The Age of Autism: 'A pretty big secret'
By Dan Olmsted
UPI Senior Editor
It's a far piece from the horse-and-buggies of Lancaster County, Pa., to the cars and freeways of Cook County, Ill.
But thousands of children cared for by Homefirst Health Services in metropolitan Chicago have at least two things in common with thousands of Amish children in rural Lancaster: They have never been vaccinated. And they don't have autism.
"We have a fairly large practice. We have about 30,000 or 35,000 children that we've taken care of over the years, and I don't think we have a single case of autism in children delivered by us who never received vaccines," said Dr. Mayer Eisenstein, Homefirst's medical director who founded the practice in 1973. Homefirst doctors have delivered more than 15,000 babies at home, and thousands of them have never been vaccinated.
The few autistic children Homefirst sees were vaccinated before their families became patients, Eisenstein said. "I can think of two or three autistic children who we've delivered their mother's next baby, and we aren't really totally taking care of that child -- they have special care needs. But they bring the younger children to us. I don't have a single case that I can think of that wasn't vaccinated."
The autism rate in Illinois public schools is 38 per 10,000, according to state Education Department data; the Centers for Disease Control and Prevention puts the national rate of autism spectrum disorders at 1 in 166 -- 60 per 10,000.
"We do have enough of a sample," Eisenstein said. "The numbers are too large to not see it. We would absolutely know. We're all family doctors. If I have a child with autism come in, there's no communication. It's frightening. You can't touch them. It's not something that anyone would miss."
No one knows what causes autism, but federal health authorities say it isn't childhood immunizations. Some parents and a small minority of doctors and scientists, however, assert vaccines are responsible.
This column has been looking for autism in never-vaccinated U.S. children in an effort to shed light on the issue. We went to Chicago to meet with Eisenstein at the suggestion of a reader, and we also visited Homefirst's office in northwest suburban Rolling Meadows. Homefirst has four other offices in the Chicago area and a total of six doctors.
Eisenstein stresses his observations are not scientific. "The trouble is this is just anecdotal in a sense, because what if every autistic child goes somewhere else and (their family) never calls us or they moved out of state?"
In practice, that's unlikely to account for the pronounced absence of autism, says Eisenstein, who also has a bachelor's degree in statistics, a master's degree in public health and a law degree.
Homefirst follows state immunization mandates, but Illinois allows religious exemptions if parents object based either on tenets of their faith or specific personal religious views. Homefirst does not exclude or discourage such families. Eisenstein, in fact, is author of the book "Don't Vaccinate Before You Educate!" and is critical of the CDC's vaccination policy in the 1990s, when several new immunizations were added to the schedule, including Hepatitis B as early as the day of birth. Several of the vaccines -- HepB included -- contained a mercury-based preservative that has since been phased out of most childhood vaccines in the United States.
Medical practices with Homefirst's approach to immunizations are rare. "Because of that, we tend to attract families that have questions about that issue," said Dr. Paul Schattauer, who has been with Homefirst for 20 years and treats "at least" 100 children a week.
Schattauer seconded Eisenstein's observations. "All I know is in my practice I don't see autism. There is no striking 1-in-166," he said.
Earlier this year we reported the same phenomenon in the mostly unvaccinated Amish. CDC Director Dr. Julie Gerberding told us the Amish "have genetic connectivity that would make them different from populations that are in other sectors of the United States." Gerberding said, however, studies "could and should be done" in more representative unvaccinated groups -- if they could be found and their autism rate documented.
Chicago is America's prototypical "City of Big Shoulders," to quote Carl Sandburg, and Homefirst's mostly middle-class families seem fairly representative. A substantial number are conservative Christians who home-school their children. They are mostly white, but the Homefirst practice also includes black and Hispanic families and non-home-schooling Jews, Catholics and Muslims.
They tend to be better educated, follow healthier diets and breast-feed their children much longer than the norm -- half of Homefirst's mothers are still breast-feeding at two years. Also, because Homefirst relies less on prescription drugs including antibiotics as a first line of treatment, these children have less exposure to other medicines, not just vaccines.
Schattauer, interviewed at the Rolling Meadows office, said his caseload is too limited to draw conclusions about a possible link between vaccines and autism. "With these numbers you'd have a hard time proving or disproving anything," he said. "You can only get a feeling about it.
"In no way would I be an advocate to stand up and say we need to look at vaccines, because I don't have the science to say that," Schattauer said. "But I don't think the science is there to say that it's not."
Schattauer said Homefirst's patients also have significantly less childhood asthma and juvenile diabetes compared to national rates. An office manager who has been with Homefirst for 17 years said she is aware of only one case of severe asthma in an unvaccinated child.
"Sometimes you feel frustrated because you feel like you've got a pretty big secret," Schattauer said. He argues for more research on all those disorders, independent of political or business pressures.
The asthma rate among Homefirst patients is so low it was noticed by the Blue Cross group with which Homefirst is affiliated, according to Eisenstein.
"In the alternative-medicine network which Homefirst is part of, there are virtually no cases of childhood asthma, in contrast to the overall Blue Cross rate of childhood asthma which is approximately 10 percent," he said. "At first I thought it was because they (Homefirst's children) were breast-fed, but even among the breast-fed we've had asthma. We have virtually no asthma if you're breast-fed and not vaccinated."
Because the diagnosis of asthma is based on emergency-room visits and hospital admissions, Eisenstein said, Homefirst's low rate is hard to dispute. "It's quantifiable -- the definition is not reliant on the doctor's perception of asthma."
Several studies have found a risk of asthma from vaccination; others have not. Studies that include never-vaccinated children generally find little or no asthma in that group.
Earlier this year Florida pediatrician Dr. Jeff Bradstreet said there is virtually no autism in home-schooling families who decline to vaccinate for religious reasons -- lending credence to Eisenstein's observations.
"It's largely non-existent," said Bradstreet, who treats children with autism from around the country. "It's an extremely rare event."
Bradstreet has a son whose autism he attributes to a vaccine reaction at 15 months. His daughter has been home-schooled, he describes himself as a "Christian family physician," and he knows many of the leaders in the home-school movement.
"There was this whole subculture of folks who went into home-schooling so they would never have to vaccinate their kids," he said. "There's this whole cadre who were never vaccinated for religious reasons."
In that subset, he said, "unless they were massively exposed to mercury through lots of amalgams (mercury dental fillings in the mother) and/or big-time fish eating, I've not had a single case."
Federal health authorities and mainstream medical groups emphatically dismiss any link between autism and vaccines, including the mercury-based preservative thimerosal. Last year a panel of the Institute of Medicine, part of the National Academies, said there is no evidence of such a link, and funding should henceforth go to "promising" research.
Thimerosal, which is 49.6 percent ethyl mercury by weight, was phased out of most U.S. childhood immunizations beginning in 1999, but the CDC recommends flu shots for pregnant women and last year began recommending them for children 6 to 23 months old. Most of those shots contain thimerosal.
Thimerosal-preserved vaccines are currently being injected into millions of children in developing countries around the world. "My mandate ... is to make sure at the end of the day that 100,000,000 are immunized ... this year, next year and for many years to come ... and that will have to be with thimerosal-containing vaccines," said John Clements of the World Health Organization at a June 2000 meeting called by the CDC.
That meeting was held to review data that thimerosal might be linked with autism and other neurological problems. But in 2004 the Institute of Medicine panel said evidence against a link is so strong that health authorities, "whether in the United States or other countries, should not include autism as a potential risk" when formulating immunization policies.
But where is the simple, straightforward study of autism in never-vaccinated U.S. children? Based on our admittedly anecdotal and limited reporting among the Amish, the home-schooled and now Chicago's Homefirst, that may prove to be a significant omission.
--
This ongoing series on the roots and rise of autism welcomes comment. E-mail: dolmsted@upi.com
December 7, 2005
How Not To Eat Teflon
In our eternal attempt to get poisonious crap out of our homes and our diets, we have come accross concerns about cooking with teflon. Since I have known no other way of cooking, it didn't really occur to me that going back to iron age cook ware was a possibility. After reading this I think we are gonna give it a try.(Hat tip: Binstock.)
Ever So Humble, Cast Iron Outshines the Fancy Pans
By MARK BITTMAN
The New York Times
AS cookware becomes more expensive and the kinds available become more varied, it's increasingly clear to me that most "new" pots and pans are about marketing. For most tasks, old-style cookware is best. So these days when I'm asked for a recommendation, I reply with an old-fashioned answer: cast iron.
My personal return to cast iron began less than a year ago when I began to heed the warnings against preheating chemically treated pans and putting them in hot ovens, which could create potentially harmful fumes.
As most experienced cooks know, you can't brown food unless you preheat your skillet, and I frequently transfer food from stove top to oven.
So cast iron is a logical choice, especially in skillets, unless you require gorgeous stainless to make a style point or you can afford copper - which is ideal for sautéing because its heat distribution is incomparable - and the time to care for it. The only disadvantages are that cast iron is heavy (look for skillets with handles on both sides) and it requires a bit of care to keep it seasoned and looking nice.
But cast iron has so many benefits. Well seasoned, it is nearly as nonstick as any manufactured nonstick surface and far more so than stainless, aluminum or even copper pans.
Cast iron is practically free compared with other high-quality pots and pans ($20, say, for a skillet). In addition, it lasts nearly forever: the huge skillet I bought around 1970 for $10 is still going strong.
Furthermore, it is an even distributor of heat, which you will instantly appreciate if switching from stainless steel or aluminum. And you can move it from stove top to oven without a thought.
Cast-iron pans are created by pouring molten iron into sand molds. After the metal solidifies, the sand crust is blasted off, and any rough edges are removed. This is pretty much the way cast iron has been made for
centuries.
A couple of variables might influence your buying decision: the purity of the cast iron and the issue of seasoning it.
Lodge, the only domestic maker of cast-iron cookware, uses only "pig-iron ingot and scrap steel converted back into iron" to make its cookware, according to the company's chief executive, Bob Kellermann. Anonymously made imported cast-iron cookware, though often less expensive, offers no such guarantees. In my experience the cheapest cast-iron pans have far more "hot spots."
But the biggest fear most people have about cast iron is the seasoning process. The metal is porous and rough, and until it gains a patina from use it is the opposite of nonstick. Lodge, in an attempt to make this a non-issue, has introduced a line of preseasoned cookware, which now makes up something like 80 percent of its sales.
But I'd rather control the process: seasoning is simple, and maintaining it is even simpler. To season a new pan wash it well and dry it. Preheat the oven to 350 degrees while you warm the pan gently over low heat on top of the stove. Using a brush or a paper towel, spread a tablespoon or so of a fresh neutral oil like corn or grape seed in the pan; the surface should be evenly covered, with no excess. Put the pan in the oven, bake it for about an hour and let it cool in the oven.
