A Public Health Conundrum: Boys, Cervical Cancer and HPV Vaccines

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!!!!!

 

The Future: DNA Identify Theft?

Advances made in DNA sequencing technology and genomic analysis has lowered the cost of sequencing a genome from millions of dollars a decade ago to less than $500 today. And, because of this, there are a growing number of companies that are willing to quickly and cheaply sequence and analyze your DNA. While this may be medically beneficial and appealing to some, it may not be for everyone. Moreover, and perhaps more importantly, who will control access to and insure the privacy of your genetic information if you choose to have your genome sequenced and analyzed. 

Alan McHughen, PhD, a molecular biologist and Professor of Botany and Plant Sciences at the University of California-Riverside, who has previously written about privacy and access to personal genomic data, wrote an article for BioJobBlog that explores the ramifications and possibility of DNA identity theft in the future. Also, he has written a book 'Pandora's Picnic Basket; The Potential and Hazards of Genetically Modified Foods' to refute the myths and explore the genuine risks of genetic modification technology

Genetic Privacy

By Alan McHughen

For just $399 (plus shipping and handling), the scientists at 23and me.com will scan your complete genome. The DNA analysis reports on 118 different medical and health dispositions, your maternal and paternal ethnic ancestry, and a curious bunch of genetic trivia concerning your persona (is your earwax sticky or flaky?). All you do is pay the money and spit into a collection tube; they extract your DNA from the spit and look for half a million single nucleotide polymorphisms (SNPs) scattered throughout your genome, including many in or near genes associated with particular traits. Other companies offer similar services. For example, Decodeme.com charges $985, but catalogs twice as many SNPs, and you collect your DNA with a cheek swab.

Alternatively, if you don’t need the complete genome scan but are curious about specific medical conditions or family lineage, you can get less expensive gene tests from an increasing number of companies willing to take your money and DNA sample in exchange for the genetic information their scientists reveal. If heart disease runs in your family, you may either relieve or exacerbate your anxieties by shelling out $200 to have a cardio scan for relevant genetic predispositions. Or, for as little as $99, a man can have his Y chromosome probed to confirm his place in the family patrilineage, and possibly connect to ancient and famous princes or pirates.

These genetic information services, with prices now well into recreational and hobby budget range, provide the most personal, private — and unchangeable— information possible about you. The sinister side of this fascinating field is all too often overlooked—it can reveal your most intimate genetic details to strangers and nosy neighbors. While the various testing labs assure confidentiality, there is little to no control over personal genetic information. In the US, anything you discard is salvageable by anyone else, and your trash can become another’s treasure if it carries blood, saliva, hair, semen or any other DNA-laden bodily secretions.

While we worry about identity theft, personal financial or other private information, our uniquely personal information is up for grabs. The Genetic Information Nondiscrimination Act (GINA) of 2008 offers some protection, but it is limited to employment and medical insurance issues. GINA does not protect your genetic information from being abused by life insurers. Or nosey neighbors. 

Genetic privacy raises a whole spectrum of social, ethical, legal and medical issues. Suppose your neighbor salvages your trash and has your DNA analyzed. This local gossip then shares the juicy news that you have a “higher than average predisposition” to, say, alcoholism. Soon, everyone in the community shuns you as a latent alcoholic, and you have no idea why. The community knows more about your genetic makeup than you do. And, because they don’t know how to interpret statistical language such as “a higher than average predisposition”, those conditions may easily be exaggerated into probabilities, if not certainties.

If people have a right to know their own genetic information, they have the obverse right to NOT know. People can choose to remain ignorant about their genetic makeup. Consider, for example, Huntington’s disease (HD). This death sentence is one of the few health conditions almost due to genetics, and the DNA assay has been available for years. Curiously, most people at risk, i.e., those with HD in their direct lineage, choose NOT to take the test; they prefer not to know until (or if) symptoms appear. What happens when the local busybody lets the cat out of the bag on HD? Word will get around and the at-risk person will inevitably find out, if only by the ‘different’ treatment by neighbors, thus obliterating the exercise of their right to remain ignorant. Whether the test result is positive or negative on HD is immaterial at this point, the rights will have been violated. The DNA test for HD is currently more elaborate than the simple SNP analysis, but because SNPs associated with HD are being reported, it’s only a matter of time before they come generally available.

