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Talk About Curing Autism (TACA) provides general information of interest to the autism community. The information comes from a variety of sources and TACA does not independently verify any of it. The views expressed herein are not necessarily TACA’s. TACA does not engage in lobbying or other political activities.

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TACA E-Newsletter

May 2010 #3

Here is your update on TACA (Talk About Curing Autism). If you are new to our site... WELCOME! This newsletter is produced two to four times each month.

We are an autism education and support group. We want to make this e-newsletter informative for you. As always, contact us your thoughts and/or questions so we can improve it.

We focus on parent information and support, parent mentoring, dietary intervention, the latest in medical research, special education law, reviews of the latest treatments, and many other topics relating to autism. Our main goal is to build our community so we can connect, share and support each other.

Talk About Curing Autism (TACA) provides general information of interest to the autism community. The information comes from a variety of sources and TACA does not independently verify any of it. The views expressed herein are not necessarily TACA’s.

1. Find a TACA Meeting

Come to a TACA Meeting!

TACA holds monthly meetings in many locations throughout the United States that feature educational speakers on important topics and allow family members to connect with one another and stay on top of the latest information in the autism world. Each TACA group maintains a resource library of the latest autism books, CDs and DVDs that can be checked out by members at no charge.

Check out our group listings: each contains information on TACA meetings and special events as well as a contact form.

Are you wondering what happens at a TACA meeting? Watch our video.

2. Join Us for Coffee Talk!

Come and receive some extra support or to
chat all topics related to autism and meet
other TACA families at these informal,
monthly get-togethers.

  

3. Autism Journey Seminars

Orange County, CA

Saturday, June 26, 2010, 8:30 a.m.-4:30 p.m.

Saturday, September 25, 2010, 8:30 a.m.-4:30 p.m.

After receiving the diagnosis of autism for a beloved child (or children), parents typically struggle as they search through various resources to locate information needed to help their child the fastest. The goal of the one-day Autism Journey Seminar is to provide parents and caretakers the “jump start” they need at the beginning of their journey from parents who have “been there, done that.” In addition to sage advice, parents who attend will receive: an overview of beginning therapies and biomedical intervention, where to go for what information, and recommended first steps. The seminar will be given by experienced parents who volunteer their time in providing the education new parents need.

Who should attend?
Our one-day seminar is geared for parents and caretakers of children affected by autism. Content will be provided in an “overview” presentation with web and book resource information for additional details. This seminar is geared to parents and caretakers new to the autism journey (less than 18 months) who have not yet started a behavioral/educational program or biomedical testing and interventions.

Register Online

4. Daily Autism Updates for Families

All news related to autism: AgeofAutism.com

5. A License to Kill? Part 1: How A Public-Private Partnership Made the Government Merck’s Gardasil Partner

Mark Blaxill, Age of Autism

Below is part one of a series which includes Part 2 and Part 3.

“Perhaps no other recent product on the market demonstrates successful health care technology transfer better than the human papillomavirus (HPV) vaccine, Gardasil, produced by Merck & Co. and approved by the FDA in June 2006,” proclaimed a recent National Institutes of Health (NIH) newsletter. In a February 23, 2007 article entitled “From Lab to Market: The HPV Vaccine”, the NIH Record celebrated the pivotal role of government researchers in developing Merck’s Gardasil product. “Based largely on technology developed at NIH,” the newsletter reported, “the vaccine works to prevent four types of the sexually transmitted HPV that together cause 70 percent of all cervical cancer and 90 percent of genital warts (HERE).

The occasion motivating this celebratory article was the “Philip S. Chen, Jr. Distinguished Lecture on Innovation and Technology Transfer” given by Douglas T. Lowy, one of the NIH scientists involved in developing the HPV vaccine. In the ceremony pictured above, Lowy is receiving an honorary poster from the head of NIH at the time, Elias Zerhouni, who took advantage of the occasion to shower praise on his team’s work, one he viewed as a model for future efforts. “It’s a ‘heroic’ story about the effort to fight cervical cancer, the second most deadly cancer for women worldwide, said NIH director Dr. Elias Zerhouni,” in the NIH Record’s account. “He noted that he has talked about the vaccine’s creation to Congress and with the President on his recent visit to NIH. How researchers took the technology ‘from the lab to the marketplace is a journey we can learn from,’ Zerhouni said.”

While Zerhouni was bragging to anyone in Washington D.C. who would listen about the NIH team’s role in this historic accomplishment, the vaccine's developers were actively spreading the news of their achievement in scientific circles. It’s hard to blame them, because at the time Lowy and his colleague John T. Schiller, leaders of the team that had invented the technology for the “virus-like particles” (or VLPs) that made Gardasil possible, were in some pretty heady company. In 2008, Harald zur Hausen, the scientist who discovered the role of human papillomavirus (HPV) in cervical cancer during the 1980s, received one half of the Nobel Prize in Medicine; the two researchers at the Pasteur Institute who had discovered the human immunodeficiency virus (HIV) had to share the other half.

