FDA warns doctors of counterfeit Botox






WASHINGTON (AP) — Federal regulators have warned more than 350 medical practices that Botox they may have received from a Canadian supplier is unapproved and could be counterfeit or unsafe.


The Food and Drug Administration said in a letter sent last month, a letter released publicly last week, that batches of the wrinkle treatment shipped by suppliers owned by pharmacy Canada Drugs have not been approved by the FDA and that the agency cannot assure their effectiveness or their safety.






The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.


The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. It is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs.


In February, the agency warned 19 medical practices that they had received a counterfeit version of the cancer drug Avastin. On three more occasions the FDA issued similar warnings about counterfeit Avastin and Altuzan, another brand name for the same drug. The alerts were also primarily targeted at drugs distributed by Canada Drugs.


A request for comment from the drug distributor was not immediately returned.


Drug shortages increased the financial incentives for some pharmacies to provide counterfeit or illegally imported drugs. The drugs subject to warnings have all been injectable treatments typically distributed through medical practices and not directly to patients.


In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs. The site was still operating Friday.


Genuine Botox is made by Allergan Inc., based in Irvine, Calif. Avastin is made by Roche Holding AG’s Genentech unit.


___


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Snow threatens post-Christmas travel




A huge storm that dumped heavy snow and rain on the West Coast is
expected to move east and could spoil travel plans for people looking to
return home the day after Christmas, which is considered one of the
busiest travel days.

The powerful storm that has already blanketed much of Northern California is expected to move east over the next few days and drop snow from Oklahoma starting today before finishing up in the Northeast sometime Wednesday.



The Midwest will be covered with snow by Wednesday, likely causing delays at major airports in cities including Cleveland, Detroit, St. Louis and Chicago just in time for post-Christmas travel, when millions of Americans will be on the move.



Snow could arrive in the Northeast by Thursday, dropping 1-3 inches over parts of New England.



In Syracuse, N.Y., plows are working overtime, dealing with two consecutive days of snow this weekend during the city's first snowstorm of the season. As the city continues to dig out, all eyes are watching the storm roll in from the west.



Torrential rain and heavy winds have also caused trouble for California's Bay Area over the weekend, which has seen severe flooding, power outages and delays for those planning to fly out for the holidays.



Ryan Damstra of Northern California spent seven hours at San Francisco's International Airport Sunday but was not able to fly.



"After I found out my flight had been canceled after four hours of waiting in the airport, I had to wait another three hour customer service line," Damstra told ABC News Radio.



More than 400 flights were canceled on Sunday at San Francisco International Airport. Travelers had to deal with more than 200 cancelations on Saturday.



So far this month San Francisco got almost five inches of rain that is almost twice as much as they get for the entire month of December.



Severe snow and rain are not the only issues facing Americans looking to get home before the New Year. Several states in the Gulf of Mexico all the way from Houston to Raleigh, N.C., are bracing for possible tornadoes starting today and lasting until Wednesday.



The biggest chance for tornadoes will be tomorrow from Houston to New Orleans to Birmingham and Atlanta.



AAA predicts 93.3 million people will travel more than 50 miles this holiday season, from Saturday through New Year's Day. That's a 1.6 percent increase from last year. Christmas is the third-busiest holiday for travelers, after Memorial Day and Thanksgiving.



AAA is urging drivers to leave earlier or later to dodge bad weather.



ABC News' Max Golembo contributed to this report.

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Pro-gun rights US petition to deport Piers Morgan






LONDON (AP) — Tens of thousands of people have signed a petition calling for British CNN host Piers Morgan to be deported from the U.S. over his gun control views.


Morgan has taken an aggressive stand for tighter U.S. gun laws in the wake of the Newtown, Connecticut, school shooting. Last week, he called a gun advocate appearing on his “Piers Morgan Tonight” show an “unbelievably stupid man.”






