SCHAFER AUTISM REPORT "Healing Autism:

No Finer a Cause on the Planet" ________________________________________________________________

Monday, January 05, 2004 Vol. 8 No. 3

RESEARCH

* Japanese Thimerosal Study Abstract

* DNA Trailblazer Foresees Designer Genes

COMMENTARY

* San Francisco Chronicle Editorial: California Legislature Should

Pass Health-Monitoring Bill

PUBLIC HEALTH

* Missing The Mercury Menace?

TREATMENT

* A Suicide Side Effect? What Parents Aren't Being Told About Their

Kids' Antidepressants

EDUCATION

* Special Ed Pupils’ Testing Standards May Be Changed

* Judge to Settle Education Dispute For Retarded Boy in North Carolina

RESEARCH

Japanese Thimerosal Study Abstract

'Effect of thimerosal, a preservative in vaccines, on intracellular Ca(2+) concentration of rat cerebellar neurons.'

ds=14698570&dopt=Abstract

Ueha-Ishibashi T, Oyama Y, Nakao H, Umebayashi C, Nishizaki Y, Tatsuishi T, Iwase K, Murao K, Seo H. Laboratory of Cellular Signaling, Faculty of Integrated Arts and Sciences, The University of Tokushima, 770-8502, Tokushima, Japan 1: Toxicology. 2004 Jan 15;195(1):77-84.

The effect of thimerosal, an organomercurial preservative in vaccines, on cerebellar neurons dissociated from 2-week-old rats was compared with those of methylmercury using a flow cytometer with appropriate fluorescent dyes.

Thimerosal and methylmercury at concentrations ranging from 0.3 to 10microM increased the intracellular concentration of Ca(2+) ([Ca(2+)]i) in a concentration-dependent manner. The potency of 10microM thimerosal to increase the [Ca(2+)]i was less than that of 10microM methylmercury. Their effects on the [Ca(2+)]i were greatly attenuated, but not completely suppressed, under external Ca(2+)-free condition, suggesting a possibility that both agents increase membrane Ca(2+) permeability and release Ca(2+) from intracellular calcium stores. The effect of 10microM thimerosal was not affected by simultaneous application of 30microM L-cysteine whereas that of 10microM methylmercury was significantly suppressed.

The potency of thimerosal was similar to that of methylmercury in the presence of L-cysteine. Both agents at 1microM or more similarly decreased the cellular content of glutathione in a concentration-dependent manner, suggesting an increase in oxidative stress. Results indicate that thimerosal exerts some cytotoxic actions on cerebellar granule neurons dissociated from 2-week-old rats and its potency is almost similar to that of methylmercury.

PMID: 14698570 [PubMed - as supplied by publisher]

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DNA Trailblazer Foresees Designer Genes

Watson says humans could shape evolution

For James Watson, the future of humanity lies in what science can tell us about our genes.

On the surface, that may not seem like a shocking statement from a man who 50 years ago helped divine the structure of DNA, the double helix of molecules that encodes our biology.

But Watson, who shared a 1962 Nobel Prize with co-discoverers Maurice Wilkins and Francis Crick of the Salk Institute in La Jolla, also predicts that 21st century science will empower humans to actually direct their own evolution.

Scientists will find the genes behind a long list of diseases and cure many of them, Watson said. Parents will be able to find out if their children are genetically predisposed to alcoholism and violence and be able to warn them.

Babies may be genetically engineered to be smarter, happier, more athletic and better looking. A pregnant mother could have the power to know if her unborn child will be handicapped or mentally ill and choose to end the pregnancy.

It is all because of science's grasp of deoxyribonucleic acid, DNA – the subject of a five-part series on public television beginning today that recounts the discovery of DNA's structure in 1953 and the biological revolution it sparked.

One of the biggest legacies of the DNA discovery is an emerging appreciation for human diversity, Watson said.

"We're going to understand why people are different," he said during a recent trip to San Diego. "I think that's going to lead to a better society because we'll be more tolerant."

During an interview in La Jolla, Watson talked about the future of genetics and how the advancing knowledge of DNA will give people choices they never thought possible.