Perhaps campaigning for their own place in the pantheon of medical heroes, Lowy and Schiller described their VLP technology in several review articles on the history and development of the Merck vaccine. These treatments were studiously scientific in tone and at points openly critical of their commercial partner, as the authors commented with disapproval on the high price Merck was charging for Gardasil. But in one May 2006 review in The Journal of Clinical Investigation, the pair also made the following disclosure about their own commercial interests:

“Conflict of interest: The authors, as employees of the National Cancer Institute, NIH, are inventors of the HPV VLP vaccine technology described in this Review. The technology has been licensed by the NIH to the 2 companies, Merck and GlaxoSmithKline, that are developing the commercial HPV vaccines described herein.”

Attached to an otherwise heroic narrative of the triumph of technology over cancer, this disclosure struck a discordant note. Conflict of interest? Inventors? Vaccine technology? Licenses? Pharmaceutical companies? Commercial vaccines? This isn’t scientific language, but rather the language of money and commerce. What was this unusual concession doing there in the fine print?

This is not an idle question, for Lowy and Schiller’s conflict disclosure forms the basis for an alternative to Zerhouni’s narrative, one that spotlights the unusually self-contained set of Department of Health and Human Services (DHHS) activities that surrounded HPV vaccine development. This alternative narrative is more of a business story than a scientific one, a narrative in which commercial interests were inextricably linked to matters of life and death. In this narrative, Gardasil is perhaps the leading example of a new form of unconstrained government self-dealing, in arrangements whereby DHHS can transfer technology to pharmaceutical partners, simultaneously both approve and protect their partners’ technology licenses while also taking a cut of the profits. Literally and figuratively, DHHS has the authority in such situations to allow its business partners to get away with murder for the greater good, effectively granting its private business partners a license to kill.

DHHS officials have their own language for such arrangements. They call them public-private partnerships, and DHHS agencies have gotten progressively more aggressive about pursuing them. NIH, for example, launched its own “Program on Public-Private Partnerships” in 2005, shortly before Gardasil’s launch. On the web-site describing this program, the NIH program managers concede that the kind of technology transfer involved with Gardasil carries unavoidable ethical risks, acknowledging that “The potential for conflict of interest exists any time the NIH and NIH staff engage with non-Federal entities to achieve mutual goals.” They provide little more than a pro forma solution for such conflicts, however: any concerned NIH staffers are encouraged to “contact their Deputy Ethics Counselor.”

It’s important to shed light on this alternative narrative as a counterpoint to the heroic story promoted by Gardasil’s many sponsors. An uninformed observer might like to assume that the responsible agencies of DHHS care not at all about commercial opportunities and exclusively attend in a disinterested fashion to the issues of health and safety that would naturally concern any consumer of vaccine products.

But that assumption would be incorrect. By taking a commercial perspective on Gardasil’s development and regulation, one is forced to confront a new and disturbing question. How is disinterested vaccine safety governance even remotely possible when DHHS employees stand as heroes at the head of the parade when a new vaccine is invented within its walls, while agency leaders are leading the cheering section, approving the new product’s launch, making the market for the product with its recommendations and then turning around to cash multi-million dollar checks? In order to better understand the real lessons of Gardasil under the harsh light of the business interests at work, let’s take a closer look at how the Merck-NIH partnership on Gardasil was forged.

Conflicts of interest in vaccine development and regulation

As the world’s largest single sponsor of biological research, NIH frequently funds research with commercially valuable outcomes. When that R&D generates potentially valuable inventions, NIH submits patent applications to the U.S. Patent and Trademark Office (USPTO) and actively pursues the approval of those patents, which when granted become valuable commercial property for DHHS, the patents’ owner. Since NIH has neither the authority nor the capability to pursue product commercialization efforts, in order to encourage private companies to invest in conducting the necessary clinical trials, NIH’s Office of Technology Transfer (OTT) was created to grant commercial licenses for such DHHS patents to commercial partners, including vaccine manufacturers. When new products invented at NIH clear the requisite regulatory hurdles at the Food and Drug Administration (FDA) and reach the market, OTT then shares in the profits. They also distribute the rewards back to the scientific teams whose products have succeeded in reaching the commercial stage: when license fees flow into OTT’s coffers, the Federal employees who invented the technology are entitled by NIH policy to a share of the royalties.

From a technology development standpoint, such commercial arrangements are the result of an intentional public policy; in fact they resulted from an Act of Congress. The Bayh-Dole Act of 1980 was written with the express purpose of making it easier for federally-funded academic research to receive patent protection that would allow the ready licensing of the fruits of commercially valuable R&D to private businesses. At the time, the concern of Congress was that federally funded inventions too often languished within the academy because businesses had insufficient incentive to invest in clinical trials, since these inventions were often unsupported by the powerful competitive protection afforded by an exclusive patent license.

The policy worked. Within the research universities that receive the vast majority of federal funding, Bayh-Dole has had the desired effect and has enabled university technology transfer offices all over the world to generate billions of dollars of licensing revenue in the last few decades--especially in the life sciences--by licensing patents from federally-funded university research to corporate partners. Bayh-Dole has effectively turned research into big business for many universities and transformed technology transfer offices into important profit centers at academic institutions all over the world.

