The Judicial Panel on Multidistrict Litigation will meet today in St. Louis to consider creating nationwide MDLs for three fast-growing areas of product-liability litigation: social media addiction lawsuits, primarily against Facebook and Instagram’s parent Meta Platforms Inc; claims that acetaminophen use during pregnancy increases the child’s risk of autism-spectrum disorders and ADHD; and cases spurred by Exactech Inc’s recent recalls of many of its knee, ankle and hip-replacement products.
MDL No. 3043 − IN RE: ACETAMINOPHEN − ASD/ADHD PRODUCTS LIABILITY LITIGATION Dozens of lawsuits have been filed in the past year, quoting recent studies that link pregnant women’s use of acetaminophen to an increased risk of autism spectrum disorders (ASD) and ADHD in their children. In June, plaintiff Aujenai Thompson sought to consolidate 19 actions against the sellers of “store-brand” acetaminophen products for pretrial coordination or consolidation. Since then, more than 30 related actions have been filed, naming Costco Wholesale Corp, CVS Pharmacy Inc, Rite Aid Corp, Safeway, Target Corp, Walgreen Co and Walmart Inc as defendants.
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Thursday, September 29, 2022
Wednesday, September 28, 2022
In The Politics of Autism, I write:
For those who remain at larger residential institutions, the horrors of yesteryear have generally ended. In 2012, however, a ten-year-old video surfaced, showing disturbing image of an electric shock device at the Judge Rotenberg Center in Canton Massachusetts. Staffers tied one student to a restraint board and shocked him 31 times over seven hours, ignoring his screamed pleas to stop. The Rotenberg Center is the only one in the nation that admits to using electric shocks on people with developmental disabilities, including autism. Center officials said that they had stopped using restraint boards but insisted that shocks were necessary in extreme cases to prevent officials insist the shock program is a last resort that prevents people with severe disorders from hurting themselves or others.
Medical and disability leaders have worked for years to ban the use of electric shock devices for behavior modification on people with intellectual and developmental disabilities (IDD). The brutal treatment is widely recognized as cruel, harmful, and ineffective. Yet the Judge Rotenberg Center (JRC), an institution in Massachusetts for people with IDD, still subjects its residents to this extreme practice. We prevailed in 2020, but the Food and Drug Administration’s ban of the use of the device was overturned on a technicality just one year later. The Arc and our advocates have been asking Congress to put an end to this barbaric treatment in the 2022 FDA User Fee Package – and they have failed to stand up for the basic human rights of people with disabilities.
Today, Senate and House leaders announced they are moving a bill forward to fund the FDA for another five years without the ban. Initial versions of this bill that passed the House and the Senate HELP Committee with bipartisan support included the ban on the shock device. The Arc of the United States, its 600+ chapter network, and people with IDD and their families are devastated by this omission.
“This practice is torturous and a violation of basic civil rights. We will continue fighting for justice for JRC’s residents by working with our partners to get a ban into the end-of-year spending package and ensuring every single representative prioritizes the health and safety of people with intellectual and developmental disabilities,” said Peter Berns, CEO, The Arc.
Monday, September 26, 2022
Throughout the U.S., vaccination rates for polio vary significantly..
The CDC recommends that infants and young children receive a four-dose schedule of the inactivated poliovirus vaccine at 2 months, 4 months, 6 to 18 months and 4 to 6 years. For those who begin vaccination later – as older children, teens or adults – three doses is considered to be complete vaccination. This is because three doses of inactivated poliovirus vaccination have been shown to provide between 99% and 100% protection against severe disease.
Although all U.S. states are currently above the 80% herd immunity threshold for poliovirus, there are areas within the country that include many pockets of unvaccinated or undervaccinated individuals – those who have not received a total of three lifetime doses of the inactivated vaccine.
New York state, for example, holds one of the highest kindergarten polio vaccination rates in the country, with 97.9% of kindergartners vaccinated in the 2020-2021 school year. But current estimates by the New York State Department of Public Health suggest that only 79% of 2-year-olds in that state have received three doses of the polio vaccine.
Further, in certain pockets and counties of New York, such as Rockland, Orange and Sullivan, three-dose vaccination rates may be far lower based on the 2-year-old age group, which is the only data that is available by county: Rockland 60%, Orange 59% and Sullivan 62%. In fact, 46% of counties in New York are below the three-dose poliovirus vaccination herd immunity threshold for 2-years-olds
Saturday, September 24, 2022
Just four days after it was introduced, legislation to help families locate missing loved ones with Autism, Alzheimer’s disease and related conditions unanimously cleared the Senate Thursday. The bill to extend Kevin and Avonte’s Law, was introduced Monday by Judiciary Committee Ranking Member Chuck Grassley (R-Iowa) and Senator Amy Klobuchar (D-Minn.).
The original law, authored by Grassley and passed in 2018, is named in honor of two boys with autism who perished after going missing. The extension that passed Thursday continues programs established under the law to support training for caregivers to prevent and respond to instances of wandering.
“The Senate’s swift adoption of our bill honors the legacies of young Kevin and Avonte, and demonstrates our commitment to helping communities locate loved ones whose conditions cause them to wander. It’s a commonsense, time-tested bill that’s been instrumental in reuniting families – exactly the kind of policy that Congress should pass without delay,” Grassley said.
“We must do everything we can to support people who are diagnosed with Alzheimer’s, autism, and other developmental disabilities,” said Klobuchar. “Our bipartisan legislation will ensure that caregivers and law enforcement have the tools and training they need to act when these Americans go missing. Reauthorizing this bill will help families locate their loved ones, prevent tragedies and save lives. Now that it has passed the Senate, I look forward to seeing this legislation signed into law.”
The bill is named in honor of two young boys diagnosed with autism who wandered away from supervised settings and drowned. One of the two, nine year-old Kevin Curtis Wills, died in 2008 in the Raccoon River near his home town of Jefferson, Iowa. The other, high school student Avonte Oquendo of Queens, New York, drowned in NYC’s East River in 2014. Six year-old Hamza Elmi of St. Cloud, Minnesota, who was also diagnosed with autism, drowned in the Mississippi River near his home in 2015.
The bill reauthorizes an alert program to help notify communities about missing individuals with Alzheimer’s Disease, autism and other developmental disabilities. It also allows Justice Department grants to be used for state and local education and training programs to help prevent wandering and reunite caregivers with missing family members who have a condition linked to wandering. Along with Grassley and Klobuchar, the bill is also cosponsored by Sen. Thom Tillis (R-N.C.) and Senate Majority Leader Chuck Schumer (D-N.Y.). It must now be passed by the U.S. House of Representatives before it can be signed into law.
“The Autism Society of Iowa strongly supports the reauthorization of Kevin and Avonte’s Law and we thank Senator Grassley for his leadership on this important issue,” said Kris Steinmetz, Executive Director of the Autism Society of Iowa.
“The Autism Society of America applauds the introduction of a bill to reauthorize Kevin and Avonte’s Law. The law honors the memory of Kevin Willis and Avonte Oquendo, two boys with Autism who drowned after wandering from a supervised setting. This law has resulted in increased training of first responders and helped reduce the number of injuries and deaths of people with Autism due to wandering. These trainings are extremely important and must continue and be increased. The Autism Society supports Senator Grassley's leadership on this issue and stands ready to help move this bill quickly through Congress,” said Christopher Banks, President and CEO of the Autism Society of America.
“Autism Speaks strongly supports the reauthorization of Kevin and Avonte’s Law, and we are grateful to Senators Grassley and Klobuchar for their leadership in bringing this bill forward. Since its passage, Kevin and Avonte’s Law has resulted in local communities across the country receiving $10 million in critical funding for programs to reduce the dangers associated with wandering, a common behavior among autistic individuals that puts tremendous stress on families and tragically has resulted in far too many injuries and deaths. We applaud the sponsors of this legislation for their efforts on behalf of the autism community and urge swift passage,” said Keith Wargo, President and CEO of Autism Speaks.
The bill is also supported by the National Center for Missing and Exploited Children.
Read more about the original Kevin and Avonte’s Law HERE.
Friday, September 23, 2022
The National Institutes of Health has awarded a total of $100 million over the next five years to support nine Autism Centers of Excellence (ACEs). This endeavor funds large research projects to understand and develop interventions for autism spectrum disorder (ASD). Created in 2007, the ACE program is renewed every five years.
ASD is a complex developmental disorder affecting how a person behaves, interacts with others, communicates, and learns. The U.S. Centers for Disease Control and Prevention estimates that ASD affects nearly 2% of 8-year-olds in the United States.
The ACE program supports research on the diagnosis, causes of, and interventions for ASD. It also seeks to facilitate innovative and cost-effective services for people with ASD throughout the lifespan. The awards support research at individual centers, which feature collaboration between teams of experts, and at research networks, which involve multiple institutions, dedicated to the study of ASD. Each center and network focus on a specific research topic.
Each ACE will adopt a specific Plan for Enhancing Diverse Perspectives (PEDP) as part of its proposed research project. The PEDP will outline strategies to increase participation of women and individuals from traditionally underrepresented groups in the ACE biomedical, behavioral, and clinical workforce. Additionally, the PEDP is intended to increase the participation of underrepresented and underserved populations in research.
Community engagement is also a core feature of the ACE program. Each ACE will have an external advisory board that includes individuals with ASD and/or parents of individuals with ASD as members. In addition, ACE investigators will engage with the ASD community to learn about their needs and research concerns and to inform them about research findings and plans for future studies.
The ACE program is supported by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Mental Health, National Institute on Deafness and Other Communication Disorders, National Institute of Neurological Disorders and Stroke, and National Institute of Environmental Health Sciences.
Wednesday, September 21, 2022
A key question in autism policy evaluation is simple to pose, hard to answer: How do autistic people benefit? How much better off are they as a result of government action? While there are studies of the short-term impact of various therapies, there is surprisingly little research about the long term, which is really what autistic people and their families care about. As we saw in chapter 4, few studies have focused on the educational attainment of autistic youths. For instance, we do not know much about what happens to them in high school, apart from the kinds of classes that they take. One study searched the autism literature from 1950 through 2011 and found just 13 rigorous peer reviewed studies evaluating psychosocial interventions for autistic adults. The effects of were largely positive, though the main finding of the review is that there is a need for further development and evaluation of treatments for adults.
Although there is consensus in the field that individuals on the autism spectrum should receive interventions that are evidence-based, the concept of “evidence-based” is multifaceted and subject to ongoing development and debate. In this commentary, we review historical developments, methodological approaches, as well as areas of controversies and research directions in the establishment of an evidence base for autism intervention.
From the commentary:
A relevant dimension of what is tested in a trial is the distinction between efficacy trials and effectiveness trials. Efficacy studies are designed to determine whether an intervention produces beneficial effects under optimal circumstances, that is, well-controlled settings in which a variety of potential confounds are controlled for. For example, in an efficacy trial the intervention might be delivered by highly trained clinicians, with frequent fidelity checks and corrective feedback/re-training in case of low adherence to intervention protocols, often supported by University-based research grants. Additionally, participants might be selected to be homogenous across multiple dimensions, such as age, IQ, absence of specific comorbidities, availability to receive intervention at home or in a clinic for multiple hours per week, and the intervention might be delivered in research settings on top of the usual care that is normally available through community services. By maximizing homogeneity in standards of intervention delivery, participant features, and intervention features (e.g., duration, intensity), efficacy trials allow for causal inference on the internal validity of an intervention (i.e., they address the question “can the intervention work under ideal circumstances?”). The inherent limitation of efficacy trials is that participants, resources, settings, and interventionists might not resemble those in real-world settings, limiting generalizability of the results.
To address this issue, efficacious interventions should then be subject to tests of effectiveness, which measure the degree to which the beneficial effects documented in efficacy trials are obtained when the same intervention is delivered by non-University-based practitioners within normative “usual care” contexts, for example, community clinical or educational settings, and across the populations that those settings have the mandate to serve, for example, individuals who have multiple diagnoses in addition to autism. In these contexts, it is often unfeasible to assign participants to intervention conditions at random without interfering with regulatory constraints, mandates, and performance standards by which agencies are held accountable. Therefore, especially for interventions previously shown to be efficacious in tightly controlled RCT, effectiveness trials might use a quasi-experimental design (Handley et al., 2018), whereby participants are not randomly assigned to different conditions (e.g., a study comparing outcomes of two preschool programs, using children who have previously enrolled in those programs as participants; Boyd et al., 2014; Vivanti, Prior, et al., 2014; Vivanti, Paynter, et al., 2014). Although the lack of randomization in this type of studies increases the risk of bias (for example, one setting might be only accessible to more resourceful families, introducing a systematic bias), the combination of efficacy and effectiveness trials has the potential to accomplish both indication of internal validity and impact of the intervention in real world settings. Importantly, despite the previously mentioned challenges, there is a small but growing literature of effectiveness studies that use RCT designs (e.g., Kaale et al., 2012; Vivanti et al., 2019).
Tuesday, September 20, 2022
A Jackson County sheriff's deputy used his Taser on a 12-year-old autistic boy without warning as the youth sat handcuffed, shackled and hogtied in the deputy's vehicle.
The state's law enforcement oversight body says Matthew Honas on Feb. 23 used excessive force multiple times on the boy, including tying him up in a manner that threatened "his ability to breathe properly."
The Kansas Commission on Peace Officers' Standards and Training on Aug. 22 issued an order of reprimand to Honas. While Honas was discharged March 3 from his deputy's job in Jackson County, the commission chose not to revoke his certification as a law enforcement officer.
The encounter was captured on Honas' in-car camera, KSCPOST said.
