http://community.bewell.com/service/displayKickPlace.kickAction?u=19061883&as=142833 Most Recent Submissions from PaulOffitMD on BeWell Community Thu, 08 Apr 2010 18:00:11 GMT Thu, 08 Apr 2010 18:00:11 GMT community@bewell.com (bewelladmin) community@bewell.com (bewelladmin) KickApps Feed Builder 2010-04-08T18:00:11Z 5 http://community.bewell.com/service/searchEverything.kickAction?as=142833&includeVideo=on&includeAudio=on&includePhoto=on&includeBlog=on&sortType=recent 0 http://community.bewell.com/_The-FDA-the-Rotavirus-Vaccine-Decision/BLOG/2291514/142833.html On Monday, March 22nd, the Food and Drug Administration did something that on its surface didn't make much sense: they recalled a rotavirus vaccine named RotaRix. RotaRix, made from a weakened natural strain of human rotavirus, was shown to be safe and effective in pre-licensure trials of more than 60,000 infants. Sold in the United States since 2008, the vaccine has also been shown to be safe and effective post-licensure in millions of children. And rotavirus, which causes fever, vomiting, diarrhea, and dehydration in young children isn't a trivial disease in the U.S., causing about 250,000 emergency department visits, 70,000 hospitalization, and 60 deaths in the U.S. annually. In the developing world, the virus is a killer, accounting for about 2,000 deaths a day. So why did the FDA withdraw the vaccine. They did it because they found genetic sequences suggesting that a pig virus, called porcine circovirus type 1 (PCV-1), was contaminating the cells used to make the vaccine. The detection of these genetic sequences was made possible by a highly sensitive, recently developed technique that had not previously been applied to vaccines. What made the withdrawal of the vaccine surprising was that PCV-1 has never been shown to cause disease in any mammalian species, including pigs. So the virus isn't a threat. Also, in fairness, the same technique should be applied to other items ingested by 6-month-olds, like Cheetos or fruit. Using this technique, one would invariably find genetic sequences of a variety of viruses, bacteria, fungi, and parasites, all evidence that we live in a microbe-rich environment. Although another rotavirus vaccine is available in the U.S., the FDA's action might cause a shortage of rotavirus vaccine -- in which case the FDA would have elevated a theoretical risk about a real risk and done harm. It will be interesting to see where the FDA goes from here. On Monday, March 22nd, the Food and Drug Administration did something that on its surface didn't make much sense: they recalled a rotavirus vaccine named RotaRix. RotaRix, made from a weakened natural strain of human rotavirus, was shown to be safe and effective in pre-licensure trials of more than 60,000 infants. Sold in the United States since 2008, the vaccine has also been shown to be safe and effective post-licensure in millions of children. And rotavirus, which causes fever, vomiting, diarrhea, and dehydration in young children isn't a trivial disease in the U.S., causing about 250,000 emergency department visits, 70,000 hospitalization, and 60 deaths in the U.S. annually. In the developing world, the virus is a killer, accounting for about 2,000 deaths a day. So why did the FDA withdraw the vaccine. They did it because they found genetic sequences suggesting that a pig virus, called porcine circovirus type 1 (PCV-1), was contaminating the cells used to make the vaccine. The detection of these genetic sequences was made possible by a highly sensitive, recently developed technique that had not previously been applied to vaccines. What made the withdrawal of the vaccine surprising was that PCV-1 has never been shown to cause disease in any mammalian species, including pigs. So the virus isn't a threat. Also, in fairness, the same technique should be applied to other items ingested by 6-month-olds, like Cheetos or fruit. Using this technique, one would invariably find genetic sequences of a variety of viruses, bacteria, fungi, and parasites, all evidence that we live in a microbe-rich environment. Although another rotavirus vaccine is available in the U.S., the FDA's action might cause a shortage of rotavirus vaccine -- in which case the FDA would have elevated a theoretical risk about a real risk and done harm. It will be interesting to see where the FDA goes from here. Thu, 08 Apr 2010 18:00:11 GMT http://community.bewell.com/_The-FDA-the-Rotavirus-Vaccine-Decision/BLOG/2291514/142833.html PaulOffitMD 2010-04-08T18:00:11Z BeWell Community On Monday, March 22nd, the Food and