Certificate Programs Can Help Scientists Transition to Alternative Careers

By now, I think that most BioJobBlog readers understand that the job market for life scientists is lousy and that it isn’t likely to improve anytime soon. I know that many of you have spent close to 10 years training for a shot at an R&D job but the reality is that everybody needs to work to put food on the table—whether or not you find a job in your chosen profession. To that end, now may be a good time for those of you who are finding it difficult to land a job to consider one more year of training to get a certificate in a field that keeps you in science but not in R&D.

I came across interesting post today at the Resume Bear blog that discussed 10 certificate programs that can help people transition to new careers to find jobs. Interestingly, four of the programs are good fits for life scientists who are willing modify their careers to be gainfully employed. They are:

Clinical Trials Design and Management

“Pharmaceutical drug and medical device development is one of the premier industries of the 21st century, and the success of this vital industry depends upon the complex process of studying new products to verify their effectiveness and safety.”

Regulatory Affairs

Professionals are needed to guide drug development and medical device companies through FDA imposed regulation issues pertinent to the pharmaceutical and biological industry.”

Project Management

“As project cycles get shorter – and budgets get leaner – project managers are vital to the success of organizations today.”

Copyediting

“Bridging the gap between writers and publishers – especially technical and nonfiction copyediting – is one of today’s most marketable skills for both full-time and freelance work.”

Another one that was not on the list biotechnology certificate programs in which students learn about product development, regulatory affairs and best business practices in the life sciences industry.

Not surprisingly, many certificate programs are offered at local community colleges and frequently online. For regulatory affairs training you might try the Drug Information Association and Regulatory Affairs Professionals Society. The Project Management Institute offers training in project management and the Editorial Freelancers Association offers its members courses in copyediting. Mercer County College in West Windsor NJ in association with a local clinical research organization developed a “hands-on” certificate program in clinical trials design and management

In my opinion, certificate programs are worth checking out. They are designed for working professionals (courses are typically given in the evenings and weekends); usually only take 12 months to complete (what is one more year in the scheme of things) and improves the likelihood of finding a job because you now have a marketable skill set! It certainly beats collecting unemployment or sleeping in your old bed at your parent’s home—or not?

Hat tip to Resume Bear

Until next time...

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Where Have All the R&D Jobs Gone?

Over the past three years, more than 90,000 pharmaceutical employees have been layed off. While many of these former employees were drug reps, a majority who lost their jobs were R&D scientists. If drug makers have already jettisioned tens of thousands of R&D jobs, how is the next generation of medicines going to be discovered and developed? Like it or not, pharmaceutical and biotechnology R&D is beginning to be outsourced—much like information technology (IT) was in the late 1990s. And, like the IT industry much of R&D is being outsourced to countries like India and China. This should not be surprising because for the past 20 years or so, most of the people receiving PhDs in the life sciences were foreign nationals—many of whom were unable to stay in the US because of post-9/11 immigration policies and visa quotas. Without many options, many had no choice but to return to their home countries to seek employment and in some at contract research organizations (CROs) that specialize in pharmaceutical and biotechnology R&D.

According to a recent article written by J B Gupta Senior Vice President Collaborative Research GVK Biosciences Pvt. Ltd. India, for the last five years or so, Indian CROs like GVK Biosciences, Aurigene, Syngene, Advinus, Jubilant, Suven Life Sciences, Sai Lab, Accunova, iGate etc. have been positioning themselves as purveyors of R&D services to pharmaceutical and biotechnology companies. These efforts have apparently paid off! Companies like Merck, GlaxoSmithKline, Forrest Laboratories, Eli Lilly & Co, Johnson & Johnson, Merck Serono, Wyeth, Bristol Myers Squibb and others have entered into strategic R&D partnerships with many of India’s leading CROs. 

A recent study by the Kauffman Foundation suggests that India better positioned and ahead of China in R&D outsourcing. Further, the pace at which discovery collaborations are being established in India suggests that the western pharmaceutical industry is looking to Indian CROs not only to cut costs but to innovate as well.

Unfortunately, while this doesn’t bode well for American scientists, the US has nobody to blame but itself. Wrong-headed immigration policies coupled with inadequate training for life scientists who want to pursue industrial careers are largely responsible for the current R&D outsourcing activities. Like IT, I suspect that outsourcing will work for some companies but not others. Nevertheless, I think that outsourcing is here to stay and like it or not American life scientists will have no choice but to adapt to the “new normal.”