Perhaps you’ve suspected the woman down the street had a child from an adulterous one night stand a few years ago, and the cuckold husband remains a doting, if clueless, dad. Now, with just $89 (including overnight FedEx delivery!) and a little misdemeanor creativity, well within the standard ethical bounds of busybodies, you can satisfy your suspicions with a surreptitious and discrete paternity test. And, to provoke some real excitement in your sleepy small town, show the results to the husband.

A few minutes of thought and discussion generates many other issues and examples of the precarious security of personal genetic information and identity, and the potentially dire consequences of genetic information getting out. Society is yet to discuss the privacy issues surrounding genetic identity as vigorously as we have with personal financial or medical records. It’s getting late. Do you know where your DNA is?

 

Its Official: Health Informatics is One of the Hottest New Career Options for LIfe Scientists

I don’t want to brag but I have been touting career options in health informatics and health information technology (HIT) for the past year or so. Today, I came across a post by CareerBuilders declaring health informatics and HIT are the hottest new career trends to hit the market in recent years. As the drive towards digitizing medical and healthcare records continue, there will be literally thousands of job opportunities for people with the right skill set. This is what the post had to say about health informatics and HIT careers and job opportunities. 

Health Informatics
Health informatics will put technology in place that provides hospitals and other health-care providers with access to an electronic network of vital patient information such as like medical histories and prescriptions. The information age finally meets healthcare administration.

The facts
The health informatics initiative won’t succeed unless employees — that’s you! — bring the specialized skills needed to build and expand the network. All other pieces are in place:

  • The American Recovery and Reinvestment Act of 2009 includes $20.6 billion to help providers drive adoption and development of the IT infrastructure needed
  • The U.S. Bureau of Labor Statistics (BLS) projects health information management employment to grow nearly 18 percent by 2016
  • The BLS projects a need for more than 6,000 new professionals each year through 2014 — but only 2,600 graduates have entered the field this past year 

Your opportunity
To succeed, health informatics (HIM) will demand a wide variety of specialized positions across IT and health care. It will engage conventional experience from both areas — such as registered nurses and LPNs/LVNs, or IT implementation specialists and IT project managers — if you’re looking for a new twist on your current career.

But new positions will also thrive in this hybrid field. Look for new HIM job titles in your next job search, like health IT professionals, HIM coders, HIM medical records professionals and various health informatics specialists, including trainers, researchers and analysts.

Get online to check out the job titles mentioned above and listed below for related descriptions, and see if you might need any additional training to meet requirements: 

Nursing
- Telemedicine clinical professionals

- Chief nursing information officers

- Clinical IT liaisons 

Health-care administration
- Medical and health services managers

- Document scanners

- Data entry clerks

- File clerks

IT specialists
- Senior programmers

- Senior clinical analysts

- Database analysts

- Developers

- Business analysts

- Software engineers

- Data integration specialists

Not too shabby of a list! In a previous blog post I identified a variety of training options for people interested in pursuing careers in health informatics and HIT. Check it out!

Until next time....

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

 

Antibiotic Resistance and Healthcare: A Telling Statistic

I have refrained from commenting on healthcare reform until now because there wasn’t much I could add to the debate. That said, while reading an article in a local paper on bacterial antibiotic resistance and how to minimize it, the author—an infectious disease doc—offered a telling statistic that identified the root problem with our current healthcare system. According to the article, 65% of the time, physicians will prescribe antibiotics to patients suffering from upper respiratory tract infections who demand them, whether or not they are warranted. In marked contrast, 12% of patients with upper respiratory tract infections who don’t ask for antibiotics receive antibiotic prescriptions. The bottom line: physicians give patients the drugs and treatment they demand because they are afraid of losing them as customers knowing full well the patients will go to another physician who will give them what they want! After all, physicians are in business and to stay in business they need to make enough money to cover their overhead and make a profit. However, over prescribing antibiotics is one of the main reasons why we are in the midst of an epidemic of infections caused by multiple drug resistant bacteria. In my opinion, business outcomes should never supersede or trump medical or public health outcomes.

Don’t get me wrong, I am an entrepreneur and believe that people with good ideas ought to be rewarded for their efforts and make as much money as they can. However, in my opinion, for profit business practices and healthcare haven’t historically worked well for the American healthcare system. Removing profit incentives from healthcare would be an important first step to begin to repair our broken healthcare system. Can anybody say public option?

