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While studying the pathogenesis of Neisseria gonorrhoeae in Portland, OR in the early 1980s, genital herpes had replace gonorrhea as the scourge of the sexually transmitted disease community. To help to combat the spread of genital herpes, my labmates and I joined the Portland Venereal Disease Action Committee, a grass roots organization that provided public outreach and education about sexually transmitted diseases (STDs). A few years later, the Regan Administration finally admitted to the American public that HIV/AIDS was real and that HIV infections were likely to reach epidemic proportions. While genital herpes can be painful, uncomfortable and often emotionally debilitating, the unprecedented morbidity and mortality of HIV/AIDS almost pushed genital herpes into infectious diseases obscurity. Now that HIV/AIDS is more treatable than ever before, epidemiologists and sexually transmitted diseases experts have begun to reexamine the infection rates and incidence of other STDs (including herpes, gonorrhea, Chlamydia and syphilis) among Americans. To that end, I read today a very troubling article about the infection rates and incidence of genital herpes among sexually active Americans. Here are some of the facts gleaned from a recent CDC report on genital herpes:

1. One in six Americans aged 14 to 49 are infected with genital herpes, making the virus — herpes simplex 2 — one of the most common sexually transmitted diseases in the United States
2. Research shows that people with genital herpes are two to three times as likely to acquire H.I.V. as those without herpes
3. H.I.V.-infected individuals also infected with genital herpes are more likely to transmit H.I.V. to others
4. Infection rates for women are almost twice the rate of men
5. Blacks are three times as likely to be infected as whites
6. Black women have the highest rates of infection, with almost half infected

Looking back, it is understandable why HIV/AIDS took precedent over genital herpes infections. After all, most people usually don’t die from genital herpes. However, the rising infection rates of the disease suggest that the American public needs to be better educated the spread and prevention of genital herpes infections. There is no question that discussions about STDs are embarrassing and often difficult. However, these days, they can be the difference between live and death!

Until next time…

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

 

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I was introduced to single malt Scotch whisky about six years ago after my in-laws returned from a distillery tour of Scotland. Never a scotch drinker, after sampling a variety of brands, I decided that Islay single malts, most notably Lagavulin and Caol Ila, were my favorites. Over the past few years, several of my friends and I have been searching for the ultimate single malt.I thought that the Macallan 30 year old that my father-in-law received for his 90th birthday was pretty special.

Imagine my surprise after learning that a team of New Zealand scientists recovered five crates of 100 year old Mackinlay’s whisky from the ice below an Antarctic hut once used by the famed polar explorer Ernest Shackleton. While Mackinlay is a blend whisky and not a single malt, its age alone is extraordinary and impressive! Although some of the bottles had cracked because of the ice, the team who found them - restorers working on the hut - said they were sure the crates contained intact bottles "given liquid can be heard when the crates are moved".

Whyte & Mackay, which owns the McKinlay brand and supplied the whisky for Shackleton, launched the bid to recover the bottles for samples to test and decide whether to relaunch the defunct spirit. The drinks group's master blender Richard Paterson described the find as "a gift from the heavens for whisky lovers". He added,

"If the contents can be confirmed, safely extracted and analyzed, the original blend may be able to be replicated"

"Given the original recipe no longer exists, this may open a door into history."

Shackleton's expedition ran short of supplies on its long ski trek to the South Pole from the northern Antarctic coast in 1907-1909 and turned back about 100 miles short of its goal.

His loss—our gain!

 

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There was a very disturbing article on the front page of today’s New York Time about an increasingly popular practice of debarking dogs by people who live in urban areas like New York City. Debarking is accomplished by severing a dog’s vocal cords. The practice may be more widespread than reported because of nuisance pet policies imposed on apartment owners by co-op boards in the city. According to the article, the surgery usually leaves the animal with something between a wheeze and a squeak in lieu of a bark.               

While I am not a card carrying animal rights activist and find excessive barking annoy, I am a dog owner and a biologist who strongly believes in evolution. And, as far as I am concerned, if dogs weren’t meant to bark they wouldn’t! Taking away a dog’s only means of verbal communication (one of my dogs “whines” when she needs to go out and the doggy door is shut) is, in my opinion, detrimental to a dog’s physical and behavioral well being. As one animal behaviorist said in the article:

“Dogs are usually barking because of some frustration. It’s frustrating to be a sheepdog with no sheep. What I’d be concerned about is, if you are debarking a dog and it has an underlying happiness.”

Proponents of the procedure say that it is a harmless procedure and dogs that have been debarked don’t act any differently than they did before the operation. Luckily, many younger veterinarians have deemed that the surgery unnecessary and unethical and refuse to perform it.

My first experience with debarking was after I inadvertently purchased my two dogs from the daughter of a notorious and nefarious New Jersey-based puppy mill breeder. I learned that it is not uncommon among puppy mill owners, to silence their dogs to prevent detection by authorities by shoving metal rebar down their throats. The repeated assaults on a dog’s vocal cords caused scarring and sometimes rupture which, in turn, renders the animal unable to bark. Imagine my outrage when I read that some veterinarians knowingly and willingly perform this surgery because pet owners requested that it be done!

I think the practice of debarking is repugnant, reprehensible and not justified in any circumstances. If your dark has a barking problem, hire an animal behaviorist or call Cesar Milan, aka the Dog Whisperer. It is likely there is an underlying behavioral problem or cause of the problem that can be fixed by behavior modification or pharmacological interventions. Debarking surgery is a convenient and facile solution for pet owners who say they love their dogs but are unwilling to spend the time and effort required to solve the problems. 

In conclusion, if dogs weren’t meant to bark then they would not have when they first appeared on the planet!!!

Until next time...

Good Luck and Don't Forget to Hug Your Puppy Today!!!!

 

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When I first started writing BioJobBlog back in 2007, I didn’t see any reason to hide my identity. However, as many inexperienced and naive bloggers ultimately learn, whatever you say can and will be used against you at some point. To that end, I was contacted by two lawyers during my first year of operation and decided to go uncover so that I could continue to work in the life sciences industry.

Over the past two years, I believe that I have become less inflammatory, vitriolic and pedantic and matured as a writer to the point where I don’t have to worry as much about getting fired or sued as I have in the past. Also, it helps that I am gainfully employed as a freelance writer and the people who pay me know that I write BioJobBlog (and probably don't read it)! Finally, and perhaps most importantly, marketing and SEO experts have repeatedly told me that anonymously-penned blogs have substantially less traffic then blogs where the author is identified and assumes responsibility for what he/she says (not that I am trying to increase traffic to my blog or anything)

I am sure many of you have been losing sleep at night trying to figure out who I am. Of course, people who have been reading BioJobBlog from the beginning (thank you loyal readers) already know my true identity (mainly because I told you who I was). But, for those of you who don’t and desperately need to know please click here.

Once you find out who I am, it may explain things....or not!

Until next time,

Good Luck and Good Reading !!!!!!!

 

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As many BioJobBlog readers may know by now, my PhD thesis focused on elucidating the underlying pathogenic mechanisms that contributed to the pathogenesis of Salmonella gastroenteritis. Salmonella gastroenteritis, which is primarily a food-borne illness, occurs in approximately 1.4 million Americans each year. Most people who develop Salmonella gastroenteritis recover without treatment within four to seven days. However, some people develop diarrhea so severe they are hospitalized and can become critically ill. According to a former lab mate, who accidentally infected himself, Salmonella gastroenteritis is much worse than the mild form of the disease described in many microbiology textbooks!

While I haven’t performed any research in this field for about 30 years, I still consider myself to be a Salmonella expert (go figure). Therefore, it should come as no surprise that a newspaper article entitled “Salmonella outbreak linked to pet frogs”— that appeared in the Salt Lake Tribune several weeks ago—caught my eye.

According to the article, a 31-state Salmonella outbreak (which was first detected in Utah was linked to pet frogs. The U.S. Centers for Disease Control and Prevention (CDC) in Atlanta started a national investigation to find the source of the outbreak this past summer, after five Utahans were infected by the strain of S. typhimurium a common cause of gastroenteritis (I knew getting a PhD would useful one day). In all, 85 people across several states developed gastroenteritis and nearly two-thirds had had some contact with frogs. Most of the patients were children and among those whose outcomes are known, almost a third required hospitalization. None died.

The source of the outbreak was eventually linked back to a single frog breeder in California that distributed the African dwarf frogs thought to be responsible for the multi-state outbreak. According to CDC officials, the bacteria were likely spread through contact with the tanks' water, not the frogs themselves. Of those who supplied information to the CDC, 30 percent said they cleaned the frog's aquarium in the kitchen sink and 35 percent used the bathroom basin.

While this last bit of information wasn’t remarkable, I finally—after almost 30 years as card carrying microbiologist—realized how the urban legend about Salmonella and turtles got started! Like many kids, I had a pet turtle. I remember my parents cautioning me about handling the turtle because I would get sick (of course I handled the turtle and never got sick). Later on, as a microbiology undergraduate student, I learned about the relationship between Salmonella and turtles and that turtle had been associated with Salmonella gastroenteritis outbreaks in the past. An interesting but inconsequential fact because I no longer owned a pet turtle.

Early on as a graduate student, I learned that it takes a minimum of about 10⁸ salmonellae to cause gastroenteritis. At the time, I wasn’t thinking much about turtles and failed to realize that the large dose required for infection pretty much ruled out the likelihood that picking up a turtle would almost certainly result in Salmonella gastroenteritis. Although reptiles and amphibians harbor Salmonella in their gastrointestinal tracts, a child would have to suck on an infected turtle (or eat its poop) to get a large enough inoculum to initiate an infection—now this is where the PhD training become evident. However, if parents clean their children’s infected tanks in kitchen or bathroom sinks and then fail to wash their hands or the sinks with disinfectant, the number of salmonellae present in these environments would be sufficient to cause disease if infected food or water was ingested. And, this is what likely happened in the frog outbreak; based on the epidemiological data presented by CDC investigators

So, what is the lesson of this story? While it is true that turtles and frogs may carry Salmonella (in a separate study 21 percent of frogs from 16 retailers tested positive) the likelihood of developing gastroenteritis after touching or briefly handling frogs or turtles is extremely low. However, it is not a good idea to handle them for long periods of time without washing your hands before your next meal or cleaning their tanks in areas where food is prepared or people brush their teeth! Food borne illnesses are easy to prevent if appropriate personal hygiene is practiced and foods are prepared and cooked according to recommended standards. 

Finally, it took a long time, but I can now feel comfortable around turtles. This is probably a good thing—my friend Pete is a turtle fanatic and he constantly wants me to pick up his pets!

Until next time...

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

 

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At long last, marijuana for medical use is legal in New Jersey. As one of his more courageous acts while in office, outgoing Governor John Corzine signed the act into law late yesterday making New Jersey the fourteenth state to legalize medical pot. Four more states and the District of Columbia are expected to follow suit by year's end.

Many things are driving this sea change. The federal government last year announced that it would no longer prosecute medical marijuana smokers in states where it is legal, while the National Institutes of Health has begun funding research on medicinal use in a reversal of a long-standing policy.

Gallup Polls show a solid majority of Americans sympathetic to therapeutic marijuana use.

Unlike California's medical marijuana law which allows the use, possession, and cultivation of marijuana by anyone who possess a "written or oral recommendation" from their physician that he or she "would benefit from medical marijuana," New Jersey's version requires patient identification cards and state-monitored dispensaries -- easing fears that medical use will fuel illegal sales and teenage substance abuse.

While cannabis preparations have been used to relieve nausea and pain since ancient times, research involving medical uses of marijuana was under funded and in many instances discouraged according to an article in today’s New York Times. But over the last 15 years, research on the body's cannabinoid receptors has begun to decipher the chemistry and biology of the positive effects of cannabinoids especially in the areas of glaucoma and chemotherapy induced nausea and vomiting experienced by patients being treated for cancer. More recently, clinical trials have shown that these benefits outweigh the concerns about addiction, heart and respiratory diseases, cancers, and psychoses -- at least, with short-term use.

Marinol, a synthetic cannabinoid pill, is approved by the Food and Drug Administration for treating AIDS-related wasting and chemotherapy-related nausea. But many patients say choking down a slow-acting pill simply doesn't provide the convenient and immediate relief of inhaling marijuana smoke. A new drug, Sativex, made by GW Pharmaceuticals, may renew the debate. A cannabinoid-based oral spray, Sativex is approved in Canada for treating pain in multiple sclerosis and advanced cancer. The company is now completing the clinical testing needed for approval in Europe and the United States.

While I don’t endorse or use illegal drugs (any more), there is no question that medical marijuana helps patients deal with chronic and, in some instances, severely debilitating conditions that impact the overall quality of their lives. I have long contended that just because a substance is deemed illegal it doesn’t negate potential medically-beneficial properties. An example of legal drugs that don’t have any therapeutic benefits and cause much more morbidity and mortality than marijuana are cigarettes and alcohol. Need I say more?

All I gotta say is that we have come a long way since I saw the film Refer Madness while growing up and coming of age in the late 60s. For those of you who haven’t seen the film it is funny whether you are straight or high! object width="445" height="364">

 

 

 

 

I guess the nation—well NJ anyway—is finally going to pot!

Until next time...

Good Luck and Good Toking (only for medicinal purposes of course)!!!!!!!!!!!

 

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Ed Silverman, over at the newly reinvigorated Pharmalot Blog, today reported that a recent study publicized in the Journal of the American Medical Association showed that, after a decade of doubling, the rate of increase in biomedical research funding slowed from 2003 to 2007, and after adjusted for inflation, the absolute level of funding from the National Institutes of Health and industry appears to have decreased by 2 percent. The NIH remains the largest federal contributor to biomedicalresearch, accounting for 84% of total federal funding in 2007 

Further, the report indicated that research funding provided by pharmaceutical and biotechnology companies and medical devices and diagnostics manufacturers rose from $40 billion in 2003 to $58.6 billion in 2007; an increase (adjusted for inflation) of roughly 25 percent. Most of the funding came from large pharmaceutical companies. Interestingly, however, the sector of the life sciences industry that exhibited the greatest increase in growth over the same period was diagnostic and device makers (59 percent), followed by biotechnology (41 per cent) and lastly, pharmaceutical companies (25 per cent).

While the results of the study are not surprising, it is clear that the life science sector is beginning to focus more on device and diagnostics than on small molecules and even biotechnology products. Further, reductions in federal funding are forcing researchers to increasingly rely on grants and contracts from private sector companies. This suggests that an ever expanding percentage of the research conducted at many academic institutions will be financed and underwritten by for profit companies. Although more product-focused academic research is not necessarily a bad idea, it does call into question the direction and possible breadth of academic research and the availability and sharing of important scientific information, data sets and discoveries. 

Until next time...

Good Luck and Good Grant Writing!!!!!!!!!

 

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Over the past two years, I have been blogging about the progress of sequencing the giant panda genome. Well, for those of you who have been following the unfolding story, I want to let you know that the giant panda genome was published in the December 13, 2009 edition of the journal Nature. The sequence is now immortalized in the scientific literature (see the story below)

An international consortium, headed by the Beijing Genomics Institute (BGI), published its first report on the sequencing and analysis of the giant panda genome. Researchers at BGI sequenced a draft of the Ailuropoda melanoleura genome in Oct. 2008, but the new report is the first publication of their sequencing efforts and initial analyses. The panda is the first bear to have been sequenced.

Using the Illumina Genome Analyzer and a whole genome shotgun approach, the team examined the 2.4 billion kb of a three-year-old female panda, Jingjing, from the Chengdu breeding center. To verify sequence assembly, the researchers used Sanger sequencing of nine artificial bacterial chromosomes. To date, the team has analyzed 2.25 billion base pairs, representing 94% of the bear’s entire genome. The observed sequence gaps are likely a result of the tandem repeats and transposable elements.

The panda genome had more than 2500 species-specific genes, and according to the report, 36% of the genome is composed of transposable elements similar to the dog genome. The researchers said that the giant panda genome consists of 21,001 genes, including 18,643 orthologous to those in dogs, mice, and humans.
The team discovered 26 of the 27 giant panda genes catalogued in the National Institutes of Health (NIH) GenBank. The gene they did not detect is present only on the Y chromosome and was expectedly absent in the female panda.

The team’s initial analysis of the giant panda genome has provided insights in the giant panda’s diet preferences and genetic diversity. The researchers hope their study may aid in conservation efforts of the giant panda.

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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It is amazing the things you learn if you pay attention from time to time.  While attending a meeting on e-healthcare last week in Philadelphia I learned that according to the American public the pharmaceutical industry is less popular than the banking industry. This was startling to me given that the recent financial collapse was caused almost entirely by the banking industry.  That the pharmaceutical industry is more reviled than the banking industry suggests that life sciences company have a bit of PR work to do.  But, not to worry, people still hate the oil industry more than the pharmaceutical industry.

On another note, the US FDA decided to raise the cost of regulatory filings for fiscal year 2010.  The cost of filing an application with clinical data is $1.4 million (up from $ 1.2 million in FY 2009); $702, 750 for an application not requiring clinical data or a supplement requiring clinical data (up from $623,600 in 2009) and 457,200 as compared with $425,000 in FY 2009 for an establishment fee (for facilities where drugs are made).* 

I guess the agency figures that pharma can handle the increases despite poor public image and an ongoing recession.

* AAPS News Magazine, Oct-Nov '09

Until next time...

Good Luck and Good Job Hunting

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Yesterday, after giving a talk on social media to a great NYC-based PR firm called Ricochet,I decided to take an uptown trip to visit Professor Vincent Racaniello at Columbia University Medical School to talk about the new applications that we plan to introduce to BioCrowd.

