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Texas Gov orders girls to have the anti- cancer vaccine
http://neurotalk.psychcentral.com/im...cons/icon1.gif Texas Gov. orders anti-cancer vaccine (AP)
(From Yahoo) http://d.yimg.com/us.yimg.com/p/afp/...SOGRSqAcSFPw--AP - Bypassing the Legislature altogether, Republican Gov. Rick Perry issued an order Friday making Texas the first state to require that schoolgirls get vaccinated against the sexually transmitted virus that causes cervical cancer. Read the full article... here is a little more of the article: AUSTIN, Texas - Bypassing the Legislature altogether, Republican Gov. Rick Perry issued an order Friday making Texas the first state to require that schoolgirls get vaccinated against the sexually transmitted virus that causes cervical cancer. By employing an executive order, Perry sidestepped opposition in the Legislature from conservatives and parents' rights groups who fear such a requirement would condone premarital sex and interfere with the way Texans raise their children. Beginning in September 2008, girls entering the sixth grade — meaning, generally, girls ages 11 and 12 — will have to receive Gardasil, Merck & Co.'s new vaccine against strains of the human papillomavirus, or HPV. Perry also directed state health authorities to make the vaccine available free to girls 9 to 18 who are uninsured or whose insurance does not cover vaccines. In addition, he ordered that Medicaid offer Gardasil to women ages 19 to 21. Perry, a conservative Christian who opposes abortion and stem-cell research using embryonic cells, counts on the religious right for his political base. But he has said the cervical cancer vaccine is no different from the one that protects children against polio. "The HPV vaccine provides us with an incredible opportunity to effectively target and prevent cervical cancer," Perry said. Merck is bankrolling efforts to pass state laws across the country mandating Gardasil for girls as young as 11 or 12. It doubled its lobbying budget in Texas and has funneled money through Women in Government, an advocacy group made up of female state legislators around the country. Perry has ties to Merck and Women in Government. One of the drug company's three lobbyists in Texas is Mike Toomey, Perry's former chief of staff. His current chief of staff's mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director for Women in Government. The governor also received $6,000 from Merck's political action committee during his re-election campaign. |
:mad: OH NO!!!!:mad: :(
maybe someone ought to send him this info http://neurotalk.psychcentral.com/showthread.php?t=7215 !!!!!!!!! |
We have a senator in our state of Illinois trying to make it a mandatory immunization for girls going into the 6th grade also.
I don't think so!!!! |
i am going to fight this tooth and nail.
from local government to state. pta...school board...get everyone i know to learn the facts. i hope the senator there doesn't know the govenor here tracey...this stinks and really ticks me off. |
I have a real BAD FEELING about this too. Everyone is moving TOO FAST to embrace this drug.
How many times in the past five years have we heard of drugs being pulled because of deadly side effects?? Have they tested the LIFETIME side effects of this drug?? NO!! And, they want to give it to our kids. Do they know how this drug interacts with the male reproductive system when it interacts with the female system?? Do they know what will be passed to children of Mothers who use this drug?? In the 1950s, they gave drugs to Mothers to prevent premature labor. That drug is still causing reproductive problems for children (male and female) who were exposed in utero to that drug. In the 1960s, they gave thalidomide (a sleeping pill) to pregnant Mothers. It caused horrendous birth anomalies to the arms and legs of children exposed in utero. I hope every parent says **NO** to this crap. Barb |
Amen Barb. I agree they move way tooo fast when it comes to the vaccines and meds. It won't be given to my daughter I know that for 100% fact. With Megs it won't be a problem, her doc will agree with my decision. But what about all the other girls her age? Sad really sad. Sometimes I wonder if we live in a free democratic country or a communist one. I have to wear a seatbelt because someone decided it was for my best interest. I agree if you are under 18 then it is my duty to see my children are restrained, but as an adult of sound mind if I prefer to not wear it, it should be my choice not the governments. (I am a seatbelt person anyhoo, it is just the principal), Just like a state who says you can't smoke in your car?????:eek: Again, unless that state is going to take over my car payments and insurance, they can't tell me I can't smoke inside my vehicle. Again not a smoker but think it is totally wrong. What is next???? Just seems like the government is able to rule our lives a little too much. Oh well I could go on and on.
Curious send me all the info on this immunization also that you find, I want to keep it on file if it becomes a "law" here for other parents also Thanks |
I don't like the sound of this at all!
we as parents should have the option not government regulation. |
any links to any info on this, please post them here.
i agree jo. |
they are trying to pass a simulare law hear in oklahoma as well. not agreeing with it at all. this needs between the dr and aprents not the schools.plus the vacciene is to new to know actual risk ina large population of young girls.
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part of the article from this link:http://www.inciid.org/article.php?cat=cancer&id=433
Animal and human studies have shown that aluminum can cause nerve cell death [3] and that vaccine aluminum adjuvants can allow aluminum to enter the brain, [45] as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. [67] Nearly 90 percent of Gardasil recipients and 85 percent of aluminum placebo recipients followed-up for safety reported one or more adverse events within 15 days of vaccination, particularly at the injection site.[8] Pain and swelling at injection site occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients.About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. [910] Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis. "Merck and the FDA do not reveal in public documents exactly how many 9 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo. For example, if there were less than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis." According to the Merck product manufacturer insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis out of 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated. |
Curious
Kim just made a reply to my post about this on Latitudes and I think you will be especially interested in the info she has about the aluminum adjuvent in the vaccine http://www.latitudes.org/forums/inde...=0&#entry14324 |
I think it's a great idea. A way to prevent cancer?! And STDs? isn't it like requiring any other vaccination for a communicable disease that could cause an epidemic?
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Quote:
this is another vaccine thast they are using females as the testing grounds. will they pull it after they find out it has caused thousands of birth deffects? or how many have to suffer serious illness and side effects? why is it they don't give a vaccine to young males? since they are the cause of the spread of the virus inthe first place. a vaccine so they are impotent and can't have sex until they are mature enough to use a condom. why not do the reaserch and come up with a vaccine to prevent the boys from getting and spreading the virus? by making it mandetory that all these young girls have the vaccine, govenor perry is assuming that all these girls will become sexually active and not use protection. in all of the studies i have found so far that state the 4000 deaths due to cervical cancer, not one has has sited any research as to how many of those deaths are due to the virus being the cause of the cancer. how many of those deaths were caused by the woman not getting a pap on a ruetine basis. the media and Merck are using scare tactic to coerce parents into vaccinating their young daughters. they are giving the full truth so an informed choice can be made. |
mollymcn....perhaps you havent read the links I posted on the DANGERS of the actual vaccine, and it's potential to cause neurological problems in these young girls:(
Curious, tho I know you posted about this "lobbyist" on page one thought you would be interested in this that came in with one of my Health Newsletters today ( I have bolded FYI) Quote:
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mollymcm, also if you listen to the commercial and read info it is not a guarantee that it will eliminate a young girl from getting cervical cancer. I still think it is still in the very premature stages, and no government should dictate that young girls get this vaccine, not knowing how it will effect their overall health including fertilization etc later in life. I agree it would be nice to have a "magic cure" against cervical cancer. I just don't belive that this is it, nor have they done a long enough long term studies. 17 deaths during trial to me is 17 too many, whether the vaccine maker says it is related to it or not. Like they are going to say that their vaccine (money maker) is going to possibly be fatal to anyone. I guess it just erks me to think that a governor or someone else thinks they have the right to tell us as parents that we have to immunize our daughters, to me that is just wrong! Way too much governmental control for me. All I know is my daughter WONT get this shot period!!!!
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mine either....and I have had them vaccinated for everything else. Not this one~
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Merck...