"DNA," produced by Thirteen/WNET New York and stretching over five consecutive Sundays, begins with the epic discovery of DNA's double helix and continues with a look back at the first genetic engineering experiments, the emergence of today's biotech industry, the rise of genetically modified plants and crops, the race to decode the human genome, the quest to find the genetic causes of cancer, and the prospects for altering the human race through genetic engineering.

It is in the last segment, titled "Pandora's Box," where Watson, 75, shares some of his most controversial views.

Among them is the idea that new genetic tests will empower parents to decide the fate of their unborn children.

"I think if you knew a child would be born handicapped physically and mentally in some way, I wouldn't want to have a child born if I could bring a healthy child" into the world, Watson said.

The scientist's views have been shaped in part by his family's own experience. His son suffers from an undiagnosed mental illness that displays symptoms of both autism and schizophrenia.

Mental illness, physical handicaps, disease and other disorders are "genetic injustices," and science is acquiring the ability to set many of them right, Watson said.

He has spent much of the past 40 years studying the biology of cancer. At Cold Spring Harbor Laboratory in New York, where he serves as chancellor, scientists are attempting to catalog the genes responsible.

Watson said DNA can tell humans about not only what we are but also who we are. There are probably genes that make people talkative or introverted, good at math or bad at math, right-handed or left-handed, he said. There are probably genes for lust, and for maternal love.

Identify those genes, and someday people may be able to control which ones get turned on and which ones are suppressed. Designer babies shouldn't be feared but embraced, Watson said.

"I think it's human nature to try to improve your life," he said. "We should count on knowledge being used to improve human life, rather than being used to increase human problems."

* * *

COMMENTARY

San Francisco Chronicle Editorial

California Legislature Should Pass Health-Monitoring Bill

Every day, we get new warnings about what we should or should not eat. Missing from all this confusion is scientific certainty about how environmental pollution actually affects our health. Do pesticides harm our immune system? Do chemical toxins pose a heath risk? How much does air pollution contribute to the skyrocketing rate of asthma? Could air or water pollution contribute to rising rates of breast cancer, autism and birth defects? We just don't know. ...

That is why biomonitoring research that measures the levels of chemicals in our bodies by analyzing samples of blood, tissue, urine and breast milk is so urgently needed.

During the last few years, a network of public health, faith, labor and environmental health groups known as the California Body Burden Campaign has championed legislation that would make California the first state in the nation to establish a biomonitoring program.

Sen. Deborah Ortiz, D-Sacramento, has introduced legislation that would create "The Healthy Californian Biomonitoring Program.' The pilot programs established by her bill would focus on biomonitoring using breast milk as a marker of community health.

Cancer advocacy groups have long promoted breast-milk monitoring because more than 200 toxic substances, including flame retardants, dioxins, polychlorinated biphenyls (PCBs), DDT and other pesticides, have been found to accumulate in the fatty tissue of the breast.

At the same time, the bill would counter new mothers' concerns through the development of educational materials that emphasize the importance of breast feeding to community participants.

Last April, the bill passed the Senate Health and Human Services Committee. In January, however, it will face new votes in other committees.

We urge the Legislature to pass this pioneering legislation. An ounce of prevention is worth tens of thousands of health care dollars.

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PUBLIC HEALTH

Missing The Mercury Menace?

Parents of autistic children are vigorously challenging a new study by the Centers for Disease Control and Prevention. The study concludes there is no consistent evidence that a mercury-based preservative in CDC-mandated vaccines has caused an increase in the number of children with autism. A CDC official who helped write the study accepted the critics charge that it contained many children too young to be diagnosed as autistic. "This is true," said scientist Frank DeStefano.

The CDC's manipulation of the study data, say the parents, hides the true autism rate and obscures the link between autism and vaccinations. The parents and some scientists argue that the large increase in autism rates over the past decade was likely caused by some children’s genetic vulnerability to mercury in additional vaccines that the CDC mandated after 1990. The mercury is in preservative called thimerosal.

After 1999, vaccine makers ended the use of mercury in routine childhood vaccinations, following a request from government officials -— although the officials never stated that the mercury was harmful. But the mercury dispute is likely to heat up soon because CDC Director Julie Gerberding and Health and Human Services Secretary Tommy Thompson arc weighing a proposal by a panel of vaccine experts to give children between the ages of 6 months and 23 months as many as five flu shots.