That's it.
It's helpful if the first few uses of the pan involve oil, like sautéeing or deep-frying. If you care for the pan properly, it will darken with use and become increasingly smooth, beautiful and easy to cook in.
Once the pan is seasoned, routine washing can almost always be done with a scouring pad, not steel wool or anything else that will damage the seasoning (although the worst that can happen is that the pan will have to be reseasoned).
Despite many recommendations to the contrary, a little mild soap won't tear off the seasoning.
Cast iron can rust of course, but never if you dry it after washing and keep it out of rain and floods. If rust does appear, scour it off with steel wool or sandpaper, and reseason.
Cast iron really struts its stuff when you want to get a pan good and hot and keep it that way. For "grilling" a steak indoors, it can't be beat. Ridged cast-iron "grill pans" are good for two reasons: They raise the meat slightly above the surface, which promotes browning by preventing escaping liquids from contacting the meat, and they leave grill marks, which are attractive if nothing else.
Cast iron is as good at browning as any other cookware, and its mass lets it hold a steady temperature so well that it is perfect for deep- or shallow-frying.
But braising in cast iron, especially with acidic ingredients like tomato or wine, may degrade the seasoning slightly. In extreme cases, you may have to reseason the pan; more likely, you'll just have to treat it to a light coating of oil and a few minutes of warming.
In any case, this isn't a bad routine. Every so often I wash my cast-iron skillet and put it over low heat. When the water begins to evaporate I wipe it dry and spread a little oil over its surface with a paper towel. I leave the skillet over the heat a few more minutes and wipe it out again.
Yes, this is maintenance, and most cookware is maintenance-free. But it seems a small price to pay for inexpensive, high-performing, safe, nonstick pans. When it comes to cookware, new is not necessarily better.
How Prevalent Does the AAP Think Autism Is?
This was released by A-CHAMP a few months ago. Thought I would post it.
OK, folks, here's a quiz for all you autism eggheads out there:
According to the AAP website, what is the incidence rate for autism in the United States:
A) 1 in 500
B) 1 in 333
C) 1 in 166
D) All the above
And the answer is....
If you said "A", you're correct, the AAP says on their website that the autism incidence rate (including other ASDs) is 1 in 500.
See: http://www.aap.org/policy/autism.html
If you said "B" good for you! This is a correct answer too! One in a thousand for full-blown autism and 2 in a thousand for the lower-octane derivatives.
See: http://aappolicy.aappublications.org/cgi/content/full/pediatrics;107/5/1221
If you said "C" well. that's right too! There is a dead link to a document that came out a few months ago called autism A.L.A.R.M,. rember that one? It said the autism rate was 1 in 166. But you can't find this one on the AAP website anymore. It has also disappeared as far as I can tell from the websites of the other entities that sponsored the document: our good buddies at CDC, USDHHS, Medical Home Initiatives and First Signs.
Copies of Autism A.L.A.R.M. are still floating around the net. The text is below. I particularly like the "L" for listen to parents, there's a novel thought. No wonder they pulled it.
http://www.helpautismnow.com/PDFS/AutismAlarm.pdf
SO the real correct answer is "D"!
Just another example of the crackerjack job those dedicated and hardworking MDs at the AAP are doing to assure you that you should trust them with blind, unquestioning confidence. They no better than us so who are you to question them?
This has got to stop. And only we can stop it.
"Autism is prevalent
• 1 out of 6 children are diagnosed with a developmental disorder and/or behavioral problem
• 1 in 166 children are diagnosed with an autism spectrum disorder
• Developmental disorders have subtle signs and may be easily missed
Listen to parents
• Early signs of autism are often present before 18 months
• Parents usually DO have concerns that something is wrong
• Parents generally DO give accurate and quality information
• When parents do not spontaneously raise concerns, ask if they have any
Act early
• Make screening and surveillance an important part of your practice (as endorsed by the AAP)
• Know the subtle differences between typical and atypical development
• Learn to recognize red flags
• Use validated screening tools and identify problems early
• Improve the quality of life for children and their families through early and appropriate intervention
Refer
• To Early Intervention or a local school program (do not wait for a diagnosis)
• To an autism specialist, or team of specialists, immediately for a definitive diagnosis• To audiology and rule out a hearing impairment
• To local community resources for help and family support
Monitor
• Schedule a follow-up appointment to discuss concerns more thoroughly
• Look for other features known to be associated with autism
• Educate parents and provide them with up-to-date information
• Advocate for families with local early intervention programs, schools, respite care agencies, and insurance companies
• Continue surveillance and watch for additional or late signs of autism and/or other developmental disorders
For More Information: www.medicalhomeinfo.org"
Autism Speaks in Apprentice Finale
Autism Speaks, Elizabeth Glaser Pediatric AIDS Foundation Both Winners in Apprentice Finale
Contestants to Raise Awareness and Funds to Support Charities
(New York, New York – December 6, 2005) Autism Speaks and the Elizabeth Glaser Pediatric AIDS Foundation today announced that they will participate in the final two episodes of the hit NBC-TV show The Apprentice. In the final task, to be assigned by Donald Trump on Thursday’s program and concluding with the season finale December 15, one set of contestants will be assigned to produce an event to benefit Autism Speaks and the other an event to benefit the Elizabeth Glaser Pediatric Aids Foundation.
Autism Speaks is dedicated to increasing awareness of autism spectrum disorder and its effect on individuals and families, and is committed to raising money to fund scientists who are searching for the causes, treatments, prevention and cure. The Elizabeth Glaser Pediatric AIDS Foundation is the worldwide leader in the fight against pediatric AIDS and other serious and life-threatening illnesses affecting children. Mark Burnett Productions selects the charities that participate in The Apprentice, and Mr. Trump makes all decisions about contestants.
“Both Donald Trump and I strongly believe that investing in charitable causes is just good business,” said Mark Burnett, executive producer of The Apprentice, and board member of the Elizabeth Glaser Pediatric AIDS Foundation.
“Building awareness of this devastating and prevalent disorder is among our top priorities,” said Alison Singer, Senior Vice President of Autism Speaks. “We hope the large audience that tunes in to The Apprentice will learn a good deal about autism and the terrible toll it takes on families”.
"The Foundation is very appreciative of the support we receive from both Mr. Trump and Mr. Burnett, as they share our concern about doing all we can to help children with HIV/AIDS all over the world," said Pam Barnes, COO of the Elizabeth Glaser Pediatric AIDS Foundation. “Philanthropy has been given an important role on The Apprentice, and for that we are all winners.”
The Apprentice airs on NBC-TV on Thursdays from 9 PM ET/PT.
ABOUT AUTISM SPEAKS
Autism Speaks is committed to aggressively funding global biomedical research into the causes, prevention, treatments and cure for autism. It is devoted to raising public awareness about autism and its effects on individuals, families and society, and to bringing hope to all who deal with the hardships of the disorder. To learn more about Autism Speaks, please visit its web site at www.autismspeaks.org
Today, one in 166 individuals is diagnosed with an autism spectrum disorder. It occurs in all racial, ethnic, and social groups and is four times more likely to strike boys than girls. Autism impairs a person's ability to communicate and relate to others. It is also associated with rigid routines and repetitive behaviors, such as obsessively arranging objects or following very specific routines.
ABOUT THE ELIZABETH GLASER PEDIATRIC AIDS FOUNDATION
The Elizabeth Glaser Pediatric AIDS Foundation is the worldwide leader in the fight against pediatric AIDS and other serious and life-threatening illnesses affecting children. The Foundation’s innovative research programs, collaborative training initiatives, advocacy efforts, and rapidly expanding international programs are bringing dramatic changes to the lives of children worldwide. To learn more, please visit the Foundation’s Web site at www.pedaids.org.
AIDS is the result of damage to the immune system after infection with HIV (Human Immunodeficiency Virus). AIDS involves the diminished function of the immune system as critical immune cells are infected and destroyed. The immune system is no longer able to guard against illness, making the person vulnerable to other infections and cancers. Each day 1,900 children around the world become newly infected with HIV.
ABOUT MARK BURNETT PRODUCTIONS
Mark Burnett Productions (MBP) is one of the world’s leading television production companies. MBP revolutionized television with hits such as Eco-Challenge, Survivor, The Apprentice, The Contender, Rock Star: INXS, MARTHA and The Apprentice: Martha Stewart. MBP also successfully reintroduced product placement as an integral part of each of its shows and has garnered a total of 33 Emmy nominations since 2001. Mark Burnett was listed as the #1 Most Valuable Player by TV Guide and also in Time’s Top 100 most influential people in the world today.
Press Contacts:
Autism Speaks:
Adam Pockriss, (212) 843-8286, adam.pockriss@rubenstein.com
Elizabeth Glaser Pediatric AIDS Foundation
Darin Dusan, (310) 314-1459, ddusan@pedaids.org
Contestants to Raise Awareness and Funds to Support Charities
(New York, New York – December 6, 2005) Autism Speaks and the Elizabeth Glaser Pediatric AIDS Foundation today announced that they will participate in the final two episodes of the hit NBC-TV show The Apprentice. In the final task, to be assigned by Donald Trump on Thursday’s program and concluding with the season finale December 15, one set of contestants will be assigned to produce an event to benefit Autism Speaks and the other an event to benefit the Elizabeth Glaser Pediatric Aids Foundation.
Autism Speaks is dedicated to increasing awareness of autism spectrum disorder and its effect on individuals and families, and is committed to raising money to fund scientists who are searching for the causes, treatments, prevention and cure. The Elizabeth Glaser Pediatric AIDS Foundation is the worldwide leader in the fight against pediatric AIDS and other serious and life-threatening illnesses affecting children. Mark Burnett Productions selects the charities that participate in The Apprentice, and Mr. Trump makes all decisions about contestants.
“Both Donald Trump and I strongly believe that investing in charitable causes is just good business,” said Mark Burnett, executive producer of The Apprentice, and board member of the Elizabeth Glaser Pediatric AIDS Foundation.
“Building awareness of this devastating and prevalent disorder is among our top priorities,” said Alison Singer, Senior Vice President of Autism Speaks. “We hope the large audience that tunes in to The Apprentice will learn a good deal about autism and the terrible toll it takes on families”.
"The Foundation is very appreciative of the support we receive from both Mr. Trump and Mr. Burnett, as they share our concern about doing all we can to help children with HIV/AIDS all over the world," said Pam Barnes, COO of the Elizabeth Glaser Pediatric AIDS Foundation. “Philanthropy has been given an important role on The Apprentice, and for that we are all winners.”