really really needs the MONEY from this...It is losing patents, and paying
out Vioxx liability...One needs to look at the MOTIVES for forcing people into an experimental vaccine. And it is not only vaccines. Women were experimented upon with birth control pills. It began in Puerto Rico and moved to the States. I recall a pack of BCs costing $1.89. This was cost(selling them for no profit) then... and many women died and were permanently disabled from strokes! I think forcing young girls to get this vaccine is just the pits.... totally! |
Texas Gov. Merck $ Co. and Lobbyist orders anti-cancer vaccine
Texas Gov. Merck $ Co. and Lobbyist orders anti-cancer vaccine
WHAT NEXT ??? Feb. 3, 2007, 3:34AM Texas Gov. orders anti-cancer vaccine By LIZ AUSTIN PETERSON Associated Press Writer © 2007 The Associated Press AUSTIN, Texas — Some conservatives and parents' rights groups worry that requiring girls to get vaccinated against the sexually transmitted virus that causes cervical cancer would condone premarital sex and interfere with the way they raise their children. By using an executive order that bypassed the Legislature, Republican Gov. Rick Perry — himself a conservative — on Friday avoided such opposition, making Texas the first state to mandate that schoolgirls get vaccinated against the virus. Beginning in September 2008, girls entering the sixth grade will have to receive Gardasil, Merck & Co.'s new vaccine against strains of the human papillomavirus, or HPV. Perry also directed state health authorities to make the vaccine available free to girls 9 to 18 who are uninsured or whose insurance does not cover vaccines. In addition, he ordered that Medicaid offer Gardasil to women ages 19 to 21. Read Full Article: http://www.chron.com/disp/story.mpl/...n/4523513.html Feb. 2, 2007, 7:18PM Texas Orders Cancer Vaccine for Girls By LIZ AUSTIN PETERSON Associated Press Writer © 2007 The Associated Press AUSTIN, Texas — Merck & Co. stands to make billions of dollars should other states follow Texas' lead and require schoolgirls to receive its new anti-cancer vaccine. Supporters of the mandate say it would be a small price to pay to eradicate a dangerous sexually transmitted disease. At issue is whether Gov. Rick Perry's order Friday requiring the vaccinations is driven by political cronyism and a hard-lobbying drug company's hunger for profits, or is simply good public policy. About 10,000 American women will be diagnosed with cervical cancer this year, according to the American Cancer Society, and about one-third of them will die. Texas lawmakers who support requiring the vaccine say Perry's order will spare some young girls from the same fate when they grow up. Read Full Article http://www.chron.com/disp/story.mpl/ap/fn/4522664.html GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] http://www.merck.com/product/usa/pi_...ardasil_pi.pdf What are the ingredients in GARDASIL? The main ingredients are purified inactive proteins that come from HPV Types 6, 11, 16, and 18. It also contains amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection. http://www.merck.com/product/usa/pi_...rdasil_ppi.pdf Each 0.5 mL dose contains approximately 20 µg of HPV 6 L1 protein, 40 µg of HPV 11 L1, 40 µg of HPV 16 L1, and 20 µg of HPV 18 L1; and approximately 225 µg of aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 µg of polysorbate 80 (Tween 80), 35 µg of sodium borate, and water for injection. The product contains no preservatives ...[truncated] http://www.biopharma.com/cgi/full5.lasso?Key=170.1879 Products/Active Agents Index http://www.biopharma.com/biol_terms5.html I ask again, what next ??? I have studied human and animal TSEs for some time. I have also warned the public of the ramifications when you let big industry, govern over government and policy making. I understand that in some instances vaccines are an important tool in fighting deadly disease. ON the other hand, vaccines can harm you and or kill you if not tested properly over a long period of time. TO let MERCK and the Governor of TEXAS (By using an executive order that bypassed the Legislature) ORDER vaccines (any vaccine) on our children, is wrong. THE GOVERNOR STATES ; > But he has said the cervical cancer vaccine is no different from the one that protects children against polio. and i agree, lets just look at what happened to the polio vaccine blunder of long duration ; From: TSS Subject: VACCINE CONTAMINATION AT LIVERPOOL PLANT ONCE HOME OF THE MAD COW POLIO VACCINE BLUNDER Date: October 8, 2004 at 12:15 pm PST Drug Company Ailing After Vaccine Delay By Andrew Pollack 10/08/04 10:44 AM PT Vaccines accounted for about US$700 million of Chiron's $1.75 billion in revenue last year. Fluvirin, the flu vaccine, accounted for $219 million of the total. Chiron had increased spending in R&D and other areas of its business. Now the company may have to scale back its plans, and prospects for its future flu vaccine business are clouded. Find out why Transform Magazine says Verity LiquidOffice is your best software bet for designing, managing and creating workflow around thousands of electronic forms. Download "In Top Form" today to learn more about Verity LiquidOffice, a powerful Web-based business process automation solution. Read Full Article © 2004 International Herald Tribune. All rights reserved. © 2004 ECT News Network. All rights reserved. http://www.ecommercetimes.com/story/...lay-37193.html What was last week's polio BSE scare about? An oral polio vaccine, Medeva, was recalled last week over fears of CJD. The vaccine, which had been used in up to a third of inoculations for children and travellers, contained tiny traces of a feoetal calf growth serum from potentially BSE-contaminated animals. However, the risks of infection from the vaccine were said to be "incalcuably small". The Department of Health said the firm, also Medeva, had misled them on assurances the vaccine met new BSE safety guidelines. http://www.guardian.co.uk/theissues/...343393,00.html Earlier this year, according to an October, 2000 article by the The Observer, a leading British newspaper, British pharmaceutical company Medeva's Liverpool plant was found by the U.S. Food and Drug Administration to be producing vaccines in filthy conditions. The FDA report found that Medeva neither maintained nor cleaned its equipment. It also reported that Medeva was unable to prove that its vaccines were not contaminated with bacteria or fungi. Certain fungi provide the medium in which the prion protein crystal that causes bovine spongiform encephalopathy (BSE or “mad cow” disease) to proliferate. Because it exports flu vaccine to America, Medeva got a U.S. Food and Drug Administration (FDA) “warning” to clean up its act. However, in a report dated October 22, 2000, The Observer noted that the FDA had not re-inspected the filthy Medeva factory since it sent the warning letter earlier this year and has given the company the green light to sell an estimated 20,000,000 doses of its “Fluvarin” flu vaccine in the U.S. during this cold and flu season. The British government recently recalled Medeva's oral polio vaccine (OPV) as it had been grown from “bovine material of UK origin” contrary to mandated vaccine production protocols. Until its removal from the marketplace last month, Medeva's OPV had been injected into 11 million people, mostly children, commented another British newspaper the International Herald Tribune. Hundreds of thousands of “mad” cattle in Great Britain have been destroyed since 1993 in an attempt to control the spread of prion disease that is epidemic in England. Ingestion of beef and other products derived from prion-infected cattle have been linked to the epidemic of prion disease in humans. Prion disease is called mad cow disease in cattle, scrapie in pigs and sheep, whirling disease in fish and wasting disease in deer and elk, is called Creutzfeldt-Jakob Disease (CJD) in humans. It is estimated that as many as 200,000 Americans that have been misdiagnosed with Alzheimer's disease are actually victims of CJD. The Medeva Fluvarin vaccine, produced in the same plant that produced the recalled OPV, may have the potential of opening the floodgates of a “mad cow” epidemic in the U.S. Though the administration of possibly contaminated Fluvarin may be a public health disaster of unprecedented proportions, the dominant media has failed to sound the alarm and the FDA has not ordered that Fluvarin be tested for the presence of prions or the fungi in which they grow. Why? FDA approval of the potentially contaminated Fluvarin for sale in the U.S. was likely influenced by a shortage of flu vaccine here this season. According to Centers for Disease Control and Prevention (CDC) National Immunization Program Director Dr. William Atkinson, the A-Moscow-1099 strain of flu virus did not incubate properly this year and, therefore, did not produce “serum” in large enough quantities to produce sufficient doses of flu vaccine to meet demand. So, despite Medeva's “history of contamination and production blunders,” FDA has authorized the distribution of Fluvarin to clinics and hospitals all over the nation. According to The Observer, the FDA claims that the vaccine is safe. The FDA also, at one time, claimed that silicone breast implants and Phen-Phen were “safe” -- and those are just two of many FDA-approved products that have ultimately been linked to serious health side-effects that include chronic degenerative disease and death. “It stands to reason that Medeva's flu vaccine -- manufactured in the same reportedly filthy plant as the recalled polio vaccine -- could also contain BSE (prion)-contaminated materials,” commented Dr. Len Horowitz. Dr. Horowitz is the author of several books including “Healing Codes for the Biological Apocalypse” in which he meticulously documented the development and spread of prion disease world wide by following the path of published science. An official at the National Institutes of Health describes the prion which causes BSE as, “The single most resistant organism on the face of the Earth. You can boil it, you can put it in formaldehyde, you can autoclave it for a little while, you can treat it with the usual disinfectants...and it's like you didn't do anything.” If Fluvarin is contaminated with BSE, then millions of unsuspecting Americans may be injected this year with a terminal neurological disease. Prion crystals, 100 times smaller than a virus, cause lesions in brain tissue (encephalopathies) that turn the brain to mush and gradually causes dementia and death. British officials predict that hundreds of thousands of Brits will eventually show symptoms of this terminal malady. CJD is so dangerous that medical examiners are afraid to perform autopsies on people and animals that are suspected as having succumbed to prion disease. Continental Europe, which originally considered itself safe from prion disease, is in a panic over recent discoveries that some of their animals and citizens are showing symptoms. Fluvarin is currently on the shelves of doctors' offices and health departments all over the country and is being administered to the public. Medical personnel in the northwest U.S. who confirm that they have administered Fluvarin are unaware of the Medeva scandal or the likelihood that the triple-antigen flu vaccine is contaminated. There are at least two facilities in the U.S. that are capable of testing Fluvarin for prion contamination: The National Prion Disease Pathology Surveillance Center in Cleveland, Ohio, and the National Institutes of Health in Maryland. Since neither the FDA nor the dominant media have demanded that Fluvarin be tested for contamination, anyone about to receive Fluvarin should demand the vaccine be properly tested. Due to this year's flu vaccine shortage, the CDC urges health officials to prioritize the administration of flu vaccines. The CDC recommends that the most immunologically vulnerable members of society -- the elderly and the chronically ill; babies and small children -- be priority one. Healthcare workers exposed to flu victims are priority number two. Otherwise healthy people between the ages of 17-65 should be the last people to receive a flu shot. If your health officials haven't heard about Medeva's track record, it's time to get them educated. You can copy for them a series of British media reports covering the Medeva scandals. The web address is: http://www.observer.co.uk/ Go to “Information,” then “Archive,” then type “Medeva” in the keyword box. See especially the October 22 article “Revealed: full scale of vaccine blunders.” http://proliberty.com/observer/20001208.htm What measures have the FDA taken to ensure that people are not exposed to the BSE