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Tuesday, December 17, 2002

 

TREATMENT

* Help for Autism - Full-Length Expert's Interview

* New ADHD Medication A Promising Option From Eli Lilly

PUBLIC HEALTH

* Question of Smallpox Vaccine Liability Remains

* Hurt In The Name Of Security

RESEARCH

* Assessment of the Pichichero Thimerosal Study by Safe Minds

AWARENESS

* Osama bin Laden Dislikes Kelloggs Frosted Mini Wheats

MEDIA

* Giving Parents Reasons for Hope

FUNDRAISING

* Child Study Center Recognized For Research On Autism

And Asperger's Syndrome

 

 

TREATMENT

Help for Autism - Full-Length Expert's Interview

In this full-length expert's interview, Terry Hall, M.A., C.C.C., explains how a new approach to therapy boosts verbal skills in children with autism.

[This is presented for our reader's infornation only and should not be considered a recommendation for such treatment by the SAR.] http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=4970

 

Ivanhoe Broadcast News Interview with Terry Hall, M.A., C.C.C., Speech Language Pathologist, JFK Partners, Departments of Pediatrics and Psychiatry, University of Colorado Health Sciences Center, Denver, Colorado

What is the Denver Model?

Hall: The Denver Model is really a multi-faceted approach to develop communication skills, reciprocal social interaction skills, and various other areas of development. We work on treating the whole child and working with the parents, because they are key in helping us facilitate this whole process of intervention. One of the core premises of it is really building that relationship with another person and along with that, being able to engage socially with that other person. Social interactions are really one of the hallmark characteristics of weakness in autism, as well as the communication area. The Denver Model really focuses on building that relationship to develop those other areas of weakness for that child.

If I'm a parent who brings my child here and you say, "OK, we want to work with your child and using this model," how would this look different me as a parent than what I might have tried in the past? Hall: One-to-one work, which is more of a direct approach that is adult-guided and is actually more manualized behavior therapy, is one aspect of it. Then another aspect is the naturalistic approach to working with the child where it's more child-driven. So what we do is we do a combination of both. It's a combination of both one-to-one teaching, which really helps the child acquire skills quickly, embedded within a normal routine so that it's more socially based and more child driven. It's a fine balance of using both sorts of methods to be able to produce the maximum progress.

Much of the work is done with the family at home, right? Hall: Some of the work is done with families at home. It's done on a one-to-one basis at home and also in the school. We also work with consultation with the school teams there and coordinate programs between school and home.

Why do you do it at home as well? Hall: It really helps us generalize skills. We've found that getting the parents involved in being a big part of the intervention has been a very big plus definitely to the whole approach, and parents are really the ones who spend the most time with their children. They know their children the best.

We want to use that expertise as well and get them in as part of the team.

It helps us to generalize skills, and it also helps us with home and daily routines that parents are faced with trying to teach their children. We find that children with autism are isolated. They tend to not be in the flow of things. This is one way for us to get them in the flow of the family, into the flow of the school, and also build skills in a one to one so those skills can be generalized to those different environments.

Is it successful? Hall: I think it is. I've really enjoyed the whole process of working with several children over the years and figuring out what is the best mix of approaches. We've learned a lot from other programs, other researchers that have found out many things. I mean, it's incredible to think that years ago, about 50 percent of children with autism were non-verbal. Now we're finding that early intervention can make a difference for children with autism. We can say that even up to 75 percent to as high as 95 percent of children with autism become verbal before the age of 5 with the appropriate interventions.

What types of families do you usually work with? Hall: I work with many families, and the families are great that I work with. It takes a lot of effort on their part -- they really have to have some commitment. The families that we tend to work with are very committed to doing the best and the most that they possibly can for their children. It is a lot of work. There's a lot of coordination that's involved of teams, of school, that sort of thing, but also it's really important for them to know what their child is doing. They are very much a part of their child's intervention program so they would be able to tell somebody what they're actually working on. They are given assignments at home. They keep data at home, so they play a really active part in the whole process. They're a big key to the child's success as well.