The Apprentice airs on NBC-TV on Thursdays from 9 PM ET/PT.
ABOUT AUTISM SPEAKS
Autism Speaks is committed to aggressively funding global biomedical research into the causes, prevention, treatments and cure for autism. It is devoted to raising public awareness about autism and its effects on individuals, families and society, and to bringing hope to all who deal with the hardships of the disorder. To learn more about Autism Speaks, please visit its web site at www.autismspeaks.org
Today, one in 166 individuals is diagnosed with an autism spectrum disorder. It occurs in all racial, ethnic, and social groups and is four times more likely to strike boys than girls. Autism impairs a person's ability to communicate and relate to others. It is also associated with rigid routines and repetitive behaviors, such as obsessively arranging objects or following very specific routines.
ABOUT THE ELIZABETH GLASER PEDIATRIC AIDS FOUNDATION
The Elizabeth Glaser Pediatric AIDS Foundation is the worldwide leader in the fight against pediatric AIDS and other serious and life-threatening illnesses affecting children. The Foundation’s innovative research programs, collaborative training initiatives, advocacy efforts, and rapidly expanding international programs are bringing dramatic changes to the lives of children worldwide. To learn more, please visit the Foundation’s Web site at www.pedaids.org.
AIDS is the result of damage to the immune system after infection with HIV (Human Immunodeficiency Virus). AIDS involves the diminished function of the immune system as critical immune cells are infected and destroyed. The immune system is no longer able to guard against illness, making the person vulnerable to other infections and cancers. Each day 1,900 children around the world become newly infected with HIV.
ABOUT MARK BURNETT PRODUCTIONS
Mark Burnett Productions (MBP) is one of the world’s leading television production companies. MBP revolutionized television with hits such as Eco-Challenge, Survivor, The Apprentice, The Contender, Rock Star: INXS, MARTHA and The Apprentice: Martha Stewart. MBP also successfully reintroduced product placement as an integral part of each of its shows and has garnered a total of 33 Emmy nominations since 2001. Mark Burnett was listed as the #1 Most Valuable Player by TV Guide and also in Time’s Top 100 most influential people in the world today.
Press Contacts:
Autism Speaks:
Adam Pockriss, (212) 843-8286, adam.pockriss@rubenstein.com
Elizabeth Glaser Pediatric AIDS Foundation
Darin Dusan, (310) 314-1459, ddusan@pedaids.org
December 6, 2005
Kel's Candles
Kel makes candles.
Occasionally Kel makes candles for charity.
This time she is making one for Adventures In Autism and the Autism Research Institute.
Occasionally Kel makes candles for charity.
This time she is making one for Adventures In Autism and the Autism Research Institute.
"You can help prevent, diagnose & treat autism in children through your purchase of an Austism Research Soy Candle. For every one you buy, $5 goes to Adventures in Autism and $5 goes to The Autism Research Institute, a non-profit organization studying the causes of autism & methods of preventing, diagnosing & treating autism & other behavioral disorders of childhood."Kel is a good woman.
December 5, 2005
NAA Autism Confrence DVDs
From the National Autism Association:
National Autism Conference DVDs are now available!
From cutting-edge research of environmental toxins to dietary interventions, legal and legislative strategies to sensory integration, the world’s most renowned experts gathered to share their knowledge and expertise with parents and practitioners last month in Myrtle Beach, South Carolina.
If you were unable to attend, you can now bring the conference home to you by purchasing individual presentations or an entire set of DVDs.
Also available is our official 327 page 2005 National Autism Conference Program book containing speaker presentations. It comes with a free NAA book bag and conference t-shirt.
Click here for more information.
Speakers include:
KEYNOTE SPEAKER
Frank Lawlis, PhD
FEATURED SPEAKERS
Mark Blaxill, MBA
Jeffrey Bradstreet, MD, FAAFP
Rashid Buttar – DO, FAAPM, FACAM, FAAIM
Vince Carbone, PhD
Boyd E Haley, PhD
Andrew J Wakefield, MD
SPECIAL GUEST SPEAKER
David Kirby - Author of Evidence of Harm
BREAKOUT SPEAKERS
Tim Adams
Lynne Arnold
Mary Bolles
Cathi Browder
Julie A. Buckley, MD, FAAP
Thomas M. Burbacher
Beth Clay
Ashley Collins
Phillip C. DeMio, MD
Richard Deth, PhD
Jerry Evans
Carolyn Gammicchia
David Geier, PhD
Mark Geier, MD, PhD
Caroline Gomez, PhD
Doreen Granpeesheh, Ph.D., B.C.B.A.
Cindy L. Griffin, HD (R.Hom.), DSH-P, DIHom
Devin Houston,PhD
Bryan Jepson, MD
Sandra Jill James, PhD
John Kernohan
David Kirby
Jorgen Klaveness
Arthur Krigsman, MD
Roger Kendall, PhD
Michael Lang, PhD
Connie Mathis, PhD
James Neubrander, MD
Mary Beth Palo
Seth Pearl, DC CCN CNS
Lyn Redwood, RN, MSN, CRNP
Adrienne Rousseau
Karyn Seroussi
Selwyn Super, PhD
Sue Tanner
Sherri Tenpenny, DO
Anju Usman, MD
Debbie Wardell
Think Autism. Think Cure.
National Autism Conference DVDs are now available!
From cutting-edge research of environmental toxins to dietary interventions, legal and legislative strategies to sensory integration, the world’s most renowned experts gathered to share their knowledge and expertise with parents and practitioners last month in Myrtle Beach, South Carolina.
If you were unable to attend, you can now bring the conference home to you by purchasing individual presentations or an entire set of DVDs.
Also available is our official 327 page 2005 National Autism Conference Program book containing speaker presentations. It comes with a free NAA book bag and conference t-shirt.
Click here for more information.
Speakers include:
KEYNOTE SPEAKER
Frank Lawlis, PhD
FEATURED SPEAKERS
Mark Blaxill, MBA
Jeffrey Bradstreet, MD, FAAFP
Rashid Buttar – DO, FAAPM, FACAM, FAAIM
Vince Carbone, PhD
Boyd E Haley, PhD
Andrew J Wakefield, MD
SPECIAL GUEST SPEAKER
David Kirby - Author of Evidence of Harm
BREAKOUT SPEAKERS
Tim Adams
Lynne Arnold
Mary Bolles
Cathi Browder
Julie A. Buckley, MD, FAAP
Thomas M. Burbacher
Beth Clay
Ashley Collins
Phillip C. DeMio, MD
Richard Deth, PhD
Jerry Evans
Carolyn Gammicchia
David Geier, PhD
Mark Geier, MD, PhD
Caroline Gomez, PhD
Doreen Granpeesheh, Ph.D., B.C.B.A.
Cindy L. Griffin, HD (R.Hom.), DSH-P, DIHom
Devin Houston,PhD
Bryan Jepson, MD
Sandra Jill James, PhD
John Kernohan
David Kirby
Jorgen Klaveness
Arthur Krigsman, MD
Roger Kendall, PhD
Michael Lang, PhD
Connie Mathis, PhD
James Neubrander, MD
Mary Beth Palo
Seth Pearl, DC CCN CNS
Lyn Redwood, RN, MSN, CRNP
Adrienne Rousseau
Karyn Seroussi
Selwyn Super, PhD
Sue Tanner
Sherri Tenpenny, DO
Anju Usman, MD
Debbie Wardell
Think Autism. Think Cure.
From A-CHAMP
A NEWS ALERT FROM A-CHAMP... PLEASE POST AND FORWARD
The CBS Evening News is planning to run a two part report on Monday and Tuesday at 6:30pm Eastern that will explore the "myth" that antiperspirants are linked to breast cancer. Rumors of such a link have long circulated on email. However, the rumors have been dispelled by the antiperspirant industry, the FDA and others. Now, according to new and original research done by CBS News Correspondent Sharyl Attkisson, we learn that an antiperspirant-breast cancer link has not been conclusively ruled out, after all. We understand the distinction since this is similar to the government's autism study findings. Up until now, the government and industry had implied or claimed that the breast cancer link had been definitively ruled out.
Those of you who have followed Sharyl's coverage of the autism/mercury debate know that she is a very thorough investigative reporter who doesn't just accept industry and government reassurances. There is a new Executive Producer for the CBS Evening News who will take control in early January. This development may make it possible for reporters like Sharyl, who continues to have an interest in the autism/mercury story, to develop more original, important, relevent stories on various medical fraud and danger issues.
If the Evening News management gets good feedback on this report, it will help these new managers measure the importance and relevance of such stories to many viewers. The antiperspirant/breast cancer series should also be available online (both in video and printed form). Networks measures interest, in part, by how many clicks they get on these Web items as well as viewer email feedback afterward.
Please take a moment AFTER Sharyl's report (hopefully tonight and tomorrow night), to go to www.cbsnews.com and click on the story and send a message asking for continued coverage of this type of story and mention your interest for continued coverage on the autism/mercury controversy.
Below is a link to one of Sharyl Attkisson's earlier stories.
CBS News Online
Mercury Concerns
Thank you,
A-CHAMP
The CBS Evening News is planning to run a two part report on Monday and Tuesday at 6:30pm Eastern that will explore the "myth" that antiperspirants are linked to breast cancer. Rumors of such a link have long circulated on email. However, the rumors have been dispelled by the antiperspirant industry, the FDA and others. Now, according to new and original research done by CBS News Correspondent Sharyl Attkisson, we learn that an antiperspirant-breast cancer link has not been conclusively ruled out, after all. We understand the distinction since this is similar to the government's autism study findings. Up until now, the government and industry had implied or claimed that the breast cancer link had been definitively ruled out.
Those of you who have followed Sharyl's coverage of the autism/mercury debate know that she is a very thorough investigative reporter who doesn't just accept industry and government reassurances. There is a new Executive Producer for the CBS Evening News who will take control in early January. This development may make it possible for reporters like Sharyl, who continues to have an interest in the autism/mercury story, to develop more original, important, relevent stories on various medical fraud and danger issues.
If the Evening News management gets good feedback on this report, it will help these new managers measure the importance and relevance of such stories to many viewers. The antiperspirant/breast cancer series should also be available online (both in video and printed form). Networks measures interest, in part, by how many clicks they get on these Web items as well as viewer email feedback afterward.
Please take a moment AFTER Sharyl's report (hopefully tonight and tomorrow night), to go to www.cbsnews.com and click on the story and send a message asking for continued coverage of this type of story and mention your interest for continued coverage on the autism/mercury controversy.
Below is a link to one of Sharyl Attkisson's earlier stories.
