Sunday, October 31, 2010

Communication Shutdown Day

Lisa Jo Rudy reports:

Tomorrow, November 1, has been set as "Global Communication Shutdown Day." We are encouraged to cease twittering and facebooking for the day in order to raise awareness of and funds for autism - and, to some degree, to simulate the communications challenges faced by people on the autism spectrum. The non-communication is supposed to mirror autistic isolation; the fundraising will take place when you pay for a "charity app" you place on your computer which "spreads the word, gives a shutdown badge to wear online and adds your picture to a global mosaic of supporters, next to the celebs." Information about recipients of you donations can be found on the Global Shutdown Day website.
There is significant opposition to the idea:

Friday, October 29, 2010

Family Activism and MIND

Chuck Gardner writes at The Sacramento Business Journal about the origins of the MIND Institute. Like so many families, they started with worries that a pediatrician could not resolve:

Eventually, we found our way to a specialist in San Francisco and learned our son had a disorder called autism. We were told to go find a nice institution for our son and move on with our lives. Instead, on the trip home, we vowed to exhaust every avenue to find out what the proverbial “they” were doing to treat and cure autism.

We discovered there was no “they” for autism and further, there was no medical treatment, no cure. In fact, autism was considered to be such an impenetrable disorder that it received little funding from the National Institutes of Health, and thereby little attention from the research community.

Two years later, we came together with four other Sacramento families who believed that with a focused scientific effort, we could begin to see into the core biology that underlies autism. Our vision was to create a place where families, researchers, clinicians and educators would partner to mount an unprecedented effort to prevent, treat and cure autism and related disorders. We wanted families like ours to know there was a “they.”

Today there is a “they,” and thanks to the University of California Davis, it is the world-renowned MIND Institute. The team at the MIND Institute is achieving the vision set by the families by making the most significant discoveries in the history of autism and another poorly understood developmental disorder, fragile X syndrome.

When we approached UC Davis with our vision, we found a university that was not only open-minded but willing to take a risk that a few highly motivated families could deliver on that vision. With a “Field of Dreams” spirit, UC Davis built the MIND Institute and “they” came: researchers, clinicians and educators. All are focused on preventing, treating and ultimately curing autism and related disorders.

See here for an April 2006 article by Gary Delsohn providing more detail on MIND's origins.

Thursday, October 28, 2010

Autism and College

At The American Thinker, Robert Weissberg writes:
It is not easy being a connoisseur of educational foibles -- just as one is recovering from the latest foolishness, along comes something new, and it's back to the anti-depressants. The latest installment of Educators Gone Wild is the push to enroll the "intellectually disabled" in college. We are not talking about attracting eccentrics; these recruits are youngsters with Down Syndrome, autism, and other disabilities that seriously impede learning. This is college for those stymied by reading and writing.

Eight years ago, a mere four campus programs existed for the intellectually disabled; by 2009, this has soared to 250 in some three dozen states (see here). Predictably, the impetus for this good-heartedness is federal money, and more is forthcoming -- Congress recently appropriated $10.56 million to develop 27 model projects to uncover successful approaches to getting these youngsters into college. Private foundations have also kicked in (federal Pell Grant loans also permit the mentally disabled to pay tuition and thereby acquire debt).

And why should Washington push access at a time when higher education funding in general is hurting? Political lobbying, notably pressures from parents of disabled children, has seen one triumph after another, and access to college is the next agenda item (see here for these groups). This is the "logical" progression of the mainstreaming movement whereby inserting the disabled into regular settings becomes a matter of right regardless of what is accomplished (see here for the legal push).
Though he is usually a very perceptive analyst, Dr. Weissberg paints with too broad a brush here. Autism itself is not an intellectual disability, and many people on the spectrum can indeed do college-level work. Most famously, Temple Grandin earned a Ph.D. in animal science at the University of Illinois, where Dr. Weissberg himself used to teach.

Wednesday, October 27, 2010

NY Mandate Redux?

The Journal News reports that NY Governor David Paterson might still be willing to sign a mandate:

Paterson also said this morning that he would like to sign legislation for health-insurance coverage of autism. He recently vetoed the bill that was passed by the Legislature, saying it “wrenched his heart” to veto it, but he could not sign anything that did not include funding and amounted to an unfunded mandate. “If the Legislature would come back and appropriate the money, they could resubmit the bill and this time I would sign it,” the governor said.

Autism groups that were for and against the measure lobbied heavily on it. It was sponsored by Sen. Neil Breslin, D-Delmar, Albany County, and Assemblyman Joseph Morelle, D-Irondequoit, Monroe County. Morelle said in a statement that he was disappointed in the veto, which “would have prevented insurers from denying coverage on the basis that treatments are educational rather than medical in their necessity.” He said the legislation “was an opportunity to simply do the right thing for the ever-increasing number of families whose children are diagnosed with autism.”

Groups that opposed it said the requirement that state-regulated insurance companies cover “evidence-based, peer-reviewed and clinically proven” treatment and therapy, a standard that is not required for other medical problems, and would shift the burden to pay for early intervention services from insurers to local governments and taxpayers.

“We appreciate the state Legislature’s concern and interest in providing for increased autism insurance coverage,” Thomas Abinanti, a Westchester County legislator, said in a statement. “We look forward to working with the Legislature to create increased autism insurance coverage that is affordable and cost effective.”

Abinanti, a Democrat running for Assembly, has an autistic child. His Republican opponent is Thomas Bock.

Tuesday, October 26, 2010

Autism Across the Oceans

The BBC reports that autism can be contentious in the United Kingdom:

New figures from the Department of Health reveal 291 children in Northern Ireland have been delayed beyond the target and that suspected new cases rose by 38% in the 12 months to September.

Health Minister Michael McGimpsey said he hoped all Health and Social Care Trusts would be meeting the target by next March.

The battle for improvement comes amidst friction between the charity Autism NI and one of the key supporters of the Department of Health's strategy, Ken Maginnis, the House of Lords peer.

Funding

The charity interprets an email written by Lord Maginnis to the department three weeks ago was a "threat" to its funding.

According to up-to-date Government figures, it received £320,000 in core and project funding in 2008/9 from the Department of Health and trusts.

