In Contagion, Steven Soderbergh’s dark medical thriller about a viral pandemic, Jude Law plays Alan Krumwiede, a hyperventilating, overexposed anti-science blogger who convinces his 12 million “unique visitors” not to vaccinate. He also makes millions pushing a quack homeopathic remedy, and stalks a CDC scientist, tape recorder in hand.
Sound familiar? To those us who have been monitoring the real-life Krumwiedes, it’s obvious that Law spent some serious Google time to learn the anti-vaccine talking points.
“I don’t want to list anyone in particular,” Law told a Philadelphia Inquirer reporter, when asked to cite a couple of influential anti-vaccine bloggers. “I’d rather people see it and draw on their own imagination, but yeah, I certainly looked at an awful lot of blogs, and bloggers who have been interviewed and who have made a bit of a name for themselves, who have become personalities. … I drew on a few and tried to create someone that seemed to fit that particular persona.”
I don’t blame Law for making us guess. After all, it’s not like millions of people really have to know. The universe of on-line watchdogs who keep track of this sort of thing is small compared to, say, tinikling dancers or Ed Wood fans. But then the versatile Jude Law, who has also played a Red Army sniper, robot gigolo, Confederate deserter, and a gay con man, said this:
“And yet, what was most exciting was that Steven (Soderbergh) didn’t want to judge him. He didn’t want him to necessarily be a bad guy … Maybe this guy was correct all along, who knows?”
Hey, Jude, did you see the final cut? Is there an alternative version edited for the Burmese straight-to-video market? The only way Law’s character could have been “right all along” is if Contagion Part Two reveals that the pandemic was all just a dream, and the opportunistic Krumweide’s homeopathic Chinese root saved mankind.
In what universe could Law’s character have been right all along? That’s like saying the captain in Jaws was right all along, or those zany high school kids in Nightmare on Elm Street 14 were right to investigate the strange noise coming from the abandoned slaughterhouse.
Soderbergh’s story leaves little room for ambiguity, which is the movie’s strength. It’s a morality tale for the age of the internet, when the outrageous good fortune of one con-man can slow medical progress. The last moments of the movie show that Krumweide was wrong: the virus was not man made. There was no conspiracy to sell vaccines or establish martial law. And vaccines work. Not to spoil the ending or anything.
Law’s vacuous spinning aside, I hope Contagion gets the attention it deserves. One good sign: the New York Times calls it “The most high minded disaster film ever made.” It does to Big Placebo and the anti-vaccine cabal what another Soderberg film, Traffic, did to the war on drugs, by stripping away pretense to expose the human vanity, ignorance, and wishful thinking that too often passes for what is real.
In this scene from Contagion, a paid Pharma shill lures children into an autism trap.
In yet another setback for Jenny McCarthy and her angry mob, the Institute of Medicine reports that vaccines are very safe, that they prevent diseases, and that they don’t cause autism or diabetes.
The IOM’s conclusion, which is based on 1,000 published studies, will help the U.S. Department of Health and Human Services (HHS) to administer the Vaccine Injury Compensation Program (VICP). The 800-page report covers the eight vaccines that comprise the majority of claims filed in “vaccine court”, which compensates people for alleged injuries from any of 11 vaccines.
The eight vaccines under review were for chickenpox; influenza; hepatitis B; human papillomavirus; diphtheria, tetanus and pertussis (DTaP); measles, mumps and rubella (MMR); hepatitis A; and meningococcal disease.
The news has received major media coverage. Noticeably absent is the false balance that too often derails science reporting.
“Report: Vaccines generally safe, some side effects” Associated Press – “Vaccines can cause certain side effects but serious ones appear very rare — and there’s no link with autism and Type 1 diabetes, the Institute of Medicine says in the first comprehensive safety review in 17 years. The report released Thursday isn’t aimed at nervous parents. And the side effects it lists as proven are some that doctors long have known about, such as fever-caused seizures and occasional brain inflammation. Instead, the review comes at the request of the government’s Vaccine Injury Compensation Program, which as the name implies, pays damages to people who are injured by vaccines. Federal law requires this type of independent review as officials update side effects on that list to be sure they agree with the latest science. “Vaccines are important tools in preventing serious infectious disease across the lifespan, from infancy through adulthood. All health care interventions, however, carry the possibility of risk and vaccines are no exception,” said pediatrician and bioethicist Dr. Ellen Wright Clayton of Vanderbilt University, who chaired the institute panel. Still, the report stresses that vaccines generally are safe, and it may help doctors address worries from a small but vocal anti-vaccine movement. Some vaccine-preventable diseases, including measles, are on the rise.”