Gerberding and Thompson can recommend that the flu shots be mercury free, or they can allow many additional children to receive mercury-laden shots. The CDG would not say whether Gerberding will urge that thimerosal be left out of the 2004 flu vaccines. According to Rep. Dave Weldon, R-Fla Gerberding has said she is considering whether to the possible link between autism and mercury.

Weldon, a physician, wants the data used in the new study to be shared with outside researchers. This seemingly arcane fight has enormous stakes if the parents are right, then many infants overseas are endangered by vaccines that contain mercury. Moreover American parents could follow the example of parent’s in the U.K., where public distrust of the government and vaccination professionals has reduced vaccination rates and spurred harmful outbreaks of measles and other diseases Several pharmaceutical companies could he forced to pay billions of dollars if parents' groups are victorious in anti-thimerosal lawsuits in which the CDC study and other reports are being used as ammunition.

This fight has already reached Congress: In early 2002, Democratic senators defeated a Republican effort to win legal protections for the companies that made thimerosal-containing vaccines. The CDC’s report published in the November issue of Pediatrics, summarized a three-year study of brain-related diseases in children, The study titled "Safety of Thimerosal-Containing Vaccines: A Two Phased Study of Computerized Health Maintenance Organization Databases," began in 1999.

It was conducted by a panel of four CDC experts and four employees of the two HMOs that provided data on more than l00,000 children. The study examined the incidence of a wide variety of developmental problems and concluded that no consistent connection existed between the mercury-containing vaccines and the diagnosed neurological problems in children born between January 1992 and December 1998. Overall, the risk of autism does not from the lowest level of exposure [to thimerosal] the highest level," DeStefano said.

+ Article continues:

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TREATMENT

A Suicide Side Effect?/What Parents Aren't Being Told About Their Kids' Antidepressants

* Names and identifying details have been changed.

For 16-year-old Angela Reich*, 2002 was a year of hell. First, the Palo Alto teenager was diagnosed with a rare form of highly aggressive cancer.

Then she went through months of debilitating chemotherapy that made her nauseous, caused her hair to fall out and kept her in bed for much of her last year of high school. She handled it all with unflappable poise and good humor until it seemed she was out of the woods. But the worst began when she started taking the antidepressant Paxil.

"Angela had been just pushing through and pushing through," says her mother, Sara.* "She mustered all her strength and courage to face the chemo and to be sick all the time." By the end of the summer, with the most intense part of her treatment behind her, she was worn out and discouraged. "She started to feel overwhelmed and depressed."

She began seeing a therapist and talked openly about her feelings. But after a few weeks her depression had not lifted, and Angela asked about going on antidepressants.

It took six weeks for the Reich's insurance company to approve a psychiatrist, and by then Angela was in a deep funk. "She was not wanting to get out of bed in the morning," Reich recalls. "She couldn't do her homework. She said it felt terrible to live like this, but then she would say, 'I don't want to die, I don't want to hurt myself.' I remember sitting across from her at the kitchen table and tears pouring from her eyes and her saying 'This is so hard.' "

The psychiatrist prescribed Paxil, a selective serotonin reuptake inhibitor (SSRI) similar to its famous predecessor, Prozac. On a dose of 5, then 10, then 15 milligrams a day, Angela soon started feeling better.

Five weeks after she began taking the medication, Angela and her mother met with the psychiatrist, who suggested another boost in dosage. "He said she's doing well now; she could be doing even better on 20 milligrams,"

Reich remembers. She was hesitant, but Angela wanted her old life back and thought it made sense to try. The next day, she started on the higher dose.

Restless Legs, Sleepless Nights Within days, Reich says, her daughter was acting strangely. The first change was Angela couldn't keep her leg still. "She'd be sitting in a chair and her knee would be jerking up and down." She became irritable and had more trouble sleeping. Her parents would ask about her restless, jerking leg and she would snap at them to leave her alone.