agent in vaccines? It is believed that variant CJD was acquired from eating food products containing the BSE agent. However, FDA wants to minimize any chance that the BSE agent could be introduced into biologic products during manufacture. The Center for Biologics Evaluation and Research (CBER) is responsible for regulation of biologic products, including vaccines. In a 1991 letter to manufacturers CBER expressed concern about bovine sourced material. In December 1993 and May 1996 FDA issued letters advising that bovine derived materials from animals born in or residing in countries where BSE had occurred should not be used to manufacture FDA-regulated products intended for administration to humans. A 1993 Points to Consider document ("Points to Consider in the Characterization of Cell Lines Used for the Production of Biologics") stressed the importance of control of sourcing of bovine materials. On April 19, 2000, CBER issued a letter reminding manufacturers that the USDA list of BSE-countries had been expanded to include not only those countries where BSE was known to exist but also those where BSE may exist (FR, January 6, 1998). CBER strongly recommended "that manufacturers take whatever steps are necessary to assure that materials derived from all species of ruminant animals born, raised or slaughtered in countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist, are not used in the manufacture of FDA-regulated products intended for administration to humans." Although Canada and the US have each reported one case of BSE and the USDA has placed Canada on the list of countries with BSE, FDA has not recommended that manufacturers find a new source for bovine derived materials obtained from these countries for use in manufacture of drugs or biological products. The FDA believes that the control measures in place assure the safety of bovine derived materials sourced from these countries and used in manufacture of vaccines. Are bovine derived materials from North America used in the manufacture of vaccines? Yes, bovine derived materials from North America, specifically the US and Canada, are used in vaccine manufacture. Since there has been extensive movement of live cows and cow-derived materials between Canada and the US it is difficult to establish that an animal has not been born, raised or slaughtered in Canada. Moreover, control measures, such as the ruminant-to-ruminant feed ban have been similar in the two countries. Therefore, FDA has not recommended that manufacturers using bovine derived material from Canada replace those materials with materials from countries not on the USDA list of countries that have BSE or are at risk of BSE... snip... There is no evidence that any case of vCJD has resulted from use of a vaccine, and there is no evidence that any vaccines harbor the BSE agent... snip... If vaccines are safe why did the UK recall their polio vaccine? The UK recalled the Evans/Medeva Oral Polio Vaccine in October, 2000. This vaccine has never been licensed for use in the US. The Medicines Control Agency (MCA) had requested and received assurances from drug companies that they were implementing guidance not to use UK-sourced bovine materials in the manufacture of injectable medicinal products. The recall was prompted by evidence that the Evans/Medeva vaccine was manufactured using fetal calf serum from the UK at a time when there was a risk of BSE in that country. This is in contravention of European Union guidelines. According to a statement from the Chief Medical Officer at the UK Dept. of Health (10.20.00) the company had assured the MCA of the UK that UK-sourced bovine materials were not used in the manufacture of the vaccine. However, these assurances were inaccurate, thus the vaccine was withdrawn. (www.dh.gov.uk) What was the concern in the Republic of Ireland about polio vaccine and vCJD? In December, 2000 the Irish Government issued a statement indicating that an oral polio vaccine distributed in 1998 and 1999 in Ireland had been manufactured using human serum albumin from a pool of donors, one of whom had since been diagnosed with vCJD. Evans/Medeva manufactured this oral polio vaccine. This vaccine is not licensed for use in the US. Have there been vaccines produced using cow materials from countries where there is a significant risk of BSE? During review of a license application, FDA learned that one manufacturer had used bovine-derived material from a country in which the USDA had determined that BSE might exist. CBER requested all vaccine manufacturers review the source of any bovine derived material used in the manufacture of their vaccines. Additional vaccines manufactured using bovine derived products from European countries were identified. These vaccines are identified in the “Recommendations for the Use of Vaccines Manufactured with Bovine Derived Materials” section of this web site. (See Section I) snip... When will vaccine manufacturers finish replacing cow-derived materials in vaccines with materials obtained from countries free of BSE? The time to make a vaccine and bring it to market can take several months to a year. Most vaccine made using bovine derived material from non-BSE risk countries was available at the end of 2001... snip... Shouldn't all potentially contaminated vaccine be destroyed? Also see above “Why is FDA leaving on the market vaccines which may be contaminated with the BSE agent?” FDA and other PHS agencies believe that the vaccines currently licensed for use in the US are safe. A special joint meeting of the TSE and Vaccines and Related Biological Products Advisory Committees concluded that the real risk of disease due to not vaccinating far outweighs the theoretical risk posed by exposure to vaccines that have a remote chance of containing the BSE agent. http://www.fda.gov/cber/bse/bseqa.htm NOW, FOR THE REST OF THE STORY ; 8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients). http://www.bseinquiry.gov.uk/files/y...2/14010001.pdf http://www.bseinquiry.gov.uk/files/y...2/14011001.pdf although 176 products do _not_ conform to the CSM/VPC guidelines. http://www.bseinquiry.gov.uk/files/y...9/06011001.pdf TWA LITTLE minute http://www.bseinquiry.gov.uk/files/y...6/10001001.pdf http://www.bseinquiry.gov.uk/files/y...6/13010001.pdf http://www.bseinquiry.gov.uk/files/y...6/14006001.pdf COMMERCIAL IN CONFIDENCE http://www.bseinquiry.gov.uk/files/y...9/06005001.pdf http://www.bseinquiry.gov.uk/files/y...0/06005001.pdf NOT FOR PUBLICATION http://www.bseinquiry.gov.uk/files/y...1/01012001.pdf http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf http://www.bseinquiry.gov.uk/files/y...4/00007001.pdf http://www.bseinquiry.gov.uk/files/y...7/00007001.pdf http://www.bseinquiry.gov.uk/files/y...9/00004001.pdf http://www.bseinquiry.gov.uk/files/y...0/00003001.pdf http://www.bseinquiry.gov.uk/files/y...1/04001001.pdf http://www.bseinquiry.gov.uk/files/y...1/26007001.pdf http://www.bseinquiry.gov.uk/files/y...1/30001001.pdf http://www.bseinquiry.gov.uk/files/y...9/06011001.pdf NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE snip... I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use. snip... The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out... http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf more on the 1968 medicine act, they forgot to follow http://www.bseinquiry.gov.uk/files/y...1/30008001.pdf Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer) http://www.bseinquiry.gov.uk/files/y...2/22008001.pdf http://www.bseinquiry.gov.uk/files/y...2/22011001.pdf (It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.) http://www.bseinquiry.gov.uk/files/y...6/08011001.pdf http://www.bseinquiry.gov.uk/files/y...6/08011001.pdf http://www.bseinquiry.gov.uk/files/y...6/07010001.pdf TWA LITTLE STATEMENT 331 http://www.bseinquiry.gov.uk/files/ws/s331.pdf http://www.bseinquiry.gov.uk/files/y...1/04003001.pdf http://www.microbes.info/forums/inde...ew=getlastpost http://lists.ifas.ufl.edu/cgi-bin/wa...mg&T=0&P=21108 http://lists.ifas.ufl.edu/cgi-bin/wa...mg&T=0&P=16159 18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7 December 2006 are now available. snip... 64. A member noted that at the recent Neuroprion meeting, a study was presented showing that in transgenic mice BSE passaged in sheep may be more virulent and infectious to a wider range of species than bovine derived BSE. Other work presented suggested that BSE and bovine amyloidotic spongiform encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A MUTATION FOUND IN CASES OF SPORADIC CJD. snip... http://www.seac.gov.uk/minutes/95.pdf 3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve University Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain discovered recently in Italy, and similar or different atypical BSE cases were also reported in other countries. The infectivity and phenotypes of these atypical BSE strains in humans are unknown. In collaboration with Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have inoculated transgenic mice expressing human prion protein with brain homogenates from BASE or BSE infected cattle. Our data shows that about half of the BASE-inoculated mice became infected with an average incubation time of about 19 months; in contrast, none of the BSE-inoculated mice appear to be infected after more than 2 years. ***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than classical BSE in humans.*** 6:30 Close of Day One http://www.healthtech.com/2007/tse/day1.asp SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM 1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype of 'UNKNOWN' strain growing. ... http://www.cjdsurveillance.com/resou...asereport.html There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection. He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins. http://www.fda.gov/ohrms/dockets/ac/...006-4240t1.htm http://www.fda.gov/ohrms/dockets/ac/...006-4240t1.pdf JOURNAL OF NEUROLOGY MARCH 26, 2003 RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States Email Terry S. Singeltary:flounder9@VERISON.NET I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc? http://www.neurology.org/cgi/eletters/60/2/176#535 Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734. http://jama.ama-assn.org/ BRITISH MEDICAL JOURNAL BMJ http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2 BMJ http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1 [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle http://www.fsis.usda.gov/OPPDE/Comme...3-025IFA-2.pdf [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) http://www.fsis.usda.gov/OPPDE/Comme...006-0011-1.pdf THE SEVEN SCIENTIST REPORT *** http://www.fda.gov/ohrms/dockets/doc...4-Attach-1.pdf PAUL BROWN M.D. http://www.fda.gov/ohrms/dockets/doc...0490-vol40.pdf 9 December 2005 Division of Dockets Management (RFA-305) SEROLOGICALS CORPORATION James J. Kramer, Ph.D. Vice President, Corporate Operations http://www.fda.gov/ohrms/dockets/doc...3-01-vol35.pdf Embassy of Japan http://www.fda.gov/ohrms/dockets/doc...0273-EC240.htm Dockets Entered on December 22, 20052005D-0330, Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ... http://www.fda.gov/ohrms/dockets/dai...205/122205.htm 03-025IF 03-025IF-631 Linda A. Detwiler [PDF] Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4. Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12. http://www.fsis.usda.gov/OPPDE/Comme...-025IF-631.pdf 03-025IF 03-025IF-634 Linda A. Detwiler [PDF] Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2. Page 3. Page 4. Page 5. Page 6. Page 7. Page 8. http://www.fsis.usda.gov/OPPDE/Comme...-025IF-634.pdf Page 1 of 17 9/13/2005 [PDF] ... 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food ... http://www.fsis.usda.gov/OPPDE/Comme...3-025IFA-2.pdf 03-025IFA 03-025IFA-6 Jason Frost [PDF] ... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al [Docket No. 03- 025IF] Prohibition of the Use of Specified Risk Materials for Human Food and ... http://www.fsis.usda.gov/OPPDE/Comme...3-025IFA-6.pdf In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF] Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone: 732-741-2290 Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ... http://www.fsis.usda.gov/OPPDE/Comme...-025IF-589.pdf Terry S. Singeltary SR. P.O. Box 42 Bacliff, Texas USA 77518 |
:thud::thud:
that post was too long. |
the truth is a long and dangerous road sometimes. :sorry:
but to ignore the facts, that's even more dangerous. :( probably will not post anymore here, so you should not have to worry about anymore long posts......:Doh: |
no flounder...don't stop posting.
if the posts are broken up, they are easier to follow. i think that is all allicia meant. |
Wow! Lots of great information.
