21-Year Study of Children Set to Begin

October 28, 2008
21-Year Study of Children Set to Begin

By KATE MURPHY
After nearly a decade of planning, researchers will begin recruiting pregnant women in January for an ambitious nationwide study that will follow more than 100,000 children from before birth until age 21.

The goal of the federally financed project, the National Children’s Study, is to gain a better understanding of the effects of a wide array of factors on children’s health.

“What we are doing is bold and needs to be bold in order to answer some pressing questions,” said the study’s director, Dr. Peter C. Scheidt, a pediatrician on the staff of the child-health division of the National Institutes of Health.

Investigators hope to find explanations for the rising rates of premature births, childhood obesity, cancer, autism, endocrine disorders and behavioral problems. To that end, they will examine factors like genetics and child rearing, geography, exposure to chemicals, nutrition and pollution.

While few quarrel with the goal, some experts worry that the expansive project will take resources away from smaller and more focused perinatal and pediatric research, particularly when budgets are certain to be strained by the financial crisis. The total cost is estimated to be $2.7 billion.

Participating mothers and children (fathers will be encouraged but not required to take part) will be given periodic interviews and questionnaires. They will further be asked to submit samples of blood, urine and hair. Air, water and dust from their environments will also be sampled and tested.

“Something like this has never been done in this country,” said a principal investigator for the study, Dr. Philip J. Landrigan, professor and chairman of community and preventive medicine at Mount Sinai School of Medicine in Manhattan. “It’s past time for us to do this.”

Studies of comparable size and scope are under way in Britain, Denmark and Norway.

Conceived during the Clinton administration and authorized by the Children’s Health Act of 2000, the National Children’s Study is being led by a group of federal agencies. Besides the health institutes, they are the Department of Health and Human Services, the Centers for Disease Control and Prevention, the Environmental Protection Agency and the Department of Education.

Since 2000, more than 2,400 health care, environmental and technology professionals have met in panels for hundreds of hours to work out such details as sampling methodology, data collection and privacy protection.

Subjects will be chosen from 105 counties to achieve a representative mix of racial, ethnic, religious, social, cultural and geographic characteristics. Forty regional centers will administer the study — mostly well-known medical institutions like Mount Sinai, the University of North Carolina School of Medicine and the University of Texas Health Science Center-Houston.

Dr. Russ Hauser, a professor of environmental and occupational epidemiology at the Harvard School of Public Health who served on a National Academy of Sciences committee that reviewed the study’s design, said the study would be “worthy and feasible” as long as it was properly financed.

But other experts questioned whether it was worth the cost. “The question isn’t whether the goals can be accomplished,” said Dr. Arthur Reingold, professor of epidemiology at the School of Public Health at the University of California, Berkeley. “It’s more a question of is this the best use of almost $3 billion, particularly when it will inevitably take funding from other research, especially with the economy falling to pieces.”

Researchers involved in the study counter that it will more than pay for itself by leading researchers to the causes or contributing factors for so many childhood disorders. Dr. Landrigan said a “dress rehearsal” of the study, which began in 2001 with 1,500 subjects from New York and California, has already shown that pregnant women exposed to organophosphates in pesticides were more likely to have babies with small brains and impaired cognition.

Another concern is that the study’s advisory board — which is choosing the chemical exposures to be studied — includes scientists from 3M and Pfizer, who have apparent conflicts of interest.

But Richard Wiles, executive director of the nonprofit Environmental Working Group, said that since there were only 2 such scientists among the board’s 33 members, he hoped they would not have undue influence.

Copyright 2008 The New York Times Company

Too bad it'll take 20, well actually more than that, what, 25 years, for any result. I could see this not being executed very well and disputed. I also can see it as a way to lessen the blow of blame for later when it's too late. We'll all be sitting and reading our papers 20 years from now saying, "Why did they waste time and money on stuff that we already knew?". Kind of like the tobacco industry. I am still amazed by articles that are still published about the dangers of tobacco. It breaks my heart that they could approve that sum of money for that rather than helping today's generation of children.

Mommy Guilt

I was at my town's allergy support group yesterday. I don't go to these support groups very often anymore, but I knew my friend Carol that's on the wellness committee would be there, figuring we could connect. At one point people were talking about how their child had "grown out" of a certain allergy. I didn't say a word about that and just listened (still hard to hear), but instead tried to focus on my own response to what parents shared.