When I arrived at Professor Racaniello’s office, which has an outstanding view of the Hudson River and George Washington Bridge, he was in the middle of taping this week’s This Week in Virology (TWiV) podcast with co-hosts Dick Despommier and Alan Dove. Much to my surprise, Vincent invited me to join the conversation although I am a bacteriologist not a virologist. The podcast was devoted mainly to answering questions that listeners had submitted to the show. One listener alerted us to a post at Newsweek Online entitled “Fight Flu and Falsehoods” while we didn’t agree with the author’s assertion that “that hand washing doesn’t affect the transmissibility of influenza”—it does reduce infections rates of other viruses, bacteria and parasites, so it is a good idea to continue to wash your hands—accompanying the article was an outstanding online quiz that assesses how much you really know about influenza and other viruses. 

I think it would be fun for BioJobBlog readers to take the quiz, report scores and then tabulate the results.

To take the quiz, click here and to report your score click here!  I will tabulate the results and share them in a later post if enough BioJobBlog readers and their friends take!

Until next time

Good Luck and More Luck On the Quiz!!!

 

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Last week, in a post about the antibacterial properties of cinnamon oil, I mentioned a concoction consisting of cinnamon bark, lemon oil and eucalyptus called “thieves oil” that was used by grave robbers in the Middle Ages to prevent bacterial infections from routinely handling dead bodies. Interestingly, my local New York NBC affiliate filmed a video with an infectious disease physician who demonstrates how to make and use thieves oil. 

Check it out!

 

Until next time....

Good Luck and Remember to wash your hands!!!!

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There are many natural products from animals, plants, fungi and bacteria that possess antibacterial properties. This makes complete sense from an evolutionary standpoint. Therefore, it should comes as no surprise that spices like cinnamon and natural products like honey possess inherent antibacterial properties. Nevertheless, despite my over 30 years as a card-carrying bacteriologist, I always pleased and pleasantly surprised when I learn that a common substance like cinnamon oil has potent antibacterial activity against antibiotic-resistant bacterial pathogens.

A recent study showed that a cinnamon oil solution was capable of killing a variety of nosocomial bacterial pathogens including Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus (MRSA). Moreover, the cinnamon oil appeared to be as effective as several antiseptics and disinfectants widely used in many hospitals. And, this isn’t the first report on the antibacterial effects of cinnamon oil. In a 2008 study, French researchers showed cinnamon oil solutions of 10% or less were effective against S. aureus, Escherichia coli and several antibiotic resistant strains of bacteria.  Further, there is a precedent for the use of cinnamon-derived products as an antiseptic. In the Middle Ages thieves who stole jewelry from dead bodies and used “thieves oil”—a concoction consisting of cinnamon bark, lemon oil and eucalyptus—rarely got ill. Finally, cinnamon oil when topically applied to the skin is generally safe. However, in some people it can cause an allergic reaction.

This is good news for a country that has grown increasingly obsessed with chemically-based antibacterial soaps and sanitizers whose overuse may actually be selecting for the emergence of strains of multiple antibiotic resistant bacteria. Nevertheless, the use of natural antiseptics like cinnamon and other plant oils as sanitizers may help to reduce the growing incidence of  drug resistance among nosocomial bacterial pathogens.

Until next time....

Good Luck and Remember to Wash Your Hands (with plain soap, not antibacterial-containing products!)

 

 

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Since the beginning of the pandemic last spring, BioCrowd founder and virologist extraordinaire Vincent Racaniello has been vigilantly writing at his at his Virology Blog about HIN1 pathogenesis, epidemiology, immune responses and vaccines.  When not blogging about HIN1, Vincent also writes about other viral diseases and does a weekly virology podcast called This Week in Virology (TWIV).

In a very short time, Professor Racaniello has amassed a huge collection of original articles that could be compiled into a virology textbook with a title like “Everything you ever wanted to know about H1N1.” And, not surprisingly, his Herculean efforts have not gone unnoticed: today his Virology Blog was recognized and listed as a legitimate source of H1N1 information by the New York Times. 

For those of you who haven’t been overwhelmed by the unrelenting swine flu media frenzy and are seeking sound information about the H1N1 epidemic, I highly recommend that you check out Vincent’s blog. Also, you can talk with Vincent at BioCrowd when he is not too busy blogging, podcasting or conducting laboratory research.

Until next time...

Good Luck and Remember to Wash Your Hands !!!!!

 

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Did you know that there are 22 FDA -approved monoclonal antibody treatments on the market today? And that there are approximately 183 new diabetes treatments being developed by various pharmaceutical and biotechnology companies around the world?  Finally, UCB's Cimzia (certolizumab pegol), a PEGylated monoclonal antibody fragment to treat rheumatoid arthritis (RA) recently received FDA approval.  UCB believes that its product will out compete the likes of Humira, Enbrel and Remicade because it, along with corporate partner OXO is developing a specially-designed pre-filled syringe, that can be used for self injection by RA patients who frequently have limited mobility of motion because of the disease.  The other anti-RA MAb treatments require self-formulation prior to injection and more frequent injections than Cimzia for therapeutic effectiveness.

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On several occasions while driving in upstate New York, I noticed an exit sign on the NY State Thruway for Coxsackie, NY. And, not surprisingly, I began to wonder whether or not the Coxsackie virus was named after this obscure upstate NY town.

I first learned about coxsackie viruses as a graduate student while taking a medical virology course at the University of Wisconsin taught by the late noble laureate Howard Temin. However, despite a thirty year friendship with Vincent Racaniello, a BioCrowd co-founder and virologist extraordinaire, I never asked him about the origin of the coxsackie virus name. Much to my surprise, he had recently taken a trip to upstate NY and noticed the Coxsackie NY exit sign while driving on the thruway. This prompted him to blog about the coxsackie virus isolation, its pathogenic properties and of course, the origin of its name!

Coxsackie NY and the virus named after it 

by Vincent Racaniello,PhD

Recently while driving north on the New York State Thruway I passed the exit for the town of Coxsackie, NY (population 8,884). I grabbed my camera and photographed the exit sign, and reminded myself to write about the virus named after this small town.

In the summer of 1947 there were several small outbreaks of poliomyelitis in upstate New York. Gilbert Dalldorf, the director of the Wadsworth Laboratory in Albany, NY, and his associate Grace M. Sickles investigated this outbreak. In particular they sought polioviruses that could replicate in mice. This search was motivated by the fact that research on poliovirus required the use of monkeys which were extremely expensive. Dalldorf had attended the Fourth International Congress for Microbiology in 1947 where he heard that very young mice – suckling mice – could readily be infected with Theiler’s virus.

Dalldorf and Sickles made fecal suspensions from two children suspected of having poliomyelitis, and inoculated these into adult and suckling mice. Only the suckling mice (1 – 7 days old) developed paralysis; animals more than one week old were resistant to infection. The damage responsible for limb paralysis was widespread lesions in skeletal muscles, not in the central nervous system as occurs with poliovirus. Further study revealed that the viruses could be distinguished serologically from poliovirus.

Not only had Dalldorf and Sickles identified the first members of a very large group of human viruses, but they also introduced and popularized a new and inexpensive animal into the virology laboratory – the suckling mouse. In 1949 Dalldorf suggested that the new viruses be called Coxsackie viruses, because the first recognized human cases were residents of that New York village. This unique name is of native North American origin.

Over ten years later the importance of this work was recognized by Dr. Max Finland of Boston City Hospital:

The isolation by Dalldorf and Sickles of viruses which produced paralysis with destructive lesions of muscle in sucking mice and hamsters, from the stools of two children with signs of paralytic poliomyelitis was an achievement that may rank in importance with Landsteiner and Popper’s production of human poliomyelitis in monkeys.

In subsequent years many different Coxsackie viruses were isolated that cause a variety of clinical syndromes. Today at least 30 serotypes of Coxsackie viruses are classified in the enterovirus genus of the Picornaviridae. The viruses are classified into groups A or B depending upon the pathological effect in suckling mice.

Not every locale is pleased to have a virus named after it. In May 1993, an outbreak of an unexplained pulmonary illness occurred in the southwestern United States, in an area shared by Arizona, New Mexico, Colorado and Utah called “The Four Corners.” Muerto Canyon was proposed as the name for the etiologic agent of the disease, because the virus was first isolated from a rodent near the canyon. However after residents objected, the name Sin nombre virus was given to the agent of hantavirus pulmonary syndrome.

Dalldorf G, & Sickles GM (1948). An Unidentified, Filtrable Agent Isolated From the Feces of Children With Paralysis. Science (New York, N.Y.), 108 (2794), 61-62 PMID: 17777513

 

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China's Beijing Genomics Institute in Shenzhen announced that it has mapped the entire genetic code for the giant panda using DNA sequencing and analysis equipment from San Diego-based Illumina. The project began in mid 2008 and was completed by Jan.2009.

The panda at the center of this discovery is Jingjing, who lives in China's Chengdu Panda Breeding Research Center and was the mascot for the 2008 Beijing Olympics. The genetic information from Jingjing is expected to be complemented in the future with genetic information from other pandas.

Scientists hope to use the data from the sequencing project to better understand panda biology and reproduction. Giant pandas are difficult to breed in captivity and are currently on the endangered species list.

In China, the panda's genome sequencing was ranked by the Chinese government as one of the top 10 technology achievements of the year, right up there with the nation's space shuttle and the completion of the Tibetan railway.

Until next time...

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

 

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Despite dire predictions, the biotechnology industry appears to be weathering the recession better than most. According to a CNN Money.com post “Biotechnology leapt ahead as the biggest recipient of U.S. venture capital money in the second quarter, but first-time venture investments in companies overall dropped to a 15-year low.”

Biotechnology funding grew 54% to $888 million in 85 deals, software came in flat at $644 million in 135 deals and Internet companies fell 15% to $524 million in 124 deals. While biotechnology company investments are leading the pack, the current funding levels pale in comparison to those of the late 1990s and early 2000s. Also, it is important to note that many of the biotechnology company investments were in mid to late stage ventures. Fewer investments were made in seed or early stage companies which historically have outpaced funding in late stage ones.

Venture capitalists may be favoring biotechnology investments because there is a clear exit strategy—there are more acquisitions and initial public offerings in life sciences as compared with other industries.

Look for continuing investments in the biotechnology sector—especially in molecular diagnostics and medical devices.

Until next time...

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

 

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I haven't been posting much lately because I am in Stockholm at a computational biology meeting where I am reviewing resumes and offering career guidance to PhD students and postdoctoral fellows. 

 

For those of you who have never considered visiting Stockholm, I highly recommend that you do. It is a stunning city located on an archipelago of 14 different islands.  The Swedes are hospitable, the food is great and it starts getting dark around 11:00 pm.

I will be back in the US after July 4. 

 Until next time...

 Good Luck and Good Job Hunting!!!!

 

 

 

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From time to time, I come across some interesting facts and statistics that are worth noting. This month’s issue of Pharmaceutical Technology Europe offered several things that were blog-worthy. Here they are: 

• IMS Health has readjusted the growth of the pharmaceutical industry in 2009 from 4.5-5.5% to 2.5-3.6% with sales expected to exceed $820 billion
• The size of the US pharmaceutical market is expected to contract by 1-2% in 2009
• Emerging markets like China, India and Brazil are expected to contribute to more than half of the global market growth in 2009 and sustain an average growth rate of 40% by 2013
• The size of the Middle East pharmaceutical market is predicted to exceed $18 billion by 2014

As one industry analyst put it “This high level of growth in emerging markets, combined with the contraction of the US market and ongoing low single-digit growth in other developed markets, is driving the pharmaceutical market to a new world order.” If I had money, I would be investing in generic pharmaceutical companies and follow-on biologic manufacturers!

Until next time...

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

 

 

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I was in the gym the other day, trying to regain my “girlish figure,” and I happened to see Brooke Shields in television ad hawking Latisse, the new eye lash-enhancing prescription medication from Allegan. For those women (or men for that matter) who haven’t heard, Latisse was recently approved for hypotrichosis of the eye lashes. Hypotrichosis is medically-defined as a reduced amount of hair, and in this case, it refers to eyelashes. Who knew that reduced eyelash hair was a burgeoning unmet medical need? Anyway, back to Brooke.

I like Brooke Shield and I think that her very personal and public account of her struggles with postpartum depression after the birth of her first child was courageous and laudable. And, I thought she was pretty damn good in Pretty Baby and the Blue Lagoon too. But, I question her decision to use her celebrity among women to promote a prescription drug that was approved almost exclusively for cosmetic use. Yes, I know that women’s cosmetics are a multibillion industry and woman worldwide work hard to get longer and fuller lashes. But, this begs the question: Are the possible health risks associated with Latisse—an attenuated form of botulism toxin used in Allergan’s anti-wrinkle treatment Botox—worth it, simply to get longer and fuller lashes; a look that can be achieved by daily application of non prescription and much cheaper mascara? Again, as is the case with most women’s healthcare choices, the decision should be left up to individuals.

Personally, I hope that Brooke’s eyebrows—which were quite formidable back in the day—remain as manageable as they appear to be today after using Latisse to thicken her eyelashes. Not that there is anything wrong with thick eyebrows!

Until next time...

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

 

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Carl Icahn, former corporate raider, hedge fund owner and activist investor, is still trying to exert his influence at Biogen/IDEC a biotechnology company in which he owns 5.6 percent of its outstanding shares of stock.  As you may recall, last year, Mr. Icahn tried to wrest control of the Biogen/IDEC board to force the company to put itself up for sale. That attempt failed but yesterday Mr. Icahn was managed to get two of his allies appointed to the Biogen/IDEC board of directors at the company's annual shareholder meeting.

Mr Icahn has long contended that Biogen/IDEC's management team is inhibiting growth and squandering shareholder value. Wall Street analysts predict that Carl will push hard to split the company into two separate entities: one focused on neurobiology (Biogen/IDEC is a market leader for drugs designed to treat Multiple Sclerosis) and the other on cancer.  Another scenario suggests that he will leave the company intact and find a buyer for it--similar to the plan that he attempted to implement last year.

The Biogen/IDEC news follows quickly on the heels of a management coup that he orchestrated at Amylin Pharmaceuticals earlier in the week. On Tuesday, Mr Icahn, along with the hedge fund Eastbourne Capital management, were successful in ousting Amylin's Chairman Joseph C. Cook, Jr. and director James N. Wilson. Mr. Icahn exerted his influence at Amylin because he felt that sales of its key diabetes drug Byetta were too low.  Others believe that he is preparing the company for sale to Eli Lilly which co-markets Byetta with Amylin.

Mr Icahn is certainly no stranger when it comes to maximizing shareholder value at biotechnology companies where he holds substantial stock positions.  Last year, he orchestrated the sale of ImClone to Eli Lilly after getting into a protracted bidding war with Bristol Myers Squibb (BMS) over the cancer drug Erbitux.  At that time, BMS had an exclusive marketing agreement with Imclone for US sales of Erbitux.

Whether or not you like Carl, he is very good at what he does. And, in the end, he has a gift for maximixing shareholder value of companies that he and others have invested in!

Until next time...

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

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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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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

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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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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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By now everybody has heard that there is a Swine Flu epidemic that started in Mexico and may morph into a worldwide pandemic.  The media's coverage has been mind numbing and overwhelming.  For those of you who want the real skinny on the outbreak, I recommend that you read a post on the Virology Blog run by BioCrowd founder and virologist Vincent Racaniello.

Vincent did his PhD work on flu in Peter Palese's lab, one of the world's leading influenza experts.  In addition to his blog post, Vincent along with Dick Despommier and Alan Dove created a also created a podcast on swine flu last Friday as the epidemic began to unfold. Check it and other virology podcasts out on This Week in Virology (TWiV).

Until next time....

Good Luck and Good Reading/Listening

 

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The FDA has approved Johnson and Johnson’s Simponi (golimumab), a new treatment for adults with moderate-to-severe rheumatoid arthritis , psoriatic arthritis, and ankylosing spondylitis. Unlike Enbrel, Remicade and Humira, other anti-TNF-alpha monoclonal antibody products—which require multiple monthly intravenous infusions—Simponi is injected under the skin and requires only a single monthly injection. 

Simponi is intended for use in combination with the immune-suppressing drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.

In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.

Like other anti-TNF-alpha monoclonal antibody products, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and serious fungal infections with use of the drug. The most common side effects of Simponi include upper respiratory tract infection, sore throat, and nasal congestion.

I have no doubt that Simponi will provide much-needed relief to patients suffering from immune arthritis. However, I think that the marketing folks at J& J could have come up with a better name—it reminds me of Spumoni (the Italian ice cream) and The Simpsons television program. But, then again, the name is distinctive and easy to remember!

Until next time...

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

 

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The long sought after cow genome has been sequenced. Heralded as a milestone in animal genetics, unraveling the cow genome will provide scientists with “tantalizing clues to explain the essence of bovinity.” Two papers describing the results of the project will appear in today's issue of the journal Science. 

The cow who donated its DNA for sequencing was a Hereford named LI Dominette 01449 and is one of the estimated 94 million bovines in the US. The project, led by researchers at National Institutes of Health and the U.S. Department of Agriculture, was a gargantuan effort that spanned six years and involved more than 300 scientists from 25 countries and cost only $53 million. Based on sequence analyses, cows haver 22,000 genes as compared with 20,000 to 25,000 for humans. Some of the other findings include: 

• Cattle and humans have about 80 percent of their genes in common

• The organization of human chromosomes is closer to that of domestic cattle than to those of rats or mice, which are often used in lab tests of drugs intended for people.

• Cattle chromosomes, like those of humans and other mammals, contain segmental duplications, which are large, almost identical copies of DNA present in at least two locations in a genome.

