Study by NYU and PACE: another failure in obtaining ethical approval?

20 May

One issue that has come up more than once in autism research is the failure to obtain ethical approval for human studies research. Andrew Wakefield started his studies on autistic children before the Royal Free Hospital granted ethical approval. Mark and David Geier failed to obtain Institutional Review Board (IRB) approval before starting one of their studies. According to an article on neurodiversity.com:

None of the IRB members have declared expertise in the field of pediatric endocrinology. Whereas the IRB was registered in March 2006, the research described in the article was conducted between November 2004 and November 2005.

Not only did none of the members of the IRB have expertise in the field, the IRB included the researchers (Mark and David Geier), the mother of one of the children on the “Lupron protocol”, an attorney specializing in vaccine injury, and Anne Geier (wife to Mark, father to David).

Apparently following in these footsteps are the team who recently brought us a study purporting to show a high prevalence of autism amongst children compensated by the vaccine court (for more on this, see 2 ½ Studies: Autism Prevalence and the “Hidden Horde”). The vaccine-court study author list is Mary Holland, NYU School of Law, Louis Conte, Robert Krakow, and Lisa Colin. The study was published in the PACE Environmental Law Review. Further, “Pace Law School provided significant research support for this study” as noted in the footnotes of the paper:

* Mary Holland, Research Scholar and Director of the Graduate Legal Skills Program, NYU School of Law; Louis Conte, independent investigator; and Robert Krakow and Lisa Colin, attorneys in private practice. Pace Law School provided significant research support for this study. The authors thank former Environmental Law Dean Alexandra Dunn and law students Jillian Petrera, Kyle Caffrey, Sohad Jamal, Alison Kaplan, Georgine Bells, Jonne Ronquillo, Lisa Hatem, Allison Kazi and Adrienne Fortin. The authors also thank volunteers who worked under the direction of Louis Conte. For purposes of disclosure, Robert Krakow and Lisa Colin represent clients and have claims on behalf of family members in the Vaccine Injury Compensation Program.

Ken Reibel, journalist and proprietor of Autism News Beat has an article published today: Unanswered Questions from Pace Law journal study: Ethical Standards for Research on Human Subjects. He poses some very important questions:

1) Does the study methods meet the standards of “human subject” research?
2) Did NYU or PACE (or anyone else) obtain IRB approval?

The answers appear to be yes to the first, no to the second.

From Autism News Beat:

“Human subject” is defined by the DHHS as “a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.”

and,

When asked if the Pace study had IRB approval, Pace Law spokesperson Lauren Rubenstein referred the question to the study’s co-author, Louis Conte. In an email, Rubenstein wrote “Louis Conte has told me that there was no human subjects research in this study.”

Which I interpret to mean that they don’t have IRB approval as they don’t believe they require it. My read is that, yes, they did require IRB approval.

It will be interesting to see what, if anything, comes of this. Will PACE and NYU investigate and let the public know if their people went ahead with human subject research without IRB approval?

For more details: Unanswered Questions from Pace Law journal study: Ethical Standards for Research on Human Subjects

Message From Down syndrome Workers !!!! They’re more than you think

20 May

Here’s a YouTube video someone sent me just now. Really, really tough to watch.

Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine

20 May

The father-son team of Mark and David Geier have been charged with violations of medical practice. Mark Geier is a physician and his son, David, holds a bachelor of arts degree. Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine is the most recent post by Kathleen Seidel of Neurodiversity.com. This follows the suspension of Dr. Mark Geier (Maryland Medical Board Suspends Dr. Mark Geier’s License).

Ms. Seidel’s post follows her practice of a very thorough, well linked discussion of the topic. Here is her first paragraph (without links):

On Monday, May 16, 2011, the Maryland Board of Physicians charged Dr. Mark Geier with numerous violations of the Maryland Medical Practice Act, and charged his son, David Geier, with practicing medicine without a license. The charges come three weeks after the Board summarily suspended Dr. Geier’s license to practice medicine, in order to prevent harm to the many autistic children entrusted to his care. The suspension was upheld by a subsequent order issued by the Board on May 12, one day after a hearing at which Dr. Geier protested the suspension and submitted affidavits of support from the parents of seven of his patients. These included a statement from James B. Adams, Ph.D., a professor of engineering at Arizona State University who, like Dr. and Mr. Geier, has frequently exceeded the bounds of his academic specialty to conduct medical research premised on the discredited hypothesis that autism is a consequence of vaccine injury.

It is well worth the time to read the entire post: Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine

Perhaps this time I’ve gone too far….

