|Image via Wikipedia|
|Image via Wikipedia|
CAMBRIDGE — Move over, coffee and Red Bull. A Harvard professor thinks the next big thing will be people inhaling their caffeine from a lipstick-sized tube. Critics say the novel product is not without its risks.
The product, called AeroShot, went on the market late last month in Massachusetts and New York, and is also available in France. A single unit costs $2.99 at convenience, mom-and-pop, liquor and online stores.
Biomedical engineering professor David Edwards said AeroShot is safe and does not contain common additives, like taurine, used to amplify the caffeine effect in common energy drinks. Each grey-and-yellow plastic canister contains 100 milligrams of caffeine powder, about the amount in a large cup of coffee, plus B vitamins.
But Democratic U.S. Sen. Charles Schumer of New York wants the U.S. Food and Drug Administration to review AeroShot, saying he fears it will be used as a club drug so that young people can drink until they drop. Schumer’s national press secretary did not immediately respond to calls for comment.
FDA spokeswoman Siobhan DeLancey declined to comment, saying the agency will respond directly to Schumer on the matter.
Edwards said Schumer’s comments are understandable in the context of developments over the last few years, when students looking for a quick and cheap buzz began consuming caffeine-packed alcoholic drinks they dubbed “blackout in a can” because of their potency. But he said AeroShot is not targeting anyone under 18 and it safely delivers caffeine into the mouth, just like coffee.
“Even with coffee — if you look at the reaction in Europe to coffee when it first appeared — there was quite a bit of hysteria,” he said. “So anything new, there’s always some knee-jerk reaction that makes us believe ‘Well, maybe it’s not safe.’ ”
Once a user shoots a puff of calorie-free AeroShot into his or her mouth, the lemon-lime powder begins dissolving almost instantly. Each single-use container has up to six puffs.
“The act of putting it in your mouth is the act of breathing — so it’s sort of surprising and often people the first time they take the AeroShot, they laugh … that it’s kind of a funny way of putting food in your mouth,” said Edwards, who also came up with a breathable chocolate product a few years back.
Dr. Lisa Ganjhu, a gastroenterologist and internal medicine doctor at New York-based St. Luke‘s-Roosevelt Hospital, said people need to be aware of how much caffeine they are ingesting.
“You want those 10 cups of coffee, it will probably take you a couple hours to get through all that coffee with all that volume that you are drinking,” Ganjhu said. “With these inhale caffeine canisters you can get that in 10 of those little canisters — so you just puff away and you could be getting all of that within the hour.”
Even the product packaging warns people not to consume more than three AeroShots per day.
Northeastern University students who sampled the product recently gave it mixed reviews.
“This tastes really good and I think it rocks,” student Zack Huang said after puffing onto a free sample before rushing to join a group of friends who were walking away from campus.
Still, one student was not happy with the taste, echoing sentiment expressed online by some consumers.
People elsewhere vowed they would never give up their morning coffee.
“I want to brew it, I want to stir it and I want to drink it slowly as I absorb the caffeine,” said longtime coffee fan Mark Alexander.
The makers of AeroShot appear to be aware of that sentiment, declaring that the product isn’t about switching away from coffee, but rather making it easier for people with active lifestyles to get their caffeine fix.
“AeroShot can be used in a variety of settings inconvenient for liquids, such as when you study in the library, board an airplane or get into the car for a long drive,” they say in the section dedicated to frequently asked questions on their website. “It’s easy to take AeroShot with you when you go biking, skiing, curling, or any other activity that consumes energy.”
AeroShot, manufactured in France and the flagship product of Cambridge-based Breathable Foods Inc., is the product of a conversation that Edwards had with celebrity French chef Thierry Marks over lunch in the summer of 2007.
“We were discussing what interesting culinary art experiments we might do together and I had the idea that we might breathe foods since I’ve done a lot of work over the last 10 or 15 years on medical aerosols,” Edwards said.
The first venture Edwards worked on with Harvard students was the breathable chocolate, called Le Whif. Now he’s preparing to promote a product called Le Whaf, which involves putting food and drinks in futuristic-looking glass bowls and turning them into low-calorie clouds of flavor.
