Supreme court affirms 1986 Vaccine Act

22 Feb

The US Supreme Court has ruled 6-2 that pharmaceutical companies cannot be sued for a vaccine-related injury or death as long as the vaccine was properly prepared and came with directions and warnings. Associate Justice Sonia Sotomayor and Ruth Bader Ginsburg dissented. Associate Justice Elena Kagan did not participate in the case, known as Brueswitz v. Wyeth. From the Wall Street Journal:

The court ruled against parents who claimed their daughter suffers from a seizure disorder as the result of a Wyeth vaccination she received as an infant in 1992. The vaccine was discontinued in 1998.

The National Childhood Vaccine Injury Act of 1986 was enacted to reduce the potential financial liability of vaccine makers while ensuring supply. It created a no-fault arbitration process for injury claims, known as the National Vaccine Injury Compensation Program.

“Childhood vaccines are among the greatest medical breakthroughs of the last century,” said O. Marion Burton, MD, president of the American Academy of Pediatrics. The AAP was one of 22 health organizations which urged the Court to confirm that the National Childhood Vaccine Injury Compensation Act of 1986 (“Vaccine Act”) preempted design defect claims against vaccine manufacturers. “Today’s Supreme Court decision protects children by strengthening our national immunization system and ensuring that vaccines will continue to prevent the spread of infectious diseases in this country.”

The case turned on the interpretation of this paragraph in the 1986 Vaccine Act legislation:

“No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

Writing for the majority, Justice Antonin Scalia said:

The “even though” clause clarifies the word that precedes it. It delineates the preventative measures that a vaccine manufacturer must have taken for a side-effect to be considered “unavoidable” under the statute. Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State-law design-defect claims are therefore preempted.

Get ready for the flood of fetal gene screening

21 Feb

In a recent article in Nature, Henry T. Greely, proposes that the time when prenatal genetic screening may be commonplace is closer than, well, I thought.

The world’s news media was buzzing last week after researchers showed that a blood test for mothers could detect Down’s syndrome in their fetuses[1]. Last month, two research groups independently published proof that the fetal genotype — the genetic status at a given locus — can be derived for thousands of sites from samples of fetal DNA with just a 10-millilitre blood draw from a pregnant woman[2, 3].

[1] Chiu, R. W. K. et al. Br. Med. J. doi: 10.1136/bmj.c7401 (2011).

[2] Lo, Y. M. D. et al. Sci. Transl. Med. 2, 61ra91 (2010).

[3] Fan, H. C. & Quake, S. R. Nature Precedings doi:10.1038/npre.2010.5373.1 (2010).

Until now, the main prenatal testing has been for Down Syndrome. It is not common:

Prenatal genetic testing has been clinically available since the late 1960s, but the costs, inconvenience and especially the miscarriage risks have limited its use. Each year, less than 2% of pregnant women in the United States undergo amniocentesis (in which a small amount of amniotic fluid containing fetal cells is taken for analysis) or chorionic villus sampling (CVS — in which fetal tissue is extracted from the placenta). Both procedures increase the risk of miscarriage. Until now, any given sample could be tested for only one or two conditions, typically chromosomal abnormalities such as trisomy 21, the cause of Down’s syndrome.

It is uncommon, but it is offered in high risk situations (older mothers). Since the test has been offered, the prevalence of Down Syndrome has dropped significantly. This in spite of the fact that older mothers are more common now.

Amniocentesis is obviously invasive, resulting in risk to the unborn child. But a blood draw would be a non-invasive prenatal genetic diagnosis (NIPD).

The potential of NIPD goes way beyond Rhesus screening. Two of the leading researchers in cell-free fetal DNA testing — Dennis Lo of the University of Hong Kong and Steve Quake of Stanford University in California — use different methods to analyse fetal cell-free DNA from maternal serum. Each has demonstrated the ability to detect aneuploidies — missing or extra chromosomes, such as in trisomy 21 (refs 5, 6). Last month, both researchers published proof that the fetal genotype could be derived for thousands of sites from cell-free fetal DNA2, 3 — demonstrating the possibility of using maternal blood to test for all fetal genetic traits.