Until next time...

Good Luck and Good Job Hunting (try India or China)

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The Job Market: Dressing For Success

Last month, while I was presenting my seminar “Interviewing Insights and Tips: Winning That Next Job” at the Experimental Biology Meeting in New Orleans, LA, I realized that I hadn’t covered what to wear to a job interview. Until the meeting, I didn’t think I had to  mention— that while interviewing men—must wear suits (and appropriately-colored, professional-looking shoes) and women should wear suits with pants (or a skirt with an appropriate length) and shoes with reasonable heels (usually less than 3 inches). I saw more cleavage, bare thighs and high heels, not to mention men with atrocious footwear choices at the meeting than I care to admit. Not that I am a prude or complaining about the cleavage, thighs or high heels that I observed—what red-blooded American male would?  That said, it is vitally important to remember that there are professional dress codes that everyone is expected to adhere to while on the job or at national, regional or local professional meetings.

Phyllis Korrki, who writes the Career Couch for the New York Times, wrote a great piece on professional attire in this past Sunday’s Times that I think every prospective job candidate or employee ought to read. And, when it comes to cleavage, exposed thighs and high heels in professional settings she had recommendations similar to mine. She wrote “Women think they have to dress sexy to get noticed in the work world. It’s what they see on campus and what they see on TV and in movies. Cleavage is not a corporate look or what you want to be remembered for. The same goes for very short skirts and extremely high heels. Also, make sure the top of your thong, if you wear one, doesn’t show above your pants.” 

For you guys, as a rule of thumb, wear black shoes with gray, blue and black suits and brown shoes with all others. It doesn’t get much easier than that!

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While we scientists are trained to ignore appearance and not pay attention to dress codes—the reality is—the way you look may make the difference between having a job or not!

Until next time...

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

 

The National Institutes of Health to Aid Orphan Drug Development

The National Institutes of Health (NIH) announced on Wednesday that it was creating a new program aimed at “finding treatments for some of the 6,800 rare diseases that collectively affect about 25 million Americans.” 

According to NIH officials, the NIH would work with researchers and patient advocacy groups to identify new molecular entities (NMEs) that represent potential treatments for rare disorders. Once identified, NMEs will be turned over to private companies for further development. Information about molecules that failed to make the cut for further development will be published in scientific and medical journals. The NIH stressed that the goal of the program is to work with the drug industry not compete with it to develop new treatments.

Because many rare diseases only affect a few hundred or a few thousand people, there are little financial incentives or profit motives for companies to develop treatments for them. To stimulate drug development for rare diseases, the US Congress passed The Orphan Drug Act (1983) that offers companies that develop drugs for diseases affecting fewer than 200,000 people tax incentives, financial support for clinical development and seven years of US market exclusivity, i.e. the company can sell the product without competition for seven years. Since its passage, the Orphan Drug Act has been a boon to many biotechnology companies, most notably Genzyme, a profitable biotechnology company whose business model is built almost exclusively on orphan drug development.

NIH’s entry into the orphan drug development arena ought to help speed discovery and development of potential new treatments for orphan indications. It will undoubtedly help to reduce some of the cost, time and risks typically associated will corporate drug discovery. Industry experts suggest that drug discovery can sometimes cost well over $10.0 million and take between two to four years to complete. However, the program is starting with only $24 million this year and is expected to receive the same level of funding each year until 2013. While this may limit the overall effectiveness of the program, it will likely bring government and the drug industry closer to forge new relationships with the common goal of discovering much needed new treatment for orphan indications.

Until next time...

Good Luck and Good Research!!!!!!!!

 

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Trouble with the Merck-Schering Plough Deal? Johnson & Johnson to Reclaim Marketing Rights to Remicade and Simponi

Johnson & Johnson (JNJ) is trying to regain sole marketing rights to Remicade, its lucrative anti-TNF treatment for arthritis and psoriasis, because Schering Plough (SGP)—which has most of the marketing rights to the drug outside of the US—is being acquired by Merck. JNJ is seeking arbitration to determine whether or not Centocor, its subsidiary that manufactures Remicade and Simponi, can terminate a marketing agreement for the two drugs—based on terms stipulated in the original contract —if there is a “change of control” at SGP.

