"We had an ASA Board member go to the national ASA Convention-new CDC numbers are 1:100 births. CDC considers it an epidemic...soon to be released, but not sure when. 1:66 births in military families. I just want to cry. How long until there are MORE people ON the spectrum than people NOT on the spectrum??!?"
The (Not) Combating Autism Act in Action
By Katie Wright
This is an open letter to all the parents, families, teachers, therapists and others who worked so hard getting the CAA bill passed. Thousands of you called, e-mailed and wrote to your representatives. Dozens of families traveled to DC to meet with their Congresspersons and Senators and personally explain why autism research and services desperately need more funding. Some of you picketed the offices of non-supporters, my parents traveled to DC a dozen times and used every connection they had to make our families heard. It required Herculean efforts to pass a “single disease” bill but our community was relentless and determined.
Today The Interagency Autism Coordinating Committee is responsible for disbursing the millions of dollars in CAA funds. Almost no one who worked for the passage of the CAA was appointed to the committee. IACC is packed with bureaucrats who seem to have a very limited understanding of autism as a disease and autism science. Only Lyn Redwood, who has an encyclopedic knowledge of autism research, of NAA and SafeMinds is representing my child and the hundreds of thousands like him. Only Lyn comprehends the tremendous medical challenges facing our children and urges IACC to fund research that reflects a sense of urgency and purpose.
Most of the bureaucratic committee members could not make a decision about how to get out of paper bag. The talking and talking in circles, the requesting for the creation “blue ribbon panels”, more subcommittees and more outside opinion, goes on forever. Why didn’t Tom Insel just appoint autism experts to this autism committee in the first place? Why are committee members constantly struggling to understand the basics of autism science and looking to others to inform them how to make decisions? They wait and wait and wait to make decisions. Insel wants to wait for more subcommittees, wait for more expert opinion, wait for a new administration, wait until the next meeting- wait to grow old? The only thing IACC is in a hurry to do is adjourn! Then when IACC finally does make an important decision, such as to fund 2% of CAA monies on vaccine safety research, Insel hastily undoes that vote after the meeting.
The public members include Lyn Redwood, who represents 100,000s of families, as well as Lee Grossman of ASA and Stephen Shore, who represent organizations serving people with autism. An ASD Mom, Christine, was appointed because she is Insel’s neighbor. Christine seems like a perfectly nice person but represents no national autism organization and has no scientific background. And finally, Alison Singer. Singer, as you may remember, absconded with AS’s IACC seat and now runs a mysterious autism org in her basement. This bizarre org is led by Paul Offit and a handful of autism ancient history researchers. Don’t our families deserve better than this? Don’t our kids deserve REAL representation from established autism organizations?
Where are our families’ voices? Where is AS’s seat? Where is NAA’s seat? Where is Generation Rescue’s seat? Where is TACA’s seat? All these organizations are legitimate, professional 501c3 nonprofits, they have funded tremendous research, aided families and represent hundreds of thousands of our children yet they have been purposely excluded by Insel’s IACC.
At the last meeting Insel and Della Hamm rushed through the agenda as if the building was on fire. In the process they canceled scheduled appearances of 3 Moms and their seriously affected autistic children in order in order to end the meeting 2 hours early. One gets the impression that Hamm and Insel have more important places to be. Cutting out early and getting home ahead of schedule seems to be priority #1.
Please check out the IACC website and take a look at the next agenda schedule. At the bottom of the agenda is a warning that IACC will possibly end early (again) so if you tune in via telephone or computer don’t be surprised if you hear dead air. Again. What? These people should be working day and night on autism, not treating these meetings as some kind of tedious inconvenience to be dealt with as quickly as possible.
If IACC is such a burdensome responsibility for the bureaucrats I suggest that they lighten their load and step aside. There are so many brilliant minds who would work flat out 24 hours a day in order to spend this money wisely. Lisa Ackerman, Wendy Fournier, Peter Bell, Elizabeth Emken, Theresa Wrangham, Jane Johnson, Mark Blaxill, Stan Kurtz, Sallie Bernard, Becky Widen, Jon Poling, Teri Poling, Rebecca Estepp, Vicky Debold, Laura Bono, Scott Bono, Barbara Loe Fisher…I could go on forever. These people are ALL parents of affected children, leaders of large, legitimate, autism organizations and experts in autism science. These advocates would make IACC their top priority. There would be absolutely no canceling meetings or ending early. Any one of these parent advocates would view serving our community as an honor, rather than a chore.
Katie Wright is Contributing Editor for Age of Autism.
"Competing interests: None."
