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ASAN Releases Policy Brief on Organ Transplant Discrimination; Meets with Senior HHS Leaders

10 Apr

The Autistic Self Advocacy Network (ASAN) issed a policy brief last month on the subject of organ transplant discrimination. Over the past year a few cases of denial of organ transplants on the basis of disability made the news. Many more did not.

ASAN met with people in the Department of Health and Human Services (HHS) to present their brief and urge an end to discrimination in organ transplants based on disability.

The brief is:

Organ Transplantation and People with I/DD: A Review of Research, Policy and Next StepsAri Ne’eman, Autistic Self Advocacy Network
Steven Kapp, University of California, Los Angeles
Caroline Narby, Autistic Self Advocacy Network

Here is the ASAN statement:

This week, the Autistic Self Advocacy Network (ASAN) released a new policy brief on discrimination against people with intellectual and developmental disabilities in organ transplantation. In the twenty-three years since the passage of the Americans with Disabilities Act, people with disabilities have achieved much progress in securing our rights in a wide variety of settings. Unfortunately, the field of medical decision-making remains too often immune from civil rights law. In few places is this as evident as in the context of organ transplants, where our policy brief outlines widespread discriminatory practice. Many people with I/DD fail to even make it to the evaluation process, and those who do are frequently denied access to transplants on the basis of their disability. Eighteen years after the landmark Sandra Jensen case in California, it is long past time for action on this issue.

On Tuesday, ASAN, the National Disability Rights Network and Not Dead Yet met with senior leadership in the Department of Health and Human Services to urge the federal government to issue new guidance addressing discriminatory practices in organ transplantation. Our brief provides comprehensive documentation on this issue and offers next steps for regulators, legislators, funders and activists. Produced with the generous support of the Special Hope Foundation, this will be the first of several policy briefs produced by ASAN this year examining the issue of access to health care for people with intellectual and developmental disabilities.

We invite you to download a copy of Organ Transplantation and People with I/DD: A Review of Research, Policy and Next Steps on our website by clicking here. Help us spread the word about discrimination in organ transplants – together, we can achieve equal access for all of us.

Produced with support from the Special Hope Foundation

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By Matt Carey

Stephen Bustin: Why There Is no Link Between Measles Virus and Autism

9 Apr

Andrew Wakefield promoted the idea that the MMR vaccine caused autism. While his now-retracted 1997 Lancet paper is most often discussed, the strongest evidence he had actually came in later work where his team reported that they found evidence of the vaccine strain of the measles virus in the intestinal tissues of autistic children. The team used a methodology called Polymerase chain reaction (PCR). PCR amplifies a specific fragment of DNA, allowing one to identify if small amounts of that gene are present in larger samples. PCR tests were performed by John O’Leary in Dublin. As revealed later, Andrew Wakefield had a business stake in this laboratory.

As part of the MMR litigation in the UK, the vaccine manufacturers hired Stephen Bustin to review the methods and results of the O’Leary laboratory. Those results were not made public, but Prof. Bustin later was called in to testify in the U.S. Autism Omnibus Proceeding (the vaccine court). That testimony was discussed here at LeftBrain/RightBrain and elsewhere. Prof. Bustin is one of the world’s experts on PCR.

Prof. Bustin has now written his own account of the history of the measles-virus/autism work by Mr. Wakefield’s team in Why There Is no Link Between Measles Virus and Autism. The full report is free, open access. The report discusses what he already disclosed in his testimony: the multiple failures which resulted in the reporting of a false association of measles virus and autism.

Some of those failures include:

Absence of transparency: the key publication shows no data; hence an expert reader cannot evaluate the reliability of its conclusions

Unreliable techniques and protocols: analysis of the qPCR data was incorrect

Disregard for controls: obvious evidence of extensive contamination was disregarded

Lack of reproducibility: the data could not be duplicated by several independent investigators

One key failure involved skipping key steps in using PCR on measles virus. The measles virus is an RNA virus. PCR is very inefficient at detecting RNA, so a step called reverse transcriptase is used to convert the RNA to DNA before PCR (RT-PCR). The O’Leary lab did not perform this step. This result, and others, show that the samples used by Mr. Wakefield’s team were contaminated. Prof. Bustin goes into detail and covers more important topics, and as the paper is relatively short, it is worth a read for those interested in the science.