Now, gun rights activists are fighting back. A petition created Dec. 21 on the White House e-petition website by a user in Texas accuses Morgan of engaging in a “hostile attack against the U.S. Constitution” by targeting the Second Amendment. It demands he be deported immediately for “exploiting his position as a national network television host to stage attacks against the rights of American citizens.”


The petition has already hit the 25,000 signature threshold to get a White House response. By Monday, it had 31,813 signatures.


Morgan seemed unfazed — and even amused — by the movement.


In a series of Twitter messages, he alternately urged his followers to sign the petition and in response to one article about the petition said “bring it on” as he appeared to track the petition’s progress.


“If I do get deported from America for wanting fewer gun murders, are there any other countries that will have me?” he wrote.


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FDA warns doctors of counterfeit Botox






WASHINGTON (AP) — Federal regulators have warned more than 350 medical practices that Botox they may have received from a Canadian supplier is unapproved and could be counterfeit or unsafe.


The Food and Drug Administration said in a letter sent last month, a letter released publicly last week, that batches of the wrinkle treatment shipped by suppliers owned by pharmacy Canada Drugs have not been approved by the FDA and that the agency cannot assure their effectiveness or their safety.






The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.


The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. It is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs.


In February, the agency warned 19 medical practices that they had received a counterfeit version of the cancer drug Avastin. On three more occasions the FDA issued similar warnings about counterfeit Avastin and Altuzan, another brand name for the same drug. The alerts were also primarily targeted at drugs distributed by Canada Drugs.


A request for comment from the drug distributor was not immediately returned.


Drug shortages increased the financial incentives for some pharmacies to provide counterfeit or illegally imported drugs. The drugs subject to warnings have all been injectable treatments typically distributed through medical practices and not directly to patients.


In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs. The site was still operating Friday.


Genuine Botox is made by Allergan Inc., based in Irvine, Calif. Avastin is made by Roche Holding AG’s Genentech unit.


___


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The FDA’s warning letter, plus a list of doctors who received it: http://1.usa.gov/R7jKiR


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Atheist Kids and Bullying: Just an Xbox and a Football Game Away From Redemption






I’ll never forget the year my eight-year-old daughter came home from school saying she got in trouble for going to the bathroom.


“I was afraid,” she said, “that the devil was coming out of the mirror to get me…. I wanted Aya to stay with me until I was done.”






Like any parent, I sat her down and asked her to tell me why she would ever think a mirror could spawn something as terrifying as that.


“Susie told me because I didn’t believe in god, the devil was coming to take my soul.”


MORE: Bullying the Bullies: What to Do to Save the Next Amanda Todd


“Susie” as we’ll call her, was a fellow eight-year-old student at my daughter’s Catholic school. Susie attended church every Sunday with her family—the same church that many of her classmates to this day all go to.


Was my daughter being bullied for being an atheist? I quickly dismissed it. After all, these were only eight-year-old girls, and it wasn’t like we talked about god hating with our morning cereal.


I soon noticed a new pattern of my daughter: She wouldn’t enter a bathroom without a friend or parent and began wetting the bed at night for fear of our extensive collection of bathroom mirrors pulling her into almighty hell at 2 a.m.


Sure enough, the religious eight-year-old was still pressuring my daughter to consider her morality, spirituality and reason for living daily in the school bathroom.


“When the child goes to school, and encounters for the first time other kids who don’t believe the same thing, whether it’s no belief or a different belief system, that can rock a kid’s world.”


I got on the phone and made sure the principal was aware of the bullying, that the child was reported and that my daughter would hopefully make the choice not to play with her anymore. The school thought I was a little crazy. Bullying was getting punched in the stomach in a dark place behind the school, not a little girl being taunted for not believing she was going to have life eternal. This was a new place they were afraid to gain control of. The principal, a former nun, kept a tight lip.


According to the American Society for the Prevention of Cruelty to Children, every day “an estimated 160,000 students in the U.S. refuse to go to school because they dread the physical and verbal aggression of their peers. Many more attend school in a chronic state of anxiety and depression.”