As you may recall, Merck was acutely aware of the terms of marketing agreement before it decided to purchase SGP and cleverly engineered the acquisition as a reverse merger— to prevent triggering provisions that could return Schering’s marketing rights for Remicade and Simponi to JNJ if their were leadership changes or a change of control at SGP. JNJ’s announcement contesting wasn’t unexpected after the Merck-Schering Plough deal was announced early last winter—sales of Remicade outside of the US topped $2.0 billion in last year. Simponi, Remicade’s highly touted successor (which recently received FDA approval), is also expected to reach blockbuster status after it reaches the market. 

The Merck-Schering deal left JNJ with few alternative or choices. The company could have counter offered to purchase SGP in its entirety or simply, as it did, invoke terms of the original agreement that would terminate SGP’s marketing rights if there was a “change of control” at the company. JNJ rightfully believes that a change of control will occur when Merck acquires SGP. According to a JNJ spokesperson “As its public statements make clear Merck is acquiring Schering Plough. The acquisition constitutes a change of control and trigger’s Centocor’s right to terminate.” It will be interesting to see how an arbitrator rules in the case.

While the loss of Remicade and Simponi isn’t likely to jeopardize the Merck-Schering Plough deal (according to Merck executives), it may affect the financial terms and overall benefit or upside of the acquisition. The expected completion of the deal is scheduled for the fourth quarter of this year.

Until next time...

Good Luck and Good Job Hunting!!!!

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Life Sciences Layoffs Beginning to Spill Over To Medical Devices Companies

Medtronics, the world's largest medical-device company, announced today that it will lay off 1,500-1,800 employees after posting a fiscal fourth-quarter profit that plunged 69 percent on slipping sales,restructuring and other charges. About 400 employees already have accepted buyout offers and will leave the company by the end of the month.

Until now, the medical devices and diagnostic industries, unlike pharma and biotech had had remained unscathed by the current economic downturn. Medtronic’s financial woes are mainly a result of questions about its implantable devices which have come under fire recently because of safety concerns. Nevertheless, don’t be surprised if you see other medical devices and diagnostic companies begin to layoff workers as the financial crisis deepens and medical and healthcare costs continue to rise.

Hat tip to Iguana Bio.

Until next time...

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

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BioJobBlog Back Up and Running

BioJobBlog was not accessible for about six hours yesterday evening because of a power outage in Seattle.  The problem has been fixed and things are running smoothly again. So, please come back and read what you missed!

Until next time,

Good Luck and Good Blogging

Time for a Change: BIO Study--US Students Falling Behind in Bioscience Education

The Biotechnology Industry Organization (BIO) kicked off its annual meeting in Atlanta, Georgia today and shortly thereafter, issued a press release detailing an education study (that it commissioned) which suggests that American high school students are continuing to fall behind in life sciences education and competitiveness. The timing of the BIO education report is curious, given that over 100,000 life sciences employees have lost their jobs over the past several years and more job cuts at pharmaceutical and biotechnology companies are expected in the next six months or so.

The report concluded that “middle and high school students across the country are generally falling behind in life sciences, and the nation is at risk of producing a dearth of qualified workers for the life sciences industry. Students are showing less interest in taking life sciences and science courses, and high schools are doing a poor job of preparing students for college-level science, The deficiencies will hurt the country's competitiveness with the rest of the world in the knowledge-based economy.”

Some of the report's finding include:

  • 52 percent of 12th graders are at or above a basic level of achievement in the sciences as measured by the NAEP science test
  • Average scores on the NAEP for 12th graders in the sciences and life sciences declined from 1996 to 2005
  • Only 28 percent of high school students taking the ACT reached a score indicating college readiness for biology.

The report also found a deficiency in the number of well-qualified biology teachers available in high school, with one-in-eight biology teachers not certified to teach biology. To improve U.S. competitiveness in the biosciences industry, the report recommends that states incorporate biotechnology into their science standards, make sure students are ready to take college biosciences courses and focus more on professional development for teachers.

