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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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Without fanfare, GlaxoSmithKline (GSK) quietly announced today that the US Food and Drug Administration (FDA) granted approval for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

It has taken GSK over three years to garner US regulatory approval for CERVARIX® which has been approved and used in over 100 other countries in the world. Early "unspecified concerns" delayed approval and, as recently as two weeks, FDA delayed a decision despite recommendations from an advisory panel to approve the vaccine. Coincidentally, a week before the agency was expected to announce approval for the vaccine, a British girl died after she was vaccinated with Cervarix. While FDA spokespersons claimed that the girl’s death following vaccination had nothing to do with the delaying a decision on Cervarix, many industry pundits believe that the FDA was reluctant to approve the vaccine in light of the sensational media coverage in the UK surrounding the incident. After an autopsy was performed on the girl, British authorities announced that a massive cardiac tumor that had infiltrated one of her lungs, not Cervarix was responsible for her death.

Today’s approval of Cervarix provides American consumers with an alterative to Gardasil, Merck’s cervical cancer vaccine that was approved about two years ago. That said, the ability to protect girls and young women from the possibility of developing cervical cancer is more important than which of the two vaccines is used to induce immunity. I plan on immunizing my daughter when she is old enough!

Until next time...

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

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My son, who is a 9^th grader, was recently asked to write an essay for his social studies class about the application of Machiavellian principles to modern day rulers and governments. One of Machiavelli’s ideas that he chose to write about was the notion that a good ruler or government must do it’s very best to insure the safety and health of its subjects or constituents. While this may seem altruistic or philanthropic don’t be fooled—workers who are afraid, unhealthy or regularly ill aren’t productive and can threaten the economic well-being and stability of a society. In any event, he asked me to help with a modern day example of how safety can be reconciled with the Machiavellian principle; “the end justifies the means.” As an infectious disease professional, I quickly realized that mandatory vaccination of newborns and school-aged children against viral and bacterial diseases is a great example.

Prior to the development and subsequent worldwide use of childhood vaccines, epidemics and pandemics of smallpox, measles, polio, diphtheria and other serious diseases routinely ravaged the planet with impunity. During the recurring outbreaks, large numbers of people became ill, and while some sustained life-long debilitating injuries, many others suffered long, painful and excruciating deaths. The recognition that often devastating and regularly occurring outbreaks and epidemics could threaten the well being— and possibly destabilize monarchies and democratically elected governments—  led to the development of  20^th century vaccines against many bacterial and viral childhood diseases. However, it is important to note, while most vaccines are safe and offer protection for many individuals (typically 90% or higher), a small percentage (usually 1% to 5%) of those vaccinated, may experience side effects ranging from mild to severe and possibly life threatening. I believe that vaccination is a polemic for the “ends justify the means” principle because while some vaccinated individual may suffer serious side effects or death greater numbers will benefit from the protection and safety afforded by most vaccines. In other words, governments must be willing to risk harm and possibly death to some of its citizens to insure the productivity, well being and ultimately the safety of the majority.

Despite the medical and health benefits of vaccines, the anti-vaccine movement in the US has steadily been gaining strength of late. Vaccine opponents’ fears have been stoked and promulgated by bogus clinical data offered by fraudulent scientists (which have subsequently been discredited and refuted) and media outlets seeking sensational stories to sell magazines and newspapers. Last week, a 14 year old British girl died shortly after being vaccinated with Cervarix, GlaxoSmithKline’s (GSK) cervical cancer vaccine. This story was quickly pounced upon by the British tabloids and widely circulated.  In the end, the safety of the Cervarix—a vaccine administered to 1.8 million girls without a single death similar to the one that had occurred—became suspect. Almost immediately, anti-vaccine advocates publicized this unfortunate incident as another other reason why parents shouldn’t vaccinate their children. The girl’s death prompted UK officials to immediately suspend all nationwide Cervarix vaccinations; even though an autopsy hadn’t been performed to determine the actual cause of the girl’s death. After an autopsy was finally performed, British health officials announced that the girl had a large cardiac tumor that had infiltrated one of her lungs and that it was likely cancer not Cervarix that caused her death. Unfortunately, the media’s feeding frenzy fanned by the anti-vaccine lobby’s loud voice may have cost GSK US FDA approval of  Cervarix—a product approved and safely used in over 100 countries! 

About three weeks prior to the British girl’s death, an FDA advisory committee unanimously recommended approval of Cervarix. Generally, the agency follows recommendations of its advisory committees. Ironically, the girl’s death occurred several day’s prior to an FDA decision on whether or not to approve Cervarix. Much to the surprise of many industry experts, this past Tuesday, FDA delayed its decision on Cervarix’s approval. FDA spokespeople claimed that the girl’s death had no bearing on its decision to delay Cervarix’s approval (if you believe that, would any of you be interested in some land in Florida?).