Prof. Bustin concludes:

As a result, the conclusions put forward by this [the Wakefield/O’Leary] paper are entirely incorrect and there is no evidence whatever for the presence either of MeV genomic RNA or mRNA in the GI tracts of any of the patients investigated during the course of the studies reported by O’Leary et al. Instead, it is clear that the data support the opposite conclusion: there is no evidence for any MeV being present in the majority of patients’ analysed. Unfortunately, the authors do not report whether any the patients had received the MMR vaccination. However, assuming that a significant proportion had done so, it is also clear that there is no link between the MMR vaccine and the presence of MeV in the intestine of autistic children.

The Wakefield MMR hypothesis is already failed, so this does not really change the conversation. What this report by Prof. Bustin does is document his own observations, measurements and analyses for the historical record so we can see just how bad the science was that promoted the Wakefield hypothesis.

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By Matt Carey

San Jose Mercury News: Three East Bay parents of autistic kindergarten children file federal civil rights lawsuit claiming teacher abuse

5 Apr

Following on the discussion of Texas allowing video monitoring of special education classrooms, a story from the California San Francisco Bay Area points out why such monitors are needed: Three East Bay parents of autistic kindergarten children file federal civil rights lawsuit claiming teacher abuse. The story begins:

With the filing of a federal lawsuit Wednesday, a horrific child abuse scandal burst into public view in the Antioch school district, involving three autistic students who allegedly were slapped, pinched and verbally abused by a teacher — and school officials who failed to report the accusations to police as the law requires.

The incidents, which bear a sad similarity to others that have come to light around the Bay Area in recent months, have already forced the accused teacher’s resignation and compelled a criminal investigation into the abuse claims. And now the district’s leadership stands accused by the students’ parents of creating a hostile environment that violated the autistic children’s civil rights.

Documents show the Antioch district’s own investigation of the concerns about teacher Theresa Allen-Caulboy ramped up only after this newspaper first reported on a similar abuse situation in Brentwood, where a convicted child abuser was allowed to continue teaching special needs students. A classroom aide to Allen-Caulboy cited the newspaper report as her impetus for reporting the abuse allegations.

More at the Mercury News.

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By Matt Carey

San Francisco Chronicle: Texas Senate passes special education cameras bill

4 Apr

A big question is how does one monitor the status of a special education classroom when the students are unable to communicate effectively? With a non disabled child, or a disabled child who can communicate well, a parent can ask the child what is going on in the classroom and know to some degree of certainty what is going on. A parent can find out if, for example, another child is a bully or if the teacher is not treating students well. But for some classes, this is not the case. The parents must rely on the teacher reports. And changes in behavior for their children.

Such was the case in New Jersey last year when a parent sent his kid to school with a recording device. The child was having more difficuties with time and the father found that staff were verbally abusing the students.

Another state, Texas, has now passed a law requiring video monitoring in specual education classrooms. The San Francisco Chronicle discusses this in: Texas Senate passes special education cameras bill.

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By Matt Carey

Letter from New York State Education Department to Judge Rotenberg Center: cease use of electric shock devices

4 Apr

The Judge Rotenberg Center (JRC) is known for its use of strong aversives in the educational programs of many of the students resident there. These aversives are delivered via electric shocks from “GED” devices many of the students wear. The GED devices have undergone some revisions over time and the current versions have not been approved for use on humans. Thus, the NY State Department of Education has notified JRC that they must cease using the unapproved devices. Apparently, JRC no longer manufactures nor has on hand the older, FDA approved devices. Thus, this letter in effect ends the use of electric shocks on New York students.

Below is a letter sent to JRC’s executive director, Glenda Crookes on March 12th, 2013 (the pdf is here, and I apologize for any mistakes in the OCR of that document).

Upon review of the “Warning Letter” CMS #367480 issued by the Department of Health and Human Services, Food and Drug Administration (FDA) on December 6, 2012 to the Judge Rotenberg Educational Center (JRC), and your responses thereto, the New York State Education Department (NYSED) finds JRC in violation of 8 NYCRR §200.22(f)(2)(viii) which states:

The use of any aversive conditioning device used to administer an electrical shock or other noxious stimuli to a student to modify undesirable behavioral characteristics shall be limited to devices tested for safety and efficacy and approved for such use by the United States Food and Drug Administration where such approval is required by Federal regulation.

In the above-referenced warning letter, the FDA states:

“In a letter dated May 23, 2011, FDA notified your facility that the changes and modifications to the originally-cleared GED device require a new premarket notification under 21 CFR 807. 81 (a)(3). As a result, the GED3A and GED4 devices violate the Federal Food, Drug, and Cosmetic Act (Act) because your facility has failed to obtain FDA clearance or approval. Specifically, the devices are adulterated under section 501(f)(1)(B) of the Act, 21 US.C. § 351(f)(1)(B), because your facility does not have an approved application for premarket approval in effect, pursuant to
section 515(a) of the Act, 21 US.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 US. C. § 360j(g). In a letter dated June 29, 2012, FDA again notified, your facility that the GED3A and GED4 devices are adulterated and require the submission of a premarket notification. In responses to the letters dated May 23, 2011, and June 29, 2012, your facility stated that it is planning to make a submission under section 510(k) of the Act, 21 US.C. § 360(k), for changes and modifications to the GE03A and GED4 devices by December 2012. We still have not received any submission from your facility. “

Therefore, consistent with the March 5, 2013 order by the Honorable Gary L. Sharpe, Chief Judge of the U.S. District Court, Northern District of New York, NYSED requires JRC to cease use of the GED-3A and GED-4 devices with NYS stUdents with disabilities not later than 30 days of receipt of this letter. All parties affected by this corrective action have been notified. This notification, which provides 30 days’ notice to JRC, replaces the corrective action letter issued to you on January 15, 2013.

As noted on the FDA website “Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.” (emphasis added) 8 NYCRR §200.22(f)(2)(viii) specifically requires that devices used for aversive interventions be “limited to devices tested for safety and efficacy and approved for such use by the FDA where such approval is required by federal regulation.” Without premarket approval, the devices have not been ‘tested’ and determined to be safe and effective for their intended use or uses. The use of the word “approval” for purposes of the above-referenced regulation was intended to encompass all requirements by FDA regarding such devices, including premarket approvals.

JRC was first notified by the FDA that the above-referenced devices did not have FDA clearance or approval as early as May 2011, yet you chose not to disclose this information to the New York State Education Department (NYSED), despite your direct knowledge since 2006 of New York State (NYS) regulations that specifically require FDA approval or clearance of devices used for aversive conditioning. It is JRC’s responsibility to ensure compliance with applicable NYS laws and regulations relating to the education of NYS’ students with disabilities.

In a letter dated January 18, 2013, Mr. Flammia raises the claim that “treatment with the GED devices is federally mandated by the students’ IEPs.” While the IEPs of the NYS students may indicate use of Level III aversives or a GED device, only one specifies the use of the GED 4 device. Further, while IDEA guarantees a free appropriate public education (FAPE), 34 CFR §300.18 specifically states that FAPE means special education and related services that meet the standards of the State Educational Agency. The standards of this State include the requirement for a prohibition on the use of aversive interventions, except as provided in 8 NYCRR §200.22(e) and that the use of any aversive conditioning device used to administer an electrical shock or other noxious stimuli to a student to modify undesirable behavioral characteristics shall be limited to devices tested for safety and efficacy and approved for use by the FDA. The FDA has publicly posted that the GED3A and 4 do not meet their standards for a determination that they are “safe and effective for its intended use or uses.”

Nothing in Mr. Flammia’s response to the New York State Education Department (NYSED) provides any documentation that the FDA now finds these devices safe for use, even during a transition period. Further, Mr. Flammia states “JRC is currently assessing 2 the time that it would take to revert back to use of the original version of the GED device” … and that the “time that it will take to revert back to the original version of the GED device is being reviewed and is unknown at this time.” Even if a transition period were appropriate, it would be irresponsible and inappropriate for NYSED to authorize JRC to continue to use devices not tested and determined to be safe with NYS students. As I stated in my letter of January 15, 2013 if you have a letter or other documentation indicating that the FDA finds it safe to continue the use of such devices during a transition period or that it has issued premarket approval of such devices, determining them to be “safe and effective for its intended use or uses,” then you should immediately fax that information to me.

In Mr. Flammia’s January 18, 2013 letter, he notifies NYSED that JRC no longer manufactures the FDA-approved GED devices or has such devices in your inventory. (This is information that was not previously disclosed by JRC to NYSED.) Therefore, you must take immediate steps to provide an approved device to implement the students’ IEPs or, until such time as the FDA notifies JRC that such devices have been determined safe for continued use, you must implement an interim alternative behavioral intervention plan with these students that does not include the use of GED 3A or GED 4. We are notifying each of the school districts that their Committees on Special Education must take immediate action to address this issue in the students’ IEPs.

