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I am not sure how I missed this announcement last week but Sanofi Aventis will invest $300 million in a vaccine (biologics) manufacturing facility in India. The investment is in addition to the $784 million that Sanofi paid two years ago to acquire the Indian biologics company Shanta Biotech.

Sanofi executives originally thought that the purchase of Shanta would give immediately give them biologics manufacturing capability in South Asia. This did not occur because of manufacturing problems with the existing Shanta facility.  Sanofi claims to have corrected the manufacturing issues and investment of an additional $300 million into the facility is to bolster both R&D and manufacturing capacity. The new manufacturing facility is consistent with Sanofi’s publicly announced strategy of earning as much as 40 percent of its profits in emerging markets by 2015.

Like China, emerging markets like India, Brazil and Russia will be squarely on big pharma’s radar for the foreseeable future.

Until next time...

Good Luck and Good Job Hunting (in India!)

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Christopher Rutty, a science writer and historian and member of a LinkedIn Group that I belong to, posted a link to a Penn and Teller  YouTube video on childhood vaccinations.  I had no idea what to expect, but after viewing the video all I could say was "Wow, how brilliant."  I don't think that I have ever seen a more elegant and easy-to-understand piece on the science and ultimate benefits of childhood vaccinations! 

Hat tip to Penn and Teller and the creative folks behind the video!

Until next time,

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

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Vincent Racaniello, author of the award-winning Virology Blog and  a BioCrowd co-founder wrote in a recent post about the upcoming vote on whether or not to destroy the last remaining smallpox virus stockpiles in the world:

"After the eradication of smallpox in 1980, the World Health Organization called for destruction of known remaining stocks of the virus. The United States and Russia, which hold the known stocks of smallpox virus, have not destroyed their stocks. The WHO met in January 2011 to debate the future of smallpox, and a committee will issue a final recommendation sometime this year. For further information on this topic, there is an editorial in Vaccine entitled “Why not destroy remaining smallpox virus stocks“, and a WHO review on smallpox research."

For those of you less science-minded BioJobBlog readers (or those who prefer visual learning) I added a CNN video on the topic.

So what do you think?  Should the remaining American and Russian smallpox stockpiles be destroyed or saved?  You can weigh in on the topic by visiting Vincent's blog and voting!

Until next time...

Good Luck and Good Job Hunting!!!

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Ed Silverman, author of the fabulous Pharmalot Blog, showed his investigative reporting bona fides by revealing today that there may be a direct link between pharma manufacturing facilities, US national security and the brouhaha over WikiLeaks.

Ed uncovered a cable dated Feb. 18, 2009 from the US Secretary of State to all overseas diplomats that stated pharma facilities are vital to US national security and that “losing these facilities could critically impact the public health, economic security, and/or national and homeland security of the United States.”

The cable stressed that these facilities produce insulin, a variety of vaccines that protect against potentially devastating infectious agents and other medications and a vital part of the US National Infrastructure Protection Program. According to Ed’s post, the facilities mentioned in the cable are located all over the world and included companies such as Baxter, GlaxoSmithKline, Novo Nordisk, Sanofi-Aventis, Genzyme, Novartis, IDT Biologika, Vetter Pharma, Roche, CSL Behring and Grifols. Interestingly, only two of the companies mentioned, Baxter and Genzyme, are US-owned companies. Go figure!!!!!!!

Until next time...

Good Luck and Be Alert (you never know who may be watching)

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The Pharmalot Blog today reported that Abbott will be cutting about 3,000 jobs. The downsizing comes about a year after Abbott purchased Solvay Pharmaceuticals for about 6.2 billion but failed last month to find a buyer for the Solvay vaccine unit (which was expected to fetch about $600 million). 

According to the post, most of the jobs will be eliminated in R&D, manufacturing and commercial operations mainly at former Solvay Pharmaceutical sites in the Netherlands and Germany. Also, Solvay’s current US headquarters in Marietta Georgia will be closed in the near future.

Abbott has approximately 90,000 employees worldwide. While the recession may be officially over the job cuts continue and unemployment continues to rise.

Until next time...

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

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Despite a court ruling last week that dismissed the bogus link between vaccination and autism, I continue to receive comments from so-called “non-vaccinators” about a post that I published last week about New Jersey’s dismal vaccinations rates. Most of the comments are anecdotal and suggest that childhood vaccination was the likely culprit for their children’s autism, brain damage or other ailments. While I feel their pain, the notion that children should not continue to be vaccinated is misguided and has serious negative public health implications.