If I'm a parent somewhere around the country and I hear about this, what should I do next? Hall: Right now, we hold yearly trainings. What happens is we have a weeklong intensive training of professionals. Hopefully it will be opened up to parents as well. That's one way to learn and to actually incorporate some of the strategies and different components of the approach. So, we have a five-day institute here. It has components of presentation, lecture-type of information given to the parents and then professionals in the audience.

Then we also go into hands-on where they actually get to work with children and work up from beginning to implementation, treatment plans, goals and objectives, and activities, how they would like to teach it. So that's one way of learning more about it. Another way would be to contact us directly because there have been other trainings that have happened across the United States and then we can guide them to sources that are close to them.

How does the fact that they go from being non-verbal to verbal, how dramatic is that on your entire life? Hall: It's so incredible. Communication impacts all facets of a child's life and it really is a prognostic factor for how they will be able to function as an older person, as an adult, later on in this society. It really affects their social life, their family life, also their social circle of friends, and it really impacts academics and school progress.

I bet it's rewarding to do your job every day.

Hall: It definitely is. I really enjoy what I'm doing and the children and the families that I work with. It's difficult at times. We work hard to get a little amount of progress, and then it seems all of a sudden, it just really takes off. So those are very exciting times.

Before the last couple of years, how big a challenge has autism been to try to figure out treatments? Hall: Prior to the present, I think that there wasn't as much that people knew about autism then. Since even in the past decade, even to diagnose autism is has been more difficult. I think that we've gotten better at diagnosing autism and really looking at the treatment, looking at core areas of weakness that these people present to us, and then really focusing on those areas of treatment. Looking at communication, looking at imitation, looking at the child's ability to non-verbally as well as verbally communicate with us and also socially interact with us. So, it's been a process of the whole community of researchers really looking at and finding out more about what autism is and how to treat this disorder. We are running a research study here that we're really looking specifically at our treatment approach, the Denver Model approach, with another treatment approach called The Prompt approach, which is out of Santa Fe by Debra Hayden. Those two approaches really look at different facets of the child and emphasize different areas of treatment. We're constantly looking for something that will more effectively treat children with autism and get them to be more verbal.

If you would like more information, please contact: Sarah Ellis,

Director, News Media Relations, University of Colorado Health Sciences Center and University of Colorado Hospital, 4200 East Ninth Avenue, #A092, Denver, CO 80262 (303)-315-7470

* * *

New ADHD Medication A Promising Option From Eli Lilly

When atomoxetine reaches pharmacies next month, it will be the first noncontrolled drug in 30 years approved by the FDA for treating the disorder.

[By Susan J. Landers, AMNews.] http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsc1223.htm

Physicians are awaiting with interest the arrival of a newly approved drug to treat attention-deficit/hyperactivity disorder.

On Nov. 26 the Food and Drug Administration approved atomoxetine, which will be marketed as Strattera, as the first new drug in 30 years to treat the disorder that affects 3% to 7% of children and 4% of adults in the United States.

"It certainly is helpful to have a variety of medications available to treat conditions such as ADHD," said David Fassler, MD, a child and adolescent psychiatrist in Burlington, Vt.

Atomoxetine appears to be both safe and effective in the studies that have been presented and published, said Dr. Fassler. But the new drug will be in competition with medications that are backed by decades of experience and hundreds of studies, he noted.

However, atomoxetine does enter the market with one possible advantage over the other drugs now prescribed to treat ADHD. It will be the first noncontrolled option for the treatment of the disorder.

The more traditional treatment options, methylphenidate, dextroamphetamine and amphetamine (marketed as Ritalin, Dexedrine and

Adderall) are stimulants and are classified as controlled substances.

3% to 7% of U.S. children and 4% of adults have ADHD.

Since atomoxetine is not controlled, physicians will be able to write prescriptions for longer than a month at a time, and they will also be able to distribute samples.

Lengthier prescribing periods are an advantage for physicians and for families, said James Perrin, MD, professor of pediatrics at Harvard Medical School, "especially for the child who is pretty stable, who is doing fine and needs to be seen and monitored maybe two or three times a year."