Drug Administration did something that on its surface didn't make much sense: they recalled a rotavirus vaccine named RotaRix. RotaRix, made from a weakened natural strain of human rotavirus, was shown to be safe and effective in pre-licensure trials of more than 60,000 infants. Sold in the United States since 2008, the vaccine has also been shown to be safe and effective post-licensure in millions of children. And rotavirus, which causes fever, vomiting, diarrhea, and dehydration in young children isn't a trivial disease in the U.S., causing about 250,000 emergency department visits, 70,000 hospitalization, and 60 deaths in the U.S. annually. In the developing world, the virus is a killer, accounting for about 2,000 deaths a day. So why did the FDA withdraw the vaccine. They did it because they found genetic sequences suggesting that a pig virus, called porcine circovirus type 1 (PCV-1), was contaminating the cells used to make the vaccine. The detection of these genetic sequences was made possible by a highly sensitive, recently developed technique that had not previously been applied to vaccines. What made the withdrawal of the vaccine surprising was that PCV-1 has never been shown to cause disease in any mammalian species, including pigs. So the virus isn't a threat. Also, in fairness, the same technique should be applied to other items ingested by 6-month-olds, like Cheetos or fruit. Using this technique, one would invariably find genetic sequences of a variety of viruses, bacteria, fungi, and parasites, all evidence that we live in a microbe-rich environment. Although another rotavirus vaccine is available in the U.S., the FDA's action might cause a shortage of rotavirus vaccine -- in which case the FDA would have elevated a theoretical risk about a real risk and done harm. It will be interesting to see where the FDA goes from here. administration, and, drug, fda, food, offit, paul, rotarix, rotavirus, vaccines nonadult false The FDA & the Rotavirus Vaccine Decision text blog administration,and,drug,fda,food,offit,paul,rotarix,rotavirus,vaccines 119 0 0.0 http://community.bewell.com/service/displayKickPlace.kickAction?u=19061883&as=142833 http://media.kickstatic.com/kickapps/images/user/defaultImage_160x120_E.jpg false 0 0 2291514 19061883 Member 425 http://community.bewell.com/_Lets-Get-Behind-the-HPV-Vaccine-for-Boys/BLOG/1915998/142833.html In October 2009, the Advisory Committee on Immunization Practices (ACIP) made a curious decision. At the time, the Food and Drug Administration (FDA) had just licensed the human papillomavirus (HPV) vaccine for boys. The FDA licensed the vaccine because it had been shown to prevent anal and genital warts, as well as persistent HPV infection. This meant that the vaccine was also invariably going to prevent another problem caused by HPV: anal and genital cancers. The ACIP, however, did not fully recommend the vaccine. Rather, voting members gave the vaccine a "permissive recommendation," meaning physicians and parents could use the vaccine if they wanted. One reason for the ACIP's tepid recommendation was that it didn't think that the HPV vaccine for boys and young men represented the best use of healthcare dollars. Unfortunately, by not fully recommending the vaccine, many boys will be unlikely to receive it, leaving them vulnerable to this common and occasionally fatal infection.   In October 2009, the Advisory Committee on Immunization Practices (ACIP) made a curious decision. At the time, the Food and Drug Administration (FDA) had just licensed the human papillomavirus (HPV) vaccine for boys. The FDA licensed the vaccine because it had been shown to prevent anal and genital warts, as well as persistent HPV infection. This meant that the vaccine was also invariably going to prevent another problem caused by HPV: anal and genital cancers. The ACIP, however, did not fully recommend the vaccine. Rather, voting members gave the vaccine a "permissive recommendation," meaning physicians and parents could use the vaccine if they wanted. One reason for the ACIP's tepid recommendation was that it didn't think that the HPV vaccine for boys and young men represented the best use of healthcare dollars. Unfortunately, by not fully recommending the vaccine, many boys will be unlikely to receive it, leaving them vulnerable to this common and occasionally fatal infection.   