"Ginger,
Alan Emond is on the JCVI:
http://www.advisorybodies.doh.gov.uk/jcvi/DOI-2007.htm
While Emond declares no competing interests on the JCVI he is closely associated with ALSPAC which receives funding from the Wellcome Trust and the MRC (who funded the new paper), as well as historically many industrial sources. The change in status of the JCVI was not quite as you describe in your blog. The vaccine schedule in the UK has never been mandatory and has not required legislative acts. The state simply acted on the recommendations of the JCVI - and citizens could take it or leave it - the innovatory (and illegal) change earlier this year placed an obligation on the government to enact their advice, which led to reasonable suspicions that the government was trying to introduce compulsory vaccination by the back door. However, they seem to be backing off this at the moment.
Emond was involved early on in the Georgie Fisher case:
http://www.ageofautism.com/2008/12/mmr-and-the-inq.html
Georgie's dad wrote to JABS Forum in 2006:
'Hello to all thank you for your kind words and support. we had meeting wiyh the coronor today to talk about our concerns regarding George's symtoms before he died it made him raise his eyebrows when we showed him the leaflet from mmr manufactures.He cancelled the inquest due to further investigation. He has asked professor/doctor Emond who apparently an expert in mmr to have a look at our case.More samples are going to be tested with more sophisticated equiptment to find the virus that was responsable.We do feel that he listened to us and said he would do his best.We have also written a letter to mr blair to express our concerns and dissapointments as to MMR,NHS,and the secrets around it all. It all makes us sick they need telling in person not keep hiding away.'
http://www.jabs.org.uk/forum/topic.asp?TOPIC_ID=198
I remember it was I who told Chris Fisher in an email that Emond was on the JCVI, so no one else had.
John"
The UK vaccine rally will be too late in October. They're starting [administering the vaccine] in August? That's 1-2 weeks from now?
Well looks like we will have some testing data after all - the UK population. Sorry Britain. Keep a stiff upper lip. We appreciate your sacrifice.
Europe fast-tracking swine flu vaccine
by Barbara Loe Fisher
On April 26, a national public health emergency was declared by officials in the U.S. Departments of Health and Homeland Security. 1,2 We were told it was necessary to declare a national emergency because people were getting sick from a new swine flu virus that began in Mexico and might cause a deadly influenza pandemic.
So far, the vast majority of people who get sick with swine flu have symptoms that are no worse than the regular flu and recover completely. 3,4,5, 6
Three Week Testing of Swine Flu Vaccines
The declaration of a national public health emergency last spring set a chain of events in motion: some schools were closed, 7 some people were quarantined 8, 9 and drug companies were given billons of tax dollars to create experimental swine flu vaccines. 10 These new vaccines are being fast tracked by the FDA. We are being told they will only be tested for a few weeks on a few hundred children and adults 11 before being given to children in schools in October.
Liability Protection for Vaccine Injuries & Deaths
Under federal legislation passed by Congress since 2001, an Emergency Use Authorization (EUA) 12,13,14 allows drug companies, health officials and anyone who gives experimental vaccines to Americans during a declared public health emergency, to be protected from liability if people get hurt.
Safety and Informed Consent At Risk in Schools
The National Vaccine Information Center has been a vaccine safety watchdog since 1982. We are questioning the need to turn schools into medical clinics this fall where swine flu vaccines being rushed to market will be given to children first. We are calling on the Obama Administration and state Governors to provide solid evidence to parents that it is necessary to give children experimental swine flu vaccines in schools.
Are the states prepared to obey vaccine safety provisions in the 1986 National Childhood Vaccine Injury Act,15 which include:
1. Giving parents written information about vaccine benefits and risks before children are vaccinated; 16
2. Keeping a record of which vaccines the children get, including the manufacturer’s name and lot number;
3. Recording which vaccines were given in the child’s medical record;
4. Recording serious health problems that develop after vaccination in the child’s medical record and immediately making a report to the federal Vaccine Adverse Event Reporting System (VAERS) 17
Will States Compensate Vaccine Injured Children?
And there are more questions that need to be answered: Are the states prepared to provide financial compensation to children harmed by swine flu vaccines given in schools? Are parents going to be given complete, truthful information about swine flu vaccine risks and have the right to say “YES” or “NO” before their children are lined up and vaccinated in the school setting?
Vaccines are pharmaceutical products that carry a risk of injury or death and those risks are greater for some than others. 1 in 6 children in America is learning disabled18. 1 in 9 has asthma 1 in 150 develops autism. 1 in 450 has diabetes and millions more suffer with allergies and autoimmune disorders. Will the swine flu vaccine be safe for them?
Although it is a good idea for health officials to prepare for a worst case scenario and stockpile vaccines, it is a bad idea to turn schools into medical clinics and basically test experimental swine flu vaccines on children first. Especially when nobody has any liability. That has the potential to hurt children instead of keeping them well.