CBS News Online
Mercury Concerns
Thank you,
A-CHAMP
A Reminder to Shop Online and Support My Blogging
Shop through my new fund raising portal and sleep tight knowing that half of the money brought in will be going to the Autism Research Institute.
TACA's Adopt A Family Campaign
ANNOUNCING TACA's HOLIDAY ADOPT A FAMILY CAMPAIGN
Talk About Curing Autism (TACA) is pleased to announce its first annual Adopt-A-Family Holiday Campaign! The holiday season is a happy time filled with warmth, love, generosity and hope – and it is through the special holiday generosity of the Northrop Grumman Corporation that we are able to launch this program.
TACA will be adopting approximately 20 families to help provide the things that will make this holiday special. We will be providing holiday gifts for your children, assistance with special needs such as diapers, groceries, vitamin supplements, etc., and the delivery of a special holiday dinner. Holiday giving will be valued at approximately $200 and will be based on family need and family size.
Apply to be Adopted – Deadline December 14, 2005
If you are a family in need, we will do our best to make 2005 a special holiday season for your family. To qualify, you must:
* Be a TACA member
* Have at least one child with autism
* Live in California
* Be recommended by a TACA coordinator
Please Send the Following Information to Your Local TACA Coordinator:
* Your name, address, and telephone number
* The number of children in your family and their ages (please include some ideas of what they might enjoy for the holidays.)
* Information about your child with autism and their special needs.
* A brief statement on your need this holiday season.
* Whether you are being considered for another adopt-a-family program
TACA Coordinators:
Orange County Lisa Ackerman tacanow@cox.net
Greater Los Angeles Area Debbie Gonzalez bluerus@hotmail.com
San Fernando Valley Moira Giammetteo moira@netzero.com
San Diego County Becky Estepp restepp@sbcglobal.net
Inland Empire Tami Duncan TACAInlandEmpire@aol.com
Central California Lynne Arnold lynne@autisminterventioncentralca.org
Family applications will only be accepted by e-mail.
Join TACA in Making This Holiday Season One to Remember:
Your help will allow us to reach more than the 20 families we are budgeted for:
* Sign up to be a delivery person, shop for the family, and experience the joy of helping others in your area.
* Enjoy your holiday even more by knowing you have made a difference through adopting a family yourself (guidelines below)
* Donate cash or in kind items to the TACA Adopt-A-Family Campaign. You can do this via mail (see address below) or via online at http://www.tacanow.com/shop.htm.
To help please contact Lisa Ackerman at (949) 640-4401 or e-mail tacanow@cox.net.
Adopt-A-Family Guidelines:
* Call (949) 640-4401 or email tacanow@cox.net to register to Adopt-A-Family.
* Purchase gifts for each child. You are not obligated to spend more than $25 for each gift.
* Purchase a gift certificate from a grocery store chain. The dollar amount should be at least $15 for each family member regardless of age.
* Make plans to prepare or purchase a holiday dinner for your family.
* Call your family no later than December 20 and make arrangements to drop off your gifts.
* Call or email tacanow@cox.net TACA and let us know that you have dropped off gifts to your family and share the story of giving during this holiday season.
Special note: if funds received exceed number of qualified families we will continue this program throughout the year to assist families in crisis.
Special thanks to Debbie Gonzalez and Northrop Grumman Corporation for their assistance in making this happen! We truly appreciate the support and the desire to help TACA families in need. HAPPY HOLIDAYS!
Talk About Curing Autism (TACA) is pleased to announce its first annual Adopt-A-Family Holiday Campaign! The holiday season is a happy time filled with warmth, love, generosity and hope – and it is through the special holiday generosity of the Northrop Grumman Corporation that we are able to launch this program.
TACA will be adopting approximately 20 families to help provide the things that will make this holiday special. We will be providing holiday gifts for your children, assistance with special needs such as diapers, groceries, vitamin supplements, etc., and the delivery of a special holiday dinner. Holiday giving will be valued at approximately $200 and will be based on family need and family size.
Apply to be Adopted – Deadline December 14, 2005
If you are a family in need, we will do our best to make 2005 a special holiday season for your family. To qualify, you must:
* Be a TACA member
* Have at least one child with autism
* Live in California
* Be recommended by a TACA coordinator
Please Send the Following Information to Your Local TACA Coordinator:
* Your name, address, and telephone number
* The number of children in your family and their ages (please include some ideas of what they might enjoy for the holidays.)
* Information about your child with autism and their special needs.
* A brief statement on your need this holiday season.
* Whether you are being considered for another adopt-a-family program
TACA Coordinators:
Orange County Lisa Ackerman tacanow@cox.net
Greater Los Angeles Area Debbie Gonzalez bluerus@hotmail.com
San Fernando Valley Moira Giammetteo moira@netzero.com
San Diego County Becky Estepp restepp@sbcglobal.net
Inland Empire Tami Duncan TACAInlandEmpire@aol.com
Central California Lynne Arnold lynne@autisminterventioncentralca.org
Family applications will only be accepted by e-mail.
Join TACA in Making This Holiday Season One to Remember:
Your help will allow us to reach more than the 20 families we are budgeted for:
* Sign up to be a delivery person, shop for the family, and experience the joy of helping others in your area.
* Enjoy your holiday even more by knowing you have made a difference through adopting a family yourself (guidelines below)
* Donate cash or in kind items to the TACA Adopt-A-Family Campaign. You can do this via mail (see address below) or via online at http://www.tacanow.com/shop.htm.
To help please contact Lisa Ackerman at (949) 640-4401 or e-mail tacanow@cox.net.
Adopt-A-Family Guidelines:
* Call (949) 640-4401 or email tacanow@cox.net to register to Adopt-A-Family.
* Purchase gifts for each child. You are not obligated to spend more than $25 for each gift.
* Purchase a gift certificate from a grocery store chain. The dollar amount should be at least $15 for each family member regardless of age.
* Make plans to prepare or purchase a holiday dinner for your family.
* Call your family no later than December 20 and make arrangements to drop off your gifts.
* Call or email tacanow@cox.net TACA and let us know that you have dropped off gifts to your family and share the story of giving during this holiday season.
Special note: if funds received exceed number of qualified families we will continue this program throughout the year to assist families in crisis.
Special thanks to Debbie Gonzalez and Northrop Grumman Corporation for their assistance in making this happen! We truly appreciate the support and the desire to help TACA families in need. HAPPY HOLIDAYS!
Autistic Teen Makes Film About Autism
Autistic license: Teen filmmaker sheds light on his own disorder
By Tenley Woodman
Monday, December 5, 2005
It’s not that unusual for a teen, especially one from California, to be a budding filmmaker. But Taylor Cross, 17, turned his camera on a subject few directors have touched: the mind of the autistic child.
Cross’ 10-minute film “Normal People Scare Me,” which will be shown tonight at the Flutie Bowl in Boston, shows nonautistics what it is like to live with autism.
“Pretty much I’ve been living in a cave for several years, except for the autisic kids,” said Cross during his visit to Boston last week.
Autism is a developmental disorder that alters a person’s social interaction and communication skills and is typically diagnosed in early childhood.
According to the National Institutes of Health and the Centers for Disease Control and Prevention, autism affects one in 166 births.
Cross was diagnosed at age 6. Doctors told his mother that he might never walk or talk.
Eleven years later, the high school junior is trying to turn his short documentary into a feature film with the help of Joey Travolta, owner of Entertianment Experience and the older brother of actor John.
“Make no mistake about it, we have pulled each other’s hair out (at times). It has not been easy,” said Keri Bowers, Cross’ mother. “Taylor looks damn good in life because he works at it.”
Cross interviewed dozens of kids with autism and their parents. Among them was world-class surfer Izzy Paskowitz, who discussed his frustration with his son’s disorder.
“It would be difficult for other kids. It would be and it is. You can imagine another teen in this situation and he’s not autistic. How would he feel?” Cross said.
Though Cross attends regular classes, he has few friends without autism. He said he chooses to hang out with autistic kids, who vary in functioning levels from verbal to nonverbal.
“I think I understand what’s been going on in the head,” he said. “It’s a comfort level.”
Cross has never been invited to a birthday party, play date or engagement by a peer without autism. Those he interviewed have had similar experiences.
“They don’t judge each other,” Bowers said.
Cross, an avid fan of film and video games, hopes to pursue film as a career. In “Normal People Scare Me” he interviewed the dean of New York University’s film program.
Though his path to success has not been easy, Cross said he believes others can make it further than he has.
“When it comes to that, work on it on your own terms. Try to reach out, because it will make you more insecure if you don’t,” he said.
A film about siblings of autistic kids is in preproduction and will be directed by Cross’ younger brother Jace, 10.
To learn more about Taylor Cross’ projects, go to www.artistsforautism.com
“Normal People Scare Me” will be screened at The Flutie Bowl, Lucky Strike, 145 Ipswich St., Boston. Tonight, 6-11 p.m. Tickets are $100, with all proceeds benefiting the Doug Flutie Jr. Foundation for Autism.
By Tenley Woodman
Monday, December 5, 2005
It’s not that unusual for a teen, especially one from California, to be a budding filmmaker. But Taylor Cross, 17, turned his camera on a subject few directors have touched: the mind of the autistic child.
Cross’ 10-minute film “Normal People Scare Me,” which will be shown tonight at the Flutie Bowl in Boston, shows nonautistics what it is like to live with autism.
“Pretty much I’ve been living in a cave for several years, except for the autisic kids,” said Cross during his visit to Boston last week.
Autism is a developmental disorder that alters a person’s social interaction and communication skills and is typically diagnosed in early childhood.
According to the National Institutes of Health and the Centers for Disease Control and Prevention, autism affects one in 166 births.
Cross was diagnosed at age 6. Doctors told his mother that he might never walk or talk.
Eleven years later, the high school junior is trying to turn his short documentary into a feature film with the help of Joey Travolta, owner of Entertianment Experience and the older brother of actor John.
“Make no mistake about it, we have pulled each other’s hair out (at times). It has not been easy,” said Keri Bowers, Cross’ mother. “Taylor looks damn good in life because he works at it.”
Cross interviewed dozens of kids with autism and their parents. Among them was world-class surfer Izzy Paskowitz, who discussed his frustration with his son’s disorder.
“It would be difficult for other kids. It would be and it is. You can imagine another teen in this situation and he’s not autistic. How would he feel?” Cross said.
Though Cross attends regular classes, he has few friends without autism. He said he chooses to hang out with autistic kids, who vary in functioning levels from verbal to nonverbal.
“I think I understand what’s been going on in the head,” he said. “It’s a comfort level.”
Cross has never been invited to a birthday party, play date or engagement by a peer without autism. Those he interviewed have had similar experiences.
