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Late last week, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s cervical cancer vaccine Cervarix for use in girls and women ages 10 to 25 and also approved Gardasil —Merck’s cervical cancer vaccine previously approved in 2006 for use in girls and women—for boys and men ages 9 to 26. For those of you who may not know, over 99% of human cervical cancers are caused by infections with cancer-causing strains of the human papilloma virus (HPV) which also causes venereal warts. Vaccination with Cervarix protects against cervical cancer by inducing immunity against HPV 16 and 18 (which cause most cervical cancers in developed nations) whereas Gardasil affords protection against HPV 16 and 18 as well as HPV 6 and 11, strains that cause venereal warts (which don’t lead to cancer).

Despite FDA’s approval to vaccinate boys with Gardasil to prevent HPV infections, the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP)— which guides national policy on use of vaccines—decided yesterday to recommend the use of the vaccine in girls and women but didn’t fully endorse its use in males. Typically, ACIP recommendations are adopted by professional medical associations and set the standards of practice for physicians. Also, its recommendations play a major role in determining whether or not insurers and third party payors will reimburse patients who are vaccinated. The new recommendations mean, in effect, that physicians and clinics may now administer the vaccine at their discretion to boys and men ages 9 to 26, but they are not expected to offer it. In contrast, vaccination of girls and women ages 10 to 25 will be strongly recommended, readily available and reimbursable. This means that parents may consider the vaccine as an option for their sons, but some health insurers may choose not to cover the shots—an option which is sure to severely limit the numbers of boys and men who are vaccinated with Gardasil.

The ACIP committee decided not to include Gardasil immunization for boys and men on its recommended list because several members, most notably a medical economist, questioned whether vaccinating boys would be cost effective in the long run. At the heart of the debate was whether or not it was appropriate and cost-effective to vaccinate boys for a problem (venereal warts) that can be embarrassing and uncomfortable but is not life-threatening. For those of you who may not know, Gardasil immunization is expensive and requires a series of three injections that cost $130 each ($390 total).  Cervarix, which also requires a series of three injections, is planned to be offered for $385.

Last year in the United States, about 37 percent of girls ages 13 to 17 started the Gardasil vaccine series, a national immunization survey showed, and about half of them completed it. Not a great track record for a vaccine demonstrated to prevent cervical cancer and dramatically reduce the transmission of venereal warts. Nevertheless, yesterday’s decision to recommend vaccination for girls and women but not boys and men makes no sense to me from a public health perspective and it almost smacks of gender bias. Let me explain.

Like all other sexually transmitted diseases (STDs), HPV is transmitted from men to women and visa versa. Based on years of epidemiological studies, the only effective way to reduce the overall incidence of STDs is to implement strategies that prevent infections in both females and males. While boys and men can’t develop cervical cancer, they do contract venereal warts and perhaps, more importantly, can serve as carriers or reservoirs of HPV infection in the population. In other words, infected males (who may or may not show symptoms of HPV infection) still possess the potential to transmit it to sexually-active, unvaccinated girls and women. Consequently, while the incidence of HPV infections may begin to decrease among women after immunization, it will never be completely eliminated and the possibility of developing cervical cancer will continue to be a public health concern.

While the ACIP’s understanding of the transmission of STDs is tragically flawed, its willingness to publicly disclose cost effectiveness as a reason to not endorse HPV vaccination for males is even more egregious! The agency’s decision begs the question: Which is more costly; 10,000 American women developing cervical cancer each year (and countless others going for unnecessary cervical biopsies because of “bad” Pap smears) or a heads up to insurance companies that they ought to cover the costs of male HPV immunizations? 

The ACIP’s reluctance to recommend male HPV vaccination based on economic and health care cost concerns rather than on public health implications is yet another example of how broken the US healthcare system is and how drastically it needs to be reformed. Allowing 3,700 women to die each year in the US from cervical cancer when there is a safe and effective way to prevent these deaths is, in my opinion, unconscionable!

Until next time...

Good Luck and Good Job Hunting!!!!!