Until next time...

Good Luck and Support the Public Option!!!!

 

Health Information Technology: The Next Frontier

In a previous post I lauded health information technology (HIT) aka health informatics as a possible new career choice for scientists with life sciences PhD degrees who also have a proclivity for software development and data base management. Shortly after I posted the piece, I happened to read an article in a local publication about a NJ-based company called the MISI Company that is at the forefront of the HIT field and developing software to help digitize American healthcare records. 

I invited Dave Roth, an MISI executive, to share his views on the future of HIT and what ought to be done to insure that e-medical records are appropriately and successfully created. BTW, for my bioinformatics and genomics friends, MISI is looking to hire a few talented men and women who are interested in HIT careers.

HIT: The Other Missing Link

by Dave Roth

Health information technology (HIT) is hot. There’s every reason to believe that HIT will play a major role in the reforms envisioned for our health care system. From President Obama announcing $5B in grants to aid medical research, to bioinformaticists developing tools for predicting genetic predisposition to diseases, to software developers working on electronic medical records (EMR) systems, HIT is a burgeoning field. What concerns people like me – read: people who are users of technology rather than the developers of it – is that all this HIT talk seems to have very little mention of us in it.

Not long ago, I wrote an article called The Missing Link in Healthcare IT: The Consumer. In it I pointed out that none of the current government definitions being proposed for "meaningful use" of electronic medical record (EMR) systems define meaningful from the healthcare consumer's perspective. I also noted that whatever rules the government establishes for receiving stimulus money for the development of HIT solutions, none of them will exclude technologists from collaborating with consumers in the development of their solutions. I posited that technologists would be doing us all a favor if they would stop to consider for a moment how their systems will affect the consumer’s experience of health care services.

I was encouraged when David Goldhill, in his cover story in the September 2009 issue of Atlantic Monthly, How American Health Care Killed My Father, wrote, “[A] guiding principle of any reform should be to put the consumer, not the insurer or the government, at the center of the system.” Goldhill’s prescription for a better health care system begins with advocating for the consumers of services and focusing on how to get the best outcomes for those consumers at a reasonable cost. He was channeling the views of many people, such as Harvard Business School professor Regina Herzlinger, who believe consumer-driven health care is the only reform that will truly be meaningful.

The growing visibility of the consumer in this debate has gotten me to thinking there is real opportunity in the HIT job market for another missing link: Consumer-centric Health IT Developers. It is a rare developer who brings to his/her craft an appreciation of the importance of understanding who you are developing for. Rarer still is the developer who is aware of and employs tools and techniques for capturing end-users’ feedback during the development process. More often than not, user-centered design (UCD) is considered a luxury that burns up time and precious dollars. This misconception is largely the result of development teams typically waiting until they are too far into the development cycle before engaging with those who will be using their creation. Inevitably, problems are discovered with the usability or utility of the system that will hinder adoption. But the problems are discovered too late to be fixed by the target launch date and/or within budget. Users/Consumers become the enemy in this scenario.

There is another way. HIT technologists should understand how and why to engage their target audience at the beginning of the development process, long before anything is actually developed. They should begin by understanding who they are developing for, what these people are looking to accomplish, and how they can best help them accomplish it. Using such techniques has been shown to actually reduce downstream development work and increase adoption. I believe technologists schooled in the techniques of consumer-centered design will be central to any successful, long-term health care reform.

Dave is Vice President and  heads MISI Company's Experience Design (XD) group - a group of strategists, experience architects, visual designers and technologists whose mission is to help ensure the success of every interaction between a business and its target audience. His career spans 30 years and includes award-winning work in documentary and corporate film/video, print advertising, and interactive software application development for computers and the Internet. Dave is a Stanford University grad, a SF 49ers fan and a member of the Single Malt Scotch Whiskey Society.

 

Upcoming Conference on Social Media and Digital Health

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!

 

MRSA in the News Again: Another Misleading Report

Last week, I took a group of Seattle researchers to task about issuing a press release about isolating methicillin resistant Staphylococcus aureus (MRSA) from sand samples taken from public beaches in Washington State. Their findings were neither remarkable nor news worthy and likely did more harm than good. Sadly, another article about MRSA—designed to alarm rather than inform and educate the American public—appeared in today’s Science section of the NY Times.