+ Article continues:

http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsc1223.htm

* * *

PUBLIC HEALTH

Question of Smallpox Vaccine Liability Remains

CDC Admits 10% could have a serious reaction, 30% to become too ill to work

[Brief Commentary follows. By Maggie Fox for Reuters Health.] www.reutershealth.com/archive/2002/12/13/eline/links/20021213elin029.html

Close to a million Americans are about to be vaccinated against smallpox starting in the next few weeks under a plan to be laid out later on Friday by President Bush.

Past experience suggests that one to two people are likely to die as a result, and another dozen or more will be hospitalized, because the vaccine uses outdated and crude technology.

The first 500,000 people vaccinated will be military personnel, taken care of by the Department of Defense health system. But what about the half a million civilian health workers who will volunteer to be the first? The Homeland Security Act passed in November protects the smallpox vaccine makers and the hospitals and staff who would administer it from lawsuits.

This is in keeping with current laws on childhood vaccines--the idea being that no one would make or give vaccines if they risked being sued by everyone who had a side effect.

For childhood vaccines there is a fund, the Vaccine Injury Compensation Fund, that pays out to children and their families if they are seriously hurt by a vaccine.

But there is no provision for anyone who becomes disabled because of the smallpox vaccine, or for the families of anyone who may die. Under the terms of the act, they will have to sue the government and prove not only that they were injured, but that negligence was involved.

This has raised the concern of the Service Employees International Union, which represents 1.5 million health care workers.

VOLUNTEERS SHOULD NOT SUFFER "People who volunteer to receive the vaccine should not face loss of income if they cannot work as a result," the SEIU said in a statement.

"The CDC (Centers for Disease Control and Prevention) estimates that approximately 30 percent of those who are vaccinated will feel too sick to work and provide proper patient care for one or more days. Roughly 10 percent could have a serious reaction," it added.

"A simple and fair compensation system--like the federal Vaccine Injury Compensation Fund--should be made available to assist anyone who is injured from receiving the vaccine or coming into contact with someone who received it."

The House of Delegates of the American Medical Association, which represents 300,000 doctors, voted on Tuesday to ask that a federal liability program be in place before vaccination starts.

The government is aware of the problem, said Jerome Hauer, assistant secretary at the Health and Human Services Department and an expert on emergency preparedness.

"We looked at the liability issue--it is clearly a key component of this program," he told reporters in a recent briefing. "I hope to get that resolved in the very near future."

The Infectious Diseases Society of America opposes widespread vaccination. "Many infectious disease physicians are concerned that immunizing the general public now, in the absence of known disease, will put persons receiving the vaccine at unnecessary risk of adverse reactions," the group said in a statement.

Copyright © 2002 Reuters Limited.

[Brief Commentary: With vaccines this dirty, liability, or lack of it, is the least of our problems. This could end up a public relations nightmare for those promoting public health innoculations. Every third person getting sick?! You've got to be kidding. If to protect ourselves against terrorism, 10 to 30 percent of us must become seriously ill from semi-poisonous vaccines nobody wants to be held accountable for, it would seem that the terrorists have already won. Eli Lilly shouldn't waste anymore of their shareholders' money on bumbling Senate Republicans, they should give it directly to Al Qaida - who really know how to drum up business.** –LS.]

 

** Intended as sarcasm - prompt for our more phenotypical readers

* * *

Hurt In The Name Of Security

[By Marita Lowman in the Scranton Times Tribune.] www.zwire.com/site/news.cfm?newsid=6376525&BRD=2185&PAG=461&dept_id=415898

When Tara McHale gave birth to her first child, Samantha, she recorded every wonderful moment of her baby's life. The first smile, the first word, the first step, the first hug, the jutting of each tooth, the nuance of each new gesture.

In every way, Samantha was developmentally on target. At 15 months, she walked and talked and joyfully played.

Then, during a regular medical checkup, the pediatrician injected four childhood vaccines into Samantha's bloodstream.

Samantha, of Clarks Summit, has never been the same.

The next morning, her cognitive skills were dulled. Her physical abilities spun backward.

When she was 4, she could not be toilet trained. She no longer made eye contact. Her speech shrunk to one- or two-word sentences. She flapped her hands in bizarre gestures.

All the while, her mother pursued pediatricians, neurologists, audiologists and other professionals to find out what was wrong.

In 1997, a developmental pediatrician confirmed the diagnosis.