The methods demonstrated are already interesting commercial firms:

Commercial firms are already interested. Sequenom in San Diego, California, is working with Lo; another, Artemis Health of Menlo Park, California, is working with Quake; and still others are also exploring the technology. For-profit development of these methods seems likely within five years, at least for chromosomal abnormalities, such as trisomy 21, and possibly for single-gene traits.

My insurance plan will pay for prenatal genetic testing, but not for genetic testing of a child. I find that thought a bit chilling.

Until now, prenatal genetic testing has been relatively uncommon. The ethics discussions have been largely academic. Important, but academic. The time for academic discussions of the ethics is drawing to a close.

Professional organizations, in medicine and in genetics, need to get involved, both in training their members about these technologies and in beginning to consider guidelines for their use, especially with regard to informed consent. Regulators, companies and consumer advocates need to be talking about pathways for assuring the safety, efficacy and quality of NIPD testing. In the United States, the Food and Drug Administration should start that process immediately. And it is time for ethics commissions, such as the US Presidential Commission for the Study of Bioethical Issues, to report on these issues.

Most importantly, we need to start conversations, between all those concerned, about the limits, if any, to place on this powerful technology. Whether we view NIPD gladly as a way to reduce human suffering, warily as a step towards a eugenic dystopia, or as a mix of both, we should agree that the better we prepare, the more likely we are to avoid the worst misuses of this potentially transformative technology.

What disabilities will eventually have genetic screening possible? How will we as a society take on the ethical challenges? If the drop in Down Syndrome is any indication, I think there is reason to take this discussion very seriously. Now.

Garry Trudeau of Doonesbury takes on Jenny McCarthy and the “bogus vaccine-autism link”

20 Feb

One of the big problems with the media has been their willingness to give the vaccine-induced-autism-epidemic idea far more wight than it deserved. While the science has been very one sided against the theories presented, the media usually puts out “he said/she said” type stories. You know the type. A new study will come out. A news story will be produced. They will open with people talking about the increasing numbers of people diagnosed with autism and the belief in the vaccine link in some groups. The scientists for the new study will be interviewed. And then the story will end with parents saying, “but I know the link is real”. It was a world of false balance.

That world has changed, at least for now. Sure not everywhere, but the media and the public’s perception of vaccines and autism has changed.

Case in point: the comic strip “Doonesbury”. For about 40 years Gary Trudeau has had his finger on the pulse of American society. He has been a harsh critic of political figures and popular culture figures (many papers have placed his comic on the opinion or editorial pages).

Here are a couple of panels from today’s strip (click to enlarge). Boopsie, former cheerleader and Playboy playmate, is discussing Jenny McCarthy:

The full strip can be found at Doonesbury.com.

The vaccine-causation idea has only survived through the media and public relations. The science never really supported the hypotheses. Jenny McCarthy rode the vaccine story back into the public’s eye, and appears to be trying to jump ship before it drags her back down. If today’s Doonesbury is any indication, she may have waited too long. She could do a lot of good by making a public statement distancing herself from the junk science and PR campaigns that created the image of a vaccine-induced-epidemic. It wouldn’t make up for all the damage she caused, but it would be better than having her publicity people beg the Colbert show to not be harsh on her, while she was at the same time writing pieces supporting the junk scientists for the Huffington Post.

When Doonesbury is calling you out for promoting a “bogus vaccine-autism link” and for causing real harm to preventive health care, you’ve lost public support. You can either try to stay low and ride it out, or do the right thing and repair some of the damage you’ve caused. The choice is yours, Ms. McCarthy.

California’s Specific Learning Disabilities Counter Epidemic

19 Feb

The U.S. and California Departments of Education recently released special education data (child counts) for the 2008-2009 school year. A particular focus in the media has been a tripling of the number of students who wear a special education label of “autism” in California.

Needless to say, some probably see this as confirmation of an “autism epidemic”. For a particularly myopic and emotional (anger and fear) interpretation of this recent news story, one need go no further than “Autism Epidemic” central (AoA) and read the data-free opinion piece by Anne Dachel.

For the bigger picture in California, a look at the actual data might be in order.

California Data

For those who may not be able to see the graph of the IDEA data that most closely represents the K-12 age group as a percentage of the resident population, receiving special education services for the last ten years in California: Autism has steadily increased from .13% to .64%, Specific Learning Disabilities has steadily decreased from 5.64% to 4.41%, and totals for all disabilities has remained flat at about 9.2%.

If you believe there’s been an “autism epidemic”, and that special education data from California proves that the schools are overwhelmed, here are a two questions for you:

1. What has caused the decrease in Specific Learning Disabilities (a decrease that more than offsets the increase in autism)?

2. If the special education totals remain unchanged, why are the schools “overwhelmed”?

Work stress, burnout, and social and personal resources among direct care workers.

18 Feb

No surprise, people who have jobs caring for people with intellectual and developmental disabilities face a lot of stress. A recent paper has looked into what causes and alleviates the stress for these workers.

Work stress, burnout, and social and personal resources among direct care workers.

Gray-Stanley JA, Muramatsu N.

School of Nursing and Health Studies, Northern Illinois University, 253 Wirtz Hall, DeKalb, IL 60115, United States.
Abstract

Work stress is endemic among direct care workers (DCWs) who serve people with intellectual and developmental disabilities. Social resources, such as work social support, and personal resources, such as an internal locus of control, may help DCWs perceive work overload and other work-related stressors as less threatening and galvanize them to cope more effectively to prevent burnout. However, little is known about what resources are effective for coping with what types of work stress. Thus, we examined how work stress and social and personal resources are associated with burnout for DCWs. We conducted a survey of DCWs (n=323) from five community-based organizations that provide residential, vocational, and personal care services for adults with intellectual and developmental disabilities. Participants completed a self-administered survey about their perceptions of work stress, work social support, locus of control, and burnout relative to their daily work routine. We conducted multiple regression analysis to test both the main and interaction effects of work stress and resources with respect to burnout. Work stress, specifically work overload, limited participation decision-making, and client disability care, was positively associated with burnout (p<.001). The association between work social support and burnout depended on the levels of work overload (p<.05), and the association between locus of control and burnout depended on the levels of work overload (p<.05) and participation in decision-making (p<.05). Whether work social support and locus of control make a difference depends on the kinds and the levels of work stressors. The findings underscore the importance of strong work-based social support networks and stress management resources for DCWs.

What adds to burnout? Work overload. Not being involved in decision making. Also, levels of client functioning, mobility, and intellectual abilities are a factor. If I read the paper correctly, levels of client functioning are a bigger factor than work overload.

Supervisor support and coworker support alleviated some of the stress and burnout.

The study concludes:

Policies or interventions developed as a result of this analysis might include strategies to foster work-based social support networks (i.e., team building efforts), as well as interventions to help workers develop personal stress management resources (Tierney, Quinlan, & Hastings, 2007). Successful protocols, once identified, can contribute to improved DCW job morale and ultimately better client care.

I don’t think stress and the sources of stress come as any great surprise. However, the more information available to make notions into supported facts, the better. If this can help caregivers and caregiver organizations support in reducing workload and adding methods to alleviate stress, so much the better for all. Especially the clients.

Should a person who victimizes the disabled be allowed a short sentence?

18 Feb

A recent case in the Los Angeles area involved the sexual assaults of women in group homes. The case came to light when videos of the assaults were provided to the police. At least two of the assailants have been identified.