In summary, effective 30 days from receipt of this letter, unless otherwise directed by the court, JRC must cease the use of the GED 3A and GED 4 devices with NYS students until such time as the FDA notifies you that the use of such devices have the required FDA approvals. If you have additional information from the FDA that it has determined that it is safe to use such devices during a transition period, and you would like to discuss this transition plan, please contact my office to arrange a meeting.

The letter was dated March 12, so the 30 day time limit is approaching fast.

I think the New York Department of Education could do much more to support these students through this transition than merely inform their school districts that their IEP’s need to be updated. This is a major change for students with quite extraordinary needs.

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By Matt Carey

New York to pull students from the Judge Rotenberg Center?

27 Feb

The press release below was just forwarded to me. New York City Councilmember Vincent Gentile is calling for students from the city (roughly 1/2 of the total) at the Judge Rotenberg Center (JRC) to be pulled from the school.

The JRC is facing other pressures, including losing medicaid funding for students in their care.

GENTILE CALLS ON CHANCELLOR TO REMOVE ALL NYC CHILDREN FROM CONTROVERSIAL SCHOOL ONCE AND FOR ALLCITY HALL – In light of recent developments, Councilman Vincent J. Gentile, a long-time advocate for New York’s most vulnerable, is calling on New York City Department of Education Chancellor Dennis M. Walcott to remove all New York children from the infamous Judge Rotenberg Center in Canton, Massachusetts once and for all. The Centers for Medicare & Medicaid Services (CMS) sent a letter to the Massachusetts Executive Office of Health and Human Services saying it would no longer allow federal Medicaid money to be used by anyone who lives at a facility that employs electric shock intervention, even if that person is not receiving the treatment themselves. Massachusetts has begun notifying the families of its students that they must either move to a new facility or unenroll from state benefits immediately.

“CMS made the right decision – no federal tax dollars should be going to an institution that uses these electric shock techniques on children. It’s time New York State and New York City to do the same – no city or state money should go to support an institution which subjects its students to these cruel and unusual forms of ‘behavior modification’. The Rotenberg Center in Massachusetts where 120 NYC developmentally disabled students currently attend, is in gross violation of the most fundamental standards of humane treatment of people with disabilities”, Councilman Gentile said. “With CMS pulling its funding, we are one step closer to shutting down Rotenberg once and for all.” As a New York State Senator, Councilman Gentile introduced legislation to mandate oversight and accountability when developmentally disabled students are sent out-of-state for education and treatment. Then, in late 2009, Councilman Gentile sponsored “Billy’s Law” which requires the Department of Education to provide the City Council with bi-annual reports monitoring all out-of-state residential facilities that house New York State children for specialized educational services – both pieces of legislation passed unanimously. “It is a sad fact that our City still sends children to this Center, and sadder still that it is our tax-payer dollars that fund about half of the children at this school,” Gentile wrote in a letter to Chancellor Walcott. “I know that with your leadership, we can finally remove our children from this barbaric facility. I am asking that you immediately develop a plan, if one does not already exist, to bring these students home and that you share it with my office and the New York City Council.” New York City Education officials have paid more than $13 million last year to treat 120 city kids at Judge Rotenberg Educational Center outside Boston, which until now was the only clinic in the country that uses electric shock treatments to discipline students.

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By Matt Carey

Newspaper Poll: Should Electric Shocks Continue at the Judge Rotenberg Center

26 Feb

I just received this message from Nancy Weiss. A newspaper local to the Judge Rotenberg Center is hosting a poll on whether the electric shocks should continue.

The Canton Journal (the local newspaper from the town in which the Judge Rotenberg Center is located) is conducting a poll to determine whether people support the Massachusetts Governor’s efforts to terminate the consent decree that gives the Judge Rotenberg Center the right to use electric shock to control residents’ behavior. So far the responses have been about even. The poll is quick to take. It’s wording is a little odd:

Sen. Brian A. Joyce applauded Governor Deval Patrick’s effort to get a 1987 court order overturned allowing the Judge Rotenberg Center in Canton to continue to use aversive therapies, like electric shocks, on disabled children. Do you agree with Joyce?
If you agree that the use of electric shock for behavior control should be eliminated; please click below and vote “yes”.

http://www.wickedlocal.com/canton/x1551253715#axzz2LrVLeM8e

Robert Saylor’s death ruled homicide

19 Feb

A gentleman with Down Syndrome went to the movies recently. When the movie was finished, he decided to stay to see it again. In other words, he did not get out of his seat; he did not buy a new ticket. The theater has security guards. Three of them.  Off duty police who were in police uniforms.  All three were called in to deal with this gentleman who would not get out of his seat.