But when technology licensing takes place within federal agencies, Bayh-Dole creates an entirely different problem: an unprecedented web of conflict, one in which the same departments that are tasked with regulating the health and safety of medical products are also profiting from them. As Lowy and Schiller conceded in their review article disclosure, this conflict of interest came into play directly on Gardasil: both men are named inventors on the technology that makes Gardasil possible; NIH filed for and received patents on their invention of the VLP technology; DHHS is the owner of the patent family that protects the commercial rights to the invention; in order to bring the product to market, OTT licensed the vaccine technology to Merck; and as Merck has generated billions in Gardasil revenue, OTT has received millions in Gardasil profits.

But DHHS is also responsible for regulating Gardasil in numerous ways. The FDA reviewed the clinical trials in which Gardasil was tested in human populations and passed judgment on Gardasil’s safety. An Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) decided whether or not to recommend Gardasil for young women and children. The FDA and CDC together now conduct the surveillance to decide whether or not Gardasil is proving safe in larger populations. And as some families are now beginning to seek compensation based on claims that Gardasil caused injury in some of its recipients, the division of the Health Resources and Services Administration (HRSA) that oversees the Vaccine Injury Compensation Program (VICP) will soon sit in judgment as to whether, to whom, and how much compensation will be provided to Gardasil’s victims.

As you can see in the chart below, all of this activity is supervised in a single department by one Cabinet official, the Secretary of Health and Human Services. The sole non-governmental agency involved in this commercial enterprise is Merck’s Vaccine Division. In effect, the Merck-DHHS partnership leaves the business side to Merck while DHHS is solely responsible for

1. Creating the market for Gardasil by funding commercial research, supervising the conduct of clinical trials, judging the outcome of those trials and promoting a policy of universal vaccination;
2. Collecting the license fees that result from Gardasil revenues from Merck and other vaccine manufacturers and then distributing these financial benefits to Federal employees; and
3. Deciding whether or not to protect the policy decisions and profit streams of their sister DHHS agencies through postlicensure safety monitoring and vaccine injury compensation rulings.

Is this good government at work or an example of the medical-industrial complex run amok? In this investigative series, Age of Autism will take a look at how DHHS agencies have managed Gardasil in all three of these sequences. We’ll start by taking a closer look at the NIH patent portfolio and the associated license fees that have been flowing into NIH coffers since 2006. (Click chart to see original slide.)

Celebrating the invention of a new market

Lowy and Schiller are both employed by the National Cancer Institute (NCI). One of the largest of the NIH institutes, NCI was established in 1937 by Franklin Delano Roosevelt. For many decades, NCI has been the agency at the forefront of the so-called “War on Cancer.” Perhaps the earliest inspiration for the both the Cancer War and the Gardasil program began during the 1960s, when NCI researchers first began looking in earnest at viruses as a potential cause for cancer. In 1961, NCI leaders created the Laboratory of Viral Oncology to begin the search for cancer-causing viruses; in 1962 the Human Cancer Virus Task Force was first convened; and by the end of the decade, enthusiasm over this research was part of the scientific momentum that persuaded President Richard Nixon to launch the War on Cancer in 1971. Unfortunately for Nixon’s legacy, and for most subsequent cancer victims, the War on Cancer has famously failed to find a cure for cancer or to validate theories of viral causation in the vast majority of human cancers.

But starting in the 1980s, the two exceptions to this litany of failure—hepatitis B virus and the human papillomavirus--led to the launch of two blockbuster new vaccine products. The infant hepatitis B vaccine was developed in the 1980s and launched in 1991 with an ACIP recommendation that all American infants be vaccinated on the first day of life. And after 1984, when Harald zur Hausen first pinpointed the role of certain strains of human papillomavirus in cervical cancer, the work on another anti-cancer vaccine could begin. By the early 1990s, laboratories all over the world were racing to develop the first HPV vaccine.

Lowy and Schiller’s NCI team were among the four most active research teams in this race, all of whom were aggressively filing patents on their HPV inventions. Along with a third NCI colleague, Reinhard Kirnbauer, Lowy and Schiller filed their first application for a patent entitled “Self-assembling recombinant papillomavirus capsid proteins” on September 3, 1992. Since then--and after splitting the original application into 29 “children” in the form of numerous “divisionals”, “continuations” and “continuations-in-part”--nine patents from that family have been granted, as well as four from a branch of the family tree entitled “chimeric papillomavirus-like particles.” The ability of the novel “L1 proteins” described in their patent to “self-assemble” into virus-like structures, which when deployed in a vaccine solution could stimulate a protective immune response against HPV, formed the essence of their invention. Although OTT doesn’t specify the royalty-bearing patents, the commercially valuable technology that Merck has licensed likely comes from this group of nine “self-assembling recombinant papillomavirus capsid proteins” patents: US5437951, US5709996, US5716620, US5744142, US5756284, US5871998, US5985610, US7220419, and US7361356.

The NCI team was among the leaders in HPV technology, but the race to make a commercially viable HPV vaccine involved several other research teams from all over the world. Most notable among these were the University of Queensland in Australia, Georgetown University and the University of Rochester. In addition to NCI’s filings, each of these university-based research teams filed their own patents; eventually, Merck and GSK got into the act as well. Like many promising areas of technology, the HPV patent landscape became large and crowded in a short period of time.

