SCHAFER AUTISM REPORT "Healing Autism:

No Finer a Cause on the Planet"

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Wednesday, December 18, 2002

RESEARCH

* Researchers at Rutgers Hope To Solve Autism Puzzle

* Body Language, Conversation And Environment Key To Communication

* COMMENTARY: Mercury And Autism: Washington Times Editorial

* New Evidence That Casein (Milk) Plays Role in Parkinson's in Men

PUBLIC HEALTH

* Debate Rages Over Safe Levels Of Toxin for Adults and Infants

* Combined 5 in 1 Vaccine Gets F.D.A. Approval

* Revealing Transcript of FDA Meeting over 5 in 1 Vaccine

AWARENESS

* 'Treating Disease With a Famous Face' Sniffs NY Times

* Full Page Ad Project Changes Hands

READERS' POSTS

RESEARCH

Researchers at Rutgers Hope To Solve Autism Puzzle

[Note: this is a non-standard URL – it ends with a "," - and will only work under Windows by cut-and-pasting into your browser.]

With autism legislation pending at the state level and grant money awarded to Rutgers for indexing images of the brain, scientists may crack the riddle of autism yet.

Research mapping brain patterns in patients with disorders such as autism is being implemented at Rutgers, The State University of New Jersey, to develop a new approach to indexing and comparing images of the brain.

A $2 million grant from the National Science Foundation will allow Rutgers’ researchers to compile living images of brain scans that physicians worldwide could access for diagnosis and treatment.

The state Department of Education explains autism as a complex developmental disability that typically appears during the first three months of life. It is caused by a neurological disorder that affects the functioning of the brain in the areas of social interaction and communications skills.

Incidents of autism have dramatically risen during the past decade. The rate of children diagnosed with autism in New Jersey increased 559 percent from 446 cases in 1992-1993 to 2,925 cases in 2000-2001. It is a pressing health problem with no apparent cause, according to researchers.

And according to the Center for Disease Control Web site, 53 infants are born daily in the United States who will be diagnosed with autism spectrum disorder this year, or roughly 19,000 infants per year.

Jennifer Desaye, child study county supervisor for the state Department of Education said the department formed a coalition on autism to study the increase in the incidence of the disorder and effect a curriculum for students.

“Both Vernon and Sparta school districts have recently implemented autistic programs within their special education program,” Desaye said.

Judy Geddis, child study supervisor for the Sparta school district said an explosion of students diagnosed with autistic spectrum disorder reached the district in 1999. A nationwide increase of 544 percent has spurred educators to identify autistic children and execute a core curriculum, she said.

“It really doesn’t matter what the cause of the disorder is,” said Geddis. “We must educate them."

Geddis said the district became aware of the glut of autistic children in 1999 and made plans to see what could be done to educate the increasing number of autistic students.

“They learn very differently,” she said. “They don’t learn by imitating behavior, like you or I. You have to teach them each step in a process, whether it’s brushing teeth or reading."

According to recent statistics from the CDC, one in 150 children suffer from autism spectrum disorder, which includes Aspergers Syndrome, a milder form of autism.

A 2001 CDC press release cited numerous law firms that are actively prosecuting cases alleging that a mercury preservative in children’s vaccines causes neurological damage to infants who are ultimately diagnosed with autism or autism spectrum disorder.

Ten law firms across as many states claim to have unreleased confidential CDC reports stating that mercury in children’s vaccines is a potential source of the neurological damage found in autism, it said.

Children are required by law to be inoculated by age five when they enter the school system. When asked if she thought mercury in children’s vaccines was a potential cause of the disorder, Geddis said, “I am not going there. All I know, at this point, is we have to teach these children."

A combination of factors may cause autism, according to the Autism Society of America Web site: Viral infections during pregnancy and birth, environmental factors, allergies, yeast and children’s vaccines.

State Assemblywoman Loretta Weinberg (D-Bergen) and fellow Assemblyman Matt Ahearn (D-Bergen) sponsored a bill that would add $1 surcharge to all highway litter violations for autism research.

The collected surcharges would be placed into an account labeled the “Autism Medical Research and Treatment Fund” for use by Gov. James E. McGreevey’s Council for Medical Research and Treatment of Infantile Autism.

“Autism is a perplexing disease that warrants much more in-depth and technologically advanced research,” said Weinberg. “The surcharge will generate funds to benefit autistic children while supplementing the appropriation of the governor’s council in the current budget."

