Archive | Legal RSS feed for this section

Barbara Loe Fisher’s lawsuit against Paul Offit dismissed

11 Mar

If you recall, last October Wired Magazine had an article: An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All. Barbara Loe Fisher of the self-named National Vaccine Information Center took issue with a section of that article and sued Dr. Paul Offit. The complaint is here.

Ms. Fisher was suing Dr. Offit, Amy Wallace (who wrote the story for Wired) and Conde Nast Publishing (who publish Wired).

For background, you can read Respectful Insolence Suppression of speech through legal intimidation, anti-vaccine edition: Barbara Loe Fisher sues Dr. Paul Offit, Amy Wallace, and Condé Nast for libel, as well as One possible reason why Barbara Loe Fisher chose to sue Paul Offit in Virginia?

Autism News Beats “Barbara Loe Fisher: “Not a person to be believed””

SkepticBlog (Steve Novella) Another Libel Suit – This Time Against Paul Offit ,

And Terra Sigillata’s Paul Offit, Amy Wallace, and Conde Nast being sued by anti-vaccinationist

The complaint centers around this section of the Wired story:

Paul Offit has a slightly nasal voice and a forceful delivery that conspire to make him sound remarkably like Hawkeye Pierce, the cantankerous doctor played by Alan Alda on the TV series M*A*S*H. As a young man, Offit was a big fan of the show (though he felt then, and does now, that Hawkeye was “much cooler than me”). Offit is quick-witted, funny, and — despite a generally mild-mannered mien — sometimes so assertive as to seem brash. “Scientists, bound only by reason, are society’s true anarchists,” he has written — and he clearly sees himself as one. “Kaflooey theories” make him crazy, especially if they catch on. Fisher, who has long been the media’s go-to interview for what some in the autism arena call “parents rights,” makes him particularly nuts, as in “You just want to scream.” The reason? “She lies,” he says flatly.

“Barbara Loe Fisher inflames people against me. And wrongly. I’m in this for the same reason she is. I care about kids. Does she think Merck is paying me to speak about vaccines? Is that the logic?” he asks, exasperated. (Merck is doing no such thing). But when it comes to mandating vaccinations, Offit says, Fisher is right about him: He is an adamant supporter.

Ms. Fisher argued:

“If defendants are correct, Plaintiff Fisher is not a person to be believed and because her stock and trade is information and opinion derived from it, she has no business worthy of acceptance and use, honesty being the foundation of every such reliance.”

The court’s decision is online.

The decision is quite clear. Ms. Fisher has no case against Dr. Offit, Amy Wallace or Conde Nast.

In this case, the article’s quotation of Defendant Offit’s comment that Plaintiff “lies” cannot reasonably be understood to suggest, as the Complaint alleges, that Plaintiff is “a person lacking honesty and integrity . . . [who should be] shunned or excluded by those who seek information and opinion upon which to rely.” Rather, the context of the remark – in a lengthy article describing an emotional and highly charged debate about an important public issue over which Defendant Offit and Plaintiff have diametrically opposed views – plainly signals to readers that plainly signals to readers that they should expect emphatic language on both sides and should accordingly understand that the magazine is merely reporting Defendant Offit’s personal opinion of Ms. Arthur’s [Barbara Loe Fisher’s] views.

In my opinion, this case was an attempt to shut Dr. Offit up, restrict his right to free speech by forcing him into costly litigation. In my opinion, the key section of the Wired article was this paragraph:

[Dr. Offit], meanwhile, still rises every morning at 4 am and heads to his small, tidy study in a spare bedroom. Every morning, he spends a couple of hours working on what will be his sixth book, a history of the anti-vaccine movement. Offit gets excited when he talks about it.

I wish Dr. Offit well in his next book. I thank him for standing up for free speech. In my view, Barbara Loe Fisher and the organizations that ally with her are very dependent on the very right that Dr. Offit just defended. They have the ability to voice opinions which are in direct contradiction to established science. I would think they would cherish the first amendment to the U.S. Constitution.

Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.

U.S. Supreme Court to hear vaccine-autism case

11 Mar

The Supreme Court of the United States (SCOTUS) has agreed to take on a vaccine injury case. SCOTUS is an appeals court, i.e. they only hear cases that have been already heard in other courts and this case is no different, having been heard in Vaccine Court and at least one appeals court. SCOTUS only hears a fraction of the cases that are submitted, choosing cases that set important precedents to help define U.S. laws. It is also worth noting that SCOTUS tends to decide on issues involving interpretation of law. In this case, they are not going to decide whether the child in question was injured, but, ratehr, the Court is to decide if a vaccine manufacturer can be sued directly. The question posed by the family in their petition is:

Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 [“the Act”] expressly preempts certain design defect claims against vaccine manufacturers “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.” 42 U.S.C. § 300aa-22(b)(1). A-104.

The Question Presented is

Whether the Third Circuit erred in holding that, contrary to its plain text and the decisions of this Court and others, Section 22(b)(1) preempts all vaccine design defect claims, whether the vaccine’s side effects were unavoidable or not?

As noted above, the case was heard previously in the Third Circuit Court of Appeals. The plaintiffs (family) lost in that case:

We hold that the plaintiffs design defect claims are expressly preempted by the Vaccine Act. We also conclude that the plaintiffs have failed to establish either a manufacturing defect or a warning defect claim under the Vaccine Act. For the reasons discussed above, we will affirm the District Court’s grant of summary judgment in favor of Wyeth.

In other words, they were not able to prove that the had the right to bring a “design defect” claim at all, and they failed to prove if there was a manufacturing defect or a warning defect.

The SCOTUS docket is online. I found it interesting that the self-named “National Vaccine Information Center” has filed a “friend of the court” brief, with Jim Moody listed as the attorney. Mr. Moody is on the board for SafeMinds, a group active in promoting the notion that mercury causes autism, and has been active in the public relations effort to support Dr. Andrew Wakefield.

The paragraph of the Vaccine Act covering this is partially quoted in the question posed to SCOTUS above. This is from § 300aa–22. Standards of responsibility

(b) Unavoidable adverse side effects; warnings
(1) 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.
(2) For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
(A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa–23 (d)(2) of this title, or
(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).

I often read comments by parents claiming that vaccine manufacturers have zero liability. This is not accurate, as noted below (and referenced in the quote above):

(2) If in such an action the manufacturer shows that it complied, in all material respects, with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and this chapter applicable to the vaccine and related to the vaccine injury or death with respect to which the action was brought, the manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in—
(A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine under section 262 of this title,
(B) intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or
(C) other criminal or illegal activity relating to the safety and effectiveness of vaccines,

which activity related to the vaccine-related injury or death for which the civil action was brought.

In other words, if there is really the corruption many parent groups claim, the vaccine manufacturers are liable for lawsuits. But, this is a diversion as the present case before SCOTUS is not about this. As noted above, they are trying to define the question of whether the Vaccine Act precludes suits for design defect claims.

They had argued (and lost) in previous cases that the vaccine was “negligently designed because the defendant knew of a safer alternative and failed to produce it”.