“Vaccine Safety: New Report Finds Few Adverse Events Linked to Immunizations” TIME – “In a new report investigating adverse events caused by vaccines, a panel of experts says there are relatively few health problems caused by the most commonly recommended immunizations, which public health experts advise that all children receive. The conclusions, issued by the Institute of Medicine (IOM) in its latest report, “Adverse Effects of Vaccines: Evidence and Causality,” represent the most comprehensive review of the available literature on the potential side effects of eight vaccines — for mumps, measles and rubella (MMR); chicken pox; influenza; hepatitis A; hepatitis B; human papillomavirus (HPV); diphtheria, tetanus and pertussis (DTAP); and meningococcus… Of note, they conclude that there is no evidence to support a connection between the MMR vaccine and autism, as many parent groups continue to believe, spurred on by the claims of British physician Andrew Wakefield, who lost his medical license last year when his findings were found to be fraudulent. The committee’s report joins many other past studies that have come to the same conclusion that vaccines and autism are not related.”
“Vaccines are generally safe, National Academy of Sciences say” Washington Post – “Some vaccines can cause seizures, brain inflammation and other complications, but those side effects appear to be rare and there is no link between immunizations and autism or other serious medical problems, the National Academy of Sciences has concluded. In the first comprehensive review in 17 years of the scientific evidence about the safety of vaccines, a committee formed by the academy’s Institute of Medicine analyzed more than 1,000 research studies to examine persistent questions about the safety of vaccines. In the 667-page report released Thursday, the 16-member committee found convincing evidence that vaccines could cause 14 health problems, including seizures, brain inflammation and fainting, but that those complications appeared to be very uncommon. The committee also concluded there was evidence that some vaccines could cause other complications, such as allergic reactions and temporary joint pain. But the committee found that there was no link between being immunized and the most serious health problems that have raised concern, including autism and Type 1 diabetes.” “Vaccines largely safe, U.S. expert panel finds” Reuters – “After a close review of more than 1,000 research studies, a federal panel of experts has concluded that vaccines cause very few side effects, and found no evidence that vaccines cause autism or type 1 diabetes. The report, issued on Thursday by the Institute of Medicine, part of the National Academies of Sciences, is the first comprehensive report on vaccine side effects since 1994. Fears that vaccines might cause autism or other health problems have led some parents to skip vaccinating their children, despite repeated reassurances from health authorities. The concerns have also forced costly reformulations of many vaccines. “We looked at more than 1,000 articles evaluating the epidemiological and biological evidence about whether vaccines cause side effects,” said committee chair Ellen Wright Clayton, professor of pediatrics and law, and director of the Center for Biomedical Ethics and Society at Vanderbilt University in Nashville. “The big take-home message is that we found only a few cases in which vaccines can cause adverse side effects, and the vast majority of those are short-term and self-limiting,” she said in a telephone interview.”
“Vaccine-safety report should reassure doctors and parents, experts say” Los Angeles Times – “Vaccines rarely cause serious side effects, health officials say. When problems do arise, they most often occur in people with preexisting immune system disorders. The report, issued Thursday by an independent panel of medical experts convened by the Institute of Medicine — which provides independent, science-based analyses — should be used to help administer claims through the Vaccine Injury Compensation Program. That program was established in 1986 to provide financial compensation to people who were harmed by eight recommended vaccines. Vaccine safety is a highly charged issue. Fears that vaccines can cause various side effects have led to a decline in childhood immunization rates in recent years and a re-emergence of preventable infectious diseases such as pertussis and measles. “The utility of this report is enormous,” said Dr. Ellen Wright Clayton, the committee chairwoman and director of the Center for Biomedical Ethics and Society at Vanderbilt University. “Claimants and the government and the vaccine court will now have available to them the best analysis that has ever been done about the potential adverse events caused by these vaccines.””