NVIC Oct. 2-4 Conference Addresses Vaccine Risks
This Oct. 2-4, 2009 in Washington, D.C., parents concerned about the lack of vaccine safety and informed consent protections in the vaccination system will gather with doctors, scientists, bioethicists, legal experts, journalists, and consumer advocates at the Fourth International Public Conference on Vaccination to talk about the science, policy, law and ethics of vaccination.
Register now
– Special Early Bird registration ends on July 31.
Click here for more information about swine flu, swine flu vaccines, public health laws that govern you and you family, and how you can be better prepared to make well informed decisions during the declared national public health emergency.
Endnotes:
1 U.S. Department of Homeland Security. Press Briefing on Swine Influenza with Dept. of Homeland Security, Centers for Disease Control and White House. April 26, 2009.
2 U.S. Department of Health & Human Services. Determination That A Public Health Emergency Exists. April 26, 2009.
3 Gale J. Bloomberg News. Swine Flu May Be Less Lethal Than Earlier Estimated, Study Says. July 6, 2009.
4 Schmid RE. The Seattle Times. Study: New flu inefficient in attacking people. July 2, 2009.
5 Centers for Disease Control. FluView. 2008-2009 Influenza Season Week 27 Ending July 11, 2009.
6 Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Vaccine Research and Review. Regulatory Considerations Regarding the Use of Novel Influenza A (H1N1) Virus Vaccines. July 23, 2009.
7 US Department of Education. H1N1 Flu & U.S. Schools: Answers to Frequently Asked Questions. May 5, 2009.
8 NBC. Marine Tests Positive for Swine Flu. April 29, 2009.
9 CBS. DHS Sets Guidelines for Possible Swine Flu Quarantines. April 28, 2009.
10 The Independent. Obama earmarks emergency funding to fight swine flu. July 16, 2009.
11 Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Vaccine Research and Review. Regulatory Considerations Regarding the Use of Novel Influenza A (H1N1) Virus Vaccines. July 23, 2009.
12 Project Bioshield Act of 2004 (PL 108-276)
13 The Pandemic and All Hazards Preparedness Act of 2006 (PL 109-417).
14 Nightingale SL, Prasher JM, Simonson S. Emergency Use Authorization (EUA) to Enable Use of Needed Products in Civilian and Military Emergencies, United States. Emerging Infectious Diseases Vo. 13, No.7: July 2007.
15 National Childhood Vaccine Injury Act of 1986 (PL99-660)
16 CDC. Fact Sheet for Vaccine Information Statements.
17 MedAlerts. Online Access to the U.S. VAERS Database.
18 Fisher BL. Vaccine Safety Research Priorities: Engaging the Public. National Vaccine Advisory Committee. April 11, 2008.
Legal immunity set for swine flu vaccine makers
By MIKE STOBBE, Ap Medical Writer – Fri Jul 17, 8:15 pm ET
ATLANTA – The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.
Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.
Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.
The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed.
The government takes such steps to encourage drug companies to make vaccines, and it's worked. Federal officials have contracted with five manufacturers to make a swine flu vaccine. First identified in April, swine flu has so far caused about 263 deaths, according to numbers released by the Centers for Disease Control and Prevention on Friday.
The CDC said more than 40,000 Americans have had confirmed or probable cases, but those are people who sought health care. It's likely that more than 1 million Americans have been sickened by the flu, many with mild cases.
The virus hits younger people harder that seasonal flu, but so far hasn't been much more deadly than the strains seen every fall and winter. But health officials believe the virus could mutate to a more dangerous form, or at least contribute to a potentially heavier flu season than usual.
"We do expect there to be an increase in influenza this fall," with a bump in cases perhaps beginning earlier than normal, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.
On Friday, the Food and Drug Administration approved the regular winter flu vaccine, a final step before shipments to clinics and other vaccination sites could begin.
The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.
Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.
"The government paid out quite a bit of money," said Stephen Sugarman, a law professor who specializes in product liability at the University of California at Berkeley.
Vaccines aren't as profitable as other drugs for manufacturers, and without protection against lawsuits "they're saying, 'Do we need this?'" Sugarman said.
The move to protect makers of a swine flu didn't go over well with Paul Pennock, a prominent New York plaintiffs attorney on medical liability cases. The government will likely call on millions of Americans to get the vaccinations to prevent the disease from spreading, he noted.
"If you're going to ask people to do this for the common good, then let's make sure for the common good that these people will be taken care of if something goes wrong," Pennock said.
___
AP Medical Writer Lauran Neergaard contributed to this report from Washington.
"Joining us now from Atlanta, the former head of the Centers for Disease Control, Dr. Julie Gerberding. ... do you have an update on when that vaccine might be available?
Well if everything goes well, we should have vaccine early in the fall. But we've never had the luxury of being able to count on vaccine as the magic bullet in the early months. We know there is not going to be enough globally, and it will be many months before we can even cover our own population under the best scenario...