As noted in a recent post by Mary Holland at the Age of Autism blog:

A three judge panel of the Third Circuit unanimously decided in March 2009 that petitioner Hannah Bruesewitz did not have the right to sue vaccine manufacturer Wyeth, Inc. to assert that its vaccine design was unsafe. [See Bruesewitz-Decision] Hannah was born in October, 1991, and received her third DPT shot on schedule on April 1, 1992. Shortly thereafter she developed “residual seizure disorder,” recognized as a Table Injury at the time, meaning that causation was presumed. “Residual seizure disorder” was deleted from the Table just one month before she filed her case. Finally, on December 20, 2002, more than ten years later, Vaccine Court categorically rejected her claim. This hardly complies with Congress’ promise in the 1986 NCVIA that awards be “made to vaccine-injured persons quickly, easily, and with certainty and generosity.” The Bruesewitz family argues that the safer acellular DTaP vaccine was long available by the time Hannah received the DPT and suffered seizures, and that her vaccine injury was avoidable had the manufacturer used this demonstrably safer vaccine design.

There is a lot of history involved in the above paragraph. Let’s start with the fact that the NCVIA (National Childhood Vaccine Injury Act) was put into place largely because of a number of claims filed about the safety of the older, whole cell, DPT vaccine. “Whole-cell” means that the pertussis vaccine component (the “P” in DPT) was made from whole pertussis bacteria which were killed. The concept of the pertussis vaccine, and the DPT vaccine in particular, as being dangerous is largely due to a study in 1981, Pertussis immunisation and serious acute neurological illness in children. That study claimed, “A significance association was shown between serious neurological illness and pertussis vaccine, though cases were few and most children recovered completely.”

Another study (in 1981) showed a significant number of temporary adverse reactions, Nature and Rates of Adverse Reactions Associated with DTP and DT Immunizations in Infants and Children.

Given Ms. Holland’s statement above (and similar statements I have read recently by others), one might assume that the removal of seizure disorders from the Table Injuries was somewhat arbitrary. This is not the case. Between the time of the 1981 study and 1995 (when seizure disorders were removed from the Table), numerous studies were performed which showed no link between DTP and seizures or other neurological injuries. One large study, published in 1994 (shortly before the Table injury was removed) is Risk of serious acute neurological illness after immunization with diphtheria-tetanus-pertussis vaccine. A population-based case-control study. They found no increased risk due to DTP in about 380,000 doses given. A more recent study (2001) The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine, concluded “There are significantly elevated risks of febrile seizures on the day of receipt of DTP vaccine and 8 to 14 days after the receipt of MMR vaccine, but these risks do not appear to be associated with any long-term, adverse consequences.”

The question before the Supreme Court is not whether the vaccine causes an injury. But, it would seem that the plaintiffs might be able to argue that the DTP vaccine resulted in more short-term adverse effects, but not that the science supports the idea that seizure disorders were caused by the vaccine.

Vaccine injury cases must be first heard in the special “Vaccine Court”. This case is no different. The decision can be found on the Vaccine Court’s website. The girl, Hannah, started having seizures after her third DPT vaccination. These progressed to a very serious seizure disorder, including times of status epilepticus (a continual state of seizures).

On April 14, 1992, Dr. Ira Bergman, a pediatric neurologist, wrote that she was entirely well until April 1, 1992 when she went for her third DPT and HiB which were given at 10:00 a.m. She did well until 12:30 p.m. when she suddenly began screaming and had a stiffening spell of her arms and legs that lasted for less than one minute. She was mildly groggy afterwards and, then, within a few minutes, was back to normal.

Her parents argued that Hannah suffered an acute encephalopathy (which is a table injury), with their expert witness defining it as ““any disease of the brain.” The Court, however, recognizes a different definition, where brain function must be depressed for a significant time. In other words, even though Hannah suffered seizures, the fact that she appeared normal, even happy, between the seizures was taken as evidence that the seizures were not the result of an acute encephalopathy.

The statement by Ms. Holland above notes the long delay between when the vaccine was administered and when the hearing was held (10 years). This is, of course, not acceptable. However, it is worth noting that it appears that the family’s attoney (Mr. Clifford Shoemaker) was not prepared when the first

1) April 1992, the third dose of DPT was administered
2) April 1995, the family filed with the vaccine court.
3) July 2001, the hearing is scheduled (for late August)
4) August 2001, the hearing is postponed at Mr Shoemaker’s request
5) February 2002, the trial was postponed again at Mr Shoemakers request
6) March 2002, the one of the family’s expert witnesses withdraws and another is unavailable to testify on the specified date. The Special Master (judge) allows the family another extension.
7) July 2002, the hearing is held. The family is requested to submit some medical information.
8) November 2002 (there appears to be a typo of 2001 here), the final reports are submitted by the Government (HHS).
9) December 2002, the claim is denied.

Could the system have been more efficient? Yes. That includes the family’s attorney and expert witnesses.

While we are talking about the expert witnesses, I realized as I read this decision that there were familiar parts. First, one regular expert witness, Dr. Marcel Kinsbourne was supposed to testify for the family. He “chose to withdraw” from the case. Another regular expert witness to the vaccine court, Dr. Mark Geier was also involved. Dr. Geier’s “expert” report left something to be desired.

First, his second report has obvious mistakes:

Petitioners filed Dr. Geier’s second affidavit, dated August 28, 2001. P. Ex. 22. In it, Dr. Geier confuses Hannah’s case with someone else’s because he refers to her death and subsequent autopsy. Hannah is still alive. Based on a meta-analysis from the Institute of Medicine (IOM), Dr. Geier concludes that DPT caused her purported encephalopathy. He also refers to the VAERS reports regarding arthritic symptoms and hepatitis and rubella vaccines. (Hannah does not have arthritic symptoms; hepatitis and rubella vaccines are not at issue here.)

His fourth report has some odd statements, including using a movie as a reference (yes, a movie):

Petitioners filed Dr. Geier’s fourth report, dated March 22, 2002. P. Ex. 33. Here, inter alia, he discusses the movie “A Beautiful Mind” as evidence that DPT can cause afebrile seizures because the lead character was administered insulin in order to cause him to have afebrile seizures which was hoped to be a cure of his schizophrenia. Dr. Geier thinks DPT lowered Hannah’s blood sugar, causing afebrile seizures.

Why use a movie? I can’t be certain, but from what I’ve heard, there is no scientific evidence that pertussis vaccines (either DPT or DTaP) can reduce blood sugar.

Dr. Geier’s testimony was not convincing:

Regarding Dr. Geier, the specialist in genetics and forensic medicine, his affidavits and report are not credible. First, being a board-certified geneticist and forensic medicine specialist does not qualify him to diagnose neurological diseases and offer an opinion as to how doctors who do specialize in neurology define “encephalopathy.” Dr. MacDonald’s testimony about the definition of acute encephalopathy is more credible than Dr. Geier’s and is well-supported in the medical literature. Hannah did not have acute encephalopathy.

Beyond that, the facts were not convincing. As noted above, the fact that between seizures Hannah appeared normal was evidence against an acute encephalopathy.

The family’s counsel also argued a “non-table” encephalopathy. However, this argument also did not prevail. The girl’s EEG’s did not indicate an encephalopathy, and the seizure activity in the EEG’s did not appear unusual for someone with epilepsy.

