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I have refrained from commenting on healthcare reform until now because there wasn’t much I could add to the debate. That said, while reading an article in a local paper on bacterial antibiotic resistance and how to minimize it, the author—an infectious disease doc—offered a telling statistic that identified the root problem with our current healthcare system. According to the article, 65% of the time, physicians will prescribe antibiotics to patients suffering from upper respiratory tract infections who demand them, whether or not they are warranted. In marked contrast, 12% of patients with upper respiratory tract infections who don’t ask for antibiotics receive antibiotic prescriptions. The bottom line: physicians give patients the drugs and treatment they demand because they are afraid of losing them as customers knowing full well the patients will go to another physician who will give them what they want! After all, physicians are in business and to stay in business they need to make enough money to cover their overhead and make a profit. However, over prescribing antibiotics is one of the main reasons why we are in the midst of an epidemic of infections caused by multiple drug resistant bacteria. In my opinion, business outcomes should never supersede or trump medical or public health outcomes.

Don’t get me wrong, I am an entrepreneur and believe that people with good ideas ought to be rewarded for their efforts and make as much money as they can. However, in my opinion, for profit business practices and healthcare haven’t historically worked well for the American healthcare system. Removing profit incentives from healthcare would be an important first step to begin to repair our broken healthcare system. Can anybody say public option?

Until next time...

Good Luck and Support the Public Option!!!!

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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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The media frenzy surrounding the impending H1N1 swine flu pandemic has spawned a recent spate of articles and television news segments on “germs.” In the last 48 hours, articles on germs have appeared in the New York Times, my local paper (The Trenton Times via the Chicago Tribune), on news channels and most recently this morning on the Today Show on MSNBC. Most of these have focused on where “germs” are found, how they are spread and ways to minimize or prevent their transmission. For those of you who may be interested, the word germ was first coined in 1664 and is defined as a “small mass of living substance capable of developing into an organism or one of its parts” or more conventionally, as a “microorganism that causes disease.” While these media pieces are intended to inform the public about infectious agents and their transmission, most people who read or see these reports don’t understand that the word germ can encompass viruses, bacteria and fungi. And, to make matters worse, most Americans don’t know that viruses, bacteria and fungi are different microorganisms.

Unfortunately, after reading newspaper articles and seeing reports on television about so-called germs, many consumers rush out to their local groceries and purchase a variety of antibacterial soaps and detergents—erroneously believing that these products will protect their families from infection by the dreaded H1N1 virus and other pathogens. Although frequent hand washing and the appropriate use of viricidal disinfectants can help to reduce transmission of H1N1 and other viruses, antibacterial products are generally less effective (or ineffective) against viruses and overuse can result in emergence of multi-drug resistant bacteria.

To that end, I think it is high time that the news media eschew the use of the anachronistic term germ in favor of bacteria, virus or fungi when referring to causative agents of infectious diseases. Promulgating the use of the word germ will continue to keep the lay public in the dark about infectious agents and the diseases they cause and hinder people from making informed decisions about treatment and preventing their transmission.

Until next time...

Good Luck and Good Job Hunting!!!!

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Several weeks ago, I blogged about a growing need to improve the American public’s perception and understanding of the life sciences if the US wants to remain competitive in science and technology. Much to my delight, there was an article this Sunday’s NY Times entitled “Microbes R Us” which explores the evolutionary relationship with bacteria and humans. It was written by Dr. Olivia Judson an evolutionary biologist and author of “Dr. Tatiana’s Sex Advice to All Creation: The Definitive Guide to the Evolutionary Biology of Sex,” which was made into a three part television program.

While the evolutionary relationship between bacteria and humans isn’t as titillating as the biology of sex, the article sheds light on the importance of bacteria and how genetic changes in bacteria that normally inhabit the human intestinal track can have a positive impact on human nutrition and health. Many lay people believe that bacteria are “bad” because certain species can cause serious and potentially life threatening diseases. However, the benefits, advantages and uses of bacteria e.g., to make food, antibiotics and other medicines, far outweigh their negative impact on society. 