The article, “Ties to Pets Has Germ Jumping To and Fro” in which the word “germ” appeared several times, reports on the possible transmission of MRSA between humans and their pets, most notably dogs and cats. Much of the article focuses on the “strong link between animal to human transmission,” offers several frightening examples of serious zoonotic cases that have been recently reported and suggests that cats are eight times more likely than other pets to transmit MRSA to their owners. After reading the first part of the article, readers would rightfully believe that we are in the midst of a massive zoonotic MRSA epidemic with family pets at its epicenter.  However, on the second page of the article the author mentions an epidemiological survey study conducted by Dr. J. Scott Weese, a veterinarian from the University of Guelph in Ontario Canada which showed  that only “two to three percent of pets carry MRSA on their fur or skin or in their saliva.” Further, the study suggests that healthy animals that are transiently colonized by MRSA eliminate them “in a manner of weeks.” Compare the 2 to 3 per cent carrier rate in pets with an almost 70% human carriage rate of MRSA. While I am a PhD-trained infectious disease microbiologist, I don’t think it requires a PhD to quickly realize that pets really aren’t a major source or cause of MRSA infections for humans. That said, raising awareness among veterinarians about MRSA might aid in the development of appropriate disease surveillance, diagnostic testing, andinfection control to lessen the impact of MRSA on smallanimals.

I have no doubt that many people will look at and possibly treat their pets differently after reading the Times article. Further, many will unnecessarily spend money to have their pets tested for the presence or absence of MRSA. While informing the American public that pets (like humans) might unknowingly transmit MRSA is a good thing, turning the rare transmission of MRSA from animals to humans into a major epidemiological brou-ha-ha is misleading, scientifically disingenuous and reckless. Good journalism should inform and educate, not alarm and frighten people by presenting misleading and wrong-headed information. 

Until next time....

Good Luck and Good petting your pets (it will do more good than harm)

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"The Great Flu" Online Game: Improving Public Health Awareness

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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Managing Emotional Fallout After Losing a Job

Losing a job is a BIG deal whether you were layed off, fired or right-sized out of it. Not only do you have to worry about health insurance, bills and paying rent or making a mortgage payment, you must also deal with a myriad of self esteem and emotional issues that frequently arise after losing a job. While there are many articles and books that describe how to functionally conduct a job search after being layed off, there are only a handful that discuss how to cope with the stress and negative emotions that frequently accompany job loss.

Many people who lose their jobs frequently experience emotions like anger, desperation, hopelessness and even depression. These feelings must be acknowledged and then addressed and managed because they not particularly useful when looking for a new job. Further, when left unattended, these feelings can exact both a financial and an emotional toll on the unemployed.

In this Sunday’s New York Times, Phyllis Korkki, who writes “The Search” column describes how to manage the negative emotions and financial problems commonly associated with losing a job. She also provides tips on how to minimize “the pain” and accentuate the positive after experiencing a job loss.

Until next time...

Good Luck and Good Job Hunting!!!!

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The Importance of Digital Communications During Infectious Diseases Oubreaks

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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The Swine Flu Pandemic of 2009: Much Ado About Nothing?

A quick perusal of the media coverage of the swine flu outbreak of 2009 would lead many to conclude that this outbreak has the potential to rival or surpass the 1918 flu pandemic—widely regarded as the worst influenza outbreak in history. While the emergence of a new H1N1 swine flu variant is significant note worthy— and has possible public health implications— the unrelenting, often scientifically-inaccurate media coverage did little to quell the fear and anxiety of many Americans.  Once again, the media—rather than physicians, public health officials and influenza experts—“got out in front of the story” and managed to create enough panic, fear and anxiety, the likes of which haven't been seen since the 2003 SARS pandemic. It wasn't until last Friday, when the Wall Street Journal published an interview with Dr. Peter Palese—a leading scientific expert on influenza A infections— did a clearer picture emerge about the severity and public health implications of the current swine flu pandemic.

