausea, abdominal pain, diarrhea and sometimes vomiting.  Although textbook descriptions of the pathogenesis of Salmonella gastroenteritis generally portray it as a mild illness, I can tell you that people I know (lab mates of mine) who came down with the disease (gee, how did that happen?) suggest otherwise!

I suspect that fecally-contaminated water may be source of the infection. But, then again, it has been almost 30 years since I thought about Salmonella gastroenteritis. That said, I don’t think that you ever forget the essence or minutiae of your thesis work!

For those of you who are interested, the electron micrograph of Salmonella typhimurium shown with this post is from my PhD dissertation. As I recall, the electron micrograph was taken in 1980 and the bacterium shown in the micrograph was grown for 48 hours on nutrient agar . Althought I would like to take credit for the shot (nice pose eh?),  it was taken by Phil Hegge in the Department of Bacteriology at the University of Wisconsin-Madison, my alma mater. if you look closely you may be able to see fimbriae along with the flagella.

Until next time

Good Luck and Good Job Hunting (and remember to wash your tomatoes)!!!!!