“They don’t judge each other,” Bowers said.
Cross, an avid fan of film and video games, hopes to pursue film as a career. In “Normal People Scare Me” he interviewed the dean of New York University’s film program.
Though his path to success has not been easy, Cross said he believes others can make it further than he has.
“When it comes to that, work on it on your own terms. Try to reach out, because it will make you more insecure if you don’t,” he said.
A film about siblings of autistic kids is in preproduction and will be directed by Cross’ younger brother Jace, 10.
To learn more about Taylor Cross’ projects, go to www.artistsforautism.com
“Normal People Scare Me” will be screened at The Flutie Bowl, Lucky Strike, 145 Ipswich St., Boston. Tonight, 6-11 p.m. Tickets are $100, with all proceeds benefiting the Doug Flutie Jr. Foundation for Autism.
Autistic 15-Year-Old Tasered At School
Autistic 15-Year-Old Tasered, Arrested At Florida School
November 30, 2005
FT. MYERS, Fla. -- A school resource officer is being accused of excessive force after using a taser on an autistic student. Now, that boy's mother says a misunderstanding has left her child confused and bruised.
Dennis Caliguri, 15, has bruises to show for what happened when he encountered a school resource officer and his taser. Investigators said Dennis was so violent and out of control that it took five faculty members to restrain him and the taser was used to calm him down.
Dennis is autistic and functions at the level of a six-year-old. But at 5'8" tall and 220 pounds, his mother, Susan Caliguri, said he is big but harmless. So she was shocked to get a call from Cypress Lake High School saying he was acting out. When she got to the school, she was horrified.
"It was a nightmare. They had him handcuffed, his legs were tied, he was on the ground. They had four sheriffs on top of him. I mean, he is bruised down his back, they were stunning him and he was already down. He couldn't do anything," she said.
Susan calls it excessive force, but the Lee County Sheriff's Office said the taser was the only way to calm him down.
"The matter is that the deputy, if he is that tired out and he has a fear of being overpowered, his weapon being taken away from him, he has to be able to overpower and be able to take control of the situation," said Charles Ferrante, Lee County Sheriff's Office
School administrators said Dennis got upset after being told not to come to school one day last week. He misunderstood and thought he was in trouble and started throwing papers.
Despite his mother's concerns, Dennis was arrested and charged with disturbing the peace and resisting arrest.
November 30, 2005
FT. MYERS, Fla. -- A school resource officer is being accused of excessive force after using a taser on an autistic student. Now, that boy's mother says a misunderstanding has left her child confused and bruised.
Dennis Caliguri, 15, has bruises to show for what happened when he encountered a school resource officer and his taser. Investigators said Dennis was so violent and out of control that it took five faculty members to restrain him and the taser was used to calm him down.
Dennis is autistic and functions at the level of a six-year-old. But at 5'8" tall and 220 pounds, his mother, Susan Caliguri, said he is big but harmless. So she was shocked to get a call from Cypress Lake High School saying he was acting out. When she got to the school, she was horrified.
"It was a nightmare. They had him handcuffed, his legs were tied, he was on the ground. They had four sheriffs on top of him. I mean, he is bruised down his back, they were stunning him and he was already down. He couldn't do anything," she said.
Susan calls it excessive force, but the Lee County Sheriff's Office said the taser was the only way to calm him down.
"The matter is that the deputy, if he is that tired out and he has a fear of being overpowered, his weapon being taken away from him, he has to be able to overpower and be able to take control of the situation," said Charles Ferrante, Lee County Sheriff's Office
School administrators said Dennis got upset after being told not to come to school one day last week. He misunderstood and thought he was in trouble and started throwing papers.
Despite his mother's concerns, Dennis was arrested and charged with disturbing the peace and resisting arrest.
December 4, 2005
Pentagon Withheld Anthrax Vaccine Injury Information
An Incomplete Picture
Despite promises that hospitalizations after anthrax vaccinations would be reported, the Pentagon withheld data on more than 20,000 cases.
BY BOB EVANS
December 4, 2005
Daily Press - Hampton Roads, Virginia
First of four parts
bevans@dailypress.com
The Pentagon never told Congress about more than 20,000 hospitalizations involving troops who'd taken the anthrax vaccine, despite repeated promises that such cases would be publicly disclosed.
Instead, a parade of generals and Defense Department officials told Congress and the public that fewer than 100 people were hospitalized or became seriously ill after receiving the shot from 1998 through 2000.
They also showed Congress written policies that required public reports to be filed for hospitalizations, serious illnesses and cases where someone missed 24 hours or more of duty.
But only a sliver of those cases were reported, while the rest were withheld from Congress and the public, records obtained by the Daily Press show.
Critics of the vaccine, veterans' advocates and congressional staffers say the Pentagon's deliberate low-balling of hospitalizations helped persuade Congress and the public that the vaccine was safe.
Keeping the actual number of illnesses secret contributed to a shorter list of government-recognized side effects for the drug, giving patients and physicians a false idea of what might constitute a vaccine-related illness or problem. Doctors are expected to know the full list of side effects and alert federal drug safety officials whenever they see a repeat of those symptoms.
Repeated evidence of the same adverse side effect after a vaccination is one of the most telling signs of a systematic problem with a drug or vaccine, as opposed to a coincidental relationship, vaccine safety experts say.
During the Daily Press' investigation of the vaccine and its effects, the newspaper found three cases of amyotrophic lateral sclerosis - ALS, or Lou Gehrig's disease - that the military hadn't reported. The disease destroys muscles and nerves, is always fatal and rarely hits people younger than 45.
One of the three cases involves Navy Capt. Denis Army of Virginia Beach. Army died in 2000, after developing symptoms less than a week after his first anthrax vaccination - and a few days before his 45th birthday. His widow filed the first public acknowledgement of his death and its temporal connection to the vaccine this year. That occurred after she talked to a Daily Press reporter and learned that she could file a report with the federal Vaccine Adverse Event Reporting System, or VAERS.
SAILOR'S DEATH NOT REPORTED BY MILITARY
Navy Petty Officer 2nd Class Kristin Shemeley died of ALS in 2001, at 29. Her symptoms began about two months after her third shot, a sworn legal document detailing her illness says.
Before Shemeley died, she spent 14 months in Walter Reed Army Medical Center in Washington, where she was regularly visited by high-ranking military officers, said her mother, Ginger Shemeley of Quakertown, Pa. She says her daughter repeatedly told those generals and admirals that she was suffering because of the vaccine and even pleaded with one of them to stop giving it to troops. Several of those generals and admirals had promised Congress that such cases would be publicly reported to VAERS.
The military never filed a VAERS report on Kristin Shemeley. Ginger Shemeley filed one after her daughter died.
Col. John Grabenstein, director of the military's vaccine agency, said no one from the military intentionally misled Congress or the public. He said the 20,765 hospitalizations merely followed vaccinations in time, without documented proof of a cause-and-effect relationship.
He said a statistical analysis showed that those who'd been vaccinated weren't more likely to be hospitalized or likely to seek medical treatment than those in the military who hadn't been vaccinated from 1998 through 2000.
Some medical experts say this approach doesn't adequately address the problems of many people who report illnesses after anthrax vaccination. That's because the approach is limited to comparing rates of illness involving one symptom or disease - instead of the complex combination of symptoms and illnesses that many veterans report after getting their shots.
The data that the Daily Press used to document the underreporting of hospitalizations came from a report that Grabenstein supplied in response to the newspaper's request. It's never been made public until today.
It covers 1998 through 2000, when the Pentagon did detailed evaluations every three months to compare hospitalizations, clinic visits and medical treatment data for those who'd been vaccinated, compared with troops who hadn't. This quarterly analysis stopped and hasn't been done since, Grabenstein said.
The practice of not reporting all hospitalizations continues.
Quarterly analysis of the vaccine's effects ended just as the nation's only manufacturing site for the drug regained its license. That was in 2002, after federal inspections found many safety and other problems that prompted a shutdown and renovation that began in early 1998.
The company's current manufacturing techniques provide greater potency compared with earlier versions of the drug, said the Government Accountability Office, Congress' investigative arm. The manufacturer, BioPort Inc., says there's no difference in the drug made since 2002 that might cause health problems.
TOP GENERAL NOT TOLD MONITORING TO END
The decision to discontinue the quarterly health monitoring program means that the biggest gap in research about the vaccine remains: There are no systematic long-term studies of the health of those who've taken the drug. Most studies that the Pentagon cites as support for the vaccine's safety involve monitoring that lasted days to a few months.
None lasted as long as five years, the minimum length of time recommended by a nationally recognized panel of scientists assembled by the Institute of Medicine in 2002. The institute is a nonprofit organization that provides expert advice to Congress and other government agencies.
After the quarterly reviews of the vaccine's effects stopped, more than a million troops were forced to take the vaccine - until a federal judge ruled last year that the drug had never been adequately licensed for protection against anthrax use in warfare.
He ordered the military to make vaccination voluntary. The Pentagon is appealing that ruling. Lawyers argued the case Thursday, and a decision is expected by February.
VACCINE MONITORING STILL IMPORTANT
Grabenstein said he decided to halt the quarterly studies after consulting the chairman of the Institute of Medicine panel and its staff, and with doctors affiliated with the military. He acknowledged that he didn't consult the general who ultimately was responsible for the anthrax program.
The chairman of the institute panel, Brian Strom, said he didn't recall what was discussed at the time about the quarterly reports. But he said, "I think they should continue to be using it," in case there's a problem.
Another panel member, Linda Cowan, said she's sure the committee expected quarterly reviews to continue and pointed to a number of the panel's recommendations and findings that she said clearly contradicted Grabenstein's interpretation of its report.
Strom and Cowan emphasized that they thought the vaccine was still safe.
Beth Clay isn't so sure. She directed the staff of Congress' House Government Reform Committee investigation into the anthrax vaccine from 1998 to 2001. She continued working on the subject as a congressional staff member through 2003, after her Republican boss was no longer chairman of the committee.
Clay said the military's decision not to report all the hospitalizations gave the public and Congress a rosier picture of the vaccine than it deserved.
"We were never given this data," she said. "Had we seen this, the committee would have had significant questions" and would have demanded more information about the program.
After reviewing the report obtained by the Daily Press, Clay said it raised several questions about the vaccine's safety. She said Congress was never told about the detailed level of data in the report but was assured regular monitoring of the vaccine and its health effects would continue.
Terminating the quarterly reviews would seem to break those promises, she said. "It's just appalling that they didn't keep up with this," she said.
LINK BETWEEN VACCINE, HOSPITALIZATIONS?