Articles like the one written by Ms. Judson, offer the public unqique insights into  the amazing and often fascinating world of microbiology. I hope that a few aspiring young scientists read the article and tell all their friends about it!

Until next time....

Good Luck and Good Reading!!!!!!

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A quick perusal of the media coverage of the swine flu outbreak of 2009 would lead many to conclude that this outbreak has the potential to rival or surpass the 1918 flu pandemic—widely regarded as the worst influenza outbreak in history. While the emergence of a new H1N1 swine flu variant is significant note worthy— and has possible public health implications— the unrelenting, often scientifically-inaccurate media coverage did little to quell the fear and anxiety of many Americans.  Once again, the media—rather than physicians, public health officials and influenza experts—“got out in front of the story” and managed to create enough panic, fear and anxiety, the likes of which haven't been seen since the 2003 SARS pandemic. It wasn't until last Friday, when the Wall Street Journal published an interview with Dr. Peter Palese—a leading scientific expert on influenza A infections— did a clearer picture emerge about the severity and public health implications of the current swine flu pandemic.

According to Dr. Palese, there are several reasons why people and public health officials ought to be optimistic about the current pandemic:

• In 1976 there was a an outbreak of an H1N1 swine virus in Fort Dix, New Jersey, which showed human to human transmission but did not go on to become a highly virulent pandemic strain
• The presently circulating swine virus is most likely not more virulent than the other seasonal strains we have experienced over the last several years
• The current swine virus lacks an important molecular signature (the protein PB1-F2) which was present in the 1918 virus and in the highly lethal H5N1 chicken viruses.  If this virulence marker is necessary for an influenza virus to become highly pathogenic in humans or in chickens, then the current swine virus doesn’t have what it takes to become a major killer
• Since people have been exposed to H1N1 viruses over many decades, we likely have some cross-reactive immunity against the swine H1N1 virus. While it may not be sufficient to prevent becoming ill, it may very well dampen the impact of the virus on mortality.  I would postulate that by virtue of this “herd immunity” even a 1918-like H1N1 virus could never have the horrific effect it had in the past.  The most likely outcome is that the current swine virus will become another (fourth) strain of regular seasonal influenza

The landscape of vaccines and anti-influenza drugs has dramatically improved over what it was just a few years ago. Based on what we know of the structure and sequence of the swine virus, these FDA-approved drugs and FDA-licensed vaccines (modified to include the swine strain) would be highly effective against this new virus.  Also, present technologies as well as manufacturing capacities will allow us to make sufficient quantities of a swine virus vaccine for the winter 2009-10 influenza season in the US.

In other words, there is reason for concern but no need to panic beyond typical public health precautions that are taken during “normal” influenza outbreaks.

Dr. Vincent Racaniello, a viral disease expert who writes the Virology Blog, reported that as of Monday there have been laboratory confirmed cases of H1N1 infections in 30 US states with a total of 226 cases and one death in Texas. Globally, 20 countries had reported 985 cases of infection. The highest numbers are in Mexico, with 590 cases and 25 deaths. While there have been 26 deaths to date, the severity of the infection appears to be waning and person-to-person transmission appears to be low.

Unfortunately, there has been some fallout from the news media’s oft times “over the top” coverage of the pandemic. Many US hospital emergency rooms (most notably in Texas and California) have been overwhelmed and overburdened by visits from people who think they may have swine flu. Also, while some schools and daycare center closures were warranted, others may not have been. Finally, and perhaps most important, it is becoming increasingly apparent that the lay public's understanding of infectious agents and the outbreaks that they cause is grossly deficient and must be improved. 

We live in a world where viral pandemics, food poisoning outbreaks and infections caused by multiple-antibiotic resistant bacteria are becoming commonplace. While vaccines, antivirals and antibiotics can afford some protection against many viral and bacterial disease, the best way to fight infectious diseases is to understand what causes them, how they are spread and what public health measures can be implemented to prevent or control their transmission. Until the world becomes better educated about infectious diseases, we will continue to be overly-dependent on the news media during future outbreaks and epidemics.