Autism is a neurological condition that forever alters a child's life.

"It was a crushing blow," Mrs. McHale said.

It is a blow most members of Congress know nothing about. So when the federal legislators approved the Homeland Security Act last month, they glossed over a last-minute provision tucked secretly into the bill.

It granted Eli Lilly and other pharmaceutical companies retroactive protection from lawsuits such as those that say Lilly's vaccines caused or contributed to autism.

Childhood vaccines have been suspect for many years, but the claims gained more credence when research found dangerously high levels of mercury and the preservative thimerosal in the vaccines.

One thousand lawsuits were pending against the vaccine makers, but the last-minute addition to the Homeland Security Bill canceled all of them.

Mrs. McHale, Rita Cheskiewicz, of Dallas, and Frank Scholz, of Mehoopany -- all parents of autistic children -- met Thursday with U.S. Rep. Don Sherwood, R-Tunkhannock, to seek his support in overturning the provision.

They are hurt by the government's seemingly cavalier attitude toward children with autism. They are frustrated by what appear to be cozy relationships between pharmaceutical manufacturers and the White House.

Mrs. Cheskiewicz, a former administrator at Hahnemann Hospital in Philadelphia, gave up her job when her son A.J. was diagnosed with autism.

He was normal in every way until age 18 months, when he received three vaccines at once. He stopped speaking and stopped responding to his name.

"As a mother, it is heartbreaking, and it did not have to happen," Mrs. Cheskiewicz said.

Mr. Scholz, whose son, Joey, was diagnosed as autistic several years ago, drives two hours a day to take his son to an educational program geared to children with autism.

The children will need lifelong care. The parents want more government resources put into autism research. They want more recognition of autism's devastating effects.

Mr. Sherwood, visibly moved by the families' plight, said he will try through the Health and Human Services Committee to direct funding for autism through national health institutions.

He also will recommend overturning the Homeland Security provision, but the prospect of success is not good.

"There will be some support, and I'll give it a shot when we go back into session in January, but to turn the provision around now will be a major proposition," he said.

Samantha McHale is 10 now, and despite intensive care, she is wrapped in the limitations of autism.

She needs help dressing, bathing, toileting. She doesn't understand gender or relationships, time or numbers.

She does not recognize family names, and when she's in pain, she cannot explain why or where she hurts.

She does not go to ballet classes or listen to music with friends or take part in other activities most 10-year-old girls enjoy.

* * *

RESEARCH

Assessment of the Pichichero Thimerosal Study by Safe Minds

[From Sallie Bernard at Safe Minds.] http://www.safeminds.org

This analysis describes the concerns which Safe Minds has over a recently published study in The Lancet by Michael Pichichero et al.(1) in which blood measurements were taken of infants after administration of vaccines containing thimerosal. The article and accompanying commentary contain several sweeping statements about thimerosal safety:

"Overall, the results of this study show that amounts of mercury in the blood of infants receiving vaccines formulated with thiomersal are well below concentrations potentially associated with toxic effects." "Administration of vaccines containing thimerosal does not seem to raise blood concentrations of mercury above safe values in infants." "This study gives comforting reassurance about the safety of ethyl mercury as a preservative in childhood vaccines."

The design and results of the study do not support these statements. In fact, the results suggest that thimerosal exposure from vaccines may have caused neurological damage in some children. Safe Minds questions the objectivity of the study authors, due to their ties to vaccine research and vaccine manufacturers, which may have resulted in a biased study design and biased interpretation of the results.

Objectivity Of The Authors

Pichichero has an acknowledged financial tie to Eli Lilly, the developer of thimerosal and the main target of thimerosal litigation. He has also claimed financial ties to a number of vaccine manufacturers, including manufacturers of thimerosal-containing vaccines.(2) For example, in an article in the American Academy of Family Physicians newsletter of April 2000, Dr. Pichichero makes this disclosure statement (3):

"The author has received research grants and/or honoraria from the following pharmaceutical companies: Abbott Laboratories, Inc.; Bristol-Myers Squibb Company; Eli Lilly & Company; Merck & Co.; Pasteur Merieux Connaught; Pfizer Labs; Roche Laboratories; Roussel-Uclaf; Schering Corporation; Smith Kline Beecham Pharmaceuticals; Upjohn Company; and Wyeth-Lederle."