Rutgers plans to index brain images using a functional magnetic resonance imaging (MRI) that would aid doctors in diagnosing and planning a course of treatment for patients with similar brain scans, says Paul Kantor, professor of library and information studies science at Rutgers’ School of Communication, Information and Library Studies in New Brunswick.

Millions of bytes of data from the brain would be transformed into moving images, allowing doctors to see how brain signals move across the brain.

“Scientists would greatly benefit from accessing these images, to look for patterns that might provide clues about the differences between a diseased brain and a normal brain,” said Kantor.

According to Kantor, the new research tools being developed are based on the brain’s activity. When a thought, emotion or sensation occurs in the brain, signals create a pathway through the brain’s neurons that are pictured by brain imaging techniques such as MRIs.

The complex chemistry of the brain camouflages the existing pathways, much as a vine is hidden by its leaves, said Kantor. The Rutgers research team aims to find the vine through the leaves filtering away the secondary signals and noise finding the original pathway.

A second component would match pathways similar to one another, he said, aiding doctors with diagnosis.

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Body Language, Conversation And Environment Key To Communication

Body language is often portrayed by the media as the key to understanding peoples' feelings, thoughts and behaviors. But according to new research by professors at the University of Colorado at Boulder and Brigham Young University, body language -- while important -- is only part of the interpersonal communication picture.

Focusing on body language alone in order to "mind-read" can cause serious misinterpretations, say CU-Boulder communication department Professor Stanley Jones and BYU Professor Curtis LeBaron.

The new perspective, they say, is that one has to read the total message, including how body language and spoken words fit together and how individuals synchronize their behavior with each other. Even the environment where the communication takes place can give special meaning to both body language and spoken words.

"Nonverbal communication, vocal conversation and the environment of personal exchanges play a large role in how people relate and communicate," said Jones. "But many academics in the communication field appear to be drawing more distinct lines between verbal and nonverbal communication."

As a result, Jones and LeBaron -- a former CU-Boulder communication department professor -- have written two articles and edited seven others that appeared in the September issue of international Journal of Communication.

The most effective method of understanding human communication is to videotape a conversation with the participants' consent and do a frame-by-frame analysis, said LeBaron, a business professor in BYU's Mariott School of Management. LeBaron uses videotapes of workplace interactions to help organizations improve communications.

"Emerging technology has been paramount in this line of research," said LeBaron. "We have moved from field notes to film and tape recorders to multimedia to better understand the spectrum of interpersonal communication."

The September issue of the Journal of Communication was sent out with CD-ROMS containing video clips that journal contributors used in case studies, said LeBaron. "This is very exciting, since it is the first time a journal has done this."

According to Jones, certain nonverbal behaviors signal different intentions. "Turn-requesting" behavior, for example, often involves a person seeking to speak leaning toward the speaker and nodding rapidly with direct eye contact. "What the person is signaling means 'I want my turn to talk,' " said Jones.

In contrast, "turn-suppressing" behavior often involves the speaker holding a hand in the air and keeping his or her voice tone at a higher pitch, he said. "Turn-relinquishing behavior involves the speaker finishing a sentence with a slow drawl, dropping his or her hand at the same time."

Successful turn-taking communication between speakers is the most valuable skill people in an organization can use to successfully communicate, said Jones.

One study in the special issue authored by LeBaron and Jones shows how people effectively close conversations. The person who needs to depart, for example, can signal his or her intentions by turning slightly to the side, perhaps inspecting a handbag or briefcase as if getting ready to leave while nodding enthusiastically with affirmatives but not contributing new content to the conversation, Jones said.

For the conclusion to be effective, the other person must catch on and do his or her part, perhaps saying, "Well, I better let you go," and getting up from the chair and getting ready to say good-bye. "The most positive departures require coordination of words and body language as well as synchronization between people," Jones said.

In another study in the special issue, British scholar Christian Heath examines videotapes of doctor-patient interactions. As patients describe their illness to a doctor, he shows, they often dramatize their condition by acting out the symptoms with facial expressions, gestures and body touching behaviors.

The idea, said Jones, is to prevent the doctor from rushing ahead to fill out a prescription before the patient's condition has been thoroughly diagnosed.