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It is great info and a good post .
just a lot to absorb all at once:) |
Challenging Gov. Perry's vaccine plan
Feb. 19, 2007, 5:01AM
Challenging Gov. Perry's vaccine plan By CLAY ROBISON Copyright 2007 Houston Chronicle AUSTIN — By now, it should be obvious that Gov. Rick Perry's legally questionable order on the cervical cancer vaccine is on a fast track to nowhere. It simply will remain a catalyst for discussion of a critical health issue, which may be mainly what the governor had in mind anyway. If Chairwoman Dianne White Delisi has her way, the House Public Health Committee will take the first major step today toward overturning the edict. The full House and the Senate likely will follow suit. Delisi's opposition to the governor's mandate is philosophical. She thinks the new vaccine against the human papillomavirus, or HPV, has tremendous potential but that it needs to be studied more before requiring schoolgirls to be inoculated. A health care advocate It, nevertheless, is ironic that Delisi, R-Temple, will play a key role in deep-sixing the initiative. Her daughter-in-law, Deirdre Delisi, is Perry's chief of staff. Also, the legislator is a former chairwoman — and still is listed as a state director, although she says she is no longer active — of Women in Government, a health care advocacy group partially funded by Merck, the HPV vaccine's manufacturer. Delisi also received a $1,000 contribution from Merck's political action committee during the 2005-06 election cycle, according to Texans for Public Justice, which tracks political donations. There even have been whispers, which Rep. Delisi adamantly denies, that she played a behind-the-scenes role in drafting the controversial order for the governor. Delisi said she was blindsided by Perry, as were other lawmakers. "It was a great surprise to me," she said. Delisi is confident that her committee and the full House will approve separate bills to overturn Perry's mandate and, in its place, order the Texas Department of State Health Services to develop an education program on HPV. She wouldn't make any predictions about the Senate, but 26 of the 31 senators have signed a letter asking Perry to withdraw his order. Delisi also opposes legislative proposals to impose a similar vaccine requirement by law. Instead, she said, education needs time to work while the vaccine proves itself. At least one of her committee members, Rep. Garnet Coleman, D-Houston, disagrees. "I don't think you can protect children with just another PR campaign," he said. Coleman, however, may be in the committee minority. Getting a head start Rep. Delisi said she scheduled legislation to rescind the governor's HPV order early because it was timely, and she wants to leave the Public Health Committee time to tackle other major issues, including Medicaid, later in the session. But Rep. Dennis Bonnen, R-Angleton, the sponsor of the bill, indicated there is another reason. He said he wanted to leave time for the Legislature to have a chance to override a Perry veto, if the governor tries to strike down the legislation. I doubt Perry would do that and further antagonize lawmakers weighing the fate of other proposals that are important to him, but the possibility presents an interesting scenario. The Legislature doesn't usually get the chance to override gubernatorial vetoes because most vetoes are issued after sessions have adjourned. Most bills go to the governor's desk in the final days of a session, which means the governor can wait until after lawmakers have gone home to kill bills he finds objectionable. The goal, as outlined by Bonnen, is to get his bill to the governor in time for Perry to have to sign or veto it while the Legislature is in town. Perry would have a 10-day deadline. A veto override requires a two-thirds vote of both the House and the Senate, and only one veto has been overridden in recent memory. That was in 1979, when a Legislature, still dominated by Democrats, defied Republican Gov. Bill Clements' veto of a local hunting bill. Other options There are still a few other ways in which Perry's HPV order could be thwarted: •Attorney General Greg Abbott could rule the order exceeds the governor's authority. Abbott has been asked for an opinion. •The Legislature could put a "rider," or special provision, in the appropriations bill prohibiting funds from being spent to carry out the order. •Perry could rescind it. "Not going to happen," said Robert Black, the governor's spokesman, of the third possibility. In any event, as Perry noted the other day, he has succeeded in focusing public attention on a critical health care issue. "I think the beauty of what we have done here is created a very extensive conversation, debate, discussion about an issue that is causing a lot of grief, heartache and death," he said. 'Jessica's Law' update Lt. Gov. David Dewhurst's main re-election issue last year was his proposal to enact a "Jessica's Law," cracking down on sexual assaults against children, including making repeat offenders eligible for the death penalty, even if their victims don't die. He held a news conference on the proposal again last week in the Senate, but the House will take the first shot at moving the legislation. The House Criminal Jurisprudence Committee has scheduled a public hearing for Tuesday on a similar bill by Rep. Debbie Riddle, R-Houston. You can write to Clay Robison at 1005 Congress, Suite 1060, Austin, TX 78701, or e-mail him at clay.robison@chron.com . http://www.chron.com/disp/story.mpl/...n/4563315.html TSS |
Merck suspends lobbying for cervical cancer vaccine
http://www.chron.com/disp/story.mpl/...n/4567385.html |
well well well
big pharma taking a step back because of public pressure....now that is very encouraging! |
I just wanted to chime in here with some information.
In VA http://leg1.state.va.us/cgi-bin/legp...071+ful+SB1230 Quote:
OMG they pulled the exemption specific to this vax!!!! I just printed it out within the last 3wks and now it's changed!!! It was the only reason I wasn't fighting this bill... Ugh... I've got some legislative research to do now... Okay, it looks like the wording is there, but I'm not 100% sure that it's for the current bill meaning there have been many changes to the bill and I'm seeing all the stages without knowing which one is going before the house and senate. Quote:
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http://www.medscape.com/viewarticle/552503_print
Merck Ending Lobbying for Mandatory Gardasil Vaccine Quote:
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any news on whether the Texas Governor is going to heed the public outcry and change this ruling?
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Embattled FDA chief fights back
March 3, 2007, 10:44PM
Embattled FDA chief fights back Von Eschenbach calls his agency 'a team few people fully appreciate' By BENNETT ROTH Copyright 2007 Houston Chronicle Washington Bureau WASHINGTON — Dr. Andrew von Eschenbach, a former official at Houston's M.D. Anderson Cancer Center who has twice beaten back cancer, is facing another challenge as he struggles to right the ship at the tempest-tossed Food and Drug Administration. With 12,000 employees and an annual budget of more than $2 billion, the FDA has enormous reach. It is responsible for approving the gamut of medical devices and drugs, from cancer treatment for humans to motion-sickness medicine for dogs. The agency, created just more than a century ago, is also charged with monitoring the safety of the bulk of the nation's food supply, recently issuing warnings about tainted spinach and peanut butter. In an interview with the Houston Chronicle, von Eschenbach expressed frustration with the mounting criticism of his agency. "It is a team few people fully appreciate. It is a team where people make decisions and immediately their motives are questioned," he said. "It is very hard for people to work under those conditions. How many cheerleaders have you seen on the streets for the FDA?" Long confirmation fight Von Eschenbach, who had been acting commissioner since 2005, was finally confirmed by the Senate to the permanent job in December but only after numerous holdups because of bipartisan criticism aimed at him and the actions of his predecessors. Critics charged the FDA has succumbed to pharmaceutical industry pressures, leading to approval of drugs with dangerous side effects, such as the antibiotic Ketek, which has been linked to liver cancer. Some lawmakers also accused the FDA of bowing to political pressure from social conservatives when it delayed approval of the Plan B "morning after" contraceptive pill for over-the-counter use after an expert panel had approved it. The drug was ultimately cleared last year for women 18 and older without a prescription after several Democrats threatened to block von Eschenbach's confirmation. The agency's top officials, including von Eschenbach, have also been accused of stifling dissent and threatening whistleblowers. And it was recently disclosed that the agency is conducting half as many food-safety inspections as it was three years ago. Von Eschenbach, who is fond of using sports metaphors and often refers to the FDA as his "team," acknowledged that he is dealing with an agency that is, in his words, enormously challenged as it labors to oversee 20 percent of what Americans consume. A cancer story He has sought to motivate agency scientists by stressing their vital role. The commissioner related the story of how one of his daughter's friends who had cancer had called him. The woman, who was having a birthday party for her 6-year-old daughter, told von Eschenbach she was running out of options and asked whether there was anything else to treat her cancer because she wanted to survive to be there for her daughter's next birthday. "You are what will determine whether there will be anything else," von Eschenbach told his FDA employees. "There can be nothing else without the FDA. We regulate everything." Raised in Philadelphia, von Eschenbach, 65, became a urologic surgeon and joined the faculty of University of Texas M.D. Anderson Cancer Center in 1976. In 1989 he became a patient when it was discovered he had melanoma. He was later diagnosed with prostate cancer. Friend of the Bushes Rising to become the head of the Prostate Cancer Research Program, he became friends with former President Bush and former first lady Barbara Bush, who are supporters of the cancer center. Those ties proved beneficial when their president son tapped von Eschenbach to direct the National Cancer Institute in 2002. In September 2005, President Bush appointed von Eschenbach acting director of the FDA to replace Lester Crawford, who last week was sentenced to three years' probation and fined $90,000 for lying about stocks he owned in companies regulated by the FDA. Von Eschenbach has faced a rocky initiation at the FDA, but Dr. John Mendelsohn, president of M.D. Anderson, said that in conversations he has had with his former colleague, he appears to be holding up. "He is accepting of the fact that there are going to be challenges and disagreements in government, but he bears it," said Mendelsohn. Mendelsohn also said that von Eschenbach, a Roman Catholic, relies on his faith and his family, including his wife, Madelyn, for support. Since taking over as permanent commissioner, von Eschenbach has moved to address some concerns by unveiling a plan to monitor safety of drugs for 18 months after they have been approved by the FDA. The agency also restricted the use of Ketek for treatment of pneumonia. The administration has proposed adding $10 million in next year's budget