Pichichero's work has been cited in 21 vaccine patent applications He was involved in the recommendation for the Wyeth rotavirus vaccine and failed to anticipate its risks. (4) This vaccine was withdrawn soon after licensure due to adverse reactions.

A substantial proportion of Dr. Pichichero's work involves vaccines. Safe Minds conducted a simple Medline search of publications listing M Pichichero as an author.(5) A breakdown of these publications by subject area shows that many focus on vaccines, especially those which contained thimerosal.

161 publications 23 DPT 7 Hib 1 HepB 1 Polio 3 Pneumococcal Conjugate 3 Rotavirus 4 New combination vaccines or general vaccine discussions The remainder deal with otitis media and use of antibiotics Note some articles were counted more than once because they addressed more than one vaccine

Similarly, the University of Rochester web site provides biographical information on Dr. Pichichero, which describes his focus on vaccine research. (6) It describes him as an immunologist, not a toxicologist. None of his work involves safety assessment of a heavy metal or other toxicant. One paragraph cites his work on the Haemophilus influenzae type B vaccine, one of the thimerosal-containing vaccines that was added to the CDC/AAP-recommended infant schedule in 1991, nearly doubling the thimerosal load.

John Treanor, another author, has also conducted substantial research into thimerosal-containing vaccines, and the University of Rochester is one of a few sites designated by NIH for evaluating new vaccines. Investigators at the University of Rochester helped develop the Haemophilus influenzae B vaccine. Per its web site, "Rochester has become a national model...in ensuring that as many people as possible are immunized." (7)

Study Design Issues

Sample The sample size was small. Although the overall sample size was stated as 61 infants, there were only 33 exposed children who were used for the blood mercury assessment upon which the safety conclusions were made. One major shortcoming of a small sample size is the low chance of including infants who are especially sensitive to mercury's effects, or who may have detoxification difficulties. We know from the mercury literature that there is wide variability in the population in regard to mercury sensitivity and clearance. Since vaccines are given to virtually all infants, even if 1% retained mercury to a much greater degree than the "norm", this would represent a large number of injured children.

The small sample size means that the study lacks sufficient power to establish safety claims.

The sample was not randomly drawn, but was a convenience sample, and therefore not representative of all infants in terms of health status, socio-economic status, ethnicity, and other potentially important factors.

Dose Given that the half life of ethylmercury appears to be 6-7 days, virtually all, if not all, blood draws missed the peak blood concentrations of mercury. It is evident that earlier peaks existed because the feces contained high mercury values, and feces reflect earlier blood levels. It is impossible to state what the peak values are if they were not measured. It is also impossible to calculate average blood concentrations unless peak concentrations are measured. Standard methylmercury pharmacokinetic (PK) studies consider peak and average blood concentrations, along with tissue distribution, as necessary components of toxicity assessment. It is disingenuous to compare the blood levels in this study with past methylmercury ones without any type of adjustment factor, because the methylmercury studies incorporated peak levels into their values, whereas this study only included the smaller values.

The dose of ethylmercury given to subjects varied greatly and was less than what a typical child in the 1990s could receive. In a rationally designed PK study, the dose is kept constant. In the Pichichero study, the 2 month old subjects were injected with between 37.5 mcg and 62.5 mcg of ethylmercury reflecting a 67% difference between the lowest and highest dose. The mean was 45.6 mcg. The typical child in the 1990s could receive 62.5 mcg of mercury at age 2 months and an additional 12.5 mcg at birth (from the Hepatitis B vaccine), or 37% and 64% more Hg, respectively, than the children in this study. The 6 month old subjects were injected with between 87.5 mcg and 175 mcg of ethylmercury reflecting a 100% difference between the lowest and highest dose. The mean was 111.3 mcg. By 6 months of age, the typical child in the 1990s would have received 187.5 mcg Hg, or 68% more than the Pichichero study group average.