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For the first time in history, more people are searching the Internet for health information than asking doctors. Web 2.0 and social media tools are allowing people to discover new ways to connect, learn and engage one other in search of healthcare and drug information.

e-Patient Connections 2009 which will be held in Philadelphia, PA on  October 26 and 27 will feature a number of leading authorities on social media and digital health  Some of the featured speakers include Wired Magazine’s Thomas Goetz, Jay
Bernhardt of the CDC, and Lee Aase of the Mayo Clinic. The conference also offers case studies, 1:1 coaching sessions with industry experts and the latest products from digital health companies.

BioJobBlog readers can use the discount code kru500 to save $500 off the current price.

See you there!

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The bad news is that the US unemployment rate is close to 10 percent. The good news is that the government is looking for scientists at FDA, NIH, USDA, CDC, EPA and other agencies. For those of you who haven’t applied for a government job, the process can be daunting and overwhelming. To alleviate some of the pain, Cyndi Fischer, MSA at the BioCareer Center has written a post on the salient features of filling out a job application for a government job!

Capturing Your Worth in a Government Job Application 

You’d like to consider government employment but are not sure where to start. You know the government has a generous compensation and benefit plan, can offer long term employment stability, and in most cases its employees do not need to seek research grants or funding to continue their rewarding scientific work. Sounds like a dream, so why haven’t you applied? Perhaps you’ve heard that it’s hard to get a government job, that the hiring process is mysterious, slow and a confusing maze of information. While some of those concerns are valid some of the time, government employment has such positive benefits it is indeed a career path you don’t want to overlook. The most important thing to remember about applying for a government position is that all the items that appear to be drawbacks to you in the application phase, are really set in place to ensure that the most qualified candidate, hopefully you, will get the job!

So what do you need to know to ensure that you have the best shot at being considered for a coveted research position within the government? First you must apply to a vacancy announcement published by the government in order to be considered, and subsequently offered employment. Almost all government entities now use an automated system to post vacancy announcements and receive applications. The most widely used website to post vacancy announcements is USAJOBS.opm.gov. Once you have established an account on the site and placed your resume in the space available, you are ready to apply for any vacancy announcement you would like. Be keenly aware though, this is where attention to detail separates the candidates to be interviewed from the resumes in the scrap pile. The government hiring system revolves around merit. Specifically, the candidate who has the most knowledge, skills and abilities (KSA) to be successful in the vacant position should be offered the job, as the desired KSA’s for an opening are derived from the position description itself. Your role is to ensure that you capture your KSA’s as accurately as possible so that you are considered for the positions you are most qualified to hold.

If KSA’s are the key to government employment, how do you ensure you include everything that needs to be considered? In many cases this will be easy to discern as the vacancy announcement will list specific KSA questions prompting your response. If there are questions that seek specific answers, it is a requirement that you answer them or your application will not even be considered. In the event there are not specific questions presented, you must ensure you cover the likely KSA’s for that position within the body of your resume. Knowing what the KSA’s are for the position being advertised is one

aspect of being qualified for the position you are seeking. Let’s take a quick look at each element of the KSA’s so you know how to present your talents.

Knowledge covers the body of intellectual information you possess that will assist you in the position. This knowledge is not limited to your academic knowledge, though critical, but encompasses all aspects of what you know that pertain to the position. Included in your mental reference library are federal, state and local regulations that govern the work you will be doing, policies and procedures that apply to the work environment, industry standards and cutting edge technology that you are current in that would make you a good fit for the position. Essentially any knowledge that you possess and can articulate in your resume that is pertinent to the job you are seeking is something you should capture in your resume or the KSA questions presented as part of the announcement.

Skills represent the manipulation of systems, processes, people and things that will allow you to be competent in the position in question. They can include specific skills that require you to operate technical equipment or work with particular software or hardware systems or they may be more generic such as the skills required to communicate effectively. These skills are often the core competencies of the position and are incredibility important. Conversely, some of them are areas that professionals often under-report in their resumes as they take many of these skills for granted such as problem solving, creative thinking, decision making and stress tolerance. In most cases, government application software systems allow you a very generous amount of character space to document your KSA’s or resume, so leave no skill uncaptured!

Abilities refer to your capabilities as they apply to the work environment. Your ability to manage people and programs; to organize, plan, implement, and evaluate; to analyze, supervise or otherwise effectively impact the mission of the organization. One of the unique aspects of this element is that you do not have to have a vast work history to quantify what you can offer an employer in this category. You may have organized a large volunteer effort or been part of a regional political campaign. Any quantifiable information that depicts your role in a challenging environment which allows you to capture the results of your efforts is value added in this element.