“Report: Vaccines Are Safe, Hazards Few and Far Between” NPR – “Vaccines do come with risks for trouble, but problems are generally rare, according to a new review of the evidence from the Institute of Medicine. The independent panel considered adverse effects from eight common childhood vaccines, and found that in many cases there wasn’t enough evidence to if say there was a problem. But the committee came out loud and clear on the controversial question which drove the report. Do vaccines — such as the one against measles, mumps and rubella — cause autism? Nope. “The MMR vaccine does not cause autism,” Ellen Clayton, a pediatrician who chaired the panel, said in a media briefing Thursday. “The MMR and the DTaP do not cause Type 1 diabetes. And the killed flu vaccine does not cause Bell’s palsy, and it does not trigger episodes of asthma.” The group found convincing evidence for 14 health problems, including seizures and brain inflammation, and identified the vaccines that are linked to those problems. The panel of experts looked at both studies of whole populations, and individual case reports of adverse events.”
“Report Finds Few Side Effects for Vaccines” Forbes – “Only a small number of manageable side effects can be conclusively linked to routine childhood vaccinations, according to a report from the Institute of Medicine, a non-profit chartered by Congress forty years ago to give advice about scientific controversies. “The reassuring message of this report is we’ve looked very hard at the scientific evidence for adverse effects, and we found very few things, and the majority of things that we found tend to be very short lived and easy to deal with,” says Ellen Wright Clayton, director of the Center for Bioethics and Society at Vanderbilt Uversity and the IOM committee’s chairperson. “That’s amazing news.” The IOM’s full 667-page report can be viewed on its Web site. The 18-person committee examined 158 different potential adverse events for 8 different vaccines types, including common childhood immunizations against measles, mumps and rubella (the MMR vaccine) and pertusis (the DTaP vaccine) and newer shots like Merck‘s Gardasil and Pfizer‘s Prevnar.”
“Study: Some vaccines cause medical problems in rare cases” Seattle Times – “A high-powered scientific committee that examined the possible connection between vaccines and health problems found convincing evidence that some vaccines can cause rare adverse events in certain people, including seizures, brain inflammation and fainting. The committee also found the evidence doesn’t support any connection between autism and the MMR vaccine for mumps, measles and rubella (German measles). In most cases, the committee said, there was insufficient evidence to reach any conclusion about connections between vaccines and dozens of other serious conditions. The 647-page report, “Adverse Effects of Vaccines: Evidence and Causality,” was released Thursday. The committee analyzed more than 1,000 research reports to reach its conclusion that 14 medical conditions can be linked to vaccines in rare cases. It noted that many of these conditions are very unusual in the general population and most often occur without being preceded by vaccination.” “Report Finds Few Health Problems Tied to Vaccines” Wall Street Journal Health Blog – “Certain vaccines have been linked to rare health problems, but in general, immunizations don’t carry many side effects, an analysis of more than 1,000 studies finds. The report is by the Institute of Medicine, an independent federal advisory group. A committee including pediatricians, epidemiologists and experts in certain diseases was charged with evaluating the potential harms of vaccination, not assessing how any risks stacked up against the benefits. Still, the introduction of the report notes that the dangers of infectious disease, including death, “have greatly diminished over the past century,” in part thanks to immunization. The group says that “the evidence convincingly supports 14 specific vaccine-adverse event relationships,” including a link between the measles, mumps and rubella vaccine and fever-related seizures (which one expert previously called frightening, but benign) and the chickenpox vaccine and brain swelling and other problems.”
California is the latest state to suspend Geier’s medical license. His New Jersey license expired June 30, 2011, and hasn’t been renewed. Four other states have suspended Geier: Maryland, Virginia, Indiana, and Washington.
A preliminary hearing is set for Aug. 22 in Chicago to determine Geier’s future in that state.
Geier claims to operate nine clinics in eight states, under the name ASD Centers, LLC.
Dr. Mark Geier, the Maryland physician who chemically castrates disabled children, is still licensed to practice medicine in seven states, down from eleven. Four states have suspended or revoked his privileges since April 27, when his home state took action against him. Washington followed on May 26, then Virginia on June 9. On June 29, Indiana issued an emergency 90-day suspension, citing the Maryland action.
More states are taking action. The St. Louis Post-Dispatch reports that Illinois has scheduled a preliminary hearing on Geier’s license for Aug. 22. The story hints that the Missouri Healing Arts Board may be investigating Geier as well:
A doctor who is disciplined in another state is also subject to discipline in Missouri and Illinois. A spokesman for the Missouri healing arts board would not confirm an investigation of Geier, whose license is active.