The total recorded dose of ethylmercury was not administered during the study data collection period. According to the national immunization schedule that existed during the data collection period (November 1999 to October 2000), it is not possible for a six month old infant to receive 175 mcg of ethyl mercury at only the six month visit. Rather, at 6 months of age, an infant would receive a maximum of 62.5 mcg Hg, from a DTaP, a HiB, and a Hep B vaccine. Thus, the Pichichero study, in calculating dose, included exposures which occurred months prior to the last injection. Thus, when the study characterizes blood draws as being "X" days after the mercury exposure, this is misleading, because it refers only to the last injection. Thus, the reader really doesn't know how much dose any infant received at that last exposure from the data presented in the table in the study.

In a properly designed PK study, multiple blood draws should be taken from each subject, and blood collection times should be consistent for all subjects. In this study, there was a single draw per child, and the collection times varied from 3 to 21 days for two month old infants, a 700% difference, and from 4 to 27 days for six month old infants, a 675% difference.

Modeling The single compartment model and safety assumptions looked at blood levels as the determinant of safety. However, a more important measure is mercury distribution into tissue, particularly the brain. Estimation of brain accumulation would require a two compartment model and measurement of peak blood levels, neither of which were components of this study. Yet it is apparent that the mercury is moving through the body and is redistributing because it is in the feces at substantial levels.

Study Interpretation

Improper use of methylmercury safety levels as a marker for ethylmercury risk: the Pichichero study compares ethylmercury blood levels with levels from methylmercury risk assessments, but obviously, ethylmercury is a different molecule than methylmercury, and therefore it needs its own safety assessment. A slight change in molecular structure can have very different effects in the body. There has never been a full safety assessment of thimerosal, as the FDA has admitted. The only way to do this is to conduct a series of cellular or molecular level studies as well as population studies consisting of either (a) animal studies which measure behavioral, neuropsychological, or physiological outcomes (that is, does "x" dose result in "y" aberrant behavior or "z" reduction on memory tests, etc.), or (b) human studies on exposed populations, again looking at behavioral, neuropsychological, or physiological outcomes. These types of studies have been done extensively for methylmercury, and this is why methylmercury blood levels can be correlated with certain outcomes or risk, but it has never been done thoroughly for thimerosal. The Pichichero study does not address adverse outcomes at all, and therefore does not constitute a true safety assessment.

Improper interpretation of 1994 Grandjean study to assess safety: the Lancet study authors cite a 1994 article by Philippe Grandjean as saying that a 29 nMol/L blood concentration is the level for methylmercury which is thought to be safe, since it is ten times lower than the levels at which adverse effects have been found in methylmercury research. (Ten times 29 nMol/L equates to 290 nMol/L, or 59 part per billion.) Actually, as the EPA explains (8), the EPA incorporated a ten-fold factor into their safety assessments due to "uncertainty factors" because the methylmercury studies are small, have a high margin of error, and there is immense variability in human response to mercury. Thus, to be truly protective of the population, blood levels should not exceed 29 nMol/L (which equates to 5.8 parts per billion, or the 6 mcg/L the EPA refers to in their document). The EPA was concerned when a national study (NHANES) showed that 10% of the US women of child bearing age had blood mercury over 6 ppb. Thus, a level of 6 ppb or over, equivalent to 29+ nMol/L, is considered by EPA to be cause for alarm.

In the Pichichero study, there is one infant blood level out of the 17 2-month old blood samples (12%) which was 20.55 nMol/L, or 4.1 ppb. This infant had its blood drawn at day 5, received 37.5 mcg/Hg, and weighed 5.3 kg.

a) Day 5 is past the peak value in blood, meaning that at days 1-3, levels would be much higher. b) A 37.5 mcg dose is (conservatively) 60% of what a typical 1990s infant may have received (37.5/62.5=60%). c) A 5.3 kg infant is at the 95th percentile of weight for a 2 month old, that is, a large, heavy baby. Since blood Hg concentrations are in part dependent on weight, a child with a lower weight than this infant (that is, 95% of the 2 month old population) would have had a higher blood level than this infant.

The implications of points a, b, and c are that (1) if the study infant's blood were taken at 1-3 days, it is more than likely that the Hg levels would have exceeded 6 ppb; (2) it is likely that the peak levels of more than 12% of 2 month old children children given the full 62.5 mcg of mercury would exceed 6 ppb; and (3) a larger percentage of smaller infants - but still those of "normal" weight - would be likely to have blood levels exceeding 6 ppb.