Courtney Campbell, Professor of Religion and Culture at Oregon State University, says he encountered the same case with his own children who were told at a very early age by some of their “friends” that they were “going to hell.” Though there were no physical beatings, the “psychic bullying” may have been worse.


“There is a phenomenon of religious-bullying at an early age, though in my own view/experience with raising my kids, it’s less of an issue than lookism [obese kids], size [‘big’ bullies], or gender, or clothes, or any of a number of things that kids do to manifest power over others,” says Campbell.


He points out that in most conservative/evangelical/fundamentalist Christian traditions, kids are taught at a very early age in their Sunday schools or summer bible camps that there’s only one path to happiness and salvation. That teaching, absorbed at a young age, is on its own rather threatening to the child.


“When the child goes to school, and encounters for the first time other kids who don’t believe the same thing, whether it’s no belief or a different belief system, that can rock a kid’s world,” Campbell adds.


Blame it on fear, maybe a calling out of one’s most sacred and learned family beleifs, but this form of push and shove is only getting more sophisticated.


Rachel Wagner, Associate Professor for the Department of Philosophy and Religion at Ithaca College and author of Godwired: Religion, Ritual and Virtual Reality, says we are overlooking a major player of the religious bullying model—video games.


“If we compare video games to rituals as similar kinds of interactive experiences that are meant to shape how we see ourselves and others in the world, then we can argue something more basic—that video games (like rituals) can teach people habits of encounter—and offer youth deeply problematic models of encounter with difference,” says Wagner, who adds that in her next book, she’ll argue that religion has always had the ability to be “played” like a game, a religious encounter she coins “shooter religion.”


While Wagner admits it’s very important to remember that all world religions also have “deep and abiding practices urging compassion, understanding, tolerance, and social justice,” in today’s media-soaked society, feeling the need to retreat into a simpler world where people can be reduced to camps can be terribly tempting.


Stacy Pershall, author of Loud in the House of Myself: Memoir of a Strange Girl, says that growing up in Prairie Grove, Arkansas, in an athletics-focused, Christian bible belt, she was used to being surrounded by “Jesus talk.”


Pershall, who was bullied for being a “strange girl,” when young, unathletic and atheist to boot, now works and empowers high school and college students as a writing teacher and mental health speaker.


“Although it still makes my heart pound a little to stand in front of a crowd and admit that I don’t believe in god (as I recently did at Catholic University in D.C.), somebody needs to do it. I get to be the adult who says to kids, ‘I’m an atheist, I have morals, I have friends, I’m happy, and I care about how you feel.’ That’s a wonderful, powerful thing. I get to tell bullied kids who might be considering suicide that they’re not alone, and that they have kindred spirits. It’s what the Flying Spaghetti Monster put me on Earth to do.”


Were you ever bullied? Leave what you were bullied about in COMMENTS.


These are solely the author’s opinions and do not represent those of TakePart, LLC or its affiliates.


Related Stories on TakePart:


• 5 Things to Keep in Mind About Bullying


• A Bully’s Paradise: Hidden Halls, Dark Corners and No Supervision


• Mother Bullied to Abort Unborn Twins?



Amy DuFault is a writer and editor whose work has been published in EcoSalon, Huffington Post, Ecouterre, Organic Spa, Coastal Living, Yahoo!, The Frisky and other online and print publications. In addition to being a former co-owner of an eco-boutique, she coaches and connects the sustainable fashion community to feed her soul. She also dreams of singing in an all-girl punk band even though she has stage fright. @amytropolis | TakePart.com


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New Zealand level series thanks to Guptill century






EAST LONDON, South Africa (Reuters) – A brilliant, unbeaten century from opener Martin Guptill led New Zealand to an eight-wicket victory off the final ball against South Africa in the second T20 international on Sunday.


Chasing 169 for victory in 19 overs at Buffalo Park, Guptill helped erase the memory of Friday’s embarrassing capitulation to 86 all out in Durban with a stunning batting display as the tourists reached their target for the loss of just two wickets to level the series 1-1.