Both Jones and LeBaron at times take on private consulting work for business groups who perceive they have communication problems. Communication consultants often use tiny, inconspicuous video cameras set near conference tables with the knowledge of the employees, tape a session, and then break it down frame-by-frame and phrase-by-phrase to help employees improve their communication skills.

Physical touch also is a form of non-verbal communication that requires verbal communication to clarify meaning, said Jones, author of "The Right Touch" published in 1994, which was sponsored by the National Communication Association.

Appropriate, positive modes of workplace touch include appreciation touches, congratulatory touches, support touches and enthusiasm touches, Jones said.

"However, you can't tell what a touch means just by observing what part of the body is touched," Jones said. "A touch on the shoulder, for example, could have all of those meanings, depending on whether the toucher is saying 'thanks,' 'nice going,' 'hope you feel better,' or 'I'm really excited about today.'

"You really have to read the whole message, and not just a part of it," said Jones.

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Mercury And Autism: Washington Times Editorial

The descent is terrible, shocking: A bubbly, gregarious child slowly becomes mumbling and reclusive. Autism has set in. It's a tragic, incurable developmental disorder that now afflicts an estimated one in 500 children every year — up from one in 10,000 15 years ago.

Is there an explanation for this tragic epidemic? House Government Reform Chairman Dan Burton believes that at least part of the reason may be thimerosal, a mercury-based preservative that until recently was used in many vaccines. Mr. Burton, himself the grandfather of an autistic child, recently held hearings in an attempt to determine if the two could be linked in a chain of causation.

The chairman pointed to a 2001 report by the Institute of Medicine, which stated that the link was "biologically plausible" even though the evidence is "inadequate to accept or reject a casual relationship." The correlation seems reasonable, since most forms of mercury are known to be toxic to living things, and many parents have reported that their children began experiencing autism-like symptoms shortly after being vaccinated. In addition, since the 1980s, the number of vaccination shots (many of them containing thimerosal) given to children has increased dramatically. Before they are 6 years old, children often receive more than 10 vaccinations through an estimated 30 doses. Moreover, the increase in cases of autism, which are growing by about 10 percent each year, seems to be more than just an artifact of increased awareness or better diagnoses.

Unfortunately, it's not clear if this is a correlation or a causation, since no one is exactly certain what causes autism. As the younger siblings of autistic children are more vulnerable to the disease, scientists are fairly certain that there's a genetic link, possibly involving between 10 and 20 genes. There's almost certainly environmental components as well — especially given the rise in the disease — but no specific causative agent(s) has been established.

For instance, until recently many thought that the measles, mumps and rubella vaccine may have played a role (the MMR theory). That theory seems to have been greatly weakened by a study published last month in the New England Journal of Medicine, which found no statistical difference between occurrences of autism among 500,000 MMR vaccinated and non-vaccinated Danish children born between 1991 and 1998.

However, those who didn't receive inoculations faced higher risks of disease. In fact, while vaccinations often have unfortunate side effects, the consequences of not vaccinating — namely, catching a disease — can be far worse. Even those concerned about a possible link between thimerosal and autism, such as Mr. Burton, are still avowedly pro-vaccination.

Parents concerned that they or their child might receive a vaccine containing thimerosal should check the label and ask their health-professional first. While vaccine makers voluntarily phased out the use of thimerosal at the FDA's request, some may still be on the market.

Congressional and scientific investigations into the matter should continue. In the meantime, reasonable people concerned about the matter can take the proper precautions.

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Debate Rages Over Safe Levels Of Toxin for Adults and Infants

Perchlorate is one of a newly recognized group of toxins called endocrine disrupters -- chemicals such as dioxin and PCBs that can alter hormonal balances and thus impede human reproduction and development.

The debate is over how much perchlorate causes harm, and whether fetuses and infants are more susceptible than adults to perchlorate's effects at very low doses.

The EPA, citing experiments on rats and epidemiological studies in Arizona and California, says perchlorate is dangerous in drinking water at levels above one part per billion. The Pentagon and defense industry, citing human experiments and epidemiological studies in Chile, say perchlorate is safe in drinking water below 200 ppb. Billions of dollars in cleanup and liability costs may hang in the balance, since most perchlorate plumes in the U.S., including the Colorado River, range between four and 100 ppb.