I do not know if the arguments the family would put forth would be different in civil court, but it doesn’t seem likely that the arguments they made in vaccine court (which has rules

Back to the present case in front of the Supreme Court (SCOTUS). Why would the Court hear this case? The Vaccine Act is a major piece of legislation. Whenever the U.S. Government (or any sovereign power) alloys itself to be sued (which is what the Act does), it is a big deal. But, this case actually involves what happens outside of the vaccine court. This affects the vaccine program, a major piece of the American public health program. The government extended protection to vaccine manufacturers by taking on liability itself. The question is how far does this protection go? A recent case (2008) from an appeals court in Georgia stated that people could sue the vaccine manufacturers for a “design defect”, contrary to the decision from Colorado that is the basis for this SCOTUS case. We have two different appeals courts with two different decisions on a very important piece of legislation. In addition, the Obama administration, through the Department of Justice, filed a “friend of the court” brief in regards to the Georgia case. The administration would like to see the “design defect” question answered before the Omnibus Autism Proceeding completes and thousands of families look to the civil courts for their next step. The Georgia case was withdrawn by the family, but the DoJ requested that the Supreme Court take on the Bruesewitz case in order to answer this question. This is perfect territory for the Supreme Court. They won’t decide if any child was injured, but they will clarify the definition of a key piece of legislation.

This case isn’t specifically about the question of vaccines causing autism. The Bruesewitz case, as argued in vaccine court, involves a seizure disorder. The impact for the many families who may be denied claims in the Omnibus Autism Proceeding is obvious: if the Supreme Court allows “design defect” claims, this will open a window for these families to sue in civil court.

Lawsuit against alternative medical practitioners Usman and Rossignal

5 Mar

A lawsuit has been filed in Chicago claiming that a child has been harmed by the treatments prescribed by Dr. Dan Rossignol and Dr. Anju Usman.

This is being reported in a story, Father of 7-year-old autistic boy says treatment harmed son. (also now on the Chicago Tribune’s website)

Doctor’s Data has also been named:

Coman also alleged that Doctor’s Data Inc., the St. Charles laboratory that performed the tests Usman and Rossignol used to justify these treatments, was negligent for using an “improper method” of testing.

We here at LeftBrainRightBrain have commented many times about the concept of “challenge” testing to “prove” heavy metal toxicity.

The suit spotlights a test often used to diagnose metal poisoning in children with autism. To conduct the test, doctors give children a chelation drug that forces the body to let go of some of the metals that exist in everyone – healthy or sick – in trace amounts. Those metals show up in urine, which is sent to a lab for screening.

In the case of Coman’s son, Doctor’s Data then compared those drug-provoked results to a reference range calculated for people who had never been given a chelation drug. Based on this apples-to-oranges comparison, Coman’s son was found to have elevated levels of lead, aluminum, tin and mercury – some with results Doctor’s Data listed in the “90% range of metal contamination,” according to the lawsuit.

According to the story, there are no comments from Doctor’s Data, Dr. Rossignol’s office nor Dr. Usman’s office.

U.S. Department of Justice opens investigation on Judge Rotenberg Center

23 Feb

The Judge Rotenberg Center (JRC) is probably the best known and most controversial special education school in the world. The JRC describes itself as:

The JUDGE ROTENBERG CENTER (JRC) is a special needs school in Canton, Massachusetts serving ages 3-adult. For 38 years JRC has provided very effective education and treatment to both emotionally disturbed students with conduct, behavior, emotional, and/or psychiatric problems and developmentally delayed students with autistic-like behaviors.

If you haven’t heard of them, you are probably wondering how they could be controversial. From the JRC website:

If positive and educational procedures alone are not effective, then after trying them for an average of 11 months, we approach the parents to suggest supplementing the rewards with a corrective (aversive) consequence for the problem behavior. If the parent approves, and if we obtain an individualized authorization from a Massachusetts Probate Court, we apply an aversive in the form of a 2-second shock to the surface of the skin, usually on the arm or leg, as a consequence each time the problem behavior occurs.

Yes. The JRC uses aversives. Not just any aversives, they use electric shocks. When I first read that it sounded like they get parental and Court approval for each shock. Not so. Children are fitted with backpacks or “fanny packs” which have control units. Children are monitored 24/7. If a staff member believes an aversive is called for, the JRC staff can remotely signal the control unit to apply a shock to the child. Children can be shocked 30 times–or more–in a single day.

A coalition of disability organizations have filed a complaint against the Judge Rotenberg Center with the United States Department of Justice.

The Department of Justice responded with a letter stating they have opened a “routine investigation”.

A letter from Nancy Weiss informing people of the investigation is below. Ms. Weiss is from the National Leadership Consortium on Developmental Disabilities and the University of Delaware.The Complaint letter, signed by 31 disability organizations, is quoted below that.

Disability advocates have cause for celebration today. In response to the September 30th letter signed by 31 disability organizations, the U.S. Department of Justice, Civil Rights Division has announced that they have initiated an official investigation of the Judge Rotenberg Center (JRC); see the Department of Justice letter attached.

I’ve been waiting to receive the official notice before announcing this exciting news for the 31 disability organizations that signed the September 30th letter and for all of the disability advocates who have been fighting for over twenty-five years to put an end to the use of electric shock, other painful and aversive procedures, seclusion, unnecessary restraint, and food deprivation as methods of behavior control. Our September 30th letter was sent to seven government agencies and three human rights organizations (see list of letter’s recipients below and the letter and addendum, attached).

The initial response of the Department of Justice was that they didn’t believe that they could take action because they didn’t believe they had jurisdiction over privately operated facilities (like the Judge Rotenberg Center) since CRIPA, the Civil Rights of Institutionalized Persons Act (http://www.justice.gov/crt/split/cripa.php) applies only to state-run (not state-funded or -licensed) institutions. I suggested to them that they consider jurisdiction under the ADA on the basis that people with disabilities are being treated in ways that are neither legal nor would be tolerated if applied to people who do not have disabilities (see my email to them below). Their letter states that they are pursuing this investigation under Title III of the ADA which prohibits discrimination against people with disabilities.

None of the other government or human rights organizations that were recipients of the letter have so far been able or willing to take action – Human Rights Watch and Physicians for Human Rights had other priorities; Amnesty International is seeking guidance through their international headquarters in London but, as has been our experience in the past, they have shown little interest. The U.S. Department of Education referred us to their efforts with regard to seclusion and restraint, which, while related and important issues, do not address the concerns about electric shock and other aversive procedures described in the letter. The Office on Disability suggested that advocates should “think about finding a way to connect this issue to regulatory compliance,” though clearly we have pursued this approach with limited success for over twenty-five years.

While it is not possible to say how long the Department of Justice investigation will take (they just chuckled when I asked this) or what the impact of this investigation will be, we know that Department of Justice investigations are customarily thorough and rigorous. I will certainly keep the 31 signing organizations and others who have expressed interest in this effort informed along the way. If you are not sure you are on that list and would like to be kept posted, just send a reply email.

If you have first hand knowledge of JRC/BRI related issues and would like to be interviewed by the Department of Justice investigators, please let me know and I will pass this on to them.

To each of you who has maintained energy for this issue over a long, frustrating and mostly unproductive battle, I am most appreciative of your continued commitment. When you think about how long these abuses have been known and generally ignored, I know you share my sense that we must have fallen down the rabbit hole. We can only keep our fingers crossed that this is the first step in righting a long history of wrongs.

With renewed hope,

Nancy

This is the complaint letter.

September 30, 2009

We are writing to ask the above Government agencies and human rights organizations to take action to put an end to the use of electric shock, other painful and aversive procedures, seclusion, unnecessary restraint, and food deprivation – all inhumane and unnecessary methods of behavior modification used in some schools and residential facilities for children and adults with disabilities in the United States. This letter is signed by 31 disability organizations concerned with the humane treatment of people with disabilities.

