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

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

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

Until next time....

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

 

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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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The 2009 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) is currently taking place in San Francisco. For those of you who may not know ICAAC, is an annual meeting mainly attended by infectious disease physicians and researchers where the latest and most cutting edge research on infectious agents is reported. Things must have been a little slow at this year’s meeting (except for H1N1 of course) which led the newswires to pick up a story about the isolation of methicillin resistant Staphylococcus aureus  (MRSA) at public beaches in Washington State. While MRSA infections are certainly a public health concern, particularly among infants, older adults and immunocompromised individuals finding MRSA at public beaches isn’t particularly surprising nor newsworthy.

S. aureus is an opportunistic pathogen that isn't particularly virulent and is incapable of causing disease unless it is accidentally introduced into a wound, surgical incision or similar environment. In humans, the bacterium colonizes mainly the nasal passages, but it may be regularly found in most other anatomical locales, including the skin, oral cavity and gastrointestinal tract. Epidemiological studies have demonstrated that over 70% of people transiently carry S. aureus in their nasal passages at one time or another in their lives. This means that S. aureus is very common and ubiquitous in human populations. Consequently, I wasn’t surprised when I learned that Seattle researchers had isolated S. aureus at public beaches in Washington State. Nor was I shocked to learn that some of the isolates were MRSA strains!  After all, the incidence of methicillin-resistant S. aureus has been steadily increasing in the US and elsewhere for the past 20 years. And, healthy people who carry MRSA (and regularly shed it from their bodies) do like to go to beach and lay in the sand when the weather is warm. That said, I would have flabbergasted if the researchers didn't isolate MRSA from the beach sand samples that they surveyed. As an aside, I want to let my readers know that I isolated S. aureus from a soil sample while an undergraduate microbiology  major at Cornell University. Finally, while some MRSA infections can be fatal, those that are diagnosed correctly and early are usually easy to eliminate with conventional antibiotic regimens.

Because the work mentioned in the ICAAC press release hasn’t been published, it is  difficult to evaluate the results and implications of the study's findings.  Nevertheless, I don’t think it was prudent for the scientists who conducted the research to issue a press release about finding MRSA at public beaches—especially when the American public is already jittery about infectious agents like H1N1. If the authors’ intent was to make a big splash (pun intended) by mentioning the “dreaded MRSA” in their press release, they were successful—the story is all over the news. However, in my opinion, we are obliged as scientists to accurately inform the lay public about important scientific and public health issues—not play into its worse fears and misconceptions about them.

Until next time...

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

 

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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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Rumors are rife that Novartis is going to purchase Lexington, MA-based Cubist for $1.6 billion. Wall Street analysts are speculating that Novartis may announce the deal as early as Monday.

Cubist manufactures Cubicin (daptomycin), one of only a handful of new antibiotics brought to market in the past 20 years that is effective against many infections caused by Gram-positive bacteria, most notably methicillin-resistant Staphylococcus aureus (MRSA). The company is developing new lipopeptide antibiotics similar to Cubicin and also has an active anti-viral drug discovery program.

Over the past 10 years, big pharma companies largely abandoned antibiotic research and placed all discovery efforts in the hands of only a few smaller public companies and startups. Cubist is the only independent biopharmaceutical company that successfully brought a new antibiotic to market. 

Novartis’ possible acquisition of Cubist signals, that at least one major pharmaceutical company sees opportunities and upside in the antibiotic drug discovery market. Several years ago, Pfizer acquired another antibiotic discovery company, Vicuron (formerly Versicor) but to date the acquisition has not yielded any new antibiotics. While Novartis’ acquisition of Cubist is yet another sign of consolidation that is taking place in the life sciences sector, it may bolster new efforts in the antibacterial drug discovery area. Unlike Cubist, Novartis has enough money and marketing muscle to increase Cubin sales and develop some of the exciting new molecular entities in Cubist’s drug development pipeline.

Until next time…..

Good Luck and Good Job Hunting!!!!

 

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That methicillin resistant Staphylococcus aureus (MRSA) is in the news again is not surprising. However, to my knowledge, Nicholas Kristof‘s article in today’s New York Times may be the first Op-Ed piece written by a non-scientist about the growing threat and seriousness of MRSA infections. Mr. Kristof apparently became aware of MRSA when he was contacted by Tom Anderson, MD, a Camden, Indiana physician who was experiencing “phenomenal levels of MRSA infections" in his community.