Lord Maginnis complained of the charity's "persistently obstructive attitude" - something it has denied - and asked whether it should function "independently of any formal provision."

In Australia, there is a regional gap. The Age reports:

While Melbourne's eastern suburbs have two prep-to-year-12 autism schools, and the Northern Autistic School has campuses in Preston and Jacana, parents say there is nowhere for autistic children in the west after age nine.

''Inclusion into mainstream school does not work for all children,'' says Chris Saunders, of Autism Schools Action. ''This is a human rights issue.''

Yesterday about 20 parents from the group confronted state Education Minister Bronwyn Pike at the launch of the new Laverton campus of the Western Autistic School, to demand the same options in the west as in other parts of Melbourne.

KUAM-TV has a two-part series about autism on Guam:


Monday, October 25, 2010

Autism Stabilizes in WI Schools

Reuters reports:

Autism rates could be leveling off at just above one percent of children, Wisconsin researchers suggest.

Between 2002 and 2008, they found the number of kids in the state's special education autism category nearly doubled. But the increase was only seen in those schools that started out with very few autistic kids, hinting that the statewide rates may be stabilizing.

...

The new study hints that at least some of the increase could be due to schools putting more and more kids in the autism category, said Matthew Maenner, a PhD student at the University of Wisconsin-Madison, who worked on the new study.

"The prevalence of autism in special education doesn't seem to be the same everywhere, and it doesn't seem to be increasing at the same rate everywhere," he said.

The findings, published in the journal Pediatrics, show that the statewide rate of children receiving special education for autism went from five to nine cases per 1,000 over seven years.

Not all of these kids may have a medical diagnosis of autism, but Maenner said data on enrollment in special education programs are often used as a proxy for the prevalence of disabilities.

Schools varied widely in the number of autistic children they had. But over time, the gap narrowed from a spread of more than 24 times to less than two.

The schools with more than one percent autistic kids at the beginning of the study period saw little or no change.

Dr. John Harrington, an autism expert who was not involved in the research, said it looked as if the autism rate could be stabilizing.

"As you get better at identifying something, your numbers get less varied," he told Reuters Health. "Finally we can look at these kids and say, they are not just odd, they have a diagnosis."

Sunday, October 24, 2010

Views of Autism Speaks

Zach at AspieWeb shows video of a protest against Autism Speaks:

I find it very disturbing to watch this video. Here are people who want to be treated equally, who want to be included in society – not research to find a way to selectively abort them and there told the following:

  • 2:25 – Are you really that stupid?
  • 3:25 – How do you sleep at night?

If your in the Washington DC area November 6th please consider joining the ASAN in protesting Autism Speaks. For more information and coordination ASAN has created a facebook event page – even if your not going to be there please join it and show your support. If your going to be there I have created several items just for occasions such as this – check them out.

At The Huffington Post, Holly Robinson Peete takes a more positive view of the organization:

Parents across the country have banded together and fought to change state insurance laws to end this injustice. In just four years, they have already won the fight in 23 states, and the battle continues (New York's Governor Paterson just vetoed an insurance bill that passed unanimously in the state legislature, making him just the second governor to take this misguided action). They're fighting against some powerful people, including the insurance companies and their lobbyists. They're also fighting against ignorance. You may have read about one notable Senate candidate who mocked the idea of autism coverage -- she used air quotes when she talked about autism. But these parents are smart, they're organized and they're truly inspirational. That's why they're winning.

Autism Speaks has a wonderful advocacy web site, AutismVotes.org (I serve on the organization's board) with information about the insurance reform effort. Check the map and see if your state has done the right thing yet. If not, you'll find out how you can get involved and help make important change happen for people with autism.


Saturday, October 23, 2010

Staten Island Rally

The Staten Island Advocate reports on a rally for people with autism:

Last night, their biggest cheerleader was Borough President James Molinaro, who hosted his inaugural “Stand Together for Autism Services on Staten Island,” in the Michael J. Petrides Educational Complex, Sunnyside.

Molinaro told the crowd that this was just the beginning of “a very long, long journey” of letting government know “what we want and what we deserve” in terms of services for those with autism.
...

A critical, but often neglected component noted during the evening, is the care of autistic adults.

“The biggest spike in autism came about 15 years ago and those kids are adults now,” said Dr. Joanne Gerenser, executive director of the Eden II School for Autistic Children. “We recognize early intervention is critical, but what are the effects of time. You’re a kid for 18 years and an adult for 70. The amount of money spent on adult services is inordinate.”

State Sen. Roy McDonald, who proposed an Autism Bill of Rights, said often politicians will use the bad economy as an excuse not to provide services. The only way to combat that, he said, is for parents, advocates and others to stand together to make their voices heard.

“Make sure your cause is addressed by the people in power appropriately,” he said.

Funding right now stands in the way of research and services.

“It’s one of the fastest growing developmental disabilities, but agencies are being asked to do more with a lot less,” said Donna Long, executive director of theG.R.A.C.E. Foundation. “The demand is so great that the needs can’t be met. It’s a very difficult thing to say to a family searching for a service that we have to put their child on a waiting list.”

Autistic children who can’t get spots in programs geared toward them often wind up in places devoted to a wide range of developmental disabilities.

“They are well-intentioned, but they don’t have the expertise,” said Dr. Gerenser.

Friday, October 22, 2010

Autism, the Health Bill, and Medicaid

Bloomberg Business Week reports:

The health law passed in March requires that insurers led by UnitedHealth Group Inc. and WellPoint Inc. begin covering a package of “essential benefits” in 2014. The law doesn’t say what care should be included, leaving that up to the U.S. Department of Health and Human Services. That, in turn, has spurred a lobbying push by advocacy groups for chiropractic care, autism treatments and dozens of therapies.

...

Coverage is still to be determined on “behavioral health” services, which are a concern for people with autism and their families, said Stuart Spielman, senior policy adviser and counsel for the advocacy group Autism Speaks in Washington.

Insurance coverage for autism services vary from state to state, with people with the condition often getting “very poor care,” he said by telephone. Spielman’s 16-year-old son has autism.