While BIO ought to be commended for the study, the results and the conclusions of the report are nothing new and have been known for over a decade by industry thought leaders and life sciences industry executives. The crux of the problem is that neither academia nor industry is willing to provide funds or invests in ways to find a solution to this vexing, ongoing issue. Also,while high school science curriculum experts and teachers are typically cited as the cause of the problem, most of the blame more aptly lies with life science educators at the undergraduate and graduate school levels.

Today, many US high schools and community colleges already offer life sciences and biotechnology training to their students. In fact, biotechnology curriculum development and outreach has been ongoing in US for well over a decade. For example, Bio-Link, an NSF-funded consortium of community colleges that began in the late 1990s, has diligently worked to create a network of community colleges and high schools that offer biotechnology education and training ranging from biomanufacturing to bioinformatics to forensic DNA sciences. Further, a quick perusal of many high schools and science academies in biotechnology-rich locales like the Northeast, California, New Jersey, Maryland, North Carolina and others reveals that life sciences education and training are readily available to many students interested in biology and bioscience.

In my opinion, the system doesn't break down at the high school level but at the undergraduate and graduate school levels. This is because for the past 15 years, many undergraduate life sciences courses have jettisoned their hands on laboratory components in favor of more lecture driven and e-based learning experiences. This is because these laboratories are costly to run and extremely labor intensive. Further, many undergraduate students may choose not pursue science careers because of the mistaken perception that life sciences jobs require a PhD. Ironically, there are many more jobs in the life sciences industry for students with undergraduate or masters' degrees than for those with PhD. This is because there is a glut of PhDs in today's market and the number of jobs in academia and the life sciences industry are growing smaller. I believe that academia and industry are responsible for the rapidly declining job market for PhD-life sciences.

First, let's look at academia. Most academicians who are charged with training PhDs and postdoctoral fellows have little appreciation or understanding of the technical and regulatory skill sets required in the life sciences industry. Second, many academics don't feel that it is their responsibility to prepare students and postdoctoral fellows for jobs in industry because that is tantamount to job training—a big no-no in academic circles. Finally,and perhaps most important, graduate programs are reluctant to provide career counseling or job-specific training for their students because it might interfere with their productivity, which in turn may reduce the amount of data principal investigators have to write papers and win grants to fund their laboratories. In other words, there is little or no incentive for education and training to change at the graduate level because there is no benefit or upside to principal investigators and tenured faculty members.

While the American life sciences industry has loudly and repeatedly complained about a lack of qualified job candidates to work at its companies, they have done little to support and fund efforts to reform US life science education and training. This is likely because many life sciences executives contend that they are in business not education and the responsibility to prepare students for careers in science should not fall on them. Rather, it rightfully belongs in the purview of secondary and post secondary educational institutions. And, rather than train new employees without previous industrial experience (to inject new talent and ideas into their organizations), companies typically only hire job candidates with previous industrial experience. As many newly minted PhD and postdoctoral students frequently ask: “How are we suppose to get industrial experience if nobody will hire us without previous industrial experience?” Good question! 

The BIO report warns that the US is falling behind in bioscience education and American life science companies may experience workforce shortages in the future. The fact that about 100,000    (many of whom were scientists) pharmaceutical employees have lost their jobs over the past several years, suggests otherwise. Nevertheless, American science education and training needs to be improved and reformed if the US wants to maintain its dominance in the life sciences. The piecemeal approach that has been pursued for past decade or so hasn't worked. And why should it? Neither academia nor industry, the two main players in the story, don't really have any “skin in the game.” In other words, they have nothing to lose right now!

I believe that its time for academia, industry and government to come together to craft a cohesive, national life science curriculum that meets the needs of all stakeholders. We have a President in the White House who believes in science, the ingenuity of the American people and change. The time is now!

Until next time...

Good Luck and Good Job Hunting!!!!! 

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Social Networks More Popular Than e-mail!!!

The New York Times reported today that for the first time, Internet users are spending more time on social networking and video sites than on e-mail. According to a report by Nielsen, there was a 1,905 percentage change in the time that users spent viewing online video and an 883 percentage increase in social networking use from February 2003 to 2009.

These changes represent something of a paradigm shift in consumer's relationship with the Internet. People are increasingly moving away from portal-oriented sites, like shopping directories to social networking sites like YouTube and Facebook and providers of niche content.