Beginning in the early 1990s, Dr Anderson noticed a rapidly rising incidence in the number of community acquired skin infections caused by MRSA among his patients. Most of Dr Anderson’s patients were swine farmers—the predominant industry in Camden. At first puzzled by the growing incidences of MRSA outbreaks, Dr. Anderson began to suspect that his patient’s pigs may be the source of growing number of cases of MRSA skin infections. He was reluctant to alert public health officials about his suspicions because any hint livestock-related health issues might jeopardize the livelihood of many of his neighbors and friends. By last fall, however, Camden’s MRSA epidemic had grown so large that Dr. Anderson could no longer remain silent. Rather than alert the authorities himself, he decided to invite Mr. Kristof, an investigative reporter, to visit him in Camden and break the story. Unfortunately, before Mr. Kristof could visit, Dr. Anderson died abruptly at age 54. There was no autopsy, but a blood test suggested he may have died from a heart attack or aneurysm. And—this is where the story gets interesting—a recent Dutch study has linked porcine MRSA isolates to a case of human endocarditis. Dr. Anderson had himself suffered at least three bouts of MRSA infections.

In another Dutch study conducted in 2004, MRSA strain ST398 (which caused the endocarditis in the more recent study) was isolated from three family members, three farm workers and 8 of 10 pigs from a single farm. Since then, strain ST398 has spread rapidly through the Netherlands — especially in swine-producing areas— and pig farmers there are 760 times more likely than the general population to carry MRSA. More recently, a study conducted by public health officials in Ontario, Canada showed that 20% of pig farmers were colonized by strains of MRSA genetically identical to those isolated from European pigs. Finally, a 2008 study conducted in Iowa, reported that strain ST398 was isolated from 45 percent of pig farmers and 49 percent of hogs that were tested. Together, these studies suggest that colonization of swine by MRSA and pig farmers is very common and that swine (and possibly other agricultural animals) could become an important reservoir for strains of MRSA.

While not conclusive, most infectious diseases experts believe that the emergence of MRSA and antibiotic resistant bacteria can be directly linked to the widespread and rampant use of antibiotics as growth enhancers in livestock feed. Despite the alarming emergence of multiple antibiotic resistance bacteria, livestock producers in the US and elsewhere continue to add antibiotics to livestock feeds. This led Mr. Kristof to lament that “we as a nation have moved to a model of agriculture that produces cheap bacon but risks the health of all of us.” Not surprisingly, as is frequently the case, big business has chosen to place profits before the health and safety of society.

Until next time...

 

Good Luck and Good Reading (look for Mr. Kristof’s Sunday column on the emergence of antibiotic resistant "superbugs")

 

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

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

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

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

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

Hat tip to the WSJ Health Blog

Until next time…

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

 

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Targanta Therapeutics, a Cambridge, MA-based biopharmaceutical company, announced that it will lay off 85 of its 115 employees or almost 75% of its workforce. The news follows the FDA’s rejection of its application for oritavancin, an antibiotic it is developing to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and other antibiotic resistant bacteria. The agency wants Targanta to conduct another Phase III clinical trial to further assess of oritavancin’s safety and efficacy.

The company estimates that the new clinical trial will cost about $20 million. Targanta CEO Mark Leuchtenberger said “We are no longer a pre-commercial company. We are back to being a Phase three company, and that requires us to right-size and to streamline our operations.”

Things are not going well for companies in the antibacterial drug discovery and development space. Late last month, FDA rejected Swiss-based Arpida’s NDA for iclaprim an antibiotic it was developing to treat complicated skin and soft infections caused by MRSA. Shortly after receiving the news, Arpida layed off roughly 72% of its employees and is down to about 30 employees like Targanta.

It is unfortunate that big pharma decided to abandon antibacterial discovery and development research about eight years ago. Consequently, development of  new, much-needed antibiotics has been relegated to financially-strapped, small biopharmaceutical companies whose likelihood of success is questionable.

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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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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A friend of mine accidentally gashed his leg on an open dishwasher door and thought nothing of it for several weeks until he noticed that the wound wasn’t healing and it hurt really badly. He eventually went to the emergency room at a local, where the ER docs cultured the wound and sent him home with a prescription for oral antibiotics. The antibiotics stopped working several days later and he wound up in another local hospital–this time he was admitted and the spent the next 5 days on a variety of intravenous antibiotics. Despite the treatment (they could not find the right antibiotic combination at first because  they never recultured the wound) his leg turned black from his ankle to his knee and they almost had to amputate. He is back at home now and will be treated with a regimen of iv antibiotics for the next 6 weeks or so. I talked with him last week and I learned that his leg wound is still not completely healed and the infectious disease docs are worried!

My friend almost lost his leg because of a lack of understanding about bacterial infections and antibiotic resistant bacteria and— unfortunately— because of substandard wound care treatment. With this in mind, I am posting what I think are useful tips (from the June issue of the Mayo Clinic Women’s Health Source) about how to prevent, manage and treat wound infections to minimize the emergence and spread of multiple, antibiotic- resistant bacteria.