Medical costs for people with autism are four to six times greater than for those without the condition, the Atlanta-based CDC estimates. Twenty-three states have adopted laws requiring insurers to cover screenings, therapy and related services, according to Autism Speaks.

Lifetime treatment for autism costs about $306,000, Michael Ganz of the Harvard University School of Public Health estimated in a 2007 report that didn’t distinguish between severe or mild forms.

Autism advocates are lobbying the government to interpret language in the law requiring coverage of “behavioral health” services to include autism treatment.

The Science Blog reports:

Autism was described as early as 1940 [sic: 1943], but a marked increase in the prevalence for the broader class of autism spectrum disorders (ASDs) during the past decade highlights the demand for treatment of affected individuals. The Centers for Disease Control and Prevention (CDC) reported that the prevalence of ASD was one in 110 children in 2006 and increased at an average annual rate of 57% between 2002 and 2006.1 The rising prevalence has heightened concern about the financial impact of treating ASDs in the private and public health care systems.[1]

The escalating health care expenditures associated with autism spectrum disorders (ASDs) in state Medicaid programs is the subject of a study by Penn State College of Medicine researchers in the November issue of the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP).[2]

In the article titled "Health Care Expenditures for Children with Autism Spectrum Disorders in Medicaid," Drs. Li Wang and Douglas Leslie used Medicaid data from 42 states from 2000 to 2003, to evaluate costs for patients aged 17 years and under who were continuously enrolled in fee-for-service Medicaid. Total expenditures included Medicaid reimbursements from inpatient, outpatient, and long-term care, as well as prescription drugs, for each treated patient.

During the study period over two million children were diagnosed with some type of mental disorder. Of these children, nearly 70,000 had an ASD, with approximately 50,000 having autism. Researchers found that total health care expenditures per child with ASD were $22,079 in 2000 (in 2003 US dollars), and rose by 3.1% to $22,772 in 2003.

Strikingly, the increase in the treated prevalence of autism was higher than in any other mental disorder, rising by 32.2% from 40.6 to 53.6 per 10,000 covered lives. Total health care expenditures for ASDs per 10,000 covered lives grew by 32.8% from $1,270,435 in 2000 (in 2003 dollars) to a remarkable $1,686,938 in 2003.


More on the Paterson Veto

Assemblyman Joseph D. Morelle, D-Irondequoit, today said he is “deeply disappointed” that Gov. David Paterson has vetoed a landmark bill that would have extended health care coverage to families affected by autism.

“This was an opportunity to simply do the right thing for the ever-increasing number of families whose children are diagnosed with autism,” said Morelle, chairman of the state assembly’s Committee on Insurance and the bill’s primary sponsor.

“As insurance chairman, I am always wary of adding new mandates and costs to a health care system that’s already too expensive,” Morelle said. “But parents who pay health care premiums and are dealing with this diagnosis should not be told that treatments for their children are out of reach.”

The Age of Autism applauded the veto:

The bill would have repealed existing anti-discrimination language hard won in 2006, and required that any treatment for autism meet a standard far higher than that required for any other health condition under New York law, or in any other state. “This standard if passed was so onerously high that we could identify no treatments that we were certain would be covered,” said Marcia Roth, a Budget and Policy Analyst with the Autism Action Network, “And it would have created a dangerous precedent that could serve as a model for other states.”

“Costs currently paid by insurers would have been shifted to county and school district taxpayers, said Tom Abinanti, a Westchester County Legislator and Democratic candidate for Assembly in the 69th district (Greenburgh, Pleasantville and parts of Yonkers).

A coalition of more than 30 autism organizations (HERE) had been working to pass another bill, A6888, last year when S7000b was suddenly announced at an Albany at which the only non-legislative people present were representatives of Mannatt, Phelps and Phillips, a national lobbying firm, who represents more than 100 insurance companies, hired by Autism Speaks to lobby on their insurance efforts. Persons familiar with Autism Speaks lobbying efforts confirmed that Manatt was paid at least $100,000 by Autism Speaks.

Autism Speaks denounced the veto:

Autism Speaks joined with tens of thousands of families and advocates across New York State to express extreme disappointment in Governor David Paterson’s veto of landmark autism insurance reform legislation – passed unanimously by the state legislature – and challenged the cost projections cited by the governor in justifying his decision. The organization immediately began conferring with key legislative allies to determine a course of action, which could include a call for a post-election session of the legislature and an override effort.

“Today is a sad day for tens of thousands of people with autism and their families, the result of a misguided fiscal decision that will actually cost taxpayers untold millions of dollars in the coming years,” said Bob Wright, co-founder of Autism Speaks. “This is a significant setback, but it is far from the end of the battle. We will not stop fighting until every child with autism in New York State has access to the treatments they need and deserve.”

...

The governor’s veto memo stated that his decision was based purely on fiscal considerations and not the legislation’s merits. The memo, though, cited inaccurate costs projections. Actuarial reports have concluded that the actual costs to the state and local municipalities would be negligible during the first year and no more than $30 million once fully implemented. Moreover, private insurance policyholders would see minor premium increases of less than 0.65% – far less than the inflated figures included in the memo.

WHEC in Rochester reports:



Thursday, October 21, 2010

Paterson Vetoes Autism Mandate

New York Governor David Paterson has vetoed legislation mandating insurance coverage.

Politics on the Hudson reports:

Paterson, who has about two months left in his term, wrote that he is “extremely sympathetic to the very real struggles faced by families of individuals” with autism spectrum disorder, which he said is a priority for society to address. Autism spectrum disorder, which occurs in roughly one out of every 100 kids, is characterized by difficulty with speech and social interaction and repetitive behavior patterns. Symptoms vary depending on where children are on the spectrum .

“It will be a subject of my continued advocacy as a private citizen. But now I am governor, and I cannot sign a bill that would impose costs that the Legislature does not fund,” Paterson wrote.

The bill has been the subject of intense lobbying by autism advocates who support and those who oppose the legislation. It was sponsored by Sen. Neil Breslin, D-Delmar, Albany County, and Assemblyman Joseph Morelle, D-Irondequoit, Monroe County.