for more food inspections. Vaccine controversy Von Eschenbach was acting commissioner when the FDA last summer approved the vaccine to protect women from the virus that causes cervical cancer. In Texas, the recent decision by Gov. Rick Perry to require girls 11 and older to receive the vaccine has sparked an uproar, with some opponents questioning the effectiveness of the vaccine. While sidestepping the issue of whether it should be mandatory, von Eschenbach said the vaccine is "an opportunity for us to prevent this disease from occurring in the first place." "We have a vaccine that is effective, and it is a vaccine that is safe," he said. Some FDA scientists have expressed concern that the agency has tried to suppress warnings about safety of new drugs and intimidate whistleblowers. A survey published last summer by the Union of Concerned Scientists of 997 FDA scientists found that 40 percent feared retaliation for airing concerns about drug safety in public. David Ross, a former FDA reviewer, told a House panel that von Eschenbach last summer summoned scientists who had reviewed Ketek after members of Congress had begun to question the drug approval. Ross said that Von Eschenbach, who was acting commissioner at the time, compared the FDA to a football team and told reviewers that if they told anyone outside the FDA about the problems with Ketek approval, they'd be "traded from the team." Ross testified that rather than be silenced, he left the agency. Von Eschenbach bristled at the suggestion that he doesn't allow the airing of different opinions. The commissioner said when he gave what he called "my locker-room talk" to the Ketek reviewers, he stressed that he wanted to hear diverse points of view during the deliberations but that once a decision had been made, "we go out on the field together." What lies ahead New challenges await the commissioner. Sen. John Cornyn, R-Texas, has joined with Democratic Sen. Ted Kennedy of Massachusetts in sponsoring legislation that would require the FDA to regulate nicotine as a drug. Congress also will be considering the renewal of a 1992 law that assesses a fee on drug companies to help pay for FDA review of new drugs. Revenue from industry fees, slightly more than $305 million this year, was intended to speed FDA drug reviews. Critics say the arrangement has resulted in the pharmaceutical industry getting too much sway in the approval process. "He who pays the piper calls the tune," said William Vaughan, senior policy analyst at Consumers Union. The drug industry has been a major player in the nation's capital. The Pharmaceutical Research & Manufacturers of America spent $8.8 million lobbying the executive and legislative branches on drug-related issues during the last six months of 2006, according to PoliticalMoneyline. Alan Goldhammer, vice president for regulatory affairs for the industry group, said the reliance on industry fees to underwrite part of the cost of drug reviews has not undermined the safety of drugs allowed on the market. He said the number of drugs, about 3 percent, withdrawn from the market has not changed since the law imposing the fees was enacted. Von Eschenbach said he receives more input from consumer groups than the drug industry. "The industry doesn't tell me what to do," he said. Von Eschenbach, who has a vacation home on Lake Conroe, said he intends to return to the Houston area once his stint at the FDA is over. But he does not envision resuming his practice at M.D. Anderson, having not done surgery for five years. He added, "I have no idea what life will have in store for me after the FDA." BIOGRAPHY • Born : Oct. 30, 1941 • Place of birth: Philadelphia • Education: B.S., St. Joseph's University in Philadelphia in 1963; medical degree from Georgetown University in Washington D.C., in 1967 • Career highlights: Joined University of Texas M.D. Anderson as urologic oncology fellow in 1976. In 1983 was named chairman of the Department of Urology. Founded the Prostate Cancer Research Program and served as executive vice president and chief academic officer at M.D. Anderson. Appointed by President Bush to head the National Cancer Institute in 2002. In 2005, tapped by Bush to be acting commissioner of the Food and Drug Administration. Confirmed by Senate in December 2006 as permanent FDA commissioner. IN HIS WORDS Quotes from Dr. Andrew von Eschenbach, FDA commissioner: •"You are really buffeted by an unbelievably diverse set of issues. One day you are dealing with some issue having to do with food. Another day it is drugs" •"I think it is fair to say I am a surgical personality. What is important to me is the outcome. Are we making a difference in those people's lives and do(ing) it in a way that is efficient and effective" •On speeding up drug approvals: "Rapid does not mean reckless. I believe we can create processes that will enhance the rigor and precision of decisions but do it in way that is actually faster. You put up guardrails, not speed bumps" •On FDA approval of a vaccine for cervical cancer: "There are parts of this country where cancer of the cervix is a major cause of death, unnecessary death, of women. For many of them here's an opportunity for us to prevent this disease from occurring in the first place ... If you are asking me as a cancer doctor, 'Is this a major step forward?', I'd say absolutely. If you are asking me as head of the FDA, 'Do you believe this vaccine is safe and effective?', absolutely" bennett.roth@chron.com http://www.chron.com/disp/story.mpl/...s/4600344.html Virginia to Require Vaccine for Girls By The Associated Press Fri, Mar. 02 2007 05:20 PM ET RICHMOND, Va. (AP) - Gov. Timothy M. Kaine said Thursday he would sign legislation requiring all sixth-grade girls to be vaccinated against the sexually transmitted virus that can cause cervical cancer. Virginia would become the second state to mandate the vaccine for the human papillomavirus, or HPV, and the first to do it through legislative action. Texas Gov. Rick Perry sidestepped the Legislature and ordered the shots for girls there, but lawmakers are considering overriding that order. "I think it strikes the right balance," said Kaine, who wanted to make sure parents would have enough time to review the vaccine and allow them to opt out "without having to jump through hoops." The requirement would go into effect for the 2009 school year. If parents want to opt out, they must review literature provided by their child's school, then sign a form. The federal government approved Gardasil, the only vaccine on the market, in June and suggested it be given to females before they become sexually active. Copyright © 2007 The Associated Press. All rights reserved. The information contained in the AP News report may not be published, broadcast, rewritten or redistributed without the prior written authority of The Associated Press. http://www.christianpost.com/article..._for_Girls.htm March 3, 2007, 10:19PM FDA poised to approve cattle antibiotic despite warnings Agency likely will approve antibiotic despite fears it could harm people By RICK WEISS Washington Post The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous — for people. The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defense against several serious human infections. No drug from that class has ever been approved in the United States for use in animals. The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotic, as has happened with other drugs. Those super-microbes could then spread to people. Echoing those concerns, the FDA's advisory board voted last fall to reject the request by InterVet Inc. of Millsboro, Del., to market the drug for cattle. Yet by all indications, the FDA will approve cefquinome this spring. That is all but required by a recently implemented "guidance document" codifying how to weigh threats to human health posed by proposed animal drugs. The wording of "Guidance for Industry 152" was crafted within the FDA after a long struggle. Some say it makes it too difficult for the FDA to say "no" to some drugs. "The industry says that 'Until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,' " said Edward Belongia, an epidemiologist at the Marshfield (Wis.) Clinic Research Foundation. "But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open." The FDA knows how hard it can be to close that door. In the mid-1990s, overriding the objections of public health experts, it approved the marketing of Baytril and SaraFlox for use in poultry. Both are fluoroquinolones, drugs important for their ability to fight the bacterium that causes anthrax and the food-borne bacterium campylobacter, which causes a diarrheal disease in people. Before long, doctors began finding fluoroquinolone-resistant strains of campylobacter in patients hospitalized with severe diarrhea. When studies showed a link to poultry, the FDA sought a ban. Abbott Laboratories pulled Saraflox, but Baytril's manufacturer, Bayer, pushed back. Late in 2005, Bayer gave up, but not before fluoroquinolone resistance had spread further. http://www.chron.com/disp/story.mpl/nation/4600179.html MRSA and anti-biotic resistance http://www.microbes.info/forums/index.php?showtopic=155 TSS |
Governor Rick Perry TEXAS Executive Order HPV update
March 13, 2007, 5:03PM
TX House Votes to Override Vaccine Order By APRIL CASTRO Associated Press Writer © 2007 The Associated Press AUSTIN — The Texas House approved a bill Tuesday that would keep the human papillomavirus vaccine off the list of required shots for school attendance, tentatively circumventing Gov. Rick Perry's executive order. The vaccine protects girls against strains of HPV, a sexually transmitted virus that causes most cases of cervical cancer. The measure, approved 119-21, still needs final approval in the House and approval in the Senate. It's also possible that Perry will veto the legislation, but the 119 voters that approved the bill Tuesday are more than enough to override a veto. Perry's order asked Health and Human Services Executive Commissioner Albert Hawkins to adopt rules to vaccinate all girls entering the sixth-grade as of September 2008. Parents could have refused the shots for their daughters. Perry's chief of staff met with key aides about the new vaccine on the same day its manufacturer donated money to his campaign, The Associated Press reported in February. A calendar for chief of staff Deirdre Delisi obtained under Texas' open records laws shows she met with the governor's budget director and three members of his office for an "HPV Vaccine for Children Briefing" on Oct. 16. That same day, Merck & Co.'s political action committee donated $5,000 to Perry and a total of $5,000 to eight state lawmakers. A spokeswoman for Perry estimated only 25 percent of young women in Texas would get the vaccine if it is not required. "Governor Perry's executive order on HPV would help to protect 95 percent of young women in Texas against the strains of HPV that cause cervical cancer," said spokeswoman Krista Moody. "The governor believes we should protect as many young women as possible _ rich and poor, insured and uninsured _ while maintaining parents' rights to opt their daughter out of receiving the vaccine." Perry's order angered lawmakers who said the governor circumvented the legislative process. The bill adopted Tuesday "will not take away the option for a single girl or a single family in this state to choose to vaccinate a child," said Republican Rep. Dennis Bonnen of Angleton, the lead author of the bill. "It simply says a family must make that choice, not a state government." Perry acknowledged weeks ago that the Legislature has the authority to supersede his mandate. But he has also insisted a