• Wash your hands: This simple procedure, done properly, remains the best defense. Carry alcohol-based hand sanitizers for times when hand washing isn’t possible.
• Keep personal items personal: Don’t share towels, soap, sheets, razors, clothing or athletic equipment.
• Sanitize linens: If you have a cut or abrasion, wash towels and sheets with hot water and added bleach. Wash gym and athletic clothes after each use.
• Get infections tested: If an infection requires treatment, ask your care provider to take a culture to confirm what bacteria are present before you are given an antibiotic. (Editor’s note: Unfortunately, this is no longer standard practice—most infections are treated empirically which is partly responsible for the increasing frequency of antibiotic resistant bacteria.) If you test positive for a Staphylococcus (Staph) infection, ask that a culture be tested specifically for MRSA in case you need a special antibiotic.
• Use antibiotics appropriately: When you take antibiotics, take all doses even when you start feeling better. Don’t demand antibiotics for viral illnesses; antibiotics don’t work with viruses. Taking too many antibiotics over time could become a detriment because the medication’s effectiveness can be compromised by overuse.
• Use antibacterial products sparingly: Antibacterial soaps and cleaning products probably don’t prevent infections at home and may make these products less effective in hospitals.
• Take precautions in the hospital: Ask all hospital staff and visitors to wash their hands or use an alcohol-based hand sanitizer before touching you. Ask care providers to wipe stethoscopes and other equipment with alcohol. Don’t set food or utensils directly on tables or beds. Make sure that intravenous tubes and catheters are inserted under sterile conditions.

I hope that these tips will help to keep you out of the hospital with potentially life-threatening, antibiotic resistant bacterial wound infections!

Until next time….

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

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Novartis announced today that it intends to purchase Malvern, PA-based Protez Pharmaceuticals for $400 million. Protez is developing a novel spectrum carbapenem antibiotic that is active against variety drug-resistant Gram positive (most notably MRSA )and Gram negative bacterial pathogens. Its lead compound, PZ-601, is in Phase II human clinical testing. Protez acquired PZ-601 (formerly SMP-216601) in 2005 from Dainippon Sumitomo Pharmaceuticals.   

Novartis is buying Protez to sure up its antibacterial drug pipeline. Novartis already sells Cubicin, (manufactured by Massachusetts-based Cubist Pharmaceuticals Inc.,) in Europe and is developing other antimicrobials including Aurograb and Tifacogin to treat infections.

Like many of the newly marketed antibiotics, PZ-601 is injected and not orally bioavailable. Nevertheless, it is likely that PZ-601 will provide much needed help against the ever increasing number of drug resistant bacterial isolates. Swiss companies Basilea Pharmaceutica AG and Arpida Ltd. are also working on experimental medicines to treat MRSA.

It is not clear how the acquisition will affect Protez employees.  I suspect that most of the employees will keep their jobs except for Company officers.

Until next time…

Good Luck and Good Job Hunting!!!!!

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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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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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There has recently been an inordinate amount of press coverage about methicillin-resistant Staphylococcus aureus (MRSA) or “MERSA” as it is called on my local nightly news. As a card-carrying microbiologist, I think that it is great that the American public is finally learning about multidrug resistant bacteria and the serious public health threat that these bacteria pose. For those of you who don’t know, the incidence of MRSA (and other multidrug resistant bacteria) has been steadily rising since the early 1990s –mostly in healthcare and hospital settings (not in the general population). Not surprisingly, the recent media focus on MRSA has resulted in a lot of misinformation about MRSA strains. For example, every MRSA news clip that I have seen in past week has a school janitor in a mask, gloves and laboratory coat feverishly washing walls, desks (and even toilets) at the schools where MRSA-infected students and staff have identified. I can’t help but chuckle (after I get righteously indignant) when I see these clips because S. aureus (whether it is methicillin resistant or not) is an opportunistic pathogen that is transiently carried in the nasal passages of over 50% of all Americans! Contrary to popular belief, S. aureus does not survive for long periods outside of the human body. That said, school janitors can scrub as much as they want but they will not eliminate the natural reservoir of the organism which is the students and staff who work at the schools! Further, the organism, although infectious, is not easily transmitted from person to person–it requires direct and intimate personal contact in order for that to occur. Also, just because the organism is resistant to methicillin it doesn’t mean that there are no other antibiotics that can be used to treat MRSA infections. In fact, if diagnosed early and correctly, MRSA infections are easily treated. So, why is the news media making such a big deal about MRSA? As far as I can ascertain, people who die from bacterial infections is big news because people ARE NOT suppose to die from infections in modern medical practice. There is nothing inherently more diabolical about MRSA than other strains of S. aureus except that they are methicillin resistant. In other words, MRSA strains are not more infectious nor do they cause more serious disease than non-MRSA isolates. That said, what is noteworthy about the majority of people who have died from MRSA infections is that most of them either had limited or no access to adequate medical care. People with S. aureus infections who do not seek treatment in a timely fashion or are misdiagnosed by a poorly trained emergency room physician increase their risk of serious illness (or even death) whether the organism is MRSA or your run-of-mill S. aureus isolate. The point that I am trying to make is that MRSA strains have been around for almost a generation–what has changed is that millions of Americans no longer have access to adequate healthcare. Until we improve access to healthcare for ALL Americans, I suspect that millions more will die from otherwise treatable bacterial infections.

Until next time…

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

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