It is no secret that GSK has struggled to get Cervarix approved in the US —a decision on its approval has been delayed three times over the past several years. In the interim, the company has managed to successfully address all of the agency’s concerns over Cervarix’s safety and efficacy.

FDA’s decision to delay Cervarix’s approval is great news and something of a victory for Merck, the manufacturer of Gardasil— the ONLY cervical cancer vaccine approved in the US and Cervarix’s main competitor. Failure of Cervarix to win FDA approval will undoubtedly help Merck to bolster Gardasil sales and help it maintain its stranglehold on the US anti-cervical cancer market for the foreseeable future!

Until next time...

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

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As an iPhone user, I am constantly amazed at the applications that are developed for it. I recently downloaded a flashlight app that converts my iPhone into a flash light in case of a power outage or finding myself in the dark like I did two summers ago at Moosehead Lake in Maine. Just when I thought iphone apps couldn’t get cooler, I learned about a new app called “Outbreaks By Me.” It was developed by researchers at Children's Hospital Boston in collaboration with the MIT Media Lab, enables users to track and report outbreaks of infectious diseases, such as H1N1 (swine flu), on the ground in real time. The application can be downloaded from iTunes.

According to a press release “the application builds upon the mission and proven capability of HealthMap, an online resource that collects, filters, maps and disseminates information about emerging infectious diseases, and provides a new, contextualized view of a user's specific location – pinpointing outbreaks that have been reported in the vicinity of the user and offering the opportunity to search for additional outbreak information by location or disease.” An additional feature of Outbreaks Near Me is the ability to set alerts that will notify users via text or by e-mail when new outbreaks are reported in their proximity, or if users enter a new area of activity. It also offers an option for users to submit an outbreak report which will allow people in cities and countries around the world to interact with the HealthMap team and participate in the public health surveillance process.

What will iPhone app developers think of next— an app for swine flu vaccination?   Now that would be way cool!

Until next time....

Good Luck and Good Swine Flu Hunting!!!!!!!

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Professor Vincent Racaniello, a BioCrowd co-founder and virologist who studies the pathogenesis of polio and influenza viruses commented that there will likely be two influenza vaccines offered this fall: a trivalent vaccine consisting of seasonal H3N2 and H1N1 strains and an influenza B strain; and a monovalent one consisting of the 2009 pandemic H1N1 strain.

He posited an interesting question to BioCrowd members earlier today: "Will you be receiving a flu vaccine this fall, and if so, which one?"

To weigh in on the topic and find out which vaccines makes sense for you, check out Professor Racaniello’s influenza vaccine survey and discussion at BioCrowd!

Until next time...

Good Luck and Good Networking @ BioCrowd!

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The appearance of the Swine Flu aka H1N1 last spring not only created a worldwide panic, it demonstrated to Albert Osterhaus, head of virology at the Erasmus Medical Center in the Netherlands how uninformed the lay public was about viral outbreaks, epidemiology and public health. This prompted Dr. Osterhaus and his colleagues to create a free, online video game called the “The Great Flu” which challenges players to control a new viral pandemic.

As the virus has spread worldwide, countries have tried different methods to slow it down and pharmaceutical companies are now racing to produce a swine flu vaccine (sound familiar?). To fight the emerging outbreak, players use public health measures including setting up surveillance systems, stockpiling antivirals and vaccines, and closing schools and airports. Players also have a limited budget and are warned that "your actions to control the virus cost money, so keep an eye on it." In other words, while the goal is to control the pandemic, there may not be sufficient funds and resources to accomplish those goals!

A running tally of the numbers of people infected and those who have died are displayed above the budget. Newspaper stories about the deadly virus and the global response to it — like riots breaking out worldwide — pop up to help players monitor the outbreak and plan their next moves. Messages from governments mirror the difficulties faced by international agencies like WHO that are responsible for containing worldwide epidemics. For example, when players set up costly surveillance systems, sometimes participating governments will send a message "we will comply with your directions...but we must inform you that the political support for this action is low in this region. Therefore, the effectiveness of the system to control the outbreak may differ from your expectations."

The goal of the game is make the lay public aware of the difficulties that public health officials encounter during pandemics and the tight rope they sometimes must walk to insure that the virus is contained and doesn’t continue to spread. To test your skill level at controlling pandemics, you can choose different viruses (which range from easy to difficult to manage) at the beginning of the game.

I think “The Great Flu” is a great way to educate the public about infectious diseases and epidemiology and have fun at the same time. If you are interested in more sinister online swine flu games check this out.  Who said learning science has to be tedious and dull?

Until next time...

Good Luck and Good Virus Hunting!!!!!