When Reich left on a business trip, Angela called her three or four times a day and begged her to come home early. When she returned, Angela "burst in my room and hugged me," Reich says. "She kept saying, 'Mommy, I'm so glad you're home.' She was scared, like she couldn't cope. She said she dreaded going to bed because she had so much trouble sleeping. She'd lay there thinking and her thoughts got darker and became unbearable."

That night, Reich shared her daughter's bed but Angela slept little and was still wound up in the morning. When her mother tried to get her ready for a piano lesson, she said she wasn't going. "She looked funny and had a weird smile on her face," Reich remembers. "I knew something was wrong. I looked around the room and saw some pill bottles. I asked if she took any pills and she said 'Yes.' "

Under questioning, Angela told her mother she had taken four tablets of the sleeping pill Ativan. Then Angela ran to the bathroom, locked the door, and started going through pill bottles. Her father, Jim, smashed the door open and snatched a bottle of Benadryl from her hands. She ran to her purse, seized a bottle of Tylenol and began shoving pills in her mouth.

Her mother grabbed her, pinned her arms, and marched her to the car, as Angela's younger brother watched.

Reich drove straight to a nearby hospital. One block from the house, Angela turned to her mother. "She said 'Mom, I don't know why I did that.

It was like something took me over.' And I said 'I know, it wasn't like you. But I will keep you safe.' "

At the emergency room, the staff administered charcoal to absorb the drugs, then transferred Angela to a psychiatric hospital. The next day, the hospital psychiatrist called Reich. "He told me it was a drug-induced suicide attempt," she said, related to the increased dosage of Paxil.

Neither Angela, Sara nor her husband, Jim, an internal medicine doctor, knew Paxil might carry a risk of triggering suicidal thoughts or actions.

Aside from a generic statement that depressed people are more likely to attempt suicide, there is no mention of such a risk in Paxil's prescribing information.

England Acts, United States Follows The risk Paxil may pose to children and teenagers burst into the news this summer, when British regulators issued a warning urging doctors not to prescribe the drug to children. They were acting on new data presented to United States and British authorities showing that among 1,100 children enrolled in clinical trials of Paxil, those taking the drug were nearly three times as likely to consider or attempt suicide as children taking placebos. "There is an increase in the rate of self-harm and potentially suicidal behavior in this age group," said a statement from the British Medicines and Healthcare Products Regulatory Agency (MHRA). "It has become clear that the benefits (of Paxil) in children for the treatment of depressive illness do not outweigh these risks."

Nine days later, the FDA issued a similar warning and announced that it would conduct a detailed review of pediatric trials of Paxil, a review soon broadened to include seven other antidepressants, including top sellers Prozac, Zoloft and Effexor. In August, Wyeth Pharmaceuticals warned doctors that its drug, Effexor, triggered hostile behavior or suicidal thinking in children at twice the rate as the sugar pills taken as placebos.

Then, last month, the MHRA announced that it was urging doctors to stop prescribing a group of six antidepressants, including Paxil, Zoloft and Effexor because they caused an increase in suicidal thoughts and actions.

"These products should not be prescribed as new therapy for patients under 18 years of age with depressive illness," wrote Gordon Duff, chairman of the MHRA's Committee on Safety of Medicines, in a "Dear colleague" letter to British physicians.

Prozac, the only SSRI approved for use in depressed children, was not included in the new warning. The British review did not find a significant increase in the risk of suicide-related events among children taking the drug.

The British and American warnings were a stunning turnaround that left thousands of parents whose children are using the drugs wondering whether their children were at risk. But it was also long-sought vindication for a small group of researchers, family members and lawyers who have been arguing for years that antidepressants cause some people to become violently unhinged. They say they've been frustrated in getting this word out to the public, in large part because of the FDA's unwillingness to confront and control the drugmakers.

The FDA's warning about a possible suicide risk from Paxil left Sara and Jim Reich feeling furious, betrayed, and ready to sue. "Had I known there was a threefold increased risk of suicide among kids taking Paxil, I would not have allowed my daughter to go on that drug," said Jim. In fact, Jim has prescribed the drug himself and is outraged that the Physician's Desk Reference, or PDR - the drug bible for doctors, based on FDA-approved prescribing information - says nothing about Paxil's suicide risk.

The British and American warnings also raised some troubling

questions: How did drugs that have been widely promoted as nearly risk-free, and that are commonly prescribed by pediatricians and child psychiatrists, come to be seen as potentially dangerous? What should parents whose children are taking them do about it? And just how effective are these drugs that can sometimes cause such serious problems? An Uncontrolled Experiment Since 1987, when Prozac became the first SSRI on the market, America's love affair with antidepressants has worked its way down the age ladder.

Between 1987 and 1996, the use of antidepressants and other psychotropic medications by children and adolescents tripled, with most of that increase occurring after 1991, according to a recent study in the Archives of Pediatric and Adolescent Medicine. By 1996, the study found, 6 percent of American children and teenagers were taking psychotropic medications, one-third of which were antidepressants.

Biological solutions to behavioral problems were becoming increasingly acceptable, even fashionable. "I think there's been a revolution in the way people think about behavior," says Lawrence Diller, a behavioral pediatrician in Walnut Creek. "The idea that children's behavior is the product primarily of their genetics and biochemistry was promoted by American psychiatry and hijacked by the drug industry. It's simply become more acceptable to see behavior as a reflection of an imbalance in chemistry rather than an imbalance in life."

The phenomenal growth in antidepressants prescribed to children leaves many doctors and therapists uneasy. Diller, who has written about his misgivings in two books ("Running on Ritalin" and "Should I Medicate My Child?"), cautiously prescribes antidepressants to some children, but says the new data about a possible link to suicide is making both him and some parents think twice. "It hasn't caused me to stop using SSRIs, particularly in teenagers, but I think it's another reminder that our information is incomplete."

To understand how we got here, it's important to know a bit about the

drug- approval process. When a drug company applies to the FDA for approval to sell a medication, it must demonstrate that the drug is safe and effective for a particular population, such as adults, and a specific condition, such as depression. Once the drug has been cleared by the FDA and is on the market, doctors are free to prescribe it to anyone for any reason. "Off-label" prescribing, is quite common; the only real restriction is that drug companies cannot market drugs to unapproved groups. From 1987, when Prozac was first approved for adults, until early last year, when Prozac became the first SSRI approved for use in depressed children 7 and older, all antidepressants used by depressed children were prescribed off-label.

The widespread use of antidepressants by children, critics say, amounts to an uncontrolled national experiment. The prescribing physicians are often pediatricians or family doctors with little or no training in psychopharmacology. The drugs are frequently given in the absence of therapy or other interventions. The subjects of the experiment - children - are too young to give meaningful consent. There is little understanding of the long- term effect these medications have on the architecture of children's developing brains. And the evidence that the drugs are effective is less than impressive.

When Prozac was approved for depressed children last year, it was on the strength of two controlled trials. One, published in 1997 in the Archives of General Psychiatry, found that after eight weeks, 56 percent of kids taking Prozac showed some improvement, according to the clinicians who evaluated them, compared with 33 percent of the kids in the placebo group.

But 69 percent of the kids taking Prozac still had significant symptoms of depression. Clinical trials of Paxil, Zoloft and Effexor found those drugs to be no more effective than placebos in treating depressed children.

Perhaps the most notable finding from clinical trials of antidepressants is how many children respond well to placebos - as many as 59 percent in some studies. This high placebo response rate is a common finding in pediatric drug trials, in which children are generally seen once or twice a week by clinicians, says David Healy, an internationally known psychopharmacologist from the University of Wales College of Medicine who has emerged as a prominent critic of drug company practices. "This suggests that simple support can help children in many cases," Healy says.

SSRIs: Cleaner and Safer? In the years since 1987, SSRIs have developed a reputation for being largely free of serious side effects, vastly improved over the older generation of so-called tricyclic antidepressants. In some respects, this is true: Distressed patients who attempt to kill themselves by overdosing are unlikely to succeed; they can usually tolerate the pills. And patients taking tricyclics are more likely to suffer from constipation, urinary retention, blurred vision and dry mouth.

But SSRIs cause sexual problems at fairly high rates, as well as insominia, nausea, dizziness and other side effects. Studies also have not found them to be more effective than the older pills at relieving symptoms of depression. "The SSRIs have sold themselves very heavily as safe and clean drugs compared to the old antidepressants," says Healy. "Well, it's not clear that they're safer, and it's not clear that they cause fewer side effects."

One side effect of SSRIs, recognized for at least 15 years, is a sensation called akathisia, a restless agitation that ranges from jitteriness to a sensation described by some people as "jumping out of their skin." Healy believes akathisia is the principal trigger for impulsive violence in some people taking SSRIs. "They became anxious, agitated, terrified, unable to sleep at night and restless," he says - the symptoms that plagued Angela Reich.

There have long been signs that SSRIs sometimes cause these reactions, which drug manufacturers have tried mightily, and largely successfully, to keep out of the public eye and off the labels. This issue first arose a couple years after Prozac went on the market, amid a raft of media reports about grisly acts of murder and suicide. The most notorious event took place in 1989, when Joseph Wesbecker went on a shooting frenzy, killing nine fellow workers of a Louisville, Ky., printing plant before turning his gun on himself. Wesbecker, who had a history of mental problems, was taking Prozac. No one could prove Prozac caused his rampage, but by early 1991, some 350 suicides of Prozac patients had been reported to the FDA, according to one former FDA official. Those reports, which occurred outside the context of scientific clinical trials, were dismissed as anecdotal and sensational by company officials.

Harder to dismiss, though, was a study published by Harvard researcher Martin Teicher and two colleagues in the American Journal of Psychiatry in 1990 about six patients who developed "violent suicidal preoccupation"

after taking Prozac for two to seven weeks. "It was also remarkable how violent these thoughts were," the authors reported. "Two patients fantasized, for the first time, about killing themselves with a gun," they wrote, while one placed a loaded gun to her head, another had to be restrained to prevent self- mutilation, and another fantasized about killing himself in a gas explosion. None of the patients was suicidal when they started taking Prozac, the researchers reported, and their fixation with violence and death abated when they stopped.

Similar symptoms were noted the next year in a paper in the American Journal of Child and Adolescent Psychiatry about six children ages 10 to 17 who developed "intense self-injurious ideation or behavior" while taking Prozac. After three weeks on the drug, one 14-year-old girl, who had been depressed but never suicidal, began cutting and otherwise injuring herself. She told hospital staff, "I'm just waiting for the opportunity to kill myself, " and chanted, "Kill, kill, kill; die, die die; pain, pain, pain," according to the paper. The Yale University authors noted the complexity of reaching any conclusion about the cause of these events since the children all had lengthy histories of psychiatric difficulties that put them at risk for suicide. They also noted that many children taking Prozac become agitated, restless, and disinhibited and developed insomnia to boot.

A 1998 paper by Roger Lane, a scientist at Pfizer, the maker of Zoloft, stated that "all SSRIs have the rare potential to cause akathisia." In its most extreme form, Lane wrote, patients may feel that "death is a welcome result."

Lane also warned that akathisia can sometimes be mistaken for worsening depression, prompting some doctors to increase the dosage - and the danger. Healy agrees. "[Doctors] have been educated to think that SSRIs take four, five, six weeks to work," he says. "But they can cause problems long before that."

In response to the Teicher paper and the growing media furor connecting Prozac to acts of violence and suicide, the FDA in September 1991 convened an extraordinary special hearing of its Psychopharmacological Drugs Advisory Committee. Speakers told of family members who committed suicide or homicide while on Prozac and begged agency officials to ban or restrict the drug. But representatives of Eli Lilly, maker of the blockbuster drug, backed by FDA and academic researchers, argued that suicide is an inherent risk among depressed patients. The Lilly officials presented figures from the company's clinical trials database suggesting that people on Prozac were at no greater risk of suicide than people taking placebos.

Committee members voted unanimously in Lilly's favor, and Prozac remained on the market. No warning that the drug might induce violent or suicidal urges in some people was added to its label.

'Cooking the Books' The Prozac suicide controversy, and the huge number of suicide reports that were streaming into the agency, reverberated inside the FDA, where two other SSRIs, Paxil and Zoloft, were being considered for approval. The FDA medical officer charged with reviewing Paxil's safety and efficacy data was Martin Brecher, now an executive with the British pharmaceutical company Astra Zeneca. "The reports of successful suicide were coming in in bunches," he said in a recent deposition. "It was extraordinary, especially in comparison to other annual reports where, you know, you had 20 reports of a cold and maybe two reports of some liver enzyme elevations and here you are with 20 deaths in a report."