In addition, there were two other 2 year olds with mercury levels at between 10 and 15 nMol/L. These values are with 1/2-1/3 of the EPA margin of safety, with blood draws on days 6-7.

For these reasons alone, the results of the Pichichero study are anything but "reassuring" to parents whose children were exposed to thimerosal as infants.

Learning From The Study

Despite its many limitations, the Pichichero study does provide new or confirming information about the pharmacokinetics of ethylmercury injected into infants.

The half life of ethymercury in infants appears to be shorter than methytlmercury, approximately 6-7 days. Pharmacologically, this period would be considered a very long half life and a long time for a toxic substance to be circulating in the body. In fact, the single blood draw after 20 days for which mercury quantitation could be made showed mercury being circulated at about 5 nMol/L. In a developing brain a few days are significant time periods for an agent that interferes with cell division and organization. The control group had no detectable mercury, indicating that the mercury in the exposed group was due to the thimerosal in the vaccines.

Summary

The Pichichero is a small-scale descriptive study with many design limitations, which has moderate value in advancing understanding of ethylmercury pharmacokinetics. It has little if no value as a safety assessment of thimerosal from vaccines, and its conclusions are overreaching, perhaps reflecting a bias on the part of its lead author towards absolving lisenced vaccines of any adverse effects.

References

(1) Mercury concentrations and metabolism in infants receiving vaccines containing thiomersal: a descriptive study, by Michael E Pichichero, Elsa Cernichiari, Joseph Lopreiato, John Treanor. The Lancet. November 30, 2002. http://www.thelancet.com/journal/vol360/iss9347/full/llan.360.9347.original_

(2) UpToDate.com web site. Accessed 11/29/02. http//www.utdol.com/application/help/conflict.asp

(3) Acute Otitis Media Part I. Improving Diagnostic Accuracy, by Michael E. Pichichero, M.D. American Academy of Family Physicians newsletter, April 2000. Site accessed 11-29-02. http://www.aafp.org/afp/20000401/2051.html

(4) Rotavirus vaccines and vaccination in Latin America, by A. C. Linhares and J. S. Bresee. Pan Am J Public Health. 8(5) 2000. Accessed 11-30-02. http://www.paho.org/english/dbi/es/ARTI--Linares.pdf

(5) Pichichero Publications based on Medline Search of November 30, 2002, by Safe Minds

(6) Biographical Information on M. Pichichero, University of Rochester web site. Accessed 11-29-02. http://www.urmc.rochester.edu/gebs/faculty/Michael_Pichichero.htm

(7) Vaccine Technology Takes Center Stage in Rochester, University of Rochester press release, October 8, 1998. Accessed 11-30-02. http://www.rochester.edu/pr/releases/med/vaccines.htm

(8) Development of Methylmercury Reference Dose, by Dr. Kathryn Mahaffey, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency. Site accessed November 30, 2002. http://www.masgc.org/mercury/abs-mahaffey.html

[Contact: Sallie Bernard, Executive Director, Safe Minds sbernard@arcresearch.com; 908 295-6648; www.safeminds.org

* * *

AWARENESS

Osama bin Laden Dislikes Kelloggs Frosted Mini Wheats

The gloriously unambitious world of John Patrick

McKenzie, who doesn't care that he's a rising star in the

visual arts. And who, as it happens, is autistic.

[By Lessley Anderson. From sfweekly.com. Originally published by SF Weekly Nov 27, 2002 ©2002 New Times, Inc. All rights reserved.] http://sfweekly.com/issues/2002-11-27/feature.html/1/index.html

Most visual artists would drink their turpentine for the kind of attention that John Patrick McKenzie is receiving. He has a cult following in San Francisco. He has shown in galleries in New York, Los Angeles, and Boston. His work has commanded four-figure prices and favorable mention in the press. A New York dealer who wished to represent him recently sought McKenzie out. In the now-trendy branch of the art world known as "outsider art," he is a rising star.