Revisores: Ochoa Sangrador C1, Andrés de Llano JM2
1Servicio de Pediatría. Hospital Virgen de la Concha. Zamora (España).
2Servicio de Pediatría. Hospital General del Río Carrión. Palencia (España).
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The original Google Docs document contains more details, negative and positive social media-related pharma case studies as well.
Dr. Bertalan Mesko
OBJECIONES EN RELACION CON AMBAS VACUNAS DISPONIBLES CONTRA EL VIRUS DEL PAPILOMA HUMANO
(especial para SIIC © Derechos reservados)
|Se presenta un análisis del diseño, evaluación, aplicación y seguimiento de las 2 vacunas disponibles contra el HPV llevado a cabo por ambos laboratorios fabricantes para comentar sobre su aplicación. Se incluye una breve revisión bibliográfica sobre la historia natural del HPV, el comportamiento del sistema inmune y otros factores en el desarrollo del cáncer cervical uterino.|
Columnista Experto de SIIC
Hospital Materno-Neonatal Artículos publicados por Teresita Audisio
Vainer Osvaldo*** Ramallo Rogelio* Vásquez Federico** Ringelheim Claudia**** Pelliza Palmes Maria Nuria****
Doctor, Clínica del Niño, Córdoba, Argentina*
Doctor, Clínica del Noreste, Córdoba, Argentina**
Doctor, Hospital Materno-Neonatal, Córdoba, Argentina***
Doctora, Hospital Materno-Neonatal, Córdoba, Argentina****
|Recepción del artículo
10 de marzo, 2010
26 de junio, 2010
26 de agosto, 2011
|Segunda edición, ampliada y corregida
21 de septiembre, 2011
Las infecciones genitales por el virus papiloma humano (HPV) son altamente frecuentes tanto en adultos como en niños; varios estudios demuestran la relativa frecuencia en esta población de los serotipos oncogénicos del HPV (16 y 18), como sus proteínas tempranas (early proteins); por lo que se objeta que la vía de transmisión sexual sea la única. El comportamiento biológico de las neoplasias intraepiteliales cervicales (CIN) I y II en las adolescentes y adultos jóvenes es similar y presenta una alta tasa de regresión espontánea. Por lo tanto, la indicación de las dos vacunas para el HPV disponibles actualmente en el comercio no condice con la historia natural del HPV y las CIN. Los estudios realizados con ambas vacunas han demostrado la baja efectividad y el efecto contraproducente cuando los sujetos eran ADN-HPV positivos a los tipos de HPV que contiene la vacuna, por lo que sería peligroso vacunar si no está asegurado el control de los sitios donde se ubican los tipos de HPV, como el aparato genital. Además, el corto seguimiento de los estudios realizados con ambas vacunas no permitió observar la repercusión en el estado inmunitario, como también el remplazo por los serotipos de HPV que no contiene la vacuna. La rápida autorización de la US Food and Drug Administration (FDA) y de la European Medicines Agency (EMEA) llevó a la introducción de la vacuna en muchos países, sin tener en cuenta las indicaciones y las repercusiones mencionadas.
Clasificación en siicsalud
Artículos originales > Expertos de Iberoamérica >
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Genitals infection through human papilloma-virus (HPV) is frequently found in both adults and children, and several studies show the relative frequency of oncogenic HPV (16 and 18) in this population as well as their early proteins. This is why we object to the claim that this virus is exclusively sexually transmitted. The biological behavior of cervical intraepithelial neoplasia (CIN) I and II in teenagers and young adults is similar, presenting high spontaneous regression. Therefore, the indications for the two HPV vaccines do not match the natural history of HPV and CIN. The studies performed with both these vaccines have shown their low rate of efficacy and their counterproductive effect when the vaccinated subjects were HPV DNA positive to the HPV types in the vaccine, on account of this, vaccination without control of possible HPV type locations such as the genital apparatus would be dangerous. Besides, the short follow-up that has been made of the studies carried out with both vaccines has not allowed us to see their effects on immune system status nor on possible replacement by other types of HPV not contained in the vaccine. The fact of its rapid authorization by the U S Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) led to the introduction of the vaccine in many countries without considering its indications and the repercussions mentioned above.