19 May

OK, it isn’t me that’s gone too far this time. It’s Alison Singer of the Autism Science Foundation. Here’s her message:

What won’t I do to raise money for autism research? This time, I’ll be riding on the back of a motorcycle from Rockville Centre NY to the Montauk Lighthouse with the AML Bikers for Charity, who have chosen to support the Autism Science Foundation with their ride again this year on June 13. Am I scared? In a word, YES!. But not as scared as I am that we are not funding autism research fast enough. Having just returned from the International Meeting for Autism Research, I am more optimistic than ever that we are on our way to finding new treatments and eventually a cure for autism, but there is still a lot of work ahead of us and we need your help.

Please sponsor me as a rider in the AML Bikers for Charity by clicking on this link and then clicking the “donate” button underneath the thermometer. Your support will mean more funds for research that will make a difference for individuals with autism and their families.

The Autism Science Foundation is a 501(c)3 public charity. Donations are tax deductible to the full extent allowed by law. Learn more about ASF at www.autismsciencefoundation.org.

Here’s the donation link again: https://ssl.charityweb.net/autismsciencefoundation/activities/alisonsinger.htm

Want to join the ride? Click here to learn more and register as a biker.

Thank you so much!

Alison

NICHD Brain and Tissue Bank

19 May

Thinking about death is just no fun. Plain and simple. It isn’t fun to plan ahead for a future where you or a loved one is no longer here. Many of us avoid planning for death because it is so hard to think about. But we should face those fears. Depending on your circumstances, you may either be a person being supported, or you may be supporting others. Obviously, some form of financial planning is key, especially within the disability community. Shannon Rosa discussed this topic at The Thinking Person’s Guide to Autism.

But there are other things to think about too. When Eric Courchesne spoke at IMFAR, he started out by noting how there are very, very few sources of postmortem brain tissue. There are really only a few dozen. According to the NICHD (National Center for Child Health and Human Development), here’s what’s in the brain bank:

Autism = 43
Autism-Pending = 10
Autism suspected = 8
Pervasive developmental disorder = 1
Unaffected autism relatives = 3

ASD related:

Rett = 10
Asperger = 4
Angelman = 5
Epilepsy/seizures = 61
Tuberous Sclerosis = 34

That’s it. And this has to serve:

Number of researchers who have received tissue = 72
total autism tissue samples distributed =>1,500
total control tissue samples distributed for autism reearch = >2000
Number of autism papers that utilized NICHD tissue = 82
Number of autism abstracts that utilized NICHD tissue = 103

If you want more information, go to www.btbank.org. There you can register yourself or your minor child as a tissue donor.

OK, it isn’t the way any of us want to contribute to autism science. But just look: there are 43 autism cases available. That’s it. We all know about the diversity of the autism population. 43 is a pitifully small number.

Tissue needs to be collected within 24 hours. Let’s face it, no one wants to have to face the decision of whether to donate a loved one’s tissue in that time of immense grief. Plan ahead. register

Interviews from IMFAR: Alex Plank brings the conference to the public

18 May

One of the unexpected joys of attending the IMFAR conference this year was meeting Alex Plank of Wrong Planet. I plan on writing more about Alex soon, but for the moment, let me bring you some of the interviews he did. His team is the same one that brought us the press conference. That was no small effort. They were up most of the night getting that out so fast. As you will see, Alex takes videography very seriously. As such, I would recommend playing these full screen or going to YouTube and playing them in a larger format that is afforded by out column size. It’s quality work. I love the way he’s working with various locations in these interviews.

John Robison at Imfar

David Mandell at IMFAR 2011

Clara Lajonchere, VP of Clinical Programs at IMFAR

Peter Bell of Autism Speaks – IMFAR Interview in San Diego

Geraldine Dawson Interview

What I did with your money

18 May

Now LBRB is successfully moved (with a few little bits of tidying needed her and there) I need to tell you what I did with the nearly $1000 so generously donated.

First and foremost of course I bought some new hosting. I think you’ll agree that the site feels much faster and slicker as a result of the move. Gone is the churning away and (hopefully) gone is the CPU throttling.

However, I did have some money left over so I decided that as you all had been so generous that the right thing to do was pay it forward. In that spirit I split the remaining money into three parts and donated thusly:

The Autism Science Foundation – A good deal of LBRB contributors and visitors are American so to donate to a science based autism foundation in the States seemed like a good idea. ASF do not place _any_ research monies into the blind alley of vaccines.