Mark Geier and his son, David, reportedly received a standing ovation from anti-vaccine activists at May’s cult-like AutismOne conference. But few in the movement have publicly defended their actions. That stands in stark contrast to Andrew Wakefield, the disgraced UK gastroenterologist whose 1998 Lancet paper jump-started the modern anti-vaccine movement, whose defenders are vocal and vociferous.
UPDATE: Geier also holds a “telemedicine license” in Texas, which expires Nov. 30, 2012.
WUSA-TV in Washington, DC, is the oldest CBS affiliate in the country, dating back to 1949 when the station’s call letters were WOIC. Since 1985, it has been owned by the Gannett Company, the largest newspaper publisher in the country
If you didn’t know this, and just happened to tune into yesterday’s 5 pm broadcast, you might think you had stumbled onto a small market news outlet, where the reporter doubles as camera operator and green screen technician.
The story was Dr. Mark Geier’s appearance before a state administrative law board, where he is fighting to keep his license to practice medicine in Maryland. The state’s medical board suspended his license last month for medical malpractice, and allowing his son to practice medicine without a license.
WUSA’s report ignored these details. According to general assignment reporter Scott Broom, Geier’s license suspension “has all gone unexplained.” You see, the Maryland Board of Physicians “has no obligation to make its proceedings public, and they’re not doing it now.” When Broom tried to attend today’s hearing, he was asked to “vacate the room”, such was the shroud of secrecy.
Here’s what Broom doesn’t know, but should:
Physician disciplinary hearings are held behind closed doors in order to protect patient privacy.
Geier’s medical malpractice is hardly breaking news. The Chicago Tribune wrote about it here on May 4. The next day, the Washington Post ran a story which said:
The Geiers’s views, spelled out in papers and by the state Board of Physicians that suspended Mark Geier, have been discredited by the Institute of Medicine and mainstream medical science. They connect autism to the mercury in vaccines. Among the treatments the Geiers say they’ve developed is one that uses Lupron — a drug that many autism experts have called dangerous for children.
How did Broom miss that? It’s in the Washington Post, which is delivered daily to the doorstep of WUSA! And if WUSA’s weather mascot chewed up the paper that day, Broom could have Googled Geier’s name and found the same article online.
But who needs court documents and mainstream medical science when a spokesperson for the Autism Society of America is camera ready? Jeff Sell, ASA’s VP , told WUSA that Geier’s theories “hold water”, and he has no idea if they are accepted by mainstream medicine, telling the credulous Broom “Whether their treatment protocol has been worked out in a scientific way that meets the rigorous criteria of medical boards I just don’t know.”
Sell is a Texas trial lawyer whose firm worked on legal cases linking autism with vaccines, another fact that either escaped Broom or not considered important enough to mention. As a trial lawyer, Sell knows that Mark Geier’s testimony is routinely blocked by judges in vaccine cases, and that chemical castration is not the standard of care for autism in the US or any other civilized nation.
“The Geier name at one time had a lot of credibility,” Broom says in the closing minute. “(Mark Geier’s) son, David, until recently served on the state’s autism commission. But he was removed as this all unfolded in the last couple of months.” Broom has no idea why. “It’s hard to say what information we may be able to pry out of this,” says Broom, referring to Geier’s court hearing, “Because they’re closed.”
David Geier was removed from the state autism commission because the medical board says he was practicing medicine without a license, a story factually covered in the Baltimore Sun and elsewhere. The state autism commission went along with the conceit for two years, listing Geier fils as “Dr. David Geier, diagnostician” on its website.
“If there is research to back up (Geier’s) treatment, that would be valuable for the public arena,” says news anchor/ health reporter Anita Brikman.
“Yes, it’s hard to understand why the state doesn’t want this information out there.” says Broom, “on the doctor’s side or not.”
If chemical castration is a viable treatment for autism, the proof would not be found in an administrative law hearing. It would be published in numerous peer reviewed journals. And if Washington, DC residents want to know why a Maryland physician is about to lose his medical license, the answer is not to be found in a Washington, DC, CBS affiliate’s newscast about the administrative law hearing. For that you’d have to change channels.