Steve Robinson is executive director of the National Gulf War Resource Center, a lobbying and advocacy group for veterans. He said he was stunned when he learned that the reviews had stopped: "They track the flu vaccine and not the anthrax vaccine, which is totally crazy to me."
He said discovery of the hospitalization data showed that the Pentagon couldn't be trusted to monitor the vaccine's safety.
"You can't let Enron investigate Enron, and you can't let DOD (the Department of Defense) investigate DOD," he said. "We work with the people who have been hurt by this vaccine every day."
No one knows how many, or how few, of the 20,765 hospitalizations are directly attributable to the vaccine. Ruling out certain illnesses, such as broken bones or injuries from falls or other accidents, might appear a safe bet. But military doctors have documented cases where broken bones and other injuries from falling were the result of vaccine-induced loss of consciousness affecting the nervous system - sometimes beginning mon thsaftervaccination.BRBRThe difficulty of figuring out what's related and what isn't is why safety officials encourage people to file reports even if they're not sure.
WHY PENTAGON DIDN'T FILE HOSPITAL REPORTS
Still, medical experts consulted by the Daily Press said it's unlikely that the vast majority of the 20,765 hospitalizations resulted from the vaccine. They said that if all hospitalizations had been filed with VAERS, it would have overloaded the system and caused problems for experts trying to analyze the data.
Grabenstein said those were among the reasons that the full number of hospitalizations was not reported. Another reason, he said, was that examinations of the data showed that if there were adverse effects from the vaccine, they were so infrequent, they weren't detectable by statistical analysis. Doing this type of analysis - instead of simply reporting the incidents to VAERS - provided a more definitive look at the health effects of the vaccine, he said. As a result, "we decided not to file" public reports about all hospitalizations, he said.
Those considerations weren't relayed to Congress or the public.
During the years covered by the hospitalization report obtained by the Daily Press, dozens of sick veterans who'd received the shot went to Capitol Hill, complaining of various health problems. Some got the shot for the 1991 Persian Gulf War, in which the vaccine had its first widespread use. Others were members of the military forced to take the shots under a mandatory program that began in 1998.
Their complaints had common themes: Fatigue. Chronic pain in joints and other symptoms of arthritis. Tingling in their feet, arms and hands. Mental lapses. Often, more than one of the symptoms were present, making diagnoses difficult.
Sympathetic doctors testified that these complaints were indicative of autoimmune problems, in which the body's natural protective mechanisms go haywire and start attacking healthy cells and tissue. The doctors said that could result if the vaccine overstimulated the vets' immune systems. The vaccine primes the system to develop protection against anthrax.
Bewildered and sometimes-angry members of Congress asked how many vets were affected. Pentagon doctors and generals used the cases reported to VAERS - fewer than 100 hospitalizations or other "serious events" from 1998 to 2000 - or said the number was so small, it couldn't be detected.
VACCINE REPORTS ARE FIRST LINE OF DEFENSE
The two sets of numbers for how many hospitalizations followed the shot come from a comparison of two sets of data kept by three federal agencies.
The Food and Drug Administration and the Centers for Disease Control and Prevention maintain the only database open to public inspection, VAERS. VAERS is the nation's first line of defense in identifying possible problems with vaccines after they've been licensed, said Susan Ellenberg, who led the FDA's efforts to monitor vaccine safety from 1993 to 2004.
During congressional testimony before the House Government Reform Committee's Subcommittee on National Security, Veterans Affairs and International Relations in July 1999, Ellenberg explained how and why the system worked.
VAERS was established to help identify and head off problems once a vaccine is licensed and more people are taking it, she said. The few hundred people typically involved in vaccine or drug testing and licensing trials can't mimic the diversity of age, race, gender and other biologic variables encountered once the vaccine gets widespread public use, she explained.
Reports to VAERS by civilian doctors and hospitals are mostly voluntary, based on suspicion of a connection between an illness or injury and a vaccination, Ellenberg told Congress.
Doctors and others are encouraged to file a report, known as a VAERS-1, even when they aren't sure there's a cause and effect, she said. That's because VAERS requires as many reports of problems as possible, so experts can identify possible patterns and investigate further, she said.
GENERALS' TESTIMONY PROMISED REPORTS
During the same congressional hearing, Lt. Gen. G. Robert Claypool - then the deputy assistant secretary of defense for health operations policy - assured Congress that military doctors, hospitals and medical officials were filing VAERS-1 forms, too.
And, he said, they were expected to report even more cases than civilians - including all hospitalizations.
"The duty to report adverse medication events has been codified for many years," Claypool testified. "The joint regulation requires submission of a form VAERS-1 for all adverse events resulting in more than 24 hours of lost duty time or any period of hospitalization. These requirements represent a higher standard than in comparable civilian community health care settings."
There was no mention that the word "all" didn't mean all hospitalizations.
Two months later, Lt. Gen. Ronald R. Blanck, then the Army's surgeon general and the top Pentagon official responsible for the anthrax vaccine program from 1998 to 2000, gave similar assurances to Congress.
He said, "We have a reporting system that when either of those two criteria are met, that is, either a patient is hospitalized following an anthrax immunization or misses duty because of it for greater than 24 hours, we have an active reporting system. That must be reported to us. We, in turn, report it to the Food and Drug Administration, and they have a group that reviews those reactions."
Clay and other congressional aides say these assurances came in private, too. "We had lengthy conversations that they were supposed to report," she said.
But the numbers reported were very low. And the Pentagon stuck with them for years to persuade the public that the shot was safe.
In December 2003, Pentagon officials conducted a news conference to rebut a judge's ruling that the shots had been given illegally and that troops had been used as "guinea pigs." Grabenstein was asked whether he had "any data on the numbers of people who have had bad adverse reactions to the vaccine and would have required hospitalization."
He said that only 69 hospitalizations had been reported to VAERS for the anthrax vaccine from 1998 through 2000. A panel of civilian experts had analyzed each, he said, and decided that 11 were results of the shot. The 69 cases were "a complete, exhaustive list of what was reported," Grabenstein said.
Grabenstein told the Daily Press that his statement wasn't misleading. He said no one should expect all hospitalizations after vaccination to be reported to VAERS - despite the Pentagon's written policies - because the number included cases unrelated to the vaccine, sometimes years after vaccination.
He said, "The simple answer is it's so obvious, it's never appeared in the memo."
NO EXCEPTIONS NOTED IN POLICY MEMOS
The memo, "Policy for Reporting Adverse Events Associated With the Anthrax Vaccine," serves as the standing order for all military personnel. It reads: "For the purposes of reporting anthrax vaccine adverse events, a Form VAERS-1 must be completed and submitted using service reporting procedures for those events resulting in a hospital admission or time lost from duty for greater than 24 hours or for those events suspected to have resulted from contamination of a vaccine lot."
The memo lists additional circumstances requiring a report, but nothing that would permit excluding hospitalizations after vaccination. It refers to the Pentagon's formal regulations, which don't include the exclusions that Grabenstein cited.
The data on all hospitalizations after anthrax vaccination comes from the Pentagon's Defense Medical Surveillance System, or DMSS. This computerized tracking system pulls medical records for every shot, clinic visit, hospitalization or other instance of medical treatment for active-duty military personnel.
Experts in health care and statistics say it's one of the most important medical databases in the world. That's because of its precision, its millions of patients, and the diversity of drugs and vaccines used by the armed forces. By design, it's more complete and accurate than VAERS. Unlike VAERS, its data isn't open to the public.
EXPERTS: NO EXCUSE FOR SECRET DATA
The Institute of Medicine report that Grabenstein cited as supporting the vaccine's safety and his decision to end the quarterly monitoring program also says the DMSS database should be open to researchers outside the government, with precautions to protect the privacy of individuals' health records.
This hasn't been done. Grabenstein said the military had not been able to figure out how to protect individuals' health records and make it work.
Strom of the institute panel and other experts say it should not be that difficult. "There's no excuse," he said. "We use these kinds of data sets in Medicaid and Medicare data all the time. There are technological solutions."
Cowan, another member of the panel, said the institute's recommendation was based, in part, on the military saying it couldn't afford all the analysis that the data was good for: "That way, you get the most of what the American people have invested in."
Strom said keeping the data from the public only bolstered the perception that the military was hiding the truth about the vaccine.
Walter Schumm is a professor of family studies and an expert on statistical methods at Kansas State University. He said he and other researchers would love to get the DMSS data. He's a retired Army colonel who's spent more than a decade using statistical analysis to examine the vaccine's safety - after friends and others in uniform began complaining about health problems after the shots.
Schumm has used other data made public on the anthrax vaccine to publish several scientific papers that poke holes in the safety assertions made by Pentagon doctors and researchers.
Good science involves people with different approaches to the same problem having a chance to test their theories, Schumm and others say. Their findings might cement the safety assertions, he said, but no one knows for sure until the military loosens its hold on the facts and data.
He said, "If you let independent people have the data, you risk losing control. In combat, letting things get out of control gets people killed, so loss of control is a very sensitive issue. I'm just sure they're trying to protect their program."
Despite promises that hospitalizations after anthrax vaccinations would be reported, the Pentagon withheld data on more than 20,000 cases.
BY BOB EVANS
December 4, 2005
Daily Press - Hampton Roads, Virginia
First of four parts
bevans@dailypress.com
The Pentagon never told Congress about more than 20,000 hospitalizations involving troops who'd taken the anthrax vaccine, despite repeated promises that such cases would be publicly disclosed.
Instead, a parade of generals and Defense Department officials told Congress and the public that fewer than 100 people were hospitalized or became seriously ill after receiving the shot from 1998 through 2000.
They also showed Congress written policies that required public reports to be filed for hospitalizations, serious illnesses and cases where someone missed 24 hours or more of duty.
But only a sliver of those cases were reported, while the rest were withheld from Congress and the public, records obtained by the Daily Press show.
Critics of the vaccine, veterans' advocates and congressional staffers say the Pentagon's deliberate low-balling of hospitalizations helped persuade Congress and the public that the vaccine was safe.
Keeping the actual number of illnesses secret contributed to a shorter list of government-recognized side effects for the drug, giving patients and physicians a false idea of what might constitute a vaccine-related illness or problem. Doctors are expected to know the full list of side effects and alert federal drug safety officials whenever they see a repeat of those symptoms.
Repeated evidence of the same adverse side effect after a vaccination is one of the most telling signs of a systematic problem with a drug or vaccine, as opposed to a coincidental relationship, vaccine safety experts say.
During the Daily Press' investigation of the vaccine and its effects, the newspaper found three cases of amyotrophic lateral sclerosis - ALS, or Lou Gehrig's disease - that the military hadn't reported. The disease destroys muscles and nerves, is always fatal and rarely hits people younger than 45.