"The PR genius behind all stages of Merck's HPV and Gardasil campaigns is the PR giant Edelman. The world's largest independent PR firm, Edelman boasts more than 2,100 employees working in 46 wholly owned offices worldwide, plus the additional resources of more than 50 affiliates. They report $299 million in revenues for FY 2006. In addition to Merck, Edelman works on behalf of the industry lobby group PhRMA, as well as some of the largest pharmaceutical companies, including AstraZeneca, Novartis, Pfizer, Abbott Laboratories, and Johnson & Johnson. They proudly promote their health-related expertise as being adept in pioneering "health relationships with health care companies, advocacy organizations, foundations, NGOs and academic institutions." Co-optation, anyone?"
Edelman has made a name for itself outside of the pharmaceutical realm as well. A key chapter in Edelman's long and sordid history is their work on behalf of Big Tobacco. For example, in 1978, Edelman, working on behalf of R.J. Reynolds, produced a document titled Taking the Initiative on the Smoking Issue: A Total Program. The introduction states "The public mind-set against cigarettes is so firm that one cannot conscientiously promise miracles from the campaign suggested here. But we believe this program, executed effectively, can begin to slow or reverse the growing negative trends in public opinion regarding smoking; can stimulate a more balanced media coverage of smoking; and can generate a more congenial dialogue between smokers and non-smokers.... (Read that whole article.)"
“In this era of exploding media technologies there is no truth except the truth you create for yourself.” – Richard Edelman
"Just prior to Dr. Julie Gerberding’s January 2009 resignation as Director of the U.S. Centers for Disease Control, advertising industry mogul Richard Edelman praised her as a “selfless crusader, a throw-back to a time when public service was the highest calling.” Edelman cited Gerberding’s ability in “humanizing communications” and “the need to tell stories to buttress traditional CDC reliance on science and facts.”
“We must shift America from a needs to a desires culture. People must be trained to desire, to want new things even before the old have been entirely consumed. We must shape a new mentality in America. Man’s desires must over shadow his needs.”
- Paul Mazer, Public Relations, Lehman Brothers in the 1930’s
W.H.O. Says It Plans to Stop Tracking Swine Flu Cases
New York Times
By DONALD G. McNEIL Jr.
Published: July 16, 2009
In a move that caught many public health experts by surprise, the World Health Organization quietly announced Thursday that it would stop tracking swine flu cases and deaths around the world.
Skip to next paragraph
Related
Times Topics: Swine Flu (AH1N1 Virus) | World Health Organization
The announcement, made in a “briefing note” posted on the organization’s Web site late in the day, perplexed some experts, and even baffled a W.H.O. spokesman, Gregory Hartl, who said in an e-mail message, “I don’t have reliable info” about what his agency would track instead.
Only a little earlier in the day, Mr. Hartl had confirmed that Argentina, with 137 swine flu deaths since June, had surpassed Mexico, where the epidemic began in February, as the country with second largest number of swine flu deaths. Mexico has 121, and the United States, with a much larger population, has 211.
The last W.H.O. update, issued on July 6, showed 94,512 confirmed cases in 122 countries, with 429 deaths.
Many epidemiologists have pointed out that, in reality, millions of people have had swine flu, usually in a mild form, so the numbers of laboratory-confirmed cases were actually meaningless. And performing the tests has overwhelmed many national laboratories.
The briefing note said countries would still be asked to report their first few confirmed cases. It also said countries should watch for clusters of fatalities, which could indicate that the virus had mutated to a more lethal form. Other “signals to be vigilant for,” it said, were spikes in school absenteeism and surges in hospital visits.
The American Thoracic Society: Flu Shot Not Effective in Preventing Flu-Related Hospitalizations in Asthmatic Children
News Release
FOR RELEASE MAY 19, 2009 at 1:30 p.m. PDT
FOR MORE INFORMATION, CONTACT:
Keely Savoie or Brian Kell
ksavoie@thoracic.org or bkell@thoracic.org
ATS Office: 212-315-8620 or 212-315-6442 (until May 13)
Cell phones: 917-860-5814 (KS) or 516-305-9251 (BK)
ATS Press Room: 619-525-6323, 619-525-6324 or 619-525-6325 (May 15 to 20)
Mini-Symposium time: May 19: 1:30 p.m. to 4 p.m.
Presentation time: May 19: 3:20 p.m.
Location: San Diego Convention Center, Room 3 (Upper Level)
Flu Shot Not Effective in Preventing Flu-Related Hospitalizations in Asthmatic Children
ATS 2009, SAN DIEGO— The inactivated flu vaccine does not appear to be effective in preventing influenza-related hospitalizations in children, especially the ones with asthma. In fact, children who get the flu vaccine are more at risk for hospitalization than their peers who do not get the vaccine, according to new research that will be presented on Tuesday, May 19, at the 105th International Conference of the American Thoracic Society in San Diego.