The attached information focuses on the practices of the Judge Rotenberg Center in Canton, Massachusetts. While there are examples of the use of prolonged seclusion and unnecessary restraint in schools and residential facilities across the country, studies prepared by government agencies and investigative reports that have appeared in the media suggest that the Judge Rotenberg Center uses these procedures as well as painful electric shock and food deprivation. According to public sources, residents of the Judge Rotenberg Center receive painful electric shocks for behaviors as innocuous as stopping work for more than ten seconds, getting out of their seats, interrupting others, or whispering1. In the view of the undersigned, the use of painful and dehumanizing behavioral techniques violates all principles of human rights. We are sending this letter to a number of government and human rights organizations. We ask that you show leadership in protecting the rights of all people in the United States by acting to put an end to these inhumane practices wherever they occur.

The type of practices against which we ask you to take action have been documented in numerous government reports and other public documents. One of the best documentations of these practices is the June, 2006 New York State Education Department report2 that noted the following concerns about the Judge Rotenberg Center (JRC):

“Students wear the GED device [the device that delivers the electric shock] for the majority of their sleeping and waking hours, and some students are required to wear it during shower/bath time. The GED receivers range in size and are placed in either “fanny” packs or knapsacks. Staff carry the GED transmitters in a plastic box. Students may have multiple GED devices (electrodes) on their bodies. For example, one NYS student’s behavior program states, “C will wear two GED devices. C will wear 3 spread, GED electrodes at all times and take a GED shower for her full self care.” (p.7)

“A combination of mechanical restraint and GED skin shock is also used to administer a consequence to students that attempt to remove the GED from their bodies. In instances where this combined aversive approach is used, the student, over a period of time specified on his or her behavior program, is mechanically restrained on a platform and GED shocks are applied at varying intervals. … An example of this is found on one NYS student’s behavior program; a consequence for pulling a fire alarm is to receive 5 GED [shocks], over a 10-minute period, while being restrained on a four-point board.” (p. 9)

Another example of these inhumane practices was documented by NPR Health Reporter Joseph Shapiro, in his book No Pity. His observations of The Judge Rotenberg Center include the following:

” … one young man got tired of picking out matching shapes on a computer screen. But his teacher demanded that he continue and pinched him on the palm for disobeying. The young man …made a guttural noise of protest and tried to get up. In a second, two staffers had thrown him face down on the floor. This only made him more agitated. Then came a squirt in the face with ammonia water. The man spent a minute on the floor, trying to move and protest, but was restrained by one staffer’s knee in his back and another’s grip on his arm.”3

The JRC website describes these practices as “intensive treatment procedures”4 but almost every national disability organization agrees that the use of painful procedures to change a person’s behavior is unnecessary, inhumane, and should be banned.5

With this letter, we ask The House Committee on Education and Labor to take legislative action to end the use of these practices. In our view the practices described in the New York State Education Department report on JRC meet the definition of torture in the United Nations’ Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment that is, “any act by which severe pain or suffering, whether physical or mental; is intentionally inflicted on a person; for such purposes as:

* obtaining from him/her or a third person information or a confession;
* punishing him/her for an act s/he or a third person has committed or is suspected of having committed;
* intimidating or coercing him/her or a third person;
* or for any reason based on discrimination of any kind;

when such pain or suffering is inflicted by or at the instigation of or with the consent or acquiescence of a public official or other person acting in an official capacity.”6

We the undersigned urge you to review the attached information which documents extensive instances of inhumane practices and take legislative and regulatory action to halt the continued abuse of children, adolescents and adults with disabilities. Through numerous pleas and campaigns, advocates have seen little action from federal, state or local regulatory agencies or the criminal justice system. These entities have been aware of the documented abuses for over thirty years. Even though there is broad professional agreement that a wide range of positive interventions are available which are at least as effective in managing dangerous behaviors, and which do not inflict pain on or dehumanize individuals with disabilities, no regulatory agency has been able or willing to act to eliminate these practices.

As a group of advocates concerned with the support of persons with disabilities, we call on these Government agencies and human rights organizations to work with us to expose and condemn these behavioral techniques, take the legislative and other necessary steps to protect the rights of people with disabilities, and bring an end to these practices.

For additional information, to discuss proposed action, or to contact the organizations below, please contact Nancy Weiss by phone: 410-323-6646 or e-mail: nweiss@udel.edu

Signed:

Alaska Youth and Family Network and YouthMOVE

Anchorage, AL

American Association on Intellectual and Developmental Disabilities

Washington, DC

Association of University Centers on Disabilities

Silver Spring, MD

The Arc of the U.S.

Silver Spring, MD

Autism National Committee (AutCom)

Forest Knolls, CA

The Autistic Self Advocacy Network

Washington, DC

Center on Human Policy, Law, and Disability Studies, Syracuse University

Syracuse, NY

The Coalition for the Legal Rights of People with Disabilities

Boston, MA

Cobb and Douglas Counties Community Service Boards

Smyrna, GA

Connecticut Council on Developmental Disabilities

Hartford, CT

Disability Rights Education and Defense Fund

Berkley, CA

Easter Seals

Chicago, IL

Exceptional Parent Magazine

Johnstown, PA

Hope House Foundation

Norfolk, VA

The Learning Community for Person Centered Practices

Annapolis, MD

The Maine Independent Media Center

Waterville, ME

Maryland Coalition for Inclusive Education

Hanover, MD

National Association of County Behavioral Health and Developmental Disability Directors

Washington, DC

National Association of Councils on Developmental Disabilities

Washington, DC

National Association for the Dually Diagnosed (NADD)

Kingston, NY

National Disability Rights Network

Washington, DC

The National Leadership Consortium on Developmental Disabilities, University of Delaware

Newark, DE

Respect ABILITY Law Center

Royal Oak, Michigan

RHA Howell, Inc.

Raleigh, NC

Self Advocates Becoming Empowered

Kansas City, MO

TASH

Washington, DC

United Cerebral Palsy

Washington, DC

Values Into Action

Media, PA

University of Medicine and Dentistry of New Jersey, School of Nursing

Newark, NJ

University of San Diego Autism Institute

San Diego, CA

The Voices and Choices of Autism

Lakewood, CO

Here is an addendum letter.

Addendum to Sept ’09 Letter from Disability Advocates – End Inhumane Practices.doc

If you can stand reading more about JRC, Mother Jones ran a story on JRC in 2007, School of Shock.

The disability advocates say it much better than I ever could. Picking but one sentence: We cannot condone treating persons with disabilities in a manner that would not be tolerated if applied to other segments of the population.

Fees for the Omnibus Autism Proceeding hit $7M

20 Feb

In the United States, the court hearings on whether vaccines cause autism were held under the Omnibus Autism Proceedings (OAP). These proceedings represented over 5,000 families who filed for consideration that they had a child who (a) suffered a vaccine injury and (b) this injury resulted in autism.

The OAP heard six “test cases”. Each test case represented both the question of whether the specific test-case child considered suffered a vaccine injury and also the general question of whether the idea that vaccines cause autism was proven.

The first three test cases considered the question of whether the MMR vaccine could cause a vaccine injury resulting in autism. The second three test case considered the question of whether thimerosal containing vaccines could cause vaccine injury resulting in autism.

The decisions from the MMR cases have been handed down, and they were unanimously and definitively against the MMR causes autism theory. These have been appealed and that appeal was denied. I believe an appeal to the U.S. Supreme Court has been either filed or planned.

The decisions in the thimerosal cases have not been handed down yet.

The OAP was a very long process, starting in 2002 and still ongoing, involving multiple law firms and many lawyers and experts. It has been an expensive process. We are slowly learning just how expensive.