WUSA removed the video of its newscast, and ran a correction and its mea culpahere. The money quote:
In Maryland’s Administrative Hearing process, judges have the discretion to open hearings. In this case, a request by Geier’s attorneys to open the hearing was denied.
However, to suggest the reasons for the Board’s findings against Geier are a “secret” is not accurate.
After sitting through two very boring presentations at this year’s Autism One conference, it was apparent to my colleague and I that writing about the annual anti-vaccine trade fair would be a challenge bordering on pointlessness. What could we say that hasn’t been said before?
An hour later we were standing in the lobby of the Westin Lombard, surrounded by four policeman, three hotel security guards, and a growing crowd of curious parents. And then were kicked out, for no serious reason. For me, it was deja vu all over again.
We arrived in Lombard, a Chicago suburb of 42,000, at 10 am, after a 30 minute drive from Hyde Park. That’s where my friend and colleague, Jamie Bernstein lives. She’s a graduate student at the University of Chicago and VP of Women Thinking Free, and blogs at Hug Me I’m Vaccinated. This was Jamie’s first AutOne conference, and she wasn’t sure what to expect.
We walked down narrow hallways packed with exhibitor tables before heading to the Grand Ballroom for the disgraced UK gastroenterologist’s 10 am talk on Münchausen Syndrome by Proxy. When he walked to the podium, the magical sparks from his boyish grin, amplified by two giant flat screens, convinced 1,000 grateful parents to leap to their feet and applaud the man whose fraudulent 1998 Lancet article resuscitated the modern anti-vaccine movement. Wakers, as he is known, spent the next hour sharing the sad tale of corrupt doctors, clueless social workers, and the brave parents of five autistic children in a case Wakefield calls “The Arizona 5.” The story first surfaced last fall, when Wakefield promised a giant December rally to focus the nation’s attention on the anti-vaccine movement’s “Rosa Park’s moment.” The rally fizzled, Rosa’s bus route stopped short of Crazy Town, and the Arizona 5 slipped down the memory hole.
Chicken Tenders, Pizza, and ThinQ® Energy Drink still life by Jamie Bernstein
While Wakefield spoke, the efficient and polite Westin staff set up folding tables with white linen and gleaming metal trays of chicken strips and pizza, with a frozen dessert treat, coconut milk and a fruity energy drink in a solid metal container that could safely store nuclear waste. The chicken strips had a faint, chemical aftertaste that reminded me of novocaine, and my fudgesicle tasted like wheat germ. But the coconut milk, served in a juicebox, was delicious. So far, lunch was the big story. I started to look at my watch.
Jenny hit her mark at 11:45, all curls and smiles. She told a touching story about Evan’s love of escalators, and long hours spent at the local mall, just your average single mom and her special needs child. Then she introduced her friend and spiritual guru Katie Byron, a silver-hair matron with a penchant for long pauses and thousand-yard stares which she used to great effect as she plumbed our deepest fears. She started by walking her audience through a questionnaire that read like a Mad Lib for the terminally melancholy. Examples: I am ______ with _______ because _____________ . I want _____ to _________ . She invited audience members to read their Mad Libs aloud while McCarthy held a mic, Phil Donohue style, which made me think Byron was auditioning for her own Oprah Network talk show. My suspicion was soon confirmed when Byron invited an audience member to sit with her on a generic talk show set – two comfortable chairs facing one another, every word streamed live on the internet. For two mind-numbing hours. This was McCarthy’s keynote address: a visit with her shrink, who isn’t a doctor but wants to play one on TV. The grand ballroom was emptying fast. When the session had mercifully ended, half the seats were vacated.
McCarthy made one more appearance to thank everyone for coming, and to introduce a familiar 20-minute video which homologously recombined into the movement’s tinikered DNA about three conferences ago. Jenny on Oprah, Jenny on Dr. Oz, Jenny on Good Morning America, Jenny leading her angry mob in another grand ballroom.
We decided it was time for a cup of coffee, and walked to a nearby Starbucks where Jamie and I talked about what we had see. Jenny made no mention of vaccines, and one parent whose Mad Lib read “I am angry with the pharmaceutical companies because they hurt our children” was talked down from her ledge by Katie Byron. Was this Jenny’s way of distancing herself from the craziness? Did we just witness the first step of McCarthy’s 12-step career recovery process? Jamie was skeptical, but that comes with the territory when you are a Woman Thinking Free. Still, I saw no clear theme to this year’s conference. Just speculation and finger pointing, which I can’t do without paying royalties to Generation Rescue.
We finished our lattes and walked back to the Westin. It was raining, and we probably looked pathetic when we reached the lobby a few minutes later. I felt bored and anxious, more eager to get back home than to revisit the vendor tables. We were on time for a talk on “Cannabis and Autism”, but Jamie and I thought that was just too depressing. If we waited 90 minutes we could catch Mark Blaxill and Dan Olmsted talk about their anti-vaccine book which rocketed to number five million on the Amazon sales charts. Did we want to do that? The thought of killing time in the gauzy, bordello-themed Generation Rescue salon did not appeal to either of us.
As we entered the l0bby I saw two women staring at us with a look of low-grade panic on their faces. I knew right away we had been spotted. Obviously a “be on the lookout” had been issue for two heretics. The women quickly turned and walked to the registration desk, where an animated conversation ensued. The women looked at us, then looked quickly away.
“We been spotted,” I said to Jamie, as we continued to walk toward the exhibit areas at the back of the lobby. We stopped near a hyperbaric oxygen tank display. I wondered if it mattered to anyone that a recent paper co-authored by Wakefield found no benefit from HBO for the symptoms of autism. So little of what I had seen and heard made sense.
Then Jamie took her 35mm SLR digital camera out of her handbag and snapped a picture of an HBO poster. Seconds later the conference organizer, Teri Arranga, walked up to us. She was all business. “There is no photography allowed here,” she said. To prove her point, Teri sent a volunteer to bring back one of the many signs posted throughout the area that said “No video or audio recording allowed.”
Jamie pointed out, politely and correctly, that a 35mm camera which only takes still pictures is not a video or audio recorder. No problem: Arranga had a sign for that too, and sent her volunteer to fetch it. We were soon joined by two hotel security guards, then four uniformed Lombard police officers. The “no still cameras allowed sign” was never produced, but it didn’t matter. After much scurrying about and conferring with persons unseen, a visibly upset Arranga had made her decision – we had to go.
Arranga had an answer for that – the registration rules posted on the AutismOne website, which she read verbatim in a quavering voice. First, Autism One had the right to deny registration to anyone for any reason. I had registered in March, paid my $25 with a credit care, and received confirmation via email. Jaime was also pre-registered, and had a name badge ready at the registration desk that morning. The second part said that the conference organizers could ask someone to leave if their conduct interfered with the other attendees. “How is our conduct interfering,” I asked Arranga. She had no answer.
We were warned that if we returned we’d be charged with trespassing, then were led, Dead Man Walking style, to the front door. On the way out we passed David Geier, accused by the Maryland Board of Physicians of practicing medicine without a license. He was standing behind the ASD Centers table, expressionless. One day the police will come for him, I thought. But not today.
According to US Department of Health and Human Services rules, research on human subjects is subject to prior approval by an Institutional Review B0ard (IRB). Pace University has two IRBs, according to the DHHS’s Office of Human Research Protection database. “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.”
IRB approval for research on human subjects, even studies that only administer an autism screening questionnaire, is a universally-accepted ethical standard, with the exception of rogue nation states such as North Korea, Libya and Somalia.
According to the Pace University Institutional Review Board (IRB) website, “The IRB was established to protect the rights and privacy of human participants in research that is conducted by members of the Pace University community – faculty, students, and staff – and by external parties who wish to conduct research on any Pace University owned and/or operated site.”
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.”
“If an investigator believes that his/her project qualifies for exemption, he/she should submit one copy of the completed signed Proposal Form (included in application packet) and associated materials. A designated member of the IRB must “concur” that the project qualifies for exemption. An investigator cannot exempt him/herself.”
Conte did not respond to an email asking if EBCALA sought IRB approval for its study. A call to EBCALA’s Brooklyn office was not returned. There is no mention of an IRB in the study.
Rubenstein distanced Pace Law School or Pace University from the study, and said her office would have no further comment on the article. “Pace had no participation in the paper. Pace Law students assisted with legal research of the vaccine court decisions and creating an objective database of the case holdings and facts, but neither Pace Law School nor any of our students had anything to do with the article or its findings or conclusions nor do we express any opinion on the article or its findings.”