There is ample public health and scientific information that suggests that childhood vaccination has worked well to reduce the incidence of morbidity and mortality in Western nations. Ironically, if it wasn’t for mandatory childhood vaccinations, the death and lasting physical or neurological damage caused by many preventable diseases like smallpox, measles, mumps, diphtheria and whooping cough would be much higher. Unfortunately, we Americans have been lead to believe —intentionally or not—that there should be no side effects associated with drugs, vaccines and other medicines. The bottom line is that all drugs, vaccines and medicines have side effects; some more serious or noticeable than others! Further, the decision to develop new drugs and vaccines is always based on a risk to benefit ratio. Pharmaceutical and biotechnology companies will only develop products to address unmet medical needs when the benefits of these products clearly outweigh the potential risks. However, in some cases, most notably cancer drugs, the risk to benefit ratio becomes less obvious. There is no question that most cancer drugs have serious and potential life threatening side effects. Nevertheless, the benefit—survival and not death—far outweighs potential downstream risks!

Like it or not, the medical benefits of vaccination far outweigh the risks associated with them. As many of you may know, there is currently a whooping cough epidemic in California. California health officials assert that the epidemic likely started among unvaccinated individuals and then spread to the larger population. The observation that many of the patients with whooping cough were previously vaccinated against the disease in childhood suggests that either their immunity to whooping has declined over the years or that the causative bacterium, Bordetella pertussis has become more virulent. 

The former hypothesis is more likely than the later mainly because Bordetella infections were almost non-existent until increased immigration and the non-vaccination movement began in earnest about 15 years ago! Students of infectious diseases will tell you that virulence of infectious agents tends to increase as they are passed from one infected individual to the next. Consequently, the lack of any significant B pertussis outbreaks (until very recently) suggests that changes in the underlying virulence mechanism of the bacterium are not responsible for the current outbreaks.

Again, as a parent, I understand the pain and suffering of those whose children may have experienced debilitating effects coincident with childhood vaccination regimens. However, as more parents continue to eschew vaccination against childhood disease, the incidence of death and children with serious life long debilitating effects associated with many common childhood diseases is certain to rise. With this in mind, I will continue to write and post articles that support childhood vaccinations. I will gladly stop posting these articles when someone can provide me with scientifically accurate and valid data that suggest that vaccination does more harm than good!

Until next time...

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

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There was an extremely troubling article in today’s New Jersey Trenton Times that indicated that a New Jersey’s childhood vaccination rates ranked 42nd in 2009—45^th in 2008—in the nation. The ranking were based on annual vaccination statistic compiled by the Centers for Disease Control in Atlanta, GA.

The lead-in paragraph to the article elegantly captured the irony of the dubious statistic:

“One of the most affluent (and most populous states) states in the country, home to more than a few giants in the pharmaceutical industry also has one of the lowest rates of immunizing babies and toddlers in the nation.”

New Jersey’s vaccination rates among infants and toddlers for childhood diseases— mumps, measles, diphtheria, Pertussis (whooping cough), hepatitis B and rubella—was roughly 64 percent in 2009. This was significantly lower than the national average of 71 percent and the lowest in the Northeast. For example, in Pennsylvania and New York, two of the states bordering New Jersey, the vaccination rates in 2009 were 72 and 71 present respectively.

The reasons given for the low rate are plausible but, in most cases, incomprehensible from an infectious diseases and public health perspectives. It has been postulated that low-income and immigrant communities lack health insurance and access to medical information about mandatory childhood vaccination regimens. While it is facile to blame low income and immigrant populations for New Jersey's  egregiously low vaccination rate, the problem may actually lie with more affluent and educated NJ citizens who have medical insurance (help to pay the salaries of medical billing workers) and understand the public health implications of mandatory childhood immunizations. 

According to the article, parents and even some health care professionals are backing away from mandatory vaccination because they “don’t like seeing kids cry” after sometimes receiving up to four vaccinations during a single office visit! Say what????? I accompanied my three children for most of their childhood immunizations, and while some tears may have been shed, they recovered quickly and are now protected against a variety of potentially life-threatening diseases.  Apparently, some parents and health care professionals are willing to jeopardize the public health of a nation because the “shots hurt.” To that I say; get over it—like it or not, life can be painful and no matter how hard you may try you cannot shield your kids from it!

The fallacious and recently publicly discredited link between childhood vaccination and autism, coupled with the growing public distrust of the pharmaceutical companies that manufacture the vaccines may be more plausible explanations for New Jersey’s declining immunization rates in NJ. This suggests that vaccine manufacturers and public health officials ought to work closely together to be educate the American public about the benefits and potential risks associated with childhood vaccination.