In 1993, several defense contractors, backed by the Pentagon, created the Perchlorate Study Group to research toxicity. The group's "goal," according to an internal document written in 1996 by GenCorp's Aerojet subsidiary, was "to provide EPA with a scientific-based argument to justify a higher [reference dose] and thus a more reasonable remediation standard." The industry group has spent roughly $7 million on toxicity studies.

Yet, as with other contentious toxins such as arsenic and lead, the more information EPA scientists learned about perchlorate, the more they worried about its effects. Their main concern focuses on changes found in the brain size of laboratory rat pups exposed to low doses of perchlorate in utero. Such changes in so-called brain morphometry indicate perchlorate's thyroid effects may cause permanent neurological damage -- in rats as well as people, the EPA says, because the thyroid system works similarly in both species.

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New Evidence That Casein (Milk) Plays Role in Parkinson's in Men Got Milk? Got Parkinson's?

Men--but not women--who eat a lot of dairy products appear to have a slightly higher risk of developing Parkinson's disease, but researchers cautioned that more study is needed to confirm the finding.

Dr. Honglei Chen from Harvard School of Public Health in Boston, Massachusetts said that even if diet played a role in the development of Parkinson's disease, it would likely be only one of many factors. Consequently, cutting back on dairy may not affect risk of Parkinson's disease in men, and may increase their risk of other conditions linked to low calcium and vitamin D.

"Like other chronic diseases, Parkinson's disease is multi-factorial. Many hypotheses have been proposed and nearly all of them need further evidence for their relevance in human Parkinson's disease. Diet, if it plays a role in Parkinson's disease, is going to be one of the factors that predispose a person to Parkinson's disease," Chen said.

Parkinson's disease causes tremor, muscle rigidity and movement problems. The underlying cause is the slow loss of neurons that produce dopamine, a brain chemical involved in movement. The exact cause of Parkinson's disease has eluded the research community since the condition first appeared, and many suspect a combination of environmental factors, genetics and aging are at work.

Many previous studies have sought to examine whether some aspect of diet brought on the condition, most of which have produced murky and contradictory results.

In the newest venture into an understanding of the role of food in Parkinson's, Chen and colleagues found that men who ate the most dairy products had a higher chance of developing Parkinson's than did men who ate the least dairy products. The biggest dairy lovers ate at least 3 servings a day, while the lowest consumers said they downed less than 1 serving per day.

The authors report their findings in the December issue of Annals of Neurology.

Although the association between dairy products and the risk of Parkinson's disease appeared strong, Chen told Reuters Health that researchers need to confirm this finding in other studies, and understand more about how these ingredients might raise risk before recommending that men scale back on dairy.

"Until further evidence comes out, I do not think there is need to cut dairy consumption as the incidence is still low," Chen said.

"On the other hand, if our finding is confirmed, we should reconsider it because dairy consumption is high in Western countries," the researcher added.

Chen and colleagues base the findings on a follow-up of 47,331 adult men and 88,563 adult women from the 1980s to 1998, tracking what they ate and noting if any developed Parkinson's disease. During the study period, 210 men and 184 women developed Parkinson's disease.

SOURCE: Annals of Neurology 2002;52:793-801.

Copyright © 2002 Reuters Limited. All rights reserved

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PUBLIC HEALTH

Combined 5 in 1 Vaccine Gets F.D.A. Approval

Vaccine Reform Advocate "Stunned" by FDA Approval of 5 in 1 Vaccine

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The first vaccine that protects infants against five diseases has been approved for use in the United States, its manufacturer announced yesterday. The new formula could mean as many as six fewer injections in the first year for many babies.

The vaccine, called Pediarix, is made by GlaxoSmithKline and is already in use in several European countries. It combines vaccines against diphtheria, pertussis (whooping cough), tetanus, hepatitis B and polio, and is intended to be given three times, at 2, 4 and 6 months of age.

Children in the United States are typically given up to 15 injections in their first year, a schedule that experts say has led some parents to resist immunizations. The combined vaccine should cut that number to 9 for many children.

"It's good news that this is out," said Dr. Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins University. "It'll be nice to have one product so kids don't have to have multiple injections."

Theoretically, with the combined vaccines now used abroad or being developed, the immunization schedule for infants could eventually be reduced to just three shots. Combined vaccines against haemophilus influenza b and streptococcal pneumonia are in use in Europe or being tested by Glaxo, Aventis and other pharmaceutical companies.