According to Dr. Palese, there are several reasons why people and public health officials ought to be optimistic about the current pandemic:

  • In 1976 there was a an outbreak of an H1N1 swine virus in Fort Dix, New Jersey, which showed human to human transmission but did not go on to become a highly virulent pandemic strain
  • The presently circulating swine virus is most likely not more virulent than the other seasonal strains we have experienced over the last several years
  • The current swine virus lacks an important molecular signature (the protein PB1-F2) which was present in the 1918 virus and in the highly lethal H5N1 chicken viruses.  If this virulence marker is necessary for an influenza virus to become highly pathogenic in humans or in chickens, then the current swine virus doesn’t have what it takes to become a major killer
  • Since people have been exposed to H1N1 viruses over many decades, we likely have some cross-reactive immunity against the swine H1N1 virus. While it may not be sufficient to prevent becoming ill, it may very well dampen the impact of the virus on mortality.  I would postulate that by virtue of this “herd immunity” even a 1918-like H1N1 virus could never have the horrific effect it had in the past.  The most likely outcome is that the current swine virus will become another (fourth) strain of regular seasonal influenza

The landscape of vaccines and anti-influenza drugs has dramatically improved over what it was just a few years ago. Based on what we know of the structure and sequence of the swine virus, these FDA-approved drugs and FDA-licensed vaccines (modified to include the swine strain) would be highly effective against this new virus.  Also, present technologies as well as manufacturing capacities will allow us to make sufficient quantities of a swine virus vaccine for the winter 2009-10 influenza season in the US.

In other words, there is reason for concern but no need to panic beyond typical public health precautions that are taken during “normal” influenza outbreaks.

Dr. Vincent Racaniello, a viral disease expert who writes the Virology Blog, reported that as of Monday there have been laboratory confirmed cases of H1N1 infections in 30 US states with a total of 226 cases and one death in Texas. Globally, 20 countries had reported 985 cases of infection. The highest numbers are in Mexico, with 590 cases and 25 deaths. While there have been 26 deaths to date, the severity of the infection appears to be waning and person-to-person transmission appears to be low.

Unfortunately, there has been some fallout from the news media’s oft times “over the top” coverage of the pandemic. Many US hospital emergency rooms (most notably in Texas and California) have been overwhelmed and overburdened by visits from people who think they may have swine flu. Also, while some schools and daycare center closures were warranted, others may not have been. Finally, and perhaps most important, it is becoming increasingly apparent that the lay public's understanding of infectious agents and the outbreaks that they cause is grossly deficient and must be improved. 

We live in a world where viral pandemics, food poisoning outbreaks and infections caused by multiple-antibiotic resistant bacteria are becoming commonplace. While vaccines, antivirals and antibiotics can afford some protection against many viral and bacterial disease, the best way to fight infectious diseases is to understand what causes them, how they are spread and what public health measures can be implemented to prevent or control their transmission. Until the world becomes better educated about infectious diseases, we will continue to be overly-dependent on the news media during future outbreaks and epidemics.

Until next time....

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

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The Swine Flu Epidemic: It Isn't The First and Won't Be the Last!

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

 

A New Life Sciences Career Option: Health Informatics

Are you a life sciences or healthcare professional with a passion for computers, IT or software development? If so, you might want to consider a career in health informatics—one of the hottest, new fields in the life sciences and healthcare industries. Health informatics specialists typically have expertise in medical records and claims, clinical care and programming. In other words, they have a foot in two worlds— medicine and technology — and can easily bridge the often daunting gap between them. It is important to point out that there is a difference between healthcare IT and informatics personnel. The health IT people run the servers and install software, but the informatics people are the ones who analyze and interpret clinical/ medical information and work with clinical and other healthcare staff to advise and help them.

According to an article in this Sunday’s NY Times, health informatics specialists usually start as computer programmers or as doctors, nurses, pharmacists or health record administrators. After earning a graduate health informatics degree, they find jobs as mid level or senior employees at hospitals, doctor’s offices, insurance companies, pharmaceutical companies or other organizations concerned with health data. Mid level jobs, like those for clinical analysts or informatics analysts, are usually about $70,000 a year, but salaries can be much higher for more senior level positions.  Senior level jobs, which sometimes require a Ph.D., include chief clinical information officer or other management/leadership roles at medical devices, life sciences or insurance companies. Consulting firms are also hiring health informatics experts to serve many of their health care clients who frequently don’t have the resources to hire permanent informatics staff.

At present there are no educational, licensing or credential requirements to become a health informaticist. However, a growing need for health informaticists has resulted in the creation of a number of degree programs at two and four year colleges and universities. For example, within the past four years, Columbia University, St. Louis University, the University of Minnesota and Oregon Health and Science University have all added master’s programs or certificates in health informatics. Other schools offer short courses or part-time certificate programs to healthcare employees or programmers. Still others are adding undergraduate majors or associates degrees programs to their curricula.