Last year an interim award of over $2M in legal fees was granted for lawyers working on the Cedillo test case. That was the first case heard in the MMR segment of the AOP.

The Court has now granted an interim award of $2,300,000 for the King test case, the first heard in the Thimerosal segment of the AOP.

During an unrecorded telephonic status conference on July 1, 2009, the law firm of Williams, Love, O’Leary, and Powers (WLOP) agreed to reduce its interim attorneys’ fees and costs request from $3,101,764.84 to $2,300,000.00, including $2,070,000 in fees and $230,000 in costs. Respondent’s counsel then indicated that respondent will not object to that amount. WLOP’s reductions included: the withdrawal of time and expenses relating to direct legislative lobbying, that is, any activity relating to efforts to affect the outcome of the political process; the withdrawal of time and expenses relating to “case specific” work in cases other than this claim, and unrelated to “general causation” work on the OAP; the withdrawal of time and expenses WLOP conceded were related exclusively to civil cases outside of the Vaccine Program; and the withdrawal of time and cost claims relating to public relations and media work during the pendency of the OAP. In addition, WLOP generally reduced the fees it requested for time spent on the OAP. Finally, WLOP agreed to significantly reduce the expenses for which it sought reimbursement, particularly those costs incurred while on travel.

Let me highlight a couple of statements:

the withdrawal of time and expenses WLOP conceded were related exclusively to civil cases outside of the Vaccine Program.

and

WLOP’s reductions included: the withdrawal of time and expenses relating to direct legislative lobbying, that is, any activity relating to efforts to affect the outcome of the political process

Bold is mine.

Apparently, the law firm applied for and was denied funding for work done for civil cases that were outside of the vaccine program and for lobbying efforts. What were they thinking trying to get tack that onto their fee request? Let’s face it, the Omnibus has already subsidized any upcoming civil cases by giving the lawyers time to research their arguments and pay experts. And, really, asking the program to pay for lobbying?

This is only an “interim” fee request. Fees are still mounting, and not all the past fees have been assessed:

Of note, this Decision resolves all fees and costs requested by the WLOP firm in the King interim fees application, at Tabs A & B of that application. This Decision does not resolve the amounts requested at Tabs C through U of that application.

I don’t know how much is involved with “Tabs C through U”, but it sounds like the remaining fees could be considerably more than the $2.3M granted.

It is interesting to note that the father/son team of David and Dr. Mark Geier have expert fee requests submitted (and as yet unpaid) for this case, even though they were not called as witnesses and, to my knowledge, did not submit expert reports:

This does not resolve the vast majority of fees and expenses relating to Drs. Geier and Young. The majority of expenses relating to Dr. Geier, David Geier, and Dr. Young are included in the PSC Committee Costs, at Tab C of the initial Fee Application

The Geier’s are well known “experts” in the vaccine court. Young, I suspect, is the same person as co-authored a paper with the Geiers purporting to show a link between neurodevelopmental disorders and thimerosal in vaccines. That paper was reported to have been recieved funding “…from the Autism Petitioners’ Steering Committee of the no-fault National Vaccine Injury Compensation Program (NVICP).”

I am all for petitioners in the Vaccine Court having access to good experts. I don’t consider the Geier team to meet that standard. Should the Petitioners’ Steering Committee have decided to fund this reasearch, I see that as their expense, not one that should be passed on to the vaccine program. Dr. Mark Geier has been referred to in court documents as:

There are multiple cases where Dr. Geier’s opinion and testimony have been given little or no weight because they exceeded the scope of his expertise.

and

Dr. Geier is “a professional witness in areas for which he has no training, expertise, and experience”

I frankly suspect that funding The team of Young, Geier and Geier in this instance is another attempt to get the Vaccine Program to pay for work the lawyers expect to use in the civil cases that will follow the likely rejection of the Vaccine Court hearings. Remember, they weren’t called as expert witnesses in the Omnibus.

One other expert witness of note, Dr. Vas Aposhian, is also mentioned in the fee ruling:

This decision resolves the $34,048.25 that WLOP requested for expenses related to Dr. Aposhian ($31,750.00 in fees; and $2,298.25 in expenses incurred in May 2008). This decision does not resolve the $207,382.53 in fees and expenses included in the PSC Committee Costs for costs relating to Dr. Aposhian, nor does it resolve the $7,910 requested by Williams Kherkher for costs associated with Dr. Aposhian. See Tab C at 3887 and Tab E at 4396-98.

We don’t have the decisions from the King hearing yet, but here are some comments from the Cedillo decision:

Thus, concerning this issue [genetic hypersensitivity to mercury], I conclude that the testimony of Drs. Brent and Cook was persuasive, and that the testimony of Dr. Aposhian was not.

I find that Dr. Brent’s testimony on this point [the lack of an established mercury efflux disorder] was persuasive, and that the testimony of Dr. Aposhian was not.

I wonder if Dr. Brent, whose expertise was persuasive, will be paid anything like the roughly quarter million dollars that Dr. Aposhian has billed.

So we have $2M in fees granted for the Cedillo hearings, and now $2.3M for the King hearings. This is part of a total of over $7,000,000 requested in interim fees:

In their application, the petitioners sought a total of $7,202,653 for interim fees and costs. This total reflected the fact that this case was, as explained above, one of the “test cases” in the OAP. Because this was a “test case,” in which the petitioners sought to present all of the “general causation” evidence concerning the theory that thimerosal-containing vaccines can cause autism, several different law firms participated in the development and presentation of the evidence, while five expert witnesses prepared expert reports and testified at length for petitioners during the evidentiary hearing. The high total sought reflects the participation of all those law firms and expert witnesses.

I don’t think anyone is surprised that this is a very expensive proceeding.

Millions of dollars were spent trying to prove the now discredited (and never well supported) hypothesis of Dr. Wakefield. The thimerosal hypothesis also never had much substance, and has cost millions more.

One thing good out of all this is that the proceeding also paid to compile expert reports from some real experts debunking the MMR and Thimerosal myths.

Andrew Wakefield – I have no need of continued registration

14 Feb

In a remarkable and somewhat odd statement put out by Andrew Wakefield, he states:

I have no need of continued registration with the GMC…

Which is somewhat contrary to his statement of 2004 that;

It has been proposed that my role in this matter should be investigated by the GMC. I not only welcome this, I insist on it…

Why would someone insist upon being heard by an organisation he holds so little respect for he longer wants to be a member?

During the rest of the statement, he provides thanks to the support of his economic fan base – the parents, imcluding no doubt the parents of the children whom counr amongst the 11 counts of sticking tubes and needles into developmentally-challenged children without ethical approval, and nine counts of doing so contrary to the children’s wellbeing.

In a private email Brian Deer stated his opinion – which I share – that:

There can’t by any doubt that with four charges of dishonesty, including research and financial misconduct, that he knows he will be erased from the medical register.

Just _one_ of these substantiated charges would be enough to get a GP struck off. With the amount Andrew Wakefield has against his name it would be a small miracle if this didn’t happen and he is pre-emptively striking back at the GMC, declaring he doesn’t care if they do strip him of his right to be referred to as ‘doctor’.

I’ll leave the last words to Brian Deer, the man who single handedly brought down Andrew Wakefield:

His latest statement illustrates a more sinister aspect of Andrew Wakefield’s conduct: the mismatch between what has occurred outside the hearing and what has gone on inside. Outside – appealing to his economic base – he claims he is a victim of sinister forces – the drug industry and government and so forth – when he’s not the slightest evidence of this, (and neither have I). He was taken down by an old fashioned journalistic investigation, executed in the public interest.