• In domestic cattle, there are duplications related to immunity, metabolism, digestion, reproduction and lactation. Such duplications in humans have been related to a variety of disorders.

Researchers hope that elucidating the bovine genome will help them find ways to improve milk and meat production, develop new strategies to treat and prevent diseases and to reduce the carbon foot print of cows that release large amounts of greenhouse gases that contribute to global warming.

Great news to receive on National DNA Day! 

Science rocks.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

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Colony Collapse Disorder (CDD) a mysterious syndrome that kills adult worker bees outside of the hive has been plaguing Europe and the US in recent years. The US Department of Agriculture (USDA) reports that American beekeepers have lost 37% of their hives to CCD in 2008 after losing 31% the year before. The government estimates that a third of the US food supply may be at risk--$15 billion annually in vegetables, nuts and fruits from plants that depend on bee pollination. The cause of CDD is still hotly debated but many scientists believe that it is caused by a virus

A start up company in Miami FL (my old stomping grounds) called Beeologics is developing a vaccine against all of the apiary viruses that could be responsible for CDD. The company was started by two Israelis, Eyal Ben-Chanoch at tech entrepreneur who helped design the first Intel Pentium chip and Ilan Sela a bee genomics expert. 

The vaccine is pending FDA approval and Beeologics expects it to hit the US market this summer and sell it for $2 per dose. A hive will need one dose per month and current estimates suggest that there are 2.5 million hives in the US. Not a bad revenue stream!

For those of you who may not know, bee keeping is big business and can be lucrative for beekeepers. I learned everything I know about bee keeping as an undergraduate at Cornell when I took Introduction to Beekeeping in my senior year. It was one of the best courses that I ever took at Cornell because it was taught by an entomologist who was also a commercial beekeeper!   Since then, I have always been extremely fond of honey bees—they are fascinating creatures.

Until next time…

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

 

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I just returned from a weekend of teaching regulatory affairs to biotechnology students at Georgetown University where I tried to convince them that the US Food and Drug Administration (FDA) is fundamentally sound despite its near demise during the Bush administration. Even before the Bush-induced wreckage, the agency was chronically understaffed, under funded and had serious leadership and morale problems. This, coupled with two nationwide Salmonella outbreaks in the past year, several highly publicized drug recalls, and steadily declining drug approval rates has prompted its critics to propose that FDA be split into two separate agencies—one that oversees the drug industry and another that would have responsibility for cosmetic and food safety. For those of you who may not know, FDA became responsible for oversight and regulation of the food and drug industries, in addition to the drugs, after passage of the Food, Drug and Cosmetic Act in 1938.

Drug industry advocates and longtime FDA critics contend that the agency as it exists today can no longer effectively oversee and insure the safety of American food and drug supplies. Critics argue that the history of FDA suggests that the agency focuses on medical products and only focuses on food safety when a crisis comes up. And when they occur, FDA is so distracted that it interferes with the drug review/approval process. While this is what FDA critics want you to believe, it is simply not the case. Despite its recent problems, the FDA has historically done an outstanding job when it comes to drug and food safety—when it is funded and staffed to appropriate levels.

Unbeknownst to the American public, food borne illnesses are very common and Americans are only alerted when the outbreaks reach a certain size. While the recent Salmonella outbreaks were larger in scope and breadth than past outbreaks, they were not extraordinary. However, they were extremely media worthy at the time that they were reported on. You may recall that at the time of the outbreaks, the American economy was beginning to fail and there was an inordinate amount of China, Mexico and free trade bashing going on in the US. Unfortunately, the news media decided to exploit the outbreaks to make a case that Americans ought to reduce their reliance on imported foods—a practice that was beginning to cut into the revenues of the US agriculture and food industries. Ironically, the Salmonella outbreaks might have been prevented if the production facilities (owned by American companies) were compliant with FDA mandated quality control and assurance regulations which were designed to insure food safety.

Drug industry advocates who argue that FDA ought to be split into two separate agencies have financial interests rather than safety concerns in mind.  As an investment banker or VC will tell you, slow, new drug approval rates can have serious financial consequences for the companies that are developing them—it can literally cost a company millions of dollars a day for every day the drug is kept off the market.  Interestingly, when FDA increased its drug approval rates in the late 1990s and early 2000s, there weren’t many industry insiders advocating a break up of the agency. Only recently, as FDA has become more risk adverse which in turn, has caused the new drug approval rates to slow again have critics begun to call for massive organizational changes at FDA.

Like I told my biotech students over the weekend, the only mechanism by which FDA can insure food and drug safety is by conducting regular inspections of drug and food manufacturing facilities. Unfortunately, FDA hasn’t been able to keep up with its mandatory inspections schedule because the agency has been under funded and poorly staffed for over a decade. Several FDA inspectors, who I talked with suggested that routine inspections of manufacturing facilities takes place every three to five years rather than every two years as required by FDA regulations. While in theory this shouldn’t affect a company’s ability to remain compliant with FDA regulations, in reality it does. Put simply, pharmaceutical and food companies, like most other for profit industries are incapable of policing themselves in the absence of regulatory oversight.

I ‘m not certain that the agency needs to be split into two separate agencies to continue to insure the safety of the American drug and food supplies. What I know is the agency needs more funding and much larger numbers of trained inspectors to be successful. In my opinion, the safety of the American food and drug supplies can only be guaranteed if the companies regulated by FDA make a commitment to quality manufacturing and play by the rules.

Until next time...

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

 

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A team of researchers at the University of Wisconsin-Madison (my alma mater) genetically engineered a strain of Streptomyces platensis to overproduce the antibiotics platensimycin and platencin. They accomplished this by deleting a regulatory gene (ptmR1, whichencodes a putative GntR-like transcriptional regulator) in the antibiotic synthetic pathway that controls production. The newly engineered strain has been reported to overproduce platensimycin and platencin with yieldsof 323 ± 29 mg/L and 255 ± 30 mg/L, respectively. This represents a 100-fold increase in the yields observed with corresponding S. platensis wild type strains.

Platensimycin is the first of a new class of natural product antibiotics (with a novel mode of action) to be discovered in the past 40 years.  It exhibits strong, broad-spectrum Gram-positive antibacterial activity by selectively inhibiting cellular lipid biosynthesis. Treatment with platensimycin eradicates Staphylococcus aureus infection in mice. Because of its unique mode of action, platensimycin shows no cross-resistance to other key antibiotic-resistant strains tested, including methicillin-resistant S. aureus, vancomycin-intermediate S. aureus and vancomycin-resistant enterococci.

Platencin, also a natural product, is chemically and biologically related but different from platensimycin. Like platensimycin, it exhibits a broad-spectrum Gram-positive antibacterial activity through inhibition of fatty acid biosynthesis. And, it doesn’t exhibit cross-resistance to methicillin-resistant Staphylococcus aureus, vancomycin-intermediate S. aureus, and vancomycin-resistant Enterococci. Moreover, platencin shows potent in vivo efficacy without any observed toxicity.

Both antibiotics show promise for commercialization. While we need new antibiotics, both platensimycin and platencin target only Gram positive bacteria. Infections caused by multiple drug resistant Gram negative bacteria are threatening to overtake those caused by Gram positive in the very near future. At present, to the best of my knowledge, there are no new antibiotics in the pipeline directed against multiple drug resistant Gram negative strains.

Until next time...

Good Luck and Good Antibiotic Hunting!!!!!!!!

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Anybody who has started a biotechnology company will tell you that it is a labor intensive, time consuming and daunting task. After the patents are filed and the business plan is finished, the next step in the process is determining whether or not somebody is willing or crazy enough to invest in your fledgling company.

Like most other things in life, there is an art to raising venture capital and if you are a scientist, I highly recommend that you hire a professional rather than attempt it yourself—it will save lots of time and anxiety. That said, one of the most trying parts of raising venture capital is correctly identifying which firms or networks may right for you! There are literally hundreds or perhaps thousands of investment firms that specialize in a wide variety of technologies to choose from. This can sometimes be overwhelming because information about potential investors is difficult to find at a single website or database.

The advent of the semantic web and social networking has spawned a few websites devoted to venture capital. One that may be of particular interest to bioscientists is OnBioVC.  Copy on its website states: “OnBioVC’s mission is to be the premiere destination for timely coverage and comprehensive trend analysis of global bioscience venture capital investment activity.” The site offers provides a FREE database that can sorted by technology and indication and also offers monthly Trend Analysis surveys. While the site is currently in beta, it looks to have potential to be a valuable resource for entrepreneurial bioscientists who are crazy enough to want to start their own companies. Check it out!

Until next time... 

 

Good Luck and Good Money Hunting!!!!!!!

 

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Allergan, the drug maker that brought us Botox is at it again! The company has a new FDA-approved drug called Latisse that can be used to grow longer, lusher eyelashes. It will be available by prescription at the end of this month.

Latisse contains the same prostaglandin analog that is found in Allergan’s Lumigan, an eye drop treatment for glaucoma. A side effect of the analog is to make the eyelashes of many patients who use the eye drops longer and fuller. Other side effects can include red, itchy eyes and changes in eyelid pigmentation.

Allergan conducted a 16 week clinical trial with about 280 volunteers to assess the safety and efficacy of Latisse. In the study, half of the participants used Latisse daily for 16 weeks. Study results showed that the eyelashes of patients treated with Latisse typically grew 25 percent longer, 106 percent thicker and 18 percent darker. While 3.6 percent of patients experienced eye itching and red eyes, none exhibited a change of eye color. These results were reviewed by the Food and Drug Administration, which approved the drug in late December, 2008.

While some medical experts are concerned about these Latisse’s side effects, the financial upside for the drug is considered by some analysts to be substantial. At present, the annual size of the worldwide mascara market is about $5 billion. Allergan expects sales of Latisse to eventually rival those of Botox —Allergan’s other FDA-approved drug used for therapeutic and cosmetic purposes. Sales for cosmetic use of Botox were $600 million in 2007.

Longer, lusher lashes will come at a price for the people who chose to get a prescription for Latisse. Unlike mascara which is relatively inexpensive (so I am told), a monthly dose of Latisse will cost $120. However, according to my wife, longer, lusher lashes are the equivalent of the Holy Grail for most women. When I mentioned the Latisse’s monthly cost, she said quickly replied “I don’t care. I would still do it”—this from a woman who rarely wears any make up. Although my wife doesn’t constitute a valid statistical sample size, her responses suggests that Latisse just might be the biggest thing to hit cosmetic medicine market since well—uh— Botox!

Until next time…..

 

Good Luck and Good Job Hunting (try Allergan, they are hiring!)

 

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Each year, after the holiday season has ended, there is a spate of articles and posts related to weight lost. I typically avoid reading them but a post about weight lost and better sex was too good to ignore. Who doesn’t want to have better sex?  Anyway, as usual, the title was  more titillating than the article itself.

Anyway, let me know your thoughts—I’ll read your comments when I get back from the gym! 

 

Until next time… 

Good Luck and Have Fun Working Out!!!

 

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Pfizer announced yesterday that it would invest $75 million upfront and possibly $410 million more to buy the European rights from Auxilium Pharmaceuticals to develop an experimental biologic (a clostridial collegenase) called Xiaflex to treat Peyronie’s Disease (PD). For those of you who have never heard of PD—I hadn’t— it is “a condition of uncertain cause is characterized by a plaque, or hard lump, that forms on the penis. The plaque develops on the upper or lower side of the penis in layers containing erectile tissue. It begins as a localized inflammation and can develop into a hardened scar.” The buildup of collagen on the shaft of the penis reduces flexibility and makes intercourse uncomfortable. Apparently, this condition can affect close to 1 percent of men according to the National Institutes of health. Prior to development of Xiaflex, treatments for PD ranged from oral Vitamin E therapy to corrective surgery.

I am sure that PD is very painful and causes a lot discomfort and anxiety for men who suffer from it. And there should be a treatment for it!  However, Viagra, another Pfizer product that was approved for erectile dysfunction (ED), has become more of a recreational drug than an ED treatment. I suspect that Xiaflex will not reach blockbuster status like Viagra because it requires penile injection for efficacy (Ouch!). That said, Pfizer may also develop Xiaflex to treat Dupuytren’s contracture and Frozen Shoulder syndrome, two other collagen-related diseases that afflict a significantly higher number of patients than PD. Nevertheless, from a marketing perspective, any drug that is developed to treat penile dysfunctions or problems is likely to be a BIG winner! Now, I understand what has been keeping Pfizer execs at night (sorry, but I couldn't  resist)!

Hat tip (so to speak) to Ed at Pharmalot!

Until next time…

 

Good Luck and Good Job Hunting

 

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Sometimes reality is stranger then fiction. The Pharmalot blog reported today that US Senator Sherrod Brown, an Ohio Democrat, is nominating several candidates for the post and one of them is Peter Rost, MD!

For those of you who may not know Dr. Rost, he is a former Pfizer marketing executive who blew the whistle on some alleged marketing and sales violations at the drug maker. His court case is working its way up the judicial ladder and Dr. Rost apparently has the upper hand so far.

Pfizer fired Dr. Rost “for cause” after a raucous, public skirmish that went on for almost 2 years. After he left Pfizer, he wrote a book, worked for the Huffington Post and started his own blog, which currently has a post about his candidacy for the FDA Commissioner job. 

I first met Peter when he was still at Pfizer and I was organizing a meeting on drug reimportation (he is an ardent supporter). He agreed to talk at the meeting but unfortunately the conference was canceled for one reason or another. I have no doubt that he has the medical credentials and business acumen to handle the job. The one thing that worries me is his penchant for self promotion—something that is not a desirable trait in  an FDA Commissioner.

Time will tell. Personally, I would like to see Dr David Kessler come back and run the agency—another whistleblower (at UCSF) who ran the agency from 1990-1997 and did an outstanding job. The way things are going at FDA these days maybe being a whistleblower ought to be one of the requirement for the job!

Until next time…

Good Luck and Good Job Hunting

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U.S. regulators have delayed a decision on approval of an antibiotic from Johnson & Johnson and Basilea saying they need further audits of clinical sites, the two companies said on Wednesday.

Ceftobiprole, a broad-based spectrum antibiotic targeted mainly against infections caused by methicillin-resistant Staphylococcus aureus (MRSA), is Basilea's lead product and the news hit the Swiss biotech shares, which plummeted 27 percent.

In a so-called complete response letter on the drug's approval application, for complicated skin and skin structure infections, the Food and Drug Administration (FDA) said it was unable to review the clinical data submitted with the NDA until issues of data integrity had been resolved. The FDA has asked J&J to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring."

Ceftobiprole is approved in Canada and Switzerland and has been recommended for approval in the European Union. A new application in the United States is planned within a year.

Late last week, FDA rejected an NDA for another antibiotic, iclaprim, being developed by Arpida, another Swiss company. It has been a bad two weeks at FDA for approval of new antibiotics—drugs that we desperately need.

Until next time….

Happy Thanksgiving

 

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A Food and Drug Administration (FDA) advisory panel Thursday rejected a proposed antibiotic by Arpida Ltd. (ARPN.EB) to treat serious skin infections, a Food and Drug Administration spokeswoman said. The rejection was expected because results from Phase III clinical trials showed that patients taking iclaprim (a trimethoprim-like antibiotic) had lower cure rates than Pfizer's Zyvox (linezolid) which was used as a comparator antibiotic in the studies.

The panel voted 17 to 2 against a question that asked whether the data presented demonstrated the safety and effectiveness of iclaprim for the treatment of skin infections. Although FDA isn’t required to follow the advice offered by its advisory panels, the agency typical follows the panels’ recommendations. This means that it is unlikely that FDA will approve iclaprim to treat complicated skin and soft structure infections (cSSIs).

This is bad news for Arpida Ltd, a small, Swiss biopharmaceutical company and Americans with cSSIs infections that are caused by  multiple drug resistant bacteria.

Until next time…

Good Luck and Good Job Hunting!!!!!! 

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Researchers at the ARC Centre of Excellence for Kangaroo Genomics (KanGO), including University of Melbourne, ANU, WEHI, University of Sydney, University of UNSW and the Australian Genome Research Foundation (AGRF) announced today (yesterday in Oz) that they have built a framework to assemble the genome of a model kangaroo, the tammar wallaby.  DNA sequence data obtained by the Australian Genome Research Facility (AGRF) with funding from the Victorian government will be arranged using the genome map.

KanGO Director Prof. Jenny Graves said “Australia’s weird and wonderful animals are making crucial contributions. The kangaroo has helped to consolidate Australia’s reputation in this important genomics era,” More importantly the map and DNA sequence may open up new areas of research into how genes are turned on and off during development of all mammals.

Those Aussies…you gotta love ‘em!

 

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An article in today’s New York Times reports that several FDA scientists have accused the agency of granting market approval to several unsafe medical devices. According to published reports, “the House Committee on Energy and Commerce will investigate the accusations, first aired when eight agency scientists wrote a private letter in May to FDA commissioner Andrew von Eschenbach.”

Unfortunately, the allegations made by the eight scientists against the agency are nothing new. Frequently, agency managers (and sometimes political appointees) lean toward approving drugs or devices when the data pertaining to efficacy and safety are equivocal.

My sources at FDA suggest that this is what happened with approval of Merck’s ill-fated pain medication Vioxx.

Recently, there has been a spate of safety claims made against medical devices manufacturers. This is not surprising because the regulatory hurdles for marketing approval of devices are much lower for devices as compared with drugs and the medical devices and diagnostics business is the fastest growing sector in the life sciences. For an overview of the medical devices and diagnostics industry please read my recent article published in Science Careers.

Hopefully, new leadership at the agency will turn things around!!!!!!!

Until next time…

 

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

.