National Autistic Society is the UK’s leading autism charity, giving an actual voice to actual autistic people is vital and the NAS do this better than anyone else in my opinion.

Speur Ghlan are a small, recently incorporated charity based in the land of my fathers – Scotland. I know the founder well and am constantly impressed at her drive and enthusiasm for her subject matter.

The amounts involved were not huge obviously but I hope that I’ve managed to meet with your approval both in choice and reasons for choice.

Thank you once again for your generous donations to get LBRB a better home. I hope I can repay you with years more quality blogging from Sullivan and the odd bit of snark from me 😉

New hosting environment – occassional weirdness

17 May

Hi folks,

Thanks to your extreme kindness, LBRB has been able to move to a much better hosting environment 🙂

However, as we’re moving _right now_ you’re going to see some oddness. Posts are going to disappear as will some comments. Hopefully we’ll be able to reinstate them ASAP but please bear with me whilst I get it all ship shape and bristol fashion.

This is happening now

13 May

In my town, in my county. The same county that has David Cameron amongst its MP’s.

Parent Reported Status and Expectations for Their Autistic Student Children: An Analysis of the 2007 National Household Education Survey

13 May

I have written in the past that I will be attending IMFAR, the International Meeting For Autism Research. I will be supported by a stakeholder travel grant from the Autism Science Foundation, for which I am very grateful. What I haven’t mentioned before is that I was planning to attend IMFAR even before applying for the stakeholder grant. I’ve been planning on attending since I submitted an abstract: Parent Reported Status and Expectations for Their Autistic Student Children: An Analysis of the 2007 National Household Education Survey.

For those who have read this blog for some time, it will come as no surprise that I have a keen interest in autism research. In my writing I have often analyzed data from public datasets like the California Department of Developmental Services data. A while back there was a lot of attention placed on the National Survey of Children’s Health. The big news was the announcement of an autism prevalence of about 1%, and a notion that these data pointed to a very high “recovery” rate from autism. I took a look at the recovery rate question. I also looked for a what other information we might gather from the survey, including debunking the idea that 80% of parents of autistic kids divorce.

One of the big news stories from last year’s IMFAR was the announcement that autism does not result in a high divorce rate. The team presenting at IMFAR were much more rigorous in their analysis than the report of raw data that I did. But I have to say that when I read the IMFAR abstract I thought, good to see that team make this fact known. I also thought to myself: I’m asking the right questions of the data I am analyzing.

I also know how to give a presentation at a conference, having done so many times in the past. But conferences don’t let people present using a pseudonym. This was somewhat frustrating, as I have been looking at data from the National Household Education Surveys Program (NHES) and found some very interesting results. Once people took it upon themselves to out me, that was no longer an obstacle, so I submitted an abstract for IMFAR 2011:

Parent Reported Status and Expectations for Their Autistic Student Children: An Analysis of the 2007 National Household Education Survey.
M. J. Carey
Background: National surveys provide a good source of information on autistic populations within the United States. The 2007 National Survey for Child Health was used to estimate autism prevalence (Kogan 2009), as well as to make comparisons of such family factors as the divorce rate (Freedman 2010). A similar survey, the National Household Education Surveys Program (NHES), is an opportunity to explore comparisons between parent-reported factors involving the lives and education of autistic and non-autistic students.

Objectives:
1. Compare educational placements and perceived educational abilities between children with (a) parent-reported autism spectrum disorders (ASD) and (b) children in the general population.
2. Explore parent expectations for the future of their ASD student.

Methods: Data used for this study were taken from the National Household Education Surveys Program (NHES 2007). NHES had 10,682 total respondents, representing students ages 3 to 20 years. 127 parents identified their child as having autism and an additional 37 identified their child as having pervasive developmental disorder. Parent responses for this group (164 total, or about 1 in 65) were compared to those of the parent responses within the general survey population.

Results: 75% of students with parent-reported ASD have an Individualized Education Plan. Parents reported that their ASD students are more likely to have repeated a grade (23% ASD vs. 9% without) or be home schooled (5.5% vs. 2.9%) or be in a program that does not assign letter grades (37% vs. 22%). ASD students were reported as less likely to be in private school (9.6% vs. 13.4%) and to have moved in order to attend a specific school (17.7% vs. 21.6%). Parents are generally satisfied with their child’s school (82.2% rated somewhat or very satisfied), but less so than for non-autistic students (90.7%). Of those children who receive letter grades, the number of ASD students getting “mostly A’s” or “mostly B’s” is high (79.6%), but less than the general population (84.1%). Parents of students in middle school or above were asked about their future expectations. The fraction of ASD students whose parents’ expectation were that their child would receive less than a high school diploma is much higher than for the general population (6.3% vs. 0.6%). However, by far the majority of parents expect their autistic student to receive a high school diploma, with most expecting at least some vocational school or college to follow. Most parents in the general population expect that their child would achieve a 4-year or graduate degree (72.7%). While the parental expectations for ASD students to obtain a bachelor or higher degree is much lower (28%), this is still a notable fraction of the autistic population.

