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Saturday, December 10, 2016

Update on Retraction of Vax Article

A journal posted an abstract online suggesting a link between vaccines and autism. After a firestorm of criticism, it removed the abstract, saying it was going to be re-reviewed. Now, the journal has decided to formally reject it.
As we reported last month, Frontiers in Public Health removed the abstract after it sparked criticism on social media. After doing so, the journal released a public statement claiming that the paper was “provisionally accepted but not published,” noting that the journal had reverted it to peer review to ensure it was re-reviewed.
Now, Gearóid Ó Faoleán, ethics and integrity manager at Frontiers (the journal’s publisher), told Retraction Watch that after consultation with an external expert, the journal has rejected the paper, adding:  "The rejection was merited due to severe limitations in the validity of the results."

Friday, December 9, 2016

Trump, FDA, and Quackery

In The Politics of Autism, I write:
The conventional wisdom is that any kind of treatment is likely to be less effective as the child gets older, so parents of autistic children usually believe that they are working against the clock. They will not be satisfied with the ambiguities surrounding ABA, nor will they want to wait for some future research finding that might slightly increase its effectiveness. They want results now. Because there are no scientifically-validated drugs for the core symptoms of autism, they look outside the boundaries of mainstream medicine and FDA approval. Studies have found that anywhere from 28 to 54 percent of autistic children receive “complementary and alternative medicine” (CAM), and these numbers probably understate CAM usage.

At Bloomberg, Drew Armstrong Jennifer Jacobs , and Robert Langreth report on Trump's rumored pick to head the FDA.  Jim O’Neill is a managing director at Peter Thiel’s Mithril Capital Management.  He worked at HHS during the Bush 43 administration but has no medical or scientific background.
O’Neill also could push the agency in new directions. In a 2014 speech, he said he supported reforming FDA approval rules so that drugs could hit the market after they’ve been proven safe, but without any proof that they worked, something he called “progressive approval.”
“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety -- and let people start using them, at their own risk, but not much risk of safety,” O’Neill said in a speech at an August 2014 conference called Rejuvenation Biotechnology. “Let’s prove efficacy after they’ve been legalized.”

Kevin and Avonte's Law Passes the House

The Politics of Autism discusses the problem of wandering, which is the topic of legislation before Congress.


The role call was 346-66.

Voting aye were 167 Republicans and 179 Democrats.