Because Paxil and Zoloft were members of the same chemical class as Prozac, the FDA asked officials at SmithKline Beecham (the predecessor to

GlaxoSmithKline) and Pfizer, Zoloft's maker, to submit reviews on the drugs' effect on suicidal behavior of patients. Brecher called Thomas Donnelly, a SmithKline Beecham executive, and asked him to prepare such a report. In an internal company memo uncovered in a lawsuit, Donnelly described his conversation with Brecher, noting that the FDA "does not see it as a real issue but rather as a public relations problem."

What happened next is controversial. Critics charge that the company manipulated data to diminish the apparent suicide risk among Paxil users and submitted it to the agency. One of the harshest critics is an unlikely plaintiff's attorney in San Rafael, a self described conservative Republican and retired Navy officer named Don Farber.

Farber, who has spent the better part of the past five years suing

Glaxo- SmithKline and other drug companies, is one of a handful of lawyers handling such cases. His first case involved a San Jose man, Reynaldo Lacuzong, who, in 1996, drowned his two children and himself in a bathtub three days after he began taking Paxil. After the suit was filed, GlaxoSmithKline and the surviving Lacuzong family resolved the case with an undisclosed settlement.

The same thing has happened in dozens of other cases of alleged SSRI- induced suicide or violence; few cases ever go to jury. In June 2001, however, a case did. Three years earlier, Donald Schell, a 60-year-old Wyoming man, killed his wife, daughter and granddaughter three hours after taking two tablets of Paxil given to him as samples by his internist.

Surviving family members sued GlaxoSmithKline, and the jury awarded them $6.4 million for the wrongful deaths of their relatives.

"[The company] knew there was a small group at risk and Don Schell was one of those vulnerable people," the family's attorney, Andy Vickery told the jury. Farber makes the same argument: Drug companies have an obligation to warn doctors and patients that these drugs can pose a threat to some people.

"If there was a warning that said 'Caution: this drug may cause suicide in some people,' then doctors are going to know about it," Farber says.

Instead of warning people, Farber charges, Glaxo-SmithKline tried to hide the true numbers. "They cooked the books," says Farber during a recent interview. "They cheated on the results. And the FDA is part of this."

Farber says the company manipulated the figures. Documents obtained by The Chronicle show that in its initial application to the FDA, the company reported that out of 2,963 adults taking Paxil during clinical trials in the United States or other countries, seven patients killed themselves and 42 attempted suicide. But in a review submitted in April 1991, in response to Brecher's request, the seven suicides had dropped to five and the 42 attempts had gone down to 40.

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EDUCATION

Special Ed Pupils’ Testing Standards May Be Changed

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Angela Polley understands that her son’s autism makes him different from the other students in his third-grade class, and she hopes his disability doesn’t harshly affect the rest of his school.

Under the No Child Left Behind test standards, schools are held accountable for the scores for all students.

Polley, however, argues that students like her son Chad, 8, should not be held to the same standard when they simply cannot perform at the same level.

"He cannot work at the same level as the average third-grader," she said. "He just doesn’t have the capability of doing that. The work that he does do he does very well, but he just doesn’t have the capability of comprehending the work that regular third-graders do."

Chad is in a special education class at Garth Elementary, and his mother said his reading ability is limited.

The No Child Left Behind tests do not currently provide any different scales for children with disabilities, leaving some Scott County schools in jeopardy of future penalties. Four schools, Georgetown and Scott County middle schools, Scott County High School and the Ninth Grade School, missed goals on the No Child Left Behind reports issued Nov. 17 in the "with disability" category, which includes any students needing special education services.

The reports held all students to the same annual measurable objectives

(AMOs): the percentage of students needing to score at proficient level or above in math or reading on the Commonwealth Accountability Testing System.

A new rule may help schools with large populations of special-needs children. It says students with "significant cognitive disabilities" may be held to different testing standards from other students, but each state must define who fits into that category.