One of the three cases involves Navy Capt. Denis Army of Virginia Beach. Army died in 2000, after developing symptoms less than a week after his first anthrax vaccination - and a few days before his 45th birthday. His widow filed the first public acknowledgement of his death and its temporal connection to the vaccine this year. That occurred after she talked to a Daily Press reporter and learned that she could file a report with the federal Vaccine Adverse Event Reporting System, or VAERS.
SAILOR'S DEATH NOT REPORTED BY MILITARY
Navy Petty Officer 2nd Class Kristin Shemeley died of ALS in 2001, at 29. Her symptoms began about two months after her third shot, a sworn legal document detailing her illness says.
Before Shemeley died, she spent 14 months in Walter Reed Army Medical Center in Washington, where she was regularly visited by high-ranking military officers, said her mother, Ginger Shemeley of Quakertown, Pa. She says her daughter repeatedly told those generals and admirals that she was suffering because of the vaccine and even pleaded with one of them to stop giving it to troops. Several of those generals and admirals had promised Congress that such cases would be publicly reported to VAERS.
The military never filed a VAERS report on Kristin Shemeley. Ginger Shemeley filed one after her daughter died.
Col. John Grabenstein, director of the military's vaccine agency, said no one from the military intentionally misled Congress or the public. He said the 20,765 hospitalizations merely followed vaccinations in time, without documented proof of a cause-and-effect relationship.
He said a statistical analysis showed that those who'd been vaccinated weren't more likely to be hospitalized or likely to seek medical treatment than those in the military who hadn't been vaccinated from 1998 through 2000.
Some medical experts say this approach doesn't adequately address the problems of many people who report illnesses after anthrax vaccination. That's because the approach is limited to comparing rates of illness involving one symptom or disease - instead of the complex combination of symptoms and illnesses that many veterans report after getting their shots.
The data that the Daily Press used to document the underreporting of hospitalizations came from a report that Grabenstein supplied in response to the newspaper's request. It's never been made public until today.
It covers 1998 through 2000, when the Pentagon did detailed evaluations every three months to compare hospitalizations, clinic visits and medical treatment data for those who'd been vaccinated, compared with troops who hadn't. This quarterly analysis stopped and hasn't been done since, Grabenstein said.
The practice of not reporting all hospitalizations continues.
Quarterly analysis of the vaccine's effects ended just as the nation's only manufacturing site for the drug regained its license. That was in 2002, after federal inspections found many safety and other problems that prompted a shutdown and renovation that began in early 1998.
The company's current manufacturing techniques provide greater potency compared with earlier versions of the drug, said the Government Accountability Office, Congress' investigative arm. The manufacturer, BioPort Inc., says there's no difference in the drug made since 2002 that might cause health problems.
TOP GENERAL NOT TOLD MONITORING TO END
The decision to discontinue the quarterly health monitoring program means that the biggest gap in research about the vaccine remains: There are no systematic long-term studies of the health of those who've taken the drug. Most studies that the Pentagon cites as support for the vaccine's safety involve monitoring that lasted days to a few months.
None lasted as long as five years, the minimum length of time recommended by a nationally recognized panel of scientists assembled by the Institute of Medicine in 2002. The institute is a nonprofit organization that provides expert advice to Congress and other government agencies.
After the quarterly reviews of the vaccine's effects stopped, more than a million troops were forced to take the vaccine - until a federal judge ruled last year that the drug had never been adequately licensed for protection against anthrax use in warfare.
He ordered the military to make vaccination voluntary. The Pentagon is appealing that ruling. Lawyers argued the case Thursday, and a decision is expected by February.
VACCINE MONITORING STILL IMPORTANT
Grabenstein said he decided to halt the quarterly studies after consulting the chairman of the Institute of Medicine panel and its staff, and with doctors affiliated with the military. He acknowledged that he didn't consult the general who ultimately was responsible for the anthrax program.
The chairman of the institute panel, Brian Strom, said he didn't recall what was discussed at the time about the quarterly reports. But he said, "I think they should continue to be using it," in case there's a problem.
Another panel member, Linda Cowan, said she's sure the committee expected quarterly reviews to continue and pointed to a number of the panel's recommendations and findings that she said clearly contradicted Grabenstein's interpretation of its report.
Strom and Cowan emphasized that they thought the vaccine was still safe.
Beth Clay isn't so sure. She directed the staff of Congress' House Government Reform Committee investigation into the anthrax vaccine from 1998 to 2001. She continued working on the subject as a congressional staff member through 2003, after her Republican boss was no longer chairman of the committee.
Clay said the military's decision not to report all the hospitalizations gave the public and Congress a rosier picture of the vaccine than it deserved.
"We were never given this data," she said. "Had we seen this, the committee would have had significant questions" and would have demanded more information about the program.
After reviewing the report obtained by the Daily Press, Clay said it raised several questions about the vaccine's safety. She said Congress was never told about the detailed level of data in the report but was assured regular monitoring of the vaccine and its health effects would continue.
Terminating the quarterly reviews would seem to break those promises, she said. "It's just appalling that they didn't keep up with this," she said.
LINK BETWEEN VACCINE, HOSPITALIZATIONS?
Steve Robinson is executive director of the National Gulf War Resource Center, a lobbying and advocacy group for veterans. He said he was stunned when he learned that the reviews had stopped: "They track the flu vaccine and not the anthrax vaccine, which is totally crazy to me."
He said discovery of the hospitalization data showed that the Pentagon couldn't be trusted to monitor the vaccine's safety.
"You can't let Enron investigate Enron, and you can't let DOD (the Department of Defense) investigate DOD," he said. "We work with the people who have been hurt by this vaccine every day."
No one knows how many, or how few, of the 20,765 hospitalizations are directly attributable to the vaccine. Ruling out certain illnesses, such as broken bones or injuries from falls or other accidents, might appear a safe bet. But military doctors have documented cases where broken bones and other injuries from falling were the result of vaccine-induced loss of consciousness affecting the nervous system - sometimes beginning mon thsaftervaccination.BRBRThe difficulty of figuring out what's related and what isn't is why safety officials encourage people to file reports even if they're not sure.
WHY PENTAGON DIDN'T FILE HOSPITAL REPORTS
Still, medical experts consulted by the Daily Press said it's unlikely that the vast majority of the 20,765 hospitalizations resulted from the vaccine. They said that if all hospitalizations had been filed with VAERS, it would have overloaded the system and caused problems for experts trying to analyze the data.
Grabenstein said those were among the reasons that the full number of hospitalizations was not reported. Another reason, he said, was that examinations of the data showed that if there were adverse effects from the vaccine, they were so infrequent, they weren't detectable by statistical analysis. Doing this type of analysis - instead of simply reporting the incidents to VAERS - provided a more definitive look at the health effects of the vaccine, he said. As a result, "we decided not to file" public reports about all hospitalizations, he said.
Those considerations weren't relayed to Congress or the public.
During the years covered by the hospitalization report obtained by the Daily Press, dozens of sick veterans who'd received the shot went to Capitol Hill, complaining of various health problems. Some got the shot for the 1991 Persian Gulf War, in which the vaccine had its first widespread use. Others were members of the military forced to take the shots under a mandatory program that began in 1998.
Their complaints had common themes: Fatigue. Chronic pain in joints and other symptoms of arthritis. Tingling in their feet, arms and hands. Mental lapses. Often, more than one of the symptoms were present, making diagnoses difficult.
Sympathetic doctors testified that these complaints were indicative of autoimmune problems, in which the body's natural protective mechanisms go haywire and start attacking healthy cells and tissue. The doctors said that could result if the vaccine overstimulated the vets' immune systems. The vaccine primes the system to develop protection against anthrax.
Bewildered and sometimes-angry members of Congress asked how many vets were affected. Pentagon doctors and generals used the cases reported to VAERS - fewer than 100 hospitalizations or other "serious events" from 1998 to 2000 - or said the number was so small, it couldn't be detected.
VACCINE REPORTS ARE FIRST LINE OF DEFENSE
The two sets of numbers for how many hospitalizations followed the shot come from a comparison of two sets of data kept by three federal agencies.
The Food and Drug Administration and the Centers for Disease Control and Prevention maintain the only database open to public inspection, VAERS. VAERS is the nation's first line of defense in identifying possible problems with vaccines after they've been licensed, said Susan Ellenberg, who led the FDA's efforts to monitor vaccine safety from 1993 to 2004.
During congressional testimony before the House Government Reform Committee's Subcommittee on National Security, Veterans Affairs and International Relations in July 1999, Ellenberg explained how and why the system worked.
VAERS was established to help identify and head off problems once a vaccine is licensed and more people are taking it, she said. The few hundred people typically involved in vaccine or drug testing and licensing trials can't mimic the diversity of age, race, gender and other biologic variables encountered once the vaccine gets widespread public use, she explained.
Reports to VAERS by civilian doctors and hospitals are mostly voluntary, based on suspicion of a connection between an illness or injury and a vaccination, Ellenberg told Congress.
Doctors and others are encouraged to file a report, known as a VAERS-1, even when they aren't sure there's a cause and effect, she said. That's because VAERS requires as many reports of problems as possible, so experts can identify possible patterns and investigate further, she said.
GENERALS' TESTIMONY PROMISED REPORTS
During the same congressional hearing, Lt. Gen. G. Robert Claypool - then the deputy assistant secretary of defense for health operations policy - assured Congress that military doctors, hospitals and medical officials were filing VAERS-1 forms, too.
And, he said, they were expected to report even more cases than civilians - including all hospitalizations.
"The duty to report adverse medication events has been codified for many years," Claypool testified. "The joint regulation requires submission of a form VAERS-1 for all adverse events resulting in more than 24 hours of lost duty time or any period of hospitalization. These requirements represent a higher standard than in comparable civilian community health care settings."
There was no mention that the word "all" didn't mean all hospitalizations.
Two months later, Lt. Gen. Ronald R. Blanck, then the Army's surgeon general and the top Pentagon official responsible for the anthrax vaccine program from 1998 to 2000, gave similar assurances to Congress.
He said, "We have a reporting system that when either of those two criteria are met, that is, either a patient is hospitalized following an anthrax immunization or misses duty because of it for greater than 24 hours, we have an active reporting system. That must be reported to us. We, in turn, report it to the Food and Drug Administration, and they have a group that reviews those reactions."
Clay and other congressional aides say these assurances came in private, too. "We had lengthy conversations that they were supposed to report," she said.
But the numbers reported were very low. And the Pentagon stuck with them for years to persuade the public that the shot was safe.