But Dr. Joel Ward, director of the Center for Vaccine Research at the University of California at Los Angeles and the principal investigator of Pediarix, said that it had taken 10 years to get Pediarix approved by the Food and Drug Administration and that other mixes of vaccines had thus far not provided enough antibody protection against all the diseases to please the agency.

Even under an abbreviated schedule, the vaccine against hepatitis B will still be given immediately to newborns whose mothers are infected or whose status is unknown, doctors said.

After children are over a year old, they are normally given more vaccines against measles, mumps, rubella and chicken pox. Because these vaccines are made with viruses that are weakened but not killed, they cannot normally be combined with the killed vaccines given earlier in life, vaccination experts said.

Even as it approved Pediarix, the F.D.A. said children vaccinated with it had one side effect, fever, more frequently than those given separate vaccines.

Dr. Ward acknowledged that, but said the fevers were typically less than 101 degrees, lasted less than 24 hours and did not lead to serious reactions or hospitalizations.

Dr. Karen Midthun, director of vaccine research and review for the F.D.A., agreed that the more common fevers did not cause serious problems. The Pediarix label cautions doctors to expect fevers among patients, she said, especially those getting it at the same time as measles-mumps-rubella shots.

The F.D.A. still feels the vaccine "has an acceptable safety profile," Dr. Midthun said.

Reducing the number of shots will let pediatricians consider introducing new vaccines, Dr. Ward said. Those in the works include new vaccines against bacterial meningitis, rotavirus and the flu.

Barbara Loe Fisher, a founder of the National Vaccine Information Center, which is often described as an antivaccine group, said she was stunned by the approval because an F.D.A. advisory committee of which she was a member had expressed concern about side effects and asked for more information.

Dr. Midthun said the agency had received the additional information from Glaxo and had adjusted the label accordingly.

[Note: Reader Jim Donnelly writes in with this bit of information: "I called Glaxo today to find out what they have in the new PEDIARIX vaccine. They manufacture the vaccine with a larger amount of Thimerosal and then reduce it through a "purification process" until the end product has <= 12.5 nanograms per dose. The vaccnie also has 0.85 milligrams of Aluminum Adjuzant and an unstated amount of 2-phenoxy-ethanol as preservatives."]

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Revealing Transcript of FDA Meeting over 5 in 1 Vaccine

TRANSCRIPT:

Discussion: Infanrix DTPa - HepB - IPV from SmithKline Beecham Biologicals

MS. LOE FISHER: How long did you monitor children for persistence of antibodies to all antigens in the combination vaccine versus the separate injection controls to confirm long-term immunity?

And how long did you monitor children which had acute reactions, particularly the more serious reactions, for development of autoimmune neurological or behavioral disorders following the 30 day acute observation period?

DR. KAHN: Dr. Barbara Howe.

DR. HOWE: So with respect to persistence of immunity we followed infants, after the three dose primary series up until the time of the booster in a number of the trials.

We have data with us in the context of persistence and boosting data. In the U.S. studies that included up to a mean age of 14 months, that is in study 015, we followed the children out until mean age of 14 months and administered a booster dose of, actually, separate injection DTPa and Hib. So Infanrix and U.S.-licensed Hib vaccine.

And in study 044, which was the consistency study, we followed children out to a mean age of 16 months, and administered booster doses there. And I do have data to show that persistence was comparable in those who received the combination vaccine at 2, 4, 6, out to the mean age of 14 months as to those who had received separate administration of the U.S.-licensed products out to the mean age of 14 months.

MS. LOE FISHER: For hepatitis B too?

DR. HOWE: Yes.

MS. LOE FISHER: And then the reactions?

DR. HOWE: In terms of the reactogenicity and the safety data children were followed up until 30 days after the last dose of vaccine.

Some of these children would have gone on to be included in booster trials as well, but not all of the children.

MS. LOE FISHER: So you don't know what happened to those children after 30 days?

DR. HOWE: Unless they were subsequently in booster trials. MS. LOE

FISHER: I'm interested in the -- getting more information about the two seizure cases. One was, I think, in the adverse event category of febrile seizure, which was then determined to be caused by an underlying seizure disorder, the other was a death that had the cause of death listed as an underlying seizure disorder.

Was this the same patient, and what determination was made that the seizure, was this the first time that the seizure had occurred following the vaccination, had there been pre-existing seizures?

And what was the determination, how did you determine that they were not connected to the vaccine? And I have the same question on the deaths. Because you had five deaths in the combination group and only one death in the controls.