Government employment has many rewarding aspects – not the least of which is that the infrastructure of the whole civil service is based on merit. Now that you know a little more about how to present yourself and what you have to offer in the three key government consideration areas (KSA’s) you are one step closer to accepting your first federal research position. Remember it’s not what you know and what you can do that counts in a job application; it’s what the selecting official knows you can do that matters. Good luck!

Cyndi Fischer, MSA is the Director of Strategic Recruitment for STG International. As a Human Capital Management specialist her work concentrates on agency level recruitment strategies and workforce planning. During her tenure at STG, Mrs. Fischer has designed and implemented recruitment strategies, branding techniques, and succession plans for many federal agencies seeking Phd/MD level candidates for research, managerial, and professional opportunities. Mrs. Fischer has a Bachelor of Science degree in Criminal Justice and Psychology and a Master of Science in Administration degree in Human Resources. www.stginternational.com

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As we all know, the H1NI pandemic has been raging on for close too 10 ten days now. Curiously, “Fear & The Flu: The New Age of Pandemics” is the title this week’s cover story in Newsweek magazine. From an informational standpoint point, “this may be too little, too late”—as the old saying goes. While the Internet has been around for over twenty years now, government agencies, most notably the US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continue to rely almost exclusively on old media to communicate with the American public during infectious disease outbreaks. Apparently, the administrators who run these government agencies haven’t been listening closely enough to President Obama’s assertion that “we live in the digital age.”

Communications between the public and government health officials is vital when trying to manage and control infectious disease outbreaks. “Every single government agency as well as companies and non-profits need to be digitally literate and competent in a time of pandemic” asserts Eye on FDA blogger Mark Senak. For their performances in recent infectious disease outbreaks, Mark gives CDC an “A” for effort—although there is substantial room for improvement. FDA on the other hand didn’t fair as well. “The FDA is not nearly as sophisticated in terms of digital. Their only Twitter account is for food recalls.  And their YouTube channels are all confusing and unorganized. They have a long way to go.”

The Internet was originally designed as a digital tool to transmit and move large amounts of information from one place to another. That said, it is also a powerful communication vehicle that can be used to broadcast valuable, scientifically-accurate information during infectious disease outbreaks by leveraging social media tools like Twitter, Facebook and instant messaging. To that end, it’s time for public health agencies to recognize the power of digital media and craft communication plans that can be implemented in the next infectious disease outbreak.

Until next time...

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

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Salmonella enteriditis, an organism dear to my heart (luckily not my posterior small intestine) is a common cause of food poisoning. As some of you may know, I did my PhD thesis work on Salmonella gastroenteritis (aka food poisoning) and I like to think that I am something of an expert on the topic. 

Typically, Salmonella food poisoning outbreaks are localized and rarely reach epidemic proportions. However, there have recently been two major nationwide Salmonella outbreaks in the US —one in 2007 and now in early 2009.

The current outbreak has afflicted 388 people in 42 states and may be caused by the same strain (Saint Paul) that was responsible for the 2007 outbreak. Ultimately, the 2007 outbreak was linked to contaminated tomatoes. The jury is still out on the cause of the most recent outbreak. Needless to say, CDC scientists are scurrying to quickly identify the source of the current outbreak because it took the agency over 5 months to conclusively identify the culprit in the 2007 epidemic. Not surprisingly, many grocery stores and restaurants suffered financially because of the outbreak.

Many of you may be wondering why Salmonella food poisoning is becoming such a problem in the US. I don’t believe that the strains responsible for the most recent outbreaks are more virulent than the ones that have traditionally caused more localized outbreaks. Instead, the reliance of food manufacturers and grocery store chains on one or two major food distributors (rather than multiple suppliers) is likely responsible for the severity and breadth of these nationwide outbreaks. This suggests that regulatory agencies ought to more closely scrutinize the microbiological quality of the operations of the major distributors. I believe that those efforts would greatly reduce the likelihood of future major outbreaks of food poisoning.

Until next time.

Good Luck and Good Job Hunting (avoid raw vegetables, undercooked poultry and raw eggs)
 

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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!!!!!!!

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 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

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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!!!

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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 (6^th 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)!!!!!

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