Amid this blizzard of activity, the USPTO’s Bureau of Patent Appeals and Interferences (BPAI) had to step in to sort out whether these competing patent applications interfered with each other and to distribute the credit, making a series of hotly contested decisions that were ultimately appealed to the Court of Appeals for the Federal Circuit (CAFC), the nation’s most powerful patent court. By 2007, all the BPAI and CAFC rulings had come in and the respective contributions of all four groups were conclusively allocated for commercial purposes. The team led by Ian Frazer at the University of Queensland received credit for the being the first to propose the idea of using VLP technology for a vaccine, since their application was filed on July 20, 1992, just six weeks earlier than the NCI team’s. But thanks to their unique technology of “self-assembly,” most of the invention claims of the NCI patent family remained intact as well; Lowy and Schiller’s invention has since been generally accepted as a critical advance in the wave of new technology that made Gardasil possible. In terms of the distribution of financial reward, both Rochester and Queensland have reported receiving royalty income for their HPV inventions (in undisclosed amounts) in addition to the revenues reported by OTT.

As the technology transfer officials at OTT were paving the way for the financial benefits from Gardasil to flow back to NIH, Lowy and Schiller were benefiting in other ways as well, especially when it came to scientific credit. Throughout much of 2006 and 2007, they received awards from many quarters for their role in developing Gardasil’s “virus-like particles.” Their joint awards included the Dorothy P. Landon-AACR Prize for Translational Cancer Research in April 2007 and the 2007 Novartis Prize for Clinical Immunology. In addition, Lowy by himself received the Daniel Nathans Memorial Award in September 2007 and the American Cancer Society’s Medal of Honor for Basic Research in October 2007.

In addition to these awards, on September 19, 2007, Lowy and Schiller received what was perhaps their crowning honor. That’s when the Partnership for Public Service awarded the pair the “Federal Employees of the Year Service to America Medal.” According to its sponsors, “The Service to America Medals have earned a reputation as one of the most prestigious awards dedicated to celebrating America’s civil servants. Often referred to as the 'Oscars' of government service," they are more commonly known in government circles as the “Sammies.” Upon receiving his crowning honor, Lowy was interviewed for the NIH Record and professed the requisite modesty in its October 2007 edition, saying “We are simply symbols of the many people who have made critical contributions to understanding the relationship between papillomavirus infection and cervical cancer.”

If Lowy was modest, the top brass at NIH could barely conceal their pride over their employees’ accomplishments. According to the Partnership for Public Service, “Lowy and Schiller’s 20-year partnership has been a boon to the nation’s health and for the advancement of scientific discovery.”

Collecting the licensing fees

Alongside the science and policy celebrations, the business side of the Merck-NIH partnership proceeded with a bit less fanfare and with a different kind of currency. Once their patent was approved, OTT could then turn to extracting their share of the benefits from their commercial partners’ new products, which in the case of HPV vaccine included sales first from Merck’s Gardasil product and later from GlaxoSmithKline’s Cervarix. Merck reached the market first in 2006, but GSK followed shortly thereafter in 2007. As each company began collecting revenue from their new vaccines, OTT began collecting royalties. The table below shows Age of Autism’s analysis of how Merck and GSK’s revenues may have flowed into OTT’s coffers.

	Gardasil Revenue ($M)	Cervarix revenue ($M)	NIH Top 20 Revenues ($M)	HPV Rank in NIH Top 20	HPV Revenue: estimated at 1% license fee ($M)
2006	235	--	NA	NR
2007	1,481	20	71 (est)	#4	15
2008	1,403	229	77.4	#2	16
2009	1,108	292	75.7	#1	14

Both Merck and GSK itemize revenue for Gardasil and Cervarix in their quarterly and annual earnings statements. Their annual results are summarized in the first two columns of the table. For Merck, Gardasil has been a blockbuster success, yielding a cumulative total of over $4 billion in revenue through year end 2009. By contrast, GSK’s revenues have been growing more slowly and have not yet reached a cumulative total of half a billion dollars.

For their part, OTT does not itemize their HPV license revenues. However, they do report their total royalty revenue as well as the cumulative revenue from their “top 20” technology licenses since 2007. These top 20 licenses have been worth over $70 million annually in profits for NIH in the last three years, and HPV licenses have soared to the top of those rankings quickly. Last year, OTT reported that HPV licensing was its top revenue generator. OTT doesn’t disclose exactly how much the Gardasil and Cervarix royalties contribute to NIH, but if we make the assumption that their patent licenses entitle them to 1% of the HPV vaccine revenues of their partners (an assumption that appears reasonable based on the available data), then we can safely estimate that OTT has been collecting somewhere in the range of $15 million per year from Lowy and Schiller’s invention.

In addition to their numerous scientific awards for their discoveries, Lowy and Schiller have received cash distributions from NIH based on their patents. As Federal employees, they are each eligible to receive a share of patent royalties up to $150,000 per year and Gardasil’s success has guaranteed that they would receive the maximum reward. That means that since FDA’s approval in 2006, each man has earned roughly a half million dollars in royalty revenue.