Bibliografía del artículo 1. VRBPAC. VRBPAC background document. Gardasil HPV quadrivalent vaccine. Vaccine and Related Biological Products Advisory Committee Meeting. Washington, DC, USA; May 18, 2006 http://www.fda.gov/ohrms/dockets/ac/06/briefi ng/2006-4222B3.pdf (accessed may 20, 2008).
Image by PHYLOMON! via Flickr
Delayed FDA Removal of Painkiller Propoxyphene (Darvon, Darvocet) From U.S. Market Has Cost More Than 1,000 U.S. Lives
Statement by Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group
Note: Public Citizen petitioned the FDA in 1978 and 2006 to ban propoxyphene.
The announcement by the U.S. Food and Drug Administration (FDA) that propoxyphene-containing products are finally going to be taken off the market * because of dangers previously known and acted upon, with bans announced in the UK almost six years ago, and in Europe, almost 1½ years ago * is a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller. In announcing the ban in 2005, the UK stated that the efficacy of propoxyphene (sold generically and under the brand name Darvon) “is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable” and that “[I]n relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal therapeutic dose and a proportion of fatalities are caused by inadvertent overdose.” The FDA’s claim that this is the first evidence that the drug is dangerous at the “standard therapeutic dose” thus rings dangerously hollow.
The FDA’s deadly delay in this case starkly illustrates how one of the most important public health concepts, the precautionary principle, was embraced by the UK and Europe, but was for too long recklessly rejected by the FDA.
Evidence going back more than 30 years indicates that propoxyphene is not very effective, is toxic at doses not much higher than the recommend dose because a heart-toxic metabolite accumulates in the body, and is somewhat addictive. It has been linked to many thousands of U.S. deaths since 1981, a large proportion of which were likely caused by cardiac toxicity, including the interruption of electrical conduction in the heart.
Since the time of the UK announcement in January 2005 of a phased, two-year withdrawal of this drug (which was followed by an immediate steep decline in use), approximately 120 million retail prescriptions have been filled in the U.S. for propoxyphene-containing drugs. These include Darvocet, which contains propoxyphene and acetaminophen and, primarily, the generic versions of the drug.
Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since time the UK ban was announced. The best forensic data, the kind relied upon in those countries for the UK and European bans, come from Florida where, because of routine drug testing required by the state medical examiner as part of many autopsies, deaths are categorized as being “caused” by certain drugs if the levels found are to be above a certain level. From 2005 through 2009, in Florida alone, 395 deaths were “caused” by propoxyphene. If data from 2007 are representative, in that year, 78 percent of the Florida deaths caused by propoxyphene were ruled accidental.
Our February 2006 petition to the FDA to ban the drug, following the UK ban announcement, did not even result in an FDA advisory committee hearing until we had sued the agency in 2008 to force them to respond to our petition. The subsequent January 2009 FDA advisory committee hearing resulted in a 14-12 vote in favour of banning propoxyphene, despite some FDA efforts to sway the committee against voting for a ban. In July 2009, several weeks after the European Medicines Agency announced its ban, the FDA denied our petition to ban the drug.
The FDA’s pitiful excuse that it needed to order a human study to find that “the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities” before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world * which already had enough human evidence of death and near-death in tens of thousands of people to act accordingly.
In a study on dogs published 31 years ago, researchers at Lilly, the discoverer of propoxyphene, stated that “cardiac conduction depression may be a factor in some of the [human] cardiac toxicities associated with propoxyphene overdose.” This study examined the same kind of function measured in the human study now being put forth by the FDA as a justification for belatedly banning propoxyphene.
We will ask for and support a congressional investigation into whom in the FDA, specifically in the Centre for Drug Evaluation and Research, was responsible for the loss of so many lives in this country. It is clear that long before today, many drug safety experts in the Office of Surveillance and Epidemiology had decided the drug should be removed from the market.
Note: For a chronology of events related to Darvon and Darvocet, go to
Public Citizen is a national, non-profit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.
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