While many schools are beginning to offer health informatics programs, not all informatics programs are “created equal.” Generally speaking, “medical” or “biomedical” informatics programs focus on data that doctors need for treating patients. Bioinformatics” programs concentrate on biological or genetic data, while “health informatics” programs often emphasize clinical data and health records. Even among programs with the same name, the emphasis and expertise may vary at different institutions that offer the training.

By all accounts, health informatics —despite some early confusion—is one of the fastest growing careers in the bioscience and healthcare fields. Unlike other fields in the shrinking life sciences industry, there are plenty of jobs out there for health informaticists. Ironically, the failing US economy is what is driving the growth of the health informatics industry. The US government’s economic stimulus package has allocated $19 billion to hastening the adoption of electronic health records, so demand for health informatics specialists is skyrocketing. “My rough estimate is that we need about 70,000 health informaticists,” said Don E. Detmer, president and chief executive of the American Medical Informatics Association, a nonprofit industry group.

However, as a word of caution, it usually takes more than technical skills and an understanding of health care to succeed as a health informaticist. Diplomacy and conflict resolution skills are crucial when dealing with two potentially contentious groups: healthcare workers and programmers. Nevertheless, healthcare informatics is an ideal field for bioscientists and healthcare workers who also like to work with technology, computers or develop software. Based on my recent experiences as a bioscience career counselor, I know that there are thousands of you out there that fit this description. Now be the time to take a closer look at the exciting, new field of health informatics to determine whether or not it may be a career option for you!

Until next time...

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

 

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Uh Oh, Here We Go: Another Grocery Chain Offers "Free Generic Antibiotics"

News Day reported today that Wegmans Food Markets, a grocer with 72 locations in New York, Pennsylvania, New Jersey, Virginia and Maryland is giving away “free generic antibiotics” for customers (with a prescription). Wegmans joins a growing list of supermarkets pharmacies including Giant Food and Publix that are giving free generic antibiotics to its customers.

I first learned about the “free generic antibiotic give away offers” several weeks ago after reading a post on the Wall Street Journal (WSJ) Health Blog. I took the WSJ health blog to task for posting the story without editorial comment on the potentially dangerous practice of “hawking free antibiotics” to drive business at regional and nationwide grocery store pharmacies. Luckily, in today’s WSJ Health Blog post about the Wegmans program, the author (Sarah Rubenstein) did suggest that the practice may lead to unnecessary promotional  use of antibiotics.

As you all should know by now, we are in the midst of bacterial antibiotic-resistance epidemic. People are beginning to regularly die from bacterial infections that were easily treatable a decade ago. Ironically, we are slowly approaching the morbidity and mortality rates for bacterial infections that previously existed in the pre-penicillin era. Moreover, there are no new, orally bioavailable, broad spectrum antibiotics on the horizon. A lack of new antibiotics coupled with rapidly emerging resistance to extant ones is wreaking havoc on the healthcare system in both community and hospital settings.

The “free generic antibiotics” advertising and marketing programs concocted by Giant, Publix and Wegman’s are egregious examples of how a lack of or unwillingness to understand science poses a serious public health threat to all Americans. I have no doubt that the marketers who devised the give away programs have nary a clue about the relationship between antibiotic use and the emergence of antibiotic resistance strains of bacteria. Further, while physicians may be aware of increasing rates of antibiotic resistance, many are reluctant to not prescribe antibiotics to patients who request them. After all, these physicians are running a business and if they don’t write the script, the patient will take his/her business elsewhere. The potential public health implication of these free antibiotic programs begs the question: Why not give away generic ace inhibitors, generic statins or other generic medications whose profits margins are also negligible but don’t carry any public health risks?

Put simply, the promise of free generic antibiotics is a marketing strategy that is in my opinion, reckless, dangerous and may have serious public health implications in the future. Make no mistake about it, I am a capitalist but not when profits are placed before human lives.

Hat tip to the WSJ Health Blog

Until next time…

Good Luck and Good Job Hunting (try antibiotic drug discovery—we need new ones)

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The Pharmalot Blog Is No More!

Today is a sad day in the pharmaceutical and biotechnology blogging world. Pharmalot, a two year old, pioneering blog created by the intrepid Ed Silverman and the Star Ledger News has decided to call it quits. Unfortunately, the Star Ledger is in dire financial straits and it could no longer provide Ed with the support he needed to continue to run the Pharmalot blog. Please read Ed’s last blog post for the full story.