Flu vaccine (trivalent inactivated flu vaccine—TIV) has unknown effects on asthmatics.
“The concerns that vaccination maybe associated with asthma exacerbations have been disproved with multiple studies in the past, but the vaccine’s effectiveness has not been well-established,” said Avni Joshi, M.D., of the Mayo Clinic in Rochester, MN. “This study was aimed at evaluating the effectiveness of the TIV in children overall, as well as the children with asthma, to prevent influenza-related hospitalization.”
The CDC’s Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) recommend annual influenza vaccination for all children aged six months to 18 years. The National Asthma Education and Prevention Program (3rd revision) also recommends annual flu vaccination of asthmatic children older than six months.
In order to determine whether the vaccine was effective in reducing the number of
hospitalizations that all children, and especially the ones with asthma, faced over eight consecutive flu seasons, the researchers conducted a cohort study of 263 children who were evaluated at the Mayo Clinic in Minnesota from six months to 18 years of age, each of whom had had laboratory-confirmed influenza between 1996 to 2006. The investigators determined who had and had not received the flu vaccine, their asthma status and who did and did not require hospitalization. Records were reviewed for each subject with influenza-related illness for flu vaccination preceding the illness and hospitalization during that illness.
They found that children who had received the flu vaccine had three times the risk of hospitalization, as compared to children who had not received the vaccine. In asthmatic children, there was a significantly higher risk of hospitalization in subjects who received the TIV, as compared to those who did not (p= 0.006). But no other measured factors—such as insurance plans or severity of asthma—appeared to affect risk of hospitalization.
“While these findings do raise questions about the efficacy of the vaccine, they do not in fact implicate it as a cause of hospitalizations,” said Dr. Joshi. “More studies are needed to assess not only the immunogenicity, but also the efficacy of different influenza vaccines in asthmatic subjects.”
###
Session # C94: “Viral Infections in Childhood Respiratory Disease”
Abstract # 561: “Flu Vaccination in Asthmatics: Does It Work?”
http://www.call4abstracts.com/ats/society_admin/abs_preview.php?absnum=561
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ATS 2009 · San Diego
International Conference
Abstract Number: 561
Contact/Presenting Author: Avni Y. Joshi
Department/Institution: Internal Medicine, Mayo Clinic
Address: 200, First St. SW
City/State/Zip/Country: Rochester, MN, 55905
Phone: 01-507-284-2511 Fax: 01-507-284-0902 E-mail: joshi.avni@mayo.edu
ATS member: No Student or in training: Yes
Funding Source: None.
Abstract Category: 14.03 - Pediatric Asthma
Presentation format: Either Poster or Oral
Preview Disclosure
Travel Award: Yes
Publication of email address: Yes, joshi.avni@mayo.edu
I confirm that all authors listed on this abstract have knowledge of the abstract submission:
Yes
Title: Flu Vaccination in Asthmatics: Does It Work?
A. Y. Joshi, MD1, V. N. Iyer, MD,MPH1, M. F. Hartz, MD1, G. W. Volcheck, MD,Ph.D1, A. M. Patel,
MD1 and J. T. Li, MD,Ph.D1. 1Mayo Clinic College of Medicine, Rochester, MN.
INTRODUCTION: Influenza is known to be associated with asthma exacerbation but the
effectiveness of the trivalent inactivated flu vaccine (TIV) in asthmatics is unknown.
METHODS: We conducted a cohort study of all pediatric subjects( 6 months to 18 years age) who were evaluated at Mayo Clinic, Rochester, MN, USA who had laboratory confirmed influenza during each flu season from 1999-2006 to evaluate the efficacy of TIV. A case control analysis was performed with the cases and the controls being the subjects with asthma who did and did not required hospitalization with the influenza illness respectively.
RESULTS:
There were 236 subjects with laboratory confirmed influenza from 1996-2006.
In assessing the effectiveness of the TIV for preventing hospitalization with influenza in all subjects, there was an overall trend towards higher rates of hospitalization in subjects who got the TIV as compared to the ones who did not get the TIV( OR:2.97, CI: 1.3,6.7).Using Cochran-Mantel-Haenszel (CMH) test for Asthma status stratification, there was a significant association between hospitalization in asthmatic subjects and TIV (P=0.006).
http://www.call4abstracts.com/ats/society_admin/abs_preview.php?absnum=561 (1 of 2) [5/11/2009 1:43:56 PM]
http://www.call4abstracts.com/ats/society_admin/abs_preview.php?absnum=561
In the asthmatic subset:
There was no association between ER visit and receiving the TIV ,severity of asthma and the risk of hospitalization or the hospital length of stay and receiving the TIV.
In assessing access to medical care, there was no association between hospitalizations and health care insurance plans (Odds ratio:0.3, P= 0.13)
CONCLUSION:
1) TIV did not provide any protection against hospitalization in pediatric subjects' esp. children with asthma. On the contrary, we found a 3- fold increased risk of hospitalization in subjects who did get the TIV vaccine.This may be a reflection not only of the vaccine effectiveness but also the population of children who are more likely to get the vaccine.
2) More studies are needed to assess not only the immunogenicity but also efficacy of different influenza vaccines in asthmatic subjects.
http://
Swine flu vaccine to be cleared after five-day trial
July 12, 2009
The Sunday Times
byJon Ungoed-Thomas
The path of a popular medicine from the laboratory to the chemist or doctor’s surgery can involve years of clinical trials on a select group of patients.
When the new vaccine for swine flu arrives in Britain, regulators said this weekend, it could be approved for use in just five days.
Regulators at the European Medicines Agency (EMEA) said the fast-tracked procedure has involved clinical trials of a “mock-up” vaccine similar to the one that will be used for the biggest mass vaccination programme in generations. It will be introduced into the general population while regulators continue to carry out simultaneous clinical trials.
The first patients in the queue for the jab - being supplied to the UK by GSK and Baxter Healthcare - may understandably be a little nervous at any possible side effects. A mass vaccination campaign against swine flu in America was halted in the 1970s after some people suffered Guillain-Barré syndrome, a disorder of the nervous system.
However, regulators said fast-tracking would not be at the expense of patient safety. “The vaccines are authorised with a detailed risk management plan,” the EMEA said. “There is quite a body of evidence regarding safety on the trials of the mock-up, and the actual vaccine could be assessed in five days.”
The UK government has ordered enough vaccine to cover the entire population. GPs are being told to prepare for a nationwide vaccination campaign.
Dr Peter Holden, the British Medical Association’s lead negotiator on swine flu, who has been attending Department of Health meetings on the outbreak, said GPs’ surgeries were prepared for one of the biggest vaccination campaigns in almost 50 years.
He said although swine flu was not causing serious illness in patients, health officials were eager to start a mass vaccination campaign, starting first on priority groups. First, the jabs would reduce the chances of a shortage of hospital beds because of people suffering from swine flu. Second, it would reduce the effect on the economy by ensuring workers were protected from the virus.
“The high-risk groups will be done at GPs’ surgeries. People are still making decisions over this, but we want to get cracking before we get a second wave, which is traditionally far more virulent.”
Holden said it was likely the elderly would be given their seasonal flu jab as well as the swine flu vaccination. The new vaccine is likely to require two doses.
Details of the inoculation plans emerged after the death of a patient, reportedly a middle-aged man, at a hospital in the Basildon area of Essex. The victim had no underlying health problems, but officials say there is no evidence the swine flu virus had mutated into a more dangerous strain.
Holden said it would be the biggest campaign in response to an outbreak since mass vaccination against smallpox in 1962. He said surgeries would be aiming to inoculate about 30 people an hour in a “military-style operation”.
The Department of Health said it had still not finalised which groups would be vaccinated first, but children, frontline health workers, people with underlying illnesses and the elderly are likely to take priority.
The European Commission is also identifying population groups which it believes should get priority. It is keen to ensure that countries such as the UK, which had ordered supplies of the vaccine in advance, do not cause inequities in treatment elsewhere in Europe.
It warned health ministers in a note circulated last month that if the vaccines were more readily available in some countries it could cause “vaccine tourism/shopping in other member states”.
About 15 people have died of swine flu in Britain, but most of those infected get only mild symptoms. According to the latest figures from the Health Protection Agency, the UK has had 9,718 confirmed cases of the disease.
Interviewer: "Why does this report from your own agency list neurological complications as a possibility?"
Director of CDC: "I think the consensus of the scientific community was that the evidence relating neurologic disorders to immunizations was such that they did not feel that this association was a real one."
Rep. Maloney and Rep. Smith To Host A Second Autism Congressional Briefing An Update On Federal Autism Research And Treatment Initiatives
PLEASE CONTACT YOUR US SENATORS (HERE) AND MEMBERS OF CONGRESS (HERE) AND URGE THEM TO ATTEND OR SEND A STAFF MEMBER TO THIS IMPORTANT AUTISM-VACCINE BRIEFING ON CAPITOL HILL
Friday, July 17 at 9:30 AM
210 Cannon House Office Building
Independence Avenue, Washington, DC.
FREE AND OPEN TO THE PUBLIC
Rep. Carolyn Maloney (D-NY) and Rep. Christopher Smith (R-NJ) is hosting a special briefing for Members of Congress and their Staff to discuss issues related to autism research and treatment. We hope that you will attend the briefing to learn about the changing dynamics of the autism debate, as you will find many in government and science believe this debate is far from settled.