Thu, 25 Feb 2010 16:11:30 GMT http://community.bewell.com/_Lets-Get-Behind-the-HPV-Vaccine-for-Boys/BLOG/1915998/142833.html PaulOffitMD 2010-02-25T16:11:30Z BeWell Community In October 2009, the Advisory Committee on Immunization Practices (ACIP) made a curious decision. At the time, the Food and Drug Administration (FDA) had just licensed the human papillomavirus (HPV) vaccine for boys. The FDA licensed the vaccine because it had been shown to prevent anal and genital warts, as well as persistent HPV infection. This meant that the vaccine was also invariably going to prevent another problem caused by HPV: anal and genital cancers. The ACIP, however, did not fully recommend the vaccine. Rather, voting members gave the vaccine a "permissive recommendation," meaning physicians and parents could use the vaccine if they wanted. One reason for the ACIP's tepid recommendation was that it didn't think that the HPV vaccine for boys and young men represented the best use of healthcare dollars. Unfortunately, by not fully recommending the vaccine, many boys will be unlikely to receive it, leaving them vulnerable to this common and occasionally fatal infection.   anal, and, genital, hpv, human, offit, papillomaviru, paul, vaccines, warts nonadult false Let's Get Behind the HPV Vaccine for Boys text blog anal,and,genital,hpv,human,offit,papillomaviru,paul,vaccines,warts 480 0 0.0 http://community.bewell.com/service/displayKickPlace.kickAction?u=19061883&as=142833 http://media.kickstatic.com/kickapps/images/user/defaultImage_160x120_C.jpg false 0 0 1915998 19061883 Member 425 http://community.bewell.com/_The-Power-of-Bill-Melinda-Gates-10-Billion-Donation/BLOG/1778991/142833.html For 200 years, vaccines have been available to save children's lives. And for 200 years, children in the developing world often haven't had access to them. The reasons are many. But by far the biggest problem has been creating an infrastructure to get the vaccine from the tarmac to the child's arm or mouth. Pharmaceutical companies haven't felt that it is their responsibility to create an infrastructure; developing world countries simply don't have the resources to do it; and the World Health Organization, although clearly interested and responsible, don't have the money. The situation was stagnant, unresolved. Then Bill and Melinda Gates came along. It is remarkable that one American couple actually have the kind of resources that allow them to create an infrastructure in the developing world-to distribute vaccines to the 72 poorest nations.   Of interest, Melinda Gates has said that the reason she and her husband turned to vaccines was because of a virus called rotavirus. When they first learned that this virus caused 500,000deaths a year, they were amazed, primarily because they had never heard of it before. This week The New England Journal of Medicine reported the results of trials of the rotavirus vaccine in Africa. The vaccine clearly works and will save lives. But those lives would never have been saved had it not been for the kindness, foresight, and remarkable commitment of two American citizens.    For 200 years, vaccines have been available to save children's lives. And for 200 years, children in the developing world often haven't had access to them. The reasons are many. But by far the biggest problem has been creating an infrastructure to get the vaccine from the tarmac to the child's arm or mouth. Pharmaceutical companies haven't felt that it is their responsibility to create an infrastructure; developing world countries simply don't have the resources to do it; and the World Health Organization, although clearly interested and responsible, don't have the money. The situation was stagnant, unresolved. Then Bill and Melinda Gates came along. It is remarkable that one American couple actually have the kind of resources that allow them to create an infrastructure in the developing world-to distribute vaccines to the 72 poorest nations.   Of interest, Melinda Gates has said that the reason she and her husband turned to vaccines was because of a virus called rotavirus. When they first learned that this virus caused 500,000deaths a year, they were amazed, primarily because they had never heard of it before. This week The New England Journal of Medicine reported the results of trials of the rotavirus vaccine in Africa. The vaccine clearly works and will save lives. But those lives would never have been saved had it not been for the kindness, foresight, and remarkable commitment of two American citizens.    Fri, 29 Jan 2010 23:47:46 GMT http://community.bewell.com/_The-Power-of-Bill-Melinda-Gates-10-Billion-Donation/BLOG/1778991/142833.html PaulOffitMD 2010-01-29T23:47:46Z BeWell Community For 200 years, vaccines have been available to save children's lives. And for 200 years, children in the developing world often haven't had access to them. The reasons are many. But by far the biggest problem has been creating an infrastructure to get the vaccine from the tarmac to the child's arm or mouth. Pharmaceutical companies haven't felt that it is their responsibility to create an infrastructure; developing world countries simply don't have the resources to do it; and the World Health Organization, although clearly interested and responsible, don't have the money. The situation was stagnant, unresolved. Then Bill and Melinda Gates came along. It is remarkable that one American couple actually have the kind of resources that allow them to create an infrastructure in the developing world-to distribute vaccines to the 72 poorest nations.   Of interest, Melinda Gates has said that the reason she and her husband turned to vaccines was because of a virus called rotavirus. When they first learned that this virus caused 500,000deaths a year, they were amazed, primarily because they had never heard of it before. This week The New England Journal of Medicine reported the results of trials of the rotavirus vaccine in Africa. The vaccine clearly works and will save lives. But those lives would never have been saved had it not been for the kindness, foresight, and remarkable commitment of two American citizens.    offit, paul, rotavirus, vaccinations, vaccines nonadult false The Power of Bill & Melinda Gate's $10 Billion Donation text blog offit,paul,rotavirus,vaccinations,vaccines 452 0 0.0 http://community.bewell.com/service/displayKickPlace.kickAction?u=19061883&as=142833 http://media.kickstatic.com/kickapps/images/user/defaultImage_160x120_B.jpg false 1 0 1778991 19061883 Member 425 http://community.bewell.com/_Missed-Vaccines-Weaken-39Herd-Immunity39-In-Children/BLOG/1777271/142833.html Editor's Note: Dr. Paul Offit helps to explain how vaccinating one child helps to protect other kids who can't protect themselves in this thoughtful piece in USA Today. Editor's Note: Dr. Paul Offit helps to explain how vaccinating one child helps to protect other kids who can't protect themselves in this thoughtful piece in USA Today. Thu, 07 Jan 2010 15:41:09 GMT http://community.bewell.com/_Missed-Vaccines-Weaken-39Herd-Immunity39-In-Children/BLOG/1777271/142833.html PaulOffitMD 2010-01-07T15:41:09Z BeWell Community Editor's Note: Dr. Paul Offit helps to explain how vaccinating one child helps to protect other kids who can't protect themselves in this thoughtful piece in USA Today. nonadult false Missed Vaccines Weaken 'Herd Immunity' In Children text blog 125 0 0.0 http://community.bewell.com/service/displayKickPlace.kickAction?u=19061883&as=142833 http://media.kickstatic.com/kickapps/images/user/defaultImage_160x120_C.jpg false 0 0 1777271 19061883 Member 425 http://community.bewell.com/_New-York39s-Flu-Vaccine-Mandate-for-Healthcare-Workers-A-Patient-Safety-Issue/BLOG/1691930/142833.html Recently, the New York State Department of Health mandated influenza vaccine for its healthcare workers (read the story at NYTimes.com). Judging from the protests in front of the state house in Albany, not everyone agrees with the decision.Certain facts about influenza virus and its transmission are undeniable:1. People with influenza are often admitted to the hospital with severe pneumonia. 2. Healthcare workers taking care of people with influenza can catch the virus. 3. Healthcare workers can transmit influenza to patients in the hospital. 4. Patients who acquire influenza in the hospital—some of whom have chronic lung, heart or kidney abnormalities—can develop severe and occasionally fatal pneumonia.5. Hospitals with high rates of immunization with influenza vaccine among health care workers have lower rates of hospital-acquired infection.  Vaccine mandates are a patient safety issue; the New York State Department of Health is standing up for the rights of the patient. Our country invariably struggles with the rights of the individual versus the rights of society. In this case, the hospitalized patient represents society and the healthcare worker the individual. Some healthcare workers will argue that the issue is one of vaccine safety. But the influenza vaccine (both seasonal and novel H1N1) is made using the same technology that has been available for more than 40 years. And, apart from those who suffer from severe egg allergies, no evidence supports the notion that current influenza vaccines cause serious side effects; vaccine safety is a straw man issue.  