To say McKenzie hasn't let success go to his head is a gross understatement. He isn't aware, for instance, that Michael Stipe of R.E.M. bought several of his works. He doesn't know who collects his art, and he doesn't care what they pay, as shown in this recent exchange: Do you want to be famous? "No? Yes? No?"

Do you want money? "No?"

Why not? "Because money is hard to get."

McKenzie is 40 years old, and lives with his parents and two younger adult sisters in a Mission District apartment. A painfully shy and obedient son, he hates crowds and usually doesn't speak unless spoken to. McKenzie doesn't see himself as a cultural critic -- the way his fans do -- or a burgeoning talent in the art world. In fact he sometimes signs his work, in the rare case that he does, "John Patrick McKenzie is nobody." And he seems to want to remain that way. Also, he is autistic.

For the past 14 years, John McKenzie has been making his art at Creativity Explored, a nonprofit arts center in San Francisco for mentally disabled adults. He is the center's biggest seller, and, in cooperation with his parents, the center makes decisions about his career. So far, those decisions have done little to capitalize on McKenzie's grass-roots following. McKenzie has made no objections.

The studios of Creativity Explored are located up the street from the congested hub of restaurants and bars at 16th and Mission, in a former turn-of-the-century dance hall that still has the stamped tin ceiling tiles that were once used as a fire retardant. The colorful artwork made by the "clients," as the students are referred to, is everywhere -- stacked in bins, stuck on the walls, piled in the corners.

If you got hold of the membership roster of the Screen Actors Guild, and shook out all the most eccentric-looking character actors, you might approximate the cast of Creativity Explored. The clients range in age from their early 20s to senior citizens, and are almost every ethnicity you can think of. Only a few show the recognizable signs of Down syndrome; the others display quirks whose roots are harder to identify. Marilyn Chen, a perpetually agitated middle-aged Chinese woman, rants about her snack money, which she forever claims has been filched by another student. Saed Nasser, a Palestinian man who wears a helmet, creeps around the studio, touching people gently with two fingers, like a human tuning fork. Evelyn Reyes, a tiny woman always dressed in a woolly knit cap and huge sunglasses, looks up from her oil pastel drawings of cakes and shouts, "Hello! What's your name?" to every visitor who walks into the studio.

Usually, the clients sit together at long tables covered in butcher paper. On the Friday after Halloween, however, they are dancing. A new instructor who used to be a modern dancer leads the clients in free-form movement to a mix of pop tunes blasting from a boombox.

John McKenzie and another instructor, Pilar Olabarria, sit across from one another at a little card table in the back of the room, where the staff usually eats lunch. Their view of the dancers is blocked by a filing cabinet. A baby-faced Filipino with a mustache, a slight overbite, and large, expressive eyes, McKenzie is dressed immaculately, in contrast to many of the other clients. He wears a sporty blue and green windbreaker and a muted Hawaiian-style flowered shirt tucked into belted chinos.

+ Article continues:

http://sfweekly.com/issues/2002-11-27/feature.html/1/index.html

 

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MEDIA

Giving Parents Reasons for Hope

Lynn M. Hamilton, parent and author of "Facing Autism: Giving Parents Reasons for Hope and Guidance for Help" will be a guest on the international radio program Focus on the Family with Dr. James Dobson. The three day series, which originally aired in April, will be rebroadcast December 19, 20, and 23, 2002. To find a radio station near you, visit www.focusonthefamily.org or http://www.family.org/fmedia/radiolog/index.cfm.

* * *

FUNDRAISING

Child Study Center Recognized For Research On Autism And Asperger's Syndrome

[Thanks to Alison Tepper Singer.] http://www.yale.edu/opa/v31.n11/story3.html

The Yale Child Study Center has received $11 million in funding from the National Institutes of Health to continue its internationally recognized studies of autism and Asperger's syndrome. The Child Study Center was also designated the top research center among those awarded funds through the National Institutes of Health's Collaborative Program of Excellence in Autism.

"Because of the work we've done and continue to do, we can make a big difference in the lives of the autistic," said Fred Volkmar, M.D., professor of child psychiatry, pediatrics and psychology. "With earlier detection more and more people with autism are leading active and productive lives."

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Lenny Schafer, schafer@sprynet.com Kay Stammers Edward Decelie

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