One of them has pled “no contest” to the charges. In return he is being offered a reduced sentence: 8 years (down from a maximum possible of 27). He would have to serve at least 85% of the time, and would have to register as a sex offender.

The deal is not sitting well with everyone:

The mother of one of the victims, a Rosemead woman, said that the deal came as a surprise and that she hoped the judge would reject it.

“Eight years is nothing for all the damage he has done to all these kids and their families,” the mother said.

A spokesperson for the LA district attorney’s office is quoted as:

“With these kinds of cases we never want to subject the victims to more trauma, and this was a difficult case because of the victims’ disabilities,” she said. “We felt that this [resolution] was appropriate.”

I am left with the question of whether the victims approached on this plea deal. Were the victims willing to testify, it should be their decision. The rationale put forth by the DA’s office that this is to prevent further trauma.

ARCA, the Association of Regional Center Agencies, has come forward calling the plea deal an injustice:

The Association of Regional Center Agencies, an advocacy group representing 21 California regional centers serving children and adults with developmental disabilities, says the plea bargain for Juan Fernando Flores is an injustice.

Irony and fear

17 Feb

I tried to stay away. Honestly. I’ve had enough of Andrew Wakefield for a long time. But a news story came out with two paragraphs that I couldn’t let go.

From DallasNews.com is an article “Some parents embrace discredited researcher whose studies link autism to vaccinations”. In it, Andrew Wakefield is quoted as saying:

“The tragedy is that it’s taking attention away from the real issues of how to help these poor children,” the 54-year-old surgeon said in
an interview Friday.

How much time has been wasted by parents and researchers in the MMR story?

That’s the irony. Now the fear.

Today, Wakefield, who hopes to open an Austin residential facility for autistic adults, said he regrets having to spend so much time
defending his 13-year-old study.

OK, I don’t really fear this as (a) I doubt it will come to pass and (b) I doubt my kid will end up in Austin.

So many thoughts go through my head thinking about Andrew Wakefield running programs for autistic adults. I seriously am at a loss for how to put those thoughts into words.

Prevalence and functioning of children with cerebral palsy in four areas of the United States in 2006: A report from the Autism and Developmental Disabilities Monitoring Network

16 Feb

Most of what we hear (especially on this blog and other autism focused sources) about the Autism and Developmental Disabilities Monitoring Network (ADDM) is, well, autism related. Mostly we get the prevalence estimates for the CDC from this source. Sometimes I admit, I forget that “and Developmental Disabilities” is in there.

A recent paper shows that the ADDM is more broad than just autism. And, at the same time, gives some interesting autism information. The paper is: Prevalence and functioning of children with cerebral palsy in four areas of the United States in 2006: A report from the Autism and Developmental Disabilities Monitoring Network

Here is the abstract:

Prevalence and functioning of children with cerebral palsy in four areas of the United States in 2006: A report from the Autism and Developmental Disabilities Monitoring Network.

Kirby RS, Wingate MS, Van Naarden Braun K, Doernberg NS, Arneson CL, Benedict RE, Mulvihill B, Durkin MS, Fitzgerald RT, Maenner MJ, Patz JA, Yeargin-Allsopp M.

Department of Community and Family Health, College of Public Health, University of South Florida, 13201 Bruce B. Downs Blvd, MDC56, Tampa, FL 33612, United States.
Abstract

AIM: To estimate the prevalence of cerebral palsy (CP) and the frequency of co-occurring developmental disabilities (DDs), gross motor function (GMF), and walking ability using the largest surveillance DD database in the US.

METHODS: We conducted population-based surveillance of 8-year-old children in 2006 (N=142,338), in areas of Alabama, Georgia, Wisconsin, and Missouri. This multi-site collaboration involved retrospective record review at multiple sources. We reported CP subtype, co-occurring DDs, Gross Motor Function Classification System (GMFCS) level, and walking ability as well as CP period prevalence by race/ethnicity and sex.