Finally, as some of you may know, many states like New Jersey have religious exemptions that allow children to skip mandatory childhood immunizations. Interestingly and troublingly these children are allowed to attend public schools despite the fact that they haven’t been vaccinated. Again, I say what??? Increasingly, these unvaccinated students have been implicated as the reservoirs for the pertussis outbreaks that are currently ravaging school aged children and older adults throughout the US. It is my belief that children who fail to receive the appropriate immunizations because of religious reason should not be allowed to attend public school. This is because, unlike many of the low income and immigrant families who may be unaware or cannot afford to immunize their children because they lack health insurance, many of the folks claiming religious exemptions have health insurance and are living above the poverty level. Consequently, if these parents choose to not immunize their children (and fail to meet mandated public health requirements for entry into public schools), then they ought to be financially responsible for their child’s education.

Paradoxically, the plummeting vaccination rates in New Jersey and elsewhere are being driven by a small but extremely vocal segment of the American public. Unfortunately, this anti-vaccine sentiment in America is unlikely to abate until an increasing number of children begin to die from easily preventable childhood diseases. As far as I am concerned, the benefits of childhood vaccines far outweigh their risks and help to maintain the public health of all Americans.

Until next time...

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

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Earlier this month, Merck BioVentures, the company’s new division focused on developing follow-on biologics aka biosimilars announced that it was scuttling plans to develop MK-2578, a PEGylated version of erythropoietin (EPO); its first follow-on biologics candidate (someone should have mentioned to Merck that PEG-EPO is NOT a follow-on product but actually a NME that would require full regulatory approval).  In yet another setback, this past week the US Food and Drug Administration (FDA) postponed a decision to broaden usage of its Gardasil human papillomavirus (HPV) vaccine to women between the ages of 27 and 45.

The company had submitted new data to agency and had hoped to hear by the end of June about the new indication for Gardasil; FDA will likely delay a response until the end of 2010. Gardasil is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. It is also approved to prevent genital warts in males of the same age. Merck has aggressively been trying to expand the indications for the vaccine to bolster sales. Gardasil revenue in 2009 was $1.1 billion, down from $1.4 billion in 2008 and $1.48 billion in 2007.

Decreasing sales have been attributed to high cost of the vaccine and concerns over side effects after vaccination. Also, some parents’ worry that Gardasil vaccination may suggest to teenagers that premarital sex is okay. Interestingly, while cervical cancer remains a risk among HPV-infected girls and women, a recent study found that only 34 percent of teenage girls ages 13 to 17 received Merck’s Gardasil human papillomavirus vaccine. Finally, sales of Cervarix, a competing HPV vaccine developed by GlaxoSmithKline, are beginning to cut into Gardasil market share.

Until next time...

Good Luck and Good Job Hunting!!!

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The US Food and Drug Administration (FDA) has advised GlaxoSmithKline (GSK) to suspend sale of Rotarix, its rotavirus vaccine, because it may contain porcine circovirus type 1 (PCV-1) DNA sequences. The FDA and the company both found traces of PCV-1 DNA in the vaccine. It is not clear whether whole virus is in the vaccine or just pieces of its DNA. Luckily, PCV-1 isn’t known to cause disease in humans and infants vaccinated with the vaccine are not likely to experience any health or medical issues..

The agency insists that this is a temporary and cautionary suspension of Rotarix sales. FDA officials are advising physicians to use Merck’s RotaTeq rotavirus vaccine instead, which is made using a different method and which shows no evidence of PCV-1 contamination. Merck and GSK have been vigorously competing for market share in the US vaccine marketplace.

Unfortunately, things haven’t been going well for the highly regarded GSK vaccines division in the past few years. First, the company had trouble getting its anti-cervical cancer vaccine, Cervarix approved in the US. And the company just recently announced that it may not seek regulatory approval for Synflorix, a new pneumococcal disease vaccine that was suppose to compete with Pfizer’s  (formerly Wyeth’s) second generation 13-valent pneumococcal vaccine called Prevnar.

This isn’t the first time that animal DNA sequences have been found in human biotechnology products. Last June, Genzyme was forced to shut down one of its biomanufacturing facilities to clean up viral contamination that had been slowing down production of two of its main products, Cerezyme and Fabrazyme. The virus, Vesivirus 2117, is known to interfere with the growth of Chinese hamster ovary (CHO) cells and is believed to have been introduced through a cell culture nutrient. The virus doesn’t infect humans, but the shutdown cost the company millions in revenue and caused shortages of Cerezyme and Fabrazyme.