Polley is uncertain if the new rule will help and said it will depend on which students fit into the special category.

"If you’re going to give Chad a standardized test, you’re not going to get the score you want," she said. "He wouldn’t know how to read it. He would probably scribble all over it."

Superintendent Dr. Dallas Blankenship hopes the new rule helps schools that were at a disadvantage in the No Child Left Behind reports.

"That doesn’t change the fact that we have a huge responsibility, and we’ll be working diligently to meet the needs of every one of our special-needs children," Blankenship said.

Thousands of schools nationwide missed testing goals this year because of their scores in the "with disability" category, the Associated Press reported.

GMS "with disability" students missed the math AMO (16.49 percent) with 0 percent scoring proficient or above. The school’s "with disability" population also missed its reading AMO (45.6 percent) by scoring 14.63 percent.

SCMS and SCHS/Ninth Grade School each missed the reading AMOs for students with disabilities. SCMS scored a 12.12 percent and needed a 45.6 percent. SCHS/Ninth Grade scored a 11.54 percent and needed a 19.26 percent.

"That’s the only (population) where the high school didn’t meet their AYP (annual yearly progress) goals," Blankenship said. "At our middle schools, that’s also an area that we need to target. The fact that the federal government is beginning to work with states to make sure that the guidelines are aggressive, but also reasonable, is a good step."

Blankenship acknowledges it will take time to bring special education students up to the No Child Left Behind standards.

"We think it’s fair to look at students and their achievement at the present and then set high goals for future improvement," he said. "That’s something we were already doing.

"But if you evaluate a school or individual child and then establish that moment as the only evaluation, then you’re not getting a true picture. You need to look at the progress being made for each child over time."

The district wants special education students achieving at the highest levels possible, Blankenship said.

"In order to do that, we have an individual education plan that is tailored to meet the needs of each child," he said. "The district works closely with the parents, the school, the school psychologist and the special education department to help design that program."

Polley believes Garth teachers are doing all they can for her son.

"I don’t think there’s anything else the teachers could learn or have training in to bring Chad up to the work the other third-graders do," Polley said.

Schools that do not make all their target goals for two or more years straight face consequences from giving parents the opportunity to transfer their children to another school up to implementing an alternative governance.

While she likes No Child Left Behind’s purpose, Polley opposes penalizing schools for not meeting goals in the "with disability" category.

"The school should not be held accountable when they’re doing everything they can do with the teachers and programs for those particular children," Polley said.

"Not to divide special ed kids between typical kids, but I don’t think it’s fair to expect them to do the same kind of work when they don’t have the ability to do it. I don’t think it’s fair to penalize schools because their special ed kids are not meeting the standards set up by the federal government."

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Judge to Settle Education Dispute For Retarded Boy in North Carolina Parents say program can't meet needs

Archdale, N.C. - A 13-year-old with mental disabilities is at the center of a legal dispute that tests whether a school district's obligation to educate him includes a Maryland school costing $135,000 a year.

U.S. District Judge William Osteen delayed issuing his opinion last week in the lawsuit filed by Elliott Cone's parents until Wednesday. Osteen told the Cones and the Randolph County public school system he was leaning toward bringing Elliott back to North Carolina. He urged both sides to agree to a smooth transition period.

The Cones and Elliott's doctors say a new program at the Murdoch Center, a residential center for the severely mentally retarded in Butner, cannot meet Elliott's needs and could cause the boy serious harm if he were forced to move.

The state is required to provide disabled students with a free, appropriate public education in the "least restrictive environment" possible. But what is appropriate and what is least restrictive is open to interpretation - and can pit the wishes of parents against those of the school district.

For three years, Elliott has attended the Benedictine School in Maryland, where he was moved after school officials and his parents determined that there was no appropriate setting for him in North Carolina. His education before Benedictine was a jumble of different schools, home schooling and stays in various hospitals.

But in 2001, North Carolina and the Randolph County school system, which pays for much of Elliott's $135,000-a-year education, told the Cones their son would be moved to the new program for autistic children in Butner.

Elliott suffers from Fragile X Syndrome, an inherited genetic disorder that can cause mental retardation and autism.

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