requirement is good public policy that will save young women's lives. Critics argued that the vaccine, called Gardasil, was too new and its effects needed to be further studied before mandating it for Texas schoolgirls. The Food and Drug Administration approved Gardasil last year. On Monday, two prominent lawmakers said Attorney General Greg Abbott told them state health officials are not required to follow Perry's order because it does not carry the weight of law. Republican Sen. Jane Nelson and Rep. Jim Keffer had asked Abbott to clarify the governor's authority to issue executive orders and the Legislature's ability to overrule them. Cervical cancer can usually be prevented if precancerous cervical lesions are found by a Pap test and removed. Doctors recommend women get Pap tests once a year, but about half of the women in the U.S. who develop cervical cancer have never had a Pap test, according to the Centers for Disease Control and Prevention. ___ The measure is HB 1098. http://www.chron.com/disp/story.mpl/ap/fn/4626405.html March 12, 2007, 7:24PM HPV order does not carry weight of law, Abbott tells lawmakers By LIZ AUSTIN PETERSON Associated Press Writer © 2007 The Associated Press AUSTIN — Gov. Rick Perry's anti-cancer vaccine order does not carry the weight of law and state health officials are not required to follow it, two prominent lawmakers said Monday after meeting with Attorney General Greg Abbott. Abbott's informal opinion comes a day before the Texas House is scheduled to vote on a bill that would bar state officials from requiring the human papillomavirus vaccine for school attendance. Lawmakers were outraged in early February when Perry issued an executive order directing the Texas Health and Human Services Commission to adopt a rule requiring the vaccine for girls entering the sixth grade as of September 2008. The vaccine protects girls against strains of HPV that cause most cases of cervical cancer. Days after Perry issued the order, Republican Sen. Jane Nelson, of Lewisville, and Rep. Jim Keffer, of Eastland, asked Abbott to clarify the governor's authority to issue executive orders and the Legislature's ability to overrule them. Nelson said she and Keffer met with Abbott on Thursday and he told them the order "was more like a suggestion to the head of the agency." Abbott spokesman Jerry Strickland said the attorney general's office does not discuss the content or substance of its discussions with lawmakers. The governor acknowledged weeks ago that the Legislature has the authority to supersede his mandate. But he has also insisted the requirement is good public policy that will save young women's lives. "Because Gov. Perry's executive order is consistent with current law, nothing has been issued today that in any way alters the governor's directive," Perry spokesman Robert Black said in a Monday statement. Some conservatives have said the order contradicts Texas' abstinence-only sex education policies and strays too far into families' lives. Others have balked at the $360 cost for the vaccine, called Gardasil, and questioned the vaccine's efficacy and safety. With or without Perry's order, state law gives Health and Human Services Executive Commissioner Albert Hawkins the authority to require schoolgirls to get the vaccine. Opponents of the mandate have argued that it would be difficult for Hawkins to defy Perry since he's appointed by the governor. The bill the House is set to debate on Tuesday would add a sentence to the existing law stating that the HPV vaccine is not required for school attendance. With 93 co-sponsors, the proposal is almost sure to pass. An identical bill has been filed in the Senate. Black said 65 percent fewer women will be vaccinated if lawmakers make the shots optional. "While some would make this debate about the separation of powers, it is about saving lives," he said in the statement. Nelson, chairwoman of the Senate health and human services committee, said her committee will hear several bills about the HPV vaccine, including one that would institute a requirement similar to the one Perry has sought. In the month since Perry issued the order, lawmakers in Virginia and New Mexico have approved similar requirements. The governors of both states have said they will sign the bills into law. http://www.chron.com/disp/story.mpl/ap/tx/4623490.html March 13, 2007, 1:08PM HPV Notification Passes Wa. House By JENNIFER BYRD Associated Press Writer © 2007 The Associated Press OLYMPIA, Wash. — The Washington state House has voted to require that all schools in the state provide information about a sexually transmitted virus that can cause cervical cancer and about a vaccine to protect against it. http://www.chron.com/disp/story.mpl/ap/fn/4625529.html March 12, 2007, 10:15PM N.M. lawmakers approve cancer vaccine By MATT MYGATT Associated Press Writer © 2007 The Associated Press ALBUQUERQUE, N.M. — New Mexico is on the verge of becoming the latest state to require sixth-grade girls to be vaccinated against a sexually transmitted virus that can cause cervical cancer, a spokesman for the governor said Monday. http://www.chron.com/disp/story.mpl/...n/4623956.html why can't they just _offer_ them for free, instead of the executive order ??? heck, even the manufacturer of the vaccine saw the writing on the wall of what the 'executive order' of perry's was doing, why can't the Governer ??? TSS |
I am glad they voted this way
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me too!
i am hoping the mass emails that got sent out helped spread the word. i know our threads here got a lot of views. thanks flounder for posting the update. |
Dose of reality
March 17, 2007, 7:50PM
Dose of reality First, let's inoculate with the facts Controversial Gardasil may be better for Merck than it is for Texas girls By SIGRID FRY-REVERE There's nothing wrong with a drug maker publicizing its products and their benefits, but the lure of lucrative government contracts can prompt them to play fast and loose. In lobbying Texas lawmakers to make its latest vaccine mandatory, Merck has exaggerated both the threat of a disease and the ability of a drug to prevent it. The drug in question is Gardasil, a vaccine for four types of human papillomavirus, two of which are responsible for cervical cancer. The federal Food and Drug Administration approved Gardasil last year for use against human HPV in females aged 9 to 26. By a veto-proof majority of 119 to 21, the Texas House of Representatives voted last week against mandating Gardasil for middle school-aged girls, but the Texas Senate has yet to weigh in on the issue, and Gov. Rick Perry is expected to veto the bill. If he does — and the Texas Legislature doesn't have the votes to override his veto — then his earlier executive order mandating vaccination will stand. These mandates would be quite a boon for Merck, as Gardasil is one of the most expensive vaccines on the market. With a price tag of $360 for a series of three shots, vaccinating approximately 30 million middle school-aged girls in the United States would bring in more than $10 billion. Gardasil is not all it is cracked up to be. A recent study in the Journal of the American Medical Association indicates that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8 percent — already a number much lower than the 50 percent figure sited on Merck's Web site. But the rates for the two types of HPV responsible for 70 percent of all cervical cancers (16 and 18), are far lower: only 1.5 percent and 0.8 percent, respectively. The American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When detected early through Pap testing, the survival rate for cervical cancer is over 90 percent. Thus, when early detection methods are used, only around 0.2 percent of the girls being vaccinated are actually at risk of dying of cervical cancer from HPV 16 or 18 even without the vaccine. Under these circumstances, are we really prepared to spend $10 billion administering this vaccine? And while it's horrible that anyone at all should die of cervical cancer, the long-term risks that may be associated with Gardasil are totally unknown. Studies followed the women who participated in drug trials for an average of less than three years. What if some horrible unexpected side effect materializes? This possibility isn't as far fetched as you might think. In 1976, swine flu caused only one documented death in the United States, but the vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine caused Guillain-Barré Syndrome, a rare paralytic disease similar to polio, with a 5 percent fatality rate and a 10 percent rate of permanent paralysis. Mandatory Gardasil vaccinations would certainly brighten Merck's future, but it's not so clear that they're in the best interest of American girls. In all but the clearest cases, health risk assessments should be left up to individual families, not only because making such determinations rightly rest with families, but because it's simply not sensible policy to experiment on such a large portion of our population all at once. What if, 10 years from now, we discover that the vaccine causes infertility or another form of cancer? To add insult to injury, not only has Merck left Texas lawmakers in the dark about the myriad of possible downsides to mandatory HPV vaccination, it has actively lobbied and paid large campaign contributions to politicians willing to support such policies. According to documents obtained by the the Associated Press last month, Merck donated $5,000 to Gov. Perry on the same day his chief of staff met with his budget director for an "HPV vaccine for Children Briefing." To the casual observer, it looks a lot like Merck is paying politicians to do its bidding. Mandating HPV vaccinations would bring Merck huge profits, possibly at the expense of ordinary Texans — or at least at the expense of little girls. Fry-Revere is director of bioethics studies at the Cato Institute, a Washington-based think tank with a libertarian orientation. http://www.chron.com/disp/story.mpl/...k/4640022.html TSS |
Former science chief: 'MMR fears coming true'
By SUE CORRIGAN, Mail on Sunday - Last updated at 16:08pm on 22nd March 2006 A former Government medical officer responsible for deciding whether medicines are safe has accused the Government of "utterly inexplicable complacency" over the MMR triple vaccine for children. Dr Peter Fletcher, who was Chief Scientific Officer at the Department of Health, said if it is proven that the jab causes autism, "the refusal by governments to evaluate the risks properly will make this one of the greatest scandals in medical history". He added that after agreeing to be an expert witness on drug-safety trials for parents' lawyers, he had received and studied thousands of documents relating to the case which he believed the public had a right to see. He said he has seen a "steady accumulation of evidence" from scientists worldwide that the measles, mumps and rubella jab is causing brain damage in certain children. But he added: "There are very powerful people in positions of great authority in Britain and elsewhere who have staked their reputations and careers on the safety of MMR and they are willing to do almost anything to protect themselves." His warning follows reports that the Government is this week planning to announce the addition of a jab against pneumococcal meningitis for babies, probably from next April. It is also considering flu jabs for under-twos - not to protect the children, but adults they may infect. In the late Seventies, Dr Fletcher served as Chief Scientific Officer at the DoH and Medical Assessor to the Committee on Safety of Medicines, meaning he was responsible for deciding if new vaccines were safe. He first expressed concerns about MMR in 2001, saying safety trials before the vaccine's introduction in Britain were inadequate. Now he says the theoretical fears he raised appear to be becoming reality. He said the rising tide of autism cases and growing scientific understanding of autism-related bowel disease have convinced him the MMR vaccine may be to blame. "Clinical and scientific data is steadily accumulating that the live measles virus in MMR can cause brain, gut and immune system damage in a subset of vulnerable children," he said. "There's no one conclusive piece of scientific evidence, no 'smoking gun', because there very rarely is when adverse drug reactions are first suspected. When vaccine damage in very young children is involved, it is harder to prove the links. "But it is the steady accumulation of evidence, from a number of respected universities, teaching hospitals and laboratories around the world, that matters here. There's far too much to ignore. Yet government health authorities are, it seems, more than happy to do so." 'Why isn't the Government taking this massive public health problem more seriously?' Dr Fletcher said he found "this official complacency utterly inexplicable" in the light of an explosive worldwide increase in regressive autism and inflammatory bowel disease in children, which was first linked to the live measles virus in the MMR jab by clinical researcher Dr Andrew Wakefield in 1998. "When scientists first raised fears of a possible link between mad cow disease and an apparently new, variant form of CJD they had detected in just 20 or 30 patients, everybody panicked and millions of cows were slaughtered," said Dr Fletcher. "Yet there has been a tenfold increase in autism and related forms of brain damage over the past 15 years, roughly coinciding with MMR's introduction, and an extremely worrying increase in childhood inflammatory bowel diseases and immune disorders such as diabetes, and no one in authority will even admit it's happening, let alone try to investigate the causes." He said there was "no way" the tenfold leap in autistic children could be the result of better recognition and definitional changes, as claimed by health authorities. "It is highly likely that at least part of this increase is a vaccinerelated problem." he said. "But whatever it is, why isn't the Government taking this massive public health problem more seriously?" His outspokenness will infuriate health authorities, who have spent millions of pounds shoring up confidence in MMR since Dr Wakefield's 1998 statement. But Dr Fletcher said the Government is undermining public confidence in vaccine safety by refusing to do in-depth clinical research to rule out fears of MMR damage to children. He added that the risks of brain and gut damage from MMR injections seem to be much higher in children where a brother or sister has diabetes, an immune disorder. "That is a very strong clinical signal that some children are immunologically at risk from MMR," he said. "Why is the Government not investigating it further - diverting some of the millions of pounds spent on advertising and PR campaigns to promote MMR uptake into detailed clinical research instead?" Now retired after a distinguished 40-year career in science and medicine in Britain, Europe and the US, Dr Fletcher said that without such research, health authorities could not possibly rule out fears about MMR. He said: "It is entirely possible that the immune systems of a small minority simply cannot cope with the challenge of the three live viruses in the MMR jab, and the ever-increasing vaccine load in general." He said he had decided to speak out because of his deep concern at the lack of treatment for autistic children with bowel disease, as revealed in The Mail on Sunday two weeks ago. He called the sudden termination of legal aid to parents of allegedly vaccine-damaged children in late 2003 "a monstrous injustice". After agreeing to be a witness for the parents, he received thousands of documents relating to the case. "Now, it seems, unless the parents force the Government to restore legal aid, much of this revealing evidence may never come out," he said. The Department of Health said: "MMR remains the best protection against measles, mumps and rubella. It is recognised by the World Health Organisation as having an outstanding safety record and there is a wealth of evidence showing children who receive the MMR vaccine are no more at risk of autism than those who don't." http://www.dailymail.co.uk/pages/liv...n_page_id=1774 Official defends editing climate papers By H. JOSEF HEBERT, Associated Press Writer Mon Mar 19, 5:54 PM ET WASHINGTON - A former White House official accused of improperly editing reports on global warming defended his editing changes Monday, saying they reflected views in a 2001 report by the National Academy of Sciences. House Democrats said the 181 changes made in three climate reports reflected a consistent attempt to emphasize the uncertainties surrounding the science of climate change and undercut the broad conclusions that man-made emissions are warming the earth. Philip Cooney, former chief of staff at the White House Council on Environmental Quality, acknowledged at a House hearing that some of the changes he made were "to align these communications with the administration's stated policy" on climate change. The extent of Cooney's editing of government climate reports first surfaced in 2005. Shortly thereafter, Cooney, a former oil industry lobbyist, left the White House to work at Exxon Mobil Corp. "My concern is that there was a concerted White House effort to inject uncertainty into the climate debate," said Rep. Henry Waxman (news, bio, voting record), D-Calif., chairman of the House Government Reform Committee. Cooney's appearance before Waxman's committee Monday was the first time he has spoken publicly, or was extensively questioned, about the issue. Cooney said that many of the changes he made to the reports — such as uncertainty about the regional impact of climate change and limits on climate modeling — reflected findings of a 2001 National Academy of Sciences report on climate. Waxman's committee also heard from James Hansen, director of NASA's Goddard Institute for Space Studies and one of the country's leading climate scientists, who said the White House repeatedly tried to control what government scientists say to the public and media about climate change. "Interference with communications of science to the public has been greater during the current administration than at any time in my career," said Hansen, who was one of the first to raise concerns about climate change in the 1980s. Hansen's battles with NASA and White House public affairs officials are not new and resulted in an easing of NASA's policies toward scientists talking to the media about their work. But that was not always the case. Hansen said that in 2005 he was told by a 24-year-old NASA public affairs official he could not take part in an interview with National Public Radio on orders from senior NASA public affairs officials. Instead, three other NASA officials were offered for the interview. The young press officer, George Deutsch, now 26, sat next to Hansen at the witness table Monday and told the committee he had simply been "relaying" the views of higher-ups at NASA that Hansen was not to participate in the interview. Rep. Darrell Issa (news, bio, voting record), R-Calif., suggested that Hansen was not being muzzled at all and that there is nothing wrong with government scientists being subject to some limits in what they say. "You're speaking on federal paid time. Your employer happens to be the American taxpayer," Issa lectured Hansen. He said a Google search had shown Hansen cited on more than 1,400 occasions over a year in interviews and appearances. Hansen said he accepted only "a small fraction" of the requests for interviews and appearances and that, as a matter of free speech, government scientists should not be restrained in their remarks or have public affairs officers listening in on interviews. "It doesn't ring true," said Hansen. "It's not the American way. And it's not constitutional." http://news.yahoo.com/s/ap/20070319/...ntists_warming VACCINES AND CJD 'CONFIDENTIAL' snip... 2.1.3. _______________, England Ltd) contains BOVINE HEART AND BRAIN SOURCED FROM USA. This is an oral product which declares a number of bacteria as active ingredients and is said to use BOVINE BRAIN AND HEART in process, sourced from the USA. (It also uses UK derived equine blood.) This product holds a PLR, and is indicated for the prevention and treatment of bronchial catarrh, sinus and antrum infections and bacterial infections following virus colds. There are no efficacy data. snip... 4.3 The following companies did NOT KNOW THE SOURCE of some or all of the serum they used XXXXXXXXXXXXXXXXXXXXXXXX - (Factor VIII) XXXXXXXXXXXXXXXXXXXXXXXX - (Rabies Vaccine) XXXXXXXXXXXXXXXXXXXXXXXX - Measles, Rubella, MMR and rabies vaccine. snip... http://www.bseinquiry.gov.uk/files/y...9/06011001.pdf Two million children innoculated with BSE vaccines The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts. TIP740203/l 0424 CONFIDENTIAL http://www.mad-cow.org/00/may00_news.html#aaa http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh http://www.emergingdisease.org/phpbb...9587&view=next 18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7 December 2006 are now available. snip... 64. A member noted that at the recent Neuroprion meeting, a study was presented showing that in transgenic mice BSE passaged in sheep may be more virulent and infectious to a wider range of species than bovine derived BSE. Other work presented suggested that BSE and bovine amyloidotic spongiform encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A MUTATION FOUND IN CASES OF SPORADIC CJD. snip... http://www.seac.gov.uk/minutes/95.pdf 3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve University Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain discovered recently in Italy, and similar or different atypical BSE cases were also reported in other countries. The infectivity and phenotypes of these atypical BSE strains in humans are unknown. In collaboration with Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have inoculated transgenic mice expressing human prion protein with brain homogenates from BASE or BSE infected cattle. Our data shows that about half of the BASE-inoculated mice became infected with an average incubation time of about 19 months; in contrast, none of the BSE-inoculated mice appear to be infected after more than 2 years. ***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than classical BSE in humans.*** 6:30 Close of Day One http://www.healthtech.com/2007/tse/day1.asp SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM 1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype of 'UNKNOWN' strain growing. ... http://www.cjdsurveillance.com/resou...asereport.html There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection. He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins. http://www.fda.gov/ohrms/dockets/ac/...006-4240t1.htm http://www.fda.gov/ohrms/dockets/ac/...006-4240t1.pdf i don't know whom, or what to believe anymore. we must get politics and the industry (one of the same), out of science based decision making, that much i do know. TSS |
sorry, my dd got the vaccine. If I can help her to prevent getting HPV, then I will. I have seen the effects of HPV and it is devastating. We are solid strong Christians, as is her dr, but we all felt it would be in her best interests for her to get the vaccine.