* * *
This is the DHHS vision of public private partnership at work. Contrary to the rhetoric, these partnerships aren’t simply a high-minded collaboration of scientific visionaries, but rather a large commercial enterprise with extraordinary profits at stake: an enterprise from which NIH receives credit and money and based on which its corporate partners build multi-billion dollar businesses.

How does such a partnership affect the incentives of regulators whose job it is to make sure the products are safe? It’s not obvious that they do. Just because DHHS has a financial stake in Gardasil doesn’t necessarily mean that every subsequent decision its employees make is corrupt, part of some nefarious conspiracy to kill young women for money. Indeed, HPV royalty revenues of $15 million represent just a small fraction of a DHHS budget that rose to well over $700 billion in 2009. In the larger scheme of things, DHHS revenues on Gardasil are just a small drop in a very large bucket.

Far more likely to play a role, however, in public-private paternerships like the Gardasil vaccine are the insidious cultural pressures that emerge in a supremely political organization like DHHS. Can we really expect the Secretary of HHS to take his or her FDA Director to task for implementing lax standards on vaccine approval when the Director of NIH is simultaneously praising the “heroic” researchers who invented the product in the first place? Is it more likely that CDC will apply extra caution in their vaccine policy recommendations when its sister agency is involved or will they be more likely to activate the fast track in their process of making recommendations for Gardasil? What we have observed so far merely suggests the potential for bias in the regulation of products in which DHHS holds a direct stake. In the next part of our series, Age of Autism will investigate the question of whether or not there have been actual patterns of bias in the ways in which regulators at FDA and CDC have conducted their duties with respect to Gardasil.

This series continues with:

A License to Kill? Part 2 and A License to Kill? Part 3

6. Attention-Deficit/Hyperactivity Disorder and Urinary Metabolites of Organophosphate Pesticides

Published online May 17, 2010
PEDIATRICS (doi:10.1542/peds.2009-3058)

Maryse F. Bouchard, PhD, David C. Bellinger, PhD, Robert O. Wright, MD, MPH, Marc G. Weisskopf, PhD

Departments of Environmental Health and Epidemiology, School of Public Health, Harvard University, Boston, Massachusetts; Department of Environmental and Occupational Health, Faculty of Medicine, University of Montreal, Montreal, Quebec, Canada; Departments of Neurology and Pediatrics, School of Medicine, Harvard University, and Boston Children's Hospital, Boston, Massachusetts; and Channing Laboratory, Department of Medicine, School of Medicine, Harvard University, and Brigham and Women's Hospital, Boston, Massachusetts

Objective The goal was to examine the association between urinary concentrations of dialkyl phosphate metabolites of organophosphates and attention-deficit/hyperactivity disorder (ADHD) in children 8 to 15 years of age.

Methods Cross-sectional data from the National Health and Nutrition Examination Survey (2000–2004) were available for 1139 children, who were representative of the general US population. A structured interview with a parent was used to ascertain ADHD diagnostic status, on the basis of slightly modified criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.

Results One hundred nineteen children met the diagnostic criteria for ADHD. Children with higher urinary dialkyl phosphate concentrations, especially dimethyl alkylphosphate (DMAP) concentrations, were more likely to be diagnosed as having ADHD. A 10-fold increase in DMAP concentration was associated with an odds ratio of 1.55 (95% confidence interval: 1.14–2.10), with adjustment for gender, age, race/ethnicity, poverty/income ratio, fasting duration, and urinary creatinine concentration. For the most-commonly detected DMAP metabolite, dimethyl thiophosphate, children with levels higher than the median of detectable concentrations had twice the odds of ADHD (adjusted odds ratio: 1.93 [95% confidence interval: 1.23–3.02]), compared with children with undetectable levels.

Conclusions These findings support the hypothesis that organophosphate exposure, at levels common among US children, may contribute to ADHD prevalence. Prospective studies are needed to establish whether this association is causal.

7. China: Over 1 Million Have Autism

www.examiner.com

In preparation for World Autism Awareness Day [on Friday April, 2, 2010], health facilities in China offered free check-ups and information on autism. This information was presented by way of the report style forms, speeches and training sessions.

World Autism Awareness Day was created to help emphasize the importance of early detection and prevention of autism. Unfortunately, China and many other countries still have a limited amount of help.

According to a series of non-government studies, at least 1-million Chinese children have autism.

Although the Chinese government statistics state that one in 250 children have autism, many other non-governmental autism professionals beg to differ. Rough estimates from several different reports, state that the incidence rate could be as high as one in 100 children for both sexes, and one in 68 for boys [boys stats in the U.S are 1 in 58]. By simple math alone, using the numbers of the non-government studies, it is easy to see how when China’s immense population (at least four times the size of the U.S.) is factored in, there are more individuals in China that suffer from autism.

China Disabled Persons’ Federation
Since 1982, China has been fully re-cognizant of autism spectrum disorder and in 2006 the Chinese government added autism as a disability. In response, China Disabled Persons Federation was formed in 1988. In 2009, the China Disabled Persons Federation set up rehabilitation centers for children with autism in 31 Chinese cities.

In addition, the Chinese government dedicated 725 million Yuan to 60,000 handicapped preschoolers from poor families. This particular funding only helped 1,200 children with autism.

Beijing Wucailu Rehabilitation and Research Center
Meanwhile, in Northern Beijin, Sun Menglin has been running the private school, Beijing Wucailu Rehabilitation and Research Center since 2004. The center’s mission to provide training for autistic children and their caregivers has resulted in benefitting thousands of children with autism. But, Sun foresees problems in the Center’s future.

She says that the center "suffer[s] a severe brain drain. Many of our best teachers have resigned over the years for better-paid and less stressful jobs. Some of them have been hired as private teachers and earn more than 200,000 yuan a year."

While Sun also comments that private tutoring is more effective on improving children with autism’s academic performance, it also prevents their need for social interaction and introducing them into society as they age.

The Beijing Wucailu Rehabilitation and Research Center offers training programs (spanning over three-months in length) and servicing both children with autism and their parents. For example, while the children take part in exercise, music, painting, simple skills like getting dressed, and interactive games, the parents are trained in how to teach and handle their special-needs child or children.

Sun comments "No public school in China trains teachers exclusively for autistic children as far as I know," Sun continued to say that, "It's in everyone's interest that these children grow up to be independent citizens."

Sun continues to fight autism as her new campus just opened in the northeast suburbs of Beijing.

For more information on this topic and autism please visit www.icare4autism.org

8. Censured doctor says he'll resume autism research in Austin

By Mary Ann Roser, Statesman.com
AMERICAN-STATEMAN STAFF

Andrew Wakefield, the British doctor who came to Austin after fueling a worldwide scare over vaccines and autism, said Wednesday that he expects to have his British medical license yanked next week in a final effort by the mainstream medical establishment to silence him and stop his research.

It won't work, said Wakefield, who insisted he is more convinced than ever that he was right 12 years ago when he suggested a link between vaccines, gastrointestinal illness and autism, despite scientific studies contradicting such a link. He said he will get back to his research in Austin soon, working with Dr. Arthur Krigsman, who was with him at the Thoughtful House Center for Children, where Wakefield was executive director before resigning in February.

In January, the General Medical Council, which regulates doctors in the United Kingdom, found Wakefield, 53, guilty of acting dishonestly and irresponsibly in researching children with autism in England. That work culminated in a 1998 paper in the prestigious Lancet journal that was retracted in February. The council also said Wakefield showed a "callous disregard" for children at his son's birthday party in 1999 when he had blood taken from them, paying them about $10 each and later joking about it at a conference.

In his first in-depth interview since the council's findings, Wakefield — hailed as a hero by some parents and a false prophet by many doctors — said the charges were unfair, false and pre-determined from the outset because he dared to take on the vaccine industry. He said he does not intend to fade away.

"Now that they have come to their determination, I will make absolutely sure the truth comes out," Wakefield said. "I think I am in a position to encourage people to take a more serious look at the kinds of projects I am considering," such as researching the long-term health of children who have been vaccinated and those who have not been vaccinated.

Wakefield said he resigned from Thoughtful House so he wouldn't be a distraction from its work. He said Thoughtful House was getting away from a focus on gastrointestinal issues and autism. Krigsman posted a message to former Thoughtful House patients saying their records would be forwarded to him, and they could see him at a "new, independent" office in Austin where Wakefield said he would do research similar to what he did at Thoughtful House.

Thoughtful House official Anissa Ryland said the center has not changed focus, and "we do not foresee there being any competing interests" with Wakefield and Krigsman.

Its staff will refer patients to doctors when needing gastrointestinal assessments, Ryland said in an e-mail.

Wakefield's new book, "Callous Disregard," will be out Monday, the same day the General Medical Council is scheduled to decide whether to invalidate his license. The book gives Wakefield's side of the story and lays out what he thinks was behind his prosecution: an effort by the vaccine industry to stop him from probing into vaccines that could be causing harm.

Wakefield contends that he learned from a whistle-blower that Britain had told the medical schools to stop investigating unsafe vaccines and any potential link to autism for fear the government might be sued. The government, in turn, manipulated the media and furthered his prosecution, Wakefield said. The bias, he said, continues with the media giving credence to studies that dispute links between vaccines and autism and discrediting any that suggest an association.

"Vaccine safety is built upon the confidence of the public \u2026 and I'm not prepared to (compromise) that," he said Wednesday, adding that he hopes people will read the book and "make up their own minds about what is real and what isn't real."

The book has a small publisher, Skyhorse, with a foreword by actress Jenny McCarthy, who claims vaccines made her son autistic but that he has recovered.

9. Parents of kids with autism not more likely to divorce, study suggests

By Madison Park, CNN
May 19, 2010 2:14 p.m.

(CNN) -- Emerson Donnell III had heard that 80 percent of marriages that include a child with autism end in divorce. And he felt certain it would happen to him.

About two years after the birth of his son, he found himself feeling disconnected from his family. His wife, Jennifer, devoted most of her time and energy to Emerson IV, and they rarely had time for each other. His son barely acknowledged him.

"Autism is something you can't swallow all at once," he said. "You're first run over by the truck, overwhelmed and shut down. I sometimes wished I could be the guy who could say, 'I'm out of here.' That's the easy road. The hard road is sticking in."

It's a common problem for families with the disorder, autism experts say.

Overwhelmed by the needs of their children with autism, parents can neglect their marriages. Conventional wisdom has held that families of autism have a higher rate of divorce than others, but a study released Wednesday challenges this notion.

Researchers from Kennedy Krieger Institute in Baltimore, Maryland, found that 64 percent of children with an autism spectrum disorder have married parents, compared with 65 percent of children without the condition.

The authors are scheduled to present their findings Friday at the International Meeting for Autism Research in Philadelphia, Pennsylvania.

Despite widely held beliefs, the results of the study, based on nearly 78,000 children from the 2007 National Survey of Children's Health, showed that divorce is not more common in families of autism, said Brian Freedman, the lead author of the study and clinical director of the Center for Autism and Related Disorders at Kennedy Krieger Institute.

The study was based on a snapshot -- the marital status of the survey participants at the time. It was not a study over time.

When families receive a diagnosis of autism and then hear about high divorce rates, it can be crushing, Freedman said.

"It leaves many families with a sense of hopelessness about family and relationship. I felt like it was important to get better info about this out there," he said.

It's unclear where the the 80 percent divorce rate figure originated. Autism experts said they had not found any scientific research citing that number.

The notion that parents of autistic children are more likely to get divorced is a "a little bit like an urban myth," said Dr. Patricia Manning-Courtney, director of the Kelly O'Leary Center for Pervasive Developmental Disorders at the Cincinnati Children's Hospital Medical Center in Ohio.

"There's an assumption that the divorce rate is higher," she said. "Why would people perceive it to be higher? Is it because we hear about families that end in divorce? Maybe it's more public and gets talked about more? I don't know."

Despite the conclusions from the recent study, Donnell, a Califon, New Jersey, resident, said he has a hard time believing that autism divorce rates are no different.

"With the additional financial and emotional stress, I can't imagine it's the same across the board," he said.

Donnell recalled the strain in his family life three years ago.

After a long day at work, Donnell wanted nothing more than a hug from his young son when he came home. But the 2-year-old would wince and push away all affection.

"It'd send me into an emotional tailspin," Donnell said of not being able to connect with his son. "I'd get frustrated, so I'd throw the keys on the counter and look for wine -- now my wife had two dysfunctional children on her hand."

His wife was absorbed in Emerson's care.

"Mothers focus just on the child. They put their own needs aside, their husband's needs aside, and their whole adult life aside, which is completely unhealthy. It consumes you," said Donnell, who wrote the book "Dads and Autism: How to Stay in the Game."

"Next thing you know, you don't have a relationship as a husband and wife," he said. "All you do is sit there and talk about autism."

These schisms among parents of autism tend to occur, Manning-Courtney said. From her 13 years of practicing, she observed that mothers and fathers reacted differently.

"The primary one is the division of labor," she said. "Moms sort of take over all care, and dads take over everything else -- breadwinning, money earning, the resource-providing role. That harsh division of labor can be tough over a long period of time."

Even when Donnell and his wife made an effort to get out of the house, dinner dates turned into discussions about autism therapy and doctor's appointments, Donnell said. While the two never argued, both of them felt angst.

"The picture of what parents have in mind of raising a child is different when raising a child with autism," Freedman said. "Many children with autism have behavioral challenges. Those can be challenging to handle. Taken together, it can cause stress for families."

Donnell felt irrelevant in his son's life, but he decided to take charge.

He set a routine where he would greet his son with a hug when he arrived from work. Little Emerson fought "tooth and nail" against this, but he eventually started to comply, even though the whole process of hugging and interacting was a mystery, Donnell said.

A few months later, Donnell was holding the then-2-year-old and trying to get him to say "Pop" to describe a Popsicle stick. The toddler looked frustrated, but instead of having a meltdown, he reached up to his father and gave him a hug and kiss on the cheek.

That left tears in Donnell's eyes.

These days, Donnell takes care of Emerson's therapies and schoolwork. His wife takes charge of Emerson's medical needs and his doctor's appointments. As they worked as a team, they bonded.

"We have real mutual respect for each other's strengths -- luckily in different places," he said. "It has opened both of our eyes."

He and his wife have tried to focus more on their relationship. After putting Emerson to bed, they have a baby sitter come over so they can go out for a date.

"It doesn't sound romantic, but that's the reality," he said.

10. Newsweek Reports on "Genetics False Promises"

Sharon Begley, Age of Autism

Perhaps this report on the utility of DNA/genetics/genomic research will help move autism research away from the genetics-heavy approach of the last decades and into more usable, actionable research for biologically based treatments. It's time to re-evaluate the current funding model within the autism grant community.

Read the full article in Newsweek.

DNA As Crystal Ball: Buyer Beware When it comes to predicting risk of disease, Alzheimer's genes—and others—strike out.

...Yet, as the JAMA study shows, there are serious doubts about how useful genomic information is going to be, outside of a few rare applications such as the ability of a child with leukemia to metabolize chemotherapy, one of the earliest attempts to pair genomics with medicine...

Personalized medicine has many high-profile partisans, such as Francis Collins*, director of the National Institutes of Health, who made the case for the field in his recent book. (emphasis and asterisk ours.) Nevertheless, second thoughts are clearly setting in as a result of studies like those I outlined above. Last year, geneticist Steve Jones of University College London wrote in The Daily Telegraphthat despite the billions of dollars that governments, industry, and foundations have poured into genomics and personalized medicine, "the mountain has labored and brought forth a mouse," one that will have little effect on how medicine is practiced, let alone predicting someone's risk of disease.

* You may recall a post written about Dr. Collins by David Kirby titled. NIH Director Francis Collins Blames Resignation of Top Health Official from Autism Panel on “Tension and Lack of Trust"

11. Autism link with migrant parents, study finds

BBC News

It is thought migration might "trigger" the onset of autism

Researchers have discovered that where you used to live could affect your child's chances of being autistic by up to five times.

The study looked at children whose mother had moved to the UK from outside Europe.

It showed an increased risk of autism in children whose parents had migrated from Africa, the Caribbean and Asia, the UK researchers said.

The greatest risk was for the Caribbean group, the BBC World Service reported.

Speaking on Health Check, Dr Daphne Keen, from St. George's Hospital London, said while the findings show a clear link between immigration and autism - they could not determine exactly why this was the case.

Stress factors and social isolation and so forth may operate as triggers.

Dr Daphne Keen
The research covered 428 children diagnosed with autism during a six-year period.

"We didn't find there was an increased risk in the parents who had migrated from other European countries," Dr Keen added.

"The size of the increased risk was greatest for the Caribbean group. This was at least five times.

"The risk was also very significant, but slightly less, for the African population and much lower, but still a little present, for the Asian population."

Two factors

The study took into consideration that it may just be a case of ethnicity - rather than migration - that caused the rise in cases.

However, researchers compared their results with children born of UK-born parents with Caribbean, African and Asian roots.

"We found when we analysed the two factors together, that the risk fell considerably.

"It seemed to suggest that immigration was the major factor, and ethnicity was just possibly a factor."

One theory is that the stress of migrating could act as a "trigger" for the disability, a factor discovered in similar studies looking at the causes of schizophrenia.

"There have been some interesting studies that seem to suggest that those sort of stress factors and social isolation and so forth may operate as triggers."

12. Allergen free Diet Can, and Does, Help Many Children with Autism

Editor's note: This is Dr. Bob Sear's response to a University of Rochester study, which found that eliminating gluten and casein from the diets of children with autism had no impact on their behavior, sleep or bowel patterns.

I've seen over 500 children with autism in my pediatric practice over the past 10 years, and in my experience the majority have benefited from the diet. Children with chronic GI symptoms, such as loose stools or constipation, seem to benefit the most, which would make sense. But I've seen some children without any GI symptoms improve on the diet.

So when I see a study come out that conflicts with my extensive clinical experience, I take a very close look at the study before I decide whether or not it should influence my medical decision-making. This new study, published by Dr. Susan Hyman on May 19, 2010 from the University of Rochester definitely does not change my opinion of the possible effectiveness of the diet for children with autism. First, this was a tiny study of 14 children. The medical community rarely considers such a small study clinically useful. A much larger study would have more weight. Second, the study didn't allow for enough time to pass for the diet to create enough improvement to be clinically significant. In my experience, parents often see results from casein elimination within a few weeks. But gluten often takes longer, up to several months before benefits can be seen. Third, gluten and casein aren't the only allergens that children have to eliminate. In my practice, I eliminate all allergic foods at the same time to allow for maximum healing. A very common allergen on the diet is soy. It is possible that some children in this study had other foods that needed to be eliminated and weren't. Finally, two children in the study were excluded because they tested extremely allergic to gluten (positive TTG test). Such kids would be virtually guaranteed to benefit from the diet. It is likely the researchers wanted to determine if the diet would help the general population of kids with autism and not just those with severe gluten allergy. But including those two children in the study could have resulted in an outcome more in favor of the diet.

The mainstream medical community looks for treatments with a very high success rate. For example, if an antibiotic only improves half of kids with an ear infection, such an antibiotic wouldn't be approved. A drug or treatment needs to work very well in most patients in order for it to be adopted. Autism is unique, however, in that many treatments work extremely well, but not always in a high percentage of children. Does that mean we shouldn't offer such treatments? Not at all. If I have a particular treatment that would help even 20% of children with autism, I would offer it to all children. Those that do benefit can be blessed by improvement they wouldn't otherwise have. When it comes to the diet, my success rates are much higher than 20%. I would say that at least 75% of parents report positive results, and many of those report amazing results.

I'm not going to let a very small study such as this one prevent me from offering the hope of healing to parents, and I hope that parents everywhere consider trying the GFCF diet for their child.

Additional studies that are positive for Autism and dietary invention can be found at
gfcf-diet.talkaboutcuringautism.org/dietary-research-in-asd.htm

Sincerely,
Dr. Bob Sears – Sears Pediatrics
and TACA Physician Advisory Board