Because many vaccine and biotechnology products are manufactured in mammalian tissue culture cell lines, detection of non-human viruses these products are neither uncommon nor unprecedented. However, the recent spate of high profile, virally-contaminated vaccines and biologics suggests that biomanufacturers must be more vigilant when it comes to virus removal and microbiological testing from these products.

Until next time…

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

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GlaxoSmithKline (GSK) Britain’s largest pharmaceutical company today announced it plans on slashing 4,000 jobs over the coming months. The bulk of the cuts will be in America and Europe, and are part of the company’s efforts to shift resources away from low-growth territories into parts of the world with greater scope to expand sales, most notably Asia. GSK’s currently employs 99,000 workers worldwide. The reduction in headcount will be combined with a drive to make the company’s research and development more cost-efficient. 

While the job losses will not be as severe as those announced last week by its rival Astra Zeneca, they will provide further depressing news for a sector that is fighting to contain costs as it reduces its reliance on big-selling blockbuster drugs, many of whose patents will expire in the next two to three years.

The pipeline of new drugs at GSK is much deeper than at many of its rivals, say industry analysts. The company’s roster of planned launches includes Menhibrix, a vaccine to combat meningitis, and Benlysta (belimumab), a novel, monoclonal antibody treatment for systemic lupus erythematosus that it is co-developing with Maryland-based, Human Genome Sciences. In total, the group has more than 30 products in the advanced stages of development and testing.

While GSK continues to develop new drugs, it has increasingly been turning to emerging markets to find and sustain corporate growth. This has meant that thousands of jobs have already been sacrificed in the West, although the company is adding staff elsewhere. For example, it recently cut 2,000 sales jobs in America but added 1,500 staff in China. Also, GSK’s vaccine division has suffered a few regulatory setbacks with its pneumococcal vaccine Synflorix and its cervical cancer vaccine Cervarix. The loss of market share in these areas has put additional financial pressure on the company.

Like many of its competitors, GSK is looking to other divisions of the company to cover projected losses in the pharmaceutical sector. Recently, GSK has shifted a lot of its attention to its consumer products division, which owns brands such as Lucozade and Ribena soft drinks, Aquafresh and Sensodyne toothpaste, and over-the-counter medicines such as Panadol painkillers and Alli, a weight-loss pill. Analysts predict the division will have raised its annual sales 18% to £4.7 billion. A deal signed last year to increase sales of Lucozade in China has provided the blueprint for how the company would like to develop the consumer healthcare side of its business.

Similarly, last week, Sanofi-Aventis, a French rival, announced a joint venture with Minsheng Pharmaceutical Group, a Chinese company, to sell vitamin pills and nutritional supplements. Also, Pfizer recently announced it would bid for the possibility of purchasing the financially-troubled German generics manufacturer Ratiopharm; signaling the possibility that the world's largest branded pharmaceutical manager may be toying with the idea of getting into the generics business.

Late last year I predicted that more pharmaceutical company employees would loss their jobs. Sadly, this prediction has come true. That said, I am surprised at the scope and size of the layoffs that have already taken place in 2010. I suspect that more layoffs are likely in the near future if the economy doesn’t turn around anytime soon.

Hat tip to Ed at the Pharmalot blog!

Until next time...

Good Luck and Good Job Hunting (try medical devices or biotech)!!!!!!!!

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While I never was involved in a corporate acquisition or merger, I have many friends who have lived through them and based on their experiences it is a never a “pretty sight.” Merger aftermaths usually feature massive layoffs, executive management disputes and turf wars and corporate culture clashes tha occur when two workforces are forced to merge as one. However, sometimes mergers may be a good thing for struggling companies. To that end, Pfizer may actually benefit from it $68 billion acquisition of Wyeth late last year.

The acquisition will cost at least 20,000 employees their jobs—not a good thing in a national economy where unemployment is well over 10 percent (despite claims to the contrary). However, this merger is strikingly different than Pfizer’s questionable past mergers and acquisitions which were primarily engineered to procure one or two drugs that had blockbuster potential e.g. Lipitor and Celebrex. This time around, Pfizer’s management team is actually re-evaluating its entire drug development portfolio and attempting to expand the company’s pipeline to include vaccines, therapeutic proteins and other biologics. As I previously noted, most major pharmaceutical companies believe that biologics will be the major driver of pharmaceutical markets in the not so distant future.

According to a post on PharmaLive, Pfizer announced that it will discontinue research and development on roughly 100 experimental new drug candidates. Pfizer officials revealed that the company will continue with 500 research projects in six areas of: 1) Alzheimer’s disease, 2) diabetes, 3) pain, 4) cancer and 5) mental illness (including schizophrenia).