In another email, Rubenstein wrote “It is accurate to say that the ARTICLE, which was published in the Pace Environmental Law Review, found that some of the children compensated by the vaccine court had autism.” She ended her final email with “I’m afraid I cannot answer any more questions about this. I’ve told you everything I know.”
Curiously, the Birt Center authors acknowledge Pace’s assistance in the study in language that cleared peer review:
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.
Under the heading “Subsequent Investigation”, we find this:
The authors began a research project with Pace Law School students to locate and analyze VICP cases assessing whether the VICP had in fact compensated vaccine-induced brain damage, including autism, while perhaps not using that term specifically.
And on the next page:
The authors, with the assistance of Pace Law students, created a database of VICP published decisions that used relevant terms related to autism.
EBCALA also partnered with Pace Law School to undertake a study of the Vaccine Injury Compensation Program of the Court of Federal Claims.
A press release issued by the Center for Personal Rights prior to last Tuesday’s EBCALA press conference claimed that Pace’s involvement went even deeper. Its headline read:
Major Law School to Join Autistic Children, Parents and Activists to Announce Historic First Study that Links Vaccines and Autism.
The Center for Personal Rights sponsored last year’s anti-vaccine rally in Grant Park that featured disgraced UK gastroenterologist Andrew Wakefield. Wakefield lost his medical license last year for, among other things, performing autism research without ethical approval.
Established in 1982, the Pace Environmental Law Review (PELR) was one of the first scholarly environmental law journals. It is run by Pace Law School JD candidates. PELR adopted a peer-review process two years ago to select articles for publication. According to the Pace Law spokesperson, submissions are reviewed internally, and then forwarded to academics, practitioners, and experts in the field, including members of Pace Law School’s faculty.
Peer reviewers have “wide discretion in selecting articles for publication,” according to the school’s website. Optional criteria for article review include such questions as “Does the author demonstrate a comprehensive knowledge of the subject matter being discussed?”, “Has the author sufficiently supported his arguments?”, “Is there any part of the article that is purely speculative?”, and “Were sound scientific research methodologies employed?”
The Birt Center study has come under withering criticism from science bloggers and others.
“The authors are trying to stretch the definition of ‘autism’ to include whatever they might like,” writes an academic researcher at Photon in the Darkness. “The reason that the DSM-IV (and, presumably the DSM-V) require a certain number of behaviors or findings in each category to qualify as a diagnosis of ‘autism’ or ‘pervasive developmental disorder’ is precisely to make a distinction between ‘autism’ and ‘autism-like symptoms.’”
Activists from an anti-vaccine law center told nine Capitol Hill staffers today that the purported connection between vaccines and autism is a national problem that Congress needs to address.
Mary Holland, Lou Conte, and Lisa Colin of the Elizabeth Birt Center for Autism Law and Advocacy (EBCALA) hosted the briefing, after they released a study Tuesday which claimed the US government has been secretly compensating cases of vaccine-induced autism for over 20 years. The paper was published in the Pace Environmental Review, a student publication associated with Pace Law School. The study claims that Pace students and faculty helped with the investigation. Pace Law School says the study was peer reviewed prior to publication.
The paper’s authors held a press conference Tuesday in front of the US Federal Court of Claims, where lawsuits claiming vaccine injury are decided under a 1986 federal law called the Vaccine Injury Compensation Program.
The major push from Holland and her colleagues for Congressional action and review into VICP follows recent devastating setbacks for the anti-vaccine movement. They include:
A US Supreme Court ruling in Bruesewitz v. Wyeth which preempted all design-defect claims against vaccine manufacturers outside of vaccine court.
An action by the Maryland Board of Physicians this week which suspended the license of Mark Geier, a geneticist and leading figure in the anti-vaccine movement who treats autistic children with a chemical castration drug.
The continued disgrace of Andrew Wakefield, the UK gastroenterologist whose fraudulent 1998 Lancet article is now publicly tied to vaccine rejectionism.
A measles outbreak in Minnesota over the winter which is tied to fear of vaccines spread by Wakefield and others
The favorable publicity surrounding several books, released over the last six months, which are heavily critical of the anti-vaccine movement.