Requiring 39 from the final four overs and 11 off the last, Guptill was on 97 and needing four for victory when Rory Kleinveldt bowled the final delivery – a low full toss which was eased away through extra cover.


Guptill’s unbeaten 101 was just the third T20 international century by a New Zealander, the first two belonging to captain Brendon McCullum who was almost anonymous with 17 from 15 balls during a second-wicket partnership of 73 with Guptill.


The right-handed opener was similarly dominant during an opening stand of 76 with Rob Nicol (25) as he drove the Proteas attack impeccably straight and displayed the skills – and patience – so obviously missing from the New Zealand batsman in Durban.


Captain Faf du Plessis led from the front once again as South Africa posted a competitive 165-5 in 19 overs after losing the toss and being asked to bat first.


Du Plessis paced his innings to perfection on a tricky pitch to reach 63 from 43 balls with eight fours and a six in a match reduced to 19 overs per side following a 52-minute floodlight failure.


The deciding match takes place in Port Elizabeth on Wednesday.


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3-day trip becomes 3-week ordeal for 2 Jamaicans






SAN JUAN, Puerto Rico (AP) — It was supposed to be a three-day fishing trip at most. It turned into a three-week ordeal, drifting under an intense sun for hundreds of miles in the Caribbean in a small boat with a broken motor.


The two Jamaican fishermen survived by eating raw fish they caught and drinking water from melted ice they had brought to preserve their catch. The Colombian navy finally plucked them from the sea a week ago and delivered them home Saturday after treating them for severe dehydration, malnutrition and hypothermia.






Everton Gregory, 54, and John Sobah, 58, recounted their story in a telephone interview from Jamaica, while the boat owner and the men’s employer also provided details.


The men set off from Jamaica’s southeastern coast on Nov. 20. The water was glassy, the wind was calm and their boat was laden with 14 buckets of ice, 16 gallons of water and several bags of cereal, bread and fruit.


They headed to Finger Bank, a nearby sand spit 8-miles-long (13-kilometers) that is known for its abundance of fish like wahoo, tuna and mahi mahi. The owner of the 28-foot (8-meter) boat said she usually joins them on fishing trips, but she couldn’t go that afternoon.


After spending a couple of days around Finger Bank, the two men set off for home with their catch. But the boat’s engine soon died. The water was too deep to use the anchor and the current too strong to use the oars, so the boat slowly drifted away from Jamaica.


At first, the men got by on sipping the water and eating the food they brought with them. But days turned into weeks, and they began to eat the fish they had caught and drink the melted ice that had kept it fresh.


Gregory and Sobah kept eating raw fish and used a tarp to try to collect water, but the rain clouds remained at a distance.


Back home, friends and family called police and used their own boats to search the area where the men were last seen. The two fishermen work for the Florida-based nonprofit group Food for the Poor, which chartered a plane to search along Jamaica’s coast.


Marva Espuet, the owner of the boat, said she knew she had packed it with more food and water than needed for a three-day trip, but the thought provided little relief.


“If I had gone, there would have been two boats going,” said the 52-year-old woman, a longtime friend of both fishermen.


With searches proving fruitless, Sobah’s niece grew frantic, recalled Nakhle Hado, a fishing manager for Food for the Poor who helped lead the search. She “begged me that she wanted John back for Christmas,” Hado said.


Hado said some people believed the two men would never be found, but he and others didn’t give up. “My gut was telling me that they were still alive,” he said.


Hado said he had trained Gregory and Sobah on how to survive at sea.


“In case something happens, they don’t have to think twice. They know how to react,” he said. “It’s very important, their mental state.”


Gregory and Sobah finally ran out of fresh water and went several days without drink. A healthy human being can die from dehydration anywhere from three to five days without water.


Then on Dec. 12, a Colombian navy helicopter patrolling off the coast of that South American country spotted the men near Lack of Sleep cay, more than 500 miles (800 kilometers) from where they started. It took two days for a navy vessel to reach them because of bad weather. The men were hospitalized for several days at the Colombian island of San Andres before boarding a plane back home to Jamaica.