Of the 500 projects, 30 drugs are being tested for cancer indications, 10 for Alzheimer’s disease, eight for pain and 11 for inflammation. Further,133 are in various stages of human clinical testing, including several that are awaiting regulatory approval in the US and elsewhere. 

On the biologics front, Pfizer has six vaccines and 27 biopharmaceutical drugs in development. Prior to the Wyeth acquisition, the company only had one vaccine and 16 new biologics that it was testing. Like most other pharmaceutical companies, Pfizer wants to be a major player in the biopharmaceutical and biologics markets by 2015.

Only time will tell!

Until next time,

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

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Flu season is upon us and, not surprisingly, there is no dearth of information available to the public about the seasonal and H1N1 flu vaccines. Mostly there are stories about the lack of availability of the vaccines, underreporting of deaths associated from H1N1 infections and perhaps, most importantly concerns about flu vaccine safety. Despite attempts by the CDC and a few dedicated virologists like BioCrowd co-founder Vincent Racaniello, flu vaccine manufacturing is an enigma to the lay public.

While I am a card-carrying microbiologist, my knowledge of the manufacturing of flu vaccine is admittedly lacking. With this in mind, I came across an outstanding tutorial about flu vaccine manufacturing published by the College of Agriculture at the University of Wisconsin-Madison (my alma mater). The UW tutorial is easy to understand and will shed light on and help to demystify flu vaccine production for lay people (and a few scientists like me).

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There was an interesting article in the New York Times this past week entitled“Do Women Need Such Big Flu Shot.” The gist of the article was that we would have more doses of influenza 2009 H1N1 vaccine if we accounted for the biological differences between the immune responses in men and women follow influenza vaccination (the article cites a study that contends that less vaccine is need to elicit an protective response in women as compared with men.

I was going to write a post about the article but I got distracted and thought I would revisit it when I had more time. Much to my surprise, Vincent Racaniello, a Bio-Crowd founder, virologist extraordinaire and host of the popular TWiV podcast series, had already “scooped” me. Professor Racaniello graciously allowed me to crib his entire post and let BioJobBlog readers decide for themselves whether or not there are real differences in the male and female immune responses to influenza vaccines or the results obtained by the scientists who conducted the study may be explain by strain to strain variation among influenza A isolates? Read Professor Racaniello’s post below and let me know what YOU think!

Do women need the same amount of influenza vaccine as men?

by Vincent Racaniello

“Do Women Need Such Big Flu Shots?” suggests that we would have more doses of influenza 2009 H1N1 vaccine if we accounted for the biological differences between men and women. The idea is that women generate a stronger antibody response than men, and therefore require less vaccine. Does this idea have scientific support?

The opinion is based in part on a study carried out in 2004-05, in which adults were immunized with full (15 micrograms) or half-doses of trivalent inactivated influenza vaccine. This vaccine, made by Aventis Pasteur, contains influenza H3N2, H1N1, and B strains. Serum samples obtained before immunization and 21 days later were assayed for antibody response to each strain of influenza by hemagglutination-inhibtion. I’ve taken the data on geometric mean serum HI titers according to age, sex, and dose and plotted them on a graph:

Based on the results the authors conclude that “Significantly higher geometric mean titer responses in women were identified for all ages, regardless of dose or influenza strain. Half-dose vaccination may be an effective strategy for healthy adults younger than 50 years in the setting of an influenza vaccine shortage.” But are these immune responses protective?

HI titers of 1:40 or more (which would be reported as 40 or higher in the graph) are believed to indicate levels of antibody that would protect against infection with influenza virus. By this criteria, the full and half dose of vaccine would provide protection agains the influenza H3N2 and B viruses in both men and women. The results confirm that females respond more strongly to the same dose of vaccine than men. But look at the results with the H1N1 strain – in all subjects, no matter the dose of vaccine or gender, the antibody response would not be sufficient to protect against infection. Furthermore, the response is only slightly better than in women.

In interpret these observations to mean that the antibody response to inactivated influenza virus vaccine is not universally more robust in women compared with men – it appears to depend on the virus strain. Clearly clinical studies are required to address this question. Even after spending millions of dollars to decide whether to give women less influenza vaccine, a new strain of influenza virus might come along that induces no better antibody response in women than in men.

My conclusion is that it would not be possible to determine conclusively that women could receive half the amount of inactivated influenza virus vaccine as men. I would rather spend money on developing new ways to produce as much influenza vaccine as needed as quickly as possible – such as by making virus-like particles in plants.