David Kirby, investigative journalist and author of The New York Times bestseller Evidence of Harm, Mercury in Vaccines and the Autism Epidemic – A Medical Controversy, will inform Members and their staff about developments regarding environmental factors in autism and the “Seven Studies to Watch” – Plus, changing ASD demographics post-thimerosal reduction. Mr. Kirby will also be joined by Mark Blaxill, Editor-at-Large of Age of Autism, Director of the Coalition for SAFE MINDS and co-author of a forthcoming book on the roots of the autism epidemic, who will address the policy and public health implications of the autism crisis.
Among the issues to be discussed are:
- The unanimous endorsement by the National Vaccine Advisory Committee to look at the feasibility of a large vaccinated-unvaccinated study, with autism as an outcome.
- The NVAC endorsement of three other vaccine-autism investigations, including children with mitochondrial dysfunction, children with regressive autism, and vaccine injury as a risk factor for ASD.
- Recent Vaccine Court decisions finding the MMR and Hep B vaccines caused injuries that led to autism and MS.
- The NIH Early Autism Risk Longitudinal Investigations EARLI study and the HHS/EPA National Children’s Study, both of which are looking at vaccination and mercury exposures, with autism as a possible outcome.
- The CDC’s Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Network, whose five-year goal includes studying "specific mercury exposures, including any vaccine use by the mother during pregnancy and the child's vaccine exposures after birth.”
- Cleveland Clinic – A recent article in PLoS Online by authors from the Cleveland Clinic, Harvard and Johns Hopkins University reported that, "Large, population-based studies will be needed to identify a possible relationship of vaccination with autistic regression in persons with mitochondrial dysfunction.”
- Recent statements by Federal health officials such as Dr. Duane Alexander, Director of the Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), who said it was “legitimate to ask” whether vaccines can trigger autism, and Dr. Anthony Fauci, Director of NIAID, who said in a US News and World report article, “we may want to screen everyone prior to vaccination (for) undetectable diseases like a subclinical mitochondrial disorder."
- The U.C. Davis M.I.N.D. Institute study which found, that the seven- to eight-fold increase in the number children born in California with autism since 1990 cannot be explained by either changes in how the condition is diagnosed or counted — and the trend shows no sign of abating. This as young adults begin to flood the social services system
- Reports of reduced Autism Spectrum Disorder (ASD) severity among the youngest children, following reduction of thimerosal in childhood vaccines.
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It’s Time to Learn From Frogs
By NICHOLAS D. KRISTOF
New York Times: June 27, 2009
Some of the first eerie signs of a potential health catastrophe came as bizarre deformities in water animals, often in their sexual organs.
Frogs, salamanders and other amphibians began to sprout extra legs. In heavily polluted Lake Apopka, one of the largest lakes in Florida, male alligators developed stunted genitals.
In the Potomac watershed near Washington, male smallmouth bass have rapidly transformed into “intersex fish” that display female characteristics. This was discovered only in 2003, but the latest survey found that more than 80 percent of the male smallmouth bass in the Potomac are producing eggs.
Now scientists are connecting the dots with evidence of increasing abnormalities among humans, particularly large increases in numbers of genital deformities among newborn boys. For example, up to 7 percent of boys are now born with undescended testicles, although this often self-corrects over time. And up to 1 percent of boys in the United States are now born with hypospadias, in which the urethra exits the penis improperly, such as at the base rather than the tip.
Apprehension is growing among many scientists that the cause of all this may be a class of chemicals called endocrine disruptors. They are very widely used in agriculture, industry and consumer products. Some also enter the water supply when estrogens in human urine — compounded when a woman is on the pill — pass through sewage systems and then through water treatment plants.
These endocrine disruptors have complex effects on the human body, particularly during fetal development of males.
“A lot of these compounds act as weak estrogen, so that’s why developing males — whether smallmouth bass or humans — tend to be more sensitive,” said Robert Lawrence, a professor of environmental health sciences at the Johns Hopkins Bloomberg School of Public Health. “It’s scary, very scary.”
The scientific case is still far from proven, as chemical companies emphasize, and the uncertainties for humans are vast. But there is accumulating evidence that male sperm count is dropping and that genital abnormalities in newborn boys are increasing. Some studies show correlations between these abnormalities and mothers who have greater exposure to these chemicals during pregnancy, through everything from hair spray to the water they drink.
Endocrine disruptors also affect females. It is now well established that DES, a synthetic estrogen given to many pregnant women from the 1930s to the 1970s to prevent miscarriages, caused abnormalities in the children. They seemed fine at birth, but girls born to those women have been more likely to develop misshaped sexual organs and cancer.
There is also some evidence from both humans and monkeys that endometriosis, a gynecological disorder, is linked to exposure to endocrine disruptors. Researchers also suspect that the disruptors can cause early puberty in girls.