The gentleman, Robert Saylor, died of asphyxiation.

Yes, for “resisting arrest” the off-duty police used enough force to result in the death of the gentleman. Because he wouldn’t buy an $11 ticket.

More at:

Autopsy finds that Md. man with Down syndrome died of asphyxia while in police custody

Robert Saylor death ruled a homicide

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By Matt Carey

Boston Globe: Patrick fights Rotenberg shock therapy decree

16 Feb

The Judge Rotenberg Center (JRC) is known for its use of electric shocks as an aversive therapy for behavior modification.  The center is named for Judge Rotenbrg, whose settlement decision 25 years ago allowed for then use of aversives.

The Governor of Massachusetts is now moving to nullify (vacate) that settlement decree.  The Boston Globe reports, Patrick fights Rotenberg shock therapy decree. (Note there is a paywall).

While some families and others connected with the Judge Rotenberg Center in Canton argue that the skin-shock procedure is necessary to treat people with the most severe conditions, others say it is tantamount to torture. Disability rights advocates and some former patients have worked for years to shut down the ­center.

The state’s motion comes two months after federal health officials said they would stop paying for treatment at Rotenberg. If approved, it could mark the beginning of the end of that decades-long debate.

I’ve also been informed that the State’s medicaid office is moving to stop payments to facilities that use electric shock treatments, even for those who are not receiving the shocks.

The electric shock devices are being considered for FDA approval.

It looks like pressure is being brought to bear on JRC from many sides all at once. They could lose their settlement decree allowing for the use of aversives. The could fail to get FDA approval for their shock devices. They could lose federal and state funding. All told, it looks like the use of electric shocks at JRC may be coming to an end.

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Matt Carey

Gluyas v Best: autistic blogger wins defamation suit

16 Feb

Long time readers of this site may recall the name John Best. Mr. Best was a very active participant on online discussions, including this blog. Mr. Best is a staunch believer in the notion that autism is mercury poisoning and that chelation is the cure.

Over time Mr. Best’s activities have, in my opinion, increasingly focused on attacking people. For example, Phil Gluyas, an Australian autistic blogger.

Examples of blog posts Mr. Best has published include:

“Is Phil Gluyas the next Adam Lanza?”
“Phil Gluyas’ history of brutality”
“Severely deranged mental case sues me again”

For those familiar with John Best, a defamation case is not surprising. For those who are not familiar with Mr. Best, count yourself lucky.

The judge found in favor of Mr. Gluyas:

The defendant’s responses to the plaintiff’s views have gone well beyond the bounds of ordinary discussion and intellectual debate. The items posted by the defendant on the internet, concerning the plaintiff, contain an extraordinary level of invective and personal denigration, which, in some measure, have been repeated in two letters which he has forwarded to the court in response to the proceedings served on him.

and Mr. Best did not argue that his statements are true:

Taken together, the article, and the imputations to be derived from them, are highly defamatory of the plaintiff. Again, the defendant has not sought to plead and prove the truth of any of those allegations. As such, each of the allegations by him about the plaintiff are false.

This, and much more, led to Mr. Best losing the defamation suit. Instead of the originally requested $10,000, the judge awarded $50,000. With a comment that he could have gone even higher:

Taking into account the foregoing considerations, I consider that it is appropriate to award the plaintiff the sum of $50,000 damages to compensate him for the publications made by the defendant of the plaintiff in Victoria. I should add that, if I had been satisfied that the publication in Victoria of the items, of which the plaintiff complained, had been more widespread than that proven in the evidence, I would have awarded the plaintiff a considerably larger sum of damages

I fear that the ability of someone finding Mr. Best capable of paying anything, much less $50,000, is slim. Accomplishing that from Australia might be even more difficult. It is an attempt to get blood from a turnip. But, Mr. Gluyas has been awarded the right to draw blood from this turnip and that alone is a victory.

There is room to be critical of the actions of others online. John Best crossed that line. To quote the TV show “Friends”, “you’re so far past the line that you can’t even see the line! The line is a dot to you!”

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By Matt Carey

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