Jackson County counselor Lee Hendricks rejected The Topeka Capital-Journal's open records request for the video.
Monday, September 19, 2022
In The Politics of Autism, I analyze the discredited notion that vaccines cause autism. This bogus idea can hurt people by allowing diseases to spread. And among those diseases could be COVID-19.
Unfortunately, Republican politicians and conservative media figures are increasingly joining up with the anti-vaxxers. Even before COVID, they were fighting vaccine mandates and other public health measures.
Objectives. To examine trends in partisan polarization of childhood vaccine bills and the impact of polarization on bill passage in the United States.
Methods. We performed content analysis on 1497 US state bills (1995–2020) and obtained voting returns for 228 legislative votes (2011‒2020). We performed descriptive and statistical analyses using 2 measures of polarization.
Results. Vote polarization rose more rapidly for immunization than abortion or veterans’ affairs bills. Bills in 2019–2020 were more than 7 times more likely to be polarized than in 1995–1996 (odds ratio [OR] = 7.04; 95% confidence interval [CI] = 3.54, 13.99). Bills related to public health emergencies were more polarized (OR = 1.76; 95% CI = 1.13, 2.75). Sponsor polarization was associated with 34% lower odds of passage (OR = 0.66; 95% CI = 0.42, 1.03).
Conclusions. State lawmakers were more divided on vaccine policy, but partisan bills were less likely to pass. Bill characteristics associated with lower polarization could signal opportunities for future bipartisanship.
Public Health Implications. Increasing partisan polarization could alter state-level vaccine policies in ways that jeopardize childhood immunization rates or weaken responsiveness during public health emergencies. Authorities should look for areas of bipartisan agreement on how to maintain vaccination rates. (Am J Public Health. 2022;112(10):1471–1479. https://doi.org/10.2105/AJPH.2022.306964)
From the article:
The trends we have identified can be explained, in part, by the rise and fall of controversies during this timeframe. Beginning in 1998, Democratic and Republican lawmakers alike were focused on the possibility that the mercury-containing vaccine preservative thimerosal could be linked to autism. The high frequency of bills to prohibit mercury in vaccines and to expand access to exemptions in the early 2000s were almost certainly motivated by these safety concerns.13 However, a 2004 Institute of Medicine report established the scientific consensus against the autism‒mercury hypotheses, the Lancet retracted the study that first proposed a vaccine‒autism link because of ethical and scientific concerns, and the study’s lead author, Andrew Wakefield, was removed from the United Kingdom’s registry of physicians in 2010.13,14,28
Faced with the loss of legitimate scientific arguments, leaders of vaccine-critical organizations were compelled to innovate new narratives that might resonate with blocks of potential supporters.28 In their analysis of antivaccine Facebook pages from 2009 to 2019, Broniatowski et al.17 found a decreasing prevalence of safety or efficacy concerns and an increasing emphasis on protecting individual liberty from government intrusion. This shift in emphasis from safety to parental freedom would certainly have been felt by policymakers. Legislators might strongly disagree about whether certain vaccines are safe for children, but such disagreements are not inherently partisan. By contrast, as vaccine policies became increasingly framed in terms of individual liberty versus the state, legislators might have faced mounting pressure to choose their side based on adherence to conservative or progressive views on the appropriate role of government.
Anthony Fauci, the nation’s top infectious disease expert, said in a new interview that the “anti-vaxxer attitude” of some Americans risks causing non-COVID virus outbreaks in the U.S.
“I’m concerned the acceleration of an anti-vaxxer attitude in certain segments of the population . . . might spill over into that kind of a negative attitude towards childhood vaccinations,” Fauci told The Financial Times in an interview published Sunday.
Sunday, September 18, 2022
The BBC has seen several groups, one with hundreds of thousands of members, in which the emoji appears in place of the word "vaccine".
Facebook's algorithms tend to focus on words rather than images.
The groups are being used to share unverified claims of people being either injured or killed by vaccines.
Once the BBC alerted Facebook's parent company, Meta, the groups were removed.
"We have removed this group for violating our harmful misinformation policies and will review any other similar content in line with this policy. We continue to work closely with public health experts and the UK government to further tackle Covid vaccine misinformation," the firm said in a statement.
However, the groups have since re-appeared in our searches.
One group we saw has been around for three years but rebranded itself to focus on vaccine stories, from being a group for sharing "banter, bets and funny videos" in August 2022.
The rules of the very large group state: "Use code words for everything". It adds: "Do not use the c word, v word or b word ever" (covid, vaccine, booster). It was created more than a year ago and has more than 250,000 members.
Thursday, September 15, 2022
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.