A rush of new research has also tied endocrine disruptors to obesity, insulin resistance and diabetes, in both animals and humans. For example, mice exposed in utero even to low doses of endocrine disruptors appear normal at first but develop excess abdominal body fat as adults.
Among some scientists, there is real apprehension at the new findings — nothing is more terrifying than reading The Journal of Pediatric Urology — but there hasn’t been much public notice or government action.
This month, the Endocrine Society, an organization of scientists specializing in this field, issued a landmark 50-page statement. It should be a wake-up call.
“We present the evidence that endocrine disruptors have effects on male and female reproduction, breast development and cancer, prostate cancer, neuroendocrinology, thyroid, metabolism and obesity, and cardiovascular endocrinology,” the society declared.
“The rise in the incidence in obesity,” it added, “matches the rise in the use and distribution of industrial chemicals that may be playing a role in generation of obesity.”
The Environmental Protection Agency is moving toward screening endocrine disrupting chemicals, but at a glacial pace. For now, these chemicals continue to be widely used in agricultural pesticides and industrial compounds. Everybody is exposed.
“We should be concerned,” said Dr. Ted Schettler of the Science and Environmental Health Network. “This can influence brain development, sperm counts or susceptibility to cancer, even where the animal at birth seems perfectly normal.”
The most notorious example of water pollution occurred in 1969, when the Cuyahoga River in Ohio caught fire and helped shock America into adopting the Clean Water Act. Since then, complacency has taken hold.
Those deformed frogs and intersex fish — not to mention the growing number of deformities in newborn boys — should jolt us once again.
Weed-Whacking Herbicide Proves Deadly to Human Cells
Used in gardens, farms, and parks around the world, the weed killer Roundup contains an ingredient that can suffocate human cells in a laboratory, researchers say
By Crystal Gammon and Environmental Health News
WEED KILLER: New research has found that an 'inert' ingredient in the herbicide Roundup can kill human embryonic, placental, and umbilical cord cells
Used in yards, farms and parks throughout the world, Roundup has long been a top-selling weed killer. But now researchers have found that one of Roundup’s inert ingredients can kill human cells, particularly embryonic, placental and umbilical cord cells.
The new findings intensify a debate about so-called “inerts” — the solvents, preservatives, surfactants and other substances that manufacturers add to pesticides. Nearly 4,000 inert ingredients are approved for use by the U.S. Environmental Protection Agency.
Glyphosate, Roundup’s active ingredient, is the most widely used herbicide in the United States. About 100 million pounds are applied to U.S. farms and lawns every year, according to the EPA.
Until now, most health studies have focused on the safety of glyphosate, rather than the mixture of ingredients found in Roundup. But in the new study, scientists found that Roundup’s inert ingredients amplified the toxic effect on human cells—even at concentrations much more diluted than those used on farms and lawns.
One specific inert ingredient, polyethoxylated tallowamine, or POEA, was more deadly to human embryonic, placental and umbilical cord cells than the herbicide itself – a finding the researchers call “astonishing.”
“This clearly confirms that the [inert ingredients] in Roundup formulations are not inert,” wrote the study authors from France’s University of Caen. “Moreover, the proprietary mixtures available on the market could cause cell damage and even death [at the] residual levels” found on Roundup-treated crops, such as soybeans, alfalfa and corn, or lawns and gardens.
The research team suspects that Roundup might cause pregnancy problems by interfering with hormone production, possibly leading to abnormal fetal development, low birth weights or miscarriages.
Monsanto, Roundup’s manufacturer, contends that the methods used in the study don’t reflect realistic conditions and that their product, which has been sold since the 1970s, is safe when used as directed. Hundreds of studies over the past 35 years have addressed the safety of glyphosate.
“Roundup has one of the most extensive human health safety and environmental data packages of any pesticide that's out there,” said Monsanto spokesman John Combest. “It's used in public parks, it's used to protect schools. There's been a great deal of study on Roundup, and we're very proud of its performance.”
The EPA considers glyphosate to have low toxicity when used at the recommended doses.
“Risk estimates for glyphosate were well below the level of concern,” said EPA spokesman Dale Kemery. The EPA classifies glyphosate as a Group E chemical, which means there is strong evidence that it does not cause cancer in humans.
In addition, the EPA and the U.S. Department of Agriculture both recognize POEA as an inert ingredient. Derived from animal fat, POEA is allowed in products certified organic by the USDA. The EPA has concluded that it is not dangerous to public health or the environment.
The French team, led by Gilles-Eric Seralini, a University of Caen molecular biologist, said its results highlight the need for health agencies to reconsider the safety of Roundup.
“The authorizations for using these Roundup herbicides must now clearly be revised since their toxic effects depend on, and are multiplied by, other compounds used in the mixtures,” Seralini’s team wrote.
Controversy about the safety of the weed killer recently erupted in Argentina, one of the world’s largest exporters of soy.