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Do you lie awake a night overwhelmed by the possibility of another infectious disease outbreak? Well, if you want to get a good night’s sleep, I highly recommend that you take a look at a brief history of American epidemics that was published in this past Sunday’s New York Times. According to the article, history shows that the number of American epidemics has been relatively small. In fact, the author suggests that there were only nine major epidemics in the US since 1892. 

While there were several major outbreaks in the early to mid 1900s (Spanish flu, 1918; smallpox, 1947 and polio, 1952), the US has been relatively unscathed in recent years—with the possible exception of the HIV/AIDS epidemic and possibly the herpes and HPV epidemics. This is because of America’s outstanding infectious diseases surveillance networks, its comprehensive vaccination programs and modern medical and hospital infrastructures.

However, no matter how vigilant we are, there is no way to prevent infectious disease outbreaks unless the pathogens that cause the diseases are eradicated from the planet as was the case for the smallpox virus. That said, the best way to manage infectious disease epidemics is to be prepared for all contingencies.  In my opinion, the recent swine flu outbreak—this was its second appearance, the first taking place in 1976—was a practice run. And I think the world did “pretty, pretty good” as Larry David, my former NYC softball teammate and co-creator of Seinfeld would say!

Until next time...

Good Luck and Good Job Hunting

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If you are not convinced that vaccines are safe, please listen to a conversation between Dr. Ginger Campbell of the Brain Science Podcast and Dr. Paul Offit.

Dr. Offit is a pediatrician who is also Chief of Infectious Diseases and Director of Vaccine Education at the University of Pennsylvania School of Medicine. He is co-developer of the rotavirus vaccine and author of the book Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure. This book should be read to obtain a complete appreciation of the vaccine-autism controversy. However, I found the podcast also highly compelling, because Dr. Offit is extremely knowledgeable and an excellent speaker.

The furor surrounding childhood vaccines began when Wakefield, a British gastroenterologist, published a Lancet article in 1998 claiming to show a link between the measles-mumps-rubella vaccine (MMR) and development of autism in children. Although the study was flawed, it established a clear question: does MMR cause autism? This question has been addressed in 12 different epidemiological studies involving millions of children who either did or did not receive the vaccine. The answer is quite clear: that vaccine never caused autism. Here are Dr. Offit’s thoughts on this:

…science is enormously self-correcting. Andrew Wakefield stands up in 1998 and says, ‘I believe MMR causes autism.’ Well, he raises a hypothesis. It’s a testable hypothesis. It’s been tested. He was wrong. And that’s what I love about science. It’s just enormously self-correcting, and I just think people don’t see it that way¹

The original Wakefield paper has been retracted by 10 of the 13 authors. However, the damage has been done: immunization rates with MMR have dropped in the UK, Europe, and the US. The incidence of measles is increasing and there have been deaths of children from the disease. Deaths that could have been prevented had parents chosen to have their children immunized with MMR. The controversy over MMR has lead the public to distrust all viral and bacterial vaccines, and consequently the incidence of other preventable diseases is rising.

The notion that MMR causes autism was accompanied by safety concerns about thimerosal - a mercury-containing preservative used in some vaccines to prevent microbial contamination. The results of several large epidemiological studies found no connection between autism and thimerosal. Nevertheless, the preservative was removed from most childhood vaccines - probably an error, according to Dr. Offit, which simply made parents more suspicious. Autism rates have not dropped since the use of thimerosal was discontinued.

Many parents still do not believe the conclusion that vaccines do not cause autism. Part of the problem is that the etiology of autism is not understood. To a parent, the temporal association of immunization with onset of autism is difficult to ignore. Dr. Offit recalls a story which addresses this issue:

…it’s hard to make a statistical argument, or an epidemiological argument, to a parent who’s seen something that’s very emotional. There’s a story that I tell, because I think it’s a powerful one. My wife is a privately practicing pediatrician in the suburbs. And she was in the office one day and there was a four-month-old sitting on her mother’s lap. And my wife was drawing a vaccine into a syringe that she was about to give this child. Well, while she was drawing the vaccine into a syringe the child had a seizure, and actually went on to have a permanent seizure disorder—epilepsy. And there had been a family history of epilepsy, so she was certainly at risk for that. If my wife had given that vaccine five minutes earlier, I think there’s no amount of statistical data in the world that would have convinced that mother that anything other than the vaccine caused the seizure, because I think those sort of emotional events are very hard to argue against.

Some have accused Dr. Offit of pandering to the pharmaceutical establishment and enriching himself by publishing Autism’s False Prophets. I don’t think these arguments contain a shred of truth. Dr. Offit is donating all the royalties from the boook to autism research. More compelling are his words from the interview:

I worked on that (rotavirus) vaccine because I thought that it could do a tremendous amount of good for children. It’s the same reason that I stand up for the science of vaccines and the science of vaccine safety. I care about children. That’s my motivation.

¹Quotations by Dr. Offit are taken from a transcript of his conversation with Dr. Ginger Campbell.

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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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