And yet, inside the hearing, his behaviour was quite different. He called no witnesses whatsoever. While the prosecution called a parent who provided devastating evidence, he didn’t risk putting any of the ringleaders outside the building into the witness chair, where they could be cross-examined over how vulnerable children came to be brought to a hospital with no department or reputation for evaluating developmental disorders, and where doctors seemed all-but-entirely uninterested in the children’s futures. Nor did he put any questions whatsoever to the government’s vaccine chief, despite Wakefield supporters turning up for a much-hyped showdown. Nothing was asked, because Wakefield has nothing.

What the Wakefield project was all about was getting into the small intestines and spines of children without anybody finding out the reason. *And this is where, rightly, that project has brought him.*

Wakefield, O’Leary and Bustin

4 Feb

Below is an old post from 2007 when the Omnibus hearings were in full swing. It goes through the testimony of Professor Stephen Bustin and why it was so deadly to the MMR hypothesis. I thought now might be an ideal time to republish it.

On Day 8 of the Autism Omnibus proceedings, the MMR section of the hypothesis under examination (that thiomersal and MMR together cause autism) was examined. Just to briefly generalise about the MMR hypothesis –

It was hypothesised that measles virus (MV) from the MMR was travelling from the injection site, to the gut and then to the brain where it either a) causes autism or b) in conjunction with thiomersal causes autism. Wakefield claims to have found MV in the gut of several kids. Krigsman claimed to have replicated this work. They both used the lab of one Professor John O’Leary (Unigenetics IIRC) in Ireland.

So, on Day 8 of these proceedings Stephen Bustin came to the stand. Bustin is possibly _the_ world expert on the techniques used in the O’Leary lab that he claimed led to identifying MV in autistic kids gut and brain. The technique is called PCR. Not only does Bustin use PCR every day, he has 14 papers in the peer reviewed literature on PCR, over 8 book chapters and is personally the author of the _A to Z of Quantitative PCR._ which is considered ‘the bible’ of PCR. One of his papers has been cited over 1,000 times. Another has been cited over 500 times. He both organises and speaks at international PCR conferences (1934 – 37).

Basically, when it comes to PCR – this is the guy.

The first part of Bustin’s testimony concentrated on an explanation of PCR techniques and how these techniques were employed in a key study relied upon the week previous to make the MMR/Cedillo case: Uhlmann 2002. This paper describes the _exact process that Unigentics lab used to carry out their PCR work_ .

This is a mind bogglingly techie area so I’m going to try and stick to laypersons terms. Basically, the Uhlmann study is badly flawed. The key issues related to controls. Uhlmann (and a subsequent, as yet unpublished Walker poster presentation) didn’t use any.

a positive control is an essential control that tells you whether your assay is working, so what you would do is you would take the target that you’re interested in detecting and put it into a test tube and use your assay to detect it. If you don’t detect it, you know there’s a problem with your assay because it’s a positive control. If you do detect it, you know your assay is working. If you do this consistently each time, you know how efficient your assay is from day to day.

The positive control is simply something that tells you that your assay is okay.

Q And a negative control?
A A negative control is something very crucial. There you leave out your target, so if you don’t detect it then that means that there’s no amplification, which is what you want. If you do detect a positive in a negative control then you know there’s a problem with your assay because it should not be there, and you always get suspicious of any assay that gives you a positive result in a negative control.

So, back to Uhlmann:

Q And did Uhlmann provide the information necessary to establish whether these controls were working as expected?
A No. One of the surprising aspects of this paper is they give you very little information about how the assay was performed, about what the results actually were, and it really does not let you evaluate at all how reliable and consistent the results are.

Q Is there any discussion in Uhlmann about contamination?
A No.

Q Is this important?
A It is essential because obviously if you are trying to detect a very low copy number target and there is contamination around, and if you do not know whether there’s contamination around, then you can’t rely on your assay.

……

Q Now, did Uhlmann discuss how the RNA was handled?
A No. As I think I said one of the things about this paper is that it’s fairly unique in my experience, and it’s given no information at all about what actually was done. It actually tells you in outline what they did, where they got their samples from and that they prepared RNA, but it gives you no information whatsoever about, for example, the quality of the RNA the quantity of the RNA and how the different RNAs were extracted from different samples which they refer to.

Without being sure of how RNA is handled, it is impossible to rule out contaminants. i.e. that the samples are contaminated. And there’s more:

Q Did you also identify a mismatch between the measles virus sequences listed in the paper and the probes?
A Yes. This is, again, well, it suggests that there’s a problem with the probe design.

Q Now, regarding consistency and reproducibility did Uhlmann provide any data regarding amplification sensitivity or efficiency?
A No. I need to come back to what I’ve been saying several times now. There’s this lack of information that doesn’t allow you to evaluate this paper properly in terms of its validity.

And specifically regarding the Walker poster presentation:

….Now, as I tried to point out today I think virtually every expert in this case has referred to controls are essential. You always want controls of your samples. There’s no controls on this. So even though this is a poster presentation at the very least there should be a negative control on there to show that the PCR in the negative control hasn’t worked.

We don’t have that information. So this immediately invalidates these results because we can’t now say whether these are genuine or not because there’s no negative control there. So that’s a real problem….

Q Unless these issues are resolved would you have confidence at least in what’s been presented from the Walker lab?
A I can’t have any confidence because there’s actually no results I can evaluate without referring to a negative or a positive control, and these don’t give them to me.

So basically, Mr PCR – the guy who literally wrote the book on PCR – thinks these two things – the Uhlmann paper and the Walker poster presentation – are essentially useless.

Lets also not forget that these two items describe the exact methodology that Unigentics – O’Leary’s lab – used to state that Wakefields/Krigsmans and a multitude of private cases had MV in their samples.

Oh yeah – and as for the old crapola about the two clinical studies done thus far not repudiating Wakefield et al because the look at blood, not gut, Bustin states emphatically:

this is not an assay that is at its limits so this should be easily detectible, and it also means that if you’ve got that much measles virus in a gut sample it probably is in other cells as well and you should be able to detect it, for example, in blood.

In blood.

Turning to Unigenetics itself, as part of the failed UK litigation against MMR, Bustin was asked to look at the lab and samples that the Unigentics team had worked on. For this work he put in an astonishing 1,500 hours of work.

Now, Professor O’Leary’s own controls tell us that this should have been shifted upwards because this is much poorer quality RNA. The evidence from his own data is completely clear. There’s no such shift. This must mean that whatever this is is a contaminant that has been introduced after the sample has been formalin-fixed.

So by definition this cannot be part of the original biopsy because if it had been it will have shifted upwards.

Ouch. But the next one is a body blow to the entire MMR hypothesis.

…if you have a reference gene in that sample that is a cellular reference gene you should detect it if the RNA is of good quality.

If you don’t detect it there’s something wrong with the RNA. As Professor O’Leary’s SOP states, if we can’t detect the GAPDH we shouldn’t use the sample for analysis, which makes perfect sense.

Now, it happens that Professor O’Leary did use those samples for his analysis, and that’s why I was able to then hopefully identify what the contaminant is.

To summarise: O’Leary’s RNA was poor quality. There is no reference gene. There is something wrong with the RNA. O’Learys lab SOP (Standard Operating Procedure) states that in the events of this happening, they shouldn’t use the sample for analysis. But they did use it. They used contaminated RNA for their analysis. And Bustin has identified exactly what the contaminant was.

But first, what is _definitely not_ ?

If you detect a target that is apparently measles virus in the absence of an RT [like this one] step by definition it can’t be measles virus because it has to be DNA [measles virus does not exist as a DNA molecule]. It’s a very simple concept. At least it is to me. It’s not to everyone else.

Whatever it is that O’Learys lab is picking up in their lab tests, it cannot possibly be Measles virus. No RT step was taken:

What I immediately observed was that they had forgotten to do the RT step

No RT step means it’s DNA. Measles virus does not exist as a DNA molecule. That’s simple medical fact. Bustin later summed up:

So all of this evidence suggests very, very strongly that what they are detecting is DNA and not RNA. Because measles virus doesn’t exist as a DNA molecule in nature, they cannot be detecting measles virus RNA. They are detecting a contaminant. All of the additional evidence, from the nonreproducibility by Professor Cotter of the same samples that Unigenetics analyzed to the analysis of the data where there are discordant positives, where the negatives came up positive, suggests very, very strongly to me that there is a lot of contamination in the laboratory, which is not unusual, but they have not handled it very well in how they have troubleshot their problems.

So I have very little doubt that what they are detecting is a DNA contaminant and not measles virus, and I do not believe there is any measles virus in any of the cases they have looked at.

And just as an added kick in the teeth:

Q Now, we know that cerebral spinal fluid samples were sent from Dr. Bradstreet to Unigenetics for testing. Do the same concerns you’ve outlined here apply to that testing?
A Yes. Exactly the same concerns would apply to that.

This testimony exposes the MMR hypothesis as totally dead in the water. What a waste of time, money and health.

Elsewhere

Arthur Allen in the Huffington Post
Autism Diva

Andrew Wakefield – What happens next?

31 Jan

So Andrew Wakefield has been found proved guilty of the vast majority of the accusations against him and been found dishonest and acting irresponsibly with both the children under his ‘care’ and the not inconsiderable sums of public money he had occassion to recieve and ‘manage’.

None of this would have come as a surprise to anyone who had taken the time to carefully read Brian Deer’s thorough works on the subject. That it was a major shock to the John Stone’s and Martin Walker’s of this world tells you more about their capacity for self delusion than how shocking the findings regarding Wakefield were.

So whats next for Andrew Wakefield? Now that the official findings have been made public, the GMC must consider:

…whether those facts found proved or admitted, were insufficient to amount to a finding of serious professional misconduct. The Panel concluded that these findings, which include those of dishonesty and misleading conduct, would not be insufficient to support a finding of serious professional misconduct.

Yeah, pointless double speak aside (would not be insufficient??) the panel are basically saying that Andrew Wakefield’s behaviour could easily constitute serious professional misconduct.

So what can result from that? Brian Deer, writing in the Times Online provides a possible answer:

Lawyers have told me that any one of the more than 30 charges that were proved against Wakefield would typically lead to his being struck off. His days as a medical practitioner will soon be history…

And so what is the next step?

In the next session, commencing 7 April 2010, the Panel, under Rule 28, will hear evidence to be adduced and submissions from prosecution counsel then Dr Wakefield’s own counsel as to whether the facts as found proved do amount to
serious professional misconduct, and if so, what sanction, if any, should be imposed on his registration.

From April 7th then Andrew Wakefield will be fighting for the right to refer to himself and be referred to by others as ‘Doctor’. That will be a victory for anyone concerned with patient care in the UK.

Wakefield’s Inquisition: Abuse of the legal system and media by anti-vaccine doctor

29 Jan

As the GMC approaches a verdict on the misconduct of Andrew Wakefield, anti-vaccine sources are engaged in a concerted effort to make the “doctor” into a martyr rather than a failed researcher. It is vital to ensure that the general public is not in any way lulled into sympathy for the “doctor”.  In my judgment, the most important point to drive home is that, while Wakefield and associates play up the image of the “doctor” being persecuted for his ideas, he is the one who has persistently acted to suppress any discussion not entirely in his favor.  To that end, I have compiled the following list, complete to the best of my ability, of recorded frivolous lawsuits, libels, complaints and harassment by Wakefield and his immediate associates against his numerous critics.

3 October 1996: Wakefield files a complaint with the Broadcasting Standards Commission over a broadcast critical of his claims that MMR was associated with Crohn’s disease.

1998-2003: Nick Chadwick withholds negative results suppressed by Wakefield from the public, apparently as required while litigation was ongoing.

February 2002: Wakefield files or threatens to file complaints to  the GMC against critical colleagues. One formal complaint involved a statement made in 1997. He reportedly told government chief medical health officer Sir Liam Donaldson: “It has come to my attention that you have sought details of our studies from the ethical practices committee of the Royal Free NHS trust. I infer from this that faced with an increasingly compelling scientific case against the MMR vaccine you are seeking to discredit the scientists involved. Your attempts to interfere in the scientific process are unacceptable. Not only do you have no right whatsoever to this information without permission, but also your action has had an indirect but nonetheless profound effect upon our ability to help these desperately ill children. I am seeking advice prior to taking this issue up with the General Medical Council.”

27 February 2004: The Sunday Times and the Lancet a letter from Wakefield’s attorneys denying Feb. 20 reports that Wakefield failed to disclose conflicts of interest related to the 1998 paper, with the stated purpose “to invite you to agree promptly to publish a full apology to our client”.

November 2004: Wakefield files a lawsuit against Brian Deer and Channel 4 for libel. At around the same time, his attorneys send a letter falsely alleging that Deer “has made a formal statutory complaint to the General Medical Council against Mr Wakefield and others concerning these matters.” The letter also refers prominently to “a current Press Complaints Commission” of Brian Deer, though no such complaint is on record. The claim of a complaint by Deer is taken up by Carol Stott, and continues to circulate to the present despite repeated denials by Deer and the GMC. Curiously, a February 27, 2004 BBC article stated, “The General Medical Council is now carrying out an investigation into Dr Andrew Wakefield, the doctor who led the 1998 study.” This statement, coming only five days after Deer’s first report was published, not only weakens any suggestion that Deer directly initiated the investigation, but raises the possibility that some form of GMC inquiry on Wakefield (conceivably rising from his own past complaints against others) was under way even before Deer’s allegations were made public.

March-October 2005: Wakefield’s attorneys seek to freeze further action in the libel suit against Deer. Justice Eady “The claim form was issued on 31st March but only served on 22nd June 2005. Thereafter, it seems, the particulars of claim were served with some reluctance following prompting by the Defendants and an order of Master Rose on 27th July of this year. They eventually appeared on 10th August. There has thus apparently been a rather relaxed and dilatory approach towards litigation of a kind which is supposed to achieve vindication of reputation.” He further questions Wakefield’s motives in the lawsuit as a whole: “Claimant wished to extract whatever advantage he could from the existence of the proceedings while not wishing to progress them or to give the Defendants an opportunity of meeting the claims.”

31 January 2005: Wakefield files a second lawsuit against Deer, over content of briandeer.com, and a third against the Sunday Times and Channel 4.

29  June 2005: Cambridge Evening News receives a letter from Wakefield’s attorneys over a citation of a Brian Deer report (worded as “the article alleged…”), calling on the paper to “publish an apology”.

July 2007: Martin J. Walker initiates smears against Brian Deer.  Claims include allegation that Deer initiated GMC hearings against Wakefield.  Though Wakefield condemns Walker on 3 November 2008, Deer reports a December 2009 newsletter for Wakefield’s “network” requesting donations to pay an additional 5,500 pounds to Walker.