While marketers have yet to master advertising on social networking sites, Internet pundits and social media enthusiasts believe that over the next year or so a viable business model will emerge that is reliant on social networking user influence and opinions.

Until next time...

Good Luck and Good Networking!!!!!

 

Pfizer Gets Out in Front of Healthcare Reform

Pfizer, the world’s largest drug maker, announced on Thursday that it is unveiling a new program that will let people who have lost their jobs and health insurance to keep taking Pfizer medications — for free, and for up to a year. The company will provide more than 70 of its prescription drugs ranging from Viagra to Lipitor at no costs to unemployed and uninsured Americans who lost their jobs since Jan. 1 and have been taking Pfizer drugs for me than three months. It is not clear how much Pfizer will spend on the program and whether or not costs will be capped.

The announcement comes amid massive job losses caused by the recession and a campaign in Washington to rein in health care costs and extend coverage. The move could earn Pfizer some goodwill in that debate after long being a target of critics of drug industry prices and sales practices. The program also likely will help keep those patients loyal to Pfizer brands. Don't be surprised if other pharmaceutical companies announce similar program over the next few weeks.

Pfizer and the rest of the drug industry wants is trying to have a voice in the debate over how to overhaul the U.S. health care system, partly by joining in a pledge this week to help hold down inflation of health costs. In the mean time, drug companies have been raising prices on their drugs, partly to offset declines in revenue as the global recession reduces the number of prescriptions people can afford to fill.

Pfizer ought to be commended on the program and its concern for the health and well being of unemployed and uninsured Americans. However, it is important to point out that this is little more than a high profile, marketing campaign designed to improve the image of drug makers. More important, it is the first public acknowledgement that drug makers are willing to engage legislators in discussions about how to reform healthcare to reduce costs and cut expenditures. 

What really is at stake here is whether or not the US government will begin regulating drug prices as part of a comprehensive healthcare reform package. As many of you may know, the US government, unlike most other governments in the world, cannot negotiate or set prescription drugs prices. Not surprisingly, the US prescription drug market is the largest and most profitable in the world. It will be interesting to see how the US healthcare reform discussion unfolds—clearly a lot is at stake for the American prescription drug industry.

Until next time...

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

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Intelligent Design Isn't That Intelligent After All

A team of scientists from the UK report in this week’s edition of Nature that they were able to induce the formation of ribonucleotides using ribose, phosphate and the bases adenine, uracil, guanine and cytosine and environmental conditions that may have been present in the early history of the Earth. This had been a fundamental but elusive step in the early evolution of life on Earth.

The results of the study entitled “Synthesis of activated pyrimidine ribonucleotides in prebiotically plausible conditions” provide evidence that self-assembling RNA molecules were likely the first to be formed and were likely the first step in the evolution of life on Earth. According to John Sutherland of the University of Manchester a co-author of the study, “Ribonucleotides are simply an expression of the fundamental principles of organic chemistry,” said Sutherland. “They’re doing it unwittingly. The instructions for them to do it are inherent in the structure of the precursor materials. And if they can self-assemble so easily, perhaps they shouldn’t be viewed as complicated. It’s like molecular choreography, where the molecules choreograph their own behavior. In other words, the origins of life may be much simpler than previously imagined—so much for intelligent design! 

Evolution rocks! Hat tip to Steve Munro.

Until next time....

Good Luck and Good Experimenting!!!!

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Tired of Twittering to Build Your Network? Check Out MeettheBoss.com and Get Immediate Access to Life Science Executives and Industry Thought Leaders!

There has been no shortage of conversation lately about current problems facing the pharmaceutical and biotechnology industries. These industries are faced with the effects of the global recession because of a dangerous combination of falling revenues and spiraling costs. Life sciences company executives are looking for ways to cut production costs and cope with the current decline in drug sales.

“Social networking sites are great to catch-up with old friends, share photographs, music and links but in this climate does the executive community have time for this?” asked Spencer Green CEO of MeettheBoss.com “Credit isn’t the only casualty of the crunch: time is another scarce resource for executives, they need immediate value when online to inform stakeholders and update the public on need developments.