When it was my turn to share, I said fortunately we only need to consider one food gluten. The mom asks me how many allergies my kid had before, so I quickly summarized by saying he had started out with 9 food allergies and 11 environmental, and didn't say ANYTHING else. Not that I have all the answers, but success with alternative treatments is something people have to WANT to hear.

A few moms stared, and said, "how did you do it"? Surprised by the interest, I said, well, I healed my son through food and supporting the immune system rather than medicine. They pressed on and asked for more details, so I gave the top line answer of organic, whole foods, fish oil, blah blah and today with homeopathy and detox. I was very brief.

They asked about testing, and I said we used it mostly as a loose guideline of where to go, but that we used IgG levels. They were very impressed, and one mom said they had used bioset. I said we love bioset and were successful with that too. They said it was inspirational to hear a positive story.

On the other hand, the group leader totally got agitated and went on a rampage about her "renowned doctor, head of what have you" says IgG is useless. I didn't have any reaction whatsoever. I just politely listened to her internal guilt and struggle she had with her choices. I think I've really mellowed.

This mom also happens to be an autism mom. I've had one big parking lot discussion with her a couple years ago, and she basically passed on advocating for an autism program for him because of the "cost" to the older sibs and family lifestyle. I offered my help to go to her IEP meeting, etc. She declined and said, "We all have to make hard choices" , which I accepted. But that was then, and today I wasn't even sure she remembered me since I don't go routinely.

It was nice walking out of there without taking on the energy of this mom that clings to her choices because she'd rather be right than accept that others have had success trying things she hasn't. I walked out friendless, but I was at peace.

The New Strep and the Role of Prevnar, a Vaccine

October 14, 2008
Worrisome Infection Eludes a Leading Children’s Vaccine

By LAURA BEIL
A highly drug-resistant germ has become a common cause of meningitis, pneumonia and other life-threatening conditions in young children. The culprit — a strain of strep bacteria — can conquer almost all antibiotics in pediatrics, and has dodged a vaccine otherwise credited with causing the number of serious infections in children to plummet.

Since 2000, American toddlers have been immunized against Streptococcus pneumoniae, or pneumococcus, an organism that preys largely on children younger than 5 and the elderly. Pneumococcal meningitis can be fatal, and survivors are often left with deafness and other lifelong neurological problems.

And by most measures, the vaccine has worked: by 2002, rates of infection from these bacteria had dropped as much as 80 percent in some places. But progress has now stalled, and infection with a particular type of pneumococcus, Serotype 19A, is steadily rising.

“It’s very much a concern,” said Bernard Beall, a pneumococcal expert at the federal Centers for Disease Control and Prevention. Last year, in The Journal of the American Medical Association, pediatricians described an outbreak of Serotype 19A ear infections in Rochester that could be cured only by surgically implanting tubes, or by turning to adult medicines not yet tested for safety in children.

A greater worry, however, is the frequency of meningitis, pneumonia and bloodstream infections from Serotype 19A. Since 2001, rates of these and other invasive pneumococcal diseases have crept upward, to more than 10 per 100,000 children from about 2 per 100,000. A fourfold increase in life-threatening infections has also occurred among the elderly.

The vaccine, Prevnar, is aimed at seven types of bacteria that were responsible for 70 to 80 percent of pneumococcal illness during the 1990s. Because pneumococci come in 91 forms, experts have worried from the start whether bacteria that were just as deadly, but not wiped out by the vaccine, might move in as opportunists when the competition suddenly vanished.

“Nature abhors a vacuum,” said Dr. Steven Black of Cincinnati Children’s Hospital. Indeed, almost all pneumococcal infections among American children today are caused by versions not covered by the vaccine, and 19A is leading the way. “People hoped against hope it wouldn’t happen,” he said.

The vaccine’s manufacturer, Wyeth, says it has been working quickly to develop a new product to counter 19A and five other pneumococcal variations, along with the original seven. The company will release results of the first large studies of the newer version this month at an infectious disease meeting in Washington.

“There was no point where we said to ourselves, ‘We missed it, we need to put in 19A,’ ” said Emilio A. Emini, head of vaccine research and development for Wyeth. The company was always prepared to remake the product, he said.

Once a new vaccine demonstrates that it can protect against pneumococcus, it must work its way through the approval process — passing tests of effectiveness and safety — before it can be licensed. Researchers will also try to determine whether young children who have been immunized with the old Prevnar should be revaccinated to protect themselves from 19A.

The remodeling of a vaccine so soon after its approval is highly unusual, but so was the effort to tackle pneumococcus.

The bacteria live in the nose and throat, usually as microbial freeloaders of no consequence. Occasionally — often after a simple viral infection — pneumococci slip into inner areas of the body and cause disease. Weaker immune systems in the very young and the very old leave them most vulnerable. (The pneumonia shot in older people includes 19A, but many elderly people have not received the immunization.)

Not all of the 91 incarnations of pneumococcal bacteria are dangerous. They developed so much variety by mingling in the back of the throat, exchanging genetic material as eagerly as children trading Halloween candy. The variation in genes slightly alters how the bacteria function and how they are received by the immune system.

For vaccine manufacturers, pneumococci’s diversity presented a challenge: how to teach the immune system to recognize a target that may look a little different from child to child. “This is the most complex biological product ever made,” Dr. Emini said.

Serotype 19A was around in the 1990s, though uncommon, and the vaccine includes a similar version called 19F. The hope in 2000 was that 19F looked enough like 19A to set off an immune reaction. It did not.

Experts say it is hard to know what role the introduction of Prevnar may have played in the rise of the bacteria, which was gaining momentum in some countries before the vaccine’s adoption. For example, researchers from GlaxoSmithKline, which is introducing its own pneumococcal vaccine, reported last month that Serotype 19A became more common in Belgium from 2001 to 2004 — years when pneumococcal vaccination was rare in that country. Similar reports have emerged from China, South Korea and Israel.

Pneumococci ebb and flow in natural cycles, and some types have gained a survival advantage by growing resistant to a host of drugs. The vaccine may have simply amplified natural trends..

“I don’t think anyone can tell you the relative contributions of these factors,” said Dr. Sheldon L. Kaplan of Texas Children’s Hospital in Houston. This summer, he and his colleagues described a growing number of cases of drug-resistant mastoiditis, an infection of an inner-ear bone, from 19A.

Experts are now watching to see how forcefully the organism will spread before the new immunization arrives. Wyeth says it hopes to file an application with the Food and Drug Administration in 2009.

Disease experts also wonder what organisms like 19A mean for the future of pneumococcal infections. Public health experts once hoped the infection could be defeated, but it now appears that pneumococci may be playing a game of cat and mouse.

“The pneumococcus has shown an extraordinary ability to evolve to our strategies,” said Dr. Beall of the C.D.C.

Yet he and others are quick to say that immunization remains highly effective, even if it leaves some children behind. “This is not a failure of the vaccine,” said Dr. George H. McCracken Jr. of the University of Texas Southwestern Medical Center at Dallas. Even with the rise of 19A, children are much less likely to become ill from pneumococcal infections.

Dr. McCracken hopes that researchers will one day avoid threats like 19A entirely by developing a vaccine that primes the immune system to recognize some element common to all 91 types of pneumococci — in the way a quiche, an omelet and a custard pie are all versions of eggs. But until such an immunization comes along, he said, pediatricians will be forced to battle the pneumococcus as they always have, by trying to stay one strain ahead of its game.

Copyright 2008 The New York Times

This isn't suprising and very disturbing. I am at a loss of what to say here.

Screaming For Antibiotics, our Lyme Hell

Leo's younger sister Sydney most likely has Lyme. Although I've been immersed in her illness only since the beginning of September, it feels like ages. It's been very scary, a chronically ill child, not sleeping through the night, not knowing for sure what the hell is going on. But, it's been day 4 on Amoxycillin, and she seems like she's slowly getting better.

The second week of school she fell ill and stayed home all week with flu-like symptoms. My instinct told me this was something bigger than your run-of-the-mill illness. She had a fever that hovered between 101 and 102 for 5 days. It would break during the day, tricking me into thinking she was better. Her complaints were a pulsating frontal headache that would travel like a band around her head. A sore throat that felt like "sticks" inside. A sore chest, a stomach ache. Most bothersome were her arm and leg soreness, and neck pain. At this time she had no rash and no joint pain, the old school symptoms of Lyme. My instinct thought Lyme! I had heard of so many people with "atypical" symptoms that turned out to be NORMAL symptoms of Lyme that were like Sydney. My doctor said abdominal symptoms are not Lyme. I just stared at her, not starting a fight just yet. My doctor would only order a strep test that eventually came back negative, chalking it up to some other illness, probably viral.

Sydney got better after 6 days of being very sick, and I thought I was out of the woods. Ah, but what came FROM the woods.....
After a week of feeling better and no facial tics I was elated. I thought perhaps this virus pulled out whatever was the cause of her tics. But, slowly her arms and legs were sore on occasion, but then would go away. I thought maybe she had a small relapse, or maybe the virus was still making its exit. Getting worse and worse, all of her flu symptoms came back along with some of her facial tics. I felt overwhelmed and very panicky. My homeopathic remedies that once kept these symptoms at bay were no longer working.

As luck would have it I went to a Lyme seminar and got educated. Good timing, it was in my book for weeks. I was shocked to learn that within traditional western medicine there are two hotly debated camps about Lyme. One camp holds the original doctors that once thought Lyme was viral and were Rheumatoid Arthritis specialists. Their symptom checklist is very narrow, the bulls-eye rash, swollen joints, high fever. A short round of antibiotics does the trick, one-size-fits-all. This is whom the insurance companies and the CDC back because they don't want to pay for all the Lyme patients or their very long rounds of antibiotics. I thought hmm...., this must be the camp my pediatrician is in.

The other camp includes the chronic Lyme patients, the missed patients that went undiagnosed and untreated for sometimes years because they had different symptoms - migraine headaches, malaise, chronic fatigue, mental symptoms, psychiatric symptoms, and all of my daughter's symptoms. There it was on the list in black and white - abdominal pain, and even tics!

I also realized there were major arguments about testing instruments, and the CDC's survey test is what many doctors believe to be the accurate testing instrument, the Western Blot. It is actually not designed for diagnosis, but it's still used. Just crazy because it misses so many people. It also doesn't help that the spirochetes, the Lyme bacteria, are evasive and hide deep within the tissues. Antibodies are not always present, the bacteria change their coating, they make spores, really difficult creatures to catch.

I couldn't believe it. Here I was, an Autism mom that is so used to fighting traditional medicine. But now, I must figure out and fight within traditional medicine?

Realizing I was under the gun, I quickly went to the pediatrician that spoke, and she assessed my daughter and ordered a battery of testing from the "right" lab, IGeneX in Palo Alto, CA. I got on the phone and online, and after a week I read the latest book on Lyme, "Cure Unknown" by Pamela Weintraub, a science writer, a mom of 2 boys with Lyme, had Lyme herself, etc. Always the moms that figure this stuff out isn't it?? My first line of defense was to contact my Autism support group, the BEST group of moms I know, for their advice. Of course they came through and had the best info. Many kids with ASD have had Lyme, and have had these "atypical" symptoms that I found are NOT unusual at all. I don't know what I'd do without their support and caring. They email me to check on me, and I'm forever grateful.

I must admit that it was disappointing to see that I could not help my daughter with homeopathy. It's my passion, what I've been studying, and our first line of treatment for illness for years. In fact, Sydney has never been on antibiotics and rarely goes to the doctor because we've been able to treat her with remedies at home (with the consult of our homeopath). But, I must move on, and as much as I dislike the side-effects of antibiotics, they are really needed in this case. I feel guilty, but it's not logical. At least we know the damage, and I am giving her lots of probiotics and other support, including drainage remedies that are homeopathic.

Tic toc I am waiting for the results to come in. The irony is that I'm hoping for a positive test. Her CBC results were normal, so if it's not Lyme, we may have done the tests too soon or it could be something else. Scary. I hope I'm not in the position to where the meds don't work and I have to change them or fight for longer treatment. I'm working on finding an infectious disease person in my area that is willing to treat kids. Many of them have been sued or investigated by the CDC for their treatment of Lyme, so they've closed shop or moved. To think that peds give out antibiotics for so many things that aren't necessary like your garden variety ear infection, but when it comes to a major full-body infestation, you must beg and scream for antibiotics. You must find the right people, and like making a drug deal or something, figure it all out and try to get it covered by insurance.

The good news is that I know how to fight and I know how to research, the sliver lining of Autism.