6 February 2009: A letter sent to Brian Deer requests that an article (published 2 days later) presenting evidence that Wakefield case histories in 1998 paper not be published: “(Y)ou appear to be considering publishing an account which covers much of the same material as is being considered by the Panel. Publication of your allegations and account at this time will give rise to serious risk that the GMC process will be prejudiced and the faimess of the hearing compromised. You also know that, at this juncture in the GMC process it would be inappropriate for Dr Wakefield to give a detailed response to you. He has denied t he allegations and gave a detailed response  over many days to the GMC Panel.”

13 March 2009: Andrew Wakefield files complaint with Press Complaint Commission, over Feb. 8 story. The key allegations are that Deer “knew that these allegations were either false or misleading, based on incomplete records – or, at the very least, open to question” and that “it was he who brought the original complaint. He therefore has an undeclared interest in its conclusions.”

20 March 2009: Andrew Wakefield files addendum to complaint over Brian Deer’s statement, “I did not lay the initial complaint against Wakefield. This allegation is a fabrication, albeit rather a small one in the MMR issue.”  Bizarrely, Wakefield presents truth of his own allegation as immaterial: “(W)hether or not Mr. Deer initiated the GMC investigation as ‘complainant’ in his letter dated Feb. 25, 2004, or acted as an ‘informant’ in an investigation already begun by the GMC, he did not disclose his own direct participation in the GMC investigation in his most recent accounts in the Sunday Times, intending to give the public the misimpression that he was acting as a neutral and disinterested reporter.“

3 July 2009: Thoughtful House release, “Press Complaints Commission Orders Sunday Times to Remove MMR journalist’s Stories on Dr. Wakefield from Paper’s Web Site”, alleges, “The PCC decision today appears to indicate there are questions about the accuracy of the Deer stories,”  despite implicit admission in Feb. 6 that Deer reported only what had been alleged by others.

9 July 2009: Second press release, “Sunday Times Defies Press Complaints Commission”, alleges that “the Sunday Times has now defied the PCC by putting the stories back online after complaining Dr. Wakefield publicly announced the PCC’s directive.”

8 September 2009: NAA press release “Offit’s Failure to Disclose Jeopardizes Swine Flu Vaccine Program” is carried by Reuters.  The stated location of “Austin, Texas”, in contrast to NAA headquarters location of Nixa, Missouri, strongly suggests that Wakefield and/or Thoughtful House are the creators of the release. The release defends Wakefield, attacks Paul Offit, and by extension attacks Dateline broadcast in which Wakefield was portrayed critically.  It includes the claim, first made in a hoax published by Age of Autism, that “Offit’s share of a royalty sale for the Rotateq vaccine to Merck is a minimum of $29 million and may approach $50 million.” Wakefield’s use of a third party to promote the hoax in September raises the possibility that he significantly contributed to the hoax itself, in which figures were inflated through an inapplicable 2007 CHOP policy and documents from a patent which preceded the one which was sold.

27 January 2009: On the day before the GMC released its first findings against Wakefield, a 104-page complaint is filed with the GMC by multiple or.  The most straightforward and prominently publicized claim is that Drs. Horton, Salisbury, Zuckerman, Pegg, and Rutter “gave false statements”. Obviously prepared long in advance, this complaint can be presumed without merit, and could easily be used as a basis for countersuits. Its greatest significance will almost certainly be as yet another obstacle to timely disclosures of findings and to further legal actions, of which US disciplinary proceedings against Wakefield and litigation against him and Thoughtful House are the most threatening to the “doctor’s” interests.

In hindsight, there are many things that were “off” about Wakefield. He relied (perhaps not wholly by his own choice) on an image of a “young maverick”, though he was in fact a well-established but not distinguished researcher with dozens of previous publications (none of which is listed in a Thoughtful House bibliography!). He earned his doctorate in 1981, at the strikingly early age of 25, yet PubMed records only 3 papers of his published before 1991. He held several formal titles at Royal Free, yet his contract stipulated that he have “no involvement in the clinical management of patients.” His previous efforts to link MMR with Crohn’s disease came very close to drawing charges of fraud (see review )  His publications in the affair show a shifting roster of coauthors and repeated changes in publishing journals. I find the path of his career (particularly his early display of apparent talent followed by surprising early difficulties) strikingly like that of artists who go on to commit forgery.

The bottom line is that the only thing necessary to stop Wakefield was for those who knew the most about his conduct to speak up before his spurious claims became cultural currency.  The best way to ensure that similar (or even worse) offenders are exposed before they do harm is to reform the courts, so that litigation is NEVER allowed to trump timely criticism among scientific professionals.

ASAN Update on Restraint & Seclusion Legislation National Call-In Day

15 Jan

I just received the following email from Meg Evans of the Autistic Self Advocacy Network (ASAN). ASAN is working on legislation to reduce seclusion and restraints within the schools. This alert calls for action next Thursday to call your representative (should you be a U.S. citizen) to support upcoming bills.

This is another ASAN Update for bloggers in the Autistic and disability rights communities. To increase support in Congress for the Preventing Harmful Restraint and Seclusion in Schools Act (H.R. 4247/S.2860), ASAN and APRAIS are asking disability rights advocates and others who favor the legislation to call members of Congress on Thursday, January 21st, and ask them to co-sponsor the bill. You can also help by reposting and distributing the announcement below.

As always, we encourage you to contact us with your comments, and please let us know if you would prefer to receive these announcements at a different address or to be removed from the list.

Best regards,

Meg Evans, Director of Community Liaison
Autistic Self Advocacy Network
mmevans@woh.rr.com

Here is the letter:

Dear Friends, Advocates and Community Members,

In one week, Congress will come back in session. The Autistic Self Advocacy Network (ASAN), in conjunction with the Alliance to Prevent Restraint, Aversive Interventions and Seclusion (APRAIS), is asking you to join us in a National Call-In Day on Thursday, January 21st to tell your members of Congress to support the Preventing Harmful Restraint and Seclusion in Schools Act (H.R. 4247/S.2860) introduced last month by Representatives George Miller (D-CA) and Cathy McMorris-Rodgers (R-WA) and Senator Chris Dodd (D-CT). This legislation would provide students with and without disabilities vital protections against abuse in schools. We are providing details on how to contact your members of Congress — please distribute this announcement widely.

WHAT YOU CAN DO:

Please call this coming Thursday and encourage your friends, family and coworkers to participate by dialing the Capitol Switchboard at 202-224-3121 and asking for your Congressional representative to Co-Sponsor H.R. 4247, and your senators to Co-Sponsor S. 2860.

To find out the names of your US Senators and Representative, click here (link to www.congress.org)
Ask for the offices of your US Senators and Representative
Ask to speak to the person working on education issues
Identify yourself as a constituent and the organization that you represent (if any)

Message: ” I am calling to urge (Senator y) to cosponsor S.2860, legislation preventing harmful use of restraint and seclusion in schools.”

Message: “I am calling to urge (Representative z) to cosponsor HR 4247, legislation preventing harmful use of restraint and seclusion in schools.”

Thanks for your advocacy. Increasing congressional support for these bills will help move them through the legislative process towards enactment. Please call on January 21, 2010 and tell your friends and family to join you. If you are interested in doing more, please e-mail us at info@autisticadvocacy.org for information about how you can arrange a meeting with your representatives to explain why this bill is essential or visit www.tash.org/aprais to learn more.

Regards,
The Autistic Self Advocacy Network and the APRAIS Coalition

← Older Entries
Newer Entries →