That seems pretty significant to me, and what determination was made that those deaths were not, indeed, in some way connected with the combination vaccine?

DR. KAUFHOLD: You are right, there were five deaths in the group that received the combination vaccines. That includes all trials that are contained in the BLA, and one death in the comparative vaccine.

If you now look at the denominator you can, and the denominators between those two groups are, obviously, very different. So if you compare the percentages the figures are virtually identical.

Perhaps we can have another look at the slide that lists all the deaths, perhaps that went too fast.

Altogether there were three cases of sudden infant death syndrome, the next one please, three cases of sudden infant death syndrome. I highlighted in my presentation, in the comparative study 011 there was one case, in the group that has received the candidate vaccine and one case in the group that received separately administered licensed vaccines.

Then there was one case of neuroblastoma, and one case of congenital immunodeficiency. And if you will read the narratives, we -- one can support only the conclusion of the investigator that stated that these cases are certainly unrelated to vaccination.

With regard to your question regarding convulsive disorder, yes, there were altogether two febrile convulsive disorders in study 011. And one occurred after four days post-vaccination, and the other case occurred more than two weeks post-vaccination.

The case with the febrile seizure is the same, that was diagnosed to have an underlying convulsive disorder, and this child died later on.

MS. LOE FISHER: So it was the same patient?

DR. KAUFHOLD: It was the same patient. MS. LOE FISHER: Earlier when I asked the manufacturer about seizures in this study, it was my understanding that there was one febrile seizure, and it was judged to be due -- the child had an underlying seizure disorder and resulted in the death.

You mentioned, it went by so fast, but seven seizures, five of which were afebrile. Now, what is it, one seizure, seven seizures, how many seizures?

DR. BALL: I think it should be clarified. I think what was referred to was the two seizures that occurred within the seven day time frame after vaccination.

The first slide that I presented, I'm sorry, I can't pull that out for you right at the moment, referred to seizures that occurred during the whole vaccination course.

It could have occurred six weeks later, you know, three weeks later after the vaccination.

MS. LOE FISHER: I really think we should have more information about the seizure picture, particularly the afebrile seizures.

DR. BALL: I'm sorry, what more information would you like?

MS. LOE FISHER: How soon after did these occur, was it the first time that it occurred in the child, did the child have a pre-existing seizure history, some more information about seizures.

And I have one more question, and then I won't ask another question.

CHAIRMAN DAUM: Well, before you go on to another question, is this information available?

DR. BALL: I think it is available, but I think the manufacturer could probably clarify or expand on the information that I have at the tip of my fingers, which is that seizures were evaluated over the full study course, and that was the first slide on the serious AEs that I presented.

In addition seizures were presented, also, within seven days of vaccination. There were two episodes of seizures within the seven day time frame. And I think that perhaps the manufacturer would want to clarify further regarding the timing after vaccination, and whether or not there was an underlying condition.

I think that infants -- my understanding was that pre-existing conditions, pre-existing seizure disorders would have kept the children out of this study.

MS. LOE FISHER: Just one other one. Nearly 5,000 of the 7,000 children came from Germany, which unlike the U.S. has a generally homogenous population with respect to genetic diversity.

And also the German children began their vaccinations at 12 weeks, rather than 8 weeks. Can you comment on the possible significance of this, when we apply this vaccine to the U.S. population?

DR. BALL: Certainly. I think that that was something that we looked at very closely, and with regard to the timing of immunization I think that the manufacturer may be able to bring up a slide.

It is in my briefing material that was presented to you that looked at the timing of each dose, and the overlap between the different doses.

And there was significant overlap, particularly for the second, and somewhat the third dose. The timing, certainly for the third dose was delayed between the infants in Germany versus the infants in the U.S.

So the question that we could readily answer is whether or not the incidence of fever, which I think we've sort of identified as one of the key focal points, did the incidence of fever differ whether the vaccines were given at 2, 4, and 6 months of age, versus 3, 4, and 5 months of age.

I think where this becomes clinically relevant, particularly to parents, and physicians who care for infants, is whether or not that fever that would occur maybe in a 6 week old to a 2 month old, would translate to more hospitalizations, sepsis workups and so on, than perhaps if the immunization is given at 3 months of age.

And I did show a slide that compared the rate of fever between the two schedules, 2, 4, and 6, and 3, 4 and 5, and the rate of any fever was remarkably similar between the two groups.