“It feels good,” Sobah told the AP in a brief phone interview after arriving.


Gregory said he had lost hope, but Sobah tried to keep him positive that they would be rescued. “I just had that belief,” Sobah said. “I believe in the Creator.”


Yet it is Gregory who plans to keep fishing despite the ordeal because he needs the job.


Sobah said he’s done. “I’m not going to go fishing again. No way.”


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Without an ‘iTV,’ Apple’s growth could shrink to the single digits by 2015






Another analyst believes that Apple is losing its shine. Toni Sacconaghi of Bernstein Research on Thursday trimmed his price target for the company, citing concerns that growth may be slowing. The analyst believes that iPhone sales will remain strong for at least the next two years, however Apple (AAPL) is expected to lose overall market share “if it does not bring out a lower-price device” in the wake of a changing industry. Sacconaghi notes that the iPad should continue to see success in a tablet market that is “a rocket…an absolute juggernaut,” with tablet PC shipments estimated to more than triple over the next five years. It is believed, however, that Apple will likely become a single digit growth company by 2015, unless it releases a new major product such as an HDTV.


[More from BGR: RIM’s biggest problem: It’s still scrambling to catch yesterday’s hottest mobile app]






“That said, it will have a pristine balance sheet, and be generating a mind-boggling $ 49 billion in free cash flow a year after paying its current dividend,” Sacconaghi wrote in a note to investors, according to Forbes. “More importantly, we believe that Apple’s innovation offers significant option value, which is not in our forecast. Three years ago, the iPad did not exist. Today it generates $ 32 billon in annual revenues, and as a standalone business would be the 11th biggest U.S. tech company. Potential ‘options’ for Apple investors include a lower-end iPhone, a television ‘solution,’ a larger iPad or converged device and monetizing advertising, e-commerce and search from its iOS platform (and credit card database) of 435 million users.”


[More from BGR: WhatsApp goes free for iPhone for a limited time]


The analyst kept his Outperform rating on shares of Apple, although he trimmed his price target from $ 800 to $ 750 and lowered his 2013 fiscal year EPS forecast to $ 49.41 per share, from $ 50.57.


This article was originally published by BGR


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Disney Sets August 9 Release for ‘Cars’ Spin-off ‘Planes’






NEW YORK (TheWrap.com) – Disney will release “Planes,” a spin-off of Pixar‘s “Cars” franchise, August 9, 2013, in the United States. DisneyToon Studios is behind the film with Pixar/Disney Animation chief creative officer John Lasseter producing.


The film follows a fleet of planes, in particular Dusty. “Two and a Half Men” star Jon Cryer was to voice Dusty, but he has dropped out and the studio is now casting the part.






Disney initially intended to release “Planes” direct to video, but it will now send it into theaters domestically and overseas.


“Planes” will compete against a pair of films that summer weekend, both of which should have more adult followings. The big-ticket item will be Sony’s “Elysium,” Neill Blomkamp‘s follow-up to “District 9.” Also opening that weekend is “We’re the Millers,” a New Line drug-smuggling comedy starring Jason Sudeikis and Jennifer Aniston.


Next summer’s biggest animated movies should all be sequels save “Epic,” Fox’s story of a teenage girl caught in a forested battle. Beyonce Knowles‘ leads the voice cast. The other big openers are Despicable Me 2,” “Monsters University” and “Smurfs 2.”


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Cancer Immunotherapy Where Are We Going?






The compelling concept of utilizing the patient’s own immune system for a stronger and more effective way to attack cancer cells is not a new one. William Coley observed in 1891 that infections produced in patients with inoperable cancer following an injection of streptococcal organisms (Gram-positive bacteria) led to tumor shrinkage especially when the patients developed fever and other signs of a full-blown infection.1 Since then, research has embraced approaches to “train” the patient’s own immune system to recognize certain biomarkers or proteins that are mainly found on cancer cells and to destroy the cells.