Engler RJ, Nelson MR, Klote MM, VanRaden MJ, Huang CY, Cox NJ, Klimov A, Keitel WA, Nichol KL, Carr WW, Treanor JJ, & Walter Reed Health Care System Influenza Vaccine Consortium (2008). Half- vs full-dose trivalent inactivated influenza vaccine (2004-2005): age, dose, and sex effects on immune responses. Archives of internal medicine, 168 (22), 2405-14 PMID: 19064822

 Until next time...

Good Luck and Good Reading!!!!!

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

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

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

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

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

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

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

Until next time...

Good Luck and Good Job Hunting!!!!!

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I regularly watch Real Time with Bill Maher and generally agree with many of the political views and ideas that he espouses. In fact, I am a fan! However, his rant two weeks ago about the H1N1 vaccines, and vaccination in general, showed me that while politically astute and incisive he has absolutely no understanding about science and modern medicine (see video below). Making matters worst, his guest, former conservative senator Bill Frist, a surgeon by training, was ill prepared to correct and refute some of Maher’s outrageous assertions regarding the differences between the two currently available H1N1 vaccines and the basic principles of vaccinology.

Maher is quick to tell people that they are stupid when they don’t agree with his ideas or political views. And, he rightfully criticized George W. Bush for routinely making decisions about important issues based on “his gut feelings” rather than facts. Ironically, this is exactly what Bill Maher does when he talks to his guests about medicine and food. Maher, who may be a vegetarian and is clearly anti-traditional medicine,  is quick to point out that Westernized medicine and food production is profit driven and consequently, any information or advice offered by the US government is little more than a ploy to keep people sick and fat. In other words, don’t trust anything that the government tells you if you believe otherwise or you heard it from a celebrity. 

I suspect that science wasn’t Bill’s “cup of tea” (he frequently calls the tea baggers who don’t trust anything that the Obama administration tells them idiots and morons) and may have never taken anything he learned about science seriously. If he had, he might have learned how vaccines work and realized that modern vaccines (the first vaccines were produced in the 1780s) protect over 95% of people who receive them from devastating childhood diseases and even cervical cancer. Instead, he cites bogus and scientifically refuted claims about vaccine safety including mercury poisoning, links to autism and the miniscule possibility of developing Guerin-Barr Syndrome (which was first observed in large number of patients following vaccination with the 1976 Swine Flu vaccine). Shockingly, despite incontrovertible evidence to the contrary he continues to spew misinformation and flat-out wrong claims about vaccines. Ironically, his wrong-headed vaccine tirades are remarkably similar to those of the Birthers —people who refuse to believe that President Obama is an American despite incontrovertible evidence to the contrary—and racists who contend that Obama is a Muslim—two groups that he is quick to bash and dismiss as crazies and morons. In other words, Maher believes that he is right even though he is clearly misinformed or wrong!

Originally, I was going to write this post after Maher’s “Real Time” tirade about vaccines almost two weeks ago on Real Time. However, I relented but couldn’t help myself after reading an article in today’s Scientist Times about a pregnant woman who lost her second child after she contracted the flu. As many of you may know, pregnant women are very susceptible to influenza which could have serous consequences for the mother and baby. This is an exchange the woman had with a physical therapist with whom she was working to regain muscle control after being hospitalized (and near death) for almost 4 months:

“Have you ever read the labels?” she (the physical therapist asked). “They’re so full of toxins.”

Asked if she realized that a shot, had it existed in June, might have saved her client and her baby, she frowned and went back to her clipboard.

Are you kidding me—full of toxins? This is exactly what Maher was trying to imply during his anti-vaccine rant on Real Time. Unfortunately, millions of people listen to him and celebrities like Oprah, Dr. Phil and Maher and many believe (and blindly follow) their recommendations and advice. While this may not be a problem when talking about hair color, books to read or weight loss it is extremely troubling and dangerous when it comes to scientific and medical advice. The problem is that a vast majority of Americans are scientifically illiterate and are either incapable or unwilling to analyze and evaluate scientific or medical information on their own. This forces many people to rely on the Internet, government agencies and sometimes healthcare professionals to do their medical and scientific thinking for them. And when things go wrong, or not as advertised, they are quick to accuse the government or the healthcare industry of withholding information and engaging in nefarious conspiracies. This is exacerbated by the fact that science and medical reporting in the US is grossly inadequate, often wrong and frequently designed to be as sensationalistic as possible. Is it any wonder why the American public is often confused and misinformed about science and medicine?

My scientific training has taught me to analyze and evaluate all available data before I draw any conclusions on a topic. And, as an infectious disease expert I believe that childhood vaccines are unequivocally safe and effective. To that end, they have substantially reduced the morbidity and mortality associated with mumps, measles, diphtheria, whooping cough, pneumonia, tetanus, almost eradicated polio and eliminated smallpox from the planet. There is no doubt that there are risks associated with vaccination and that a small number of those vaccinated may experience some side effects or serious adverse events. But, the small risks associated with modern vaccines don’t outweigh the benefits and positive effects on billions of people who may have lost their lives if they hadn’t been developed in the first place. I wonder whether or not an anti-vaccine movement would exist today if smallpox and polio were still causing as much death, disfigurement and paralysis as they had prior to development of the smallpox and polio vaccines in the mid 20^th century.

In closing, as an American, I believe that everybody is entitled to their opinions and the right to freely express them. However, I implore Bill Maher get the FACTS right before summarily bashing a topic and making recommendations to the millions of people who watch Real Time and believe what he says. Otherwise, he is no smarter or better than the ignorant, close-minded, right wingers who he regularly trashes on his show.

Until next time...

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

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

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

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

Until next time...

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

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The Belgian chemical manufacturer Solvay announced today that it had agreed to sell its pharmaceutical business unit to Abbott Pharmaceuticals for $6.6 billion. By purchasing Solvay, Abbott gains access to emerging markets in Eastern Europe and Asia along with new therapeutic areas, including hormone therapies and vaccines. Solvay's flu vaccine Influvac will give Abbott an entrant in the burgeoning vaccines market, which is currently dominated by European pharmaceutical giants like GlaxoSmithKline and Novartis.

Abbott already holds U.S. marketing rights for Solvay's Trilipix and TriCor, drugs which raise "good" HDL cholesterol while reducing triglycerides and "bad" LDL cholesterol.

Solvay's other top-selling drugs include the Parkinson's disease treatment Duodopa and hormone therapy drugs AndroGel and Duphaston. It is not clear whether or not the Solvay purchase will affect ongoing pharmaceutical operations or staffing decision in the US. However, I suspect that there will be management changes and layoffs in Europe.

In other news, Johnson & Johnson bought an 18 percent stake in Dutch biotechnology company Crucell NV, which is trying to develop a universal flu vaccine, while competitor Merck acquired the rights to sell Australia-based CSL Ltd.'s Afluria flu vaccine in the U.S.

The Solvay deal is the latest in a string of mergers and acquisitions, as cash-rich pharmaceutical companies race to acquire new products amid looming patent expiry on blockbuster drugs. Earlier this year Swiss drugmaker Roche acquired Genentech following similar deals uniting Pfizer Inc. and Wyeth, and Merck & Co. Inc. with Schering-Plough.

Expect more M&A activity in the life sciences sector before year’s end.

Until next time...

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

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

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

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

Until next time...

Good Luck and Good Networking @ BioCrowd!

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Yesterday, Sanofi-aventis (S-A) agreed to acquire a controlling stake in Indian vaccine maker, Shantha Biotechnics, for an undisclosed amount. And, recently, Abbott announced a definitive agreement to acquire the nutrition businesses of Wockhardt Limited, Carol Info Services Limited, and certain Wockhardt subsidiaries and group companies for consideration totaling approximately US$130 million in cash.

While these two recent acquisitions don’t appear to be particularly noteworthy, they speak volumes about growing Indian influence in biologics and, perhaps more importantly, in biosimilars. India, long known for its expertise in generic drug development and its ability to work with US-based companies, has expanded beyond generic pharmaceuticals into generic biologics aka biosimilars. Biosimilars have been on the Indian market for over a decade and by all accounts several Indian companies, most notably BioCon, might be able to steal biosimilar market share in Asia from the likes of Sandoz, Merck and Teva—companies expected to be major players in the emerging biosimilar market.

Both Shantha and Wockhardt possess substantial experience in biosimilar development and commercialization. To that end, Sanofi-aventis has publicly announced its desire to get into biotechnology and Abbot must expand its biotechnology pipeline beyond Humira to remain competitive. These acquisitions likely represent Sanofi’s and Abbott’s attempt to gain a foothold in the emerging Asian markets. Also, it gives both companies access to lower cost biologics R&D and manufacturing capabilities.

It will be interesting to see how things unfold over the next year or so!

Until next time...

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

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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 Pharmalot blog reported today that Merck received approval from the US Food and Drug Administration to use Gardasil to prevent vaginal and vulval cancer in addition to cervical cancer.

Of late, Gardasil has been a lightening rod for controversy—mostly because of Merck’s unrelenting marketing campaigns (and the behind-the-scenes lobbying for the vaccine to be placed on the US mandatory vaccination list)  coupled with the Christian right’s moral machinations about premarital sex and sexually transmitted diseases in general. Also, let’s not forget the brouhaha surrounding FDA’s decision to delay approval of GlaxoSmithKline’s competing cervical cancer vaccine called Cervarix. Finally, about a month ago, there was study published in the New England Journal of Medicine questioning the cost effectiveness of Gardasil vaccination of women after the age of 18.

Regardless of your moral, ethical or business concerns about Gardasil, the bottom line is this: girls/women vaccinated with Gardasil are much less likely to develop cervical cancer as compared with those who are not vaccinated.

As I have mentioned before, all approved and marketed drugs have side effects and possible safety/tolerability issues. More importantly, the decision to approve a particular drug is always based on a careful risks/benefits assessment by government healthcare regulators. Whether or not a person uses a drug or vaccine is ultimately a personal choice. With the exception of mandatory childhood vaccines (children can be exempted for moral or religious reasons), every American has the right to decide whether or not to use a medication or undergo a treatment recommend by a healthcare professional. Based on everything that I have read about Gardasil, it appears to be a safe and effective vaccine to prevent cervical cancer. When FDA finally approves Cervarix (probably sometime in late 2009), it will offer women who may have concerns about Gardasil with an alternate vaccine to protect them against developing cervical cancer.

The funny thing about the Gardasil firestorm is that cervical cancer isn’t a major healthcare problem in the US. This is because a majority of American women undergo annual routine gynecological examinations (that include pap smears, the current gold standard for cervical cancer detection). In contrast, cervical cancer is a major healthcare problem and economic concern in Asia, most notably in China and India. This begs the question—why are Merck and GSK so intent on selling their cervical cancer vaccines in the US? Put simply, there is still much more money to be made in the US than in Asia. Look for approval of Gardasil and Cervarix in China and India when the middle class of both countries reach a critical mass.

Until next time…

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

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Novartis announced today that it will open a new research facility and hire an additional 150 people by the end of 2009 for a Research Center of Excellence in Virology in Cambridge, MA. That will increase the number of people employed by the company in Cambridge to more than 1,800 workers. Researchers at the new center will study vaccines for HIV/AIDS influenza, cytomegalovirus (CMV) and respiratory syncitial virus (RSV). 

The vaccine business once avoided like the plague by most pharma companies, has been growing by leaps and bound over the past five years and is sizzling hot these days. According to analysts, vaccines generated about $16 billion dollars last year. For example, Merck’s anti-human papilloma virus vaccine Gardasil generated $1.5 billion in sales in 2007.

Novartis clearly sees an upside in the vaccine business and is willing to make a wise investment for the future.

Until next time….

Good Luck and Good Job Hunting!!!!!

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Earlier this week, Roche announced that it wanted to buy the remaining portion of Genentech that it doesn’t already own. On Friday, one of Europe’s largest pharmaceutical companies, Sanofi-Aventis, announced that it was buying the UK-based vaccine manufacturer Acambis for $547 billion.

Like Roche and Genentech, Sanofi-Aventis was already partnered with Acambis and by purchasing Acambis, Sanofi gains a smallpox vaccine that was contracted by the US government for $425 million. Sanofi is the world’s largest manufacturer of influenza vaccines and last month announced plans to open a $157 million manufacturing facility in France, citing projections that demand for vaccines will double by 2016. In case you didn’t know, vaccines, once the scourge of the pharmaceutical industry, are now the hottest”pharmaceutical” products on the market!

Because of growing demand and lucrative margins for biologics and biotechnology products, many big pharma companies are attempting (through acquisitions and mergers) to quickly enter the biologics and biotechnology markets. These days, small molecules are passé and biotech is the next big thing (where have all the pharma execs been for the past 20 years).  

Europe has long wanted to dominate the biotechnology market. This has not been possible because of the US’s large lead in the space. However, all this can change because of a weak dollar and a surging Euro! Rather than attempt to create their own biotechnology companies, large cash-rich, European pharma companies can simply buy profitable US biotechnology companies with strong product pipelines.

I suspect that the weak dollar and failing US economy contributed to Roche’s decision to buy Genentech and Teva to buy Barr Pharmaceuticals last week. I would not be surprised if there are more acquisitions of American biotechnology and pharma companies in the very near future. I think that it may be time for Amgen and Bristol-Myers Squibb employees to begin to brush up on their French or German.

Until next time….

Good Luck and Good Job Hunting (in Europe)!!!!!!!!

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