MS. LOE FISHER: It also could have an effect on death, and seizures, etcetera. I mean, the 8 weeks versus the 12 weeks starting.

DR. BALL: Do you mean in terms of the occurrence of febrile seizures?

MS. LOE FISHER: Or afebrile. In other words, the one month difference is going to have an impact, could potentially have an impact, both on immunogenicity as well as reactions.

Just because 5,000, almost 5,000 of the 7,000 children came from Germany, and had the schedule, and were not genetically diverse like we are, I think is an important point to --

DR. BALL: I acknowledge that point, and I think that we looked at that as well.

MS. LOE FISHER: Thank you.

CHAIRMAN DAUM: Thank you, Dr. Kohl. I didn't see other hands up. And so I'm going to ask to have the first question put up on the board again and begin a discussion about this first question and that is to say that the, this is a voting question. It's the only voting question for the afternoon. And it concerns efficacy.

Are the available data adequate to support efficacy of this combination vaccine when given to infants in a 2, 4, 6 regimen.

So I'd like to have discussion about this question and then after we get a sense of people's opinions and where we're going, we'll have a vote about this question. Comments? Ms. Fisher.

+ Transcript continues at:

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AWARENESS

'Treating Disease With a Famous Face' Sniffs NY Times

Publicist from a big agency with corporate clients called on a hunch.

"This might be a long shot," she said. "But this is the hot new disease."

Everybody who is anybody has I.B.S., she said, rattling off names: a comedian, an actress, a celebrity couple. Even John F. Kennedy, whose diagnosis was just made, posthumously.

And I.B.S. stands for? "Irritable bowel syndrome," the publicist said. Lynda Carter — an actress perhaps best remembered as Wonder Woman in the 1970's — was to be the new celebrity spokeswoman for the syndrome.

And so a few days later, there was Ms. Carter, addressing a luncheon at a Midtown Manhattan hotel about, well, constipation. "Sometimes people go two, three, four days, without. . . ." she said, then squeezed a toothy, anxious smile onto her face.

An expectant silence followed. Ms. Carter, who as a superheroine wore golden wristlets that magically deflected bullets, coughed and sallied forth.

"I mean, if Bob Dole can talk about his peniz. . . ." she added, sounding helpful.

She was right, of course. In America, there is scarcely any disorder, no matter how lowly, that has not had its image enhanced thanks to a celebrity spokesman. Anemia and its cures have been championed by Danny Glover, rheumatoid arthritis by Kathleen Turner and bladder control by Debbie Reynolds. Rare syndromes have found spokesmen in Ben Affleck

(ataxia-telangiectasia) and Rob Lowe (febrile neutropenia).

The public does not always understand that many of these celebrity champions are paid players in the marketing strategies of pharmaceutical companies, who pull the strings to make them dance before the public and news media. Ms. Carter is on the payroll of the Novartis Pharmaceuticals Corporation, which markets an I.B.S. drug. Mr. Dole, of course, was hired by the maker of Viagra.

While attaching a celebrity to a disease can motivate sufferers to seek treatment or lead to more research financing, the arrangements are ethically complicated, medical experts say. Last summer, CNN and ABC adopted polices to assure that viewers are told of celebrities' ties to drug companies after stars like Ms. Turner and Lauren Bacall spoke of their ailments on news programs without mentioning they were paid.

Despite the networks' bearing down, the practice continues and the relationship between stars and sickness has evolved further, affecting both the public's perceptions of treatment and financing for research. Dr. Arthur Caplan, the director of the Center for Bioethics at the University of Pennsylvania, said the relationship between celebrities and disease has become so cozy that he is now supervising a study of the impact on drug sales and public health.

The celebrity-disease partnership is a natural, if undesirable, signal of the continuing transformation of health care from a profession run by doctors and scientists to one run by marketers, he said.

+ Article continues at:

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Full Page Ad Project Changes Hands

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READERS' POSTS

My son is struggling to find socks that don't drive hime crazy- if anybody else has this problem and has a solution, please share! Celeste Proctor clhproctor@yahoo.com

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The 2002 Holiday edition of the NIDS Network Newsletter will soon be available. If we don't have your name and home mailing address in our database, please call 1-888-540-4999/1-818-951-8579 or email the information to info@healnids.org or sjsmith@erols.com

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