Pharmalot was a well crafted and informative blog. I frequently (more times then I care to admit) used Pharmalot as source material for many of my posts at BioJobBlog. I am not sure how I will fill the void left by Pharmalot’s untimely  demise!

I first met Ed about 8 years ago when he did a story about a biopharmaceutical company that I founded (along with Abe Abuchowski) called Prolong Pharmaceuticals.  His coverage was outstanding and I am pleased to report that Prolong is still in business today. Ed and I reconnected a little over a year ago at a panel discussion about scientific integrity and journalism. Ed shared the podium with the WSJ Health Blog, the New York Times, Advanstar Publications and several well known authors who write about pharma and biotech. I was truly impressed with his understanding of the pharmaceutical industry (he is a journalist not a scientist) and his commitment to telling people the truth regardless of the consequences. I took his message to heart and have attempted to apply the same philosophy to my posts at BioJobBlog.

I want to personally thank Ed for his unwavering commitment to journalistic integrity and his help in ferreting out the truth. I wish him the best for whatever the future may hold for him—he will be sorely missed.

Until next time…


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

A Web-Based Map Application that Track Infectious Diseases Outbreaks

Vincent Racaniello, my partner at BioCrowd, and I were chatting the other day about how cool it would be to develop a web-based map that was able to track infectious diseases outbreaks in real time. After a spirited chat, we both thought that we were on to something REALLY big. And, as is frequently the case, somebody else also had the very same idea.

For those infectious disease aficionados out there, you must check out the Health Map: A Global Disease Alert Map. The map was developed by Clark Freifeld and John Brownstein and is based on an algorithm that is beyond my comprehension. It is not as robust as the map that Vincent and I envisioned, but it is pretty cool and it works very nicely.

Until next time…

Good Luck and Good Disease Hunting!!!!!!!

 

 

This Week In Virology (TWiV) Rocks!!!!!!

Vincent Racaniello, Professor of Microbiology at the College of Physicians and Surgeons at Columbia University and co-founder of BioCrowd ,has created a weekly series called This Week In Virology (TWiV). Each week Professors  Racaniello and Dickson Despommier (another Columbia virologist) discuss the latest developments and public health concerns for a variety of viral diseases.

The weekly discussions are packaged as podcasts, posted on TWiV and Science Podcasters.org and can be downloaded from iTunes. Dr. Racaniello eventually wants to offer TWiV in a vcast format and use it to inform the public and teach students about viral diseases.

So far, Vincent and Dick have created nine TWIV podcasts. Some of viruses that they have discussed include: HIV, Polio, Lassa fever, Rabies, West Nile Virus and even video game viruses. The podcasts are interesting, informative and a good way to learn something about virology—something that may liven up your daily commute!

Until next time,

Good Luck and Good Job Hunting

 

Is Google Health Really Different?

Karen Ventii is a science/ medical writer and blogger—Science to Life blog—based in Atlanta GA. She is currently working on her Ph.D. in the field of cancer biochemistry at Emory University. Karen has posted some really cool stuff on her blog. I thought it would be fun to bring a younger perspective to my blog (especially on topics that I know very little about). So, let me know what you think about the following post!

Google Health, the latest service from Google, was launched about three weeks ago as a beta version. Online personal health services have been around for a while (including Revolution Health and Microsoft's HealthVault) but here's what Google says is different about theirs:

1. Portability: Through Google Health, you will be able to have access and control over your health data from anywhere. People who travel will be able to move health data between their various health providers seamlessly and with total control.

2. Ease of use: Clean, easy-to-use user experience that makes managing your health information straightforward and easy.

3. Partnerships: Due to the integration of third-party services you'll be able to automatically import information such as your doctors' records, your prescription history, and your test results into Google Health in order to easily access and control your data. In the future you will be able to do things like schedule appointments and refill prescriptions.

4. Security: Google Health will protect the privacy of your health information by giving you complete control over your data.

I was particularly curious about the security issue. Google Health is not regulated by HIPAA (Health Insurance Portability and Accountability Act)-the national policy on health information privacy-because Google does not provide health care services.