Until next time....

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

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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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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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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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The regulatory problems at Wyeth continue. The US Food and Drug Agency announced that it issued an approvable letter for Tygacil (Wyeth’s tetracycline-like antibiotic) to treat community acquired pneumonia (CAP). Apparently, FDA regulators want more data on the effectiveness and safety of Tygacil in severe cases of CAP and additional information on possible liver toxicity.

Tygacil, an intravenously administered antibiotic, won FDA approval in 2005 to treat adults with complicated intra-abdominal infections and complicated skin and skin-structure infections. Tygacil had about $138 million in sales last year; falling far short of the projected $500-$800 million in annual sales that it was expected to yield when it was first brought to market. If Wyeth gains approval for CAP, expect Tygacil sales to soar.

In other regulatory news, FDA granted Wyeth “fast-track approval” for a new version of its market-leading pediatric pneumococcal vaccine called Prevnar. The new 13-valent formulation will provide protection against 13 different pneumococcal serotypes. The older version only provided protection against 7 serotypes. Wyeth hopes to complete its filing for pediatric use of the new Prevnar vaccine in early 2009. Prevnar is Wyeth’s second-leading product with sales of about $2.5 billion in 2007.  

The new Prevnar vaccine will likely go head-to-head with GlaxoSmithKline’s new 10-valent pneumococcal vaccine  called Synflorix^Tm which is in late stage clinical development and is currently being reviewed for marketing approval in the EU. Unlike Wyeth’s vaccine, Synflorix^Tm  was found to be effective in protecting against otitis media (ear infections) caused by Haemophilus influenzae.

Until next time,

Good Luck and Good Job Hunting (avoid Collegeville, PA)!!!!!!!!

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Metals like copper and silver have long been known to possess antibacterial properties. I learned this as an undergraduate microbiology major circa 1972. That said, I didn’t know whether to laugh or cry when I read an article in today’s NY Times entitled "Regulators Stamp Copper as a Germ Killer". According to the article, the Copper Development Association (CDA), a NY-based trade group for copper companies, announced that federal regulators at the US Environmental Protection Agency (EPA) approved its application to market copper, bronze and brass-containing products as antibacterials that are effective enough to protect against bacterial infection. Apparently, what made this newsworthy is that this is the first time that EPA has allowed health claims to be attached to a solid antimicrobial material (rather than an aerosol or liquid disinfectant). For those of you who may not know, EPA (not FDA) regulates antimicrobial agents like disinfectants and air fresheners that are not directly applied to the human body.

Not surprisingly, there are many consumer products already on the market which are impregnated with silver and some other antimicrobial substances that claim to reduce the risk of infection.  Some of the more creative and pricey ones include silver-coated computer keyboards and mice manufactured by Iogear. However, none of the companies that manufacture these products can legally claim that the impregnated metals in them kill bacteria or provide a health benefit because they never thought to submit data to  EPA regulators to substantiate these claims. This is marked contrast with the CDA which smartly and painstakingly performed “clinical studies” for the past 4 years with copper and its alloys (mostly door knobs) to gain regulatory approval to claim that these metals have bona fide antibacterial properties. According to a CDA spokesperson, additional “clinical trials are underway to test how copper bed rails, arm rests and other hospital fixtures can reduce the numbers of bacteria in hospitals.”

Don’t get me wrong–you gotta love the creativity of the CDA for developing an innovative business strategy to help maintain the price of copper and bolster the sales of copper-based products. As you may know, the advent of fiber optics and silicon chips has been steadily pushing the price of copper down for the past few years–something that the CDA is keenly aware of.  Unfortunately, in contrast with CDA’s new vision, I believe that the only way to effectively reduce the high bacterial loads in our hospitals is through vigorous enforcement of hospital sanitation and hygiene programs, regular screening of hospital personnel and routine environmental monitoring.  Based on over 30 of experience with food borne and nosocomial bacterial diseases, I firmly believe that improperly sterilized equipment and instruments and people who are either unsuspecting carriers or fail to maintain good sanitation and hygiene practices are the main causes of bacterial contamination and transmission in hospital settings. I don’t think that inanimate metal objects (which have long been known to have inherent antimicrobial properties) contribute to the high levels of bacteria that are commonly found in today’s hospitals. Nor do I think that replacing existing hospital fixtures with copper, brass or bronze ones will do much to reduce bacteria levels in most hospitals.  Nice try CDA–but no cigar this time (at least not from me)!

Until next time….

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

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We all know (or should know) that eating dirty or yellow snow is a big “no-no”. Those of us who are parents (and live in regions where there are regular snowfalls) teach our children this lesson as quickly as possible. That said, should parents worry when their children eat new or freshly falling snow because it contains air-borne bacteria? 

Last week, a group of scientists at Louisiana State University reported in Science magazine that there may be a relationship between ice-nucleating, air-borne bacteria and global rainfall patterns. For those of you who don’t know, the formation of ice in clouds is required for snow and most rainfall. Although dust and soot particles serve as ice nucleation particles, bacterial ice nuclei are capable of catalyzing freezing more quickly at much warmer temperatures and their presence in the atmosphere may affect the processes that trigger precipitation. Results from the Science study suggested that bacteria like Pseudomonas syringae, which have long been know to serve as nucleators and induce ice formation, are widely distributed in the atmosphere and likely play critical roles in influencing the amount of rain that falls at various locations in the world–pretty cool new stuff for those of us interested in global warming and climate change in general. Therefore, it surprised me when I saw that lay newspaper reporters chose to “cherry pick” data from the paper to suggest to Americans that even freshly fallen snow contains large numbers of bacteria and that, perhaps, parents should be careful when they allow their children to eat snow!

As a card-carrying microbiologist and seasoned science educator, I want to assure all of you that eating freshly fallen snow will not cause disease in you or your children. The types of bacteria found in the atmosphere, and ultimately in snow, are not human pathogens and don’t cause disease. Thankfully, in a story entitled “Study: Driven snow isn’t all that Pure” that appeared in my local paper (The Trenton Times)– a member of the American Academy of Pediatrics Committee on Environmental Health was quoted as saying ; “We eat stuff that’s covered with bacteria all the time, and for the most part, it is killed in the stomach.” Another pediatrician, who is a member of the academy’s committee on infectious diseases, reinforced the claim that snow munching was not harmful and said “Children practically bathe in bacterial when they go to the playground and they won’t get anything from snow that they would not get from dirt.”  

Although most of the stories about bacteria and snow munching that appeared in the lay media were “fluff pieces”, they did alarm some parents! As one mother said in the Trenton Times article: “When I heard bacteria, at first, I went “eeeewwww”. But as long as the kids eat snow as it’s falling, I think it is okay. I tell them not to eat it if it’s on the ground.” What was particularly troubling about her remark was her initial negative reaction to the mere mention of the word bacteria. Unfortunately, most Americans have little understanding about bacteria and the negative impressions that they have formed are based on the sensationalistic and often scientifically inaccurate pieces about “dangerous” bacteria and fungi (mold) that often appear in print media and on television.

In my opinion, America’s negative attitude and poor understanding of science is a consequence of ongoing, misguided science reporting that has plagued this country for years. Although the American lay news media is mostly responsible for this, scientists are also complicit because of their unwillingness or inability to publicly speak out on important scientific issues and problems.

I believe that scientists are obliged to do everything in their powers to ensure that lay science reporting is fair and balanced and that the correct scientific messages reach the American public. Our failure to act will surely jeopardize the future of American science–something that we Americans can ill afford. Enough said–have a plate of snow on me!

Until next time….

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

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