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UCSF experts cautious about vaccine for cervical cancer virus
Corinna Kaarlela, News Director
Source: Kristen Bole kbole@pubaff.ucsf.edu 415-476-2557 10 May 2007 Karen Smith-McCune, MD UCSF experts cautious about vaccine for cervical cancer virus Unknowns about the effectiveness and safety of the new human papillomavirus (HPV) vaccine demand thoughtful deliberation by clinicians on its role in cervical cancer prevention, according to two UCSF women’s health specialists. The lack of long-term follow-up to assess vaccine efficacy and safety, as well as the lack of testing in the age group targeted for the vaccine (11 to 12 year-old girls), are among the main reasons for such caution, they say. Their analysis is reported in today’s issue (May 10, 2007) of the “New England Journal of Medicine,” which focuses on the new vaccine. The editorial and other NEJM articles are available online at http://content.nejm.org. The vaccine, which has received international attention since its approval by the Food and Drug Administration last June, targets four HPV types, two of which can cause cervical cancer, according to George F. Sawaya, MD, and Karen Smith-McCune, MD, who are co-authors of the editorial and are associate professors in the UCSF Department of Obstetrics, Gynecology and Reproductive Services. Previously published data about the vaccine have indicated 100 percent effectiveness against the pre-cancerous cervical lesions that are associated with the HPV types targeted by the vaccine. That data applied to women who had not previously been exposed to those viral types. New studies reported in this issue of the NEJM confirm these positive findings, but also provide information about the impact of vaccination in a larger, more representative population of all trial participants, the UCSF co-authors say. The new data cover all participants regardless of prior HPV exposure and all pre-cancerous lesions, regardless of HPV type. “These new studies provide a preliminary glimpse of what we might expect from vaccinating women up to age 26 who have already been sexually active, as is recommended by the Centers for Disease Control and Prevention,” Sawaya says. The overall efficacy of the vaccine for reducing pre-cancerous cervical lesions from any HPV type was modest: over 3 years, 3.6 percent of vaccinated women received this diagnosis compared to 4.4 percent of unvaccinated women. Rates of the most severe lesions were not significantly reduced by vaccination, the co-authors say. “There has been an understandably positive response to the promise of this vaccine, but we have to balance that promise with what is actually known,” says Smith-McCune, who has chosen not to vaccinate her own teenage daughters against HPV at this time. “The issue here is not whether we want to protect women against cervical cancer, but the safety and efficacy of this specific vaccine,” Smith-McCune says. “One of the largest questions is whether targeting only two of at least 15 HPV types known to cause cervical cancer is enough to impact development of cervical pre-cancer and cancer.” An estimated 9,700 American women were diagnosed with cervical cancer in 2006, according to the American Cancer Society. The vast majority of those cancers can be avoided with regular cervical cancer screening with the Pap test, the authors say. “The Pap test is a proven and effective way to reduce cervical cancer risk, whereas we are just beginning to find out about the overall effectiveness and safety of the vaccine,” Smith-McCune says. “So far, the HPV vaccine looks promising,” says Sawaya. “The diagnosis of a rare cancer usually related to HPV in one woman who received the vaccine, however, gives us pause and argues for a cautious approach until the current studies are completed and final outcomes reported.” Both stressed that since screening is widely available, cervical cancer is not a public health emergency in this country. “The rush toward mandatory vaccination is puzzling, but it is important to realize that the major studies are on-going,” Sawaya says. “As with any preventive measure, we need to be quite certain that the benefits of vaccination outweigh the harms before we embark on widespread vaccination programs.” Both doctors urged women to continue to receive regular cervical cancer screening, regardless of whether they have received the vaccine. UCSF is a leading university that advances health worldwide by conducting advanced biomedical research, educating graduate students in the life sciences and health professions, and providing complex patient care. ### Additional information: Part 1 First Appeared Wednesday, 20 September '06 UCSF Panel Discussion Airs Concerns, Hopes for New HPV Vaccines Part 1 of 2 http://pub.ucsf.edu/today/cache/news/200609198.html Part 2 UCSF Panel Discussion Airs Concerns, Hopes for New HPV Vaccines Part 2 of 2 http://pub.ucsf.edu/today/cache/news/2006092010.html http://pub.ucsf.edu/newsservices/releases/200705103/ Volume 356:1905-1908 May 10, 2007 Number 19 Next Politics, Parents, and Prophylaxis — Mandating HPV Vaccination in the United States R. Alta Charo, J.D. Cancer prevention has fallen victim to the culture wars. Throughout the United States, state legislatures are scrambling to respond to the availability of Merck's human papillomavirus (HPV) vaccine, Gardasil, and to the likely introduction of GlaxoSmithKline's not-yet-approved HPV vaccine, Cervarix, which have been shown to be effective in preventing infection with HPV strains that cause about 70% of cases of cervical cancer. At the Centers for Disease Control and Prevention (CDC), the Advisory Committee on Immunization Practices (ACIP) has voted unanimously to recommend that girls 11 and 12 years of age receive the vaccine, and the CDC has added Gardasil to its Vaccines for Children Program, which provides free immunizations to impoverished or underserved children. Yet despite this federal imprimatur, access to these vaccines has already become more a political than a public health question. Though the more important focus might be on the high cost of the vaccines — a cost that poses a genuine obstacle to patients, physicians, and insurers — concern has focused instead on a purported interference in family life and sexual mores. This concern has resulted in a variety of political efforts to forestall the creation of a mandated vaccination program. In Florida and Georgia, for example, efforts to increase adoption of the vaccine have been stalled by legislative maneuvering. The Democratic governor of New Mexico has announced that he will veto a bill that mandates vaccinations. And the Republican governor of Texas came under fire (and under legal attack from his own attorney general) when he issued an executive order to the same effect, mandating that all girls entering the sixth grade receive the vaccine; the policy was attacked as an intrusion on parental discretion and an invitation to teenage promiscuity. But all these measures included a parental right to opt out, whether on religious or secular grounds. The opposition seemed more about acknowledging the realities of teenage sexuality than about the privacy and autonomy of the nuclear family. For more than a century, it has been settled law that states may require people to be vaccinated, and both federal and state court decisions have consistently upheld vaccination mandates for children, even to the extent of denying unvaccinated children access to the public schools. State requirements vary as to the range of communicable diseases but are often based on ACIP recommendations. School-based immunization requirements represent a key impetus for widespread vaccination of children and adolescents1 and are enforceable even when they allegedly conflict with personal or religious beliefs.2 In practice, however, these requirements usually feature exceptions that include individual medical, religious, and philosophical objections. View larger version (30K): [in this window] [in a new window] State Laws and Proposed Legislation Mandating HPV Vaccination. All legislation mandating HPV vaccination includes some form of parental opt-out. The Texas mandate is the result of an executive order from the governor, and its legality is being challenged by the attorney general of Texas. There is also legislation under consideration in Texas that would prohibit a mandate. If passed, it would override the executive order. The Virginia law was passed by the legislature and signed by the governor. The New Mexico legislation was passed by the House and Senate and was then vetoed by the governor. Bills in California and Maryland have been withdrawn for consideration, and the bill in South Carolina has been tabled. Neither Alaska nor Hawaii has considered a mandate. Legislation that makes provisions for funding is under consideration in many states but is not shown here. The various bills would require insurance companies to cover vaccination, allocate state funds, direct agencies to apply for federal funds, or some combination. Information is from the National Conference of State Legislatures and is accurate as of April 27, 2007. HPV-vaccination mandates, which are aimed more at protecting the vaccinee than at achieving herd immunity, have been attacked as an unwarranted intrusion on individual and parental rights. The constitutionality of vaccination mandates is premised on the reasonableness of the risk–benefit balance, the degree of intrusion on personal autonomy, and, most crucial, the presence of a public health necessity. On the one hand, to the extent that required HPV vaccination is an example of state paternalism rather than community protection, mandatory programs lose some of their justification. On the other hand, the parental option to refuse vaccination without interfering in the child's right to attend school alters this balance. Here the mandates act less as state imperatives and more as subtle tools to encourage vaccination. Whereas an opt-in program requires an affirmative effort by a parent, and thus misses many children whose parents forget to opt in, an opt-out approach increases vaccination rates among children whose parents have no real objection to the program while perfectly preserving parental autonomy. Opposition to HPV vaccination represents another chapter in the history of resistance to vaccination and, on some levels, reflects a growing trend toward parental refusal of a variety of vaccines based on the (erroneous) perception that many vaccines are more risky than the diseases they prevent. In most cases, pediatricians have largely restricted themselves to educating and counseling objecting families, since it is rare that the risks posed by going unvaccinated are so substantial that refusal is tantamount to medical neglect. In the case of HPV vaccine, parents' beliefs that their children will remain abstinent (and therefore uninfected) until marriage render it even more difficult to make the case for mandating a medical form of prevention. Even with an opt-out program, critics may argue that the availability of a simple and safe alternative — that is, abstinence — undermines the argument for a state initiative that encourages vaccination through mandates coupled with an option for parental refusal. But experience shows that abstinence-only approaches to sex education do not delay the age of sexual initiation, nor do they decrease the number of sexual encounters.3 According to the CDC, though only 13% of American girls are sexually experienced by 15 years of age, by 17 the proportion grows to 43%, and by 19 to 70%.4 School-based programs are crucial for reaching those at highest risk of contracting sexually transmitted diseases, and despite the relatively low rate of sexual activity before age 15, the programs need to begin with children as young as 12 years: the rates at which adolescents drop out of school begin to increase at 13 years of age,1 and younger dropouts have been shown to be especially likely to engage in earlier or riskier sexual activity. Another fear among those who oppose mandatory HPV vaccination is that it will have a disinhibiting effect and thus encourage sexual activity among teens who might otherwise have remained abstinent. This outcome, however, seems quite unlikely. The threat of pregnancy or even AIDS is far more immediate than the threat of cancer, but sex education and distribution of condoms have not been shown to increase sexual activity. Indeed, according to a study conducted by researchers at the University of Pennsylvania, it is the comprehensive sex-education approaches that include contraceptive training that "delay initiation of sexual intercourse, reduce frequency of sex, reduce frequency of unprotected sex, and reduce the number of sexual partners."5 Opposition to the HPV-vaccination mandates, then, would seem to be based more on an inchoate concern: that to recognize the reality of teenage sexual activity is implicitly to endorse it. Public health officials may have legitimate questions about the merits of HPV vaccine mandates, in light of the financial and logistic burdens these may impose on families and schools, and also may be uncertain about adverse-event rates in mass-scale programs. But given that the moral objections to requiring HPV vaccination are largely emotional, this source of resistance to mandates is difficult to justify. Since, without exception, the proposed laws permit parents to refuse to have their daughters vaccinated, the only valid objection is that parents must actively manifest such refusal. Such a slight burden on parents can hardly justify backing away from the most effective means of protecting a generation of women, and in particular, poor and disadvantaged women, from the scourge of cervical cancer. To lighten that burden even further, the governor of Virginia has proposed that refusals need not even be put in writing. Perhaps it is time for parents who object to HPV vaccinations to take a lesson from their children and heed the words of Nancy Reagan: Just say no. Source Information Professor Charo is a professor of law and bioethics at the University of Wisconsin, Madison. An interview with Professor Charo can be heard at www.nejm.org. References http://content.nejm.org/cgi/content/full/356/19/1905 http://content.nejm.org/ TSS |
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