It all seems to boil down to one question: Is it the right of a healthcare worker to catch and transmit a potentially fatal infection?  Editor's Note: Where do you stand on the New York State Department of Health's decision to mandate flu vaccines among healthcare workers? Share your comment below. Recently, the New York State Department of Health mandated influenza vaccine for its healthcare workers (read the story at NYTimes.com). Judging from the protests in front of the state house in Albany, not everyone agrees with the decision.Certain facts about influenza virus and its transmission are undeniable:1. People with influenza are often admitted to the hospital with severe pneumonia. 2. Healthcare workers taking care of people with influenza can catch the virus. 3. Healthcare workers can transmit influenza to patients in the hospital. 4. Patients who acquire influenza in the hospital—some of whom have chronic lung, heart or kidney abnormalities—can develop severe and occasionally fatal pneumonia.5. Hospitals with high rates of immunization with influenza vaccine among health care workers have lower rates of hospital-acquired infection.  Vaccine mandates are a patient safety issue; the New York State Department of Health is standing up for the rights of the patient. Our country invariably struggles with the rights of the individual versus the rights of society. In this case, the hospitalized patient represents society and the healthcare worker the individual. Some healthcare workers will argue that the issue is one of vaccine safety. But the influenza vaccine (both seasonal and novel H1N1) is made using the same technology that has been available for more than 40 years. And, apart from those who suffer from severe egg allergies, no evidence supports the notion that current influenza vaccines cause serious side effects; vaccine safety is a straw man issue.  It all seems to boil down to one question: Is it the right of a healthcare worker to catch and transmit a potentially fatal infection?  Editor's Note: Where do you stand on the New York State Department of Health's decision to mandate flu vaccines among healthcare workers? Share your comment below. Tue, 06 Oct 2009 18:29:45 GMT http://community.bewell.com/_New-York39s-Flu-Vaccine-Mandate-for-Healthcare-Workers-A-Patient-Safety-Issue/BLOG/1691930/142833.html PaulOffitMD 2009-10-06T18:29:45Z BeWell Community Recently, the New York State Department of Health mandated influenza vaccine for its healthcare workers (read the story at NYTimes.com). Judging from the protests in front of the state house in Albany, not everyone agrees with the decision.Certain facts about influenza virus and its transmission are undeniable:1. People with influenza are often admitted to the hospital with severe pneumonia. 2. Healthcare workers taking care of people with influenza can catch the virus. 3. Healthcare workers can transmit influenza to patients in the hospital. 4. Patients who acquire influenza in the hospital—some of whom have chronic lung, heart or kidney abnormalities—can develop severe and occasionally fatal pneumonia.5. Hospitals with high rates of immunization with influenza vaccine among health care workers have lower rates of hospital-acquired infection.  Vaccine mandates are a patient safety issue; the New York State Department of Health is standing up for the rights of the patient. Our country invariably struggles with the rights of the individual versus the rights of society. In this case, the hospitalized patient represents society and the healthcare worker the individual. Some healthcare workers will argue that the issue is one of vaccine safety. But the influenza vaccine (both seasonal and novel H1N1) is made using the same technology that has been available for more than 40 years. And, apart from those who suffer from severe egg allergies, no evidence supports the notion that current influenza vaccines cause serious side effects; vaccine safety is a straw man issue.  It all seems to boil down to one question: Is it the right of a healthcare worker to catch and transmit a potentially fatal infection?  Editor's Note: Where do you stand on the New York State Department of Health's decision to mandate flu vaccines among healthcare workers? Share your comment below. nonadult false New York's Flu Vaccine Mandate for Healthcare Workers: A Patient Safety Issue text blog 122 0 0.0 http://community.bewell.com/service/displayKickPlace.kickAction?u=19061883&as=142833 http://media.kickstatic.com/kickapps/images/user/defaultImage_160x120_B.jpg false 0 0 1691930 19061883 Member 425