Voting nay were 65 Republicans and one Democrat (Donald Payne of New Jersey)./

Maria Jeffrey writes at Conservative Review:
The bill has incited passion from autism and Alzheimer’s advocacy groups, as well as those who are concerned about civil liberties and government overreach. Last week, the bill was scheduled for a House Judiciary Committee markup, but was postponed.
As Conservative Review reported at the time, “Multiple sources on the Hill with knowledge of the situation said that the hearing was cancelled after several GOP committee members voiced concerns about how the language dealt with privacy and civil liberty issues.”
After the Judiciary Committee markup was cancelled, the language of Kevin and Avonte’s Law was changed, so that the tracking devices overseen by the DOJ were less permanent and invasive than the ones originally proposed.
The language change “is still not good enough,” Robert Romano, senior editor at Americans for Limited Government, stated in a press release Wednesday: “There shouldn’t be any bill, because there shouldn’t be a program no matter how well-intentioned overseen by the Attorney General electronically tracking people in this manner.”
Nevertheless, the bill was brought up for a quick vote on Thursday, the last day of the House’s lame-duck legislative session before the new year.
A House source told Conservative Review that, as of last week, an informal whip count of the Judiciary Committee found that a majority of members on the committee were opposed to the bill. It is extremely uncommon for a bill to bypass a committee markup in this way and be brought to the floor under suspension of the rules, the source stated. The bill may be brought up in the Senate for a vote in the next 24 hours, where it is expected to pass with ease and head to President Obama’s desk for signature.
A release from Rep. Chris Smith (R-NJ):
Today, the House of Representatives approved Kevin and Avonte’s Law (H.R. 4919), bipartisan legislation that will help protect children with developmental disabilities, such as autism, and seniors with Alzheimer’s who are prone to wandering. Authored by U.S. Rep. Chris Smith (NJ-04), H.R. 4919 provides targeted support to communities for locally-based, proactive programs to prevent wandering and locate missing children or seniors who have wandered from safe environments.
“This is an issue that hits home for me,” said Smith, founder and co-Chair of the Autism Caucus and the Alzheimer’s Disease Task Force. He referenced the successful use of the Project Lifesaver Program to safely bring home an 8-year-old boy with autism from Bergen County, New Jersey who wandered from his family in a public park on November 4th. “Sadly, just days later, a 4-year-old boy was pronounced dead after wandering from supervision and drowning in Salem County. Like the children for whom this legislation is named, these two New Jersey boys demonstrate how critical this legislation is to prevent such needless tragedy.”
Wandering is a safety concern for both seniors with Alzheimer’s and children with developmental disabilities. It is estimated that 60 percent of the 5.3 million individuals with Alzheimer’s, and 49 percent of the 1 in 68 children with autism have wandered. The results can be devastating: this legislation is named in honor of two boys with autism, Kevin Curtis Wills and Avonte Oquendo, who both wandered from safety and tragically drowned.
“The ‘Missing Americans Alert Program’ will fill a great unmet need, particularly in the autism community—since 2011, over 100 individuals with autism lost their lives after wandering from a safe environment,” said Smith. “Time and training are of the essence when individuals wander and Kevin and Avonte’s Law can help equip local law enforcement with the training and technology to bring these children home safely.”
Specifically, Smith’s legislation will reauthorize and expand a previously authorized program, the Missing Alzheimer’s Disease Patient Alert Program, to include children with a developmental disability and rename it the “Missing Americans Alert Program.”
Grants could be made to law enforcement agencies, public safety agencies, and nonprofit organizations to provide proactive educational programing to prevent wandering to families and caretakers of individuals who wander, as well as training to first responders and school personnel in order to recognize and respond to endangered missing individuals and facilitate their rescue and recovery. Additionally, this funding could also be used for voluntary, non-invasive technologies that facilitate the rescue and recovery of wanderers.
This much needed, bipartisan legislation is supported by a number of autism, Alzheimer’s and children’s groups, including Autism Speaks, Autism New Jersey, the Autism Society, the National Autism Association, the National Center for Missing & Exploited Children, SafeMinds, the National Down Syndrome Society, the Alzheimer's Association, and the Alzheimer's Foundation of America.

Thursday, December 8, 2016

Trump, Sessions, and the Americans with Disabilities Act

In The Politics of Autism, I discuss the issue's role in presidential campaigns.  Trump has a bad record on disability issues more generally.

At Jewish Journal, Michelle K. Wolf writes that disability advocate worry about ADA enforcement in the Trump administration.  Trump properties have been subject to ADA lawsuits.
Moreover, the ADA is enforced by the Department of Justice civil rights division, which is under the purview of the U.S. attorney general. Because Trump’s nominee for that position is Alabama Republican Sen. Jeff Sessions, disability advocates are deeply worried that the Justice Department is likely to ignore ADA complaints.

A coalition of more than 200 national organizations committed to protecting civil rights and human rights sent a letter last week to Senate leaders of both parties, expressing “strong opposition” to Sessions’ confirmation. They cited, among other complaints, his opposition to efforts in Alabama “to provide community-based services to individuals with disabilities who were needlessly institutionalized.”

The Justice Department has the option of investigating complaints, then deciding if corrective steps need to be taken, such as mediation or litigation. If the department does nothing, the complaints will go nowhere.
In light of Trump’s history with ADA compliance and Sessions’ becoming the chief ADA enforcer, various disability organizations are wondering what will happen.
...

In the autism community, there are concerns that Sessions will halt the progress of community integration and inclusion for children and adults with disabilities. As the Autism Self Advocacy Network said in response to Sessions’ nomination: “For the past several years, the Department of Justice has actively enforced the Americans With Disability Act and the Olmstead decision (which advocates for integrated living), resulting in increased community inclusion for disabled people across the country. But Sessions has suggested increasing the segregation of disabled students in public schools, calling the inclusion of students with significant disabilities ‘the single most irritating problem for teachers throughout America today.’ ”
The Leadership Conference on Civil Rights has posed the letter on its website.  Here is the relevant passage:
Senator Sessions opposed efforts to implement Alabama’s obligation to provide community-based services to individuals with disabilities who were needlessly institutionalized. In addition, he called the Individuals with Disabilities Education Act's requirements to include children with disabilities in mainstream education "the single most irritating problem for teachers throughout America today" and “a big factor in accelerating the decline in civility and discipline in classrooms all over America.”[xiv] This opposition to integration and inclusion is extremely concerning given the active role that the Justice Department plays in enforcing the Americans with Disabilities Act to enable people with disabilities to live independent lives, be full participants in their communities, and to be educated in neighborhood schools and regular classrooms. Senator Sessions also opposed ratification of the Convention on the Rights of Persons with Disabilities.