MeettheBoss.com, first launched for the financial services sector in 2008, has just unveiled a new and improved version – redesigned with increased functionality and features, and specifically launched to keep life sciences professionals abreast of late breaking news and trends in the industry. Free Video Roundtables, executive broadcasts and “smartwords” are some of the new functions for the executives to communicate with stakeholders and the public at large. More importantly, it provides instant access to a network of your peers. Also included in the new launch is an upgraded version of MeettheBossTV,an online television channel dedicated to business leaders. The first week of MeettheBoss pharma will feature John Earley, global head of lean and supply at AstraZeneca and Steve Dreamer, VP and head of engineering at Novartis.

While similar to BioCrowd, a social and business networking site for ALL bioprofessionals, MeettheBoss.com is almost exclusively focused on the "goings on" in the pharmaceutical industry.

Please drop me a line and let me know whether or not you like MeettheBoss

Until next time...

Good Luck and Good Networking!!!!!!!!
 

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

 

The Curious Case of Wrinkles, Botox and FDA

One day after the US Food and Drug Administration (FDA) approved Dysport, a new product that will compete with Botox, the agency ordered that labels for all botulinal toxin-based drugs must carry a black box safety warning. For those of you who may not know, that is the most stringent kind of safety warning label—viewed by many in the industry as “the kiss of death”— that the agency can order to appear on the products that it regulates. 

Black boxes (literally a black box with bold-face risk information) are typically reserved for medications that are know to have serious or life-threatening side effects or risks. For example, many antidepressants—most recently serotonin re uptake inhibitors (SRIs)—carry black box warnings of increased danger of suicidal thoughts and actions. 

Over the last 20 years FDA approved Botox to treat crossed eyes, eyelid spasm, severe underarm sweating and cervical dystonia (a painful and severe neck condition that can cause an abnormal head position) Cosmetic Botox was approved to treat skin folds and wrinkles in 2002. Allergan, the company that manufactures Botox, reported $1.3 billion in worldwide sales of the drug in 2008. 

Botox and Dysport are injectible products made from the highly paralytic toxins produced by the bacterium Clostridium botulinum. Botulinal toxins interfere with muscle contractions and patients with botulism food poisoning exhibit what is known as “flaccid paralysis.” Afflicted individuals cannot breather and will die without early intervention. FDA order the black box safety warning labels because there were numerous reports of serious health problems, complications and deaths caused by the drug spreading from the site of injection to other parts of the body. 

Most of the problems with Botox resulted from the overuse of Botox for unapproved treatments like limb spasticity in children with cerebral palsy (although misuse of the product for cosmetic purposes may have also contributed to the problems). The agency will now require that all botulism-based products carry a black box warning explaining that the medication has the potential to spread from the site of injection to other body sites—with the potential to cause serious problems like difficulties swallowing or breathing. Also, it will require manufacturers of botulinal products [Allergan (Botox) and Ipsen/Medicis Pharmaceuticals (Dysport)] to send physicians letters warning of the risks and to craft medical guides given to patients at the time of injection. 

The new warning labels will likely do little to discourage the rampant use of Botox and Dysport for cosmetic indications. After all, beauty will always come before safety! 

Until next time... 

Good Luck and Good Job Hunting (looking younger may help)

 

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Swine Flu Pandemic: Many Questions and Few Answers

Vincent Racaniello, an intrepid virologist and BioCrowd co-founder, has been keeping folks up to date on the swine flu outbreak on his blog. Today, Vincent wrote: “There are now 257 laboratory confirmed cases, with 7 deaths, in 11 countries. In the US there are 109 cases  in 11 states. There are many more suspected cases; together the statistics indicate widespread dissemination of the new H1N1 influenza virus. I no longer doubt that this is the next pandemic strain. WHO will probably soon raise the level of influenza pandemic alert from phase 5 to phase 6. Important questions include whether spread will continue in the northern hemisphere through the summer, or stop very soon, as is the case with most influenza virus outbreaks. Unfortunately the southern hemisphere seems in for an extended flu season. Will antivirals be useful in reducing morbidity and mortality? Will the virus returns to the north in a more virulent form in the fall? Can a vaccine be prepared in time?”

 For answers to these questions and others, please visit the Virology Blog or join BioCrowd to chat with Vincent. Check his virology blog for the most up-to-date swine flu information.

 Until next time... 

 Good Luck and Good Virus Hunting (or not)!!!!

  

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