Opponents said it would hurt people seeking treatment for autism because of the “evidence-based, clinically proven and peer-reviewed” standard, which is not required for other medical problems, and would shift costs from insurance companies to counties and taxpayers for early intervention services.

The governor said another flaw in the bill is it would require the state Health and Insurance departments and a few other state agencies to develop regulations for health insurers within a year and update them regularly, but the state budget does not provide them with the extra resources they would need to do this.”

Image of veto message is below (click to enlarge)











Wednesday, October 20, 2010

Paterson Facebook Update

Now we know how activists hijacked Governor Paterson's Facebook page. From Adrants:
In a stunt that spelled out "Sign the Autism Bill," several BBDO staffers successfully letter bombed New York Governor David Paterson's Facebook page. Apparently, they want the Governor to act on the bill. To accomplish the stunt, BBDO employees Jeff Greenspan, Chris Baker and Danny Adrain out together a site called Letter Bombing with instructions on how to letter bomb any Facebook page.

CA Budget Cuts

Laura Shumaker writes at The San Francisco Chronicle:

On October 8, 2010, Governor Arnold Schwarzenegger executed nearly $1 billion in line-item vetoes to the recently approved state budget, including 132 million in funds for AB 3632 Mental Health Services for Students.

Approximately 20,000 special education pupils receive mental health services under the AB 3632 program. Services provided include mental health assessments, case management, individual and group therapy, rehabilitative counseling, day treatment, and medication support. With the Governor's veto, services will be denied or thrown into disarray for thousands of children with disabilities and mental health needs, including children with autism spectrum disorders.


See a factsheet from Disability Rights California

Tuesday, October 19, 2010

Paterson Facebook Hijack

OK Schools Ignoring Scholarship Program

Earlier posts dealt with an Oklahoma law providing scholarships for special-needs kids. But not all schools are abiding by it, as KTUL reports:
Blake Robison has Asperger's Syndrome. He's comfortable here, after a nightmarish experience in a public school.

"He was never called by his name but by a nickname that they gave him called 'Bleak," she said "And he would answer, because no one would ever call him his name,".

Blake says he was bullied, by fellow students and even a substitute teacher. At Town and Country, he's made improvements.

"I was failing almost every class. I come here and I ask for help, because I'm not afraid to ask for help and I am making better grades here," said Blake.

His parents thought they'd be reimbursed tuition fees, thanks to a new state law.

"Now it's a little scary because we get to fill in the extra amount we thought the scholarship was going to take care of, and pay for the services that we are getting," explained Blake's mom.

Town and Country is a school specifically for students diagnosed with learning disabilities and Aspergers.

"We can do things in different way that sometimes another traditional environment, whether its a public school or private school. As hard as they try to help this child be successful, they just haven't been able to figure out the best way, " said Kate Davis, schools spokesperson.

They had nearly 20-students enroll, believing the scholarship money would be there. Now, public schools are holding the money back--in protest, citing constitutional rights and education standards.

But no matter what happens. Blake is staying here.

" I joke around and tell my husband and family, that we want Blake here so badly, we would live in a cardboard box, on the side of the highway, because he is happy," exclaimed his mother.

On Monday, however, Tulsa changed course -- a bit.

Monday, October 18, 2010

Combating Autism Act Reauthorization Coalition

A press release from the new Combating Autism Act Reauthorization Coalition:

President Bush signed into law the Combating Autism Act (CAA) on December 19, 2006. This landmark legislation authorized $700 million in research funding over five years and set the goal of finding the cause (including possible environmental causes) and treatments for autism. The Act sunsets on September 30, 2011.

A coalition of leading community organizations is coordinating an effort to seek reauthorization and has prepared a list of Guiding Principles. A broad consensus on these principles is the essential first step before legislation can be crafted to implement these ten principles as policy (details on each principle follow below):

1) Recognize that our country faces a national public health emergency.

2) Direct increased resources for a lifespan of autism services through established services infrastructure at the state level.

3) Dedicate federal research to strategic research that can halt the autism epidemic in its tracks.

4) Conduct autism surveillance with the scope, timeliness and rigor appropriate to the need.

5) Focus strategic new research in areas that can yield meaningful near term results.

6) Keep individuals with autism safe from accidental death and injury.

7) Prevent harmful restraint and seclusion of autistic individuals.

8) Address critical gaps in vaccine safety research and policy governance.

9) End health insurance discrimination against individuals with autism.

10) Develop autism policy with an open, transparent approach.
The membership includes advocates of the vaccine theory:


Sunday, October 17, 2010

Questions About Ohio Autism Scholarship

The Akron Beacon Journal reports:

For almost seven years, the state has allowed parents to withdraw their autistic children from public schools and buy private services with taxpayer money.

The legislation that created the Autistic Scholarship Program [sic: the name is Autism Scholarship Program] in 2003 was deliberately written with minimal financial or academic oversight.

Lawmakers wanted to give parents frustrated with public schools the money with few strings attached.

The program swelled almost 500 percent, from 300 children in the 2004-05 school year to 1,672 during the past school year.

But since the spring of 2009, when the Ohio Department of Education started taking formal complaints from parents, who receive up to $20,000 a year, investigators have found problems with three of the providers on the state-approved list.

The first two reports were filed late last year, one about an Akron private school and one about a consulting service in northwestern Ohio.

In those cases, investigators exposed poor record-keeping; overbilling; and billing for services that were not delivered, not required or provided by unqualified, uncertified staff members.

In the northwestern Ohio case, the state found that a high-school graduate with no qualifications was tutoring an autistic child in math.

The shortcomings shouldn't surprise anyone.

The state has been warned for years by school districts as well as newspaper reports, a public-policy research group and the legislature's own research arm that the private providers need more scrutiny.

But the payments - $86 million to date - have flowed out of Columbus with few questions asked about whether the children and the taxpayers are getting their money's worth.

The paper has a separate story on a specific case:

Paula Black spent years warning the state that the money it was handing out in her autistic son's name was being misspent at a private Akron Christian school.

When the state investigated this year, it concluded she was correct.

While Black still believes in the Autism Scholarship voucher program that allows her to seek private services instead of a public education, she wishes the state cared more about the quality of those services.

At The Daily Yonder, however, the mother of a girl with Asperger has a much more positive view:

I focus on finding her the best tools possible for living life. Fortunately, the state of Ohio has the Autism Scholarship Program that allows us to choose services from a list of state approved providers in place of sending her to public school. I believe that public schools should be inclusive environments. However, when offered the opportunity of placing her among folks who specialize in educating high functioning special needs kids and a teacher to student ratio of 1:5, we jumped at it. Rosa attends Linden Grove School; a parent cooperative school here in Cincinnati that is a 30-minute drives from our home. Some students live in rural areas up to two counties away and travel over an hour to get to Linden Grove. As parents of special needs children, this is what we do. Unbound by the time eating reporting demands associated with public schools such as the No Child Left Behind Act, Linden Grove is able to focus on creating ways in which our kids can learn.

Also see:


Saturday, October 16, 2010

Wall Street Journal on Bruesewitz

From the editorial page:

While the Bruesewitz's vaccine claim is not autism related, its outcome will have legal implications for the efforts to link vaccinations to autism. Attempts to seek compensation for the diagnosis have persisted despite overwhelming scientific evidence that has found no connection. In February, the British medical journal The Lancet retracted a study that linked the measles-mumps-rubella vaccine to autism and contributed to a rash of parents fleeing the inoculation. In March, special masters in the Vaccine Court likewise ruled against parents claiming the vaccine was responsible for their children's autism.

While the 1986 Vaccine Injury Act bars state tort lawsuits alleging defective design, two other kinds of lawsuits go forward all the time in pharmaceutical industry product liability cases. In the first version, plaintiffs may allege that the manufacturer failed to give adequate warnings about the dangers of the product. In the second, plaintiffs may claim that the vaccine itself was not manufactured properly.

The Bruesewitz case is of particular interest because it falls into the bucket of so-called express pre-emption cases, in which a law explicitly bars state tort claims. In 2008's Riegel v. Medtronic, the Supreme Court ruled that federal law explicitly pre-empted state product liability for medical device claims. There, as here, the alternative remedy was favored by a horde of trial lawyers hoping for a new state tort jackpot.

At oral argument on Tuesday, the Justices seemed to be dubious of plaintiff claims that the 1986 vaccine law left room for debate. Responding to the suggestion that Congress's intent was not to pre-empt all suits, Chief Justice John Roberts responded that "I would have thought the argument would go the other way: That because they set up a compensation scheme, that was a good sign that they didn't want to allow state law claims." Anthony Kennedy, often a swing vote, was skeptical that manufacturers could survive the assault from new tort claims.

Friday, October 15, 2010

FDA v. Chelation

The Los Angeles Times reports:
Products called chelators that are sold over the counter as treatments for autism, heart disease and other conditions are dangerous and illegal, the U.S. Food and Drug Administration warned in a crackdown announced Thursday.

The chemicals, which help remove metals from the body, are potent drugs that carry serious risks, including kidney damage, dehydration and even death, said FDA Medical Officer Dr. Charles Lee. "Chelation can be dangerous and can cause serious harm," Lee said.

The FDA sent letters this week warning eight companies they are in violation of federal law by selling the products. The letters also served to caution parents and others who might be tempted to buy the chelators, which are touted on scores of Web sites and blogs as effective therapies for a wide range of chronic medical problems.

The U.S. Food and Drug Administration today warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products.
The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions. Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy.
The drug products involved have not been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug, and Cosmetic Act (FFDCA). Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care.
In addition, there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death.
“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.”
The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks and should be performed only under medical supervision.
The FDA has noted an increase in “chelation therapy” products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths.
Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy.
"FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness.” said Dara A. Corrigan, associate commissioner for Regulatory Affairs.
Under the FFDCA, companies that market products that claim to prevent, diagnose, treat or cure diseases must file an application with the FDA and provide data that demonstrate their products’ safety and effectiveness.
The companies must take prompt action to correct the legal violations cited in the warnings letters or face possible legal action, including seizure and injunction. The FDA issued warning letters to the following companies:

Thursday, October 14, 2010

Radio Ad on NY Mandate Bill

Autism Votes seeks national pressure on Governor Paterson:




In a blog post, Peter Bell (Autism Speaks executive VP for programs and service) frames the issue as one of equality:
At the end of the day, it all comes down to ending the discrimination families living with the challenges of autism face when dealing with health plans. As one New York father pointed out to me recently, individuals with autism are simply looking for equality. He went on to emphasize how this piece of legislation would require coverage for evidenced based treatments, equality in its truest sense. He spoke from an extremely personal place, sharing how last year he was diagnosed with Non-Hodgkin’s Lymphoma. His course of treatment, which was evidence-based, was covered by his health insurance and because of this treatment, he is doing well. He went on to ask the obvious question: why his beautiful nine year-old son with autism was not afforded the same opportunity?
It’s time for this discrimination to stop. You can help by emailing Governor David Paterson and urging him to sign S.7000B into law. He needs to hear from you – as a member of the nationwide community of families and loved ones of individuals with autism – even if you do not live in New York. Please take two minutes to make a difference today.

Wednesday, October 13, 2010

The Bruesewitz Case

The New York Times reports:

The Supreme Court on Tuesday struggled to divine the balance Congress had meant to strike in a 1986 law that established a system to compensate people injured by vaccines while barring some, but not all, lawsuits against vaccine manufacturers.

David C. Frederick, a lawyer for a couple who said their daughter had been badly hurt by a vaccine, said their lawsuit should be allowed to go forward. “We are talking about trying to eliminate some of the most horrifying and horrible incidents of injury from vaccines that we compel children to take,” he said.

The 1986 law, Mr. Frederick said, was meant to allow claims both in a special tribunal known as the vaccine court and in ordinary lawsuits.

Kathleen M. Sullivan, a lawyer for the defendant, said that approach would expose the industry to crushing liability that could drive companies from the marketplace and imperil the nation’s vaccine supply.

Ms. Sullivan, who represents Wyeth, now a part of Pfizer, added that the ruling in the case, Bruesewitz v. Wyeth, No. 09-152, could affect thousands of unrelated cases concerning autism in the vaccine court.

The Washington Post reports that the Court "seemed divided" on the case:

Justice Elena Kagan was recused from the case because of her past work on it when she was solicitor general. Roberts sold his holdings in Pfizer in August so that the case would not be heard by only seven justices.

The lack of a full court makes it harder for the Bruesewitzes. The justice Kagan replaced, John Paul Stevens, was one of the court's strongest believers in consumers' ability to sue in state courts. And Frederick must persuade five of the eight to overturn the U.S. Court of Appeals for the 3rd Circuit to allow the suit to proceed.

If the justices are evenly split, the judgment of the lower court is upheld, but it does not set a national precedent.

From the transcript of oral argument:

MS. SULLIVAN: But there are 5,000 claimants in vaccine court now who claim there is a relationship between the mumps, measles, and rubella vaccine and autism. They have lost all six test cases and when the individual cases are resolved, that is 5,000 potential claimants in State court.

Congress was worried about episodic waves of fear about vaccines leading to future litigation. They took care of existing Claimants with vaccine injuries back in 1986 with the compensation system. The reason they put in 22(b)(1) was to prevent future litigation in State court where manufacturers could be driven from the market by the fear of liability that had in 1986 involved the withdrawal of insurance, the escalation of insurance costs, the withdrawal of one manufacturer from the vaccine market.

And today there are very few vaccine manufacturers and the risk of the vaccine supply on which the nation's protection from contagious disease depends, it depends upon the existence of that stable supply of vaccines

Tuesday, October 12, 2010

Autism Charter Schools in Texas and Florida

The San Antonio Express-News reports:

The Foundation School opened in August, but officials with charter school operator Responsive Education Solutions plan to formally announce the school’s opening at a press conference today in Austin, where they will be joined by state senators Florence Shapiro and Leticia Van de Putte.

Suzanne Marchman, a spokeswoman with the Texas Education Agency, said the agency is not aware of any other charter schools in the state that serve primarily students with autism, although schools aren’t required to report their specialties. Marchman also said that, while there might be programs specializing in autism, no traditional public schools in Texas specialize in the treatment and education of children with the disorder.

...

The school was founded after the Treehouse Pediatric Center & Behavioral Services, a private day school for children with autism, abruptly shut down less than a year ago. The nonprofit Autism Community Network raised enough money to continue therapy in a temporary, stop-gap measure, but many families were left trying to find a good option for their children.

Ultimately, ACN partnered with ResponsiveEd, the charter holder that now operates the Foundation School. Some employees from Treehouse, including Miller, are part of the new school, as are a handful of families.

Pace and his wife, Mindy, chose the school partly because their son would be able to remain with familiar staff, but also because of the low teacher-to-student ratio.

Classrooms have a certified special education teacher, a behavior technician and an assistant. Speech and occupational therapists and a specialist in Applied Behavior Analysis also meet with students throughout the week.

The Foundation School is an open-enrollment charter school, meaning the students without autism may attend, although virtually everything at the school is done with autism in mind.

Charles Cook, CEO of ResponsiveEd, said the group still is working to hammer out a sustainable funding model for the school.

See earlier post on Texas special education and charters.

WPTV reports on a middle school in Florida:

Monday, October 11, 2010

Seclusion and Restraint in Florida

The Palm Beach Post reports:

Port Orange Republican Dorothy Hukill's legislation restricting seclusion and restraint of Florida schoolchildren earned the state representative national notice.

"Florida was going to be the model for other states to follow," said Lori Mcllwain, a spokeswoman for the 10,000-member American Autism Association.

By the time it got to the governor's desk, though, Hukill's bill was stripped of its toughest provision: Instead of banning prone restraint, the bill was altered to bar restraint that can restrict a child's breathing.

"They took a good bill that had protective language for children with disabilities and gutted the bill, took out all the safety precautions," said Phyllis Musumeci, a mother whose son was forcibly held in a prone restraint more than 20 times at a Palm Beach County school. The Autism Association agreed: In a 180-degree turn, the group urged a letter writing campaign to persuade Gov. Charlie Crist to veto the bill.

"Was it as strong as I would have liked it to be? No," said Hukill of the new law, which took effect this year. "Am I delighted that we are finally addressing the problem? Absolutely."

Sunday, October 10, 2010

Virginia Autism Project

WAVY, in Hampton Roads, Virginia, covers the Virginia Autism Project:

The group tells WAVY.com, "At present Virginia does not require insurance companies to pay for services and therapies for children with Autism. Twenty three other states have recently enacted legislation to correct this injustice and provide coverage for their children in need. Virginia needs to do the same."

The organization is holding its second Annual Autism on October 30th to strengthen its message as well as bring the community together and provide some relief for families in our area that deal with this illness and need assistance, support and help.


Saturday, October 9, 2010

Autism in West Virginia

The Charleston Daily Mail reports:

The number of West Virginia students diagnosed as autistic has more than tripled in nine years, and the superintendent of the county with the highest number told state school board members his county is paying as much as $200,000 per child in severe cases.

Manny Arvon, superintendent of Berkeley County Schools, spoke with board members about his county's unusually high number of autistic students in a meeting Wednesday.

He said when he first took the superintendent job there in 1997, the county had 11 autistic students. This year the county has about 161.

Arvon said his county has 30 teachers at 29 locations working with autistic students, but 15 of those teachers aren't autism-certified. He said 23 of the county's 42 autism aides have specialized training for the job.

His school system spends an average of more than $19,000 per autistic student every year to provide them with the services they need. Countywide, that amounts to more than $3 million, and those costs are likely to increase as Berkeley is averaging 15 more autistic students every year.

Arvon said some of the county's most severely autistic students are sent to a day program across the state line in Virginia. That costs the school system $100,000 plus transportation per child. If the child lives at the program, the school system pays $200,000.

Berkeley County Schools spends just under $1,800 per student in regular classrooms, Arvon said.

Pat Homberg, executive director of the education department's Office of Special Programs, told the board that 1,230 West Virginia students were currently diagnosed with autism. In the 2001-2002 school year, just 389 students were diagnosed.

She said some people have suggested the increase is due to better detection efforts.

"But that really doesn't account for this huge number of students who have been diagnosed," she said.

Friday, October 8, 2010

Poll on Learning Disabilities

A learning disability (LD) -- such as dyslexia -- keeps a student from performing up to his or her cognitive level. Under the law, it is separate and distinct from other disabilities such as autism. In practice, however, the distinction is blurry. First, kids with other disabilities may also have an LD. Second, autism does interfere with learning, even among high-functioning kids.

Keep such things in mind when reading a new survey from the Emily Hall Tremaine Foundation of New Haven, which makes grants in the areas of art, environment and learning disabilities. The poll has a margin of error of three points. According to the survey:
Three in four Americans (75%) also incorrectly associate autism with learning disabilities. This is much more likely to be true among both the general public (82%) and parents with a minimum of a college degree (81%). Age also plays a role in the belief that autism is linked to learning disabilities (78% of those 18 to 54 vs. 69% of those 55+). Women, in general, both moms and nonmoms, also see a strong relationship between the two.
...
Although educators are also less likely than Americans in general to mistakenly associate emotional disorders (58% vs. 64%, respectively), attention deficit disorder/attention deficit hyperactivity disorder (58% vs. 69%, respectively) and autism (68% vs. 75%) with learning disabilities, sizable numbers of educators do equate these. Also worth noting, 57% of educators associated learning disabilities with substance abuse on the part of a parent, compared to 61% of the general public. This marks a substantial decline from the seven in 10 educators (70%) who in
2004 said the two are linked. Educators and the general public are equally as likely as the population to erroneously link learning disabilities with mental retardation (79% compared to 80%).


Thursday, October 7, 2010

Cost of Insurance Mandates

The Las Vegas Journal-Review reports:

A big Nevada insurer who didn't want to discuss the political hot potato on the record has crunched the numbers and found the mandate will add 2.2 percent, or about $100 a year, to Nevadans' annual premiums.

That's a "very significant impact," given that most new mandates add less than 1 percent to premium costs, said J.P. Wieske, executive director of the Council for Affordable Health Insurance in Alexandria, Va.

......

Wieske's council published a 2009 study that also set Nevada's autism premium impact at roughly 1 percent, but Wieske said the group is updating its numbers, because the council's initial assumptions didn't account for "explosions" in the number of autism diagnoses and the condition's care costs. He said he now believes the Nevada insurer's projection of a 2.2 percent premium impact is likely to be at least fairly close to the actual effect. The state's actuarial study also acknowledged that the future costs of some therapies were "uncertain" due to increased insurance coverage.

....

Susan Pisano, a spokeswoman for Washington, D.C.- based trade group America's Health Insurance Plans, said her association isn't concerned about the autism mandate itself. Rather, the organization's issue is with policy requirements in general, which she said typically become law without regard to their effects on health-care quality or costs. Nor do mandates always come from scientific evidence that certain treatments will help, she said.

...

Autism mandates in particular have grown popular among states in the past two to three years. Nearly half the states, 23, require insurers to cover it. Some of the surge comes from high-profile advocacy efforts in front of state legislatures, Wieske said, while part of the push involves sympathy for a condition that largely affects small kids. Plus, it's only been in recent years that doctors began to better understand autism and its treatments, he said.

But at least part of the jump in autism mandates originated with subtle attempts to shift the cost of care for the condition away from school budgets and into private insurance, Pisano said. Wieske agreed, noting that interventions such as speech therapy were typically covered through school districts and states, until widespread budget crunches pinched what the public sector could or would provide.

Wednesday, October 6, 2010

Wired Interviews Ari Ne'eman

Wired Science features a fascinating interview with Ari Ne'eman, founding president of the Autistic Self-Advocacy Network and member of the President's Council on Disabilities:

Wired.com: What advice would you give to neurotypical people who want to become effective allies of the autistic community?

Ne’eman: At the political level, watch where your money is going. There are a lot of well-meaning people who think they’re helping us by donating to Autism Speaks or other groups looking for a cure. It would be better for people to get involved in their local communities and ask tough questions like, “Is my school inclusive? Is my workplace willing to hire autistic people and other people with disabilities?”

Wired.com: What do you hope to accomplish in Washington?

Ne’eman: All across the country, we have hundreds of thousands of people on waiting lists for access to community services. People with disabilities don’t have the support we need to live independently, be employed, and participate in civic life. Instead, because of a bias in the way Medicaid is structured, many of us are segregated in institutions, which offer a much lower quality of life to disabled people at the same time that it works out to be much more expensive. It’s easier to get states to pay for an institution than to get them to allow people to access services in their homes. Making community services more accessible would be a huge game changer for all kinds of people with disabilities.

Passing one particular piece of legislation — the Community Choice Act — would accomplish that. The Community Choice Act would make it so that states would be required to pay for supports and services at home or in the community, but it would actually save money, because institutional placements are very expensive. There’s no reason not to do this.


Tuesday, October 5, 2010

Michigan Mandate Hearing

WLNS reports on a Michigan State Senate hearing:

"Many children with autism will need special education for their entire school career, and will need institutionalization as adults if they don't get the treatment," said Lorri Unumb, Autism Speaks.

Treatment that for many families is a huge financial drain. "We've borrowed. I've financed from my retirement account, whatever it takes. It's something that you would almost sell your soul for. Almost," said Stacie Rulison who's son has autism.

...

"Sometimes I will be talking with families who are informing me of their plans to leave our state to go to some other state where they can receive this treatment that is covered by insurance," said Ruth Anan, Autism Expert.

Experts say it's an investment that will push insurance costs up slightly, less than a dollar a month for every individual. But they say it's well worth the price to help children with autism.

"If they do get treatment many will go on to lead productive and independent lives," said Unumb. Tuesday's public hearing is the last of four on autism health insurance reform. Lawmakers say they'll use the information to draw up a report before considering legislation.

Monday, October 4, 2010

Supreme Court & Vaccines

Jim Edwards writes at BNET:
On Oct. 12, the U.S. Supreme Court will hear Bruesewitz v. Wyeth, a case that threatens to flood the federal court system with about 5,000 largely meritless lawsuits that claim vaccines cause autism. There just isn’t any decent evidence showing that vaccines cause autism. Yet because of the Supremes’ ruling in a different, unrelated case (Wyeth v. Levine), there’s a possibility that the court could plunge the judicial system down a science-free rabbit hole in which non-specialist civil judges will be forced to hear each and every one of these cases even though the law was specifically written to prevent that happening. The case is a Trojan horse for autism activists, but the Supremes may side with them anyway.
...

The parents of Hannah Bruesewitz have come up with a clever argument as to why Wyeth’s diphtheria–pertussis–tetanus vaccine is to blame for her “autistic-like features.” They argue that because the specific batch that Hannah received was linked to two deaths and more than 60 adverse events, that it counts as evidence the vaccine was improperly made and thus not “preempted” by the 1986 law.

If this were a normal drug tort case it would have been laughed out of court. Unfortunately, the Supremes ruled in Wyeth v. Levine — a case about a migraine drug — that not all claims against drug companies are “preempted” just because the FDA has allowed them onto the market. People have a right to sue, if a drug caused injury because it was defective anyway. Following that logic, the Supremes could decide that vaccine cases are not preempted if they claim that the vaccine was defectively manufactured. In fact, that’s exactly what the autism activists are arguing in their amici brief.

Sunday, October 3, 2010

Angle Not Clear on PDD-NOS

Repeatedly, step-by-step, Angle explained how the Reid campaign has used half-truths to twist her statements.

Outside the new party branch office in upper Laughlin, she added another, about autism. She explained health insurance companies now have 52 mandated coverages to provide. When the government required autism it added a loophole “and any other developmental disabilities not otherwise classified” — meaning those paying for autism coverage also pay the freight for a lot of other conditions.
“Autism spectrum disorders” means a neurobiological medical condition including, without limitation, autistic disorder, Asperger’s Disorder and Pervasive Developmental Disorder Not Otherwise Specified.

PDD-NOS is not a "loophole." It is an autism spectrum disorder. Autism Speaks explains:
Pervasive Developmental Disorder - Not Otherwise Specified, or PDD-NOS, for short, is a condition on the spectrum that has those with it exhibiting some, but not all, of the symptoms associated with classic autism. That can include difficulty socializing with others, repetitive behaviors, and heightened sensitivities to certain stimuli.

How it's similar to classic autism

Those with PDD-NOS behave like those with classic autism in many ways. First, they are all different (meaning one person with PDD-NOS doesn't act exactly like another; the same holds true for classic autism). When interacting with others, they may appear unemotional or unable to speak, they could have trouble holding eye contact, or they may have trouble transitioning quickly from one activity to the next.

How diagnosis differs

Those with PDD-NOS are different from others on the spectrum in one specific way: While they may exhibit some symptoms of those conditions, they don't fit the bill closely enough to fully satisfy all criteria set by the experts. Perhaps they started having difficulties at a much later age than others on the spectrum. (According to the National Dissemination Center for Children with Disabilities, they are often diagnosed between the ages of 3 and 4 years old.) Or they may have the same challenges — for example, they may be oversensitive to their surroundings — but not to the extreme that others on the spectrum do.

Consequently, those with PDD-NOS are sometimes thought to have a "milder" form of autism, though this may not be technically true. One symptom may be minor, while another may be worse.

Saturday, October 2, 2010

Omnibus Stop?

The Court of Federal Claims (aka the "vaccine court") recently issued an update letter (h/t Left Brain/Right Brain).

As described above in part I of this Update, all of the court rulings in the six test cases described above have found no causal link between autism and MMR vaccines and/or thimerosal containing vaccines. Further, the PSC [Petitioners' Steering Committee] has informed the special masters that no additional OAP [Omnibus Autism Proceeding] test cases are contemplated.

Therefore, the Office of Special Masters has begun discussions with members of the petitioners’ bar and respondent’s counsel about how best to conclude the approximately 4,700 autism cases remaining open on the court’s docket. To aid in that process, some petitioners’ counsel have contacted all of their OAP clients to advise them of the results in the test cases and to recommend a course of action with regard to their claims. Additionally, all petitioners who are not represented by counsel have been ordered to inform the court either that they wish to dismiss their claim or that they intend to proceed with their case. For petitioners who wish to continue with their claim, orders to identify a theory of causation, produce an expert report, and file additional evidence will follow. Petitioners’ counsel who have not yet done so are encouraged to contact their clients and determine how their clients wish to proceed.

The issue of attorneys’ fees and costs for petitioners’ counsel is part of the discussion about how to conclude proceedings on the OAP petitions. Mediation efforts are underway to develop methods to resolve the fees and costs issues, and a report on the progress in these talks is expected at the October judicial conference.

Friday, October 1, 2010

Autism Mobilization

Mike Wasmer, Autism Speaks Kansas Chapter Advocacy Chair and founder of the Kansas Coalition for Autism Legislation (KCAL - www.kscoalitionforautism.org) writes at Autism Speaks about mobilization:

I am excited about Autism Votes’ recent introduction of the Autism Votes mobile text alert campaign. By texting “AVotes” to 30644, advocates will receive action alerts to support autism-related state and federal legislation directly to their mobile phone. This tool is exactly what we need to mobilize the autism community before the opposition tries to pull a fast one on us.

He explains that, in 2009, autism advocates were not quick enough to answer a counterattack against an insurance reform bill, which fell short by 10 votes. He notes the lessons:

First, Shelley Hendrix is a wise woman, so listen to her when she tells you, “The political process is a roller coaster. So kids, you’d better buckle up and keep your arms and legs inside the car because it’s going to be a crazy ride.” Secondly, there is a huge difference between growing your grassroots and effectively mobilizing your grassroots. Despite all of our calls, e-mails, and social network posts, when we needed a rapid response from the troops, we had to find a way to get the word out quickly and get advocates to take action immediately.

The Kansas bill was eventually signed into law this past April, becoming the 18th state to enact autism insurance reform. However, the new law is limited in its reach and until every person with autism in Kansas has meaningful access to the treatments and therapies they need, our work here is not yet done. With the new Autism Votes mobile text alert program, we will be stronger and quicker for the 2011 legislative session. We will be able to build on the 2010 law and expand coverage to all who need it.