After several setbacks the first cellular immunotherapy, Dendreon’s Sipuleucel-T (Provenge(R)), was approved for the treatment of prostate cancer in 2010. Today, new promising cancer immunotherapy approaches are in clinical trials. Most recently, researchers at the 54th American Society of Hematology (ASH) meeting reported early success with a developmental-stage cell-based cancer vaccine for the treatment of leukemia and have shown remission in several patients 2,3, including a 7-year old girl who relapsed twice after chemotherapy.Cancer immunotherapy can be thought of as either active or passive immunotherapy. The most prominent passive immunotherapies, which have revolutionized cancer therapy, are monoclonal antibodies that either target tumor-specific antigens and receptors or block important pathways central to tumor growth and survival. Therapeutic monoclonal antibodies are the market leader in the targeted cancer therapy space and include blockbusters such as trastuzumab (Herceptin(R)) or rituximab (Rituxan(R)).In general, antibodies are significant elements of the body’s adaptive immune system. They play a dominant role in the recognition of foreign antigens and the stimulation of the immune response. Therapeutic antibodies target and bind to antigens, usually proteins that are mainly expressed on diseased cells such as cancer cells. After binding, cancer cells can be destroyed by different mechanisms such as antibody-dependent cellular cytotoxicity, the activation of the complement system — an important part of the immune system — and triggering cell death.Although very successful, especially in oncology, therapeutic antibodies have a significant limitation: they don’t generate a memory response by the immune system, and thus, repeated antibody infusions are required. Further, monoclonal antibodies are only able to recognize specific proteins present of the cell surface. Monoclonal antibodies are mostly produced in cell culture systems which are often costly. Humanization of murine monoclonal antibodies by replacing of certain parts of the antibody with human sequences has improved the tolerability of antibodies and made them less immunogenic, but even fully human sequence-derived antibodies can carry some immunological risk.Novel approaches in the passive immunization strategy include antibody drug conjugates, a combination of targeting antibody with a very potent drug such as the recently approved brentuximab vedotin (ADCETRIS(TM)) for Hodgkin lymphoma and anaplastic large cell lymphoma (ALCL). ADCETRIS comprises an anti-CD30 monoclonal antibodyanti-CD30 monoclonal antibody and a cytotoxic (cell-killing) agent that is released upon internalization into CD30-expressing tumor cells. Currently, the development of next generations of ADCs is underway.Alternatively, specific and durable cancer immunotherapies designed to actively “train” or stimulate the patient’s intrinsic immune response have been more problematic; however, recent success stories, such as the cell-based immunotherapy Provenge, have revitalized this field. Dendreon’s approach modifies the patients’ own dendritic cells to present a protein specific to prostate cancer cells.Dendritic cells are the most potent, “professional” antigen-presenting cells. They process the antigen material and present it on their surface to other cells of the immune system. Once activated, the dendritic cells migrate to the lymphoid tissues where they interact with T-cells and B-cells — white blood cells and important components of the immune system — to initiate and shape the adaptive immune response. To develop Provenge, each patient’s own dendritic cells are harvested and then loaded ex vivo with the tumor-associated antigen. Now “presenting” the antigen, the dendritic cells are administered back into the patient to induce a potent, cell-mediated anticancer immune response resulting in tumor shrinkage and clinical benefit.In another experimental approach for the treatment of leukemia, patients’ own modified T-cells were infused back into the patients. Prior to this, the T-cells were transduced with a lentivirus to express the CD19-specific chimeric antigen receptor. CD19 is an antigen which is found on B-cell neoplasms, cancerous B-cells, and the lentivirus was the vehicle to transfer the genetic material for CD19 into the cells. A case report published in the New England Journal of Medicine stated that a patient with chronic lymphocytic leukemia (CLL) was in ongoing remission 10 months after