In December 2003, Pentagon officials conducted a news conference to rebut a judge's ruling that the shots had been given illegally and that troops had been used as "guinea pigs." Grabenstein was asked whether he had "any data on the numbers of people who have had bad adverse reactions to the vaccine and would have required hospitalization."
He said that only 69 hospitalizations had been reported to VAERS for the anthrax vaccine from 1998 through 2000. A panel of civilian experts had analyzed each, he said, and decided that 11 were results of the shot. The 69 cases were "a complete, exhaustive list of what was reported," Grabenstein said.
Grabenstein told the Daily Press that his statement wasn't misleading. He said no one should expect all hospitalizations after vaccination to be reported to VAERS - despite the Pentagon's written policies - because the number included cases unrelated to the vaccine, sometimes years after vaccination.
He said, "The simple answer is it's so obvious, it's never appeared in the memo."
NO EXCEPTIONS NOTED IN POLICY MEMOS
The memo, "Policy for Reporting Adverse Events Associated With the Anthrax Vaccine," serves as the standing order for all military personnel. It reads: "For the purposes of reporting anthrax vaccine adverse events, a Form VAERS-1 must be completed and submitted using service reporting procedures for those events resulting in a hospital admission or time lost from duty for greater than 24 hours or for those events suspected to have resulted from contamination of a vaccine lot."
The memo lists additional circumstances requiring a report, but nothing that would permit excluding hospitalizations after vaccination. It refers to the Pentagon's formal regulations, which don't include the exclusions that Grabenstein cited.
The data on all hospitalizations after anthrax vaccination comes from the Pentagon's Defense Medical Surveillance System, or DMSS. This computerized tracking system pulls medical records for every shot, clinic visit, hospitalization or other instance of medical treatment for active-duty military personnel.
Experts in health care and statistics say it's one of the most important medical databases in the world. That's because of its precision, its millions of patients, and the diversity of drugs and vaccines used by the armed forces. By design, it's more complete and accurate than VAERS. Unlike VAERS, its data isn't open to the public.
EXPERTS: NO EXCUSE FOR SECRET DATA
The Institute of Medicine report that Grabenstein cited as supporting the vaccine's safety and his decision to end the quarterly monitoring program also says the DMSS database should be open to researchers outside the government, with precautions to protect the privacy of individuals' health records.
This hasn't been done. Grabenstein said the military had not been able to figure out how to protect individuals' health records and make it work.
Strom of the institute panel and other experts say it should not be that difficult. "There's no excuse," he said. "We use these kinds of data sets in Medicaid and Medicare data all the time. There are technological solutions."
Cowan, another member of the panel, said the institute's recommendation was based, in part, on the military saying it couldn't afford all the analysis that the data was good for: "That way, you get the most of what the American people have invested in."
Strom said keeping the data from the public only bolstered the perception that the military was hiding the truth about the vaccine.
Walter Schumm is a professor of family studies and an expert on statistical methods at Kansas State University. He said he and other researchers would love to get the DMSS data. He's a retired Army colonel who's spent more than a decade using statistical analysis to examine the vaccine's safety - after friends and others in uniform began complaining about health problems after the shots.
Schumm has used other data made public on the anthrax vaccine to publish several scientific papers that poke holes in the safety assertions made by Pentagon doctors and researchers.
Good science involves people with different approaches to the same problem having a chance to test their theories, Schumm and others say. Their findings might cement the safety assertions, he said, but no one knows for sure until the military loosens its hold on the facts and data.
He said, "If you let independent people have the data, you risk losing control. In combat, letting things get out of control gets people killed, so loss of control is a very sensitive issue. I'm just sure they're trying to protect their program."
Cardiologist Criticizes Merck Behavior
Cardiologist Criticizes Merck Behavior
By THERESA AGOVINO
AP Business Writer Sat Dec 3, 6:12 PM ET
HOUSTON - A prominent cardiologist testifying against Merck & Co. accused the drugmaker Saturday of engaging in scientific misconduct, suppressing clinical evidence and stifling medical discourse as it promoted the painkiller
Vioxx.
Dr. Eric Topol, chairman of the cardiovascular medicine department of the Cleveland Clinic, called certain aspects of Merck's behavior "repulsive" and "appalling" during his three-hour videotaped deposition.
Topol said Vioxx can cause heart attacks any time after a patient begins taking it, and that its risks were apparent as early as 1999, when the drug was approved. Vioxx was removed from the market last year after a study showed it doubled patients' risk of heart attacks and strokes after 18 months of use.
"Vioxx's risk has been evident since trails were conducted in 1999 and all the way through the time of withdrawal in September 30, 2004," Topol said.
This is the first federal trial over Vioxx; Merck has already lost one state trial over the drug and won another, but it still faces about 7,000 lawsuits and analysts estimate its liability could reach $50 billion.
The jurors who heard Topol's testimony Saturday will be asked to decide if the drug contributed to the fatal heart attack suffered by Richard "Dicky" Irvin in May 2001. The 53-year old former manager of a seafood wholesaler had been taking Vioxx for about a month for back pain.
Merck argues that the drug wasn't responsible for Irvin's death, saying problems with Vioxx surface after 18 months of use, not one month, and alleging that plaque in Irvin's artery ruptured and caused the heart attack, not the drug.
Both sides in the case are under a gag order.
Topol said the concerns about Vioxx caught his eye after he read an article about a study released by Merck in 2000 that found patients taking Vioxx had five times the rate of heart attacks as those taking naproxen, another pain reliever. In the article, Merck explained differences found in that study by saying naproxen is cardioprotective. Topol said naproxen wasn't associated with such properties.
"To all of a sudden ascribe some type of magical protective effect (to naproxen) without any basis is not acceptable," he said.
When he compared the U.S.
Food and Drug Administration records of the study with the data in the
New England Journal of Medicine article, Topol said he found several discrepancies. In particular, he said, the number of deaths and heart attacks were higher in the FDA data. He called the discrepancies "scientific misconduct."
Topol also said that the company had conducted a trial in 1999 comparing Vioxx to a placebo and nabumetone, another pain reliever, that found Vioxx caused a "760 percent excess rate of heart attacks," but that the study was never published.
In 2001, as Topol was preparing to have published an article he had written highlighting cardiovascular risk from Vioxx, he received a visit from Dr. Alise Reicin, vice president of clinical research at Merck Research Labs.
According to Topol, Reicin told him he would be "embarrassed" if he published the article because he didn't have all the data.
After the article was published, he said, Merck sent letters to doctors all over the country saying his analysis was wrong. He was said Merck also attempted to "trash" others who criticized Vioxx.
Topol also testified that Merck's former chairman Raymond Gilmartin approached the chairman of the Cleveland Clinic to complain about his frequent criticism of Vioxx. Topol referred to that action as "repulsive."
Topol, who subpoenaed by the plaintiff to testify, declined to comment Saturday but through a spokeswoman said he only wants to be an advocate for scientific integrity and patient safety and doesn't want to be involved in litigation.
Merck filed a motion to exclude Topol's deposition but only succeeded in getting certain parts eliminated from what the jury saw. For example, at one point during the deposition, Topol read an e-mail he wrote to a colleague which said he was "bothered by the continued outrageous lies of Merck with their full page, multiple ads that 'they publish everything'...."
By THERESA AGOVINO
AP Business Writer Sat Dec 3, 6:12 PM ET
HOUSTON - A prominent cardiologist testifying against Merck & Co. accused the drugmaker Saturday of engaging in scientific misconduct, suppressing clinical evidence and stifling medical discourse as it promoted the painkiller
Vioxx.
Dr. Eric Topol, chairman of the cardiovascular medicine department of the Cleveland Clinic, called certain aspects of Merck's behavior "repulsive" and "appalling" during his three-hour videotaped deposition.
Topol said Vioxx can cause heart attacks any time after a patient begins taking it, and that its risks were apparent as early as 1999, when the drug was approved. Vioxx was removed from the market last year after a study showed it doubled patients' risk of heart attacks and strokes after 18 months of use.
"Vioxx's risk has been evident since trails were conducted in 1999 and all the way through the time of withdrawal in September 30, 2004," Topol said.
This is the first federal trial over Vioxx; Merck has already lost one state trial over the drug and won another, but it still faces about 7,000 lawsuits and analysts estimate its liability could reach $50 billion.
The jurors who heard Topol's testimony Saturday will be asked to decide if the drug contributed to the fatal heart attack suffered by Richard "Dicky" Irvin in May 2001. The 53-year old former manager of a seafood wholesaler had been taking Vioxx for about a month for back pain.
Merck argues that the drug wasn't responsible for Irvin's death, saying problems with Vioxx surface after 18 months of use, not one month, and alleging that plaque in Irvin's artery ruptured and caused the heart attack, not the drug.
Both sides in the case are under a gag order.
Topol said the concerns about Vioxx caught his eye after he read an article about a study released by Merck in 2000 that found patients taking Vioxx had five times the rate of heart attacks as those taking naproxen, another pain reliever. In the article, Merck explained differences found in that study by saying naproxen is cardioprotective. Topol said naproxen wasn't associated with such properties.
"To all of a sudden ascribe some type of magical protective effect (to naproxen) without any basis is not acceptable," he said.
When he compared the U.S.
Food and Drug Administration records of the study with the data in the
New England Journal of Medicine article, Topol said he found several discrepancies. In particular, he said, the number of deaths and heart attacks were higher in the FDA data. He called the discrepancies "scientific misconduct."
Topol also said that the company had conducted a trial in 1999 comparing Vioxx to a placebo and nabumetone, another pain reliever, that found Vioxx caused a "760 percent excess rate of heart attacks," but that the study was never published.
In 2001, as Topol was preparing to have published an article he had written highlighting cardiovascular risk from Vioxx, he received a visit from Dr. Alise Reicin, vice president of clinical research at Merck Research Labs.
According to Topol, Reicin told him he would be "embarrassed" if he published the article because he didn't have all the data.
After the article was published, he said, Merck sent letters to doctors all over the country saying his analysis was wrong. He was said Merck also attempted to "trash" others who criticized Vioxx.
Topol also testified that Merck's former chairman Raymond Gilmartin approached the chairman of the Cleveland Clinic to complain about his frequent criticism of Vioxx. Topol referred to that action as "repulsive."
Topol, who subpoenaed by the plaintiff to testify, declined to comment Saturday but through a spokeswoman said he only wants to be an advocate for scientific integrity and patient safety and doesn't want to be involved in litigation.
Merck filed a motion to exclude Topol's deposition but only succeeded in getting certain parts eliminated from what the jury saw. For example, at one point during the deposition, Topol read an e-mail he wrote to a colleague which said he was "bothered by the continued outrageous lies of Merck with their full page, multiple ads that 'they publish everything'...."
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