RESULTS: CP prevalence was 3.3 (95% confidence interval [CI]: 3.1-3.7) per 1000 and varied by site, ranging from 2.9 (Wisconsin) to 3.8 (Georgia) per 1000, 8-year olds (p<0.02). Approximately 81% had spastic CP. Among children with CP, 8% had an autism spectrum disorder and 35% had epilepsy. Using the GMFCS, 38.1% functioned at the highest level (I), with 17.1% at the lowest level (V). Fifty-six percent were able to walk independently and 33% had limited or no walking ability.

INTERPRETATION: Surveillance data are enhanced when factors such as functioning and co-occurring conditions known to affect clinical service needs, quality of life, and health care are also considered.

I will admit that I did not know that the prevalence of ASD amongst those with cerebral palsey was so high, 8%. It is interesting to note that there is a geographic variation in the prevalence estimates of CP, from 2.9 to 3.8 per 1000. This is not quite as large as the spread in autism prevalence estimates by state, but it is pretty big.

A Comparison of Autism Prevalence Trends in Denmark and Western Australia.

15 Feb

I bring this up because there is a common argument that the autism “rates” in places like Denmark and Sweden are much lower than those in the US and elsewhere. This is used to try to negate studies using those country’s populations in, for example, showing that there is no increased risk from thimerosal or the MMR vaccine. This error often stems from comparing “incidence” to “prevalence”.

Is the autism prevalence low in Denmark? Not really. This paper just out (and other reports previously, including this one cited by Steven Novella) show a prevalence pretty comparable to the US.

J Autism Dev Disord. 2011 Feb 11. [Epub ahead of print]
A Comparison of Autism Prevalence Trends in Denmark and Western Australia.

Parner ET, Thorsen P, Dixon G, de Klerk N, Leonard H, Nassar N, Bourke J, Bower C, Glasson EJ.

Institute of Public Health, Department of Biostatistics, University of Aarhus, Aarhus, Denmark.
Abstract

Prevalence statistics for autism spectrum disorders (ASD) vary widely across geographical boundaries. Some variation can be explained by diagnostic methods, case ascertainment and age at diagnosis. This study compared prevalence statistics for two distinct geographical regions, Denmark and Western Australia, both of which have had population-based registers and consistent classification systems operating over the past decade. Overall ASD prevalence rates were higher in Denmark (68.5 per 10,000 children) compared with Western Australia (51.0 per 10,000 children), while the diagnosis of childhood autism was more prevalent in Western Australia (39.3 per 10,000 children) compared with Denmark (21.8 per 10,000 children). These differences are probably caused by local phenomena affecting case ascertainment but influence from biological or geographical factors may exist.

Prevalence of 68.5 per 10,000 children. A previous estimate was 80 per 10,000. Generation Rescue claimed a rate of 1 in 2200 (4.5 per 10,000) when they tried to make the case that…oh I bet you can guess…that vaccines cause autism. The 1 in 80 figure was already published, so I doubt they will change their story given yet another study.

Special Education Programs, Private Placements, Under Assault

15 Feb

Education week has an article, Special Education Programs, Private Placements, Under Assault, describing some of the recent efforts by states to reduce special education costs.

From Michael Bloomberg suggesting pulling students out of private placements. He cites $100M spent for 4,000 students. I had to check on what that means–it works out to $25,000 per student.

Would this really save money? Probably not:

Sweet said there’s actually very little difference between the dollars spent on private and public schools for special education students because both can easily cost more than $25,000 annually compared to about $17,000, on average, for a general education student.

EdWeek reports that a Texas lawmaker proposed charging parents tuition for state-run schools for the Deaf or Blind (a proposal that is against federal law). And Utah suggested cutting cutting schools for the deaf and blind altogether. They just forgot about the fact that deaf and blind students would still be in Utah and need an education.

Times are tough, economically. Special education is expensive. Let’s hope that few lawmakers go for the false economy of cutting special ed. It really isn’t going to give a real return.

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