Conclusions: Parents report that their ASD students lag behind the general student population in academic performance. Parent report high satisfaction with their schools, but at a lower level than the general population. Many parents of ASD students report high expectations for their ASD students. Services research should consider how to support individuals with ASD with a broad spectrum of abilities and expectations.

The crude administrative prevalence is quite high at 1 in 65 (1.5%). Notably higher than the 1% value in the last CDC prevalence estimate and the estimate from the NSCH from the same year. As you can see, this is not where I placed the emphasis in this abstract.

What struck me when I looked at these data was the evidence for how broad the spectrum is. Most students are on an IEP. Students with parent-reported autism are in non-graded environments more, and are not getting as high grades. But, there are also a large fraction whose grades are high and there is a small, but notable, group whose parents have expectations of college and beyond.

One major question is how realistic are these parent expectations? How well do these students really do on transition out of school? Another presentation at IMFAR looks into that. This is by Prof. Shattuck’s group at Washington University at St. Louis. To be very clear, I had nothing to do with this study and didn’t even know it was in the works. Prof. Shattuck’s work is far more rigorous than the abstract I submitted, but I’m encouraged to be asking good questions at least. Here is his abstract:

110.096 75 The Role of Parental Expectations In Predicting Post-High School Outcomes for Youth with ASD. J. L. Taylor*1 and P. Shattuck2, (1)Vanderbilt Kennedy Center, (2)Washington University

Background: There is considerable variability in post-high school outcomes of young adults with ASD. Underemployment is common, and many young adults continuing living with their parents or in supported settings after leaving high school. Research examining predictors of independence among adults with ASD has focused on characteristics of the adult that are difficult to change, such as early language or IQ. The present study focused on one malleable factor that is related to adult outcomes in typically developing individuals: parental expectations.

Objectives: This study had two objectives: 1) to describe parents’ expectations for the post-high school educational, occupational, and residential outcomes of their son or daughter with ASD; and 2) to determine the correspondence between parental expectations and outcomes.

Methods: This study used data from waves 1 and 4 of the National Longitudinal Transition Study 2 (NLTS2), a nationally representative, 10-year longitudinal survey of adolescents in special education. Participants for this study included 390 parents whose son or daughter had received a diagnosis of ASD through the school system and had exited high school by wave 4.
Parental expectations were assessed at wave 1, while youth were still in high school, with the following questions: “How likely do you think it is that (youth) will:” 1.) “graduate from a 4-year college;” 2.) “eventually will get a paid job;” 3.) “eventually live away from home on (his/her) own without supervision.” The son or daughter’s educational activities, current living arrangement, and work status were measured at wave 4. Severity of impairment (conversational ability, social communication, mental skills) was statistically controlled in all analyses.

Results: One-quarter (27%) of parents expected that their son or daughter would graduate from a 4-year college, 88% expected that their son or daughter would work for pay, and one-half expected that he or she would live outside the home without supports. Family income was not independently related to parents’ expectations that their son or daughter would attain a 4-year degree or live outside of the home without supports. Families with higher incomes were more likely to expect that their son or daughter would work for pay, B=.08, p.10. Parental expectations did, however, predict the likelihood that youth would be working for pay, OR=6.05, p<.01.

Conclusions: For many parents of youth with ASD, expectations for their son or daughter’s post-high school living arrangements and education may not be realized. Expectations for paid employment, however, may increase the likelihood of post-high school employment.

Again, for emphasis: “Only 39% of youth whose parents said they “definitely would” graduate from a 4-year college were currently enrolled or had graduated; 45% of youth whose parents said the “definitely would” live away from home independently were currently doing so”.

The question is: how can we achieve the goal where more autistics make the transition from school to adulthood and employment or college? I don’t expect all to make that transition, but I feel strongly that we can do a lot better as a society than we are now.

note–I originally posted this last month when the Abstracts for IMFAR 2011 were first put online. Unfortunately, they were online by mistake. There was an embargo still in place. I pull the article then and am re posting it now that the embargo is lifted. Friday at 9am, I will be standing in front of the poster.

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