[xiv] Floor Statement, Education Discipline and IDEA (May 18, 2000), available at http://www.sessions.senate.gov/public/index.cfm/2000/5/education-discipline-and-idea-.

Trump, Wakefield, and the Antivax Movement


. ..Four years ago at a “Statesman of the Year” dinner in Florida, where you received a bust of Ronald Reagan, Gary Kompothecras, a multi-millionaire chiropractor in the Sarasota area — and the owner of the building that housed your campaign headquarters — made the case to you and your wife, Melania, that the current vaccine schedule was responsible for the dramatic rise in autism.
After that meeting, you Tweeted
Massive combined inoculations to small children is the cause for big increase in autism....

Kompothecras, as the father of two young adults with autism, has waged a public war on mandatory vaccination laws and public health agencies like the Centers for Disease Control and Prevention. He believes that vaccines were responsible for his children’s dramatic loss of skills in the second year of life, a phenomenon known as autistic regression.
As recounted by Kent Heckenlively in his new book, Inoculated, you attended a private meeting on August 11, 2016 in Kissimmee, Florida, arranged by Kompothecras. There you were introduced to Andrew Wakefield, the former British gastroenterologist who pushed the notion that vaccines cause autism from the realm of fringe conspiracy theory into the mainstream. 

Wednesday, December 7, 2016

Generation Rescue and a Disputed Study



Bryson Masse reports at Motherboard:
In late November, a scientific publisher abruptly removed the abstract of a study from its webpage. The as-yet-unpublished research, which would have appeared in the journal Frontiers in Public Health, concluded that unvaccinated children are less likely to suffer from autism (among other ailments). The abstract was taken down after a severe Twitter backlash.
Motherboard has determined that the research in question was funded mostly by actor Jenny McCarthy’s autism awareness nonprofit, Generation Rescue. McCarthy has famously spread the dangerously inaccurate, and scientifically unsound, view that vaccines can cause autism in otherwise healthy children. (She has somewhat softened this view in recent years.)
...
No matter how troubling on its surface, ethicists say that having a nonprofit like Generation Rescue fund of this type of study isn’t a red flag in and of itself: plenty of private companies and nonprofits pay for science. With President-elect Donald Trump threatening to cut back on funding, researchers will likely have to rely even more on private money.
Still, National Institutes of Health bioethicist David Resnik told Motherboard that funding from a particular group with a vested interest might warrant an added degree of skepticism. “You might re-examine the data more closely than you would otherwise because you think that, maybe, there is some potential bias that is affected by the research.”

Tuesday, December 6, 2016

Amicus Briefs in the Endrew F. Case

In The Politics of Autism, I write about IEPs:
At these meetings, the district has several advantages, starting with Board of Education of the Hendrick Hudson Central School District v. Rowley (1982), the first IDEA case to reach the Supreme Court. Amy Rowley was a hearing-impaired girl whose parents wanted her to have a qualified sign-language interpreter in all of her academic classes. The Court said that the district was already supplying her with sufficient supports, and that the law did not require this additional step. Even though the legislation’s sponsors said that its goal was educational equality, the majority found that there was no substantive language in the statute itself regarding the level of education that children with disabilities must get:

While Congress sought to provide assistance to the States in carrying out their constitutional responsibilities to provide equal protection of the laws, it did not intend to achieve strict equality of opportunity or services for handicapped and nonhandicapped children, but rather sought primarily to identify and evaluate handicapped children, and to provide them with access to a free public education. The Act does not require a State to maximize the potential of each handicapped child commensurate with the opportunity provided nonhandicapped children.[i]
[i] Board of Education v. Rowley, 458 US 176, at 177.  Online: http://supreme.justia.com/us/458/176/case.html.


As the U.S. Supreme Court prepares to consider how much educational benefit schools must provide students with disabilities, everyone from lawmakers to states and advocates are weighing in.
A dozen amicus briefs have been filed in the case known as Endrew F. v. Douglas County School District since the high court said this fall that it would take up the matter.
The case marks the first time in more than three decades that the Supreme Court will hear arguments about the Individuals with Disabilities Education Act’s mandate that public schools provide children with disabilities a free appropriate public education, or FAPE.
Here are links to the briefs: