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On episode #2 of the podcast This Week in Microbiology, Vincent, Cliff, and Michael review a fatal laboratory acquired Yersinia pestis infection, and how gut bacteria which are part of the normal flora of all animals control body weight and metabolic activity.

For those of you who may not know, bubonic plague—which killed thousands of people during outbreaks in the Middle Ages —still occurs at a low level in many places through out the world including sporadic cases in the Western US! About 10 to 20 Americans catch plague each year, and 1 to 3 die of it, according to the Centers for Disease Control and Prevention. Nowadays, most cases are in the Four Corners area, where Utah, Arizona, New Mexico and Colorado meet, and most victims live in rodent-infested rural housing. Despite the fear that the word plague induces in most people, the infection is easily treated with antibiotics if caught earlier enough (modern antibiotics were discovered in the 1940s starting with penicillin).

"Bring out your dead"from Monty Python and The Holy Grail

Y. pestis, the bacterium that causes bubonic plague, lives in the blood of infected prairie dogs and ferrets and other rodents and can be transmitted to human via bites from infected fleas (which are commonly found in wild rodent populations) that have previously had a blood meal on -infected animals. Interestingly, an article appeared in the NY Times last Fall, which linked climate change (aka global warning) to a reduction in the incidence Y. pestis infections in the Western US.

The article cited a study in the American Journal of Tropical Medicine and Hygiene, which  tracked climatic conditions in 195 counties in 13 Western states, from Washington to Texas, that reported even one plague case since 1950.

Cases of plague have dropped over time, and authors of the study concluded that rising nighttime temperatures since 1990 may have helped to reduce the incidence of plague. They suggested that warmer nights melt winter snow packs earlier than in the past, leading to drier soil in rodent burrows. When the soil gets too dry, fleas die and plague can no longer be transmitted from infected rodents to human hosts. Talk about an upside for global warming!!!!!!

While this may be good news for potential plague victims, the incidence of plague in the US is so low that the public health benefits offered by climate change may be nominal as compared with the damage that global warming will cause if continues unchecked. That said, who knew that climate change and bacterial pathogenesis were interconnected?

To learn more about the less well known interrelationships between bacteria, animals and the planet we invite you to continue to listen to TWiM. You can subscribe to TWiM (free) at the Zune Marketplace, via RSS feed, by email or listen on your mobile device with the Microbeworld app.

Until next time...

Good Luck and Good Listening!

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Layoffs at big pharma companies have become commonplace but downsizing at generic manufacturers? Aren’t generic drugs sales exploding through the roof? And, aren’t all major pharmaceutical companies facing patent cliffs responsible for the massive downsizing that has taken place over the past four years? Teva executives apparently didn’t get that memo and announced today that the company will lay off 200 employees at its Irvine, CA manufacturing facility. Of the 200, 195 will lose their jobs by February 6, 2011.

This is the second round of layoffs at the manufacturing facility that Teva acquired after purchasing biosimilar manufacturer Sicor Inc., in 2003 for $3.4 billion. Last July, 70 jobs were eliminated at the plant which previously manufactured Propofol, the powerful sedative implicated in Michael Jackson’s death. Teva has since discontinued production of the drug because of the drug because it was hard to manufacture and that the company got little or no profit from it.

The company had to halted production and recalled some Propofol in 2009 after 41 patients were sickened with flu-like symptoms. The problem resulted from elevated endotoxin levels found in some vials of the sedative. Several lawsuits also were filed over the drug.

Until next time...

Good Luck and Good Job Hunting!!!!

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My son, who is a 9^th grader, was recently asked to write an essay for his social studies class about the application of Machiavellian principles to modern day rulers and governments. One of Machiavelli’s ideas that he chose to write about was the notion that a good ruler or government must do it’s very best to insure the safety and health of its subjects or constituents. While this may seem altruistic or philanthropic don’t be fooled—workers who are afraid, unhealthy or regularly ill aren’t productive and can threaten the economic well-being and stability of a society. In any event, he asked me to help with a modern day example of how safety can be reconciled with the Machiavellian principle; “the end justifies the means.” As an infectious disease professional, I quickly realized that mandatory vaccination of newborns and school-aged children against viral and bacterial diseases is a great example.

Prior to the development and subsequent worldwide use of childhood vaccines, epidemics and pandemics of smallpox, measles, polio, diphtheria and other serious diseases routinely ravaged the planet with impunity. During the recurring outbreaks, large numbers of people became ill, and while some sustained life-long debilitating injuries, many others suffered long, painful and excruciating deaths. The recognition that often devastating and regularly occurring outbreaks and epidemics could threaten the well being— and possibly destabilize monarchies and democratically elected governments—  led to the development of  20^th century vaccines against many bacterial and viral childhood diseases. However, it is important to note, while most vaccines are safe and offer protection for many individuals (typically 90% or higher), a small percentage (usually 1% to 5%) of those vaccinated, may experience side effects ranging from mild to severe and possibly life threatening. I believe that vaccination is a polemic for the “ends justify the means” principle because while some vaccinated individual may suffer serious side effects or death greater numbers will benefit from the protection and safety afforded by most vaccines. In other words, governments must be willing to risk harm and possibly death to some of its citizens to insure the productivity, well being and ultimately the safety of the majority.

Despite the medical and health benefits of vaccines, the anti-vaccine movement in the US has steadily been gaining strength of late. Vaccine opponents’ fears have been stoked and promulgated by bogus clinical data offered by fraudulent scientists (which have subsequently been discredited and refuted) and media outlets seeking sensational stories to sell magazines and newspapers. Last week, a 14 year old British girl died shortly after being vaccinated with Cervarix, GlaxoSmithKline’s (GSK) cervical cancer vaccine. This story was quickly pounced upon by the British tabloids and widely circulated.  In the end, the safety of the Cervarix—a vaccine administered to 1.8 million girls without a single death similar to the one that had occurred—became suspect. Almost immediately, anti-vaccine advocates publicized this unfortunate incident as another other reason why parents shouldn’t vaccinate their children. The girl’s death prompted UK officials to immediately suspend all nationwide Cervarix vaccinations; even though an autopsy hadn’t been performed to determine the actual cause of the girl’s death. After an autopsy was finally performed, British health officials announced that the girl had a large cardiac tumor that had infiltrated one of her lungs and that it was likely cancer not Cervarix that caused her death. Unfortunately, the media’s feeding frenzy fanned by the anti-vaccine lobby’s loud voice may have cost GSK US FDA approval of  Cervarix—a product approved and safely used in over 100 countries! 

About three weeks prior to the British girl’s death, an FDA advisory committee unanimously recommended approval of Cervarix. Generally, the agency follows recommendations of its advisory committees. Ironically, the girl’s death occurred several day’s prior to an FDA decision on whether or not to approve Cervarix. Much to the surprise of many industry experts, this past Tuesday, FDA delayed its decision on Cervarix’s approval. FDA spokespeople claimed that the girl’s death had no bearing on its decision to delay Cervarix’s approval (if you believe that, would any of you be interested in some land in Florida?).

It is no secret that GSK has struggled to get Cervarix approved in the US —a decision on its approval has been delayed three times over the past several years. In the interim, the company has managed to successfully address all of the agency’s concerns over Cervarix’s safety and efficacy.

FDA’s decision to delay Cervarix’s approval is great news and something of a victory for Merck, the manufacturer of Gardasil— the ONLY cervical cancer vaccine approved in the US and Cervarix’s main competitor. Failure of Cervarix to win FDA approval will undoubtedly help Merck to bolster Gardasil sales and help it maintain its stranglehold on the US anti-cervical cancer market for the foreseeable future!

Until next time...

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

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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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It has been a long standing practice of mine to avoid co-mingling science and religious issues in any of the materials that I post online. I have refrained from doing this because I believe that enough tension already exists between religious advocates and scientists.   However, I was unable to control myself today after my wife pointed out two interesting articles in Wednesday’s New York Times.

The first article dealt with Pope Benedict XVI’s views on condom use and HIV transmission in Africa. Yesterday in Cameroon, he publicly said, for the first time, that condoms are not the answer to Africa’s fight against AIDS. Not only did this statement send a collective shiver down the spines of many HIV health workers, clergy working with AIDS patients are divided on the issue. The pope told reporters that “You can’t resolve it with the distribution of condoms. On the contrary, it increases the problem.” Apparently, church dogma suggests that fidelity in marriage and abstinence from premarital sex are crucial weapons in the fight against AIDS. There are currently 22 million people in sub-Saharan Africa infected with HIV and three-quarters of all HIV/AIDS deaths occur in the region. Apparently, attempting to be faithful and just saying no doesn’t seem to work in Africa—or anywhere else! The pope’s statement prompted a representative from the Treatment Action Campaign in South Africa to say “Instead, his opposition to condoms conveys that religious dogma is more important to him than the lives of Africans.” Ironically, Africa is the fastest-growing region for the Roman Catholic Church.

The second article reported the results of a study which showed that terminally ill cancer patients who drew comfort from religion were almost three-times as likely to seek aggressive, life-prolonging treatments as compared with less religious patents. Also, the most religious patients were much more likely to ask doctors to do ‘everything possible to keep them alive.’  Study results showed that patients who were devout were three times as likely as less religious patients to be put on a mechanical ventilator to maintain breathing during the last week of life, and they were less likely to do any advance care planning, like signing a do-not-resuscitate order or preparing a living will. The findings prompted one of the study’s authors—it will appear in Wednesday’s Journal of the American Medical Association (JAMA)—to say “People think that spiritual patients are more likely to say their lives are in God’s hands — ’Let what happens happen’ — but in fact we know they want more aggressive care.” To explain this apparent paradox, the author speculated “To religious people, life is sacred and sanctified and there’s a sense they feel it’s their duty and obligation to stay alive as long as possible.” Alternately, in my opinion it may be that religious people haven’t adequately dealt with the possibility of their demise and are hoping for miracles—medical or religious— to keep them alive because they are deathly (pun intended) afraid of dying? Regardless, aggressive life-prolonging care is expensive, Medicare spends about one-third of its budget on people who are in their last year of life and much of that is spent on patients at the very end of their lives. Moreover, researchers have found that aggressive end-of-live care for terminal patients frequently can lead to a more painful process of dying and greater shock and grief for family members.

One of the few places in the world where the nexus of religion and science is difficult to fathom is the US—one of the most scientifically advanced and religious nations in the world. Several years ago, I met a scientist at a FASBEB Career meeting who, for the first time, was able to successfully articulate to me how science and religion can co-exist in American society (she taught in the South). While I can’t recall her exact words, she said something like “Both science and religion have their purpose and place in society. However, they are belief systems that are not interchangeable. That is why I can believe in God and still fully endorse and embrace evolution. They serve different purposes for me and help me to live my life.” With this in mind, I don’t think that religious dogma should be invoked when it comes to treating patients or inhibiting advances in public health, science and medicine.

Until next time...

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

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