 

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I finally started using Twitter a couple of months ago and I think it is pretty cool. That said, I am still a neophyte and I have yet to master the intricacies and nuances of Twitter speak (why are tweets not called twits?—it was a rhetorical question).

I found an informative post entitled 'My Twittonary-Every Twitter Term and Tool I Can Find' on the Sitemasher blog that helps to clarify the Twitter lexicon and provides insights in the latest twittering tools.

BTW, you can follow me on Twitter at BioJobBlog and BioCrowd.

Until next time…

 

Good Luck and Good Twittering (or should that be tweeting?????)

 

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Optimer, a San-Diego, CA-based biopharmaceutical company, reported positive Phase III clinical trial results for OPT-80, its lead treatment for Clostridium difficile gastroenteritis. C. difficile gastroenteritis is caused by exotoxins secreted by clostridia that have colonized the colon following prolonged antibiotic treatment for other bacterial infections. If left untreated, patients can die from a pseudo-membrane that forms in the colons of C. difficile-infected people. The incidence of C. difficile gastroenteritis has drastically increased over the past decade because of prolonged treatments with multiple antibiotics that are often necessary to eradicate infections caused by multiple drug resistant bacteria.

Historically, CHO-based drugs (with a few notably exceptions like heparin) have not fared well as therapeutic agents. To my knowledge, OPT-80 is the first synthetic carbohydrate (CHO)-based antibiotic to demonstrate anti-bacterial efficacy in a Phase III clinical trial. Having worked for Transcell Technologies (now defunct) and Alchemia,Pty—both of which attempted to develop CHO-based antibiotics—Optimer’s clinical success with OPT-80 is certainly noteworthy. I wish the company continued success in the future—mostly because I have always thought that carbohydrates would make good antibiotics!

 

Until next time…

 

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

 

 

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According to a recent analysis conducted by Covalence a Geneva Switzerland-based organization that tracks the ethical reputation of multinationals, the pharmaceutical industry’s ethical reputation dropped from first to third on Covalence’s all-time EthicalQuote ranking that monitors 10 industries. Further, over the past year, pharma has only managed to achieve an overall ranking of 8th on the list.

The reasons given for the ongoing decline are increased attention on product risk and decreasing media coverage of donations and philanthropy of pharmaceutical companies. The recent high profile coverage of the safety risks associated GlaxoSmithKline’s Paxil and Merck’s Vioxx are good examples of why the ethical image of pharma continues on its downward spiral.

To improve their image, ethicists recommend that drug companies showcase innovative drugs in poor countries, reduce prices to increase access to drugs and loosen intellectual property rights so that there is global access to potentially life-saving drugs. While several companies like Merck and Roche have gone down this path, it may be too little too late.

Until next time…

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

 

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Are you, like me, wondering how we got into the economic predicament that we are currently in? Do you know what a mortgage-backed security is? For that matter, do you understand the ins and outs of the mortgage and loan business? 

I heard a snippet today from a radio program called “A Giant Pool of Money” produced by Ira Glass, the host of NPR’s “This American Life.” I had heard about the program before but didn’t have an opportunity to listen to it. After listening for 15 min, much to my surprise, I totally understood how we got into the financial that we are in. Contrary to what you may think or have been lead to believe, you don’t need a degree in economics or finance to figure out why our financial infrastructure is crumbling before our eyes.

Listen to it—you won’t be sorry.

Until next time….

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

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Each year the World Bank compiles a report that assesses the world’s friendliest business climates for small companies. The top three companies on this year’s list, Singapore, New Zealand and the US have been there four years in a row. The real shocker this year was that several previously lagging nations moved up on the list, mostly because of business-friendly reforms. This year’s most improved nation is Azerbaijan, which moved up 64 spots to a overall ranking of 33^rd because it reduced the time required to start a new business from 122 to 16 days, reforming its civil code and creating an online tax filing system.

Singapore has habitually been number one on the list because of its low import and export costs, strong government-imposed legal protections for investors and lopsided, employer-friendly labor regulations. The US placed high on the list because its labor laws are among the least rigid in the world and because business can be started quickly with a minimum amount of “red tape”.

For those of you who may be interested the top ten list looks like this:

1. Singapore
2. New Zealand
3. United States
4. Hong Kong
5. Denmark
6. The United Kingdom
7. Ireland
8. Canada
9. Australia
10. Norway

To see the rest of the list and find out more about starting a small business in your own click here

Until next time…

Good Luck and Good Job Hunting (why not start one?)

 

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 As you may have heard, three scientists Osamu Shimomura, Martin Chalfie and Roger Tsien shared this year’s Nobel Prize in chemistry for their pioneering work on the Green Florescent Protein (GFP). GFP revolutionized the fields of molecular biology and cell biology and led to a greater understanding of the roles of proteins in cell, physiology, development and molecular trafficking.

I first became acquainted with GFP back in the mid 1990s when I was working in Bill Ward’s laboratory at Rutgers University. Bill had worked on GFP for over 25 years and I convinced him that GFP would be an ideal educational tool to teach biochemistry and molecular biology to undergraduate students. Prior to my arrival in Bill’s lab, a couple of graduate students had created so-called, “brightness” GFP mutants using molecular evolution techniques that were en vogue at the time. Because they were much brighter than wild type GFP, I used these mutants to develop laboratory exercises that showcased the principles of protein purification, polyacrylamide gel electrophoresis and molecular cloning.  Although I published a paper on my work, it was the pioneering work of Ron Mardigian at BioRad that ultimately led to the development in 1997 of GFP-based education kits. Ron’s GFP kits were a huge success and are now used to teach biochemistry and molecular biology at the high school and college levels throughout the world.

GFP is an effective educational tool because everyone including children and adults is fascinated by things that glow. This brings to mind something that happened at a global GFP conference that Bill Ward organized in 1997 at Rutgers University. There were over 300 GFP researchers from all over the world in attendance. Bill, who is something of character and has a flair for the dramatic, wanted to WOW the conference attendees. Prior to the meeting, Bill asked us to prepare 2 liters of bacteria that over expressed the GFP “brightness” mutant. During the opening session of the conference, Bill had the 2 liter flask (sitting on a UV lamp) at the podium with him. The room was very dark (on purpose) and without warning he switched on the lamp—I will never forget the collective, audible gasp from the audience upon seeing the intense green glow emitted from the flask.

Even though I don’t work much with GFP anymore, I still get very excited when I see it.  I suspect that many other people who also work with GFP or any of its color variants BFP (blue), YFP (yellow), RFP (red) etc feel the same way I do about GFP--you just can't wait to see it!

Until next time….

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

 

 

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The New York Times reported today that the Wuhan Zoo in Central China has taken to feeding its two 3-year-old pandas homemade chicken soup to reduce stress and provide them with a “nutritional boost.” Xiwang and Weiwei needed a boost after China’s weeklong National Day celebration. As many as 30,000 visitors swarmed the zoo this past Wednesday and over 1000 people packed into panda enclosure to see them. This caused the pandas to pace restlessly and zoo officials decided that it would be good to give them some chicken soup because they were “fatigued and had a bit of a shock.” Their normal diet consists mainly of bamboo, milk and buns.

The pandas apparently love chicken zoo and according to the zoo “They drink it like they drink their milk.” That said who can resist a steaming hot bowl of mom’s chicken soup when feeling ill or when things just aren’t going well? Personally, I like matzo balls in my chicken soup—but that is a different story!

Until next time….

Good Luck and Have a Cup of Chicken Soup on Me!!!!!

 

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As reported yesterday by the Pharmalot Blog and verified by the New York Times today, the undisclosed “white knight” drug maker that may help ImClone ward off a hostile takeover bid by Bristol-Myers Squibb (BMS) will make a decision by Wednesday about whether or not it wants to make an offer for the biotech company. 

As you may recall, Carl Icahn, ImClone’s Chairman, announced about a month ago that an unnamed drug company may be willing to offer $70 per share for ImClone stock. BMS responded to the announcement by raising its initial offer from $60 to $62.50 per share for outstanding shares of ImClone’s stock. This feeble counteroffer did nothing but increase the hostilities between ImClone and BMS. BMS currently markets Erbitux ImClone’s blockbuster colon cancer treatment. Based on the tenor of this deal, it is becoming increasingly apparent that ImClone and BMS are not “close” even though they are business partners.

Mr. Icahn, in a brilliant display of his business acumen, has been able to prevent industry insiders from divining the identity of the mysterious suitor (if there is one at all). Conventional wisdom suggests that it is likely to be one of the larger drug companies that would like increase its market share in the biotechnology sector.  The good news is that we may only have to wait another 24 hours before this “cliffhanger” of a deal is resolved (ho-hum). Don’t be surprised that, in the end, BMS may wind up paying more than $70 per share to purchase ImClone.

Until next time…

Good Luck and Good Job Hunting

 

 

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As an undergraduate at Cornell, I took a course called "Bee Keeping" mostly because it had the reputation of being a  “gut” course (i.e., easy to ace) and I had a passing interest in entomological microbiology. To this day, I will tell you that it is one of the best courses that I have taken in my academic career. It was taught by a practicing bee keeper who maintained hives in Florida during the winter and in Ithaca during the summer (not surprisingly the course was taught in the Spring semester so that his bees could pollinate the local crops).

Not only did we learn a lot about honey bee biology and social insect behavior, we also learned a great deal about honey and its virtues (we even got to sample different types of honey from time to time). One of honey’s lesser known properties is that it is sterile. This is because honey is extremely hygroscopic and has high concentrations of fructose, thereby preventing the growth of bacteria. These properties led me to wonder in those days whether honey would be an effective antibiotic in certain situations. 

Over the next 30 years or so, I had all but forgotten about the possible use of honey as an antibacterial. Then, much to my surprise, I came across a recent Canadian study which suggests that honey may be useful to treat a variety of infections. Apparently, honey is surprisingly effective in treating bacterial biofilms which are increasingly implicated in the etiology of many chronic skin, mucosal and wound infections. Previous studies showed that honey is effective in wound healing. The researchers who conducted the study also suggested that a “honey rinse” might be effective for treating  "stubborn ear, nose and throat infections."

Interestingly, not all of the honey that was tested exhibited potent antibacterial properties. Canadian clover and buckwheat honey didn’t exhibit any antibacterial properties at all. This suggests that the plant nectars that the bees use to make honey might influence the antibiotic properties of various honeys. It is important to note that the results of these experiments are very preliminary and additional studies will definitely be required to support or refute the use of honey as an antibiotic. Nevertheless, I thought the results were exciting and worth mentioning.

Until next time….don't forget to eat your honey!

Good Luck and Good Job Hunting (try beekeeping…its lucrative these days)!!!!!!

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I vividly remember when Netscape and Microsoft were “duking it out” for browser dominance in the mid 1990s. As you may have guessed, I was an ardent Netscape supporter. Unfortunately, Microsoft cleaned Netscape’s clock and Internet Explore (IE) became the default web browser of choice for many years,

Although I run a blog, belong to many social networks and like to think of myself as somebody who readily embraces change, I have religiously used IE since Netscape’s demise. That said, I never noticed how slow and clunky IE was until I started working at home again. I always attributed IE’s slowness and frequently aberrant behavior at work to my employer’s woefully inadequate internet connection. However, because I connect to the internet at home via FIOS, IE’s continued lack of responsiveness and frequent crashes could no longer be explained by inadequate “pipe size” or poor connectivity.

The thing that sealed the deal for me were my unsuccessful attempts last evening to use IE to access my Fantasy Football League’s homepage to check yesterdays results. My obsessive need to learn my Fantasy Football fate, forced me to use Firefox to attempt to access the site (I downloaded a version of Firefox several years ago). While I still wasn’t able to connect to my Fantasy Football homepage (the servers were jammed by other obsessive people like me), I found that I was able to access many of my other favorite websites much more quickly and with greater ease than I had ever experienced with IE (with or without a FIOS connection). An apt comparison for the speed differences between Firefox and IE is Usain Bolt’s dominating performance over the rest of the field in the 100 meter race at this year’s Olympics in Beijing.

Over the past few years, many technologically-savvy people suggested that I switch from IE to Firefox. I didn’t because I subscribe to the notion that if “it ain’t broke, don’t fix it.” That said, I am now a Firefox devotee. I feel like I just emerged from the Dark Ages!!!!!

Until next time…

Good Luck and Good Web Surfing (use Firefox…it rocks)

 

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Pfizer announced today that it would withdraw marketing application being considered at FDA and the European Medicines Agency (EMEA) for Dalbavancin an antibiotic it was developing for complicated skin infections caused by bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

Pfizer acquired Dalbavancin after it purchased California-based Vicuron Pharmaceuticals for $1.9 billion in 2005. At that time, Vicuron had filed an NDA with FDA and had expected approval for the novel antibiotic. Instead, after acquiring Vicuron, Pfizer received an approvable letter from FDA that requested additional studies before the agency would approve the drug. Based on the agency’s comments, Pfizer decided to withdraw the original US and European applications filed by Vicuron and conduct addition Phase III clinical trials for the complicated skin and soft tissue infection and pediatric indications. I suspect that results from these trials will determine whether Pfizer files new applications with FDA and EMEA for Dalbavancin.

For those of you who may not know, Vicuron Pharmaceuticals was formerly called Versicor, a company founded by Eric Gordon, Mickey Gorman and others. In 1996, I was recruited to interview for a Vice President of Biology position at the company.  At that time, Versicor had about 15 employees — Eric was CEO and Mickey was a consultant.  Although Eric, Mickey and I became fast friends, I didn’t get the job (they never hired anybody for the position). 

Both Eric and Mickey left Versicor a couple of years later. Eric went on to start Sunesis, a very successful Bay area oncology company and Mickey retired to his home in Key West, FL. From time to time, I would run into Eric at BIO meetings and Mickey and I would meet up at my all time favorite Vietnamese restaurant (Hy Vong) in Little Havana in Miami, FL. Eric has since retired after 30 years in the pharma/biotech biz and Mickey unfortunately passed away from cancer in the early 2000s.

 

After meeting Eric and Mickey, I knew that Versicor would be a success one day—the $1.9 billion that Pfizer paid for Vicuron tends to validate that notion. While I didn’t benefit financially from Versicor, I was lucky and fortunate to meet two, really smart, fascinating and genuine individuals who helped me to establish my credibility in the biopharmaceutical industry.  As the saying goes “Money isn’t everything!”

 

Hat tip to Ed at Pharmalot.

 

Until next time…

 

Good Luck and Good Job Hunting!!!!!

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I came across an interesting post today that lists the medications that the US Food and Drug Administration is monitoring for possible safety risks. The agency began looking into the safety profiles of these drugs after it received reports of health problems. The list contains only 20 drugs but it is worth a look anyway. Some notables on the list include some blockbusters like Cymbalta, Tysbari, Seroquel and OxyContin. 

The list is the first  in a series of list that the agency will regularly publish. The stated goal of these lists is to keep physicians and their patients better informed about the safety of FDA approved pharmaceutical products.

While these drugs are still considered safe and effective, FDA is required by law to investigate any and all complaints about the drugs that it approves. Apparently, the drugs on the current list reached a critical threshold that triggered mandatory safety  investigations.

Until next time….

Good Luck and Good Job Hunting

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As the saying goes—the plot thickens. A couple of days ago a person who has been following our unfolding doggy drama recommended that I look into a DNA testing kit for dogs called Wisdom Panel MX. The Wisdom Panel MX was developed by Mars Veterinary, a subsidiary of the candy bar maker that also manufactures and sells dog food.

Scientists at Mars spent about 6 years mining and analyzing canine genome databases and were able to develop breed specific probes that can distinguish between 130 different breeds of dogs with close to 85% reliability. That said, while the test may not be able to reliably tell you exactly what you have, the sensitivity of the test is sufficient to tell you what you don’t have i.e., it will tell you whether or not your dog is a purebred or a mix.

 As I mentioned in previous posts, we were purportedly sold two Havanese dogs. If the dogs are truly Havanese, then the Wisdom Panel should reliably verify that assertion. Similarly, if our dogs are not really Havanese or a mix of Havanese and some other breed (s) then the Wisdom Panel tests ought to be able to tell us that as well.

As luck would have it, on our recent excursion to Maine, we literally ran into two relatively uncommon purebred dogs ( at least uncommon to us) —one was a Maltese and the other a Bichon. Moose—the rescue puppy who was advertised and sold to us as a 9 month-old Havanese—looked almost identical to the Maltese. Further, a so-called groomer (who posted a comment on a previous post about Moose) referred to him a Maltese which tended to validate our idea that Moose was not a Havanese but really a Maltese or a Maltese-mix.  

Again, coincidentally, my wife took Sandy (our Havanese puppy that we previously bought from the same breeder who sold us Moose) to be groomed today. Since it was Sandy’s first visit, the groomer asked what breed she was. After pausing for a second, the groomer replied “I am not  completely sure but I don’t think Sandy is a purebred Havanese –she looks like she has a fair amount of yorkie (Yorkshire terrier) in her.”

The Wisdom Panel MX kits arrived by FedEx today and we are taking the dogs to the vet at 4:00 to have blood drawn. Stay tuned for future updates.

Until next time…

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

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After hearing the story last night on my local late night news that scientists had discovered a “gene that causes men to cheat,” I felt compelled (as a red-blooded American male) to investigate the story in greater detail. After all, what man wouldn’t want to claim that his philandering behavior was caused by aberrant genes—“Honey, I really do love you but my genes made me do it!”

A quick perusal of several articles on the subject revealed that scientists at Sweden’s famed Karolinska Institute had previously identified a variant of a gene that may be responsible for the sexual infidelity in voles (mole-like mammals). The wild type gene is thought to encode a protein that regulates the activity of hormones involved in vole sexual fidelity.