In an Associated Press article, Pam Dixon, executive director of the World Privacy Forum, said that by transferring records to an external service, patients could unwittingly make it easier for the government, a legal adversary or a marketing concern to obtain private information.

Google has provided a chart describing how their data confidentiality practices compare to those mandated by HIPAA. I am no expert on health information security but based on this chart, Google's policies appear fairly similar to HIPAA's.

It Had to Happen Sooner or Later: Health Canada Adopts Draft Guidance for Subsequent Entry aka Follow-On Biologics aka Biogenerics

Ed Silverman over at Pharmalot reported today that Health Canada, the Canadian equivalent of the FDA has beaten the FDA to the punch and issued draft guidance for follow-on biologics known in Canada as subsequent entry biologics. The Canadian regulatory agency recently posted on its website requirements for manufacturers and says it could approve products under existing regulations until laws are amended to include the new approval pathway.

If approved, a subsequent-entry biologic would have to be similar to a previously approved biologic, relying in part on publicly- available safety and efficacy data. Product interchangeability and substitutability would not be automatic, but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A meeting to review the draft document is scheduled for May. The proposed Canadian legislation is very similar to that adopted by the European Union for biosimilar products (what they are called in Europe). Not surprisingly the recently proposed US legislation is markedly different than the Canadian and European legislation. Go figure!

The Impact of Prescription Drugs on Rising Healthcare Costs

Health care spending in the United States grew 6.7 percent in 2006 to $2.1 trillion, or $7,026 per person. This represents a slight increase over the 6.5 percent rate in 2005 (which was the slowest growth since 1999). Health spending accounted for 16 percent of US gross domestic product in 2006, outpacing overall nominal GDP growth by 0.6 percent. However, total health care spending in the US is not the real story here.

The federal government reported that the new Medicare drug benefit called Part D, which was implemented in early 2006, contributed to an 18.7 percent increase in Medicare spending that year, the fastest rate of growth since 1981 and double the rise in 2005.  In 2006, Medicare spending rose to $401.3 billion, up from $338.0 billion a year earlier, according to the government’s annual health spending report.

The impact on funding sources that paid for prescription drug benefits varied. The public share of spending (federal and state)  increased from 28 percent in 2005 to 34 percent in 2006, while funding from private sources (insurers) fell from 72 percent to 66 percent.  The shift in funding was most dramatic for Medicare and Medicaid. Medicare’s share of total retail prescription drug spending surged from just 2 percent in 2005 to 18 percent in 2006, following Part D implementation. Meanwhile, Medicaid’s share fell from 19 percent to 9 percent.

At present, the US government cannot negotiate prescription drug pricing with drug companies that produce the medications–only drug distributors and third party insurers can do that! As the baby boomer retirement continues, the amount of government spending on prescriptions drugs will increase exponentially and ultimately cause healthcare costs in this country to explode. In my opinion there are two options: impose price controls on prescription drugs or provide all US citizens with a national healthcare system that allows the government to negotiate drug pricing directly with drug manufacturers. And for those of you who think national healthcare is a fantasy–over 60% of all healthcare claims in the US are currently handled and paid by Medicare–a federally finaced and run government healthcare system!  We are closer to a national health insurance program than you think!

Until next time...

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

Are Medical Journals Haunted by "Ghost Writers"?

Fellow blogger, Jacob Goldstein, over at the WSJ Health Blog posted a story today about a prominent hypertension researcher who was approached by a medical communications agency about  putting her name on an abstract (she did not participate in the research) that was being prepared by the agency for a pharmaceutical client. According to the Health Blog, the researcher was so outraged by the offer that she decided to go public about the alleged “ghost writing” incident. I have no doubt that the story is accurate.  That said,  I think that a comment posted to WSJ’s blog about the story sums it all up nicely:

 “So, this is some new revelation for the WSJ? There are plenty of studies in the medical literature which have been ghost written by an industry-sponsored medical writer, that was then submitted under the name of a highly-recognizable leader in the field–always at a steep price”.

As much as I hate to admit it, the person who posted the comment is right--sort of. Although ghost writing was commonplace in the medical communications industry as recently as a few years ago, the practice is no longer tolerated at most medcom agencies, and, perhaps more importantly, by the would-be authors whose names ultimately appear on the publications. That said, medcom agencies and their clients must remain vigilant in their attempts to eradicate ghost writing entirely so that all medical communications are written (and published) in the most scientifically-sound and ethical manner.