An Australian naturopath claims in a Facebook video that autism in children can be cured with therapeutic healthcare including a change of diet.
The claim is false. Experts say there is no cure for autism. Research into a possible link between nutrition and autism symptoms is inconclusive.
The claim was made by Robyn Cosford, who describes herself as a former medical practitioner and now runs the School of Divine Health.
“A lot of people think, even now, that autism is irreversible. It’s a label, a diagnosis that’s given by the medical profession and people are stuck with it, but that’s not true,” Dr Cosford said in the video (screenshot here).
“In most cases with correct nutritional biochemistry and diet and other allied therapies, in most cases you can bring these children back. You can bring them back into normal behaviour and back into life and functioning” (video mark 11min 20sec).
Tuesday, September 13, 2022
[T]he success with polio elimination had helped pave the way in the United States for development and introduction of vaccines for measles in 1963, then for such other diseases as mumps and rubella. The combined “MMR” vaccines became standard for babies in the United States.
Then trouble emerged. Some reports, though definitively discredited, gave rise to the belief in a link between vaccination and autism. When the coronavirus struck, researchers and drug companies rapidly produced safe and effective vaccines to repel several versions of the mutating Covid virus. But the other side of the vaccine-versus-virus equation – getting everyone vaccinated – was no longer so readily achieved.
Whether for politics, religion, fear of side effects, or a prioritization of individualism, some people no longer embraced the collaborative spirit that made other massive vaccination drives so successful.
The commitment to social good necessary to meet public health challenges became apparent not just in the coronavirus, but also in seemingly conquered diseases like polio. An unvaccinated adult in one of New York’s suburbs was diagnosed with the disease. Polio virus samples were detected in the city’s wastewater.
Monday, September 12, 2022
In The Politics of Autism, I analyze the discredited notion that vaccines cause autism. This bogus idea can hurt people by allowing diseases to spread. Examples include measles, COVID, flu, and polio.
Only 82.2% of kindergarteners in district-run schools had all five mandatory immunizations for illnesses such as mumps and chickenpox during the 2021-22 school year, Christina Clark, spokesperson for the School District of Philadelphia, told Axios. That’s down from an 89.9% immunization rate for kindergarteners during the 2019-20 school year. ... Immunization rates for 7th graders and 12th graders — who require additional vaccines — also dropped last year compared to pre-pandemic times, according to state data released last month.
Routine vaccination rates for Fort Worth kindergartners have dropped to worrisome lows in the last school year, with just 86% of youngsters having received the vaccines that protects against measles, mumps and rubella. Fort Worth school district officials say they are stepping up outreach, enlisting campus nurses and principals to remind families that kids need to be up to date on their shots or else submit proof of medical or conscientious exemption to the vaccine.Jerod MacDonald-Evoy at the Arizona Mirror:
The Maricopa County Department of Public Health recently announced three measles cases in the county as the state has continued to see year-over-year drops in how many children are being vaccinated against the highly contagious viral infection.
The vaccine is administered to children. In Arizona, the vaccination rates among children have been dropping every year. In some parts of the state, the number of schools with herd immunity has reached single digits.
In Maricopa County, for example, there are 876 childcare or preschool facilities. Just 517 of them — not quite 60% — meet the 95% threshold that protects children in attendance from a severe outbreak.
Other counties are far less protected. In Yavapai County, only 20% of preschool or childcare facilities are protected. The figures are even worse at elementary schools: Just 14% of kindergartens and 17% of 6th grade classrooms have community immunity. A similar trend is seen in Mohave and Gila counties.
Sunday, September 11, 2022
Giavanni Alves at the Staten Island Advance:
Gov. Kathy Hochul declared a state of emergency on Friday, following increased detections of the polio virus in New York.
The virus has been found in wastewater samples in New York City and Nassau, Orange, Rockland and Sullivan Counties.
Most recently, a sequence analysis of a sample collected from Nassau County in August was genetically linked to the first confirmed case of paralytic polio in New York, which was identified in an unvaccinated individual in Rockland County in July.
The New York State Health Department (NYSDOH) said all of the samples are cause for concern, as they reflect an expanding community spread.
Hochul’s executive order allows the state to immediately expand its network of polio vaccine administrators, affording more resources to local health departments and ramping up polio vaccinations.
The State Health Department’s goal is to increase the statewide polio vaccination rate from its current approximate 79% to 90%.
“On polio, we simply cannot roll the dice,” NYSDOH Commissioner Dr. Mary T. Bassett said in a statement. “If you or your child are unvaccinated or not up to date with vaccinations, the risk of paralytic disease is real. I urge New Yorkers to not accept any risk at all.”