In an attempt to extend their observations to humans, Karolinska scientists screened 1,000 couples and found that two of five (40%) males had the so-called “cheating allele (s).” Not surprisingly, the researchers didn’t disclose whether men with the variant allele(s) cheated (or were more likely to cheat) on their mates. The researches primarily focused on men because the gene is thought to play less of a role in females.

I think the results of the study are interesting—and may have some basis in fact— but I think the news media, as usual, has made a “mountain out of a mole hill (pardon the pun)!” Undoubtedly, the discovery may provide men caught cheating with an excuse albeit a feeble one. However, it is evident that the study will provide little solace for women who are caught cheating on their mates!!!!

After spending seven long years as a medical school professor listening to one immunology seminar after another, one thing is for certain--that discoveries in mice don’t always translate well in humans. That said, I think the jury may still be out on the “cheating gene.”

Until next time….

Good Luck and Good Hunting (only jobs)

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The recent bad press about Gardasil, Merck’s anti-cervical cancer vaccine, must have been keeping its marketing and advertising executives up at night because the company recently launched a marketing campaign called Charm4Life—a line of jewelry designed to raise awareness about cervical cancer. According to a post at the Pharmalot Blog, women (or concerned men) can pay $32 for any of four “limited edition” bangles designed by Carolyn Rafaelian, a designer with Alex and Ani.  The Charm4Life campaign could also be in response to the likely approval early next year of Cervarix, GlaxoSmithKline’s anti-HPV vaccine.

Merck insists that the campaign is to promote awareness about cervical cancer and that all proceeds from sale of the bangles will go to the Prevent Cancer Foundation. Of course, the real goal of the campaign is to promote Gardasil vaccination by raising their awareness of cervical cancer.  

The $32 price tag for the bangles is way cheaper than the $365 it costs for the Gardasil vaccination series. That said, I hope women don’t buy the bangles and forego Gardasil vaccination.

 

Hat tip to Ed at Pharmalot

 

Until next time…

 

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

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The summer is drawing to a close, it is Labor Day and I decided it was time for a break.  Despite the title of this post, I am not really on a fishing trip.  Instead, my wife and I decided to take the family on a "moosing " trip in Maine.  Moose have a special place in my family mostly because of my daughter's affection for  moose toys, you know what I am talking about.

While she has an extensive moose collection, she has never seen a moose in the wild. That said, we decided to take a trip to Maine (the land of moose)  after reading about a moose cruise offered by a resort located on Moosehead Lake in northwest Maine.  Although the ten hour car ride was a bit of a schlep, a trip to Maine is always worth the effort.

I am happy to report that we spotted several moose on the cruise including an extremely large bull moose with incredible antlers, a female and two calves.  Although I have seen many moose in my time, there is something very special about seeing moose in the wild with the entire family in tow.  The only family members who didn't share the experience were Sandy (the Havanese being cared for by friends in NJ) and Moose (yes, that is his name) our rescue dog of indeterminate breeding who had to stay back in the log cabin overlooking Moosehead Lake.

I promise to make it back to NJ to continue blogging about jobs, career development and biotech news.  Also, please remember that Vincent Racaniello and I are launching our bioscience social network BioCrowd in mid to late September.  So, if you want to be part of the BioCrowd, please join today!

 

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By now, you may have guessed that I am supporting Obama for President. My good friend Jack Goldenberg has created several Obama watch designs that he will be selling at the Democratic Convention in Denver, Co June 25-28, 2008.  For those of you attending, look for Jack and buy a watch (they are really elegant and cool).  If you are unable to attend the convention you can buy a watch online at Jack’s store. Use promotional code CLF and get a 15% discount!

Go Obama….

Until next time….

Good Luck and Campaign for Obama!

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Rumor has it that Sam Waksal was released from prison and is now living in a halfway house in the Bronx, NY. Waksal has a year remaining on his 2001 conviction for insider trading and fraud.

Now that Sam is out of jail, he can watch BMS takeover the company that he created way back in the early 80s. I suspect that he feels vindicated in some ways because BMS is willing to pay over $4.5 billion for ImClone. On the other hand, think of how much money he would have made if he didn’t get greedy.  As a stock broker friend of mine likes to say, “Bulls make money but pigs get slaughtered.”

The one thing that I know for sure is that Sam will not be calling his broker about ImClone shares this time!  

Until next time….

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

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According to a post at the Pharmalot blog, Carl Icahn, Chairman of ImClone, thinks that BMS’ offer last week of $4.5 billion to purchase ImClone is way too low. Icahn feels that the bid was motivated, in part, because ImClone is developing a drug that may compete with Erbitux, and BMS may not have rights to the new drug. Bristol (like it has for Erbitux). I suspect that he is correct but as I mentioned last week, BMS is committed to becoming a next generation biopharma company and the acquisition of ImClone make perfect strategic and financial sense to me. Personally, I think that Carl is posturing (like any good businessman) because he knows that the BMS offer will not be the final offer tendered for ImClone.

As I have stated many times in the past on this blog, Carl seems to know a lot about biotechnology despite no formal training and no hands-on experience in the biz. Maybe he ought to start his own biotechnology company and own 100 percent of its stock. That way he will not have to raid other companies to gain control of their boards to purchase more stock or simply sell the companies? Life would certainly be easier for those biotechnology CEOs and their boards who have  work long and hard to create profitable businesses.

Don’t be surprised if BMS raises its purchase offer for ImClone. BMS finalized is flush with cash after it finalized the sale late last week of its former subsidiary ConvaTec for $6.6 billion.

Until next time…

Good Luck and Good Job Hunting (not in NJ)!!

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According to a post at the Pharmalot blog, a contractor who worked for Novartis was charged with running a prostitution ring from his desk at the drug maker’s facility in Hanover, NJ. Luckily (for Novartis anyway) the actual ’services’ were provided at a veterinarian clinic several miles away. Novartis noted in a statement that was sent to Pharmalot that the alleged pimp “is employed by Kelly Temp Services, a company contracted to provide services to Novartis. However, he no longer works there, and the drug maker maintains that it holds employees and contractors to the highest ethical standards. Novartis also wants us to know it is cooperating with authorities, whose investigation is ongoing.”

There were a few amusing comments posted at Pharmalot.  For example: one reader commented: “No doubt Novartis was impressed with his organization and managerial skills. A career in conference and events management beckons.” Another reader quipped; “Can anyone say - multi-tasking?” Finally, my personal favorite was from a guy with the nick “jobseeker” who boldly stated; “I’m looking for employment. What position did he hold?”

Hat tip to Ed at Pharmalot!

Until next time…

Good Luck and Good Job Hunting (I hear that there is a contractor opening at Novartis)!!!!!!!!

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First, King Pharmaceuticals posted a non-branded high blood pressure video on YouTube in early 2007. Next, Novartis added a 60-second commercial (as part of its Fluflix campaign) asking people to submit videos about what it's like to have the flu. Earlier this year, Insmed upped the ante by posting a video lobbying for new legislation for the approval of follow-on biologics in the US. However, these pharma assaults on YouTube pale in comparison to the launch of Johnson & Johnson’s health channel on YouTube earlier this week.

The channel currently showcases a small selection of health information videos created by NBC News chief medical editor Nancy Snyderman while she worked J&J. Video sites, like YouTube and Vimeo, offer pharma companies a place to feature expensive off media advertising assets (that are currently collecting dust) and to post ads for new drugs and products that are ready for launch.  J &J is the first pharma company to recognize that it can leverage the current social media craze to increase its visibility, sell more drugs and bolster its stock price!

While companies could host videos on their own websites,YouTube’s massive traffic of more than 80 million users offers companies a much larger and diverse audience. And unlike blogs or forums, pharma companies have complete control over the content of the videos that they post on video websites. Moreover, they don't have to worry about negative comments being left after a post (YouTube comments can be turned off), and they can brand and edit video content to target a particular demographic or audience. Finally, videos can be changed or removed by companies as needed.

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In case you didn’t know, chocolate is big business. Do you know of anybody who doesn’t like to snack on a piece of chocolate from time to time? Because of the growing incidence of tropical diseases, pests and global climate change, Mars, the giant candy maker (M&Ms, Snickers), announced that it will sequence and analyze the cocoa genome (cocoa is the key ingredient in chocolate) to “to discover genetic building blocks of traits like disease and pest resistance, drought tolerance and perhaps flavor.” The likely long term goals of the project are to identify ways reduce cultivation costs and increase crop yields.

Another reason why Mars is keen on the project (at least according to the corporate press release) is to protect the livelihood of more than 6.5 million cocoa growers, mostly family-run farms,70% of which are in Africa. 

Mars is working with the US Department of Agriculture (USDA, sequencing) and IBM (data analysis) on the project. The results of the research will be free through the Public Intellectual Property Resource for Agriculture.

I hope that the cocoa genome project is successful. What would the world be like without a copious supply of chocolate?????

Until next time…

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

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Have you ever felt like mixing up a few batches of DNA in your  spare time? Well, for those of you who sometimes get the urge I found an easy-to-use recipe to make your own custom designed DNA sequences. Of course I was joking about doing it at home but if you happen to be at the University of Wisconsin-Madison Biotechnology Center you can give it a whirl.

Of course, the ability to build DNA sequences nucleotide-by-nucleotide has been available for over a decade or more.  That said, the relatively simple system devised by scientists at the UW Biotechnology Center allows even the neophyte molecular biologist to do it successfully.

Until next time…

Good Luck and Good Genetic Engineering!!!!!!

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Having been called a “smartass” most of my life, I found a recent post entitled the “Science of Sarcasm” by Karen Ventii (who runs the Science to Life Blog) fascinating. After reading it, I have yet to figure out why I am a smartass, but at least I know what part of the brain may be responsible! This is what Karen wrote:

A new study aimed at confirming the region of the brain that is important in detecting sarcasm may open the door for new diagnostic tools in detecting mental illness, according to an article in The New York Times.

Study leader Katherine P. Rankin, a neuropsychologist and assistant professor in the Memory and Aging Center at the University of California, San Francisco, used MRI (magnetic resonance imaging) technology and a language test to highlight the region of the brain where the ability to detect sarcasm resides.

The findings, which were presented at the American Academy of Neurology's annual meeting, showed that the 'sarcasm center' is located in the right parahippocampal gyrus.

So, why is this research important?

The ability to perceive sarcasm is linked to one of the most important aspects of human social relations: the ability to figure out what others are thinking. This ability to detect sarcasm is characteristically lost very early during the course of frontotemporal dementia. To date, early detection of this type of dementia has been difficult because afflicted individuals can still perform perfectly well on traditional neuropsychological tests early on in their disease. Therefore, studies like this could help neurologists develop new tools to diagnose and track the early stages of this illness.

During the study, researchers used linguistic cues to localize the sarcasm detection region to the right hemisphere. This is interesting because the brain's language and social interaction centers were previously thought to be located on the left side while the right was known to specialize in a visual context.

This led researchers to propose new functions for the right side of the brain. "It's now thought that the appreciation of humor and language that is not literal, puns and jokes, requires the right hemisphere," said Dr. Anjan Chatterjee, an associate professor in the Center for Cognitive Neuroscience at the University of Pennsylvania.

This current study corroborates previous findings suggesting that the front and right regions of the brain work together to comprehend sarcasm.

Until next time…

Good Luck and Good Job Hunting (remember to keep the sarcasm at a minimum during job interviews!)!!!!!!!!!

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I want to thank Emily who sent me the following comment about red yeast rice.

"Red yeast rice is rice that has been fermented by the red yeast, Monascus purpureus. It has been used by the Chinese for many centuries as a food preservative, food colorant (it is responsible for the red color of Peking duck), spice, and ingredient in rice wine." Based on this information, I clearly had eaten some red yeast rice during my recent trip to China.

My friends and I ate Peking Duck in a restaurant in Beijing (recommended by a Chines chef ) that is  famous for it--I even have a certificate that indicates the number of the duck that we ate--the restaurant keeps track of every duck that it has served for the past 50 years or so!  That said, I doubt that the amount of red yeast rice used to prepare Peking Duck is not enough to counteract the negative effects of duck fat on cardiovascular health.  Nevertheless, my knowledge of its positive effects on the cardiovascular system will help to assuage some of the health concerns that I may have the next time I order Peking Duck in my favorite Chinese restaurant.

Until next time...

Good Luck and Good Eating (try Chinese--it's good for you)!!!!!!!!!!

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You may recall that last August, Johnson & Johnson sued the Red Cross for inappropriate use of its symbol —the red cross—that has universally become associated with the non-profit relief agency. that they reached a settlement in the dispute over the mark. Not surprisingly, a settlement was reached shortly after a judge threw out much of J &J’s trademark claim against the Red Cross. Of course, as it typically in these cases, the terms of the settlement were not disclosed.

J & J brought the suit against the Red Cross, because, starting in 2004, the Red Cross started licensing the symbol to other companies for use on commercial items sold in stores as part of the organization’s fund-raising program. J& J argued that the organization had promised not to engage in certain commercial activity—a part of the original trademark agreement that was struck between the drugmaker and relief agency almost 100 years ago. However, the judge presiding over the case ruled that Congressional charter gave the Red Cross the right to use the symbol even for business purposes.

Although J & J looked incredibly avaricious and took a PR hit by suing the Red Cross for trademark infringement, the company claimed that it had the right to vigorously protect its trademarks—after all, business is business. However, as several patent and trademark attorneys have repeatedly told me, it is advisable to settle or reach an agreement before any case goes to trial—you just never know what a judge is going to rule even if you think that you have a rock-solid claim! I guess J & J needs to hire some new attorneys!

Until next time…

Good Luck and Good Job Hunting!!!!!

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Somebody once said “Jews know two things—suffering and where to find good Chinese food”. Since I am Jewish, it is not surprising that I have experienced a fair amount of suffering throughout my life and, wherever I go, I seem to know where to find “good” Chinese food.  That said, my interest was piqued when I found a post in Yahoo Science News entitled “Study finds Chinese food good for your heart”. Given my lifelong fondness and penchant for Chinese cuisine, I thought that all of that eating that I had done had finally paid off. Unfortunately, after reading the subtitle of the article; “Chinese red yeast rice reduces repeat heart attacks/mortality rates” I realized that my joy and optimism were somewhat premature.

According to the report, researchers at Jefferson Medical College found that a partially purified extract of Chinese red yeast rice, Xuezhikang (XZK), reduced the risk of repeat heart attacks by 45%, revascularization (bypass surgery/angioplasty), cardiovascular mortality and total mortality by one-third and cancer mortality by two-thirds. The multicenter, randomized, double-blind clinical study was conducted on about 5,000 heart attack patients, ranging in age from 18-70 during a five-year period at over 60 hospitals in the People's Republic of China. Study participants were given 300-milligram XZK capsules or a placebo and tracked over a five-year period. The XZK extract used in the study contained a combination of lovastatin, lovastatin hydroxyl acid, ergosterol and several uncharacterized components.

Based on study results, the study’s authors believe that XZK may offer therapeutic benefits to people at risk of heart attack and cardiovascular disease. However, they cautioned that the active pharmacologic ingredient (API) of the red yeast rice is unknown and it isn’t clear how XZK works to fight cardiovascular disease.

Chinese medicine practitioners have long touted the benefits of red yeast rice for heart patients. Nevertheless, this is the first controlled clinical study of red yeast rice that tends to substantiate these claims. According to the study authors it is important to note that “the commercially available over-the-counter supplement found in your average health food store is not what was studied here. Those over-the-counter supplements are not regulated (by the US Food and Drug Administration), so exact amounts of active ingredient are unknown and their efficacy has not been studied yet.”

It is unfortunate that I didn’t know about the benefits of red yeast rice during my recent trip to China. I certainly would have gone out of my way to try some. That said, given the plethora of exotic foods that I tasted in China, maybe I ate some XZK without knowing it!

Until next time

Good Luck and Good Eating (Chinese of course)……

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This may be one of the more notable years for Salmonella food poisoning. First, there was a modest outbreak in the eating clubs at Princeton University and now a larger outbreak in Texas and New Mexico. This is the first time that I can recall in my almost 30 years as a card-carrying food microbiologist that there has been this many highly-publicized cases of Salmonella food poisoning in one year. Although I don’t wish Salmonella gastroenteritis on anybody, it is kind of rewarding that an organism that led to my PhD is making headlines once again. Typically, Salmonella outbreaks are not noteworthy and rarely receive much notice— usually taking a backseat to potentially life-threatening outbreaks of enteropathogenic Escherichia coli.

Like the Princeton outbreak, the exact source of the Salmonella infection is unclear. That said, public health and CDC officials are leaning towards large, raw tomatoes. In 2006, the Food and Drug Administration discovered that consumption of tomatoes in restaurants had caused a salmonella outbreak that affected 21 states. , “until the source of the outbreak is identified federal and local health officials in both states have recommended that infants, the elderly and anyone with an impaired immune system avoid eating Roma and red round tomatoes that are not grown at home or sold attached to the vine.” So far, 40 confirmed cases, with patients ranging in age from 3 to 82, have been reported in New Mexico and Texas since April. To date, 17 people have been hospitalized, but no deaths have been reported.

Molecular analyses indicated that all of the cases in New Mexico and Texas were caused by the same strain, a relatively rare serovar called Saint Paul (6^th most common serovar infecting humans). Federal health officials at the Centers for Disease Control in Atlanta, GA fear that this may be the beginning of a large national outbreak of Salmonella gastroenteritis. This is because about 30 cases caused by the Saint Paul strain, have also been reported this year in Arizona, Colorado, Idaho, Illinois, Indiana, Kansas and Utah. Like the New Jersey, Texas and New Mexico outbreaks, the cause of those other outbreaks is under investigation.

Salmonella gastroenteritis generally last between four and seven days, and most people are able to recover without medical (antibiotic) treatment. But, it can sometimes lead to death in immunocompromised adults or young children. Symptoms include headache, nausea, abdominal pain, diarrhea and sometimes vomiting.  Although textbook descriptions of the pathogenesis of Salmonella gastroenteritis generally portray it as a mild illness, I can tell you that people I know (lab mates of mine) who came down with the disease (gee, how did that happen?) suggest otherwise!

I suspect that fecally-contaminated water may be source of the infection. But, then again, it has been almost 30 years since I thought about Salmonella gastroenteritis. That said, I don’t think that you ever forget the essence or minutiae of your thesis work!

For those of you who are interested, the electron micrograph of Salmonella typhimurium shown with this post is from my PhD dissertation. As I recall, the electron micrograph was taken in 1980 and the bacterium shown in the micrograph was grown for 48 hours on nutrient agar . Althought I would like to take credit for the shot (nice pose eh?),  it was taken by Phil Hegge in the Department of Bacteriology at the University of Wisconsin-Madison, my alma mater. if you look closely you may be able to see fimbriae along with the flagella.

Until next time

Good Luck and Good Job Hunting (and remember to wash your tomatoes)!!!!!

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

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

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

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

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

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

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

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

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

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I apparently made a few errors in the post about the recent Salmonella food poisoning outbreak at PU (pun intended). I want to thank the anonymous member of the Princeton Graduating Class of ’09 for pointing out the inconsistencies and errors in the post.  First, the so-called “dining clubs” are actually called eating clubs. Second, fraternities and sororities are allowed at PU and I hear that they are alive and well. Finally, I inadvertently noted that the University has severed contracts with several of its produce suppliers which may have been the putative source(s) of the outbreak. In fact, the University didn’t cancel contracts but only temporarily closed a few of the eating stations at the Frist Campus Center. My local newspaper reported that contracts where severed–I guess you truly can’t believe everything that you read!

I was duly chastised for not adequately verifying my information before I hastily crafted the post. I stand corrected and will attempt to be more vigilant in the future. That said, I think that my lack of understanding of the practices and customs at Princeton University is directly related to the fact that I attended Cornell as an undergraduate. Mea Culpa!

Until next time…

Good Luck and Good Job Hunting!!!!!

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It looks as though Enzon Pharmaceuticals, the first company to successfully commercialize protein PEGylation, finally buckled under the pressure exerted by Carl Icahn, one of its major shareholders.  As I mentioned in a previous post, Carl recently started buying large blocks of Enzon stock to gain a controlling interest in the company to maximize shareholder value. To accommodate Icahn’s "vision" and demands, Jeff Buchalter, Enzon’s Chairman and CEO has decided to spin out a new biotechnology company.  According to an Enzon press release, the new company (to be named later) will get Enzon’s core technology (PEGylation) and its entire preclinical pipeline (i.e.; their RNA antagonist oncology portfolio). Enzon will also invest $150m in the new venture.

So, what does Enzon get out of the deal? It retains ownership of a small, aging manufacturing facility and a portfolio of nominally-performing specialty pharma drugs. I think comments made by Eben Tessari, a financial analyst who follows Enzon, sums up of the essence of the proposed spin out.  He writes: “Maybe I’m way off here but it seems to me in analyzing this deal that the new company gets all the goodies while Enzon is left with a manufacturing plant and a stable of marginal drugs (zero out of four therapies have over $50m a year in revenue). Now, I don’t mean to imply that I think Enzon is a bad company - hell, they’ve managed to make more profit this quarter than any pharma company I’ve ever worked for - I’m just saying they are selling their future based on the advice of a man notorious for breaking up companies and wringing every last dime out of a shakeup.”

Not surprisingly, Jeff Buchalter, the brains behind the deal, thinks it will provide Enzon shareholders with the value that they demand. “By separating these unique businesses into two focused companies, the opportunities for both the specialty pharmaceutical business and the biotechnology business could be substantially enhanced and greater value could be created than under the current structure. Operating separately will allow each company to benefit from greater strategic and managerial focus and appeal to their own unique shareholders. The separation will enable the two businesses to compete more effectively in their respective markets and optimize their business goals, research initiatives and capital requirements. We look forward to creating this opportunity for the shareholders,” said Buchalter.

Jeff, who learned how to turn around failing companies from his former boss Fred Hassan (turn around specialist and current CEO of Schering Plough) ought to know a little something about value. According to SEC filings, last year Jeff made $773,558 (base salary) with $1,162,500 in bonuses for a total cash compensation of about $2 million. In addition, Jeff received just over $3.1 million in equity bringing his total 2007 compensation package to approximately $5.2 million —almost 3 times the amount received by any other Enzon executive.  Not that there is anything wrong with that!!!!!!!!!!!!

Until next time….

Good Luck and Good Job Hunting (try Enzon’s spin out, they are flush with cash)!!!!!!

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The first biosimilar version of granulocyte colony stimulating factor (G-CSF) received a positive opinion from EMEA last month.  The European commission is expected to grant marketing approval for the product in the EU. The product, developed by Israel-based Teva, a global generics manufacturer, will be sold under the brand name TevaGrastim. The company is seeking EU approval for TevaGrastim a as treatment of chemotherapy-induced neutropenia.  

Amgen’s Neupogen, the innovator product, yields annual revenues of approximately $300 million in the EU. Teva hopes to cash in on a piece of that action. It appears that biosimilars are alive, well and making money in Europe!

Until next time…

Good Luck and Good Job Hunting!!!!!

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Yes, even the Ivy League isn’t immune to food poisoning outbreaks from time-to-time. There are currently 10 confirmed cases of Salmonella food poisoning at Princeton U. Another 50 people or so have also fallen ill with gastrointestinal symptoms consistent with Salmonella food poisoning.  As a precaution, university officials have temporarily discontinued doing business with their produce suppliers. For those of you who don’t know, Princeton is famous (infamous?) for its so-called dining clubs. These clubs take the place of sororities and fraternities which are not allowed at this august institution of higher education. Obviously, there is more than eating that goes on at these “dining clubs.”

The reason I am blogging about the outbreak is two-fold. First, I live about seven miles from Princeton and it has been all over the local news. Second, I did my PhD work on the pathogenesis of Salmonella gastroenteritis. So, Salmonella food poisoning is dear to my heart (thankfully, not my gastrointestinal tract). Many infectious disease experts tend to dismiss the seriousness of Salmonella gastroenteritis. This is likely because it is usually not as devastating as shigellosis or infections caused by enteroinvasive strains of Escherichia coli (which is actually Shigella masquerading as E. coli). As my major professor once put it “You know when you have Salmonella gastroenteritis—if you can’t decide than it is not salmonellosis.”

I am happy to report that I never came down with gastroenteritis while working for over three years with enteroinvasive Salmonella strains (even though I was routinely mouth pipetting and eating lunch in the lab; practices which aren’t acceptable by today’s standards). I like to think that “the bugs” were afraid of me. Alternatively I had either a great immune system or extremely good aseptic techniques. Whatever the reason, it is always embarrassing when card-carrying microbiologists come down with the disease(s) that they are studying. Luckily, I never came down with the disease caused by the bacterium that I was studying during my first postdoctoral fellowship—Neisseria gonorrhoeae. That would have been extremely difficult to explain!

Until next time…

Good Luck and Good Job Hunting (remember to wash your hands)!!!!!!!!

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Brand name pharmaceutical and biotechnology companies have been quietly spending millions to lobby Congress for changes in US patent law. Specifically, these companies want to overhaul the intellectual property rules dealing with the doctrine of “inequitable conduct”. When a company or individual engages in inequitable conduct, it means that the company or individual has misrepresented or concealed information with the intent to deceive the US Patent and Trademark Office (USPTO). In such cases, a federal judge has the legal authority to void the patent and declare that it is unenforceable. Not surprisingly, brand-name drug companies are lobbying Congress to eliminate or curtail inequitable conduct penalties. 

According to the New York Times, in the last 15 years the US Court of Appeals for the Federal Circuit (which handles appellate patent litigation) have ruled in the affirmative on 40 cases of inequitable conduct–14 of which involved pharmaceutical or healthcare companies. Similar rulings have been issued by federal district judges in an indeterminate number of cases that were not appealed (and never reached the Federal Circuit court). The article contends that some drug makers knowingly submitted false statements to the USPTO, inaccurately described experiments in patent applications or concealed information (usually prior art) that contradicted their claims. In one high profile case, the appeals court ruled that the Danish drug maker Novo Nordisk failed to disclose that it had not performed an experiment described in a patent application for human growth hormone. In another notable case, the court contends that Pharmacia (now Pfizer) used an “inaccurate and misleading” affidavit to win a patent for a new glaucoma drug.  Personally, I am aware of several instances in which companies willfully and knowingly failed to disclose prior art in patent applications that were ultimately approved.

Those of us in the biz know that patents are valuable commodities and that the financial stakes surrounding patent estates and intellectual properly are extremely high. A robust patent estate can either make or break a company. Nevertheless, in my opinion, if a company (or individual) cheats by falsifying, concealing or omitting pertinent information in a patent application, they ought to be penalized for it.  As one former USPTO commissioner, who served under George HW Bush puts it: “Patents can be very valuable. There are strong incentives to want to get them. Cheating occurs from time to time. The inequitable conduct doctrine says that if you cheated to get a patent, you should not be able to enforce it.”

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About five years ago, a friend of mine and I had an idea to form a non-profit dedicated to providing consumers with information regarding the safety of marketed pharmaceutical and biotechnology medicines.  At the time, we observed that consumers were repeatedly being misinformed about the safety and efficacy of many products, most notably follow-on biologics aka biogenerics. Unfortunately, we could not garner enough interest or financial support to get the organization off the ground. I guess that  we had a good idea, but, as usual, were a little ahead of our time. A new organization called The Coalition for a Competitive Pharmaceutical Market has recently set up shop with the same concept in mind.

Members of the coalition include insurance companies (Aetna, Humana, United Health Care and Blue Cross Blue Shield), pharmacies and drug distributors (CVS, Medco, Express Scripts, Rite Aid and Wallgreens), generic manufacturers (Barr Laboratories, Hospira, Teva, Mylan Laboratories and Watson Pharmaceuticals) and a large roster of Fortune 500 companies including General Motors, Ford, Caterpillar, Chrysler, Dow and Eastman Kodak. Think of the lobbying power–how cool is that?

I guess the time has come for rational drug pricing for the US. Big pharma and biotech beware–a nationalized healthcare system may not be far behind!

Until next time….

Good Luck and Good Job Hunting!!!!

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Has it really been 10 years since the launch of Viagra, the first drug that was approved to treat erectile dysfunction (ED)?  Why it seems like just yesterday. For those of you who don’t know, Pfizer was originally developing Viagra as a treatment for cardiovascular disease (it increases blood flow). However, members of the Viagra clinical development teams quickly observed Viagra’s unmistakable erectogenic potential and understood the impact that it would have on male sexual function for years to come.

Before Viagra’s launch in 1998, impotence, (the term previously used to describe what is now known as ED) was rarely discussed or mentioned by anyone, including many physicians. Now, with the advent of Viagra, Levitra and Cialis ED has become a part of the American lexicon.  So-called tough guys like Bob Dole to NFL players are no longer ashamed to mention that they suffer from ED now that they can take a pill to overcome the condition. All kidding aside, Viagra has helped many men with conditions ranging from diabetes, atherosclerosis to prostrate cancer. But, there is one question that I have. “Are there really that many men who suffer with ED to account for the roughly $6.0 billion per year that is spent on Viagra and related medications? 

Anyway, Happy Birthday Viagra! Maybe the little blue guy’s birthday can get a “rise” out of Pfizer’s stock today–sssshhhhhhh, let’s not put too much pressure on Viagra, it may interfere with its performance!

Until next time....

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

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

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

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

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Until recently, Amgen dominated the biotechnology industry and was anointed the world's largest biotechnology company.  However, Amgen recently lost its number 1 ranking to Genentech.  Over the past year or so, Amgen, which is now ranked number 2,  has been acting a lot  like Avis,  the car rental company , which in the 1970s adopted the slogan  “Avis: We Try Harder” when it was number 2 to Hertz in the car rental rankings.  Like Avis, which never overtook Hertz to claim the number 1 spot,  Amgen’s efforts to regain its number 1 ranking are failing.

Today, market analysts noted that, for the first time, Gilead Sciences had overtaken Amgen as the world's second most highly-valued biotech company. Genentech still maintains its comfortable number 1 ranking with an extraordinary market capitalization of more than $83 billion. That said, it is still somewhat of a horse race between Gilead and Amgen for the number 2 spot– as of this morning, Amgen's market cap was approximately $43.5 billion whereas Gilead's was $45.5 billion. Amgen is still ranked highest when it comes to annual revenues: $14.8 billion in 2007 versus Genentech's $11.7 billion and Gilead's $4.2 billion.

Are rankings really that important? Maybe we should ask the Georgetown and Duke men’s basketball teams after this weekend’s NCAA second round tournament games! They might have some interesting insights to share.

Until Next Time….

Good Luck and Good Job Hunting (Stay out of A Thousand Oaks)

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Basilea Pharmaceutica Ltd announced yesterday that the U.S. Food and Drug Administration issued an Approvable Letter for ceftobiprole, a first-in-class anti-MRSA broad-spectrum cephalosporin, for the treatment of complicated skin and skin structure infections including diabetic foot infections. Results from two Phase III studies involving 1600 patients with complicated skin and skin structure and diabetic foot infections showed that ceftobriprole was as effective and safe as other cephalosporin antibiotics.

The Approvable Letter indicates that the ceftobiprole application is approvable, subject to completion and assessment of clinical study site inspections; assessment of clinical and microbiological data provided but not yet reviewed; and further characterization of patients with diabetic foot infections. Ceftobiprole is currently being reviewed by regulatory authorities in Canada, the European Union and in Switzerland. The antibiotic is being co-developed and marketed with Johnson and Johnson.

Until next time…

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

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As you all know, the brackets for this year’s NCAA Men’s Basketball Tournament were revealed Sunday evening. As I have done for the past 20 years, I waited until this morning to find a detailed, printed version of the brackets to use for my office pool. That said, I was pleasantly surprised this morning to see that the sports editor of the NY Times decided to arrange the teams that did (and didn’t) make the tournament in a “basketball version” of the periodic table of the elements!

I want it on record that I am not a big fan of inorganic chemistry. However, I must admit that the New York Times rendering of team participation in this year’s tournament was innovative, creative and refreshing. Why, I bet that even Mendeleev – the guy who is credited with creating the first periodic table in 1869– would have been very pleased and proud of the NY Times’ effort! Does anybody know whether basketball was invented by 1869?

I say BRAVO to the NY Times for divining a creative way to make a connection between sports and science. I think that similar efforts ought to be attempted to convince American children (and possibly “grown ups”) that science can be “cool” and as much fun as sports! American science literacy is trending to an all time low. This trend must be reversed so that America can regain a  global competitive edge in science and engineering.

Again, kudos to the NY Times!

Until next time…

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

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According to a press release by IMS, a company that tracks pharmaceutical sales, growth of the US pharmaceutical market shrank from 8% in 2006 to a meager 3.8% in 2007–the slowest growth rate since 1961. Total U.S. prescription sales in 2007 only reached $286.5 billion. The 2007 slowdown in sales was attributed to:

• Loss of patent exclusivity for branded products
• Fewer new drug approvals
• Effect of Medicare Part D on annual growth
• Renewed focus on safety issues by US Food and Drug Administration

Industry officials place the blame for the slow down on FDA because fewer newer drugs were approved in 2007 as compared with years past. However, I believe that the slow down has more to do with:

• Higher prices of branded medications as compared with generic drugs
• Lack of public confidence in the pharmaceutical industry
• Increased scrutiny by regulators on direct to consumer advertising and continuing medical education (CME)
• Fewer and less innovative drugs in company pipelines

Bashing FDA is easy. The willingness of the pharmaceutical industry to assume ownership of some of its own shortcomings and missteps is substantially more difficult to do!

Until next time….

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

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Who can resist those adorable black and white Giant Pandas? Late last week, the International Giant Panda Genome Project was launched by Beijing Genomic Institute-Shenzhen, China. The goal of this project is to finish the sequencing and assembling of the draft sequence within six months. 

According to the news release:” The giant panda is a much loved animal all over the world and is considered a symbol of China, as illustrated by its being one of the mascots for the upcoming Olympics in Beijing. The excitement surrounding the launch of this ambitious project, however, has been built around how this new genomic information will have extensive impact in numerous scientific areas -- from ecology to evolution to sequencing technology. Such data will aid in understanding the genetic and biological underpinnings of this unique species, especially with regard to its very specific niche in the environment and the molecular mechanisms of its evolution.”

“Of special interest is that these data will be extremely useful for protecting and monitoring this endangered species and will provide information on the impact of captive breeding. In addition, it will have considerable use in controlling diseases that could devastate these fragile populations.” For those of you who don’t know, breeding pandas is not an easy thing. In fact, according to a guy I used to work with, who is a panda breeding expert, it is more art than science. However, it may not be as arcane as he makes it out to be considering that he had a sweet consulting gig for panda breeding with the Chinese government.

The giant panda project (GPP) will be conducted by Chinese scientists as well as scientist from other countries including, Canada, Wales, Denmark and the United States! It is truly an international collaboration!

Long live the pandas!

Until next time…

Good Luck and Good Job Hunting (try GPP- China)!!!!!!

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Where have the folks at FDA been hiding for the past decade?  I thought that by now everybody had heard about multi-drug resistant bacteria and the need for new antibiotics. Why, I bet that even President Bush knows this –hmmmm– well, okay– but you get my point!

FDA announced today that it needs more data and time to evaluate Johnson and Johnson’s “new indication” NDA for its antibiotic Doribax (doripenem). The antibiotic is already approved to treat urinary tract and intra-abdominal infections. The company is seeking approval to expand treatment to cover nosocomial or ‘hospital-acquired’ pneumonia as well as ventilator-associated pneumonia.

The new application was submitted in June 2007 but the FDA’s request for new data means that the review period has been extended by at least three months. Doribax is licensed from Japanese drug maker Shionogi and is currently undergoing regulatory review in Europe, Canada and in other countries.

This delay comes less than a month after the agency cancelled a meeting of its anti-infective drugs advisory committee which was scheduled for February 28. At that meeting, the agency was scheduled to review another J&J antibiotic ceftobiprole, which is being co-developed with Switzerland’s Basilea Pharmaceutica. No reason was given by the agency for cancellation of the ceftobiprole meeting which is being evaluated as a treatment of complicated skin and skin structure infections, including diabetic foot infections.

I am not sure why FDA can’t make up its mind about the approvability of new antibiotics. They certainly had little difficulty approving Vioxx, Zyprexa and Avandia.  Maybe FDA ought to hire some more microbiologists? 

Until next time….

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

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Maybe Pfizer executives ought to ask their doctors for Zoloft prescriptions to deal with the compulsive buying spree that they have been on for past 6 months or so. After acquiring after Encysive Pharmaceuticals just two weeks ago,  Pfizer announced plans to acquire Serenex, a privately-held biotechnology company that specializes in oncology.  Pfizer also acquired Copely Pharmaceuticals last November.

 No financial details of the deal were disclosed but Pfizer is acquiring the rights to SNX-5422, an oral heat shock protein 90 inhibitor which is currently in Phase I trials for the potential treatment of solid tumors and hematological cancers. The company is also acquiring Serenex’ proprietary drug discovery technology and “extensive small molecule Hsp90 inhibitor compound library”, which has potential uses to treat cancer, inflammatory and neurodegenerative diseases.

Surprisingly absent from the deal are the rights to SNX-1012, Serenex’ lead compound, which is for treatment of oral mucositis in cancer patients. It is scheduled to complete Phase II trials in mid-2008 and researchers working on the drug will form part of a new company that is to be spun off and owned by the current shareholders of Serenex.

I guess the adage “You can’t teach old dogs new tricks” is apt for Pfizer. I guess they still haven’t learned that bigger is always better!!! Go figure.

Until next time

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

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The US Food and Drug Administration said Monday it still had several "outstanding issues" with televancin an antibiotic being developed by Theravance Inc and Astellas Pharma of Tokyo. to treat skin infections.

The agency had canceled an advisory committee meeting scheduled for Wednesday that was set to evaluate the drug, televancin.

In a statement, the agency said that the meeting was being canceled to "allow time for the FDA to review and resolve several outstanding issues." The FDA said it would schedule an advisory committee meeting in the future, if needed.

Televancin is a once-daily injectable antibiotic that would be used to treat skin infections, including those caused by resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA). In October the FDA issued a so-called approvable letter for televancin, suggesting it needed a re-analysis of clinical data and the resolution of manufacturing issues at a third-party manufacturer that was not specifically related to televancin. The FDA said it continues to review televancin's application but didn't give a timetable for completion of the review.

Earlier this month the FDA canceled a Feb. 28 meeting for another antibiotic, ceftobiprole that would also be used to treat skin infections. That drug is being developed by a unit of Johnson and Johnson Co. and Switzerland-based Basilea Pharmaceutica Ltd. The FDA is expected to make a decision on whether to approve ceftobriprole sometime next month.

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Due to some technical problems, articles posted after February 4th, 2008 are currently unavailable. So, if you were looking for them, I apologize.  But, the good news is that the IT guys over at Lexblog, the company that built and hosts biojobblog, told me they all should be back by tomorrow AM.

Until next time (that time?).....

Good Luck and Good Job Hunting

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The Bush administration's proposed 2009 fiscal year budget for the FDA includes not only a 5.7 percent increase but a plan to seek authority to allow the agency to approve abbreviated applications for follow-on biologics.

As part of the budget package, the administration said it is seeking regulatory authority for the FDA to approve follow-on biologics, also called biosimilars or biogenerics, which would be financed through user fees.

The House and the Senate both introduced follow-on biologics legislation in 2007, with the Senate's bill moving the furthest by achieving passage by the Health, Education, Labor and Pensions Committee. Lawmakers have pledged to move the legislation forward in 2008.

Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), said "BIO strongly believes that the FDA should have a pathway for the approval of follow-on biologics, which protects patient safety and promotes continued innovation," Greenwood added that "The creation of a pathway for follow-on biologics is a top legislative priority for BIO, and we are meeting with members of the House and Senate to encourage them to consider and pass follow-on biologics legislation this session." This is quite a policy turnaround for BIO which over the past 8 years has spent tens of millions or more lobbying against allowing follow-on biologics in the US.

Continue Reading...

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Over the past few years, I have heard rumors that artificial sweeteners like saccharine, aspartame and sucralose actually cause people to gain rather than lose weight. I summarily dismissed these stories because they did not make sense to me nor did I think that they had any scientific merit–until today!

Purdue University psychologists Drs. Susan Swithers and Terry Davidson fed rats yoghurt sweetened with glucose (15 calories per teaspoon) or yoghurt containing the artificial sweetener saccharin (0 calories per teaspoon). Rats that were fed the saccharin-sweeten yoghurt subsequently consumed more calories, gained more weight, put on more body fat and were unable to regulate dietary intake of calories as compared with rats that were fed glucose-sweetened yoghurt. The authors surmised that breaking the connection between a sweet sensation and high-calorie food, changes the body’s ability to regulate caloric intake. This could partly explain why obesity has risen with the increasing use of artificial sweeteners in drinks. The study’s findings are consistent with emerging evidence that people who drink more diet drinks are at higher risk for obesity and development of the metabolic syndrome that increases the risk for heart disease and diabetes.

So, how do the authors explain their seemingly paradoxical findings? Swithers and Davidson postulate that ingestion of sugar-rich (sweet) foods provides a ‘salient orosensory stimulus” that signals that the body is about ingest a lot of calories. This, in turn, induces the body to physiologically-prepare itself for ingestion of a high calorie meal. However, when the false sense of sweetness (provided by the artificial sweetener) is not followed by consumption of large amounts of calories, the system gets “confused”– causing people to eat more or expend less energy to account for the calorie imbalance. Nevertheless, the good news is that people who use artificial sweeteners can still count calories to regulate caloric intake and body weight. Unfortunately, as the authors suggest, counting calories requires a more conscious effort and a lot more work than routinely consuming low-calorie foods.

Although this study was conducted in rats, its findings are consistent with the observations that increased use of artificial sweeteners can contribute to human weight gain. Despite the study’s findings, similar experiments must be conducted in people to substantiate or refute the authors’ hypothesis.

Until next time…

Good Luck and Good Job Hunting (lay off the aspartame and splenda)!!!!!!

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For the past 30 years or so, the Unites States government has been looking for any reason what so ever to argue against the legalization of marijuana. This is despite a growing body of evidence that marijuana use provides documented, palliative and therapeutic benefits to people who suffer from serious illness like glaucoma, chronic pain and the side effects of cancer chemotherapy. Although marijuana use for medicinal purposes is illegal at the federal level, some Western States, most notably California, have legalized its use —it can now be purchased by people who have valid prescriptions from specially-designed .

From time to time, papers have appeared in the literatures which suggest that marijuana use has deleterious effects on mental acuity, emotional stability, breathing and sperm production. A  recent report  from New Zealand (which was published in the Journal of the American Medical Association) suggests that chronic marijuana use can increase the likelihood of periodontal disease in young adults.

C’mon, gum disease….are you kidding me? Don’t get me wrong, untreated periodontal disease is a serous medical issue. That said,  I suspect that more people are likely to develop periodontal disease from poor dental hygiene and a lack of dental insurance than from smoking a joint from time to time. The fact that the American Medical Association is subliminally try to turn marijuana-induced periodontal disease into an American public health crisis signals to me that government officials are running out of credible arguments to prevent the legalization of marijuana in this country.

Growing up in the 60s, I am very familiar with the consequences and negative outcomes of drug misuse and abuse. While I don’t advocate the use of marijuana and other psychotropic drugs for recreational use, I do believe that patients with serious medical illnesses ought to have legal access to drugs that are safe and offer therapeutic benefits. Further, I think that many drugs that are currently illegal in America ought to be legalized. In my opinion, the legalization of drugs in America will help to reduce crime, allow monies currently allocated to combat illegal drug trafficking to be used for struggling social programs and to demystify the use of illegal drugs American children and young adults. Ironically, illegal drug use by  American children and young adults has been declining over the last few years whereas abuse of  legal, prescription drugs has been skyrocketing out of control. Maybe it is time for America to re-think its drug polices and craft new ones that do a better job of safeguarding America’s youth.

Until next time….happy trails to you! And as always…..

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

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Last December, the US Food and Drug Administration (FDA) asked GlaxoSmithKline for additional information related to its cervical cancer vaccine Cervarix. The company has yet to reply to unspecified queries in the FDA's "complete response letter" that it received last December.

Many analysts believe Cervarix is now unlikely to be launched until 2009 at the earliest. GSK won European regulatory approval last July for the vaccine and had originally anticipated a US launch by the start of this year. However, FDA requested clarification after GSK's submission last April based on interim clinical data that the submitted from its most comprehensive five-year clinical trial for the vaccine. Financial analysts believe that FDA concerns may center on GSK's proprietary AS04 adjuvant that is used  in Cervarix to improve the effectiveness of the vaccine.

The delay has been a serious blow to GSK’s efforts to generate fresh product sales and catch up with Gardasil, the rival HPV vaccine developed by Merck & Co, which is available in the US and Europe.

I wonder whether the delay at FDA is really based on legitimate regulatory and scientific concerns. As you may recall, Merck launched a flat-out, take-no-prisoners lobbying campaign to get State and Federal legislators to mandate that all girls 10-21 years old be vaccinated with Gardasil. While Merck abruptly abandoned its lobbying efforts last fall after it came under fire from various legislative and regulatory sources, I can’t help but wonder whether Merck achieved its intended objectives anyway—to keep Cervarix out of the US market as long as possible so that Merck can capture a majority share of the lucrative American cervical cancer market.

Until next time….

Good Luck and Good Job Hunting (try Rahway)!!!!!!!!!

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Two companies, Theravance and Targanta, have developed two new glycopeptide antibiotics, similar to vancomycin that the US Food and Drug Administration (FDA) will consider for approval. This is very welcome news because antibiotic treatment options continue to diminish as bacterial antibiotic resistance continues to skyrocket. Unfortunately, like vancomycin, both antibiotics must be administered intravenously to treat infections.

Theravance filed a new drug application(NDA) with FDA for telavancin, a bactericidal, once-daily injectable antibiotic proposed to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The company received an approvable letter from FDA for telavancin but was asked for additional information to determine whether the agency will approve the drug. Theravance received notice in December from FDA that the agency's Anti-Infective Drugs Advisory Committee will meet on February 27 to review the new information and make a recommendation on telavancin’s approvability.

Targanta expects to file a NDA for its antibiotic, oritivancin, in the first quarter of 2008. Oritavancin is a semi-synthetic glycopeptide antibiotic with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. Two Phase 3 studies for the treatment of complicated skin and skin structure infection (cSSSI) have been completed. The antibiotic was originally discovered in the mid 90s by Eli Lilly research laboratories. In 2001, Lilly licensed oritivancin to Intermune who subsequently finished the phase III studies, but delayed filing the NDA in 2004 because of adverse side effects including injection site phlebitis. In 2005, Intermune divested itself of oritavancin and sold the worldwide ownership rights to Targanta.

The company apparently delayed submitting its NDA for oritivancin to FDA (even though the data were available for a couple of years) because the agency has been described as fickle when it comes to antibiotic approvals. Apparently, Targanta executives wanted to see how telavancin fared with FDA before it filed its application. Nevertheless, approval of the ortivancin NDA is strongly contingent upon information describing the benefits of oritavancin over vancomycin.

While neither antibiotic is groundbreaking for the treatment of infections caused by Gram positive pathogens, they both offer certain benefits over vancomycin.  Further, the addition of these new antibiotics to our current antibacterial armamentarium is timely given the growing incidence of vancomycin-resistant bacterial isolates.

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Despite putting itself up for sale and finding no buyers, Carl Icahn still believes that Biogen is an attractive buyout opportunity for some unsuspecting pharma company. In fact, it was Carl who forced Biogen to put itself up for sale last fall (to avert a nasty proxy fight that he threatened). Carl, who owns 4.2 % of the company, believed that Biogen was underperforming and its stock price was too low.

To make his ongoing dream a reality, Mr. Icahn moved today to appoint three members (loyal to him) to the Biogen board. In an SEC filing, Mr. Ichan said that at Biogen's upcoming shareholder meeting he will nominate three people to Biogen's board (which elects four directors each year), and seek to cap the board's size at 12. If successful, Mr. Icahn would then be “within striking distance” to control a majority of Biogen's board by next year.

The three people that Icahn nominated were Alexander Denner, managing director of the Icahn investment vehicle Icahn Partners; Richard Mulligan, professor of genetics at Harvard Medical School and Dr. Anne Young, head of the neurology at Massachusetts General Hospital. Interestingly, Dr. Mulligan and Mr. Denner also serve on the board of ImClone Systems, which elected Icahn chairman last year, after a bitter battle during which Icahn accused the ImClone management of improperly developing its cancer drug Erbitux.

Carl has taken a fancy to biotech in recent years and now considers himself to be somewhat of maven.  Although there a molecular biology building at Princeton University which bears his name (he is an alumnus), he is still a corporate raider at heart. After moving into MedImmune stock in early 2007, Icahn threatened a proxy contest at the annual meeting if it did not find a buyer. Several days later, AstraZeneca said it would buy MedImmune for a whopping $15.6 billion. Carl usually gets what he sets out to do.

It appears that Biogen has not heard the last from Mr. Icahn. I suspect that things will continue to get ugly in Cambridge. Stayed tuned for updates!

Until next time…

Good Luck and Good Job Hunting (not at Biogen)!!!!!

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It was only a matter of time. On Thursday, a lawsuit seeking class-action certification was filed against Merck and Schering-Plough in federal court in Seattle, alleging the companies violated state consumer protection laws arising from the sale and marketing of Zetia and Vytorin. The suit claims the companies have known since 2006 that the cholesterol-lowering drugs, Zetia and Vytorin (which is a combination of Zetia and Zocor), were no more effective than a generic version of Zocor in blocking arterial plaques that can cause heart attack and stroke, as the drug makers led consumers to believe.

The lawyers who filed the suit charged that Schering-Plough promoted Zetia heavily– advertising that by adding it to a statin treatment like Zocor– patients could more effectively lower LDL cholesterol which they claimed would, in turn, reduce plaque in patients’ arteries. But they maintain that the companies had information that refuted this claim. This assertion was supported by the release, earlier in the week, of results of the ENHANCE clinical study which showed that while Vytorin reduced LDL cholesterol levels it did not significantly reduce arterial plaque or lower the risk of heart attack or stroke any more than simvastatin, a lower-priced, generic form of Zocor.

The suit also calls into question the timing of the release of the ENHANCE study results. According to the complaint, Merck and Schering-Plough knew the results of the trial but delayed sharing the findings with patients for nearly two years, but failed to change their marketing approach. , the US Congress is investigating the same allegation. The lawsuit seeks the return of money to purchasers of Vytorin and Zetia, but won’t seek relief for personal injuries alleged to have resulted from taking Vytorin or Zetia.

Wouldn’t America be a boring place to live without lawyers?

Until next time…

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

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Sometimes things just seem to occur randomly or by cosmic convergence. Yesterday, my good friend Pete learned that he had prostate cancer. His prostate specific antigen (PSA) levels were slightly elevated over the past few years (they were in a gray zone that made a definitive diagnosis difficult without doing a biopsy). After being urged by his wife and urologist, he had the biopsy performed and, unfortunately, a diagnosis of prostate cancer was made. Hopefully, his cancer is localized to the prostate and will be easily treated via conventional therapies. As many of you may know, prostate cancer is easily treat and the cure rates high if it is detected early.

The use of PSA levels to diagnosis prostate cancer is notoriously unreliable and inaccurate.Today, a group of Swedish scientists announced that they developed a DNA-based test that showed that men carrying a combination of known risk genes run a four to five time higher risk of developing prostate cancer. They envision that this test could be used in tandem with PSA monitoring to more accurately diagnose prostate cancer. I hope that they are right!

Unfortunately, the new test wasn't developed in time to help Pete; but perhaps it can be used in the future to more accurately assess the risk and diagnose prostate cancer quickly so that treatment begins as soon as possible!

Until next time…

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

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The Danish drug maker Novo Nordisk announced today that it was halting further clinical development of its inhalable insulin product called AERx. AERx was in Phase 3 clinical testing as a short-term diabetes treatment. In a press release the company stated that it was halting development of its inhaled insulin compound because the drug was "unlikely to offer significant clinical or convenience benefits" versus current diabetes treatments.” AERx joins Exubera (Nektar Therapeutics/ Pfizer) on the inhalable insulin scrap heap. This leavesEli Lilly and Alkermes’ IR insulin system as the only inhalable short-acting diabetes treatment in Phase 3 clinical development.

Interestingly, Novo didn't say that it was giving up on developing inhalable insulins— only that it was halting its current late-stage AERx program. The company did announce that it plans to pursue a Glucagon_Like Protein (GLP-1) inhalable diabetes treatment which is similar to a product being developed by California-based MannKind. Its product in Phase 1 clinical testing. Unlike Nektar, which partnered with Pfizer to develop Exubera, MannKind, a small startup, is developing its inhalable insulin product alone. Novo also disclosed plans to develop a longer-acting injectable form of insulin which would eliminate the need for daily injections by patients with diabetes.

In theory, inhalable insulins make sense—many people hate daily injections. That said, inhalable insulins may create other problems that obviate their usefulness as alternatives to daily insulin injections-just ask Pfizer and Nektar about that!

Until next time….

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

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Swiss drug maker Novartis on Thursday reported a 45% drop in its fourth-quarter profit, after taking a $444 million charge to revamp its pharmaceutical business affected by generic competition for several of its blockbuster products and a failure to roll out new drugs in a timely fashion.

A Novartis spokesperson said the $444 million charge will help pay for a program that will slash 2,500 of its nearly 100,000 jobs, as the company attempts to save $1.6 billion by 2010.

The company’s pharmaceutical business was hurt by a 21% drop in sales from the United States due to generic competition for its blood-pressure medication Lotrel, the Lamisil nail-fungus treatment, epilepsy drug Trileptal and herpes drug Famvir. The suspension of a bowel-syndrome drug Zelnorm over heart risks also weighed on U.S. sales. Novartis also has struggled to get its Galvus diabetes drug approved in the US. FDA declined to approve Galvus without the company conducting another clinical trial– and Novartis is still in talks with the FDA over what that trial should be.  Novartis also has failed to win FDA approval for a painkiller called Prexige.

Until next time….

Good Luck and Good Job Hunting (try Roche or Sanofi Aventis)!!!!!!!!!!

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It goes without saying that Amgen has had a run of bad luck over the past six months. But, just when you thought things couldn’t get much worse, two former Amgen sales representatives are suing the company, alleging it pushed its sales force to search doctor's confidential medical records for potential patients to boost sales of its blockbuster drug Enbrel.

The ex-employees are seeking lost pay, punitive damages and other compensation totaling more than $15 million apiece. One of the sales representatives, Elena Ferrante of Montvale, N.J., was fired in August 2005, while the other, Mark Engelman of Laguna Niguel, Calif., resigned last year after he received a negative performance review.

A lawyer representing the ex- reps alleges the marketing scheme to increase sales of the drug started in 2005 or sooner, after new drugs competing with Enbrel came on the market. "Amgen stepped up their marketing practices to get all these people who were not indicated for Enbrel" to start taking the drug, she said.

Enbrel which is approved to treat rheumatoid arthritis and moderate to severe cases of psoriasis generated $3.0 billion in sale for Amgen last year. Enbrel treatment can cost as much as $20,000-$50,000 per patient per year depending upon disease severity. 

Stay tuned for the next installment of the ongoing Amgen saga!

Until next time….

Good Luck and Good Job Hunting (not in A Thousand Oaks)!!!

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Despite the Martha Stewart-Sam Waksal insider trading scandal in 2001, ImClone, the company founded by Waksal in 1984, is doing well and managed to sell $1.1 billion of its anti-cancer drug Erbitux in 2006. Erbitux is a monoclonal antibody that is approved to treat colorectal cancer and certain head and neck cancers. ImClone co-markets Erbitux, its only product, with Bristol Myers Squibb (US) and Merck KGA (Europe).

In September, ImClone agreed to pay over $65 million in cash to Waltham, Mass.-based Repligen - a portion of that was designated to the Massachusetts Institute of Technology - to get royalty-free rights to U.S. Patent No. 4,663,281 and U.S. Patent No. 5,665,578. Repligen had contended that ImClone infringed both patents when developing and manufacturing Erbitux for commercial purposes.

Now, here is where it gets interesting. Repligen gained the rights to Patent No. 5,665,578 from Abbott Laboratories via a sublicensing agreement. Although Repligen settled with ImClone over the disputed patent, Abbot has not. 

Late last week, Abbot filed papers in federal court requesting a face-to-face interview with Waksal who is currently serving a seven-year term in the Otisville Correctional Facility in New York. Abbot contends that Sam “played a central role in numerous issues significant to this [patent] litigation.” ImClone is not opposing the request. I guess ImClone knows a lot more about Sam than we do!

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Can anything else go wrong at Amgen? FDA regulators said on Thursday that they were reviewing the results from two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs, sold by Amgen Inc (Epogen & Aranesp) and Johnson & Johnson (Procrit). For those you who don’t know, J&J licensed Procrit from Amgen so there is really little difference between J&J’s Procrit and Amgen’s Epogen. Aranesp is a second generation, longer-acting version of Amgen’s Epogen.

In the studies, researchers used  Aranesp or Procrit to elevate a patient's level of hemoglobin to 12 grams per deciliter or higher, although many patients did not reach that level. Current warnings on the drugs say hemoglobin levels should not rise above 12 for patients with cancer. The FDA said the studies showed that patients with breast or advanced cervical cancer who were treated with the drugs died sooner, or had more rapid tumor growth, than similar patients who were not given the medications.

Based on these new data, it is almost certain that the agency will insist on label changes to include strong warnings regarding the use of EPO drugs to treat oncology patients. Maybe there is a black box warning in Amgen’s future?

Amgen's stock hit a new 52-week low on Thursday, dipping down to $45.25 and closing at $45.69. It has traded as high as $76.95 in the last year but has taken a beating with the decline of its anemia-drug franchise.

The similarities between Amgen and Pfizer are becoming more apparent each day. Both are largest companies in their respective sectors (biotech and pharma) and have relied almost exclusively on blockbuster franchises (and weak pipelines) to bolster their stock prices! As you may recall, both companies have laid off large numbers of employees over the past year to cut costs. Maybe bigger (biggest) is not always better?

Until next time….

Good Luck and Good Job Hunting!!!!

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According to the Eye on FDA blog, FDA has announced an upcoming meeting on stem cells.  This excerpt was recently published in the federal register...

"On April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. , the committee will meet to discuss updates on the following topics: (1) Research management related to the September 29, 2005, review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; (2) 's Somatic Cell Therapy Letter; and (3) recently released FDA guidance documents."

I am not sure what they will talk about given the Bush administration’s intransigence on embryonic stem cell research. Don’t you just love it when Federal agencies waste your tax dollars to hold meetings when there is nothing to talk about? Go figure……

Until next time….

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

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Once again I have to tip my hat to Ed Silverman over at Pharmalot for his intrepid reporting. In today’s blog Ed wrote:

 “A little company in Canada is high on marijuana.  is testing its first product, CAT-310, which it says takes away the so-called “buzz” of marijuana that makes some terminally and chronically ill patients, particularly the elderly, uncomfortable and anxious, The Toronto Star reports. The med is aimed directly at the $4 billion neuropathic pain market that is mainly serviced by various opiates, anti-convulsants and anti-depressants.

The idea is to mimic smoked cannabis through the invention of a new drug delivery technology that can be absorbed on the tongue, like a thin wafer. It doesn’t get digested by the stomach and processed by the liver before reaching the brain, so it’s similar to inhaling cannabis. So far, Cannasat has raised $9 million in seed capital. Get it?”

You just gotta love Ed and those zany Canadians too!!!

Until next time…

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

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As the debate continues to rage in the US about how to regulate biogeneric drugs, the European Medicines Agency (EMEA) has given the go-ahead to Hospira and Stada to sell their copycat version of Johnson & Johnson's anemia drug Procrit.

The European Commission approved Retacrit (epoetin zeta), a biosimilar version of erythropoietin (EPO), to treat anemia associated with chronic renal failure and chemotherapy. EMEA regulators determined that the drug was comparable in efficacy and safety to Procrit.

The EPO market is a large one and more than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, Procrit (JNJ; US), Eprex (JNJ; Europe) and Epogen (Amgen; US). Worldwide annual sales of EPO drugs are estimated at more than $7 billion, $600 million of which comes from Europe.

The approval for Retacrit comes some three months after Novartis’ generics unit Sandoz got the first go-ahead in Europe to develop its version of epoetin alfa. Sales of Retracrit will begin in Germany in early 2008.

When are American pharmaceutical and biotechnology executives going to wake up and realize that they will lose millions in revenue to biosimilar competition?  I think the old adage; “If you can’t beat ‘em, join ‘em” is apt when talking about the biogenerics industry.

Until next time…

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

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I am sure that most of you have heard by now that it takes about $1.0 billion to shepherd a new drug from discovery through commercialization. It is a nice round number but methinks that “something is rotten in pharma land”. The massive pharma layoffs in 2007 were justified because of nearing patent expiry, encroachment by generic manufacturers, over zealous FDA scrutiny and failing stock prices. To that end, how do you explain this little tidbit about Wyeth that my colleague Ed Silverman at Pharmalot reported on late last week? 

As you may know, about three months ago Wyeth’s CEO Bob Essner announced his pending retirement as from the struggling drug maker. It turns out, that Bob will remain chairman through December 31, 2008 and will receive the same $1.73 million in 2008 that he received this year as company CEO.As Ed reported “Bob will also be entitled to a bonus based on his 2008 salary that is “consistent with (his) position,” although his duties are not defined—nor his title. Presumably, Bob is now a consultant.” I along with Ed will look forward to hearing his ideas and what he will be doing for Wyeth over the next 12 months. Maybe he and Bernie Poussot, Wyeth’s new CEO (who will be making a measly $1.5 million this year) can have lunch from time to time to discuss strategy.

Maybe this is why it takes a billion to commercialize a new drug?

Until Next Time

Good Luck and Good Job Hunting (try Wyeth, they apparently have money to burn)

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The New York Times reported today that Genentech resolved a dispute with ophthalmologists that will allow its cancer drug Avastin to continue to be used to treat macular degeneration. As you may recall, the dispute began in October when the Company announced that it would change the distribution of Avastin which would have made it difficult to use the drug. Many ophthalmologists felt that the policy change was an attempt to force them to used Genentech’s newly approved macular degeneration drug Lucentis which has the same mechanism of action but is much more expensive than Avastin. Although Avastin is not approved to treat macular degeneration, many ophthalmologists use it as an off-label alternative to the more costly Lucentis.

According to the agreement, Genentech will sell Avastin directly to ophthalmologists rather than to compounding pharmacies as it previously had (Avastin which was meant as a cancer treatment must be divided into tiny portions for use in the eye under sterile conditions). Physicians who purchase Avastin will have to send it to compounding pharmacies at their own expense to prepare it for patient use. However, the American Academy of Ophthalmology and the American Society of Retina Specialists cautioned that some states might have regulations that would make it difficult to use the new arrangement.

I guess Genentech wanted to spread some “good cheer” before the holidays.

Until next time….

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

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Several lawyers representing people who sued Merck over Vioxx asked the federal judge overseeing the $4.85 billion Vioxx settlement for the freedom to keep some of their clients outside of the settlement while allowing others to accept it. Currently, it is an all or nothing deal—if the lawyers want any clients to receive money from the settlement they must recommend the deal to all of their clients. This was a crucial part of the settlement offered by Merck. A Merck lawyer said that the company will oppose the motion and that the settlement had been carefully devised to be fair to plaintiffs and the company. For the deal to take effect, 85% of all plaintiffs must agree to all terms of the settlement.

The emergency motion may have been prompted by the recent firestorm surrounding Merck’s cholesterol-lowering drug Zetia. Maybe the lawyers think that renewed questions about Merck’s ongoing reluctance to release pertinent safety information about its products may induce juries to render positive verdicts in certain jury trials involving patients who took Vioxx continuously for more than a year. That said, about 18 Vioxx cases have been tried and the plaintiffs have lost most of them. Nevertheless, as the old adage goes: “It never hurts to ask.”

Merck is certainly in the hot seat today and right before the holidays too!!!!!!!  

Until next time…

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

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Until yesterday, I had never been admitted to a hospital via emergency services. I ended up in a hospital \emergency room because earlier in the week I had this sharp pain in my lower right abdomen and it bothered me enough to seek professional help. After a visit to my doctor and a CAT scan at my local hospital, I was asked to walk my films around the corner to the emergency room where I would be met by a surgeon because I had a perforated appendix–my worst fears had come true. Now, here is where it got interesting from a medical and microbiological standpoint.

Based on my recollections from childhood (how many of you know kids who had their appendixes removed?) I thought I was definitely headed to surgery for an emergency appendectomy. But hold on– much to my surprise, there are actually 3 different flavors of appendicitis. The most common form is when the appendix is inflamed and the organ remains intact and can be easily removed by routine surgical methods. The second most common form, which many of you may have heard of, is when the appendix ruptures. When this occurs, the floridly-inflamed and enlarged organ actually bursts and releases the bacteria that cause the organ to enlarge into the peritoneal (stomach) cavity. In this case, there in no option but surgery which can be messy and serious because there is always a concern that the released bacterial will cause an infection of the stomach cavity called peritonitis. Peritonitis can be fatal if not treated with appropriate antibiotic therapy. Finally, the least common and most difficult to diagnose form is called the “perforated appendix.” This is when a small lesion occurs in inflamed and enlarge appendix and small amounts of bacteria escape into the peritoneal cavity (the infectious disease resident who looked at my CAT scan films said it looked like a small bomb exploded—lucky me). Now, when this happens there are two treatment options that the patient must choose between—surgery or intravenous antibiotics for 5 days in the hospital. Surprisingly, my surgeon recommended the IV antibiotics option. After thinking it through, the IV antibiotics option made medical sense. Because only a small number of bacteria were released into the peritoneal cavity 5 days of IV antibiotics ought to prevent peritonitis from occurring. Further, antibiotic treatment will suppress bacterial growth in the appendix and allow it to return to normal. Once appendix is sufficiently healed and no longer inflamed it can be safely removed in an outpatient surgical setting (once you have had one bout of appendicitis, the likelihood of recurrence is high)

Although this experience has certainly not been a pleasant one, it has been extremely educational. But, more importantly, it restored my faith in the medical profession–which has come under a lot of fire recently and reminded how committed and dedicated most healthcare professionals are when it comes to patient health and well being.

Until next time (I ought to be out by Sunday)….

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

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The New York Times reported today that an independent study that analyzed thousands of older people with diabetes found that those treated with the widely used drug Avandia had significantly elevated risks of heart attack and death.

According to the Times article, the finding, published on Tuesday, in this month’s Journal of the American Medical Association (JAMA), could rekindle the debate about whether Avandia, a controversial treatment for Type 2 Diabetes, should remain on the market. Earlier studies drew similar links between Avandia and cardiac risks.

The new study concludes that Avandia users had a 60 percent increased risk of heart failure, a 40 percent increased risk of heart attacks and a 30 percent increased risk of death compared with patients taking other oral diabetes medicines.

Sales of the drug, formerly a $3.4 billion product globally, have declined sharply since June 2007 when an article appears in the  questioning the drug's safety.

Not good news for GSK. The big question now is whether the company ought to cut its losses and take Avandia off the market or continue to squeeze as much money out of the product until lawsuits begin to accumulate.

Until next time…

Good Luck and Good Job Hunting (not at GSK)!!!!!!!!!!!

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Shares of Amgen had their steepest decline in seven months on Friday after the company reported that it may have to revise the safety information for its largest product Aranesp. Amgen shares fell $3.05 or 5.3 percent to $52.10 in regular trading.

FDA has been scrutinizing prescribing information for all EPO-like drugs including Aranesp, Procrit, Epogen and others for the past eight months.  An FDA advisory panel will meet before the end of March 2008 to continue its review of prescribing information for this class of drugs.

Now may be a good time to buy some Amgen stock--the Company may be down but not out!!!

Until next time....

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

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The Wall Street Journal Online published an insightful article today on the future of the pharmaceutical industry.  The article did not contain anything that we didn’t already know–pharma is in deep doo-doo. Starting in 2010, the pharmaceutical industry faces one of the biggest waves of patent expirations ever, affecting dozens of top-selling drugs.

The WSJ was kind enough to put together a great table showing the drugs that will be losing patent protection in the near future, their manufacturers, the clinical indications for which the drugs were approved and the size of the current market for each product.

Don’t you just love the resources that high impact newspapers have at their disposal? Check it out…..

Until next time….

Good Luck and Good Job Hunting (if you can find one)!!!!!!

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Sinus infections are diagnosed in about 31 million Americans each year and are among the most common reasons for doctor visits. The infections affect the air spaces (sinuses) around the nose and in the lower forehead. Inflammation and excess mucous can cause nose congestion, headaches and eye and face pain. Causes include bacteria, viruses, fungal infections and allergies.

A study published in the December issue of the Journal of the American Medical Association (JAMA) showed that patients with sinus infections treated with antibiotics did not get better more quickly than those treated with placebo, And, that most sinus infections would resolve themselves over time without treatment. The lack of effectiveness of antibiotic treatment could be explained by the inability of many antibiotics to reach the site of infection in the sinuses. Also, it is important to point out, that antibiotic treatment is ONLY EFFECTIVE when treating bacterial infections; not those caused by viruses or fungi. To that end, infectious disease experts issued guidelines in 2001 advising against using antibiotics for most sinus infections in otherwise healthy people, blaming overuse for contributing to the growing problem of antibiotic resistance.

Critics of the study questioned whether all the patients in the study had true bacterial sinus infections. Although patients were recruited to the study by family doctors, the results were based on patients' self-reported symptoms rather than medical exams that confirmed actual cases of sinus infections. So it goes….

BTW, recent studies suggest that yellowish or greenish mucous doesn't always mean the infections are bacterial–another urban legend bites the dust.

Until next time….

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

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