treatment.3These promising results have spurred continued research for new and safe ways to achieve effective tumor vaccination, and drug developers have explored many cancer immunotherapy strategies. To generate an effective antitumor immunity, therapeutic intervention should drive several functions; specifically, it should promote the antigen presentation functions of dendritic cells, promote the production of protective T-cell responses, stimulate B-cells and overcome immunosuppression characteristics that are common to tumor cells.4Cell-based therapeutic vaccines are most frequently produced outside the patient’s body and involve isolation of the specific cells, such as dendritic cells, and the introduction of preselected antigens, often with the use of specific vehicle, into the cells. The antigens can be encoded in viral vectors (frequently DNA) or administered as peptides or proteins in a suitable adjuvant and carrier through a long and cumbersome process.During my doctoral thesis, I conducted immunization experiments using RNA as a negative control, assuming that the RNA would be degraded during the experiment thus making it impossible to use as a vaccine. The physiological role of messenger (m) RNA is to transfer genetic information from the nucleus to the cytoplasm where this information is translated into the corresponding protein. mRNA is known to be very unstable and has a relatively short half-life. But astonishingly, we were able to measure a solid T-cell immune response. We repeated the experiment and confirmed that the RNA we had produced had the potential to be used as a vaccine. Importantly, we didn’t need to isolate the patients’ cells: mRNA-based vaccines can be injected directly into the skin (intradermal). The mRNA-based vaccines are then taken up by antigen-presenting cells, such as dendritic cells, and are then able to induce an immune response. Importantly, mRNA-vaccines can also be synthesized quickly for any antigen sequence identified.5The first mRNA-based vaccines (RNActive(R)) are now in the clinic for the treatment of prostate cancer and lung cancer and have demonstrated that they do what they are supposed to do – induce a balanced humoral, as well as T cell-mediated, immune response that is entirely HLA independent. The HLA (human leukocyte antigen) system is used to differentiate the body’s own cells (self) and non-self cells. Additionally, RNA-vaccines do not need a vehicle such as a virus for delivery to the cells, nor do they contain virus-derived elements that are often found in DNA-vaccines. These attributes make RNActive a very safe therapeutic.The risk of integration of the RNA into the host-genome is minimized (RNA would have been transcribed first to DNA, and then it has to be transported to the nucleus), as is the residual risk of DNA-based vaccines for inactivating or activating genes or affecting cellular regulatory elements, which can induce oncogenesis. Thus, the favorable safety profile of mRNA-based therapies broadens their potential use not only for the treatment of diseases but for use as prophylactic vaccinations. A recent proof-of-concept study using mRNA-based vaccines (RNActive) in animal models for influenza was published in Nature Biotechnology.6Therapeutic cancer immunotherapies and vaccines have come a long way, and novel, promising approaches give hope for safe and effective treatment options. This may one day lead to the treatment of all cancers as chronic diseases.Literature1Kirkwood JM, Butterfield LH, Tarhini AA, Zarour H, Kalinski P, Ferrone S: Immunotherapy of cancer in 2012. CA Cancer J Clin. 20122June CH, Blazar BR: T-Cell Infusions: A New Tool for Transfusion Medicine That Has Come of Age. Presentation at 54th ASH Annual Meeting 20133Porter DL, Levine BL, Kalos M, Bagg A, and June CH: Chimeric Antigen Receptor-Modified T Cells in Chronic Lymphoid Leukemia. N Engl J Med 20114Mellman I, Coukos G, Dranoff G: Cancer immunotherapy comes of age. Nature. 2011Petsch B, Schnee M, Vogel AB, Lange E, Hoffmann B, Voss D, Schlake T, Thess A, Kallen KJ,5Hoerr I, Obst R, Rammensee HG, Jung G: In vivo application of RNA leads to induction of specific cytotoxic T lymphocytes and antibodies. Eur J Immunol. 20006Petsch B, Schnee M, Vogel AB, Lange E, Hoffmann B, Voss D, Schlake T, Thess A, Kallen KJ, Stitz L, Kramps T: Protective efficacy of in vitro synthesized, specific mRNA vaccines against influenza A virus infection. Nat Biotechnol. 2012 






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