Meanwhile the Executive Branch stands behind HHS and the CDC, two powerful federal agencies that rely on best available scientific evidence to defend the vaccine program against misleading information and outright propaganda.
Of the nine staffers in attendance at today’s briefing, half were junior colleagues. They represented Rep. Charlie Rangel (D-NY), Sen. Richard Blumenthal (D-CT), Sen. Kirsten Gillibrand (D-NY), Rep. Michelle Bachmann (R-MN), and Sen. Olympia Snowe (D-ME).
Robert F. Kennedy, Jr., a Pace law professor, had scheduled his own press conference in front of the White House on April 11 to talk about the study, but cancelled the event. A spokesperson for the law school said Kennedy cancelled because the study was still being reviewed for publication.
Tuesday’s EBCALA press conference, which was held in front of the US Court of Claims, has been largely ignored by news media. One exception is Fox News, where Alyson Camerota characterized the study as “a major investigation.”
In a Wednesday report, the Boston Fox affiliate mischaracterized today’s briefing as “a Congressional hearing.”
New research published today in the American Journal of Psychiatry shows a 1:38 autism prevalence in South Korea – more than twice what was found in a much quoted but less rigorous 2006 CDC study. Two-thirds of the Korean children diagnosed with an ASD had no previous diagnosis, and were attending mainstream schools with no special services.
“The study’s primary message,” says Dr. Bennett Leventhal, one of the study’s authors, is that “if you really go look carefully amongst all children everywhere, you find that things are far more common than you previously expected.”
Under the leadership of Yale psychiatrist and epidemiologist Young-Shin Kim, all children were screened with surveys distributed to both parents and teachers, and then evaluated using comprehensive diagnostic assessments. Unlike the CDC study, which analyzed records and registries, the researchers in Korea attempted to look at each child in every school, even those who did not have a record of any special education need. This method unmasked cases that could have gone unnoticed to epidemiologists relying on a records-based approach.
The researchers estimated that the rate of autism spectrum disorder is as high as 2.6 percent among school-age children, equivalent to 1 in 38 children. The study “Prevalence of Autism Spectrum Disorder in a Total Population Sample,” reports on 55,000 children ages 7 to 12 years in a South Korean community. These children include those enrolled in special education services and a disability registry, as well as children enrolled in general education schools.
“While this study does not suggest that Korean children have more autism than other populations or that a more accurate rate for the U.S. is closer to 2.64 percent, it does suggest that autism may be more common than previously thought,” said Roy Richard Grinker, GW professor of anthropology and international affairs and member of the study’s research team. “This research powerfully demonstrates that the methods one uses to study prevalence will profoundly influence the estimate.” Grinker is the author of Unstrange Minds: Remapping the World of Autism.
To date, researchers have not found a difference in the way ASD is expressed in children around the world, but certain cultural factors may affect diagnostic practices and prevalence estimates. Therefore, this study took a comprehensive and anthropological approach to mitigate potential cultural bias. Parent and teacher focus groups were conducted to identify local beliefs that might influence symptom reporting and other misunderstandings. Additionally, the diagnostic tools were also translated, back-translated and validated for Korean children and only best-estimate clinical diagnoses were reported. Furthermore, each diagnostic team was composed of Korean diagnosticians with extensive clinical and research experience in both the U.S. and Korea and a random sample of diagnoses was validated by North American experts.
The team considered that more Korean children with ASD may be found in mainstream education settings based on the design of the Korean educational system. In these settings, instruction is highly structured with significant behavioral regulation across a longer school day – often more than 12 hours long, with 5-6 days of instruction each week and extracurricular academic tutoring at off-site academic institutes. This structure may help children with ASD to function at various levels in the Korean general population while not receiving special education services.
The researchers emphasized that this study is further evidence that autism transcends cultural, geographic and ethnic boundaries and that autism is a global public health concern, not limited to the Western world. Additionally, they highlighted that appropriate translation and adaptation of the gold-standard assessment methods used in the U.S. and other English-speaking countries can reliably diagnose autism in other languages and cultures.
This research was primarily funded by a pilot research grant from Autism Speaks with additional funding from the Institute for Ethnographic Research, part of GW’s Columbian College of Arts and Sciences. In addition to this study, Autism Speaks is supporting similar efforts epidemiological research efforts in India, South Africa and Taiwan.