The Other Shoe Has Finally Dropped: Merck to Eliminate 8,500 Jobs

Posted in BioBusiness, BioJobBuzz

After Merck rehired Roger Perlmutter to replace Peter Kim as head of R&D (he left Merck about 10 years ago to lead Amgen R&D), it was pretty obvious that reorganization and job cuts were likely. However, it was not clear, until today, how extensive the cuts would be and what exactly what would be changing at Merck.

Today, Merck revealed plans to eliminate about 8,500 jobs–mainly in R&D, marketing and sales–in an attempt to save $2.5 billion by the end of 2015. In addition to the job cuts, R&D focus will be shifting and Merck’s headquarters will be relocated again (it was moved from Whitehouse Station to Summit several years ago) to Kenilworth, NJ (the former headquarters of Schering Plough which Merck purchased for roughly $41 billion in 2009)

According to a post at the Pharmalot Blog, while it is not exactly clear where the job cuts will take place, most industry insiders expect that the majority of them will likely take place in NJ.  The shift in R&D focus is intended to emphasize oncology, diabetes, acute hospital care, vaccines, oncology and a greater effort in biologics. Further the company intends to either license or discontinue research on “selected late-stage compounds” and reduce its investment in “platform technologies.”

Once one of America’s preeminent pharmaceutical companies, Merck has stumbled over the past decade (with the Vioxx scandal and the Vytorin and Zetia controversies) and it continues to struggle with regulatory approval of some of its new medicines. Perlmutter was hired to transform R&D and bring his expertise in oncology to bear at Merck.

Time will tell.

Until next time…

Good Luck and Good Job Hunting!!!!!

Chlamydia Infections Are Ravaging Australia’s Koala Population

Posted in BioEducation

When most people think about Australia kangaroos and koalas (the word bear is a misnomer) immediately come to mind. While the kangaroo population is thriving and, in many places, rapidly growing out of control, Australia’s treasured koala population is being ravaged by Chlamydophila pecorum, a little known, obligate, intracellular bacterial pathogen related to Chlamydia trachomatis which can cause urethritis, pelvic inflammatory disease, conjunctivitis and pneumonia in humans. C .pecorum can infect goats, koalas, sheep, swine and cattle but it is not transmissible to humans. However, C. trachomatis can infect koalas and small percentage of koala infections in the outbreak have been found to be caused by this bacterium.

Surveys conducted in Queensland, a very large state in Australia’s northeastern corner that climatically is similar to Florida and home to large numbers of koalas; suggest that from 2001 to 2008, the size of the koala population dropped roughly 45 percent in urban areas and by about 15 percent in the bush. While climate change and habitat loss due to urban expansion has contributed to the decline in koala numbers, government officials believe that C. pecorum are hastening the koala demise. Recent reports suggest that almost 50 percent of Queensland koalas are infected with C. pecorum. As is the case with C. trachomatis infections in humans, infected animals frequently do not display symptoms making its spread even more insidious. Also, like C. trachomatis, transmission of C. pecorum mainly occurs via sexual contact during mating.

Like human infections, chlamydiae can cause a host of symptoms in infected koalas including eye infections (which can often lead to blindness and an inability to forage for increasingly scare eucalyptus leaves, their primary food source), respiratory infections and pneumonia and infertility among female koalas. To make matters worse, almost all of Queensland koalas are infected with a retrovirus similar to HIV which compromises their immunes systems (like HIV/AIDS) and makes them more susceptible to chlamydiae infection.

At present there are no good treatments to combat the spread of C. pecorum in the koala population. While Australian researchers are working feverishly to develop a vaccine, it is not clear whether or not they will succeed. Historically, it has been very difficult to develop effective vaccines against bacterial intracellular pathogens.

Despite the rapidly declining koala population through Australia, late last week, the Australian government delayed a decision to place the koala on the country’s endangered species list! Recent reports suggest that there may be as few as 43,000 koalas in Australia. If Australian officials don’t do something quickly they may be at risk of losing an iconic figure that defines Australia for the rest of the world. 

With this in mind, I think that everyone ought to consider joining the global “Save the Koala” campaign! After all, who doesn’t love koalas?

Until next time…

Good Luck and Save the Koala!

 

Sanofi Invests $300 Million in a Vaccine Manufacturing Facility in India

Posted in BioBusiness

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!)

 

Penn and Teller: Why Childhood Vaccinations Make Sense and Maintain Public Health

Posted in BioEducation

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!!!!!!

 

Why Store the Smallpox Virus?

Posted in BioEducation

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!!!

WikiLeaks, Pharma Manufacturing and US National Security

Posted in Social Media

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)

 

BioEducation: Vaccines, Drugs and Risk

Posted in BioEducation

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!!!!!!!

 

Are You Kidding Me?? New Jersey Childhood Vaccination Rates Are Among the Lowest in the US

Posted in Career Advice

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—45th 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!!!!!!!!!

 

Another Setback for Merck

Posted in BioBusiness

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!!!

 

FDA Asks GlaxoSmithKline to Suspend Sale of Its Rotavirus Vaccine

Posted in BioBusiness

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!!!!!!